VDA6
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Verband der Automobilindustrie
Quality management in the automotive industry QM system audit
Part 1
Based on DIN EN ISO 9001 and DIN EN ISO 9004, Part 1
4th Revised Edition, 2nd Printing 2003
1
QM system audit
Based on DIN EN ISO 9001 and DIN EN ISO 9004, Part 1
4th Revised Edition, 2nd Printing 2003
Verband der Automobilindustrie e.V. (VDA)
Non-binding VDA Standard recommendation The Association of the German Automotive Industry (VDA) recommends its members to apply the following standard for the implementation and maintenance of quality management systems. Exclusion of Liability VDA volumes are recommendations available for general use. Anyone applying them is responsible for ensuring that they are used correctly in each case. This VDA volume takes into account state of the art technology, current at the time of issue. Implementation of VDA recommendations relieves no one of responsibility for their own actions. In this respect everyone acts at their own risk. The VDA and those involved in VDA recommendations shall bear no liability. If during the use of VDA recommendations, errors or the possibility of misinterpretation are found, it is requested that these be notified to the VDA immediately so that any possible faults can be corrected. Referenced standards The quotations from standards identified with their DIN number and issue date are reproduced with the permission of the DIN Deutsches Institut für Normung e.V. The version with the latest issue date, available from the publishers Beuth Verlag GmbH, 10772 Berlin, is definitive for the use of the standard. Copyright This publication including all its parts is protected by copyright. Any use outside the strict limits of copyright law, is not permissible without the consent of VDA-QMC and is liable to prosecution. This applies in particular to copying, translation, microfilming and the storing or processing in electronic systems. Translations This publication will also be issued in other languages. The current status must be requested from VDA-QMC.
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ISSN 0943-9412 Copyright 2000 by Verband der Automobilindustrie e. V. (VDA) Quality Management Center (QMC) D-61440 Oberursel, An den Drei Hasen 31 www.vda-qmc.de
Printed and published by: Druckerei Henrich GmbH D-60528 Frankfurt am Main, Schwanheimer Str. 110 Printed on chlorine-free bleached paper
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Foreword to the 4th Edition Quality assurance has a new dimension today - it covers and integrates all divisions of the organization in its vertical and horizontal structures (crosssectional function). Quality assurance has become an interdisciplinary key function (cooperation of all involved divisions at the right time) and therefore has a decisive influence on the organization's result. Shorter model cycles and development times, greater international competition and increasing cost pressure, new organizational forms (just in time), greater expectations placed on products and stricter product liability all demand highly effective quality assurance systems (quality management systems) in all areas of the automotive industry among automotive manufacturers as well as their suppliers. In order to do justice to this development, a working circle of the VDA/DGQ specialist group "Quality Control in the Automotive Industry" has drawn up a questionnaire on quality management system evaluation based on DIN EN ISO 9004 (Edition 5/90) which was published with the first edition in 1991. VDA Volume 6 very quickly received a good response both within and outside the automotive sector and on an international level. Practical experience has shown that this publication is not only suitable for the preparation of internal audits, but also represents an excellent aid to preparation for certification. The practical experience of auditors led to the volume being revised and defined in more precise terms as a second edition (12/92). Thus, simplified operation and a uniform assessment method were achieved. The new edition of the standard series DIN EN ISO 9000 (Edition 8/94) made revision of the second edition necessary. The 3rd Edition also includes requirements from the guidelines EAQF/94 (France) and QS-9000/95 (America). This allows comparison of the audit results. Furthermore, certification notes were incorporated.
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In the 4th Edition further corrections and up-dates were included. Comments from the users and the auditor’s symposia were considered (see Para. 12.1). The element Z1, so far only required for organizations with international business activities, now has to be considered generally during audits/certification. In order to make the decision on the issuance of a VDA 6.1 certificate supplement even more definite certain questions which are particularly important for product and process and for which noncompliance could lead to the failure of the quality management system have been specially identified. These questions lead to determined consequences during the overall evaluation, see Para. 3.3.3. and 3.3.4. DIN EN ISO 9001 (Edition 8/94) was used as the basis for the Quality management system audit which describes a comprehensive system of industrial quality management with its elements. Questions were formulated from the requirements profile of this standard relating to the explanation of a quality management system, together with specific requirements from DIN EN ISO 9004 (Edition 8/94) and supplemented with the practical experience of the automotive industry. In contrast to the standard which treats the same subject matter partially in various places and varying depth the questionnaire in this publication normally contains the subject matter only once in order to, as far as possible, avoid the repetitions contained in the standard. The 4th Edition 2003 is identical in content to the 2000 edition but with updated references and terminology according to ISO9001:2000. Quality and quality management problems are predominantly not of a purely technical nature, but often related to management, organization and structure. The questionnaire is therefore divided into the following two parts: - M Management of the organization - P Product and Process. Since the organization management and the lower management levels have a decisive influence on the definition, implementation and monitoring of quality assurance, its incorporation is the fundamental requirement of the standard. This is expressed in the structure of the questionnaire and is taken into account in the questions accordingly. The questions are therefore to be answered by the person responsible for the particular division of the organization. 6
This VDA Volume represents a supplement to those volumes already published and serves the evaluation of quality management systems under comparable conditions. It is intended to help identify weaknesses, to remedy them through corrective actions and thereby continually improve the organization's productivity. The aim of this work is to unify the necessary audits in order to reduce the workload for the auditor as well as for those to be audited. Vehicle manufacturers and suppliers agree to mutually recognize, as far as possible, audits carried out on the basis of this uniform questionnaire and evaluation system for rationalization reasons. Recognition of the system-related audit allows concentration on more specific product- and process-related audits. The Quality Standard of the German Automotive Industry encompasses further types of audit, which are described in the following VDA volumes. QUALITY STANDARD OF THE GERMAN AUTOMOTIVE INDUSTRY (VDA 6) QM system audit
VDA 6 Part 2
VDA 6
VDA 6 Part 1
Quality audit fundamentals
VDA 6 Part 3
Process audit
VDA 6 Part 4
QM system audit Production equipment
Certification requirements
VDA 6 Part 5
QM system audit Services
Product audit
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Our thanks go to the following companies, in particular to the employees involved, for their participation in the preparation of this document: -
Audi AG, Ingolstadt Adam Opel AG, Rüsselsheim BMW AG, Munich BOGE GmbH, Eitorf Robert Bosch GmbH, Stuttgart DaimlerChrysler AG, Stuttgart DNV (Det Norske Veritas Zertifizierung GmbH, Essen DQS (Deutsche Gesellschaft zur Zertifizierung von Qualitätssicherungssystemen mbH), Frankfurt, Berlin Edscha Gruppe, Remscheid FORD-Werke AG, Cologne General Motors Europe, Zurich GLYCO-Metall-Werke, GLYCO B.V. & Co. KG, Wiesbaden Happich Fahrzeug und Industrieteile GmbH, Wuppertal Hella KG, Hueck & Co., Lippstadt ITT Automotive Europe GmbH, Frankfurt Keiper Recaro GmbH & Co., Remscheid Lemförder AG & Co., Fahrwerktechnik Lemförde Mahle GmbH, Stuttgart Mannesmann Sachs AG, Schweinfurt Siemens VDO Automotive AG, Babenhausen Pierburg AG, Neuss Dr. Ing. h.c. F. Porsche AG, Stuttgart Siemens VDO Automotive AG, Würzburg SKF GmbH, Schweinfurt Teroson GmbH, Heidelberg TRW Fahrwerkssysteme GmbH & Co. KG, Düsseldorf WABCO Standard GmbH, UB Fahrzeugbremsen, Hannover Volkswagen AG, Wolfsburg YMOS AG, Obertshausen.
Thanks are also due to all who have provided suggestions for improvement as well as those organizations represented in the editorial circle. Frankfurt/Main, February 2003
VERBAND DER AUTOMOBILINDUSTRIE E. V. (VDA)
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Contents
Page
1
Introduction
2
Quality management system according to the DIN EN ISO 9000 Series 15 Explanations to DIN EN ISO 9004 (Edition 8/94) Quality Management and Quality System Elements, Part 1: Guideline 15 Quality Assurance Model (according to the introduction to DIN EN ISO 9001) 16
2.1
2.2
13
3 3.1 3.2 3.3 3.3.1 3.3.2 3.3.3 3.3.4 3.4 3.5 3.6 3.7
Quality Management System Audit General Selection of the Quality Elements and Relevant Questions Evaluation and Rating Individual Rating of Questions and Quality Elements Overall Rating of Audit Result Grading for Customer/Supplier Audits (2nd Party) Awarding of the VDA 6.1 Certificate Supplement (3rd Party): Summary of Results Close out Meeting and Report Corrective Actions VDA 6.1 Certificate
4 4.1 #3.1.2
Terms and Definitions 27 Terms relating to quality according to ISO 9000:2000 (extract) 27 Requirement 27
4.2
Terms relating to management according to ISO 9000:2000 (extract) Quality management system Quality policy Quality management
27 27 27 28
Terms relating to organization according to ISO 9000:2000 (extract) Organization Organizational structure Customer Supplier
28 28 28 29 29
#3.2.3 #3.2.4 #3.2.8 4.3 #3.3.1 #3.3.2 #3.3.5 #3.3.6
18 18 19 20 20 22 23 24 25 25 25 25
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4.4 #3.4.1 #3.4.2 #3.4.5 4.5 #3.6.5 4.6 #3.7.4 4.7
Terms relating to process and product according to ISO 9000:2000 (extract) Process Product Procedure
29 29 30 30
Terms relating to conformity according to ISO 9000:2000 (extract) 31 Corrective action 31 Terms relating to documentation according to ISO 9000:2000 (extract) 31 Quality manual 31
#3.8.1 #3.8.2 #3.8.4 #3.8.5
Terms relating to examination according to ISO 9000:2000 (extract) Objective evidence Inspection Verification Validation
4.8 #3.9.1 #3.9.5
Terms relating to audit according to ISO 9000:2000 (extract) 32 Audit 32 Audit findings 33
4.9 4.9.1 4.9.2 4.9.3 4.9.4 4.9.5 4.9.6 4.9.7
Additional Terms (Definitions for the present volume) System Method Serial Production Quality Management (QM) Procedures Work Instructions (Test and Inspection Instructions) Unit Service
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Cross-reference List of Paragraph Numbers for Corresponding Subjects (according to DIN EN ISO 9000-1, Appendix D, 1994-08), supplemented by ISO 9001:2000* 35
6
Structure and Number of Questions per Quality Element
10
31 31 32 32 32
33 33 33 33 33 34 34 34
37
7 01 02 03 04 05 06 Z1 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 8
Quality Management System Audit Questionnaire Management Responsibility Quality management system Internal Quality Audits Training Financial Considerations regarding Quality Management Systems Product Safety Corporate Strategy Contract Review, Quality in Marketing Design Control, (Product Design and Development) Process Planning (Process Development) Document and Data Control Purchasing Control of Customer-Supplied Product Product Identification and Traceability (Process Control, Inspection and Test Status) Process Control Inspection and Testing (Product Verification) Control of Inspection, Measuring and Test Equipment Control of Nonconforming Product Corrective and Preventive Action Handling, Storage, Packaging, Preservation and Delivery Control of Quality Records Servicing, (After Sales, Post-production Activities) Statistical Methods
39 40 48 58 63
129 137 147 153 159 163 169 175 181 187
Forms for the Quality Management System Audit - tangible products -
191
71 75 81 87 93 101 111 117 125
9 9.1
Literature 199 VDA-Series "Quality Management in the Automotive Industry": 199
10 10.1 10.2 10.3
Agreement with Industrial Associations Introduction Summary of the National Associations International Agreement on Mutual Recognition
203 203 203 204
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Notes on a Certification according to VDA 6.1
206
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12 12.1 12.2 12.2.1
12.2.2
Appendix Changes of the 4th Edition compared to the 3rd Edition Comparison Tables Comparison Matrix VDA 6.1 / DIN EN ISO 9001 a) DIN EN ISO 9001:1994 b) ISO 9001:2000 Comparison Matrix DIN EN ISO 9004 / VDA 6.1 a) 9001:1994 b) DIN EN ISO 9001:2000
Other VDA-FORMS
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207 207 210 210 210 214 218 218 221 224
1
Introduction
Quality management* is an interdisciplinary key function. The quality of products and services is always the combined result of activities in every phase of the total business process. Effective quality management assigns priority to planning and prevention activities for identification of interrelations and interdependencies, as well as for appropriate measures to prevent nonconformities occurring - in contrast to the previous practices of identifying, analyzing and rectifying nonconformities which have already occurred. A well-functioning quality management system* described in a quality manual,* is an essential requirement for every business in order to fulfil the demands for quality deliveries and services in a proactive and economic way. Quality management affects all areas of the business. It is therefore a primary function of business management. Management must prove that due diligence has been shown in all areas of the business, from planning to design, procurement, production, sales and user information through to the observation of a product's market position. This applies especially in the event of a claim for damages. It is not only sensible, but essential that all quality management activities be planned, implemented and combined in a quality management system. Only a well planned and purposefully selected quality management system gives business partners, authorities and, increasingly, insurers confidence in the business's ability to comply with quality requirements. The original understanding of quality, mainly shaped by the product, and the associated duties of quality management have changed in recent years and include new additional content and dimensions. The main duties of management are, therefore: -
*
Definition of the quality policy, agreeing and monitoring quality objectives Assuring cross-functional activities and interfaces during interdisciplinary co-operation
Note: The terms "Quality Management“, "Quality System" and "Quality Manual", according to DIN EN ISO 8402 replace the earlier used terms "Quality Assurance“, "Quality Assurance System" and "Quality Assurance Manual".
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-
Definition and monitoring of quality-related costs Consideration of product safety and product liability Involving all employees in the responsibility for quality
These duties are covered in part M of the questionnaire with respect to the quality management system. As operations and the interrelations of systems and processes become more extensive and complex, cross-functional activities gain in importance. Here, many resources are available, which have a great influence on productivity, overall economic performance and quality. The product- and process-related elements are covered in part P of the questionnaire with respect to the quality management system. Through the evaluation of the quality management system with the help of the questionnaire, the customer is given a general view of the supplier's ability to deliver products and services which meet his quality requirements. The purpose of this volume is to define an agreed general procedure for the uniform evaluation of a defined quality management system. In this way, the workload required for further quality management system audits, for example, by other customers, can be reduced. The result of the evaluation shall show the audited organization where its quality management system meets the requirements and in which elements improvements are necessary. The audit result is signed by the auditor and the audited organization. The audited organization confirms with its signature that the identified result has been discussed with him. He is free to provide his own response. Information acquired during the performance of the audit is, other than for the use of the audit itself, to be handled confidentially. Following written release by the auditing organization, or respectively, the certification body, in the appropriate field of the coversheet of the quality management system audit, the audited organization is free to present the audit result to other customers. This VDA Volume 6, Part 1 is the basis for internal quality management system audits (1st Party), customer/supplier audits (2nd Party) and for audits with VDA 6.1 Certificate Supplement through VDA approved certification bodies (3rd Party).
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2
Quality management system according to the DIN EN ISO 9000 Series
The DIN EN ISO 9000 series is applied as a standard in the European Union (EU) and EFTA. The German edition is identical in Austria, Germany and Switzerland. When delivering in accordance with the regulations of the EU it is compulsory to comply with the contents of the EN standard in order to guarantee free movement of goods under the same conditions. This also applies to the contents of the European Standard on quality management. Their compliance is therefore to be proven upon request. 2.1
Explanations to DIN EN ISO 9004 (Edition 8/94) Quality Management and Quality System Elements, Part 1: Guideline
This standard is an internationally agreed guideline in which the elements of a quality management system (quality elements) are described. It represents a further development of formerly known national and branch-specific regulations with the express objective of showing, descriptively and clearly, which quality elements may nowadays be included in a quality management system corresponding to the "State of the Art". In addition, it describes the obligations of the business with respect to quality management, in fulfillment of which the critical preconditions for achieving quality capability within the organization should be created. Users of this standard are enabled to select from the presented basis of elements according to extent, depth and overall requirements of the business in order to be able to completely fulfill the tasks of their own organization-specific quality management system. The scope of application is not limited. The standard is to be viewed as a universal set of regulations for quality management to achieve the quality of products and services. It can be assumed that branch-specific quality regulations will thereby be replaced. In the meantime, this standard has gained a fundamental significance.
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2.2
Quality Assurance Model (according to the introduction to DIN EN ISO 9001)
The scope and depth of the quality management system may depend on the type of products to be supplied, the applied technology and the size of the evaluated organization. The following paragraphs are taken from the national foreword and the introduction of DIN EN ISO 9001: 1994-08. There it is appropriately stated: Gaining confidence in the supplier’s ability to fulfill the defined minimum requirements on his quality system is nowadays becoming more and more a precondition throughout the world for cooperation between the customer and his supplier. This confidence can be built up by presenting the quality system to the customer or an authorized body. All systematic and confidencebuilding activities planned within the scope of this are designated by DIN EN ISO 8402 as quality assurance or quality management systems (or quality systems). The standards DIN EN ISO 9001, DIN EN ISO 9002 and DIN EN ISO 9003 each contain a quality assurance model. Only these three standards of the DIN EN ISO 9000 series are intended for demonstration purposes. They show a way to create confidence in the capability of a supplier. It has to be emphasized that the quality system requirements specified in the International Standards ISO 9001, ISO 9002 and ISO 9003 are a supplement (not an alternative) to the established quality requirements (on products1)). It is intended that these International Standards are applied in their present form. However, occasionally they may need to be tailored for special contractual situations by the addition or omission of certain requirements. ISO 9000-1 provides guidance on such tailoring as well as on the selection of the appropriate model, … namely ISO 9001, ISO 9002 or ISO 9003.
1)
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According to DIN EN ISO 8402 1.4 (and ISO 9000:2000, 3.4.2), may include product as well as services.
The following alternative models for quality assurance described in three international standards represent three differing forms of "the functional or organizational quality capability" which are suitable for use in contracts between two partners (see Chapter 5: Cross-Reference List of Clause Numbers) ISO 9001 Quality systems Model for quality assurance in design2), development, production, installation and servicing. To be applied, when conformance with specified requirements is to be ensured by the supplier/contractor during design, development, production, installation and servicing. ISO 9002 Quality systems Model for quality assurance in production, installation and servicing. To be applied, when conformance with specified requirements is to be ensured by the supplier/contractor during production, installation and servicing. ISO 9003 Quality systems Model for quality assurance at final inspection and testing. To be applied, when conformance to specified requirements is to be ensured by the supplier/contractor only during final inspection and testing.
2) DIN EN ISO 9001, 9002, 9003 (Edition 08/94) are equivalent to modules E, D and H according to 93/465/EEC, see also Foreword and Clause 1.2 of DIN EN ISO 9001:2000
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3
Quality Management System Audit
3.1
General
Evaluation of the quality management system is performed with the help of a questionnaire. The questions of the present VDA 6.1 volume are primarily applicable to the evaluation of organizations producing material (or tangible) products (For non-material or non-tangible products/services - see VDA Volume 6, Part 2). The evaluation of an organization is performed either as an internal audit by the organization itself (1st Party), through a representative of the customer (2nd Party) or through an accredited certification body (3rd Party). Auditors must be competent in the elements which they have to evaluate, as well as in the quality techniques used. They must be qualified to judge the suitability of the implemented quality measures, taking into account the production processes used, the technology and the required product quality. The extensive commercial and technical evaluation of an organization in line with this quality management system audit places considerable requirements on the auditor. In addition to this, the auditor must possess, among other things, relevant training and industrial experience, integrity and the ability to deal with people. Particularly the following quality elements: -
management responsibility quality management system internal quality audits training/personnel financial considerations regarding quality management systems product safety corporate strategy
demand special qualification requirements of the auditors, as they must be competent to discuss the above topics with the organization’s management. Department-specific questions are to be answered by the persons responsible in the organization for marketing, design, procurement, production planning, production or personnel and not by the Quality Manager. He, generally, only answers specific questions about quality function issues, e.g. about testing and documentation. 18
If the quality management system of an organization, on the occasion of a system audit, has been found to be satisfactory in accordance with Paragraph 3.3, then a periodic quality management system audit is to be carried out at appropriately defined intervals. In the case of an unsatisfactory result during a quality management system audit, corrective actions and a time schedule are to be established to improve the system. The evaluation of their effectiveness is the subject of a follow-up audit that examines the unsatisfactory areas. 3.2
Selection of the Quality Elements and Relevant Questions
The relevant elements and corresponding questions for the evaluation of the quality management system of an organization are to be defined. The elements 08, 12 and 21 can, under special circumstances, be completely/ partly omitted. Comments regarding this are given with the relevant elements. During internal quality audits (1st Party) and customer audits (2nd Party) further quality elements and questions may also be added. Furthermore, elements of a quality management system may be adapted, deleted (in exceptional cases) or extended to meet organization or product-specific needs. Additional questions regarding the quality management system must be communicated to the organization to be audited beforehand. During certification audits (3rd Party) additional requirements can only be added if they form part of the quality management system of the organization to be audited. In this case, their compliance and effectiveness are to be assessed. The points rating according to VDA 6 Part 1, Paragraph 3.3.1 is not applicable. Individual questions can only be omitted if they are unusual or not able to be evaluated for the organization size or branch. In cases of doubt, clarification with the customer is appropriate. Questions that are not applicable and supplementary questions are to be identified and justified in the audit report (identification for non-applicable i.e. questions that will not be evaluated = na).
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In the following questionnaire, elements of a quality management system which have a particular influence on product and process or which can lead to the failure of the quality management system are identified by an asterisk (*). Non compliance with these requirements has particular influence on the overall grade or awarding of a VDA 6.1 Certificate Supplement (see 3.3.3 and 3.3.4). The "Requirements/Explanations" to the question are always to be seen as an example and not as a complete checklist. The type of evidence or records listed as examples do not have to be supplied if they are not appropriate to the industry sector. Some questions concerning the quality management system can only be answered in conjunction with an evaluation of the product to be supplied and/or the corresponding technology or process applied. This can make a separate assessment (product / process audit) necessary. 3.3
Evaluation and Rating
3.3.1
Individual Rating of Questions and Quality Elements
The auditor evaluates the definition and effectiveness of the quality management activities in complying with the respective requirements by initially determining: -
Is the subject in question defined in writing in the quality management system, in operational procedures with relationships and responsibilities? (e.g.: in the quality manual, in a documented procedure or work instruction)?
He must then further evaluate: -
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Is the subject in question proven to be effective in practice?
According to the following table, answers to the questions lead to a rating for each relevant question. This rating can result in 0, 4, 6, ,8 or 10 points per question. The following point rating method is valid for each question: Subject in question
Evaluation of answer
Defined completely in the quality management system
yes
no
Proven effective in practice
yes
yes
Point score
10
8
yes
no
mostly *) 6
yes/no
no 4
0
*) Under "mostly" it is understood that all applicable requirements are proven effective in more than 3/4 of all relevant application cases and that no particular risk exists. Rating 10 points:
completely defined in the quality management system and proven to be effective
8 points:
not completely defined in the quality management system but proven to be effective
6 points:
completely defined in the quality management system and mostly proven to be effective
4 points:
not completely defined in the quality management system but mostly proven to be effective
0 points:
not proven to be effective regardless of completeness of definition in the quality management system
When compiling a summarized rating for a quality element, every question is equally weighted. Questions which are not applicable are not considered in the rating. The element rating is expressed as a percentage which results from the total points assessed for all relevant questions related to the total points possible for all relevant questions.
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If all relevant answers in an element achieve 10 points, then the level of compliance CE is 100%. Calculation of element ratings:
CE
total points assessed for relevant questions ——————————————————— x 100 [%]
=
total possible points for relevant questions
3.3.2
Overall Rating of Audit Result
For the two parts of the audit, M (management) and P (product and process), the individual levels of compliance CM and CP are calculated. They are established by calculating the average value of the levels of compliance for the relevant evaluated quality elements CM or CP =
sum of levels of compliance of all relevant elements ———————————————————————
[%]
no. of relevant quality elements
The two levels of compliance CM and CP are combined to give an overall rating, whereby the management-specific section is given one third weighting and the product-related and process-related section is given a two thirds weighting:
CTOT =
CM + 2 * CP ——————— [%]. 3
The rating system may also be applied if further elements or questions are added or if elements or questions are omitted. If additional questions relate to product, services or applied process technology, it may then be necessary to adapt the point and rating system accordingly.
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Note on the formula for CTOT*: The formula arises from the following consideration: On condition that the 7 quality elements concerning management and the 16 quality elements concerning product and process (from Chapter 6) are equally weighted in CTOT Then: CTOT =
7 * CM + 16 * CP ———————— 23
= 0,30 * CM + 0,70 * CP
should be calculated. In order to retain a simple formula and also to give more weight to the Part M quality elements, the committee defined the formula for CTOT as presented above (no mathematical background). The elements of CM are therefore more heavily weighted by a factor of 0.33/0.30 = 1,1. Thereby the elements of management, as an essential part of quality assurance, are treated with more importance in the quality rating system. •
CTOT is referred to as EGES in the original German version
3.3.3
Grading for Customer/Supplier Audits (2nd Party)
Overall level of compliance in percent
Assessment of quality management system
Designation of grading
90 to 100
full compliance
80 to less than 90
mostly compliant
60 to less than 80
conditionally compliant
B
less than 60
not compliant
C
A *) AB *)
*) Notes 1. Organizations audited and having received an overall level of compliance exceeding 90 % (or 80 % respectively), but which have a level of compliance for one or more elements of less than 75 %, will have their grading dropped from A to AB (or AB to B respectively). 2. If a question marked with * which has particular influence on product and process or which can lead to a failure of the quality management system is rated with less than 8 points, then the organization is to be downgraded from A to AB or from AB to B respectively. 3. If a question not marked with * is rated with 0 points, then the audited organization is to be downgraded from A to AB. 4. Downgrading according to notes 1, 2 or 3 above may be applied only once. 5. Downgrading is to be justified in a commentary sheet.
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3.3.4
Awarding of the VDA 6.1 Certificate Supplement (3rd Party):
1. A VDA 6.1 Certificate Supplement to an ISO 9001/9002* certificate is awarded at an overall level of compliance exceeding 90% (the level of compliance [%] is not shown on the VDA 6.1 Certificate Supplement). *) Note:
as of 15 December 2003 only in connection with an ISO 9001:2000 certificate
Exception: A VDA 6.1 Certificate Supplement will not be awarded, if - one or more quality elements achieve a level of compliance below 75 % or - one or more questions marked with * are rated with less than 8 points or - one question not marked with * is rated with 0 points. 2. Follow-up /Re-audit A follow-up audit is possible within 90 days after completion of the audit under the following conditions (Status: Open): a) a maximum of one question marked with * was rated with 0 points and/or b) one or more questions marked with * were rated with 4 or 6 points and/or c) one or more questions not marked with * were rated with 0 points and/or d) no element achieved a level of compliance below 75 % A VDA 6.1 Certificate Supplement is awarded after a follow-up audit, if all questions marked with * are rated with at least 8 points and all questions not marked with * are rated with at least 4 points. A follow-up audit is not possible if more than one question marked with * is rated with 0 points (Status: failed) A re-audit is only possible at the earliest after 90 days. The same rules apply as for a follow-up audit.
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3.4
Summary of Results
The results of the quality management system audit of Part M (management) and Part P (product and process) are to be presented as shown in the sample forms (Chapter 8). The results of each element will be entered on the sheet "Summary of Results". 3.5
Close out Meeting and Report
In the course of a close out meeting regarding the quality management system audit, the auditor informs the audited organization's management which nonconformances are present and to what extent corrective actions are necessary. These will be presented in a summary sheet "Nonconformances/ Corrective Actions". After completion of the quality management system audit, the auditor raises an audit report and establishes a time schedule with the audited organization for the corrective actions (see sample forms - Chapter 8). If necessary, a follow-up audit date is agreed. 3.6
Corrective Actions
The result of the quality management system audit, presented as shown in the main paragraphs 3.4 and 3.5 above, serves the management of the audited organization as a basis for corrective actions. It is the duty of the audited organization to work out and implement an improvement program. This has to be communicated to the lead auditor responsible for heading the audit. The auditor decides on the basis of the presented improvement program to what extent a follow-up audit is to be carried out. 3.7
VDA 6.1 Certificate
A VDA 6.1 certificate can only be awarded if the overall grade achieved is A (see 3.3.3). A precondition for this is that the auditor is registered as a Lead Auditor with the VDA. The representative of the certifying body applies to the VDA for the VDA 6.1 certificate at the request of the organization being audited. The awarding of a VDA 6.1 certificate may also be carried out under consideration of existing certificates according to DIN EN ISO 9001/9002 or QS 9000 with supplementary auditing (see VDA Volume 6). The certificate is valid for 3 years after the date of issue, however not longer than the validity of the ISO certificate being supplemented. 25
VDA
VERBAND DER AUTOMOBILINDUSTRIE E. V.
VDA 6.1 CERTIFICATE Organization: Sub-organization: Product group(s):
The organization has provided evidence of effective implementation of a Quality Management System according to VDA 6, Part 1 of the Quality Standard of the German Automotive Industry, on the basis of DIN EN ISO 9001 / 9004-1. Audit with/without Product Design and Development. Date of issue:
valid until:
Audit performed by:
VDA Registration No. _______
___________________________ Company / Signature of authorized person
VDA-Stamp
Lead Auditor(s): __________________ _________________________________ Date: ___________________ Signature ______________________ _______________________________________________________________________________
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4
Terms and Definitions
For each of the individual elements, definitions and explanations of terms are given within the questionnaire. Generic terms are briefly summarized in the following. (The numbering according to # corresponds to the ISO 9000:2000 Standard). 4.1
Terms relating to quality according to ISO 9000:2000 (extract)
#3.1.2
Requirement
Need or expectation that is stated, generally implied or obligatory. Note 1:
"Generally implied" means that it is custom or common practice for the oganization (#3.3.1), its customers (#3.3.5) and other interested parties (#3.3.7), that the need or expectation under consideration is implied.
Note 2:
A qualifier can be used to denote a specific type of requirement, e.g. product requirement, quality management requirement, customer requirement.
Note 3:
A specified requirement is one that is stated, for example, in a document (#3.7.2).
Note 4:
Requirements can be generated by different interested parties.
4.2
Terms relating to management according to ISO 9000:2000 (extract)
#3.2.3
Quality management system
Management system (#3.2.2) to direct and control an organization (#3.3.1) with regard to quality (#3.1.1). #3.2.4
Quality policy
Overall intentions and direction of an organization (#3.3.1) related to quality (#3.1.1) as formally expressed by top management. Note:
The quality policy is an element of the corporate policy and is approved by the management.
27
#3.2.8
Quality management
Coordinated activities to direct and control an organization (#3.3.1) with regard to quality (#3.1.1). Note:
Direction and control with regard to quality generally includes establishment of the quality policy (#3.2.4) and quality objectives (#3.2.5), quality planning (#3.2.9), quality control (3.2.10), quality assurance (3.2.11) and quality improvement (3.2.12).
4.3
Terms relating to organization according to ISO 9000:2000 (extract)
#3.3.1
Organization
Group of people and facilities with an arrangement of responsibilities, authorities and relationships. Example:
Company, corporation, firm, enterprise, institution, charity, sole trader, association, or parts or combinations thereof.
Note 1:
The arrangement is generally orderly.
Note 2:
An organization can be public or private.
Note 3:
This definition is valid for the purposes of quality management system (#3.2.3) standards. The term "organization" is defined differently in ISO/IEC Guide 2.
#3.3.2
Organizational structure
Arrangement of responsibilities, authorities and relationships between people. Note 1:
The arrangement is generally orderly.
Note 2:
A formal expression of the organizational structure is often provided in a quality manual (#3.7.4) or a quality plan (#3.7.5) for a project (#3.4.3).
Note 3:
The scope of an organizational structure can include relevant interfaces to external organizations (#3.3.1).
28
#3.3.5
Customer
Organization (#3.3.1) or person that receives a product (#3.4.2). Example:
Consumer, client, end-user, retailer, beneficiary and purchaser.
Note:
A customer can be internal or external to the organization.
#3.3.6
Supplier
Organization (#3.3.1) or person that provides a product (#3.4.2). Example:
Producer, distributor, retailer or vendor of a product, or provider of a service or information.
Note 1:
A supplier can be internal or external to the organization.
Note 2:
In a contractual situation a supplier is sometimes called "contractor".
4.4
Terms relating to process and product according to ISO 9000:2000 (extract)
#3.4.1
Process
Set of interrelated or interacting activities which transforms inputs into outputs. Note 1:
Inputs to a process are generally outputs of other processes.
Note 2:
Processes in an organization (#3.3.1) are generally planned and carried out under controlled conditions to add value.
Note 3:
A process where the conformity (#3.6.1) of the resulting product (#3.4.2) cannot be readliy or economically verified is frequently referred to as a "special process".
29
#3.4.2
Product
Result of a process (#3.4.1). Note 1:
There are four generic product categories, as follows: -
services (e.g. transport); software (e.g. computer program, dictionary); hardware (e.g.engine mechanical part); processed materials (e.g. lubricant)
Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example the offered product "automobile" consists of hardware (e.g. tires), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver's manual), and service (e.g. operating explanations given by the salesman). Note 2:
Service is the result of at least one activity necessarily performed at the interface between the supplier (#3.3.6) and customer (#3.3.5) and is generally intangible. Provision of a service can involve, for example, the following: -
an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired); an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return); the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); the creation of ambience for the customer (e.g. in hotels and restaurants).
Software consists of information and is generally intangible and can be in the form of approaches, transactions, or procedures (#3.4.5). Hardware is generally tangible and its amount is a countable characteristic (#3.5.1). Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials are often referred to as goods. Note 3:
Quality assurance (#3.2.11) is mainly focused on intended product.
#3.4.5
Procedure
Specified way to carry out an activity or a process (#3.4.1). Note 1:
Procedures can be documented or not.
Note 2:
When a procedure is documented, the term "written procedure" or "documented procedure" is frequently used. The document (#3.7.2) that contains a procedure can be called a "procedure document".
30
4.5
Terms relating to conformity according to ISO 9000:2000 (extract)
#3.6.5
Corrective action
Action to eliminate the cause of a detected nonconformity (#3.6.2) or other undesirable situation. Note 1:
There can be more than one cause for a nonconformity.
Note 2:
Corrective action is taken to prevent recurrence whereas preventive action (#3.6.4) is taken to prevent occurrence.
Note 3:
There is a distinction between correction (#3.6.6) and corrective action (#3.6.5).
4.6
Terms relating to documentation according to ISO 9000:2000 (extract)
#3.7.4
Quality manual
Document (#3.7.2) specifying the quality management system (#3.2.3) of an organization (#3.3.1). Note:
Quality manuals can vary in detail and format to suit the size and complexity of an individual organization.
4.7
Terms relating to examination according to ISO 9000:2000 (extract)
#3.8.1
Objective evidence
Data supporting the existence or verity (applicability) of something. Note:
Objective evidence may be obtained through observation, measurement, test (#3.8.3) or other means
31
#3.8.2
Inspection
Conformity evaluation by observation and judgment accompanied by measurement, testing or gauging. #3.8.4
Verification
Confirmation, through the provision of objective evidence (#3.8.1), that specified requirements (#3.1.2) have been fulfilled. Note 1:
The term "verified" is used to designate the corresponding status.
Note 2:
Confirmation can comprise activities such as: -
#3.8.5
performing alternative calculations; comparing a new design specification (#3.7.3) with a similar proven design specification; undertaking tests (#3.8.3) and demonstrations; reviewing documents prior to issue.
Validation
Confirmation, through the provision of objective evidence (#3.8.1), that the requirements (#3.1.2) for a specific intended use or application have been fulfilled. Note 1:
The term "validated" is used to designate the corresponding status.
Note 2:
The use conditions for validation can be real or simulated.
4.8
Terms relating to audit according to ISO 9000:2000 (extract)∗
#3.9.1
Audit
Systematic, independent and documented process (#3.4.1) for obtaining audit evidence (#3.9.4) and evaluating it objectively to determine the extent to which audit criteria (#3.9.3) are fulfilled. Note:
∗
32
Internal audits, sometimes called first-party audits, are conducted by, or on behalf of, the organization (#3.3.1) itself for internal purposes and can form the basis for an organization's self-declaration of conformity (#3.6.1).
Owing to the more precise structure and revised allocation of the Terms and Definitions in ISO 9000:2000, the previous sub-chapters 4.2, 4.3 and 4.4 have been removed.
#3.9.5
Audit findings
Results of the evaluation of the collected audit evidence (#3.9.4) against audit criteria (#3.9.3). Note:
Audit findings can indicate either conformity or nonconformity with audit criteria or opportunities for improvement.
4.9
Additional Terms (Definitions for the present volume)
4.9.1
System
The structure of an organization (#3.3.1), in which responsibilities, authorities and interrelationships, as well as procedures (#3.4.5) and processes (#3.4.1) are defined together with the necessary resources for the realization of an objective. 4.9.2
Method
A scheduled procedure (#3.4.5), to given means and a given purpose which leads to the technical proficiency in the solution of theoretical and practical tasks. 4.9.3
Serial Production
The fabrication of products (#3.4.2) of similar type and design, in recurrent orders. 4.9.4
Quality Management (QM) Procedures
QM procedures are specific instructions that are required in order to fulfill a defined quality-related activity. They come into effect when signed.
33
4.9.5
Work Instructions (Test and Inspection Instructions)
Detailed description of the working steps of an activity. Definition of individual activities and detailed instructions, order-neutral, as well as order-related. 4.9.6
Unit
That which can be individually described and examined. Note:
A unit can be e.g.: - an activity or a process (#3.4.1) - a product (#3.4.2) - an organization (#3.3.1), a system (4.9.1) or a person or any combination thereof.
4.9.7
Service
see Product (#3.4.2), Note 2.
34
5
Cross-reference List of Paragraph Numbers for Corresponding Subjects (according to DIN EN ISO 9000-1, Appendix D, 199408), supplemented by ISO 9001:2000*
Cross-reference of the paragraph numbers for corresponding subjects of the questionnaire of Chapter 7 to the paragraphs and subparagraphs of the standards DIN EN ISO 9001, 9002, 9003 and 9004-1. VDAQuestionnaire N°.
Paragraph Title according to 9001 / (9004-1)
Corresponding clause in ISO 9001:2000
Corresponding paragraph or subparagraph no. in the standard DIN EN ISO (8/94) 9001 9002 9003
9004-1 01
Management responsibility
5; 6; 8.5.1
4, 5
4.1
z
z
02
QM system (quality management system elements)
4; 5.4.2; 7.1
5
4.2
z
z
03
Internal quality audits (auditing the QM system)
8.2.2
5.4, 5.5
4.17
z
z
04
Training (Personnel)
5.5.3; 6.2
18
4.18
z
z
05
Financial considerations regarding QM systems
---
6
−
−
−
−
06
Product safety
---
19
−
−
−
−
Z1
Corporate strategy
---
−
−
−
−
−
07
Contract review (Quality in marketing)
5.2; 7.2
7
4.3
z
z
z
08
Design control - product design (Quality in specification and design)
7.1; 7.3
8
4.4
z
−
−
09
Process planning - process design
7.1; 7.3, 7.5
(8)
(4.4)
−
−
−
10
Document and data control (Quality documents)
4.2
17,17.3, 5,3
4.5
z
z
z
11
Purchasing (Quality in purchasing)
7.4; 7.5
9
4.6
z
z
−
12
Control of customer-supplied product
7.5.4
−
4.7
z
z
z
35
VDAQuestionnaire N°.
Paragraph Title according to 9001 / (9004-1)
Corresponding clause in ISO 9001:2000
Corresponding paragraph or subparagraph no. in the standard DIN EN ISO (8/94) 9001 9002 9003
9004-1 Product identification and traceability (Material control, traceability and identification)
7.5
11.2
4.8
z
z
(Process control)
7.5
11.411.6
4.9
z
z
−
Insp. and test status (control of insp. & test status)
7.5
11.7
4.12
z
z
z
14
Process control (quality of processes)
7.5
10
4.9
z
z
−
15
Inspection and testing (Product verification)
7.1, 8.2.4
12
4.10
z
z
16
Control of inspection, measuring and test equipment
7.6
13
4.11
z
z
z
17
Control of nonconforming product
8.3
14
4.13
z
z
18
Corrective and preventive action
8.5
15
4.14
z
z
19
Handling, storage, packaging, preservation and delivery (post-production activities)
7.5.5
16.1, 16.2 10.4
4.15
z
z
z
20
Control of quality records (quality documents/records)
4.2.4
17, 17.2 4.16
z
z
21
Servicing, (post-production activities)
7.5; 8.4
16.4, 4.19 16.5, 16.6, 7.3
z
z
−
22
Statistical techniques
8
20
z
z
13
4.20
Italic: Elements which extend beyond the scope of the standard * see also comparison tables in Chapter 12 Key:
36
z −
full requirement less comprehensive than ISO 9001 and 9002 quality element not present
6
Structure and Number of Questions per Quality Element
Page
No. of questions
M
Management of the Organization
01
Management Responsibility DIN EN ISO 9001, Clause 4.1 DIN EN ISO 9004-1, Chapter 4
39
6
02
Quality Management System DIN EN ISO 9001 Clause 4.2 DIN EN ISO 9004-1, Chapter 5
47
6
03
Internal Audits DIN EN ISO 9001, DIN EN ISO 9004-1,
57
4
63
7
04
Training, Personnel DIN EN ISO 9001, DIN EN ISO 9004-1,
Clause 4.17 Chapter 5 Clause 4.18 Chapter 18
05
Financial Considerations regarding Quality Management Systems DIN EN ISO 9004-1, Chapter 6
71
4
06
Product Safety DIN EN ISO 9004-1,
75
4
81
5
Z1
Chapter 19
Corporate Strategy Subtotal of questions in section M
36
37
P 07 08 09 10 11 12 13
14 15 16
17 18 19
20 21 22
38
Product and Process Contract Review, Quality in Marketing 9001, Clause 4.3 / 9004-1, Chapter 7 Design Control (Product Design) 9001, Clause 4.4 / 9004-1, Chapter 8 Process Planning (Process Design) 9001, Clause 4.4 / 9004-1, Chapter 8 Document and Data Control 9001, Clause 4.5 / 9004-1, Chapter 17.3 Purchasing 9001, Clause 4.6 / 9004-1, Chapter 9 Control of Customer Supplied Product. 9001, Clause 4. Product Identification and Traceability (Process Control, Inspection and Test Status) 9001, Clause 4.8 (4.9, 4.11, 4.12) / 9004-1, Chapter 11 Process Control 9001, Clause 4.9 / 9004-1, Chapter 10 Inspection and Testing (Product Verification) 9001, Clause 4.10 / 9004-1, Chapter 12 Control of Inspection, Measuring and Test Equipment. 9001, Clause 4.11 / 9004-1, Chapter 13 Control of Nonconforming Product 9001, Clause 4.13 / 9004-1, Chapter 14 Corrective and Preventive Action 9001, Clause 4.14 / 9004-1, Chapter 15 Handling, Storage, Packaging, Preservation and Delivery 9001, Clause 4.15 / 9004-1, Chapter 16 Control of Quality Records 9001, Clause 4.16 / 9004-1, Chapter 17.2 Servicing, (After Sales and Post-production Activities) 9001, Clause 4.19 / 9004-1, Chapter 16 Statistical Techniques 9001, Clause 4.20 / 9004-1, Chapter 20
Page
No. of questions
87
5
93
7
101
7
111
4
117
7
125
4
129
7
137
7
147
6
153
5
159
4
163
4
169
6
175
4
181
5
187
6
Sub-total of questions in section P
89
Total of all questions
125
7
Quality Management System Audit Questionnaire
For application in organizations which manufacture tangible products STRUCTURE For every quality element the general requirements are described in an introduction, the subject in its context is briefly explained and the questions are stated.. In addition, reference is made to other applicable VDA Volumes which are to be considered during the realization of the quality management system. Equivalent procedures and processes are permitted. Questions on the quality management system which have a special influence on the product or process or may lead to the failure of the quality management system are marked with an *. Each question is structured as follows: 1. 2.
The Question Definition
Where required, the terms used in the question are defined according to the relevant standard and the standard or an extract thereof is cited. The source is stated respectively. Explanation of terms Where required, the terms used in the question are explained, if no definition is given, to provide a better understanding. 3.
Requirements/Explanations
In the section ‘Requirements/Explanations’, requirements on the quality management system are defined and supplemented by explanations, if necessary. Note:
For each applicable question, the auditor has to evaluate the definition and the effectiveness of the quality measures.
The requirements and explanations are partially described in an abreviated form. Therefore, further VDA Volumes which are significant and which have to be considered are referenced (see the note in the introduction to the quality elements). Usually there is a special note in the respective question.
39
Part M: Management of the organization 01
Management Responsibility ISO 9001:2000, Clause 5; 6; 8.5.1 and ISO 9004:2000 The Management (e.g. Board of Management, Plant Management, Section Management) develops the quality policy for the organization, defines it and commits all areas and levels to it. Hereby specific quality objectives and a quality management system are to be agreed. Quality must be regarded as an overall management task. "Management" describes the organizational unit that is responsible for profit and loss.
Reference ISO 9001:2000 01.1 *
Has the quality policy been defined by management and has it been made known to all levels?
5.1, 5.3, 5.4.1
01.2 *
Have quality objectives been defined within the scope of corporate planning and the quality policy and are the results monitored?
5.1, 5.3, 5.4.1
01.3 *
Is a continual improvement process part of the 5.1, 8.5.1 quality policy?
01.4
Have the necessary resources been provided by the management of the organization?
5.1, 6.1, 6.2.1, 6.3
01.5 *
Has a management representative been assigned and are his duties, authorities and responsibilities defined?
5.5.2
01.6 *
Does management regularly evaluate the effectiveness of the quality management system?
5.6.1, 5.6.2, 5.6.3
40
01.1*
Has the quality policy been defined by management and has it been made known to all levels?
Definition: Quality Policy (according to ISO 9000:2000/3.2.4): The overall intentions and direction of an organization related to quality as formally expressed by top management. Note 1:
Generally the quality policy is consistent with the overall policy of the organization and provides a framework for the setting of quality objectives (#3.2.5).
Note 2:
Quality management principles presented in this International Standard can form a basis for the establishment of a quality policy.
Requirements/Explanation: The quality policy must be formulated in such a way that it can be understood, implemented and applied by employees at all levels The principles of the quality policy are to be described in a quality manual or an equivalent document (see Question 02.1). The publication of the quality policy is achieved, for example, by -
notices memoranda organizational guidelines and instructions informative presentations about the quality policy.
The quality objectives of the organization follow the quality policy (see Question 01.2), are decisive for the organization and incorporate the expectations of the customer(s). Evidence is given by, for example, a declaration of commitment from management within the scope of the quality policy, according to which all quality requirements for activities, not only in production but in all organizational units, are reliably fulfilled and the prevention of nonconformances has significant priority over the detection of nonconformances (Zero Defect Strategy).
41
01.2*
Have quality objectives been defined within the scope of corporate planning and the quality policy and are the results monitored?
Explanation of terms: "Quality objectives" are specifications for products, processes, operations and services, that are defined for all levels. These objectives are derived from customer requirements, the competitive situation, the legal environment and internal requirements, as well as adherence to the "zero defect strategy.“ Requirements/Explanation: Objectives for quality within the scope of the quality policy might be, for example: a) Corporate-wide objectives • Fulfillment of the general organization requirements (laws, regulations, directives) • Improving market acceptance • Making profit • Ensuring the continued viability of the organization • Continual quality improvement (see Question 01.3). b) Product-related objectives • Scrap-/ failure rates (%) • Supplier delivery quality (ppm) • Improving product quality • Improving process capability (Cpk) • Improving reliability • Environmental tolerance. c) Customer-related objectives • Shortening of order processing time (inquiries, orders etc.) (difference in days) • Improving customer satisfaction (e.g. reducing the number of customer complaints change %) • Reduction in the reaction time when dealing with complaints (difference in days) • Improving delivery reliability (on-time performance).
42
d) Higher objectives • Reducing costs but not to the detriment of quality • Advance quality planning (see Question 02.5) • Increasing improvement suggestion activities (methods, equipment, operations etc.) • Calculating and evaluating the costs assigned to all quality elements in order to minimize any loss of quality • Monitoring the effectiveness of corrective actions on the basis of audit results • Quality of the development of products and processes (time, implemenation, practicability, feasibility etc.) • Quality management system upgrade from ISO 9001/2 to VDA 6.1. Further development towards TQM, EQA etc. Note:
The demonstration of achieved quality in comparison to objectives - see Question 04.7
The quality objectives to be agreed must be achievable and, if possible, measurable, as well as periodically revised and presented in a suitable format, e.g. using data processing systems. The achievement of objectives must be monitored thoroughly at all management levels (specified/actual comparison). The objectives must be practically, clearly and comprehensively explained to the employees during informative discussions. Without the definition of objectives, an efficient improvement in quality and increase in productivity in all areas of the organization cannot be followed or achieved.
43
01.3*
Is a continual improvement process part of the quality policy?
Requirements/Explanation: Improvement programs for the operating units and for the commercial and technical functional units of the organization must be introduced and maintained. The methods cited elsewhere (see Questions 04.2 and 04.5) must be used here. Items for improvement include, for example: Note:
Reducing non-value-adding activities (e.g. rework, repairs) Simplification of processes/Optimization of production methods. Minimization of waste Reducing unplanned down-time of machines Shortening setting-up and tool change times Increasing service life/cycle times of products and equipment Improving the ease of repair of products and equipment Reducing water, air and energy expenditures Optimization of activity times Improved handling in all areas
Connections to Question 01.2 are possible. The working methods applied can be selected on an organization-specific basis.
In the continual improvement process, careful handling and economical use of resources must also be taken into account. This includes, for example: -
the logistical chain the building / factory area the equipment environmental protection
The strategy of continual improvement applies to employees, all production processes, services and business operations of the organization. It does not replace necessary innovative improvements. Improvements refer to, for example: -
44
Quality Price Service Delivery reliability.
01.4
Have the necessary resources been provided by the management of the organization?
Requirements/Explanation: For the quality management system to operate effectively, the management of the organization has the task of providing the financial and personnel resources needed to fulfil the requirements in the quality elements. These include, for example: -
-
qualified staff with task-related capabilities for management, implementation and inspection activities (including project management) inspection and testing equipment for product development and manufacture computer support, e.g. for data analysis, graphic displays, statistics, quality plans.
The effectiveness and efficiency of the quality management system depends on the provision of the necessary resources for the realization of the quality policy and the quality objectives. Note:
This question cannot be finally evaluated until the entire quality management system has become transparent as a result of the audit and until it has been ascertained that all necessary resources are available.
45
01.5*
Has a management representative been assigned and are his duties, authorities and responsibilities defined?
Explanation of terms: The "Management representative" is the person who represents the interests of management regarding strategic quality management at all management levels. The representative must belong to the management team of the organization, but does not have to be a member of the management. He/she always reports to that level of management, which is responsible for profit and loss. Requirements/Explanation: Responsibilities and authorities of the representative include: -
Note:
46
Reporting on the quality situation Defining, realizing and maintaining the quality management system in accordance with the requirements of this questionnaire, which includes branch-specific adjustments Monitoring the strategic quality objectives Controlling and coordinating quality activities using interdisciplinary cooperation Demonstrating the effectiveness of the quality management system and determining possible improvements.
The representative may at the same time be responsible for the organizational functions "quality department", "quality assurance", "quality management" etc.
01.6*
Does management regularly evaluate the effectiveness of the quality management system?
Definition: Review (in accordance with ISO 9000:2000/3.8.7): Activity undertaken to detrminie the suitability, adequacy and effectiveness (#3.2.14) of the subject matter to achieve established ojectives. Note:
Review can also include the detrmination of effieciency (#3.2.15).
Requirements/Explanation: The Management of the organization must periodically (at least once each year) assess and satisfy itself about the effectiveness of the established quality management system. The aim of this assessment is to achieve a continuous optimization and adaptation to changed conditions (market, technology etc.). This can be done by collecting and evaluating the following information, for example: -
Reports on the quality situation Regularly scheduled quality meetings Quality indices with respect to objectives (see Question 01.2) Internal quality audit reports with derived measures (see Question 03.2 and 03.3) Status of the continual improvement process (see Question 01.3) Results of product and process analysis with corrective actions Reports on customer satisfaction (see question Z1.4).
The review is carried out by comparing the findings with the objectives of the quality policy and usually results in preventive and corrective actions.
47
02
Quality management system ISO 9001:2000, Clause 4; 5.4.2; 7.1
A quality management system consists of the organizational structure, the responsibilities, procedures, processes and resources for the implementation of quality management. The quality management system is intended to promote continual quality improvement. The quality management system shall be defined and implemented by management, preferably in a quality manual and in supplementary documented procedures or equivalent documentation. Note:
VDA Volume 4.3 is an applicable reference.
Reference ISO 9001:2000 02.1 *
Is the quality management system described in a quality manual or an equivalent document?
4.1; 4.2.1; 4.2.2
02.2
Does the quality management system encompass all areas, levels and employees of the organization?
4.2.1, 4.2.2
02.3 *
Are there documented procedures defining duties, responsibilities and authority levels for quality activities?
5.5.1
02.4 *
Is there a cross-functional project management established which includes the quality planning process?
7.3.1
02.5 *
Is there a quality planning process for the necessary measures and procedures for fulfilling quality requirements?
5.4.2; 7.1
02.6 *
Are there quality plans resulting from the qual5.4.2, 7.1 ity planning process?
48
02.1*
Is the quality management system described in a quality manual or an equivalent document?
Definition: Quality manual (according to ISO 9000:2000/3): Document (#3.7.2) specifying the quality management system (#3.2.3) of an organization (#3.3.1). Note:
Quality manuals can vary in detail and format to suit the size and complexity of an individual organization.
Requirements/Explanation: All quality elements necessary for conducting the business of the organization must be described in the quality manual with reference to applicable internal and external instructions, standards, regulations etc. The documentation covers: -
Organizational structure Names of responsible individuals Implementation process for all activities affecting quality in the organization.
The manual must display the approval of the organization management, the validity date and the revision status. Responsibility for its updating, revision service and the distribution list must be defined. The main purpose of a quality manual is to define the structure of the quality management system and, at the same time, to serve as a permanent reference for the implementation and maintenance of this system. In addition, special processes can be separately defined in documented procedures, quality assurance plans etc. This also include instructions on project management (see Question 02.4).
49
02.2
Does the quality management system encompass all areas, levels and employees of the organization?
Definition: Quality management system (according to ISO 9000:2000/3.2.3): Management system (#3.2.2) to direct and control an organization (#3.3.1) with regard to quality (#3.1.1). Requirements/Explanation: The quality management system extends to all phases of the life cycle of a product (DIN EN ISO 9004-1 Paragraph 5.1) and all value-adding processes involved. Its interacting functions are a precondition for the continuous compliance with the requirements of customers, legislators and society. A universal understanding of quality and quality assurance should extend as a "leading theme“ throughout the entire organization. The understanding of quality management as a task of all employees can be demonstrated by, for example: -
actions including various departments appropriate training, presentations, publications department-related objectives for quality improvement responsibilities matrices.
Job descriptions and organization charts serve, among other things, to endorse employees, clarify relationships at interfaces and provide evidence of relevant duties. They make the organization transparent, simplify personnel qualification and assignment and promote motivation and enthusiasm for decision-making.
50
02.3*
Are there documented procedures defining duties, responsibilities and authority levels for quality activities?
Explanation of terms: "Activities affecting quality“ relate both preventatively and reactively to the entire life history of a product. "Quality Management procedures" are specific instructions that are required in order to fulfill a defined quality-related activity. They come into effect when signed. Requirements/Explanation: Duties, responsibilities and authorities are to be unambiguously and clearly defined for those departments and employees which influence product and process quality. Thereby, coordination and interfaces between various departments and activities must be observed. These definitions are best made, for example, in: -
Quality documented procedures Responsibility matrices Job descriptions,
which come into effect when signed. Hereby, it must be ensured that duties are clearly defined with the necessary independence to fulfill stipulated requirements. This requires a definition as to who, for example: -
can stop faulty products or processes is responsible for suggesting and monitoring problem solutions monitors conformity with quality requirements, particularly after changes is responsible for quality-relevant documentation.
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02.4*
Is there a cross-functional project management established which includes the quality planning process?
Explanation of terms: "Project management“ is defined as the management of activities across several departments within an organization, aimed at the realization of a particular project (e.g. introduction of a new product [see Question 08.1], a new process, start of a series [see Element 14]). This task begins as early as possible and encompasses the concept/design phase, the manufacturing process, through to product utilization and disposal. It includes, among other things, quality planning (see Question 02.5) and the quality plan (see Question 02.6). Requirements/Explanation: Project flow charts with the main details, among other things for the management of a project, must be raised and developed at a very early stage. Here, the joint activities include: -
raising the specification concept / design, development production utilization disposal
which must be outlined and explained in the context of simultaneous engineering taking interface issues into account. Quality methods (such as QFD, DFMEA, PFMEA, DOE,...) must be applied on a project-specific basis. Depending on the task, the project team should include staff from Development, Production Planning, Quality and Production departments etc. The Purchasing department and suppliers must be included when necessary. The duties and responsibilities must, for example, be defined in project plans or respectively, in product and process development plans. The appointment of a project representative (project manager) is advantageous for all projects. In the case of new projects, it must be ensured that confidentiality, protection and security of data is guaranteed through appropriate procedures for those involved in the project. Suppliers, if necessary, are also be included. Note:
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The requirement for a "Configuration management" in the standard DIN EN ISO 9004-1, Chapter 5.2.6 and 8.10, is interpreted as "Project management" in this questionnaire (also see DIN 69905[12.90] - Project implementation). See also ISO 10006:1997, Quality management - Guidelines to quality in project management.
02.5*
Is there a quality planning process for the necessary measures and procedures for fulfilling quality requirements?
Definition: Quality planning (acc. to ISO 9000:2000/3.2.9): Part of quality management (#3.2.8) focussed on setting quality objectives (#3.2.5) and specifying necessary operational processes (#3.4.1) and related resources to fulfil the quality objectives. Note:
Establishing quality plans (#3.7.5) can be part of quality planning:
Requirements/Explanation: Quality planning (also known as advanced quality planning) must be regarded as an interdisciplinary task which defines how the quality requirements should be fulfilled. It must be compatible with the quality elements of the organization and match the size, structure and working methods used (e.g. through reference to appropriate procedures/already existing planning schedules or descriptions). Quality planning must take into account the tasks and deadlines stipulated by the customer and must contain specially defined methods. Interdisciplinary teams must be used for the activities to be carried out (e.g. Product Development, Process Planning, Quality, Marketing).
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The quality planning phases for new products are: • Planning and definition - Determining the customer's requirements and expectations - All activities must be carried out from the view of the customer (end user, consumer). - Input data and results can vary - The stated input data and results represent recommendations. • Product design and product development, including verification - The quality planning team responsible for the product must consider all development aspects in the planning process in order to ensure that the end product meets the customer's expectations. - If the design responsibility lies with the customer, design aspects must also be considered. • Process design and process development, including verification - Development of a process system with the quality plans to be used - The process system must ensure that the requirements, needs and expectations of the customer are met. • Process and product validation - The production process must be validated by evaluating a trial series. - The quality planning team responsible for the product should verify that the quality plan and the process plan are fulfilled and that the products meet the customer's requirements. • Feedback, evaluation and corrective measures - The results of the trial series have to be evaluated to ensure that the products meet the customer's requirements. - The effectiveness of the product quality planning process must be newly evaluated
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Activities include, for example,: -
02.6*
Definition and identification of significant characteristics (tailored to the customer's stipulations) Development and review of risk analyses (e.g. FMEAs) and the resulting measures. Development and review of quality plans (see Question 02.6) Determining the required resources (e.g. personnel, production equipment, measuring systems) Clarification of acceptance criteria Examination of the realization of the process Determining manufacturing feasibility/practicality (see Question 07.2)
Are there quality plans resulting form the quality planning process?
Definition: Quality plan (according to EN ISO 9000:2000/3.7.5): Document (#3.7.2) specifying which procedures (#3.4.5) and associated resources shall be applied by whom and when to a specific project (#3.4.3), product (#3.4.2), process (#3.4.1) or contract. Note 1:
These procedures generally include those referring to quality management processes and to product realization processes.
Note 2:
A quality plan often makes references to parts of the quality manual (#3.7.4) or to procedure documents.
Note 3:
A quality plan is generally one of the results of quality planning (#3.2.9).
Depending on the customer’s requirements and organizational practice, a quality plan can be an independent document or the relevant stipulations are incorporated into a different document, such as, for example, in a project plan. Requirements/Explanation: Quality plans must include components, modules, subassemblies, parts and materials and the production processes associated with the marketable product.
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The quality plan must normally be drawn up for the following 3 phases: • Prototype phase A description of the dimensional, material and functional inspections and tests which must be carried out during prototype construction (when required by the customer). • Pre-series phase A description of the dimensional, material and functional inspections and tests which must be carried out after prototype construction and before series production. • Series phase Comprehensive documentation of the product and process characteristics, the process control measures, the inspections and tests and measuring systems which must be observed during series production. When quality plans are drawn up, a distinction is made between various versions. These are related to tangible products in a)
plans for a part manufacturing process with, for example, the following content: • • • • •
Part name Process plan (manufacture / inspection / storage) Process stages (working steps) Work instructions Identification of the quality-relevant characteristics which have to be monitored during production. • Process monitoring - Process description - Monitoring methods (quality control charts, automatic recordings etc.) - Responsibilities (operator inspection, quality inspection etc.) - Inspection instructions • Inspection - Parameters - Geometric/material/functional characteristics • Documentation,
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b)
plans for a finished product with, for example, the following content: • • • • • •
Responsibilities (organizational units) Review of the customer requirements Contract review Design review Production Product inspection and testing
including • • • •
Associated management plan Design and development plan Product quality plan for purchased products Manufacturing plan (provision of machines, tools, equipment, testing and inspection equipment) • Control plan (see Question 15.1) • Service plan
If required, the quality plan must be agreed upon with the customer. Quality plans are living documents and must be reviewed and updated if: -
the product has been modified the processes have been changed the processes are no longer stable or capable
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03
Internal Quality Audits ISO 9001:2000, Clause 8.2 No organizational measure, or quality management system procedure, works automatically when it is put into place. It requires constant development and monitoring. Internal quality audits carried out by trained and qualified staff serve the purpose of systematic and continuous review as to whether the activities defined in the quality management system and their results: - actually meet the requirements - are suitable for achieving the objectives and - demonstrate improvement possibilities (CIP – continual improvement process) All the elements, aspects and components of a quality management system should be regularly subjected to internal reviews (internal quality audits). The audit results shall be presented to management for their review in documented form and, if necessary, should lead to corrective actions being implemented. Audit reports are quality records. An internal audit encompasses all quality elements and thereby provides the objective evidence about the necessity for the reduction, elimination and, most importantly, the prevention of nonconformities. Note:
VDA Volumes 6.3 and 6.5 are applicable references.
Reference ISO 9001:2000 03.1 * 03.2 * 03.3 * 03.4 *
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Are the personnel (auditors) who perform internal quality audits qualified and independent of the areas being audited? Are all elements of the quality management system regularly subjected to internal audits and evaluated according to an audit plan? Do deviations lead to corrective actions and are these documented? Are the demands placed on products and processes audited and evaluated internally on the basis of an audit plan?
8.2.2
8.2.2; 4.2.4 8.2.2; 8.5.2 8.2.3; 8.2.4
03.1 *
Are the personnel (auditors) who perform internal quality audits qualified and independent of the areas being audited?
Definition: Auditor (according to ISO 9000:2000/3.9.9): Person with the competence (#3.9.12) to conduct an audit (#3.9.1). Explanation of terms: "Quality auditors" (see DIN ISO 10011, Part 2) must be impartial and free from any influences which might affect their objectivity. Personnel tasked with carrying out audits must be independent of the areas on which they are reporting. They must not come from the organizational unit to be audited. Requirements/Explanation: Auditors must be qualified to manage and perform internal quality audits. The required qualification profile must be defined. Depending on the type of audit and size of the organization , the following aspects are particularly relevant: • Qualification in accordance with DIN ISO 10011-2 and training in accordance with EOQ or equivalent guidelines. Evidence of training can also be supplied through internal training courses. • Knowledge and understanding of the standards which might form the basis for audits of quality management systems (DIN EN ISO 9000 - 9004, VDA Volume 6, Part 1) • Evidence about the methods of assessment through investigation, interview, evaluation and reporting (e.g. auditor training in accordance with VDA 6.1) • Skills that are essential for the management of a quality audit, such as planning, organization, communication and leadership • Experience in quality management and quality techniques • Personal characteristics, such as, e.g. integrity, good judgement, analytical ability, open-mindedness • Upholding of relevant qualifications with certificates. The qualification profile must be appropriately demonstrated. Note:
For further information, see VDA 6, Chapter 6.
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03.2*
Are all elements of the quality management system regularly subjected to internal audits and evaluated according to an audit plan?
Explanation of terms: The different types of audits with scheduled dates and the areas to be audited have to be defined in an "audit plan“ (according to DIN ISO 10011-1). This auditing is the systematic review of all quality elements with regard to their effectiveness, compliance with the requirements and their topicality. Requirements/Explanation: System audits must be planned and carried out. Audit plans tailored to the quality elements to be audited must be available in the organizational units. An audit plan must contain the following information: -
Reference documents (standards, quality manual, procedures, etc.) Areas and quality elements to be audited Audit sequence Questionnaire / checklist Scheduled dates Auditors / audit team
After completion of an audit, an audit report with the nonconformances found and suggested corrective actions is to be raised. It is to be distributed to the organizational units involved in the audit and to the organization management. The effectiveness of the corrective actions is to be evaluated within an appropriate period of time (see also Question 01.6). Individual quality elements or parts thereof can also be inspected and evaluated at different times. All quality elements, in all areas, and at all sites of the organization must be audited within 3 years.
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03.3*
Do deviations lead to corrective actions and are these documented?
Definition: Corrective action (according to ISO 9000:2000/3.6.5) Action to eliminate the cause of a detected nonconformity (#3.6.2) or other undesirable situation. Note 1:
There can be more than one cause for a nonconformity.
Note 2:
Corrective action is taken to prevent recurrence whereas preventive action (#3.6.4) is taken to prevent occurrence.
Note 3:
There is a distinction between correction (#3.6.6) and corrective action (#3.6.5).
Requirements/Explanation Detected deviations must lead to immediate corrective actions, i.e. remedying the cause of one or more nonconformances. A plan of action must be presented within an agreed time regarding the deviations and proposed corrective actions. The action plan contains, for example: a) Deviations - Non-compliance with a requirement of a standard - Instructions are not suitable to achieve the objective - Activity does not correspond to the instructions - Instructions not actually implemented b) Evaluating / weighting deviations with respect to - Image - Risk/product safety - Economy c) Remedial measures d) Responsibilities/deadlines e) Effectiveness check f) Reporting g) Adapting the documentation (including the quality management system)
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03.4*
Are the demands placed on products and processes audited and evaluated internally on the basis of an audit plan?
Explanation of terms: A "product audit" serves to assess the compliance of the workmanship with the defined quality requirements on the product after the final inspection. A "process audit" serves to check whether the product complies with the quality requirements and that the process is mastered and capable. Requirements/Explanation Product and process audits must be planned and carried out Audit plans must be defined for products and processes and must include the following information: -
Audit aim Reference documents Products/processes to be audited Audit sequence Questionnaire/checklist Deadlines Auditors Reporting with distribution list Pursuit of corrective measures
After completion of an audit, an audit report with the nonconformances found and suggested corrective actions is to be raised and issued to the involved parties. The effectiveness of the corrective actions is to be evaluated within an appropriate period of time (see also Question 01.6). The appropriateness of the working and ambient conditions should also be examined during these audits (see Question 14.6).
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04
Training ISO 9001:2000
Clause 5.5.3; 6.2
The organization's employees are an essential factor contributing to its quality capability. In order to achieve this, measures to train, qualify and motivate employees should be planned and implemented in all areas and at all levels of the organization.
Reference ISO 9001:2000 04.1
Are training requirements regularly determined on an individual and function-related basis and is a differentiated training program for all levels of the organization derived from this?
6.2.2
04.2
Does the training program also include actions for further training in quality techniques?
6.2.2
04.3
Are top management and other management staff included in the vocational training program?
6.2.2
04.4 *
Are there introduction and instruction programs for new and transferred employees and 6.2.2; 4.2.4 for the introduction of new or modified processes, business procedures etc.?
04.5 *
Do employees possess the formal qualification for their activities?
6.2.1; 6.2.2
04.6
Are there measures for the motivation and promotion of quality awareness?
6.2.2
04.7 *
Do clear and understandable representations of the achieved quality compared to the set objectives exist in the organization?
5.5.3
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04.1
Are training requirements regularly determined on an individual and function-related basis and is a differentiated training program for all levels of the organization derived from this?
Explanation of terms: "Training program" means the determination of the entire training needs and the derived measures in all areas of the organization. Requirements/Explanation: All employees at all levels who carry out activities which affect quality must be included. Requirement profiles must be defined on a function-related basis. The training and further training activities must be summarized on an individual basis. The summary should clearly show completed and stillopen training measures, and the qualification status must be clearly recognizable. Evidence of training performed can be in the form of reports, certificates or confirmation of participation. One person is to be made responsible for the overall training program. The further training of employees and maintenance of their qualifications is the responsibility of the direct supervisor. The training program encompasses all internal and external training activities and its effectiveness should be examined periodically.
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04.2
Does the training program also include actions for further training in quality techniques?
Requirements/Explanation: The following topics are relevant, for example: -
risk analyses design of experiments test and measurement technology capability studies statistical process control quality control chart system system, process and product audit supplier evaluation problem solving techniques evaluation procedures.
The training program must be open to all employees.
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04.3
Are top management and other management staff included in the vocational training program?
Requirements/Explanation: Training sessions must be held regularly to define and increase understanding of the elements of the quality management system. These elements in particular include, for example: -
Quality objectives Quality management / TQM Quality development Quality related costs Quality information Tools and methods of quality assurance Product safety
The organizational management and other managers, for example from: -
Marketing and Sales Design Purchasing and Logistics Production scheduling and tooling Production Quality Customer Services Personnel
represent the circle of participants to be addressed. Sufficient management understanding of the potential of quality techniques forms the basis for their targeted application within the organization.
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04.4*
Are there introduction and instruction programs for new and transferred employees and for the introduction of new or modified processes, business procedures etc.?
Explanation of terms: "Introductions and instructions" are individual training measures which enable employees to understand technical and commercial documents and operational procedures, as well as the necessary techniques/methods required for their duties, and to use production equipment correctly. Requirements/Explanation: The supervisor (foreman, superintendent, group leader) must instruct his employees on the appropriate use and operation of production tools and equipment and regarding the correct interpretation of internal instructions. The supervisor must satisfy himself as to the effectiveness of the instruction. Evidence of the instruction is shown by signature. These requirements shall be applied accordingly to all organizational areas. Introduction and instruction programs have to be developed and defined. When selecting suitable employees, their personal characteristics and their specialist knowledge / capabilities must be considered. Special attention should be paid to the selection and training of new personnel, workers on temporary contracts, workers on loan and personnel entrusted with new duties. Training and instruction involves employees in the responsibility for equipment and production results. This inevitably leads to the strengthening of the relationship between employee and supervisor. Prior to the introduction of operators performing their own inspections, all affected employees in production must be trained regarding their quality management duties.
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04.5*
Do employees possess the formal qualification for their activities?
Explanation of terms: The "formal qualification" is the professional status given an employee when he has demonstrated that he is suitable to perform the defined activities. Requirements/Explanation: Records of formal qualification are necessary when legal and/or contractual issues must be taken into account. The following, for example, can be classed as qualification records: -
materials inspector certificate welder certificate certificate for non-destructive materials testing (e.g. radiographic testing)
Regular internal instruction (first and subsequent instruction) of employees is also required, as well as a check as to whether the employees are suitable for their specific duties and that substitution of employees is controlled. For auditors who carry out external quality audits, records for the following are to be provided: -
-
-
-
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Qualification in accordance with DIN ISO 10011-2 and training in accordance with EOQ guidelines or equivalent training with certificate. Knowledge and understanding of the standards which might form the basis for audits of quality management systems (DIN EN ISO 9000 - 9004, VDA Volume 6, Parts 1 to 6) Evidence about the methods of assessment through investigation, interview, evaluation and reporting (e.g. auditor training in accordance with VDA 6.1) Skills that are essential for the management of a quality audit, such as planning, organization, communication and leadership Experience in quality management and quality techniques Personal characteristics, such as, e.g. integrity, good judgement, analytical ability, open-mindedness Upholding of relevant qualifications with certificates.
Evidence must be provided for development and testing activities, for example: 04.6
Quality Function Deployment (QFD) FMEA Design of Experiments (DOE) CAD/CAM Value analysis Simulation techniques
Are there measures for the motivation and promotion of quality awareness?
Explanation of terms: "Motivation“ means the readiness of employees to perform well. "Quality awareness“ is shown by the attitude of individual employees to quality issues. Requirements/Explanation: The continual improvement of quality awareness in all organizational units may be achieved, for example, through: -
Improvement suggestions Quality circles Zero defect programs Poster campaigns, competitions Training, information meetings Awards Workshops.
The quality and performance capabilities of the organization are not only dependent on technical and organizational capabilities and business resources, rather more on the qualification and readiness of employees to perform well.
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04.7*
Do clear and understandable representations of the achieved quality compared to the set objectives exist in the organization?
Requirements/Explanation: This is related to the named objectives, defined in Question 01.2 "Quality objectives". The current achieved quality levels is to be represented, for example, by quality indices. Periodic quality reports and general information with "specified/actual" comparisons, graphical representations and other methods of communication at all levels, for example: -
Representation of quality related costs Representation of rework (amount/costs) Presentation of audit results Comparison of development objectives and development status Representation of the satisfaction of internal and external customers
are documents which give information about this. This makes a comparison between set objectives and achievements possible. The representations must be easily comprehensible and interpretable for the employees and must allow the comparison between the set objectives and achievements to be easily recognized.
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05
Financial Considerations regarding Quality Management Systems Financial considerations regarding quality management systems are necessary because: -
quality, or respectively, "non-quality“ has a considerable effect on the profit and loss situation of the organization.
-
by improving effectiveness and efficiency of work, losses are reduced and customer satisfaction raised.
-
It is therefore important that the effectiveness of the quality management system is measured in economic terms.
The collection of quality costs can be performed parallel to, or in connection with, the classical industrial cost accounting system. It must be clearly defined and enable long term comparisons/trends to be identified. Note:
Characteristic figures and trends, but not absolute values/ amounts must be demonstrated to the external auditor.
Reference ISO 9001:2000 05.1
Is there a procedure for financial reporting of the effectiveness of the quality management system?
---
05.2 *
Does regular financial reporting and evaluation by the persons responsible take place?
5.6
05.3 *
Is there evidence about internal losses as a result of unacceptable quality (nonconformity)?
---
05.4 *
Is there evidence of external losses as a re--sults of unacceptable quality (nonconformity)?
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05.1
Is there a procedure for financial reporting of the effectiveness of the quality management system?
Requirements/Explanation: There are various methods for collecting, analyzing and displaying financial data about the quality elements. The financial reporting methods used depend on the individual structure of the organization, its activities and the maturity of its quality management system. Traditional methods do not exclude the use of others, or their adaptation and/or combination. The appropriate procedure, method and cost structure (see Questions 05.2 to 05.4) must be defined (e.g. with instructions, distribution list, cost center and cost plan and a summary of all financial outlays for the organizational management). Methods of financial reporting on activities in the quality management system include, for example: • Quality-related costs - Fault prevention - Inspection and testing - Internal and external faults • or process-related costs (profit/cost ratio calculation) with - conformity costs - nonconformity costs • or quality-related losses (calculating the quality loss) with - internal and external material losses (non-fulfillment of quality requirements). Reports to management must be prepared concerning the extent, trend and analysis of costs related to nonconformances and their causes. Note:
Detailed information is only the subject of internal audits. Only the existence of the procedure must be proven to an external auditor.
The organization has the task of recording, analyzing and outlining on a cause-related and time-related basis the financial figures which illustrate the effectiveness of the quality management system. It must also introduce and monitor the effectiveness of improvement and preventive measures.
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05.2*
Does regular financial reporting and evaluation by the persons responsible take place?
Explanation of terms: Financial reports on quality-related activities should be compiled and evaluated regularly by the persons responsible. Improvements and objectives can be derived from this. Requirements/Explanation: The reports must relate clearly to business parameters, such as sales, turnover or value-added figures, in order to provide a realistic view of the organization. Characteristic parameters and measured values must be in line with target values. Trends and potential areas for improvement must be identifiable. Quality and cost targets and improvement measures must be defined for the subsequent period. 05.3*
Is there evidence about internal losses as a result of unacceptable quality (nonconformity)?
Explanation of terms: "Internal losses“ are losses before delivery as a result of unacceptable quality. They may arise from reduced work efficiency caused by rework, poor ergonomics etc. They also include nonconformity costs resulting from the non-fulfillment of quality requirements by a product prior to delivery (e.g. repeated performance of a service, renewed production, rework, re-inspection and testing, rejects). Requirements/Explanation: These costs/expenditures include, for example: -
Rejects Rework Quantity deviation Value reduction Unplanned sorting action Re-inspection and testing Investigation of the problem Down-time caused by failures Development targets not achieved.
Key cost items must be shown with their causes, in a time-, production- and product-related manner.
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05.4*
Is there evidence about external losses as a result of unacceptable quality (nonconformity)?
Explanation of terms: "External losses“ are tangible and intangible losses which are identified as resulting from unacceptable quality. Tangible losses are nonconformity costs which result from the nonfulfillment of quality requirements by a product after delivery (e.g. sorting, rework and repair, warranty performances and return shipments, direct costs and compensation, costs of product recalls, product liability costs). Typical intangible losses include, for example, lost future sales as a result of customer dissatisfaction. Requirements/Explanation: These costs include, for example: -
Warranty (on delivery/"0 km" and after use by the customer) Goodwill cases Investigation of the problem Recall action Product liability
also possible costs from -
Loss of image Loss of customers due to dissatisfaction.
Key cost items must be shown with their causes, in a time-, production- and product-related manner.
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06
Product Safety The safety aspects of a product should be identified, with the aim of enhancing product safety. The quality management system must always be directed towards the reliable prevention of nonconformities. The employees of the organization, particularly executive/ management personnel, must, in accordance with their activities, be appropriately informed of the effects of product nonconformities and the consequences for the organization arising from product liability. Note:
VDA Volume 1 is an applicable reference.
Reference ISO 9001:2000 06.1
Are the principles of product liability known throughout the organization?
06.2
Is there a procedure to define and identify products and special characteristics, for which 4.2.3; 4.2.4; special documented evidence of the quality is 7.2.1 required?
06.3 *
Have procedures for identifying product risks been defined?
---
06.4
Do emergency plans and procedures for containing nonconforming products exist?
5.6.2
5.1
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06.1
Are the principles of product liability known throughout the organization?
Definition: Product liability (according to DIN EN ISO 8402/2.12): A generic term used to describe the onus on a producer or others to make restitution for loss related to personal injury, property damage or other harm caused by a product. Note:
The legal and financial implications of product liability may vary from one jurisdiction to another.
Requirements/Explanation: Indications concerning the knowledge of the principles of product liability can be, amongst others, evidence of: -
Instruction and qualification of responsible individuals Legal services (internal / external) Product liability insurance Observation of science and technology
Product safety deficiencies can lead to liability claims against the organization. For this reason, the organization's employees, particularly the management personnel, in accordance with their activities, must have appropriate knowledge of the principles of product liability. Principles of product liability are (amongst others): -
-
-
-
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Liability dependent on blame (characterized by the reversal of the burden of proof. i.e. the burden of proof lies with the defendant) Liability independent of blame (new product liability law), liability for direct damages and consequential damages caused by a defect It must be demonstrated that the manufacturing process (design, manufacturing and testing) is "state of the art" - simply complying with the applicable standards is not sufficient Responsibilities must be defined in writing Inspection and testing documentation with archiving Traceability must be ensured (limitation of damages) Warning of possible risks when the product is put into action by the user.
06.2
Is there a procedure to define and identify products and special characteristics, for which special documented evidence of the quality is required?
Explanation of terms: Products and characteristics, which require the corresponding documentation to be specially archived, have either special significance for functional safety (operation and use) or are directly subject to requirements derived from official specifications (see VDA, Volume 1). All products with at least one such characteristic require documentation with special archiving. Their special treatment is based on general and specific safety standards related to the state of the art and customer requirements. Requirements/Explanation: The system should take into consideration, for example: -
Recognition of product risks (see question 06.3) Definition of the characteristics concerned Identification of these characteristics on all relevant documents Identification and handling of these products Documentation system with rules for retention periods and responsibilities.
The documentation includes, for example: -
-
Test results, test decisions, process parameters Records of the calibration of test equipment Records of the instruction, knowledge, competence and suitability of personnel (e.g. medical examinations, such, as eye tests) Special processes for products with characteristics subject to documentation.
All documents which relate to such a characteristic must be specially identified. Departments involved must be informed about the need for special handling of these documents.
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A retention period of 15 years (differences specified by the customer must be taken into account) is also valid after discontinuation of production (for further instructions, see VDA Volume 1). Proper documentation can contribute towards exoneration in warranty and product liability cases. The organization obligates itself with the order confirmation to follow the appropriate procedure, if agreed. 06.3*
Have procedures for identifying product risks been defined?
Explanation of terms: "Product Risks" are safety risks that are involved in the product fulfilling its own function. Furthermore, this also refers to the risks that a component brings to a complete assembly. Requirements/Explanation: Product risks are identifiable through, for example: -
Risk analyses (FMEA, amongst others) Load-bearing tests Service life tests Crash tests Material testing Installation trials Environmental simulation tests Investigations of environmental compatibility and disposal
and the derived measures resulting from these. The safety aspects are of predominant importance during these examinations. The applicable procedures serve to identify and estimate the potential dangers, which arise from an incorrectly developed, manufactured and/or described product. If necessary, they must lead to decisions regarding actions to be taken. This applies equally to product descriptions (e.g. manuals).
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06.4
Do emergency plans and procedures for containing nonconforming products exist?
Explanation of terms: "Procedures to contain nonconforming items" serve damage limitation. They facilitate the traceability of products in a manufacturing operation back to the material and processes used. Requirements/Explanation: Emergency plans for product recalls must be defined commensurate with the product risks, which are derived from the safety relevance of a product and possible risks in the entire process chain. Procedures to contain nonconforming products (see also Questions 11.7 and 13.6), for example, can be: -
Identification on the part/product Lot/batch identification Product verification, documentation Product identification during transport and storage Following the "first-in/first-out" principle Stating and observing use-by dates
Recognized nonconformities which are relevant to safety can thereby be limited (damage limitation) in the field (during use) and possibly remedied by improvement or recall actions.
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80
Z1
Corporate Strategy Improved and constant quality, delivery reliability in the agreed time frame and cost reductions on the one hand, plus more intensive confidence-building customer/supplier relationships on the other hand, in addition to stronger international business relationships, today force many organizations to adapt their strategy to these requirements. Management of the organization, including immediately subordinate executive level, must therefore concern itself with the following subjects, e.g.: -
Business plan Business results Customer satisfaction
Note:
-
Comparison of internal and external performance data Employee satisfaction
Characteristic figures and trends, but not absolute values/amounts, must be proven to the external auditor.
Reference SO 9001:2000 Z1.1
Z1.2
Is there a strategic business plan in the organization which contains aspects relating to costs, sales, quality etc.?
---
Are there methods to measure business results and are they used regularly in order to introduce improvements?
8.4; 8.5.1
Z1.3
Is organization-wide performance data compared with results from benchmarking or simi--lar methods and are improvement measures derived from this, if necessary?
Z1.4 *
Is there a procedure which enables customer satisfaction to be measured and changes to be detected?
8.2.1; 8.4
Z1.5
Is employee satisfaction in the organization one of the principles of management and is it maintained on a continuous basis?
6.2.2
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Z1.1
Is there a strategic business plan in the organization which contains aspects relating to costs, sales, quality etc.?
Definition of terms: A "business plan" is a document with organization-specific strategic projects and targets which must be fulfilled or achieved in a defined period. Requirements / explanation: A business plan normally includes the following: a) Cost aspects - Finance and cost planning (investments, personnel and material costs) - Cost targets b) Sales and marketing aspects - Market data - Turnover/sales targets - Customer satisfaction criteria (see Question Z1.4) c) Overall corporate aspects - Growth projects - Plant structure plans - Personnel planning - Comparison with other organizations (benchmarking) d) Development aspects - Development and trial projects - Product analyses of competition results e) Process and quality aspects - Important characteristic data of process performances - Important quality related figures (see Question 01.2)
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All aspects should: -
have time details be based on project-related knowledge take into account present and future customer expectations be understandable and monitored, and adapted to any changes serve the purpose of process and quality improvement
Business planning activities must be carried out on an interdisciplinary basis Note:
External auditors are to be provided with evidence of: characteristic figures, time frame, tendencies, trend analyses but not absolute values/amounts and also not for all aspects. Attention must be paid to organization-specific matters.
Z1.2
Are there methods to measure business results and are they used regularly in order to introduce improvements?
Definition of terms: The "business result" expresses what the organization achieves with respect to its planned performance. Requirements/Explanation: Starting points for financial variables can be, for example: -
Profit Cash flow Turnover Value added
− − − −
Capital Liquidity Dividends Shareholder long-term value
In practice, these values are shown partly as absolute values and partly as ratios per capital unit or per employee. Starting points for non-financial variables can be, for example: -
Market share Rejects achieved
− Variability of products − Customer service level
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Cycle times such as: -
Innovation time Time until the profit threshold is reached Stock turnover frequency
The measured variables are orientated towards the organizational strategy and to the corporate aims and plans. They contain measured variables which enable the internal economy and effectiveness to be recognized and which are decisive for continued corporate success. Note:
Only the existing system is to be evaluated, not the absolute values / results.
Z1.3
Is organization-wide performance data compared with results from benchmarking or similar methods and are improvement measures derived from this, if necessary?
Requirements/Explanation: The evaluation, analysis and use of organization-wide performance data in comparison with the data of competitors or other organizations through benchmarking must give information on, for example: -
Productivity Economy Quality situation Efficiency
Trends in the data and information should be compared with the progress made towards the organization's overall targets and converted into useable information for the purpose of: -
development of priorities for the rapid solving of customerrelated problems determining the important customer-related trends and interrelationships in order to make a review of the organization's situation, decision-making policies and long-term planning possible.
Note 1:
Only the existing system is to be evaluated, not the absolute values/results.
Note 2:
This question can be omitted for organizations (particularly small businesses) which do not operate on international markets.
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Z1.4*
Is there a procedure which enables customer satisfaction to be measured and changes to be detected?
Requirements/Explanation: The procedure must consider the following criteria, e.g.: -
Method application Recognition frequency Data evaluation and representation Interpretation of trends Responsibility Distribution list
Measurable variables can be, amongst others: -
Flexibility regarding inquiries to new/changed products/ processes Achievement of targets Product quality at delivery Delivery reliability (see Question 19.6) Speed of reactions when quality problems occur
Comparisons with competitors and benchmarking methods are helpful. As far as possible, not only the direct customer but also the end consumer should be involved. Measures which lead to greater customer satisfaction should be derived from the knowledge gained. Note:
Only the existing system is to be evaluated, not the absolute values / results.
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Z1.5
Is employee satisfaction in the organization one of the principles of management and is it maintained on a continuous basis?
Definition of terms: "Employee satisfaction" is measured by the way the employees perceive their organization. The needs and expectations of employees must be satisfied by a comprehensive quality approach, in order to advance the employees readiness to work well. Requirements/Explanation: Points which effect employee satisfaction are, e.g.: -
Working conditions, work location, environment, equipment Health and safety measures Communication on an individual and organization-wide level Employee performance evaluation, agreed goals, career planning Knowledge of work requirements Knowledge of quality policy and corporate strategy Involvement in quality matters System for recognizing and rewarding performance Management style Job security
Further indicators for employee satisfaction can be, for example: Note:
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Results of employee surveys (questionnaire) Absenteeism and sickness quota Personnel turnover Ease in hiring recruits/trainees Use of organization facilities
Only the existing system is to be evaluated, not the absolute values / results.
Part P:
Product and Process
07
Contract Review, Quality in Marketing ISO 9001:2000 Clause 5.2; 7.2 This quality element deals with the contract review, a marketing duty. Marketing includes market research, marketing and sales. The marketing function should take priority when defining the quality requirements of the product. They determine the requirements for a product, the market demand and the customer requirements. Before a quotation is submitted or a contract or order is accepted, the requirements contained therein are to be checked for completeness, feasibility, ability to fulfill etc. (contract review). This applies equally to contract changes. The requirements of the customer should be documented in a performance specification and should be clearly communicated.
Reference ISO 9001:2000 07.1
Has a function ‘marketing’ been incorporated into the process organization?
5.2; 7.2.1
07.2 *
Are inquiries, quotations, contracts/orders checked for completeness and feasibility and approved?
7.2.2
07.3
Are technical and commercial costs ascertained when preparing a quotation?
---
07.4
Are the customer's quality requirements on the product and the quality management system available?
7.2.3
07.5
Is a procedure available that ensures the early and clear notification of all product specifica7.2.1; 7.2.2 tions to all areas involved?
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07.1
Has a function ‘marketing’ been incorporated into the operational organization?
Definition: The process organization determines the sequence of actions (control mechanism) for dealing with a very specific process, for example, from the market analysis through product development to the payment of invoices. Requirements/Explanations: The function ‘marketing’ and its tasks must be described. Marketing must determine, define and document the quality requirements and expectations for a product. To do this, a process organization has to be established in which all involved functional or organizational units are included and their tasks defined. This can be part of the project management (see Question 02.4). Tasks are, for example: -
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Projection of production numbers Providing information on prices and utilization deadlines Informing about specific customer requirements/expectations and evaluating feasibility Guaranteeing internal acceptance for the manufacture of a product with defined requirements Taking into account logistical concerns Providing for disposal.
07.2 *
Are inquiries, quotations, contracts/orders checked for completeness and feasibility and approved?
Definition: Contract Review (according to DIN EN ISO 8402/3.10): Systematic activities carried out by the supplier prior to signing the contract to ensure that the quality requirements are adequately defined, free from ambiguities, documented and can be realized by the supplier. Requirements/Explanations: Prior to the submittal of a quotation or the acceptance of a contract/order the contract documents (specifications, drawings, requirement specifications, standards, quality agreements, logistical stipulations etc.) must be checked for completeness. Hereby it must be ensured that, e.g.: -
requirements are complete, appropriate and documented agreement exist for verbally placed orders prior to acceptance ambiguities and deviations are clarified early.
For this a system must be in place in which all responsible functions of the organization (e.g. sales, development, production, production preparation, quality department and material management) confirm that they are able to fulfill customer requirements. The interfaces to the customer are to be defined. The contract review includes, for example: -
a defined sequence of events in the quality manual/procedures (flow chart) Approval ruling prior to submittal of quotation to the customer (form with approval by the responsible organizational units) Review of contract documents, among others, for: • clarity of the individual requirements • inconsistency of individual requirements • missing of individual requirements • given deadlines.
When contradictions are detected and requirements are not able to be maintained the customer (normally the responsible developer, purchaser) must immediately be informed, i.e. even prior to the submittal of a quotation. The same sequence of events also applies for contract changes.
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07.3
Are technical and commercial costs ascertained when preparing a quotation?
Definition: In a quotation a customer (the market) is offered a product for purchase or it is provided to him as property or for use. Products can be tangible or non-tangible. Requirements/Explanations: For a quotation, all decisive cost elements must be established and taken into consideration. The costs are compiled by the responsible divisions and are incorporated into the overall calculation. The individual cost elements contain, for example: -
development costs material costs investments (including hardware/software) costs for quality measures transportation costs packaging costs value-added portions/calculated profit overheads (administration and marketing cost)
Note:
The procedures in practice must be proven to the auditor, rather than the absolute values.
07.4
Are the customer’s quality requirements on the product and the quality management system available?
Definition: Requirements for quality management systems and requirements for products (see ISO 9000:2000/2.2). Requirements/Explanations: The quality requirements for a product must be documented, defined and thereby the customer’s requirements completely taken into account. All relevant functional/organizational units are to be included in these sequences.
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The quality requirements (of the customer) are described, for example, in: -
Specifications Quality agreements Drawings Performance specifications Standards Purchasing conditions Order documents.
The definitions also include requirements based on, for example: -
Delivery call offs Delivery dates Prices Packaging/Identification Disposal.
Special requirements with regard to type, scope and structure of the quality management system are to be agreed separately.
07.5
Is a procedure available that ensures the early and clear notification of all product specifications to all areas involved?
Definition: Requirements Specification (according to DIN 69905): The entirety of the customer requirements concerning the supplies and services of the supplier. According to VDI/VDE 3694: In the requirements specification, all requirements from the user’s perspective, including all boundary conditions, are to be described. These should be quantifiable and able to be verified. The requirements specification defines what the task is and why it is to be accomplished.
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Performance Specification (according to DIN 69905): All the realization requirements worked out by the supplier based on the implementation of the requirements specification. According to VDI/VDE 3694: The performance specification contains the requirements specification. The user requirements are detailed in the performance specification and described in an expansion of the realization requirements under consideration of concrete solutions. The performance specification defines how and with what the requirements are to be realized.
Requirements/Explanations: Evidence must be provided for a procedure which ensures the maintenance and distribution of all relevant documents to the responsible organizational units. Thereby, it must be ensured that the requirements are generally comprehensible, i.e. if necessary: • are translated (e.g. translations of foreign language customer standards, quality agreements, requirements specification etc.), • are explained and clarified (e.g. explanation of customer-specific abbreviations), • the customer contacts for specific topics (development, purchasing, quality assurance etc.) are known to those responsible • product function and assembly status are known. The entirety of the customer requirements on a product is to be regarded as the product specifications. They are defined, for example, in the requirements specification and as realization requirements drawn up by the contractor, for example in the performance specification. Apart from the performance characteristics, they also contain assembly instructions, applicable standards, quality assurance methods, packaging etc.
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08
Design Control, (Product Design and Development) ISO 9001:2000 Clause 7.1; 7.3 The quality element design control also called the quality at interpretation and design describes the quality-ensuring tasks in the area of product design and development. These should take care of the transferal of the customer needs from the requirements specification into a performance specification and technical specifications for products and prepare for a timely realization in conformance with customer requirements. The provision of resources for, e.g.: personnel, equipment, trials is a precondition for product development. Note 1:
Note 2:
This element is to be evaluated except when design responsibilities are contractually defined. It is not applicable when a completed product design is adopted. VDA Volumes 2, 3, and 4 Parts 1, 2 and 3 are applicable references.
Reference ISO 9001:2000 08.1 *
Does an appropriate product development plan for a new product exist?
08.2
Is it ensured that all product requirements can 7.3.2; 7.3.7 be realized?
08.3
Are product trials planned during the develop- 7.3.3; 7.3.5; ment and pre-series phase? 7.3.7
08.4 *
Are procedures and methods available to carry out a quality evaluation of designs, de7.3.4; 7.3.6; sign models and pre-series products in accor- 7.3.7 dance with the particular project phase?
08.5
Are all responsible functions involved in the release of the product design and its realization?
7.3.4; 7.3.5; 7.3.6; 7.3.7
08.6
Is the result of the product design and development documented in specifications?
7.3.3; 7.3.7
08.7
Are the experiences of product design and development experiences of products docu--mented and are they available to other areas?
7.1; 7.3.1; 7.3.7
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08.1*
Does an appropriate product development plan for a new product exist?
Requirements/Explanations: For the product development plan current milestone plans, network plans etc. with detailed plans must be produced which show all activities from placement (design and development) through to start of series. The systematic processing of the planned tasks (project planning) must be guaranteed. A person responsible for the project and all involved areas with their tasks must be name (see Question 02.4). Central monitoring of the project’s progress must be guaranteed (specified/actual comparison). Monitoring must cover the compliance with all given targets such as, e.g.: -
deadlines product qualifications costs.
Evidence must be furnished on the basis of examples, although not all steps stated below must occur, depending on the organization and product in question. The plan for the development of a new product is normally characterized by the following steps: -
Checking design requirements with regard to appropriateness Documenting design result Checking the design results with other competent organizational units Verifying design (checking) as to whether the requirements of the design tasks are fulfilled Validating the design (approving/enforcing) to determine whether the customer’s requirements are met Identifying, documenting, checking and approving design changes and modification according to Question 08.4 and 08.5 Up-dating product development plan.
To limit costs it is appropriate to design inspection and testing tools and equipment (including software) so that most of it can be reused for series production.
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08.2
Is it ensured that all product requirements can be realized?
Definition: "Quality Requirements" (see also definition in Para. 4.1/ #3.1.2) are described, e.g. in: -
laws, ordinances, etc. general standards, guidelines, specifications special standards or requirements specifications (these may contain special inspection and test instructions also for hardware and software).
Requirements/Explanations: The quality requirements as, for example, described in the requirements specification (compare Questions 07.4 and 07.5) must be checked for feasibility within the scope of a design review (compare DIN EN ISO 9004, Part 1/8.5.2). The design requirements must consider the bases and results of the contract review (compare Questions 07.2 to 07.4). Points to be considered are, e.g.: -
producibility, testability, precision inspection and test set-up, inspection and test equipment, computer support release criteria*3 experience from production and use (compare Question 21.3) external or internal standards/specifications or instructions legal requirements (safety, environmental compatibility, disposal).
Suppliers tasks are also to be included in the review. Overall responsibility remains with the organization. In cases where fulfillment is not possible, comprehensible measures are to be taken to fulfill the requirements. Unclear, contradictory requirements must be clarified with the person responsible.
*3 Release criteria, in addition to other customer-defined criteria, concern in particular special characteristics with regard to function, safety and appeal. 95
If the development responsibility for a particular product lies, as agreed, with the organization, then it should use computer-supported design and engineering (CAD, CAM, CAQ), e.g., for FMEA, QFD and quality plans. Thereby it has to be ensured that a problem-free data exchange with the customer is guaranteed.
08.3
Are product trials planned during the development and preseries phase?
Requirements/Explanations: Product trials must be considered in the project plan. The trial conditions for the product are to be determined and agreed with the customer. The results of the product trials must be compared to the requirements. When the requirements are not met the corrective actions must be comprehensible. The product trials may also be performed by an external body (e.g. independent inspection agencies, customers). The competence of external bodies must be proven; if required, accredited bodies are to be used. Product trials are, e.g.: -
assembly trials functional testing durability testing environmental simulation testing.
They may be documented in, e.g.: -
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product life cycles test reports trial plans
08.4 *
Are procedures and methods available to carry out a quality evaluation of designs, design models and pre-series products in accordance with the particular project phase?
Requirements/Explanations: The quality evaluations should include: a) assessment of function, safety, reliability, maintainability under the anticipated storage and usage conditions. b) qualification tests to confirm that all individual requirements on the quality characteristics of the design are fulfilled and that all approved design modifications are implemented and recorded. c) timely identification of problem areas and shortcomings, as well as introduction of corrective actions (compare Question 06.03 and VDA Volume 4, Part 1, 2 and 3). d) the result of the product design must be tailored to the possible processes (operating means, equipment) (process capability). e) practical preliminary planning for the quality of the series and purchasing f) consideration of test results and field experiences. A quality evaluation may be performed using various methods. In the appropriate project phases (development progress) for products and processes these are, e.g.: "Design" Phase -
Risk analyses (e.g. Failure Mode and Effects Analysis, Fault Tree Analysis) (compare VDA Volume 4, Part 1 and 2) Design of Experiments (statistical test methodology, e.g. according to Taguchi, Shainin).
"Development sample/Prototype" phase: -
Risk analysis (e.g. Failure Mode and Effects Analysis, Fault Tree Analysis) Functional tests and release Reliability testing/durability testing QFD.
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"Production prior to series start“ phase (see also Quality Element 09): -
Process analyses Process optimization Process review Compliance with specification limits.
Note:
Procedure for release of series production see Question 14.2 (Product) and Question 09.5 (Process).
08.5
Are all responsible functions involved in the release of the product design and its realization?
Requirements/Explanations: A procedure for the release to realization including responsibilities is to be established. The following, among others, must be defined for realization: -
Number, state, delivery date, packaging, delivery location of development samples (prototypes) and initial samples Form and contents of the inspection reports in agreement with the customer Release of samples Qualification and monitoring of product and cost trends, also at suppliers involved. (List of approved suppliers compare Question 11.2).
Release is based on the evaluation of the feasibility of the design by, among others, development, sales, purchasing, production, quality assurance, together with the customer (Project launch meeting). It represents the approval that the design may be realized. Note:
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VDA Volume 2 is an applicable reference.
08.6
Is the result of the product design and development documented in specifications?
Definition: Specification (according to ISO 9000:2000 / 3.7.3): A document (#3.7.2) stating requirements (#3.1.2). Note:
A specification can be related to activities (e.g. procedure document, process specification and test specification) or products (#3.4.2) (e.g. product specification, performance specification and drawing).
Requirements/Explanations: The results of design and development must be appropriately documented in the specifications (see Quality Element 10). These documents for the realization of the quality requirements must be complete and unambiguous. For products that are not clearly specified in the customer's drawings ("as delivered", "as per manufacturer's choice", “without information on inspection and test instructions“ etc.), the corresponding information in the organization’s detailed drawings and the finished part drawings must be completed. Furthermore, the narrowing of tolerances on the customer's drawings might be necessary. The organization's specifications must cover the requirements specified by the customer.
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08.7
Are the experiences of product design and development experiences of products documented and are they available to other areas?
Requirements/Explanations: The experiences/results gained during development and trials which are, e.g., applicable to other development plans must be evaluated, documented in writing or stored on a computer system. This may be done, e.g., in: -
-
design manuals data bases for design FMEA product life cycles with, for example, product optimization/ improvements, adaptation through modified/improved production procedures documentation of test results corresponding reports on materials and procedures.
It is an objective to have the development experiences in the organization readily available independent of persons thereby avoiding repeated nonconformities in design. This information is to be made available to all relevant areas.
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09
Process Planning (Process Development) ISO 9001:2000 Clause 7.1; 7.3; 7.5 The planning and development of processes and procedures for manufacturing products are an essential part of all activities prior to the start of new/modified processes. They incorporate the planning of all necessary resources such as, e.g., equipment, plants, technology, method, personnel and transports. Within the scope of production preparation it also includes the production organization, the planning of material and production flow, the layout as well as measures for safeguarding production, including tool management. Process planning is performed at the earliest possible time parallel to product development (design control), or is performed additionally after completion of product development timely prior to serial production in order to realize production processes and process sequences. (Activities prior to the initial start of series production are discussed in the Quality Element 14 "Process Control"). Note:
09.1 * 09.2
09.3 09.4 * 09.5 09.6
09.7
VDA Volumes 2 and 4, Parts 1, 2 and 3 are applicable references
Reference ISO 9001:2000 Does an appropriate process development plan for 7.1; 7.3.1; 7.3.7 new/modified products exist? Are production, assembly and maintenance processes and the material flow planned according to 7.5.1; 7.3.7 quality aspects and are process control requirements defined? Is it ensured that all product requirements are met 7.3.2; 7.3.7; 7.5.1 by the process? Are procedures and methods available to carry out 7.3.4; 7.3.5; a quality evaluation of processes and procedures 7.3.7; 7.5.2 in accordance with the respective project phases? Are all responsible functions involved in the re7.3.7; 7.5.2 lease of processes and procedures? Is the result of process planning/development 7.3.3; 7.3.7 documented in process specifications/ procedures? Are the experiences from process planning and 7.3.1; 7.3.3 development documented and are they available to all relevant areas?
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09.1 *
Does an appropriate process development plan for new/ modified products exist?
Requirements/Explanations: For the process development plan, current milestone plans, network plans etc. with detailed plans must be produced which show all activities from placement (development) to series start. The personnel and finance resources are also to be considered in the development plan. The systematic processing of the planned tasks (project planning) must be guaranteed. A project manager and all involved areas with their tasks must be named. Central monitoring of the project’s progress must be ensured (specified/ actual comparison). Monitoring must cover compliance with all stated targets such as, e.g.: -
Deadlines Process Qualifications Costs.
Evidence must be furnished on the basis of examples, although not all steps stated below must occur, depending on the organization and product in question. The following (amongst others) applies to the development of processes for manufacturing the new product: -
Production planning Equipment/tool design and construction Procurement (of products, materials, components) from suppliers Operating equipment construction External developments Purchasing and the procurement of production and manufacturing equipment Updating the process development plan.
For this, suitable technical resources are to be used. To limit costs it is appropriate to design testing tools and equipment (including software) so that most of it can be reused for series production.
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09.2
Are production, assembly and maintenance processes and the material flow planned according to quality aspects and are process control requirements defined?
Definition: Process control Process control is a quality control where the observed unit (tangible or non-tangible object of an observation) is a process. Requirements/Explanations: Processes such as production, assembly and maintenance, as well as the material flow which have a direct influence on the quality of the products to be manufactured, are to be defined. It must be ensured that controlled conditions are available. The conditions to be controlled include, for example, the definition of: -
process sequences, process parameters machines, equipment, facilities, inspection, measuring and test equipment (including identification) recording of process nonconformities and corrective measures working conditions (work plans, tooling plans) monitoring the compliance with given requirements approval procedures to be introduced standards and guidelines to be observed.
The documents (procedures/quality plan) to be produced by the supplier must include not only individual work steps but also inspection and test steps or references to inspection and test instructions. When an operator inspection is carried out references must be available in the work instruction to a defined inspection and test responsibility. These documents must be available at site, continuously updated and provided with a revision status. The relation to the revision status must be comprehenisble.
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To achieve and maintain controlled processes, it is also necessary to carry out a systematic planning for, e.g.: -
material control release of equipment for production, assembly and maintenance approval of procedures and work instructions quality plans computer software documentation requirements
as well as to describe and verify the requirements placed on the execution of work, for example, through: -
examination, comparison and limit patterns photographs quality guidelines packing instructions.
They make the decision-making easier when carrying out activities in production, especially where special visual requirements and damage risks exists. Note:
Packaging and storage, see Quality Element 19.
09.3
Is it ensured that all product requirements are met by the process?
Definition: "Quality Requirements" (see also definition in Para. 4.1/ #3.1.2) are described, e.g. in: -
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Laws, ordinances, etc. General standards, guidelines, specifications Special standards or requirements specifications (these may contain special inspection and test instructions).
Requirements/Explanations: The quality requirements (compare Question 07.4) as described in, for example, the requirements specification must be checked for their ability to be complied with within the scope of a process review (compare DIN EN ISO 9004, Part 1/8.5.2). Points to be considered are, e.g.: -
customer-specific requirements (including performance-related and visual items) producibility, test capability, precision inspection and test arrangements, inspection and test equipment, computer support release criteria*1 experience from production and use (compare Question 21.3) external or internal standards/specifications or instructions legal requirements (safety, environmental compatibility, disposal).
The compliance with legal requirements must be guaranteed in the process. The inspections are based on the relevant national requirements. A quality plan must be drawn up. Tasks for suppliers are also to be included in the review. Overall responsibility remains with the organization. In cases of noncompliance, comprehensive measures are to be taken. The organization should use computer-supported design and engineering (CAD, CAM, CAQ), e.g., for FMEA, QFD, quality plans to guarantee problem-free data exchange with the customer. The process requirements must take into account the bases and results of the contract review (compare Questions 07.2 to 07.4).
1
* see footnote to question 08.2 105
09.4 *
Are procedures and methods available to carry out a quality evaluation of processes and procedures in accordance with the respective project phases?
Requirements/Explanations: The method of quality evaluation for processes is applied to ensure that all quality-relevant findings from the various phases of product development can be realized. In detail, the process shall : • ensure that the best possible and most comprehensive picture of the desired quality of the new product is produced by involving and systematically questionning all affected functional areas, • identify potential weak spots early through the appropriately timed application corresponding to each project phase and initiate the introduce of corrective actions • guarantee and clarify the implementation of corrective actions (e.g. results from FMEA, fatigue test, field trial and assembly test) • document all important results of the quality assurance activities during the development of a new process/procedure • include the practical preliminary planning for the quality of the series and purchasing. A quality evaluation may be performed using various methods. In the relevant project phases (development progress) these are, for example: • “Design“ Phase: - Risk analyses (e.g. Failure Mode and Effects Analysis, Fault Tree Analysis) (compare VDA Volume 4, Part 1 and 2) - Design of Experiments (statistical test methodology, e.g. according to Taguchi, Shainin)
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• “Production prior to series start“ Phase: - Process analyses • Causes of dispersions • Appropriate inspection and test methods, e.g. fault tree analysis, test methodology, cause/effects diagram - process optimization - process review - compliance with specification limits Note:
Procedure for release of series production, see Question 14.2.
09.5
Are all responsible functions involved in the release of processes and procedures?
Requirements/Explanations: A procedure with responsibilities (of the individual organizational units) is to be established for the release to realization. To be considered are, e.g.: -
number, state, delivery date, packaging, delivery location of development samples (prototypes) and initial samples the form and contents of the inspection reports, in agreement with the customer release of samples production and provision of production and inspection and test equipment qualification and monitoring of process and cost trends at suppliers involved.
The release is based on the evaluation of the producibility of the design and, among others, through development, sales, purchasing, production, quality assurance, together with the customer. It represents the approval that the design may be realized. Note:
Procedure for release of serial production see Question 14.2.
Comment: Other valid document VDA volume 2.
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09.6
Is the result of process planning/development documented in process specifications/ procedures?
Definition: Specification (according to ISO 9000:2000 / 3.7.3): A document (#3.7.2) stating requirements (#3.1.2). Note:
A specification can be related to activities (e.g. procedure document, process specification and test specification) or products (#3.4.2) (e.g. product specification, performance specification and drawing).
Requirements/Explanations: The results of the design work must be appropriately documented in specifications or process descriptions/procedures (see Quality Element 10). This includes, among others: -
description of process process parameters important product and process characteristics inspection and test plans and work plans/instructions
These documents for the realization of the quality requirements must be complete and unambiguous.
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09.7
Are the experiences from process planning and development documented and are they available to all relevant areas?
Requirements/Explanations: The experiences/results gained during the development and trial of new processes which are, e.g., applicable to other requirements or production processes are to be evaluated, put down in writing or stored in a computer system. This can be done, for example, in: -
processes, process data, feasibility studies data bases for process FMEA documentation of test results and process problems capability studies of machines, plants and processes plant life cycles with, for example, process optimization/ improvements, adaptation through modified/improved production procedures.
It is an objective to have the development experiences in the organization readily available independent of persons thereby avoiding repeated nonconformities in design. This information is to be made available to all relevant areas, especially inspection and test and production planning.
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110
10
Document and Data Control ISO 9001:2000 Clause 4.2 Quality management requires documents and data which describe • the structure and processes of the quality elements, as well as • the products to be manufactures. Thereby, the identification, order, distribution, distribution, storage and maintenance must be taken into account. Documents and data may be available on media such as paper, magnetic tapes or visual data carriers. The legibility is to be ensure within the scope of the archiving period. Note:
VDA Volume 1 is an applicable reference.
Reference ISO 9001:2000 10.1 *
Are the responsibilities and procedures for the identification, maintenance, review and approval of the documents defined?
4.2.3
10.2
Is there a distribution and maintenance system with revision service available for the documents?
4.2.3
10.3
Is it defined, where, how and for how long the documents are to be archived?
4.2.3; 4.2.4
10.4
Is the timely introduction and control of external documents ensured?
4.2.3
10.5
Is it ensured that invalid documents are not used?
4.2.3
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10.1*
Are the responsibilities and procedures for the identification, maintenance, review and approval of the documents defined?
Definition: “Identification" serves the clear relation to events, processes or products. "Maintenance" encompasses the revision service and archiving whereby the ability to retrieve records must be guaranteed. "Review" includes, among others, the comparison and translation between internal and customer specifications, as well as the formal and contextual review of documents. "Release" is the approval given by the responsible departments. Requirements/Explanations: The processes are to be comprehensively laid out from the customer to the organization integrating all relevant internal departments. For the following documents, procedures and responsibilities are to be defined: Affected are, for example: -
documents for contract review specifications drawings formulations standards, regulations, internal standards inspection and test instructions inspection and test plans, control plans, inspection and test instructions work instructions work procedures, measuring programs quality plans quality procedures quality manual procedures for quality verification reference samples trial procedures.
Documents must be available with the valid revision status to all involved organizational units. Special identification instructions from customers are to be followed A clear presentation of all types of documents is advisable.
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10.2
Is there a distribution and maintenance system with revision service available for the documents?
Requirements/Explanations: Processes and responsibilities must be defined, e.g., for: -
distribution, availability completeness (reference documents) safeguarding the latest revision status (current revision status) approval of changes method of identifying changes in the document invalidation.
The introduction and realization of changes must be documented, i.e. must be provable and traceable (e.g. in the product life cycle). This includes: withdrawal, invalidation, destruction of invalid documents, signature and countersignature or similar). Summary sheets are to be established for a complete presentation of all changes. The responsibilities for this must be defined. The system must exclude misuse. The regulations relating to the approval and distribution system must describe a process which ensures that the correct documents are available at the correct time, in the correct place and that a confusion with invalid documents is excluded. Aprocedure must be available which monitors the validity of the documents at regular intervals. Note:
Listing of quality relevant documents, see Question 10.1
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10.3
Is it defined, where, how and for how long the documents are to be archived?
Requirements/Explanations: This requires stipulations on e.g.: -
retention period filing system filing location.
Thereby, the following must be considered, e.g.: -
protection against fire, water etc. storage media (files, microfilm, DP storage) if necessary, additional back-up files (e.g. double archiving, back-up copy etc.).
The retention of documents - including outdated ones - has to be controlled, in order to be able to prove also at a later stage that the quality management system, process and the product fulfilled the quality requirements in a particular time period. The retention time (archiving) must also be in line with, amongst other things, requirements of laws, general guidelines, customers and product liability aspects (see VDA Volume 1). Note:
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Listing of quality-relevant documents, see Question 10.1
10.4
Is the timely introduction and control of external documents ensured?
Requirements/Explanations: The organization must set up a procedure which ensures that all external documents such as, e.g., standards, specifications, documented procedures and their revisions are reviewed, distributed or introduced at the appropriate time. Records of this must be kept in the same way as for internal documents. Summary of the external documents at a central location is possible.
10.5
Is it ensured that invalid documents are not used?
Requirements/Explanations: The exchange of documents at site must be regulated so that invalid documents can no longer be used. Immediately after new documents are received, the invalid documents must be recalled and destroyed by the person responsible. Evidence of this must be provided for particularly important and identified documents.
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11
Purchasing ISO 9001:2000
Clause 7.4; 7.5
The quality element describes the quality assurance measures which must be implemented by the organization when purchasing products from his suppliers. These products purchased by suppliers (materials, components, subassemblies, parts and services) form part of the customer’s end product and thereby directly influence the quality of this product. Note 1: Note 2:
VDA Volumes 2 and 6 Parts 1, 3 and 4 are applicable references. This element may also be applied to internal customer/supplier relationships.
Reference ISO 9001:2000 11.1
Are the quality requirements on the products and services clearly and completely specified in the order documents for suppliers?
7.4.1; 7.4.2; 7.4.3
11.2 *
Are the evaluation and selection of suppliers defined?
7.4.1
11.3
Are sample tests for purchased products defined?
7.4.1
11.4
Does the organization provide procedures for the regular evaluation of its suppliers?
7.4.1
11.5
Do agreements with the suppliers regarding the method and responsibilities for quality inspections exist?
7.4.1; 7.4.3
11.6 *
Is the quality of delivered products and services ensured?
7.1; 7.4.1; 8.1
11.7 *
Is the traceability of delivered products to the suppliers ensured?
7.5.3
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11.1
Are the quality requirements on the products and services clearly and completely specified in the order documents for suppliers?
Requirements/Explanations: Specifications which are clearly defined and easily understood by the suppliers must be an integral part of orders (drawings, standards, requirements of test certificates, quality agreements, work and inspection and test instructions, packaging and dispatch instructions, etc.). The organization must agree these specifications with the supplier. Prior to release of the order documents, these must be checked for clarity and completeness. Specifications passed on to suppliers may exceed the quality requirements of the organization’s customers, but must at least contain all these requirements on which the supplier has an influence or which affect him. This also includes visits of the organization’s customers at his suppliers, if this is contractually agreed. Processes and responsibilities must be defined. Only an order or order confirmation which is completed with all details contributes to the complete fulfillment of the purchasing and quality requirements. Hereby, a defined and continually updated revision status is important. When purchasing tools and capital goods the following must be considered and defined, among others: -
-
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interdisciplinary cooperation on placement and acceptance through, for example: development, production, quality assurance supervision during the design phase with progress reports computer-supported design and data processing.
11.2*
Are the evaluation and selection of suppliers defined?
Requirements/Explanations: Suppliers must be evaluated by the organization prior to their acceptance. Therefore the requirements and assessment criteria, as well as the selection mode must be defined. The suitability of a supplier may be demonstrated by means of: a) Assessment of its quality management system through -
systems and process audits of the organization system audit results of other customers of the supplier certifications through accredited certification bodies.
(Such system audits also serve as a support for the supplier in setting up its quality management system. They also serve the purpose of system consultancy.) b) Assessment of the product quality of all obtained product through -
product audits initial sample testing (compare Question 11.3) quality assessments of capital goods (compare Question 14.2)
A list of approved suppliers is to be maintained and to be taken into account by the involved parties. Special care is to be paid to the selection of suppliers for products with special characteristics, the documentation of which requires special archiving. An evaluation should be repeated in case of, e.g.: -
re-location of production at the supplier new products/ product group repeated occurrence of quality deficiencies.
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11.3
Are sample tests for purchased products defined?
Definition: Sample (according to DGQ 11-04/95): Material unit which is subjected to a quality inspection for a particular reason or which is required within the scope of a quality inspection. Initial sample (according to VDA Volume 2): Initial samples are products and materials which have been completely manufactured with standard equipment under series conditions. Requirements/Explanations: For all products of a supplier a production process and product approval (PPA) must be carried out (internal or external) for new or modified products/processes prior to serial use. The results of the initial sample inspection are to be documented in writing in the initial sample report with specified and actual values (VDA form). It must contain statements on: -
geometry material (special attention to hazardous material) function reliability.
For important characteristics, proof of capability is to be produced. The scope and documentation of the initial sample inspection is to be coordinated between the organization and the supplier based on existing experience. Initial sampling provides evidence that the supplier is able to fulfil the required specifications with the applied procedures and equipment. The initial
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samples give the organization important evidence on the quality of the series to be expected. A release of the initial samples by the inspector does not relieve the supplier of the responsibility for the series of these products. For the release procedure of series products see VDA Volume 2. Note:
Depending on the application purpose, there are various types of samples. In many branches other designations are used instead of "initial sample" such as, for example, "initial lot", "initial delivery". The above requirements apply in corresponding form to all sample types.
11.4
Does the organization provide procedures for the regular evaluation of its suppliers?
Definition: A "regular evaluation" includes the periodic evaluation of the quality of the delivered products and services and the assessment of the supplier's quality management system. Requirements/Explanations: The performance of a supplier should be reviewed with a frequency that is suited to the complexity and technical requirements on the product and the previous performance of the supplier and must be recorded in a list. A quality history of the products delivered is to be provided, for example, through: -
results of material receiving inspection (compare Question 15.3) reject results delivery fulfillment (deadline/quantity) complaints warrant.
Note 1:
The assessment of the supplier’s quality management system is performed by audits (compare Question 11.2) and forms part of the overall assessment.
Note 2:
The suppliers should be informed about their evaluation on a regular basis.
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11.5
Do agreements with the suppliers regarding the method and responsibilities for quality inspections exist?
Requirements/Explanations: Where necessary, the organization has to set up clear agreements with its suppliers, regarding e.g.: -
inspection and test procedures inspection and test equipment the scope of inspection and testing.
An agreement on the methods of quality inspections serves the comparability of test results and is prerequisite for their acceptance, when they are provided by the supplier.
11.6 *
Is the quality of delivered products and services ensured?
Requirements/Explanations: Appropriate measures must be taken to ensure that the received deliveries are sufficiently monitored. A material receiving inspection must be performed according to the inspection and test plan and may be carried out as an identification, random sample or 100% inspection (compare Question 22.3). When the supplier provides quality records (e.g. test certificates according to DIN EN 10204/3.1b), then control tests are to be performed periodically. The characteristics to be shown on the quality records are to be agreed. The certificate must be based on tests carried out on goods ready for delivery. If it has been agreed with the supplier that product inspections are only carried out at his premises, then the organization has to satisfy itself as to the proper execution at the supplier. The visits shall be carried out depending on the quality capability of the supplier and on the importance of the product. The organization must demonstrate this by means of visit reports.
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A clear identification of the identity of the delivery lots and a differentiation of released and non-released lots is to be carried out. The material receiving system must bar goods that have not been released. In the event of use of the delivered product prior to the completion of inspection, a procedure (special concession) must be implemented (traceability). A consequent management of suppliers contributes to the minimization of complaints or to ensure a consistent quality level of the final product and may eventually lead to the reduction of the material receiving inspection. Note 1:
The initial sample status must be known at material receiving.
Note 2:
Acceptance conditions for services (non-tangible products) must also be defined.
11.7 *
Is the traceability of delivered products to the suppliers ensured?
Definition: Traceability (according to ISO 9000:2000 /3.5.4) Ability to trace the history, application or location of that which is under consideration Note 1:
When considering product (#3.4.2), traceability can relate to: -
Note 2:
the origin of materials and parts, the processing history, and the distribution and location of the product after delivery.
In the field of metrology the definition in VIM:1993, 6.10, is the accepted definition.
Requirements/Explanations: Corresponding to a risk assessment, a system for traceability must be established. Traceability may be realized, e.g., via delivery number, batch number or order number. Ensuring traceability serves the localization of nonconforming products and the limitation of damages in case of nonconformities. This applies particularly to products and related characteristics where a special archiving of the corresponding documents is to be provided (compare VDA Volume 1).
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12
Control of Customer-Supplied Product ISO 9001:2000 Clause 7.5.4 "Customer-supplied products" are products which are the property of the customer and are provided to the organization in fulfillment of the contract requirements. This also includes, among others, tools and packaging. The customer has full quality responsibility for the products provided. Products sold by the customer to the organization are not the subject of this quality element as the normal customer/supplier relationship applies. The contractual aspects are to be considered in the Quality Element 07 Contract Review. Note:
This element does not apply when no customer-supplied products, as defined above, are present.
Reference ISO 9001:2000 12.1
Do agreements with the customer on quality measures for customer-supplied products exist?
7.5.4
12.2 *
Is a definition available for the control, verification, storage and receipt of customersupplied products?
7.5.4
12.3
Is a procedure defined for reporting nonconformities or losses of customer-supplied prod- 7.5.4 ucts to the customer?
12.4
Does a documentation on the quality of customer-supplied products exist?
7.5.4
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12.1
Do agreements with the customer on quality measures for customer-supplied products exist?
Definition: "Customer-supplied products" are those provided to the customer, generally at no cost, for further processing. Requirements/Explanations: At contract finalization the required quality assurance activities on the customer-supplied products to be carried out by the organization should be agreed with the customer. These agreements control, for example: -
test certificates (documentation) inspections and tests (type and scope of material receiving inspection, identification check) identification traceability warranty.
Where no agreements exist, the organization can only take quality responsibility for his value- added activities (compare Question 12.2).
12.2 *
Is a definition available for the control, verification, storage and receipt of customer-supplied products?
Requirements/Explanations: In the event that no special agreements with the customer have been made, a documented procedure must define responsibilities for at least the following measures: -
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Establishing the identity and quantity, according to delivery papers Establishing the external condition and integrity (transport damage) Correct identification Appropriate storage and maintenance of value (special attention on products with limited storage life).
12.3
Is a procedure defined for reporting nonconformities or losses of customer-supplied products to the customer?
Requirements/Explanations: When nonconforming products are delivered or when products are lost the customer must be informed of the following, for example: -
Delivery condition/damage Incorrect delivery Quantity deviation/lost goods malfunction Deterioration of quality during processing Rework.
Process and responsibility are to be controlled. 12.4
Does a documentation on the quality of customer-supplied products exist?
Definition: The documentation describes the quality history of customer-supplied products. It provides a summary of the quality situation during a particular period. Requirements/Explanations: The delivery quality of customer-supplied products can have a significant influence on further processing. Deviations from defined quality characteristics are, for example, to be: -
documented upon receipt recorded within the area of the production process recorded in the case of a product ready for dispatch assigned to the delivery lot stored for a defined period.
The recordings showing the type of deviation may be carried out, for example, in: -
nonconformity tally cards quality control charts Statistics.
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128
13
Product Identification and Traceability (Process Control, Inspection and Test Status) ISO 9001:2000 Clause 7.5 This quality element covers all activities which are necessary to ensure the required production quality in series production. It includes the monitoring of processes, identification of materials and products, traceability, inspection and test status and documentation of results and measures.
Reference ISO 9001:2000 7.5.3
13.1
Is the identification of products for internal processes defined?
13.2
Is the fulfillment of the quality requirements on 7.5.1 the product ensured through process control measures? Are process parameters recorded and devia- 7.5.2; 4.2.4 tions including corrective actions reported? 7.5.1; 7.5.4; Are production as well as inspection, mea7.6 suring and test equipment appropriately stored and protected during interruptions in use? Is it guaranteed that only products which fulfill 7.5.1; 7.5.2 the quality requirements reach the next process/process phase and dispatch? Is the known product data traceable from dis- 7.5.3, 4.2.4 patch to material receiving? 7.5.2 Is there a procedure available for the rerelease to serial production?
13.3 13.4
13.5 * 13.6 13.7 *
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13.1
Is the identification of products for internal processes defined?
Definition: "Identification of products" means the clear and traceable identification through subject number, part number or comparable and of the revision status. Requirements/Explanations: The system shall ensure that products are unambiguously identified in every stage of the material flow, also with regard to their operational state, inspection and testing and modification status in order to avoid mix-ups. For products with a limited storage life, the storage limitation must also be identified. The identification of products must be effective in all production areas from entry until its departure. This may be achieved by means of, e.g.: -
accompanying product documents tags markings, numberings bar codes stampings labels inspection and test reports.
The relation to the lot or batch must be traceable. The corresponding work instructions must be available at site. Products missing identification may lead to mix-ups and incorrect deliveries and are to be regarded as barred until their identity is cleared. Note 1:
The identification system used by the organization must allow the clear relation to the customer’s drawing with revision index at the interface to the customer (dispatch).
Note 2:
Identification for traceability, see Question 13.6
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13.2
Is the fulfillment of the quality requirements on the product ensured through process control measures?
Definition: “Process control measures“ include, among others, all inspections and tests accompanying the process in the complete production sequence used for controlling. The inspection during production is a comparison between the requirement (specification) and the actual result of each work sequence on the product. It is carried out according to the stipulations of the inspection and test instruction. Requirements/Explanations: Inspections and tests accompanying the process must be carried out so that timely detection of deviations is guaranteed. This allows the timely introduction of corrective actions and prevents further processing of defective materials. The results of all planned inspections and tests are to be documented so that trends can be identified and targeted corrective actions can be introduced. Independent of the selected storage medium, the traceability of the inspection and test results to the inspector is sensible. The documentation must also contain the results from manual and/or automatic 100 % inspections. In the case of an automated 100 % inspection, a recording of inspected and rejected products must be carried out. Processes, notes concerning measures and responsibilities must be defined.
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13.3
Are process parameters recorded and deviations including corrective actions reported?
Definition: "Process parameters" are process-influencing quantities that serve to control and regulate the process. Requirements/Explanations: Typical process parameters are, for example: -
Pressure Temperature Time Torque Distance Electric current Voltage Frequency Humidity Velocity.
Monitoring of the process parameters may be performed either automatically or manually. For manual inspections and tests the results are to be documented. In the case of automatic monitoring of the process parameter the review by means of a process audit is sufficient. Process parameters must always be specified with tolerances. When deviations are found corrective actions must be recorded. The monitoring or control elements are to be treated as inspection and test equipment and must be monitored regularly. Note:
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The control elements for process-influencing should be protected from unauthorized interference.
13.4
Are production as well as inspection, measuring and test equipment appropriately stored and protected during interruptions in use?
Requirements/Explanations: Production and inspection and test equipment must be appropriately stored and protected from damage and dirt so that the performance capability is not affected. This also applies to computers and data storage media. Tools specifically linked to parts and inspection and test equipment must be related to a defined release or revision status of the related product. The revision status must be securely attached to the production mean or, e.g., must be included in the file for production means. In the production means store, the tool crib etc. the difference between tools ready for production and those still to be inspected and reconditioned must be identifiable (release status). Mix-ups lead to nonconforming production, complaints, rework costs, additional set-up costs etc. This can only be excluded through a clear process organization. 13.5*
Is it guaranteed that only products which fulfill the quality requirements reach the next process/process phase and dispatch?
Requirements/Explanations: Products must be given an inspection status after each process step (except for interlacing) which shows whether the products have been inspected, which quality inspections have been carried out and whether or not they meet the quality requirements (see Question 13.1). Hereby customer requirements must be considered. The sequence organization, with responsibilities, must be defined. This applies particularly where operator inspection is practiced. This is intended to ensure that only those products which have been released in accordance with the work instructions and which are usable reach the next operational stage or dispatch. Where the identification of products is not possible or economically justifiable the type of identification must be agreed and proven.
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13.6
Is the known product data traceable from dispatch to material receiving?
Definition: "Traceability of products" relates to -
the origin of the material and components (identification, date of inspection) the processing history the distribution and positioning of the product following its delivery.
Requirements/Explanations: Corresponding to a risk analysis a traceability system must be developed and described. Exceptions are to be agreed with the customer and demonstrated. "First in – First out" (FIFO) and/or consequent separation of lots and batches serve as supporting systems in order to prevent mixing of various manufacturing periods. The FIFO principle shall prevent products with various production dates or revision status being mixed. Clearly separated production lots/batches facilitate the traceability when probems occur. A transparent material flow is guaranteed and thus the material disposition more accurate. The mixing of products with differing revision status is prevented. Traceability is guaranteed through the connection of the known data of the processed materials and products with the delivery goods. Known product data is (among others): -
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base data (parts number, revision status) lot/batch number production date production facility shift.
The FIFO principle must be followed in all production areas (material receiving, in-process, delivery and external stores) (for example through transient or electronically controlled stores with storage date as a sorting criteria, etc.). Instructions must be available at the individual work stations. A clear date identification on the material traveler cards is required, especially for reserved and fixed storage areas and products with a expiration date. The individual production lots and batches are to be identified and kept sepaate. The identification applies to all areas of the organization (material receiving, production, stores, etc.) up to the point of use. Identification is placed directly on the parts and/or on the containers/ packaging (compare Question 13.1). 13.7 *
Is there a procedure available for the re-release to serial production?
Definition: "Re-release for serial production" is the order-related release for the renewed start of production. The release is required for product and process. Requirements/Explanations: The renewed release of the production start shall be carried out by an “authorized“ employee who performs quality assurance functions in a responsible position. If a release cannot be given directly for time reasons, then the products must definitely be clearly identified and barred until their release is granted. The particular proceedings are to be collated in a procedure. The performed release inspection is to be documented with its result. The re-release of serial production (see definition, para. 4.9.3) includes, among others: -
Documentation of the last series order (quality records, corrective actions etc.) Documentation of the data of the last series order (quality records, corrective actions etc.)
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Note:
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Completeness of equipment and documents for production and inspection and testing Determination of responsibilities for release after set-up Determination of the treatment of lead products and set-up scrap Proof of release at site Setting of process parameters
The release of the serial production for products manufactured for the first time is evaluated in Question 14.2.
14
Process Control ISO 9001:2000
Clause 7.5
This quality element covers the planning and implementation of all necessary activities as an interdisciplinary task of preparing production, assembly and maintenance processes for the initial start of series production. Within the scope of production preparation it also covers production organization, the planning of material and production flow, the spatial structuring, as well as measures for ensuring production, including tool management. Note:
VDA Volumes 2 and 4, Parts 1, 2 and 3 are applicable references.
Remark:
Activities which are necessary for restart of series production are treated under Question 13.7
Reference ISO 9001:2000 14.1
14.2 *
14.3
14.4
14.5 14.6 14.7
Are capability studies carried out on new/overhauled machines (plants) and also on new/ modified products? Are the conditions for a release to series production for new and modified products/processes regulated and are they agreed with the customer)? Is the monitoring and control (regulation) of the relevant process parameters and product characteristics ensured? Does a tool management and a planned maintenance/servicing for equipment and tools exist? Are the requirements on special processes defined? Are the environmental conditions which influence product and process controlled? Is the effectiveness of production processes evaluated with suitable methods?
7.5.2; 8.2.3
7.5.2
7.5.2; 8.2.3
7.5.1; 6.3 7.5.1 6.3; 6.4; 7.5.5 7.5.2
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14.1
Are capability studies carried out on new/overhauled machines (plants) and also on new/modified products?
Explanation of terms: Machine Capability "Machine capability" is given by the relationship between tolerance and production distribution of a production facility. Determination and evidence is normally established through mathematical-statistical methods whereby only the short term distribution is considered largely excluding the processinfluencing but machine-independent factors (compare VDA Volume 4, Part 1). Process Capability However, when looking at the long term distribution under consideration of the process-influencing parameters then one uses the term “Process Capability“. A process is capable when the statistical parameters for distribution and position in relation to the specified value and tolerance value meet the requirements (at least Cpk = 1.33). If this is not the case, the process capability must be reached through process analysis and optimization. Requirements/Explanations: The characteristics and method for performing the capability study are to be defined. Machine Capability The capability of newly aquired machinery including tools is to be demonstrated either by the machine and tool manufacturer or recipient prior to application.
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Under specific conditions, capability studies must be repeated in coordination with the customer, e.g., for: -
new parts orders new tools/equipment narrowing of tolerances modification of production processes/original state following repair (with influence on the product) following relocation of machine following longer production stops.
Evidence of machine capability should be available for the assessment of the process capability. In capability studies the machine with tools and, if applicable, integrated test and control equipment is to be treated as a unit. The short term distribution must have a capability characteristic number of at least cmk 1.67. If deviations occur corrective actions must be determined and a new capability study is to be carried out after these actions have been implemented. Process capability Process capability is to be demonstrated for product characteristics and process parameters which have a crucial influence on product quality (compare VDA Volume 4, Part 1). All characteristic values must generally lie within the tolerance range. The characteristics important to product quality must be defined and agreed with the customer. If process capability cannot be proven for important characteristics measures must be defined. These can be, for example: -
100% inspections of a production lot Constructive measures with, if necessary, tolerance modifications.
The results of a 100 % inspection must be recorded.
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For cost and risk reasons, a 100% inspection requires process optimization. In the case of non-capable processes, the 100% inspection is the only procedure for sorting out defective products and introducing fault analysis and corrective actions. Thereby, all actions should have the aim to continually improve the processes within the scope of a zero-failure strategy. The capability characteristic number for the long-term distribution must be at least Cpk = 1.33. When deviations occur corrective actions must be defined. A new capability study must be carried out after these actions have been implemented. 14.2 *
Are the conditions for a release to series production for new and modified products/processes regulated and are they agreed with the customer)?
Requirements/Explanations: For release to series production (see Definition, Section 4.5.3) all production factors must be available. Only the consideration of all production factors ensures the problem-free start of series. When determining capacities all production factors must be considered. Bottlenecks lead to quality impairments and additionally to exceeding of costs and deadlines. Production factors are, e.g.: -
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Specifications, drawings, formulations, standards with latest revision status Quality plan (compare Question 02.6) Qualified personnel Site determination Defined production sequences, production plan, production environment Released machines, equipment, operating material Maintenance instructions (compare Question 14.4) Required inspection and test equipment including capability evidence (compare Question 16.4) Approved suppliers (compare Question 11.2) Approved materials/supplied products Inspection and work instructions Process capability (compare Question 14.1). • provisional • final
-
-
-
Product qualification review • Acceptance criteria • Functional performance Initial sample with initial sample inspection report (VDA Volume 2) • geometric • material • functional • visual Production release • provisional • final
The selection and training of personnel, as well as the capability studies, quality analysis (quality evaluation, FMEA, system optimization etc.), review and correction of technical documents and specifications must be completed prior to start of series. The conditions for a release and the type of documentation (e.g. checklist) must be defined. It is advisable and in certain cases (e.g. modified / relocated processes) it is necessary to agree the release conditions (series and modifications) with the customer in advance. This includes, among other things, the production process and product approval procedure (PPA) (compare VDA Volume 2) and the procedures/methods prior to start of series (compare VDA Volume 4, Part 1, 2 and 3). When changed or relocated processes are concerned the customer must be informed and, if necessary, the PPA procedure has to be applied. In any case, an internal new sampling is required.
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14.3
Is the monitoring and control (regulation) of the relevant process parameters and product characteristics ensured?
Requirements/Explanations: The monitoring of the relevant process parameters and characteristics are to be defined in the quality plan. The necessary activities in the event of deviations from the requirements must also be stated herein. Changed requirements and agreements with the customer must be included in the quality plan (compare Question 02.6). As the compliance with the product characteristics (special customer requirements are also to be considered) depends on various process parameters, their influence on product quality must be investigated prior to series start. The parameters and monitoring frequency must be defined. In the event of deviations from the specified value they must be (manually or automatically) regulated again (e.g. SPC). The results of the monitoring must be documented and cross-referenced to the product. Instructions and sequences must be available at the work stations as instructions (documented procedures). Documentation must also contain and justify every change to the defined production parameters. A change to the production parameter may require a new process capability study.
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14.4
Does a tool management and a planned maintenance/servicing for equipment
Explanation of term: “Tool management“ is a system in which tools, appliances, accessory instruments etc. are documented, monitored and controlled. Suppliers of tools must also be included therein. Definition: Planned maintenance (according to VDI Guideline 2890): A maintenance is scheduled when the servicing and inspection of a machine/plant is carried out to a defined scope and time interval. This also includes that necessary maintenance actions are planned ahead or, if necessary, are performed on a preventive basis. Note:
This serves to ensure the continuing quality capability of the process and may also include computer and software.
Requirements/Explanations: Tool management includes, among other things: -
autonomous maintenance and repairs storage and overhauling of tools tool change program for wearing tools.
Scheduled/preventive maintenance refers to all servicing, inspection and maintenance work performed on the production equipment in order to avoid any unforeseen machine failure or a process deviation. The maintenance plan covers all necessary activities relating to preventive actions in a timedependent or number-dependent definition and must be performed for all machinery (including computers and software). Maintenance is to be presented in a clear form with time structure (e.g. blackboard, book, data file). All production equipment, including appliances and tools, must be included. The completion of the work performed is to be documented and work to be done must be sorted according to due date. Maintenance work can be carried out by the machine operator or by maintenance personnel.
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Based on a risk analysis a minimum amount of spare parts must be kept in stock for bottleneck machines and equipment. A history on the production equipment is to be kept to identify weak points. Recording of wear are useful to prevent failures at an early stage. Special attention must be given to the maintenance of equipment for "special processes“ (compare Question 14.5) Note:
The evaluation results of measurements on product and process characteristics have a significant influence on preventive maintenance.
14.5
Are the requirements on special processes defined?
Definition: “Special processes“ are processes the results of which can only be verified (checked) on the product at a later time or not at all. Requirements/Explanations: These processes must be qualified. To do this, qualification criteria must be defined, such as, e.g.: -
Characteristics Parameters Sequences Targets.
The control and monitoring of the processes must correspond to the process situation. Personnel assigned for these processes must be appropriately qualified and trained. The unambiguous allocation of the documentation for processes, equipment and personnel must be given.
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14.6
Are the environmental conditions which influence product and process controlled?
Requirements/Explanations: The environmental conditions must be tailored to the work contents and products in order to prevent contamination, damage and mix-ups. Products with "special visual requirements" have to fulfill special requirements. Criteria are, e.g.: -
definition of the responsibilities for order and cleanliness clean, intact transport and operating equipment clean, well-illuminated workplaces and inspection places clear identification systems (e.g. escape routes) clear, ordered, if possible synchronous material flow appropriate disposal containers appropriate room and storage conditions.
Order and cleanliness have a significant influence on the work result. Where possible, descriptions of the standards should be available. 14.7
Is the effectiveness of production processes evaluated with suitable methods?
Requirements/Explanations: The production process must be continually monitored for deviations from requirements and possible improvement potential. Personnel active in the process must be involved in the evaluation so that their experiences are taken into account. Recognized improvement possibilities must be implemented without delay according to a plan to be defined. Potential methods are, e.g: - process audit (compare Question 03.4) - CIP (compare Question 01.3) - Quality circle (compare Question 04.6) The following must be evaluated, among others: -
production/work plan adapted automization ergonomic and human factors value-adding work inventory management system. 145
146
15
Inspection and Testing (Product Verification) ISO 9001:2000 Clause 7.1; 8.2.4 DIN EN ISO 9004-1, Chapter 12 Quality inspections serve to ensure quality requirements are met and provide evidence through records. Recording of evidence should be carried out in all phases of production. This evidence can be provided both through internal records which directly or indirectly prove the quality of the product (product or process data, as well as through certification about this for the client (the customer). Prevention of nonconformances has priority over detection of nonconformances.
Reference ISO 9001:2000 15.1
Are all inspection activities covered by control plans with inspection instructions?
7.1
15.2
Are the quality inspections in the process and the appropriate methods/techniques defined in inspection instructions?
7.1; 8.1
15.3
Are the defined quality records maintained for all incoming products?
7.4.3; 8.2.4
15.4
Are the defined quality records maintained during the processes/working stages?
7.1; 8.1; 8.2.4
15.5 *
Are the defined quality records maintained on the end product?
8.2.4; 7.5.3
15.6
Are there records about periodic inspections and tests?
8.2.4
147
15.1
Are all inspection activities covered in control plans with inspection instructions?
Explanation of Terms: The "control plan" is a product-related representation of all quality inspections, with reference to inspection instructions, from incoming goods through to delivery. Requirements/Explanation: All inspections (including destructive testing) during the construction process of a product must be recorded in control plans and these plans must be kept available on site. The control plans must include, among other things: -
specific parts data (part number, designation) quality characteristics at the relevant process stage reference to supplementary process descriptions reference to supplementary inspection descriptions/inspection instructions references to decision possibilities (release, place on hold, rework).
If inspections are carried out externally, the same regulations apply. The organization must regularly satisfy itself of the correctness of the operations performed. When required by the customer, accredited laboratory facilities are to be used. A single inspection control plan can apply to a group or family of parts which are manufactured using the same process and the same equipment. When drawing up control plans, different information is used and obtained from, e.g.: -
Process plan System-/Product-/Process-FMEA Special characteristics which were agreed upon Knowledge obtained from similar parts / processes Knowledge obtained from the development phases Other analytical techniques (optimization methods, QFD, DOE).
The inspection control plan must be in line with the quality management plan. It can also be included within the quality management plan.
148
15.2
Are the quality inspections in the process and the appropriate methods/techniques defined in inspection instructions?
Requirements/Explanation: The way in which a product is to be inspected and tested must be defined in inspection instructions for every relevant inspection characteristic in the production process, right through to delivery. This includes, for example: -
inspection and test methods inspection and test equipment random sampling method (acceptance number C=0 / "0" defects) evaluation methods quality control charts documentation types.
Inspection instructions are necessary for complex inspections. All quality evidence which must be furnished is defined in them (see Questions 15.3 to 15.5). They represent a constantly available reference in the workplace and support management when familiarizing/instructing new employees. Inspection instructions are also necessary for repeat inspections (e.g. inspections following rework), or as a result of particular knowledge obtained (e.g. from series production). For visual inspection characteristics, limit patterns have to be defined and if necessary agreed with the customer.
149
15.3
Are the defined quality records maintained for all incoming products?
Requirements/Explanation: The inspection results from material receiving inspections are to be comprehensively documented; the documentation, related to the subject number, must contain, for example: -
type and scope of inspections and tests information about when the goods were received quantity of received and inspected units/products scope of inspection inspection results and decisions for geometry, materials, function and reliability with the date and name of the inspector.
When material receiving inspections are reduced on the basis of previous positive inspection results, then the lots not inspected must be documented with date of receipt and quantity of delivered parts. It has to be ensured, that only released products are submitted for further processing. Inspection documentation from suppliers (results from inspections on the delivery or on the relevant units by the manufacturer) with details of the values determined for the specially required quality characteristics can also serve as evidence. (see Question 11.6). In order to fulfill the obligation to show due care and attention, periodic cross-checks and repeated inspections and tests must be performed. If rework has to be carried out on delivered products, it must be checked and documented (repeat inspections).
150
15.4
Are the defined quality records maintained during the processes/working stages?
Requirements/Explanation: In all production areas, inspections must be carried out in accordance with the inspection control plan/quality management plan and inspection instructions. The following, for example, must be documented here: -
Inspection scope (number of tested products and characteristics) Inspection results (actually measured values, reject quantities, types and numbers of nonconformances) Inspection decisions (release, concession, rework, reject, return shipment, construction deviation, special treatment) Results of repeat inspections, e.g. after rework
Inspection results showing unacceptable quality must also be documented and evaluated; in this case the implementation of corrective actions must be evident. (see Question 14.1). Possible records are, among others; -
nonconformity tally charts dimensional reports quality control charts records of original values.
Quality evidence also includes, for example, results from -
series production/set-up inspection releases automatic inspection/process control process monitoring running tests batch inspections.
151
15.5*
Are the defined quality records maintained on the end product?
Requirements/Explanation: The inspections must be carried out in accordance with the inspection control plan and inspection instructions. Refer to Question 15.4 for further requirements/explanation. The defined evidence must be provided for repeat inspections (rework). Quality evidence also includes, for example, results from -
final inspections and tests functional inspections (under conditions of use) acceptance tests product audits reliability testing.
Note:
It must be guaranteed that all inspections and tests are carried out before the goods are dispatched to the customer. Special agreements must be made, if this does not apply.
15.6
Are there records about periodic inspections and tests?
Requirements/Explanation: Periodic inspections and tests should also be defined in the control plan or quality management plan; the results are to be documented. These periodic inspections and tests should prove that all quality requirements of the product are fulfilled. The type and scope of these inspections go beyond the normal inspections and tests during production. They can be performed at different times for differing requirements. "Periodic inspections" are inspections, for example, such as: -
long term tests (weathering, ozone, corrosion testing) re-qualification tests durability tests
Records about verification checks on products which are delivered with quality evidence conforming to DIN EN 10204 are included in the periodic inspections. Repeated inspections, performed as and when required, can also become necessary and be carried out for a limited period as a result of special findings, e.g. from serial inspections.
152
16
Control of Inspection, Measuring and Test Equipment ISO 9001:2000 Clause 7.6 Prior to the use of inspection and test equipment (measuring and testing equipment, including software and gauges), it has to be ensured that the equipment is suitable for the foreseen purpose, for example, through equipment capability evidence and comparison measurements. The control of the inspection and test equipment in all areas is a basic requirement to ensure the necessary confidence in the accuracy of measuring results and subsequent decisions made based on those results. Through control of the inspection, measuring and test equipment, the regular calibration of the equipment and thereby the traceability of measured results to national standards is guaranteed. This procedure corresponds with "recognized rules of technology", as defined and required in relevant national and international regulations, standards, official specifications and contractual agreements. The accuracy of the results from a piece of equipment, evidenced in its documentation, is of particular importance as inaccurate measurements could lead not only to nonconformance of an "assured characteristic", but could also present a risk when testing quality and safety-relevant characteristics. Reference ISO 9001:2000
16.1 * 16.2
16.3
16.4 16.5
Is there a procedure for the approval, identification, calibration, control and maintenance of inspection and test equipment? Is the adherence (traceability) of inspection and test equipment to the requirements of national and international standards regulated? Are only pieces of inspection and test equipment used that have a sufficiently low measurement uncertainty? Is there a procedure defined to record the inspection and test equipment capability? Are corrective actions defined following the detection of defective and damaged inspection and test equipment?
7.6
7.6
7.6 7.6 7.6
153
16.1*
Is there a procedure for the approval, identification, calibration. control and maintenance of inspection and test equipment?
Requirements/Explanation: The control of all inspection and test equipment in all areas, e.g. in development, tool making, maintenance, production, assembly, quality and customer services, must be guaranteed in order to provide confidence in decisions and actions based on the measured results of tests and inspections. Inspection and test equipment must be approved for use and calibrated regularly in order to guarantee its accuracy throughout its entire service life. The control must cover, among other things: -
standard inspection and test equipment of all kinds gauges measuring instruments sensors measurement recorders special test equipment and the corresponding software.
In addition, devices, inspection and test records, comparison references and process monitoring instruments which might influence the quality of a product or a process must be controlled in the same way. The system for controlling equipment must be described in a documented procedure or similar, including the following, for example: -
154
initial inspection and approval for use of new test equipment identification system recording of the equipment in a supply source record/approval list inspection instructions for the testing/calibration of inspection and test equipment with defined inspection intervals and documentation (see VDI / VDE / DGQ Guideline 2618 for "Inspection instructions for the control of inspection and test equipment") internal/external control body reference standards, master gauges control of test equipment used by customer services control of supplied inspection and test equipment with clear regulation in the contract permitting its use definition of the testing/calibration intervals dependent on the wear and tear and frequency of use examination of the equipment following changes, damage, and suspicion of false indications maintenance of inspection, measuring and test equipment.
Gauges linked to specific parts must be able to be clearly cross-referenced to the subject numbers of the parts, as well as their current revision status in order to prevent confusion. Appropriate equipping of the calibration room, the calibration processes and the skills of the operating personnel must be guaranteed. The test and calibration intervals depend on the frequency of use and must be evident from the files or directly on the equipment itself. Actual calibration and measurement values are to be documented (including initial calibration values prior to first use). The results provide additional information about wear and tear and the likely time the inspection and test equipment will become obsolete. Access to technical data and records about inspection, measuring and test equipment has to be provided, when required by the customer.
16.2
Is the adherence (traceability) of inspection and test equipment to the requirements of national and international standards regulated?
Definition: Calibration (according to DIN EN ISO 10012 Part 1): The set of operations which establish, under specified conditions, the relationship between values indicated by a measuring device or system, or values represented by a material measure or a reference material on the one hand, and the corresponding values of a quantity realized by a reference standard on the other. (Measurement) standard (according to DIN EN ISO 10012 Part 1): A material measure, measuring instrument, reference material or system intended to define, realize, conserve or reproduce a unit or one or more values of a quantity in order to transmit them to other measuring instruments by comparison.
155
Examples:
a) 1 kg mass standard; b) standard gauge block; c) 100 Ω standard resistor; d) Weston standard cell; e) cesium atomic frequency standard; f) solution of cortisol in human serum as a standard of concentration.
Traceability according to DIN EN ISO 10012 Part 1: The property of a result of a measurement whereby it can be related to appropriate measurement standards, generally international or national standards, through an unbroken chain of comparisons. Requirements/Explanation: Complete evidence of the traceability to the next highest level of adherence (e.g. Deutscher Kalibrierdienst [DKD], Physikalisch-Technische Bundesanstalt [PTB], equivalent national organization, research facilities or manufacturer’s standard) with validity certificates must be furnished. Traceability forms part of ensuring the correctness and precision of measurements and is legally regulated. In the case of measuring devices and material measures, calibration is necessary. Calibration takes place against a standard. The uninterrupted chain goes in rising form (calibration hierarchy) from the used standard, to the reference standard, via the national standard through to the primary standard. 16.3
Are only pieces of inspection and test equipment used that have a sufficiently low measurement uncertainty.
Definition: Uncertainty of measurement (according to DIN EN ISO 10012 Part 1/3.b): Result of the evaluation aimed at characterizing the range within which the true value of a measure is estimated to lie, generally with a given likelihood. Note:
156
The measurement uncertainty is frequently incorrectly described, contrary to the standard, as accuracy.
Requirements/Explanation: Testing equipment must be selected so that the characteristics to be tested can be measured with an acceptable level of uncertainty, which must be known. The highest permissible measuring uncertainty is dependent on the process/product specification and the inspection instructions of the customer. These factors and the corresponding surrounding conditions (e.g. temperature, humidity) must be taken into account when selecting the necessary inspection and test equipment. 16.4
Is there a procedure defined to record the inspection and test equipment capability?
Explanation of Terms: The "capability of inspection and test equipment" is determined from the measurement uncertainty of the inspection and test equipment in relation to the tolerance of the characteristic to be measured. Requirements/Explanation: The capability study of inspection and test equipment is to be proven on the basis of the statistical evaluation of ranges of measurements. This may be done by calculation or graphically (correlation diagram). Special customer requirements must also be considered here, as far as possible and other procedures are to be agreed, if necessary. The inspection and test equipment capability is determined using the repeatability or comparability of measurements, with the help of the range method or the mean value and range method under consideration of the random variability (95% / 97,5% / 99%). The result of the study is not only determined by the test equipment itself, but also through other influences, for example: -
composition of the tested products operator measurement records holding devices surrounding conditions.
The necessity for evidence of the capability of inspection and test equipment is dependent on: -
the measurement uncertainty of the inspection and test equipment 157
-
the complexity of the inspection and test equipment the use of interlocking inspection and test equipment/methods.
This applies especially to complex inspection and test equipment such as: -
measuring machines multi-point measuring devices measuring equipment for statistical recording test equipment for electrical quantities.
Note:
When technical modifications are made to products, the inspection and test equipment capability must, if necessary, be reassessed.
16.5
Are corrective actions defined following the detection of defective and damaged inspection and test equipment?
Requirements/Explanation: When it is determined that inspection and test processes are no longer controlled or the inspection and test equipment can no longer maintain its highest permissible level of measurement uncertainty or is damaged, corrective actions are required . An evaluation is to be carried out to determine the effects on finished products, calculate the deviations and to initiate suitable measures, such as, e.g.: -
rework, re-testing complete rejection informing the customer.
In order to prevent reoccurrence, an investigation of the cause is to be carried out. The responsibilities and procedures are to be defined for: -
reporting of nonconformities and/or damage actions on inspection and test equipment actions on products, if necessary, with notification to the customer detection and elimination of cause(s)
These must also form part of the content of employee instructions.
158
17
Control of Nonconforming Product ISO 9001:2000 Clause 8.3 A nonconformity according to ISO 9000:2000 / 3.6.2 is "the nonfulfilment of a requirement" Should, despite continual efforts to improve quality and to prevent nonconformities, product nonconformities not be completely avoidable, then procedures must be put into place which ensure that nonconforming products at any phase of production are quickly and accurately identified and excluded from further processing, delivery or use. The quality control systems must initiate cause analyses and corrective actions and prevent, on a long term basis, the recurrence of identified nonconformities.
Reference ISO 9001:2000 17.1 *
Are there procedures for the handling of nonconforming units?
8.3
17.2
Is the agreement of the customer obtained, prior to shipment of products which deviate from the specification?
8.3
17.3
Is rework executed according to a plan and documented?
8.3
17.4
Is there a procedure for the identification of recurrent nonconformities?
8.3
159
17.1*
Are there procedures for the handling of nonconforming units?
Requirements/Explanation: There must be a procedure that guarantees an unambiguous separation of good and nonconforming products. The identification can be in the form of tags, special containers or markings on the product, whereby tags and markings must be protected from unintended removal. The procedure must contain instructions for identification, segregation, corrective actions and evidence of effectiveness, as well as responsibilities, and must be known to all involved employees. Decisions about the disposition of nonconforming products must be made by competent persons on the basis of understandable criteria. They must be documented. These decisions can be, for example: -
rework acceptance with or without repair on the basis of a concession downgrade for another use rejection scrap.
Nonconformities may be detected or suspected in retrospect, if, for example, an inspection or work stage is left out, or deviations are subsequently detected at calibration of inspection and test equipment or a corrective production step has been forgotten. Nonconformities detected in retrospect, for example, following prolonged functional or life testing or as a result of late evaluation of control charts, must be communicated to the customer. Should nonconformities be suspected on products already shipped, then the customer must be informed immediately. Considerations about safety, product liability and customer satisfaction can lead to a finished product being recalled. The processes addressed here must describe all activities which are carried out in conjunction with the control of nonconforming products in order to remedy faults. This must also include units which are suspected of being nonconforming. This can necessitate an inspection of other products which have been developed and manufactured using the same process and/or of preceding lots of the same product.
160
17.2
Is the agreement of the customer obtained, prior to shipment of products which deviate from the specification?
Definition: Concession (according to ISO9000:2000/ 3.6.11): Permission to use or release a product (#3.4.2) that does not conform to specified requirements (#3.1.2). Note:
A concession is generally limited to the delivery of a product that has nonconforming characteristics (#3.5.1) within specified limits for an agreed time or quantity of that product
Requirements/Explanation: The internal and external concession procedure until the agreed delivery to the customer (internal/external) must be defined. The deviation from the specification must be presented in detail to the customer and documented. If necessary, the products must be identified and the approved, as well as the dispatched quantity is to be recorded. Products deviating from the specification - even where the deviation does not appear critical to the organization - may only be shipped if the customer has given his agreement. This procedure, if necessary including the validity period of the concession, must be documented.
17.3
Is rework executed according to a plan and documented?
Explanation of Terms: Rework see ISO 9000:2000/3.6.7 Requirements/Explanation: For any required rework, the working and inspection steps, together with the associated production and testing equipment, must be defined. Qualified staff must be used. The performance of the orderly work is to be monitored and documented.
161
Documentation should include, for example: -
Rework inspection reports Product designations (e.g. rejections, scrapping) Concessions Construction deviations
Note:
The responsibilities for the initiation and monitoring of corrective actions are evaluated in Question 18.1.
17.4
Is there a procedure for the identification of recurrent nonconformities?
Explanation of Terms: "Recurrent nonconformities“ mean nonconformities which reoccur because their actual cause was not correctly identified and remedied during previous corrective actions. Requirements/Explanation: The procedure must describe the activities regarding further analyses and corrective actions. The evaluation should consider internally and externally encountered nonconformities, for example, by means of: -
continuous, systematic nonconformity evaluation evaluation of complaints rework evaluation.
To do this, it is helpful, for example, to create a nonconformities file. Such a procedure must highlight problems with a similar nonconformity profile, so that they can be distinguished from those which represent unique occurrences. Note:
162
The procedure for the prevention of recurrent nonconformities is evaluated in Question 18.4.
18
Corrective and Preventive Action ISO 9001:2000 Clause 8.5 This quality element concerns corrective actions for the elimination of problem causes and for continual quality improvement. The implementation of a corrective action begins with the detection of a quality-related problem and includes the implementation of actions to eliminate or minimize the repetition of the problem. Corrective actions in design documents, in the manufacturing process, on the product itself and on quality management system elements are to be differentiated. The necessity for a corrective action to remedy a nonconformity cause can, for example, be recognized through: - Development evaluations - Analyses of potential nonconformity possibilities - Quality inspections and audits - Reports on process nonconformities - Feedback from the market - Service reports - Customer complaints - Management reviews (see Question 01.6). Reference ISO 9001:2000
18.1 *
Are the responsibilities for the initiation and monitoring of corrective actions clearly defined?
5.6.3; 8.5
18.2
Are there procedures to estimate potential nonconformity risks and to implement corresponding preventive actions?
8.5
18.3
Are there procedures for the analysis of nonconformity causes?
8.5
18.4 *
Are there procedures to prevent recurrent nonconformities?
8.5
163
18.1*
Are the responsibilities for the initiation and monitoring of corrective actions clearly defined?
Definition: Corrective action (according to ISO 9000:2000/3.6.5): Action to eliminate the cause of a detected nonconformity (#3.6.2) or other undesirable situation. Note 1:
There can be more than one cause for a nonconformity.
Note 2:
Corrective action is taken to prevent recurrence whereas preventive action (#3.6.4) is taken to prevent occurrence.
Note 3:
There is a distinction between correction (#3.6.6) and corrective action (#3.6.5).
Requirements/Explanation: The correction of internally and externally encountered deviations must be organized so that a prompt and effective elimination of the problem is guaranteed, for example, through: -
root cause analysis and identification determination of actions and responsibilities informing the affected and responsible departments determination of monitoring mechanisms.
The responsibility and authority for the initiation of corrective actions must be defined. Responsible persons must be also defined for the coordination, recording and monitoring of corrective actions. The monitoring activity includes both the performance of the remedial action and the check of its effectiveness. An appropriate operational organization must be defined in writing and, if necessary, relevant instructions must be available at the relevant workplaces. The analysis and performance could involve a variety of functional departments of the business, for example, Development, Procurement, Production, Sales and Quality (see also the quality loop). Through the management review (see Question 01.6), it must be ensured that pertinent information concerning preventive and corrective actions (e.g. changes to procedures and to the quality management system) is made known to the organization management.
164
18.2
Are there procedures to estimate potential nonconformity risks and to implement corresponding preventive actions?
Explanation of Terms: The significance of a quality problem should be evaluated with regard to its possible effect on: -
process costs quality-related costs, performance, functional capability and safety of the product, customer satisfaction.
Requirements/Explanation: The significance, frequency of occurrence and detectability of the nonconformity must be considered in the procedure for estimating risks. The following formalized methods, for example, offer assistance: -
System, Design and/or Process FMEA Fault tree analysis (FTA) Failure mode analysis Design of experiments.
Feedback of findings from nonconformities encountered where risk analyses already exist (e.g. Design/Process FMEA) must take place, in order to derive preventive measures from it. With the classical method of eliminating a nonconformity after it has occurred, technical systems with greater safety and reliability, high level of quality, lower total costs and with ever shorter innovation times can no longer be realized. Instead, preventive measures must be used so that potential nonconformities are identified at an early stage and translated into corrective actions, even before nonconformities arise. Risk analyses, for example, form the basis for the optimization of and changes to: -
specifications operations test and manufacturing equipment instructions.
165
18.3
Are there procedures for the analysis of nonconformity causes?
Requirements/Explanation: The following quality methods, for example, may be helpful: -
Fish bone diagrams (Ishikawa diagrams) Stratification (separating data and dividing it into categories) Pareto analyses (ABC analysis) Capability studies Histograms Correlation diagrams Failure mode analyses Probability charts Data collection Recording with corresponding graphic representations FMEA review.
Within the scope of preventing nonconformities, actions for elimination must be derived from the results of the root cause analysis and their performance evidenced. When a quality problem occurs, the actual root cause must be determined by analysis before corrective actions are planned. Often the root cause is not obvious; which necessitates a thorough analysis of, for example,: -
product specifications (including materials etc.), all related processes/work stages (equipment, installations, tools), quality records, customer service reports and customer complaints
As far as is appropriate, the supplier and/or customer must be involved in the analysis of the root causes of the nonconformities.
166
18.4*
Are there procedures to prevent recurrent nonconformities?
Explanation of Terms: "Recurrent nonconformities" are those nonconformities which reoccur because their root cause was not correctly identified and remedied in previous corrective actions. Requirements/Explanation: In order to prevent a problem reoccurring, special preventive actions must be implemented. When measures to eliminate nonconformities have been realized, their effectiveness must be monitored to ensure that the desired objective is achieved. Changes and the experiences resulting from them must be documented. Indications of the effectiveness can also come from customer services/ service department. Problem solving in teams: 0. 1. 2. 3. 4. 5. 6. 7. 8. Note:
Clarify the problem for yourself. Work on the problem in a team. Describe the problem. Initiate temporary actions to limit damage and check their effectiveness. Determine the root cause(s) and check that it is (they are) really the root cause(s). Define measures for the elimination of the problem and check their effectiveness through experiments/trials. Implement the measures for elimination and check their effectiveness. Define measures that will prevent a recurrence of the problem. Praise the performance and success of the team.
See also Question 17.4.
167
168
19
Handling, Storage, Packaging, Preservation and Delivery ISO 9001:2000 Clause 7.5.5 Measures to prevent quality shortcomings arising from incorrect handling, storage, packing, preservation and transport of the products are included in the terms stated in the heading. They encompass the entire logistical chain of product manufacturing from beginning to end.
Reference ISO 9001:2000 19.1
Are there instructions for the handling of prod7.5.5 ucts?
19.2
Is the packing and identification process prior to delivery defined and monitored?
7.5.5
19.3
Is it ensured that damage or deterioration in quality during storage and transport is prevented?
7.5.5
Is there a procedure to record, rectify and initiate corrective actions on packaging nonconformities and transport related damage?
7.5.5
19.4
19.5
Is the identification of products during transport and storage ensured?
19.6 *
Is there a procedure which documents delivery reliability?
7.5.5
--
169
19.1
Are there instructions for the handling of products?
Explanation of Terms: "Handling of products“ is viewed as all transport and handling methods and operations in the complete logistical chain. Requirements/Explanation: The instructions must contain orderly planning and control for incoming materials, their further processing, and for end products up to the point of use by the final customer. The methods and responsibilities must be defined for, e.g.: -
170
handling, storage, internal and external transport planning and inspection of packaging storage of only clearly identified products appropriate storage conditions first in / first out (stock control system) monitoring of limited storage-life products shipping operations orderliness and cleanliness implementation of customer instructions cleaning and preservation informing the customer about handling disposal.
19.2
Is the packing and identification process prior to delivery defined and monitored?
Requirements/Explanation: Procedures/work instructions must describe all steps which guarantee appropriate packing. The packing must ensure that products arrive at their place of use complete and undamaged. Training and instructions are necessary for this. Adherence to requirements can be proven through dispatch audits. Product packing includes the following: -
initial packing final packaging / repackaging for shipment container identification,
as well as the materials themselves which are necessary for this. Customer requirements regarding packing must be observed and must be accessible on site.
171
19.3
Is it ensured that damage or deterioration in quality during storage and transport is prevented?
Requirements/Explanation: In order to avoid damage or deterioration in quality (e.g. through dirt, corrosion, chemical reaction) written instructions for product handling are to be raised (see Question 19.1). Special attention should be paid to, for example: -
condition of containers cleaning and preservation filling of containers methods of transport (temperature, vibrations, etc.) protective measures for products and personnel effects of humidity padding secure fixing collective packaging instructions for handling (e.g. assembly, delivery).
Conformance to the requirements is to be ensured (e.g. by regular plant inspections, if necessary, in the context of audits).
19.4
Is there a procedure to record, rectify and initiate corrective actions on packaging nonconformities and transport related damage?
Requirements/Explanation: Reporting routes and processing of incidents of both internal and external transport-related damage are to be defined in writing and the responsible circle of people informed. The responsibilities for corrective actions are to be determined (if necessary, the customer must be involved). The measures implemented are to be checked for their effectiveness.
172
19.5
Is the identification of products during transport and storage ensured?
Requirements/Explanation: It must be ensured that products are identifiable at all times during transport and storage. Customer requirements must be taken into account. The identification refers to e.g.: -
-
identification in accordance with specification requirements revision status clear and permanent referencing of identification and/or accompanying documents to the product (processing stage, inspection status) expiry date removal of invalid identification.
Note:
The identification should be sufficient to allow for the identification of an individual product, if a recall or a special inspection is necessary.
19.6*
Is there a procedure which documents delivery reliability?
Explanation of Terms: Under "delivery reliability“ one understands the adherence to promised delivery deadlines and delivery quantities for products within a defined delivery period. If deviations from the delivery obligations are recognized or reported, corrective measures are to be introduced. Requirements/Explanation: The information system should continuously serve to: -
optimize the throughput time adjust the stock turnover to the needs of the customer minimize stock levels.
Furthermore, the system should be structured so that: -
the customer is informed in advance about delivery shipments an emergency strategy can be operated if a bottleneck in supply occurs.
173
174
20
Control of Quality Records ISO 9001:2000 Clause 4.2.4 Quality management need records of quality-relevant data in order to be able to demonstrate compliance with the defined quality requirements and the effectiveness of the quality management system. Their identification, collection, compilation, distribution, archiving and updating must be ensured. The ability to retrieve records and their hierarchical order must be guaranteed at all times. Quality records from suppliers must be taken into account in the same manner. All quality records must be legible and stored in facilities under suitable conditions which avoid damage, deterioration or loss and must be kept in order so that they are easily retrievable. The same applies to records on electronic media. Note:
For this element VDA Volumes 1 and 7 are appllicable references.
Reference ISO 9001:2000 20.1
Are procedures and responsibilities defined for the identification, review and approval of quality records?
4.2.4
Are there procedures and responsibilities defined for the evaluation and distribution of quality records?
4.2.4
20.3
Is it defined where, how and for how long quality records are retained?
4.2.4
20.4
Is the manner in which quality records are made accessible to the customer defined, if this has been contractually agreed?
---
20.2
175
20.1
Are procedures and responsibilities defined for the identification, review and approval of quality records?
Explanation of Terms: "Identification" serves the clear referencing to processes, operations or products. "Review" encompasses the plausibility check, as well as the formality and correctness of the contents of the records. "Approval" is the approval of the measures noted in the records. Requirements/Explanation: The operations are to be comprehensively structured from the customer through to the organization under inclusion of all relevant departments. A clear illustration of all types of quality records is advantageous. Quality relevant records are, for example: -
176
evidence to contract review evidence of inspections, tests and experiments product/process approvals and releases capability records (quality capability of men and machines, including tools/organizations) quality audits (system, process and product audits) materials tests calibrations quality control charts complaints evidence of implemented corrective actions evidence of quality related costs evidence of process related costs evidence of quality related losses documentation of preventive maintenance.
20.2
Are there procedures and responsibilities defined for the evaluation and distribution of quality records?
Explanation of Terms: "Procedures" describe what, when and to what extent evaluations are to be performed. "Responsibilities" are those functions within the organization which evaluate and distribute quality records. Requirements/Explanation: To control quality in the various areas of authority, meaningful evaluations of quality data must be available to the responsible parties. This applies to individual reports, periodic projections and status reports. The quality records of the supplier and customer must be incorporated into this process. Processes and responsibilities for the evaluation and distribution must be controlled. Note:
For a listing of quality records, see Question 20.1
177
20.3
Is it defined where, how and for how long quality records are retained?
Explanation of Terms: "Retained" refers to the filing and archiving of records, whereby it must be guaranteed that all documents are retrievable. Requirements/Explanation: This requires instruction about e.g.: -
retention period filing system filing location.
Thereby the following, for example must be considered: -
protection against fire, water etc. storage media (files, microfilm, DP storage) if necessary, additional back-up files (e.g. double archiving, security copy etc).
Retaining quality records is necessary in order to be able to prove, even at a later date, that the quality management system, the process and the product fulfilled all the quality requirements for that particular period. The retention (or archiving) period must be defined, among other things, on the basis of the requirements of legislation, general guidelines, customers and product liability aspects (see VDA Volume 1). Minimum requirements for the archiving period are: -
-
178
one year after product discontinuation: Product/ process releases, Tool inspection reports, Purchase contracts and supplements to them etc. two years: Records on quality performance (quality control charts), Inspection results, ppm lists etc. three years: Reports for the (top) management, Records to internal quality audits, management reviews etc. longer: documents requiring special archiving (DWSpA) (see VDA Volume 1)
The destruction of quality records after the defined archiving period must be regulated. Note 1:
For a listing of quality records, see Question 20.1
Note 2:
Copies of records concerning discontinued products which are required for approval of the new products must be archived referenced to these new products.
Note 3:
See Question 06.2
20.4
Is the manner in which quality records are made accessible to the customer defined, if this has been contractually agreed?
Requirements/Explanation: Quality records must be made accessible to the customer, in so far as this is contractually agreed. The procedure for this must be defined. Direct referencing and identification of the relevant records to the defined products and associated processes must be defined as a procedure. In many cases, certain product characteristics of the finished product can no longer be inspected by the customer. Therefore it must be possible to refer back to the supplier’s quality records for this purpose. Note:
For a listing of quality records, see Question 20.1
179
180
21
Servicing, (After Sales, Post-production Activities) ISO 9001:2000 Clause 7.5; 8.4 This element summarizes all quality-relevant activities which are necessary for observing a product in the utilization phase. The knowledge gained from customer service and from maintenance activities about weaknesses must be used to improve products and processes. Note:
If only the Question 21.3 is relevant for the evaluation of this element, then this question can also be considered and evaluated as an additional question 18.5 under Element 18. In this case the individual evaluation of Element 21 is no longer applicable.
Reference ISO 9001:2000 21.1
Is the preparation of operation and assambly instruction defined and are these clear and understood?
7.5.1
Is there a procedure for product surveillance and an early warning system for product failures in use?
---
Is there a procedure to analyze product nonconformities during use, as well as to implement and monitor corrective actions?
8.4; 8.5.2
21.4
Is the customer service function included in the information flow system?
7.5.1
21.5
Is there a procedure for maintenance activities, if these are agreed?
7.5.1
21.2
21.3
181
21.1
Is the preparation of operation and assembly instruction defined and are these clear and understood?
Requirements/Explanation: The preparation of operating and assembly instructions is necessary for some products. In this case, the following must be considered: -
responsibility for the preparation multilingual arrangements with respect to the range of users consideration of foreseeable misuse warnings concerning incorrect use (also during commissioning).
It must be noted that the operating and assembly instructions must be available and, if necessary, agreed with the customer in good time, that is, prior to the introduction of the product. Note:
Regarding products within the automotive industry, this question applies primarily to organizations active in the accessory business sector. The necessity of this question is to be agreed upon in individual cases.
21.2
Is there a procedure for product surveillance and an early warning system for product failures in use?
Requirements/Explanation: The procedure for this must be defined and, if necessary, agreed with customers that further process delivered products. Thereby, not only the warranty period but also the entire utilization period should be taken into account (e.g. also long-term evaluations). Every organization must be aware of how its products behave in use. The activities undertaken by the organization, in order to obtain information about the quality of its products in use, must be evidenced.
182
This includes for example: -
regular market observation evaluation of field returns / warranty cases customer surveys customer information/early warning system.
An early warning system must be agreed and built up between the organization and the customer. This should include, e.g.: -
an observation and information system an organizational system for actions when necessary the definition of the responsible person / contact person.
The information must be available to, among others, the following organizational units: Note:
Development Work planning Production Quality management.
It is especially important that systems suppliers and suppliers of complex products establish a quick feedback system for the introduction of new products. See Question 21.3 concerning the analysis and evaluation of nonconformities.
183
21.3
Is there a procedure to analyze product nonconformities during use, as well as to implement and monitor corrective actions?
Requirements/Explanation: For product nonconformities during use, or respectively for return shipments from customers, a procedure must be defined for the analysis, implementation and monitoring of corrective actions. The following steps must, for example, be understandable and documented: -
Procurement of the nonconforming product Analysis of nonconforming production with regard to location, type and cause of nonconformity Definition of corrective actions (short, medium and long term) Implementing corrective actions Monitoring of corrective actions Evidence of the effectiveness of actions carried out.
The results of the analysis of the nonconformity and the corrective actions must be informed to the customer and, if necessary, to the development department. The aim is to avoid nonconformities, to exclude the possibility of a recurrence of the nonconformity and to implement continual improvements to the process. Note:
184
The procedure for the above is to be defined with the customer.
21.4
Is the customer service function included in the information flow system?
Explanation of Terms: "Customer service“ is the care of the products at the customer (including intangible products - see Definitions in Chapter 4). Requirements/Explanation: Customer service is recognizable through, for example: -
providing special tools and testing equipment for customer services technical advice (liaison engineer, advice on processing and use) requests for quality related information support for own sales offices information flow to and from the customer qualification measures in manufacturing plants timely availability of (modified) replacement parts recall of obsolete products and evidence about this.
Evidence of customer services can be, for example: -
identified responsibilities discussion notes check lists meeting reports travel reports.
The objective is to ensure the feedback of information from the customer to the corresponding organizational departments.
185
21.5
Is there a procedure for maintenance activities, if these are agreed?
Requirements/Explanation: Where maintenance on delivered products is a requirement of the recipient, the organization must define: -
what belongs to the scope of maintenance how it is to be reported on how the requirements are to be fulfilled.
The following must also be taken into account, among other things, -
special tools inspection measuring and testing equipment work instructions for commissioning administration of spare parts
The organizational procedures must be shown.
186
22
Statistical Methods ISO 9001:2000 Clause 8 The use of statistical methods is an important quality element in all areas of the quality loop. It is dependent on the product and on the manufacturing processes implemented and encompasses the planning, the performance, as well as the evaluation of results. The use of statistical methods and procedures: - in the design phase leads to the definition of realistic tolerances and functional values - in experiments raises the meaningfulness and safety of statements using low numbers of experiment samples - in production, allows the evaluation of the quality of a quantity of (untested) parts based on a sample of products. Statistical methods are based on the laws of probability calculation. Their implementation allows, with economical expenditure, correct statements to be made about quality levels and any changes to these levels. All statistical statements are limited in that they are only valid with a certain degree of probability. This must be considered by the users of statistical methods. Reference ISO 9001:2000
22.1
Are the possibilities for using statistical methods determined and is their use planned?
8.1
22.2
Are statistical methods used for planning and evaluating experiments and estimating product risks during development?
8.2.3; 8.2.4; 8.4
22.3
Are statistical methods used for the evaluation 8.2.3; 8.2.4; of quality inspections on deliveries? 8.4
22.4
Are statistical methods used for process optimization and for process control?
22.5
Are statistical methods used for the evaluation 8.2.3; 8.2.4; of quality test at final inspection? 8.4
22.6
Are statistical methods used for the evaluation 8.2.3; 8.2.4; of product failures during use? 8.4
8.2.3; 8.2.4; 8.4
187
22.1
Are the possibilities for using statistical methods determined and is their use planned?
Requirements/Explanation: The need for statistical methods to determine, monitor and examine process and product within the process chain must be defined. It is to be defined, dependent on the results of the risk analysis (e.g. FMEA), which processes and characteristics have to be tested and evaluated and with which methods. The appropriate method must be defined and used for the particular application. Statistical methods allow the user to assess processes taking into account economic aspects within the process chain. Statistical methods are planned within the framework of project planning in the form of a advanced quality plan (quality planning). The results of the statistical evaluation must be considered within the scope of quality improvement programs. Wherever possible and economically viable, the statistical evaluation of process parameters must be given precedence over the evaluation of quality results on products. 22.2
Are statistical methods used for planning and evaluating experiments and estimating product risks during development?
Requirements/Explanation: Typical methods are e.g.: -
Design of Experiments / analysis of influencing variables variance and regression analysis significance studies calculation of failure probability FMEA failure tree analysis system optimization.
Statistical methods must be used both for product and process development in testing, design and model construction.
188
22.3
Are statistical methods used for the evaluation of quality inspections on deliveries?
Requirements/Explanation: Typical methods are, e. g.: -
Random sampling techniques Nonconformity tally cards Pareto analysis.
The evaluation of quality evidence for deliveries also forms part of this. These evaluations also serve supplier evaluations.
22.4
Are statistical methods used for process optimization and for process control?
Requirements/Explanation: Typical methods for process control and optimization, are e.g.: -
Quality control cards /SPC Random sampling techniques Nonconformity tally cards Pareto analysis Capability studies(Cmk, Ppk, Cpk) Design of Experiments Analysis of influencing variables Variance and regression analysis Significance studies
189
22.5
Are statistical methods used for the evaluation of quality test at final inspection?
Requirements/Explanation: Typical methods are e.g.: -
random sampling techniques nonconformity tally cards Pareto analysis.
Random sampling plans are to be defined from a statistical viewpoint. The Zero-Defect-Strategy is to be considered. (i.e. Acceptance figure c=0).
22.6
Are statistical methods used for the evaluation of product failures during use?
Requirements/Explanation: Typical methods are e.g.: -
nonconformity tally cards Pareto analysis probability grids.
Keeping statistics related to a production period is in many cases of great significance. It finds application, for example, in customer services and handling of warranty cases.
190
8
Forms for the Quality Management System Audit - tangible products -
The use of forms to correctly carry out the quality management system audit is advantageous because they enable the results to be gathered quickly, rationally and clearly for all parties involved. The forms shown below show examples of possibilities. The set of forms: Quality management system audit for material products in accordance with VDA 6.1 consisting of : Questionnaire (questions only) DIN A5, block of 10 sets, 12 pages each set. Assessment documents Overall evaluation of the quality management system Overall compliance Summary of results Summary of evaluated questions Corrective actions Corrective actions - summary DIN A4, block of 10 sets, 5 pages each set. Both blocks belong together and are only available as a set in German/English. Order No. 1749 Reference sources: Druckerei Henrich D-60528 Frankfurt am Main, Schwanheimer Str. 110 (0 69)67 80 06-0 (0 69)67 80 06-30
191
VDA 6, Part 1- Quality Management System Audit Overall Evaluation of the Quality management system of the Organization Customer/Certification body Area / Plant Location Auditor Report No. of System Audit: Audit period: starting
ending
Audited/Certified Organization Area / Plant Location Audited Products / Product groups Address Contact person Audit Result Overall compliance
CTOT
%
from CM
%
and CP
%
Issue of audit certificate recommended yes
no
Comments of the audited / certified organization: ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ Signature of audited/certified organization/date
Signature Auditor(s) / Date
.................................................
.................................................
The customer/certification body agrees that the audited/certified organization may communicate the audit results to other parties.
................................................. Signature 192
VDA 6, Part 1- Quality Management System Overall Compliance - only for Customer / Supplier Audits (2nd Party) Customer: Report No. of System Audit:
Supplier: Date:
Grade:
Overall Compliance
CTOT
Auditor Grading
%
from CM
%
and CP
%
(for downgrading acc. to. Para. 3.3.3 Notes 1 and 2)
Comments on Grading (Auditor): ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................ ........................................................................................................................
System evaluation: Overall level of compliance in percent
Assessment of the QM system
Designation of grading
90 to 100
fully compliant
80 to less than 90
mostly compliant
60 to less than 80
conditionally compliant
B
less than 60
not compliant
C
A *) AB *)
*) see notes under Para. 3.3.3
193
VDA 6, Part 1 - Quality Management System Audit: Summary of Results Customer/Certification body:
Organization:
Report N°. of System Audit:
Date: No. Of Score Questions max. asses max. archieposs sed poss ved . .
VDA Element No. Part M: Management 01
Management Responsibility
02
Quality Management System
03
Internal Audits
04
Training, Personnel
05
Financial considerations reg. QMS
06
Product Safety
Z1
Corporate Strategy
CM
X Compliance level 1 - Z1
Part P: Product and Process 07
Contract Review, Quality in Marketing
08
Design Control (Product design)
09
Process Planning, (Process dev.)
10
Document and Data Control
11
Purchasing
12
Control of customer supplied Prod.
13
Identification, Traceability, etc..
14
Process Control
15
Inspection + Test (for Products)
16
Control of Insp.+Test Equipment
17
Control of non-conforming Prod.
18
Corrective + Preventive Actions.
19
Handling., Storage, Pack., etc.
20
Control of Quality records
21
Servicing (Post-Production Activity)
22
Statistical Methods
CP
194
X Compliance level 7 - 22
Compl. level CE %
Compliance Profile % 20 40 60 80
VDA 6, Part 1- Quality Management System Audit: Summary of Evaluated questions Customer / Certification body: Report N°. of System Audit: Certificate N°.:
Audited/Certified organization: Date: DIN EN ISO: Valid to:
01.1
01.2
01.3
01.4
01.5
01.6
02.1
02.2
02.3
02.4
02.5
02.6
03.1
03.2
03.3
03.4
04.1
04.2
04.3
04.4
04.5
04.6
04.7
05.1
05.2
05.3
05.4
06.1
06.2
06.3
06.4
Z1.1
Z1.2
Z1.3
Z1.4
Z1.5
07.1
07.2
07.3
07.4
07.5
08.1
08.2
08.3
08.4
08.5
08.6
08.7
09.1
09.2
09.3
09.4
09.5
09.6
09.7
10.1
10.2
10.3
10.4
10.5
11.1
11.2
11.3
11.4
11.5
11.6
11.7
12.1
12.2
12.3
12.4
13.1
13.2
13.3
13.4
13.5
13.6
13.7
14.1
14.2
14.3
14.4
14.5
14.6
14.7
15.1
15.2
15.3
15.4
15.5
15.6
16.1
16.2
16.3
16.4
16.5
17.1
17.2
17.3
17.4
18.1
18.2
18.3
18.4
19.1
19.2
19.3
19.4
20.1
20.2
20.3
20.4
21.1
21.2
21.3
21.4
21.5
22.1
22.2
22.3
22.4
22.5
Note: na
19.5
19.6
22.6
= Question not evaluated, reasons to be given on a separate sheet. = *Questions with particular relevance for product, process and QMS
195
VDA 6, Part 1- Quality Management System Audit: Remarks on Status Customer / Certification body:
Audited/Certified organization:
Report No. of System Audit:
Date:
Ref. to Quality Element ________ / Question _______/Page N°.
196
VDA 6,Part 1- Quality Management System Audit: Corrective Actions Customer / Certification body:
Audited/Certified organization:
Report N°. of System Audit:
Date:
Q-Element seq. No.
Deviations, proposed corrective actions
Response and actions of the audited / certified organization
Deadline
.
197
VDA 6, Part 1- Quality Management System Audit: Corrective action - Summary Customer / Certification body:
Audited/Certified organization:
Report N°. of System Audit:
Date:
VDA
Element
No.
Part M: Management 01
Management Responsibility
02
Quality Management System
03
Internal Audits
04
Training, Personnel
05
Financial considerations reg. QMS
06
Product Safety
Z1
Corporate Strategy
Part P: Product and Process 07
Contract Review, Quality in Marketing
08
Design Control (Product design)
09
Process Planning,(Process dev.)
10
Document and Data Control
11
Purchasing
12
Control of custom-supplied Prod.
13
Identification, Traceability, etc..
14
Process Control
15
Inspection + Test (Product testing)
16
Control of Insp.+Test Equipment
17
Control of non-conforming Prod.
18
Corrective + Preventive Actions.
19 20
Handling., Storage, Pack., etc. Control of Quality records
21
Servicing (Post-Production Activity)
22
Statistical Methods
198
J F M A M J J A S O
further inD formation on sheet no.
9
Literature
9.1
VDA-Series "Quality Management in the Automotive Industry": Volume 1
Quality Evidence – Guidelines for the Documentation and Archiving of Quality Records –
Volume 2
Quality Assurance of Supplies – Supplier Selection, Quality Agreements, Production Process and Product Approval, Quality Performance in Series Production –
Volume 3
Reliability Assurance for Vehicle Manufacturers and Suppliers Part 1: Reliability Management Part 2: Reliability Tools and Methods
Volume 4Quality Assurance prior to Serial Application Part 1: Partnerships, Processes, Methods Part 2: System FMEA Part 3: Project Planning Volume 5
Measurement Systems Analysis
Volume 6
Quality Audit Fundamentals Part 1: Quality Management System Audit Part 2: QM System Audit – Services Part 3: Process Audit Part 4: QM System Audit – Production Equipment Part 5: Product Audit
Volume 7
Processing of Quality Data – Electronic Transfer with the QDX Standard –
Volume 8
Quality Assurance Guidelines for Trailer, Superstructure and Container Manufacturers
199
Volume 9
Quality Assurance Emissions and Consumption
Volume 10 Customer Satisfaction in the Supply Network Volume 12
Process Orientation (incl. CD-ROM)
Volume 17 Logistics Analysis Volume 18 From Quality Management to Business Excellence in the German Automotive Industry Part 1: The EFQM Excellence Model Part 2: Implementing and Evaluating Excellence Part 3: The 8 Cornerstones of Excellence Part 4: Excellence in large Organizations Part 6: Assessors' Evaluation Handbook QMC Report 9.2
Masing, Walter (Hrsg.), Handbuch des Qualitätsmanagement, 3. Auflage, 1994
9.3
DGQ-Schrift 11 - 04 (Stand 1995) Begriffe zum Qualitätsmanagement
9.4
DGQ-Schrift 12 - 62 (Stand 1991) Qualitätssicherungs-Handbuch und Verfahrensanweisung, Leitfaden für die Erstellung
9.5
DGQ-Schrift 12 - 63 (Stand 1993) Systemaudit
9.6
DIN EN ISO 8402 (1995) Qualitätsmanagement und Qualitätssicherung – Begriffe
9.7
DIN EN ISO 9000, Teil 1 (08/94) Qualitätsmanagement- und Qualitätssicherungsnormen; Leitfaden zur Auswahl und Anwendung
9.8
DIN EN ISO 9000 Teil 2 (03/92) Qualitätsmanagement- und Qualitätssicherungsnormen; Allgemeiner Leitfaden zur Anwend. von ISO 9001, ISO 9002 und ISO 9003
200
9.9
DIN EN ISO 9000 Teil 3 (06/92) Qualitätsmanagement- und Qualitätssicherungsnormen; Leitfaden für die Anwendung von ISO 9001 auf die Entwicklung, Lieferung und Wartung von Software
9.10
DIN EN ISO 9000 Teil 4 (05/92) Qualitätsmanagement- und Qualitätssicherungsnormen; Anwendung auf das Zuverlässigkeitsmanagement
9.11
DIN EN ISO 9001 (08/94) Qualitätssicherungssysteme; Modell zur Darlegung der Qualitätssicherung in Design/Entwicklung, Produktion, Montage und Kundendienst
9.12
DIN EN ISO 9002 (08/94) Qualitätssicherungssysteme; Modell zur Darlegung der Qualitätssicherung in Produktion und Montage
9.13
DIN EN ISO 9003 (08/94) Qualitätssicherungssysteme; Modell zur Darlegung der Qualitätssicherung bei der Endprüfung
9.14
DIN EN ISO 9004, Teil 1 (08/94) Qualitätsmanagement und Elemente eines Qualitätssicherungssystems - Leitfaden
9.15
DIN EN ISO 9004, Teil 2 (08/94) Qualitätsmanagement und Elemente eines Qualitätssicherungssystems - Leitfaden für Dienstleistungen
9.16
DIN EN ISO 9004 Teil 3 (08/94) Qualitätsmanagement und Elemente eines Qualitätssicherungssystems - Leitfaden für verfahrenstechnische Produkte
9.17
DIN EN ISO 9004 Teil 4 (08/94) Qualitätsmanagement und Elemente eines Qualitätssicherungssystems - Leitfaden für Qualitätsverbesserung
201
9.18
DIN ISO 10011 Teil 1 (06/92) Leitfaden für das Audit von Qualitätssicherungssystemen; Auditdurchführung
9.19
DIN ISO 10011 Teil 2 (06/92) - Qualifikationskriterien für Auditoren
9.20
DIN ISO 10011 Teil 3 (06/92) - Management von Auditprogrammen
9.21
DIN ISO 10012 Teil 1 (08/92) Forderung an die Darlegung der Qualitätssicherung von Prüfmitteln - Management von Prüfmitteln
9.22
VDI-Richtlinie 2890 (1986) Planmäßige Instandhaltung: Anleitung zur Erstellung von Wartungs- und Inspektionsplänen
9.23
VDI/VDE/DGQ-Richtlinie 2618 (Teil 1 - 17): Prüfanweisung zur Prüfmittelüberwachung
9.24
VDI/VDE/DGQ-Richtlinie 2619: Prüfplanung
9.25
DGQ-Schrift 14-18 (1995) Wirtschaftlichkeit durch Qualitätsmanagement
9.26
ISO 9000:2000, 9001:2000 + 9004:2000 Quality Management Systems – Terms and Definitions, Requirements
References 9.1
Verband der Automobilindustrie e. V. (VDA) Qualitätsmanagement Center (QMC) An den Drei Hasen 31, D-61440 Oberursel
9.2
Carl Hanser Verlag, Postfach 86 04 20, D-81631 München
9.3 - 26 Beuth-Verlag, Burggrafenstraße, D-10787 Berlin
202
10
Agreement with Industrial Associations
10.1
Introduction
The current publication on the auditing of quality management systems according to DIN EN ISO 9004, Part 1 and DIN EN ISO 9001 has since the publication of the 1st Edition in January 1991 received great attention even beyond the sector of the automotive industry. This was the reason why quality management working groups from several expert and industrial associations have discussed the content and formulation of this document. Thereby, it was established that the questionnaire could be adapted apart from some questions not pertinent to this industry sector. These questions not pertinent to this industry sector should not be used in audits/certification and evaluation. The final determination of the which questions are or are not used in the audit/certification process is subject to agreement between the organization to be audited and the customer or certification body under consideration of risk aspects. This may vary when comparing different associations and suppliers. 10.2
Summary of the National Associations
• Deutsche Gesellschaft für Materialkunde e. V. (DGM) Oberursel/Ts. German Association for Material Science) For the committees: Strangpressen und Walzen von NE-Metallen (Extrusion Molding and Rolling) • Deutscher Schraubenverband e. V Hagen (German Association of Fasteners) • Verband der Chemischen Industrie e. V. (VCI) Frankfurt/Main (Association of the Chemical Industry) The VCI regards all questions as applicable, however, the production processes in the chemical industry are partially structured different to other industrial branches. Therefore, supplementing explanations for some questions of the VDA questionnaire were established from a chemistryspecific viewpoint. The comparison and explanations are contained in a VCI brochure which is available from the VCI.
203
• Verband der Deutschen Federnindustrie (VDFI) Hagen (Association of the German Spring Industry) For the member associations: - VDFI Fahrzeugfedern e.V. - FF – (Vehicle Springs) - VDFI Kaltgeformte Federn - KF – (Cold Formed Springs) - Verein Deutscher Eisenhüttenleute e.V. (VDEH) Düsseldorf (Association of German Iron Foundry Workers) - Industrieverband Deutscher Schmieden e. V. (IDS) Hagen (German Forging Industry Association) • Wirtschaftsvereinigung Ziehereien und Kaltwalzwerke e. V. Düsseldorf (Drawing and Cold Rolling Works Industrial Association) For the member associations: - Eisen- und Stahldrahtvereinigung e. V. (Steel Wire Organization) - Fachvereinigung Kaltwalzwerke e. V. (Cold Rolling Works) Kaltbund und Kaltprofile (Cold Strip and Cold Profile) - Fachvereinigung Präzisionsrohrwerke e. V. (Association of Precision Tube Works) - Stabziehereien-Vereinigung e. V. (Bar Drawing Association)
10.3
International Agreement on Mutual Recognition
In March 1994, the agreement on the mutual recognition of results of quality management system audits between the French and German Automotive Industry was concluded. This was realized after an intensive comparison of the two existing questionnaires and after a corresponding alignment of the requirements, as well as after joint audits at German and French suppliers. The wording of the agreement in the German language is printed on the following page.
204
AGREEMENT on mutual recognition PSA Peugeot Citroën, Renault, FIEV and Verband der Automobilindustrie (VDA) The car manufacturers PSA PEUGEOT CITROËN and RENAULT evaluate the quality capability of their suppliers according to a procedure that is described in the publication „REFERENTIEL D’EVALUATION D’APTITUDE QUALITÉ FOURNISSEURS“ (Evaluation of the quality capability of suppliers) Edition 94, based on the standard series EN29000. The French component manufacturers, members of the FIEV (Fédération des Industries des Equipements pour Véhicules), have participated in the develop-
ment of this procedure. It forms the basis for evaluating the quality capability of their own suppliers. The German car and component manufacturers, members of the VDA (Verband der Automobilindustrie e.V. Association of the German Automotive Industry) have established an audit procedure for the evaluation of the quality systems of their suppliers that is described in Volume 6 of the series „QUALITÄTSMANAGEMENT IN DER AUTOMOBILINDUSTRIE – QUALIÄTSSICHERUNGSSYSTE MAUDIT“ and which is also based on the standard series EN 29000.
In an effort to raise the efficiency when auditing quality systems and after establishing the comparability of both evaluation procedures • The car and component manu• The car manufacturers PSA facturers of the VDA on the PEUGEOT CITROËN and REother side NAULT, as well as the component manufacturers of the FIEV on the one side and have decided TO MUTUALLY RECOGNIZE AUDITS WHICH HAVE BEEN CARRIED OUT BY ONE OF THE CONTRACT PARTNERS FOLLOWING ONE OF THE ABOVE PROCEDURES AND THEIR RESULTS. This requires, that the audited organization provides the result and audit report of a preceding audit. Specific elements of the respective partner may be subject of a supplementing audit. nine signatures - End of the agreement – 205
11
Notes on a Certification according to VDA 6.1
Certification bodies, contractually accredited by VDA, may, upon request, certify the quality management system of an organization on the basis of VDA Volume 6, Part 1. This certification is based on a certificate according to DIN EN ISO 9001 or 9002. It is supplemented by VDA 6.1-specific elements and questions whereby all appropriate questions of the VDA 6.1 questionnaire must be evaluated. A certificate supplement VDA 6.1 (for the certificate according to DIN EN ISO 9001/ 9002) may be issued by the certification body if an overall compliance of at least 90% has been reached, no element lies below 75% compliance, no question identified with a * is marked with less then eight points and no question without marking reaches zero points (compare Para. 3.3.3). When certifying according to VDA 6.1 an existing certificate according to DIN EN ISO 9001 or 9002 may be taken into account so that the expenditure for upgrading to VDA 6.1 is limited. Certification audits must only be carried out by "certified VDA 6.1 auditors" with the corresponding branch expertise. More details are given in VDA Volume 6, Quality Audit Fundamentals - Certification Requirements.
206
12
Appendix
12.1
Changes of the 4th Edition compared to the 3rd Edition
Further corrections and updating have been incorporated. The audited organization is from now on generally referred to as "the organization". The factual content of the chapters, elements and questions has widely remained unchanged. Changes have been made in: Foreword "Quality Standards of the German Automotive Industry" updated 3.
Quality System Audit Scope of application for all 3 audit types (1st-, 2nd– and 3rd-party) determined.
3.2
Selection of the Quality elements and Relevant Questions The possibility regarding the omission or addition of elements or questions have been defined more precisely. The definition of 41 questions as being of special influence to product and process quality or the quality system (*-questions) has been newly introduced.
3.3.1
Individual Rating of Questions and Quality Elements The definition of "mainly" has been extended.
3.3.3
Grading for Customer/Supplier Audits (2nd Party) The classification for customer/supplier audits (2nd –party) has been revised taking into account the questions with special influence (*-questions). An additional downgrading from A to AB has been introduced when questions are marked with 0 points.
3.3.4
Awarding of the VDA 6.1 Certificate Supplement (3rd –party) Rules for the issue of certificate, and for follow-up or re-audits have been newly included.
207
3.7
VDA 6.1 Certificate The text of the certificate has been changed. The statement of the level of compliance has been dropped.
7
Questionnaire Question 01.6: Management review "with all elements" dropped Question 03.1: Qualification requirements for internal auditors updated. External auditors now defined under 04.5. Question 04.5 Qualification requirements for external auditors newly included. Question 06
The circle of persons to be informed has been newly formulated.
Question 06.4 Definition for "Emergency Plans" revised. Element Z1
Is now generally to be taken into account during audits/certification.
Question Z1.3 Examples for data have been supplemented. Question 07.5 Formulation: "early" has been added. Question 09.4 Quality evaluation "at least three times" has been dropped. Element 10
VDA Volume 1 has been added as being applicable.
Element 11
"Supplier" is generally used instead of "Subsupplier". The note was added that the element is also applicable for internal customer/supplier relationships.
Question 11.6 "inspected“ and "not inspected" has been replaced by "released" and "not released". Question 13.2 "Inspection and test plan" has been replaced by "inspection and test instruction". Question 13.3 Formulation: "Production parameters of the process“ has been replaced with "process parameters“. Question 13.4 Formulation: "Manufacturing means" has been replaced by "production means".
208
Question 14.1 Explanation to "Process Capability" added. Question 14.2 PPA Process according to VDA Volume 2 and note on process changes added. Question 14.7 Note on applicable methods added. Question 15.1 "Destructive testing" added. Question 15.2 Procedure for rework added. Question 15.6 "Durability test" added, "Product audit" dropped (compare 03.4). Element 20
"Quality-relevant records" changed into "Quality records". Note on VDA Volume 1 added.
Question 20.1 Formulation: "maintenance" has been dropped. Question 20.3 Definition for DwSpA added (compare VDA 1). Element 21
8
Note on procedure when only Question 21.3 is relevant.
Forms
Generally, the term "supplier“ has been dropped. In the form "Corrective actions" the word "deviations" has been added. 11
Notes on Certification
This section has been updated. VDA Volume 6, Basics for Quality Audits is referenced. 12
Appendix
The notes on changes made from 2nd Edition to the 3rd Edition have been dropped.
209
12.2
Comparison Tables
In the following, the comparison tables to DIN EN ISO 9001 are shown. 12.2.1
Comparison Matrix VDA 6.1 / DIN EN ISO 9001 a) DIN EN ISO 9001:1994
VDA 6 M 01. 01.1 01.2 01.3 01.4 01.5 01.6 02. 02.1 02.2 02.3 02.5 02.4 02.6 03. 03.1 03.2 03.3 03.4 04. 04.1 04.2 04.3 04.4 04.5 04.6 04.7 05. 05.1 05.2 05.3 05.4 06. 06.1 06.2 06.3 06.4
210
Subject of the Question Management of the Organization Management Responsibility Quality policy Quality objectives Continual improvement Quality management system, resources for personnel and material costs Management representative Management review Quality Management System Quality manual Scope of the quality management system Responsibility and authority Project management Quality planning Quality plans Internal Audits Auditor qualification Internal quality audits Corrective actions and their documentation Product and process audits Training Training program Further training in quality techniques Further training - Executives New appointments, realization Qualification Promotion of quality awareness Presentation of the quality achieved Financial Considerations regarding Quality Management Systems Methods of reporting Regularity of reporting Nonconformity costs internal Nonconformity costs external Product Safety Product liability - Basics Products requiring documentation Identification of product risks Localization of nonconforming units
DIN EN ISO 9001 4.1 4.1.1 4.1.1 -4.1.2.2 4.1.2.1, 4.1.2.3 4.1.3 4.2 4.2.1, 4.2.2 4.1.2 4.1.2.1 (4.4.3) 4.2.3 4.2.3 4.17 4.17.2 4.17.1, 4.17.3 --4.18 4.18 4.18 4.18, 4.1.2.2 4.18 4.18 ---(4.1.3) ---(4.2.3a, -g) -(4.8)
VDA 6 Z1. Z1.1 Z1.2 Z1.3 Z1.4 Z1.5 P 07. 07.1 07.2 07.3 07.4 07.5 08. 08.1
DIN EN ISO 9001
Subject of the Question Corporate Strategy Business plan on costs, sales, quality etc. Measuring methods for business results and CIP use Performance data, organization-wide / comparison Customer satisfaction, measurement and modification Personnel satisfaction Product and Process Contract Review / Quality in Marketing Marketing function Contract review Structure quotation Quality requirements of the customer Requirements and performance specification known Design Control Product/process development plan
08.2 08.3 08.4 08.5
Quality requirements fully considered Product/process trial Management review Design approval
08.6 08.7 09 09.1
Result of design work Transfer of development experience Process Planning (Process Development) Process development Plan for new/modified products
09.2
Production plans, work instructions
09.3 09.4 09.5
Quality requirements fully considered Management review of processes and procedures Approval of processes and procedures
09.6 09.7 10. 10.1 10.2 10.3 10.4 10.5 11. 11.1
Result of process planning and development work Transfer of experiences from process planning Document and Data Control Quality-relevant documents, responsibility, procedures, .. Approval and revision Archiving Appropriately times introduction of customer documents Non-use of invalid documents Purchasing Order documents
11.2 11.3 11.4
Supplier selection Sample test Supplier quality performance
-----4.3 -4.3.1, 4.3.2 -4.2.3, 4.3.2a, 4.3.2c 4.4 4.4.1, 4.4.2, 4.4.4, 4.4.5 4.4.4, 4.3.2c 4.4.7, 4.4.8 4.4.6 4.4.8, 4.4.3, 4.4.5 4.4.5 4.4.3, 4.4.5 4.4, (4.9) 4.4.1, 4.4.2, 4.4.4, 4.4.5 4.9 Abs.1, 4.9a 4.4.4, 4.3.2c 4.4.6 4.4.8, 4.4.3, 4.4.5 4.4.5 4.4.3, 4.4.5
4.5, 4.5.1 to -3 4.5.2, 4.5.3 4.3.4 4.5.2 4.5.3 4.6 4.6.2, 4.6.3, 4.6.4.2 4.6.1, 4.6.2a 4.6.1, 4.6.2b 4.6.1, 4.6.2c
211
VDA 6
Subject of the Question
11.5 11.6 11.7 12 12.1 12.2 12.3 12.4 13.
Agreements on quality inspections Material receiving inspection Traceability Control of customer-supplied Products Agreed quality measures Minimum scope of inspection and testing Reporting of nonconformities Quality history Process Control/Identification and Traceability/Inspection and Test Status
13.1 13.2 13.3
Product identification Process control measures Records of process parameters
13.4 13.5 13.6 13.7 14. 14.1 14.2 14.3 14.4 14.5 14.6 14.7 15. 15.1 15.2 15.3
Production means – Storage Quality objective/subsequent process, dispatch Traceability Release on restart Process Control Machine/process capability tests Production release Control of relevant process parameters Maintenance, preventive servicing Special processes Environmental conditions specified/complied with Evaluation of the effectiveness of production processes Inspection and Testing Inspection and test plans Inspection and test plans and instructions Quality evidence for external purchases
15.4
Quality evidence according to work steps
15.5 15.6 16. 16.1
Quality evidence on the final product Periodic inspections and tests Control of Inspection, Measuring and Test Equipment Control and calibration system
16.2 16.3
Connection to national/international standards Measurement uncertainty of inspection, measuring and test equipment Inspection, measuring and test equipment capability Measures to be taken in case of nonconforming inspection, measuring and test equipment
16.4 16.5
212
DIN EN ISO 9001 4.6.2b, (4.6.4) 4.6.4, 4.10.1 4.8 4.7 4.7 4.7 4.7 4.7 4.9, (4.8, 4.11, 4.12, 4.19´6) 4.8, 4.12 4.9d 4.9 (Para.4) 4.16 4.11.2h 4.12 4.8 (Para.2) 4.9e 4.9 4.9b 4.9c, -d, -e 4.9d, 4.9f 4.9g 4.9 Para. 2, 3 4.9b, 4.11.2g -4.10, (4.2.3) 4.2.3b,-c,-d,-e 4.10.1 4.6.4.1, 4.10.1, 4.10.2 4.10.1,4.10.3, 4.12 4.10.1, 4.10.4 (4.10.1) 4.11 4.11.1,4.11.2 b,-c,-d,-e,-g,-i 4.11.2b 4.11.2a (4.11.2a) 4.11.2f
VDA 6
Subject of the Question
17. 17.1 17.2 17.3 17.4 18. 18.1 18.2 18.3 18.4 19. 19.1
Control of Nonconforming Products Treatment of nonconforming units Concessions Carrying out of corrective actions Identification of reoccurring nonconformities Corrective and Preventive Actions Initiation of corrective actions Estimating the nonconformity risk Analysis of the cause of nonconformities Prevention of nonconformity reoccurrence Handling, Storage, Packaging, Preservation and Delivery Product handling
19.2 19.3
Packaging and identification process Prevention of transport damage
19.4
Correction of packaging errors
19.5 19.6 20. 20.1 20.2 20.3 20.4 21 21.1 21.2 21.3 21.4 21.5 22. 22.1 22.2 22.3 22.4 22.5 22.6
Product identification Delivery reliability Control of Quality Records Quality-relevant documents Evaluation of quality records Archiving Customer access to quality records Quality in the application phase/Servicing/Customer Service Users manual and installation instructions Product observation/Field failure-early warning system Field failure analysis Customer service information Servicing Statistical Methods Method planning Development/Trial External sources Process development and control Final inspection Evaluation of field failures
DIN EN ISO 9001 4.13 4.13.1, 4.13.2 4.13.2 4.13.2 4.14.2a 4.14 4.14.1, 4.14.2 4.14.3 4.14.2b 4.14.2d 4.15 4.15.1,4.15.2, 4.15.3 4.15.4 4.15.4,4.15.5, 4.15.6 4.15.1 with 4.14.1 4.15.4 -4.16
4.16 4.16 4.16, 4.3.4 4.16 (4.19) (4.19) -(4.14.2b) -4.19 4.20 4.20.1 4.20 4.20 4.20 4.20 4.20
213
b) ISO 9001:2000 VDA 6.14
Subject of the Question
M
Management of the Organization
01. 01.1 01.2 01.3
01.5
Management Responsibility Quality policy Quality objectives Continual improvement Quality management system, resources for personnel and material costs Management representative
01.6
Management review
02.
Quality Management System
02.1
Quality manual
02.2 02.3 02.5 02.4 02.6 03. 03.1 03.2 03.3 03.4 04. 04.1 04.2 04.3 04.4 04.5 04.6 04.7 05. 05.1 05.2 05.3 05.4
Scope of the quality management system Responsibility and authority Project management Quality planning Quality plans Internal Audits Auditor qualification Internal quality audits Corrective actions and their documentation Product and process audits Training Training program Further training in quality techniques Further training - Executives New appointments, realization Qualification Promotion of quality awareness Presentation of the quality achieved Financial Considerations regarding Quality Management Systems Methods of reporting Regularity of reporting Nonconformity costs internal Nonconformity costs external
01.4
1) 2)
214
ISO 9001:2000
5, 6, 8.5.1 5.1, 5.3, 5.4.1 5.1, 5.3, 5.4.1 5.1, 8.5.1 5.1, 6.1, 6.2.1, 6.3 5.5.2 5.6.1, 5.6.2, 5.6.3 4, 5.4.2, 7.1 4.1, 4.2.1, 4.2.2 4.2.1, 4.2.2 5.5.1 7.3.1 5.4.2, 7.1 5.4.2, 7.1 8.2 8.2.2 8.2.2, 8.2.4 8.2.2, 8.5.2 8.2.3, 8.2.4 5.5.3, 6.2 6.2.2 6.2.2 6.2.2 6.2.2, 4.2.4 6.2.1, 6.2.2 6.2.2 5.5.3 -5.6 ---
VDA requirements concerning Process Audits extend beyond those of ISO (see VDA 6.3). Financial Considerations regarding Quality Management Systems are not seperately treated in the ISO standard.
VDA 6.14
Subject of the Question
06. 06.1
Product Safety Product liability - Basics
06.2
Products requiring documentation
06.3 06.4 Z1. Z1.1 Z1.2 Z1.3 Z1.4 Z1.5 P 07. 07.1 07.2 07.3 07.4 07.5 08.
Identification of product risks Localization of nonconforming units Corporate Strategy Business plan on costs, sales, quality etc. Measuring methods for business results and CIP use Performance data, organization-wide / comparison Customer satisfaction, measurement and modification Personnel satisfaction Product and Process Contract Review / Quality in Marketing Marketing function Contract review Structure quotation Quality requirements of the customer Requirements and performance specification known Design Control
08.1
Product/process development plan
08.2
Quality requirements fully considered
08.3
Product/process trial
08.4
Management review
08.5
Design approval
08.6 08.7 09.
Result of design work Transfer of development experience Process Planning (Process Development)
09.1
Process development Plan for new/modified products
09.2
Production plans, work instructions
09.3
Quality requirements fully considered
09.4
Management review of processes and procedures
09.5 09.6 09.7
Approval of processes and procedures Result of process planning and development work Transfer of experiences from process planning
3) 4) 5)
ISO 9001:2000 5.1 4.2.3, 4.2.4, 7.2.1
-5.6.2 -8.4, 8.5.1
-8.2.1, 8.4 6.2.2 5.2, 7.2 5.2, 7.2.1 7.2.2
-7.2.3 7.2.1, 7.2.2 7.1, 7.3 7.1, 7.3.1, 7.3.7 7.3.2, 7.3.7 7.3.3, 7.3.5, 7.3.7 7.3.4, 7.3.6, 7.3.7 7.3.4, 7.3.5, 7.3.6, 7.3.7 7.3.3, 7.3.7
-7.1, 7.3, 7.,5 7.1, 7.3.1, 7.3.7 7.5.1, 7.3.7 7.3.2, 7.3.7, 7.5.1 7.3.4, 7.3.5, 7.3.7, 7.5.2 7.3.7, 7.5.2 7.3.3, 7.3.7 7.3.1, 7.3.3,
Business results are not seperately treated in the ISO standard. Special documentation requirements are not seperately treated in the ISO standard. The ISO standard contains only rudimentary treatment of Process Planning.
215
VDA 6.14
Subject of the Question
10. 10.1 10.2 10.3 10.4 10.5 11.
Document and Data Control Quality-relevant documents, responsibility, procedures, .. Approval and revision Archiving Appropriately times introduction of customer documents Non-use of invalid documents Purchasing
11.1
Order documents
11.2 11.3 11.4 11.5 11.6 11.7 12. 12.1 12.2 12.3 12.4
13.1 13.2 13.3
Supplier selection Sample test Supplier quality performance Agreements on quality inspections Material receiving inspection Traceability Control of customer-supplied Products Agreed quality measures Minimum scope of inspection and testing Reporting of nonconformities Quality history Process Control/Identification and Traceability/Inspection and Test Status Product identification Process control measures Records of process parameters
13.4
Production means – Storage
13.5 13.6 13.7 14. 14.1 14.2 14.3 14.4 14.5 14.6 14.7
Quality objective/subsequent process, dispatch Traceability Release on restart Process Control Machine/process capability tests Production release Control of relevant process parameters Maintenance, preventive servicing Special processes Environmental conditions specified/complied with Evaluation of the effectiveness of production processes
13.
216
ISO 9001:2000 4.2 4.2.3 4.2.3 4.2.3, 4.2.4 4.2.3 4.2.3 7.4, 7.5 7.4.1, 7.4.2; 7.4.3 7.4.1 7.4.1 7.4.1 7.4.1, 7.4.3 7.1, 7.4.1, 8.1 7.5.3 7.5.4 7.5.4 7.5.4 7.5.4 7.5.4 7.5 7.5.3 7.5.1 7.5.2, 4.2.4 7.5.1, 7.5.4, 7.6 7.5.1, 7.5.2 7.5.3, 4.2.4 7.5.2 7.5 7.5.2, 8.2.3 7.5.2 7.5.2, 8.2.3 7.5.1, 6.3 7.5.1 6.3, 6.4, 7.5.5 7.5.2
VDA 6.14 15. 15.1 15.2 15.3 15.4 15.5 15.6 16. 16.1 16.2 16.3 16.4 16.5 17. 17.1 17.2 17.3 17.4 18. 18.1 18.2 18.3 18.4 19. 19.1 19.2 19.3 19.4 19.5 19.6 20. 20.1 20.2 20.3 20.4
Subject of the Question Inspection and Testing Inspection and test plans Inspection and test plans and instructions Quality evidence for external purchases Quality evidence according to work steps Quality evidence on the final product Periodic inspections and tests Control of Inspection, Measuring and Test Equipment Control and calibration system Connection to national/international standards Measurement uncertainty of inspection, measuring and test equipment Inspection, measuring and test equipment capability Measures to be taken in case of nonconforming inspection, measuring and test equipment Control of Nonconforming Products Treatment of nonconforming units Concessions Carrying out of corrective actions Identification of reoccurring nonconformities Corrective and Preventive Actions Initiation of corrective actions Estimating the nonconformity risk Analysis of the cause of nonconformities Prevention of nonconformity reoccurrence Handling, Storage, Packaging, Preservation and Delivery Product handling Packaging and identification process Prevention of transport damage Correction of packaging errors Product identification Delivery reliability Control of Quality Records Quality-relevant documents Evaluation of quality records Archiving Customer access to quality records
ISO 9001:2000 7.1, 8.2.4 7.1 7.1; 8.1 7.4.3, 8.2.4 7.1, 8.1, 8.2.4 8.2.4, 7.5.3 8.2.4 7.6 7.6 7.6 7.6 7.6 7.6 8.3 8.3 8.3 8.3 8.3 8.5 5.6.3, 8.5 8.5 8.5 8.5 7.5.5 7.5.5 7.5.5 7.5.5 7.5.5 7.5.5 -4.2.4 4.2.4 4.2.4 4.2.4 --
217
VDA 6.14
Subject of the Question
21. 21.1 21.2 21.3 21.4 21.5 22. 22.1
Quality in the application phase/Servicing/Customer Service Users manual and installation instructions Product observation/Field failure-early warning system Field failure analysis Customer service information Servicing Statistical Methods Method planning
22.2
Development/Trial
22.3
External sources
22.4
Process development and control
22.5
Final inspection
22.6
Evaluation of field failures
12.2.2
ISO 9001:2000 7.5, 8.4 7.5.1 -8.4; 8.5.2 7.5.1 7.5.1 8 8.1 8.2.3; 8.2.4; 8.4 8.2.3; 8.2.4; 8.4 8.2.3; 8.2.4; 8.4 8.2.3; 8.2.4; 8.4 8.2.3; 8.2.4; 8.4
Comparison Matrix DIN EN ISO 9004 / VDA 6.1 a) 9001:1994
DINEN Element according to DIN EN ISO 9001 ISO9001 4.1 Management Responsibility .1.1 Quality policy .2.1 Organization, responsibility and authority .2.2
Organization, resources
.2.3 .3 4.2 .1 .2 .3
Organization, management representative Management review Quality Management System General Documented quality procedures Quality planning
4.3 .1 .2a .2b .2c
Contract Review General Review, requirements documented and understood P. nonconformities quotation/order Capability to meet the requirements
218
VDA6 01 01.1, 01.2 01.5, 02.2, 02.3, 01.4, 02.2, 04.3 01.5, 02.2, 01.6, (05.2) 02 02.1, 02.2 02.1, 02.5, 02.6, 07.4, [06.2, ], 15.1 07 07.2 07.2, 07.4 07.2 07.2, 07.5, 08.2, 09.3
DINEN Element according to DIN EN ISO 9001 ISO9001 .3 Amendment
VDA6 See introductory comment. 20.3, 09.3 08, 09 08.1, 09.1 (04.5), 08.1, 09.1 (02.4), 08.5, 08.7, 09.5, 09.7 08.1, 08.2, 09.1 08.1, 08.5, 08.6, 08.7, 09.1, 09.5, 09.6, 09.7 08.4, 09.4 08.3 08.3, 08.5, [09.3], 09.5 [08.1 - 08.7, 09.1 - 09.7] See introductory comment. 10 10.1 10.1, 10.2, 10.4 10.2, [07.2 with introductory comment], 10.5 11 11.2, 11.3, 11.4 11.1, 11.2
.4 4.4 .1 .2
Records Design Control General Design and development plan
.3
Organizational and technical interfaces
.4
Design input
.5
Design result
.6 .7 .8
Design review Design verification Design validation
.9
Design modifications
4.5 .1 .2
Document and Data Control General Approval and issue of D. & D.
.3
Amendments to documents and data
4.6 .1
Purchasing General
.2a
4.7
Evaluation of subcontractors Suitability: evaluate and select Monitoring: Capabilities and performance Record corresponding data Purchasing information Inspection of purchased products (Supplier at the subcontractor). Inspection of purchased products (Inspection by the customer). Control of Customer-supplied Products
4.8
Identification and Traceability of Products
(06.3), 11.7, 13.1, 13.6
4.9 Para.1 a
Process Control Planning of quality-influencing assembly and servicing Documented procedures
9, 13, 14 9.1, 13.2 9.2, 13.2
.2b .2c .3 .4.1 .4.2
11.3, 11.5 11.4 11.1 [11.5], 11.6 [11.1, 11.5], 11.6 12
219
DINEN Element according to DIN EN ISO 9001 ISO9001 b Suitable equipment and environmental conditions c d
Compliance of standards, quality plans, documented procedure. Matching process parameters
e
Approval of processes and equipment
f g e
Criteria for work performance Maintenance Release
Para.2,3 Para.4 4.10 .1.1
Special processes Recordings of quality processes, equipment, personnel Inspection and Testing General
.2.1 .2.1 .2.2 .2.3 .3 .4 .5
Receiving inspection and testing Application after verification Scope and type of receiving inspection Pre-release and concession In-process inspection and testing Final inspection and testing Inspection and test records
4.11 .1 .2a
.2i 4.12
Control of Inspection, Measuring and Test Equipment General Determination of control procedure, inspection and testing and inspection, measuring and test equipment Determination and calibration of inspection, measuring and test equipment Determination of corresponding procedures Identification of calibration status Archiving of records on calibration Evaluation and recording of previous measurement results for nonconformities on inspection, measuring and test equipment Environmental conditions for measurements Handling, protection and storage of inspection, measuring and test equipment Protection of the calibration status Inspection and Test Status
4.13 .1 .2
Control of Nonconforming Products General Evaluation and handling of nonconforming products
.2b .2c .2d .2e .2f .2g .2h
220
VDA6 9.4, 14.1, 14.6 9.3, 9.5, 14.2 9.5, 13.2, 14.2, 14.3, (13.4) 9.4, 9.5, 13.7, 14.2, 9.2, 14.3 14.4 9.5, 13.7, 14.2 9.4, 14.5 9.6, 9.7, 13.3 15 11.6, 15.2, 15.3, 15.4, 15.5, (15.6) 15.3 15.3 15.3, 15.3 15.4 15.5 (Records always) 16 16.1 14.2 with 16.3, (16.4) 16.1, 16.2 16.1 16.1, 16.4 16.1, 20.1 16.5 14.6, 16.1 13.4 16.1 13.1, 15.4 17 17.1 17.1, 17.2, 17.3
DINEN ISO9001 4.14 .1 .2a .2b
Element according to DIN EN ISO 9001
VDA6
.2c .2d .3 4.15 .1 .2 .3 .4
Corrective and Preventive Action General Corrective actions, effective treatment of nonconformities Corrective action – cause of nonconformity in relation to production, process, system Corrective action – Determination of... Corrective action – Monitoring of their effectiveness Preventive actions Handling, Storage, Packaging, Preservation and Delivery General Handling Storage Packaging
.5 .6 4.16
Preservation Delivery Control of Quality Records
18 18.1, 19.4 17.4, 18.1 18.1, 18.3, (21.3) 18.1 18.1, 18.4 18.2 19 19.1, 19.4 19.1 19.1 19.2, 19.3, 19.4 [07.5], 19.3 [07.5], 19.3 12.3, 20
4.17 Para.1 Para.2 Para.3 Para.4 4.18
Internal Quality Audits Documented procedure Planning of audits and auditors Recording and distribution of results Follow-up audits – corrective actions Training
03 03.2 03.1 03.2 03.3 04
4.19
Servicing
(21.1 to 21.4),21.5
4.20 .1
Statistical Techniques Determination of demand
.2
Procedure
22 21.1, 21.2, 21.3, 21.4 21.1, 21.2, 21.3, 21.4
b)
DIN EN ISO 9001:2000
ISO 9001:2000
Element
4
VDA 6.14
Quality Management System 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4
General Requirements Documentation Requirements General Quality Manual Control of Documents Control of Records
02.1 02.1, 02.2 02.1, 02.2 06.2, 10.1-10.5 03.2, 04.4, 06.2, 10.3, 13.3, 13.6, 20.1 – 20.4
221
ISO 9001:2000 5
Element Management Responsibility
5.1 Management Commitment 5.2 5.3 5.4 5.4.1 5.4.2 5.5 5.5.1 5.5.2 5.5.3 5.6 5.6.1 5.6.2 5.6.3 6 6.1 6.2 6.2.1 6.2.2 6.3 6.4 7 7.1
7.2 7.2.1 7.2.2 7.2.3 7.3 7.3.1
Customer Focus Quality Policy Planning Quality Objectives Quality Mangement System Planing Responsibility, Authority and Communication Responsibility and Authority Management Representative Internal Communication Management Review General Review Input Review Output Resource Management Provision of Resources Human Resources General Competence, Awareness and Training Infrastructure Work Environment Product Realization Planning of Product Realization
Customer-related Processes Determination of Requirements related to the Product Review of Requirements related to the Product Customer Communication Design and Development Design and Development Planning
7.3.2 Design and Development Inputs 7.3.3 Design and Development Outputs 7.3.4 Design and Development Review 7.3.5 Design and Development Verification 7.3.6 Design and Development Validation
222
VDA 6.14
01.1, 01.2, 01.3, 01.4, 06.1 Z1.4, 07.1 01.1, 01.2 01.1, 01.2 02.5, 02.6, 02.3 01.5 04.7 01.6, 05.6 01.6, 05.6 01.6, 05.6, 18.1 01.4 01.4, 04.1 04.1 - 04.6, Z1.5 01.4, 14.4, 14.6 14.6 02.5, 02.6, 08.1, 09.1, 11.6, 15.1, 15.2, 15.4 06.2, 07.1, 07.5 07.2, 07.5 07.4 02.4, 08.1, 09.1, 09.7 08.2, 09.3 08.3, 08.6, 09.6, 09.7 08.4, 08.5, 09.4 08.3, 08.5, 09.4 08.4, 08.5
ISO 9001:2000
Element
7.3.7 Control of Design and Development Changes 7.4 7.4.1 7.4.2 7.4.3 7.5 7.5.1
Purchasing Purchasing Process Purchasing Information Verification of Purchased Product Production and Service Provision Control of Production and Service Provision
7.5.2 Validation of Processes for Production and Service Provision 7.5.3 Identification and Traceability
8
7.5.4 Customer Property 7.5.5 Preservation of Product 7.6 Control of Measuring and Monitoring Devices Measurement, Analysis and Improvement 8.1 General 8.2 8.2.1 8.2.2 8.2.3
Monitoring and Measurement Customer Satisfaction Internal Audit Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement 8.5.1 Continual Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action
VDA 6.14 08.1 – 08.6, 09.1 – 09.6 11.1 - 11.6 11.1 11.1, 11.5 09.2, 09.3, 13.2, 13.4, 13.5, 14.4, 21.4, 21.5 09.4, 09.5, 13.3, 13.5, 13.7, 14.1 –14.3, 14.7 11.6, 13.1, 13.6, 15.5 12.1 –12.4, 13.4 14.6, 19.1 –19.5 13.4, 16.1-16.5 11.6, 15.2, 15.4, 22.1 Z1.4 03.1, 03.2, 03.3 03.4, 14.1, 14.3, 22.2-22.6 03.4, 15.3, 15.4 - 15.6, 22.2-22.6 17.1 – 17.4 Z1.2, 21.3, 22.2 - 22.6 01.3, Z1.2, 18.1 – 18.4 18.1 - 18.4, 21.3 18.1 - 18.4
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Other VDA-FORMS INITIAL SAMPLE TEST REPORT – new version • • •
Cover page, Order No. 2661 Test results, Order No. 2662 Multipart form set, 5 copies (packed of 50 sets) Outline form for process capability verification, Order No. 2663 Pad of 50 sheets – Minimum order 1 pad
INITIAL SAMPLE TEST REPORT – previous version Initial sample Test Report – Report result, Order No. 5331 Multipart form set, 7 copies (packed of 50 sets) Initial sample Test Report – Test result, Order No. 5332 Pad of 100 sheets SYSTEM - FMEA - new version Order No. 7422, DIN A3 format, Pad of 50 sheets FAILURE MODE AND EFFECTS ANALYSIS (FMEA) - old version Order No. 769, DIN A3 format, Pad of 50 sheets QUALITY MANAGEMENT SYSTEM AUDIT (Material products) Questionnaire (only questions) DIN A5, Pad of 10 sets à 12 sheets Evaluation documents Overall evaluation of the quality management system Overall compliance Summary of results Summary of evaluated questions Corrective actions Corrective actions - summary DIN A4, Pad of 10 sets of 5 sheets The two pads form a unit and are only offered as a set Order No. 1749 Order: DRUCKEREI HENRICH GMBH Schwanheimer Straße 110, D-60528 Frankfurt Telephone (069) 96766-158, Telefax (069) 96777-159.
224
Quality Management in the Automotive Industry The current status of published VDA Volumes regarding quality management in the automotive industry can be consulted on the internet under http://www.vda-qmc.de. Direct orders can also be made on this homepage.
225
Note regarding VDA Volume 6 Part 1, 4th Edition Since the publication of the first edition in 1991, the current volume on auditing/certification of quality management systems has attracted great attention beyond the automotive industry. This was also the reason why quality work groups from various trade and industrial associations have tackled its content and preparation. Thereby, it was found that the checklist contains questions that are atypical for the industry and must not be used for auditing/certification and evaluation. The following associations have prepared appropriate interpretation guides agreed with the VDA: Gesamtverband kunststoffverarbeitende Industrie e.V. Trade association for technical parts Contact: Mr. Crößmann Gesamtverband Deutscher Metallgießereien e.V. Contact: Mr. Hinrichs Deutscher Gießereiverband Contact: Mr. Dr. Urbat Wirtschaftsverband Stahlumformung e.V. Contact for general inquiries: Mr. Dannert Deutscher Schraubenverband e.V. Contact: Mr. Naumann Eisendraht- und Stahldraht-Vereinigung e.V. Contact: Mr. Bieker Fachvereinigung Kaltwalzwerke e.V. Contact: Dr. Neuhaus Fachvereinigung Präzisionsrohrwerke e.V. Contact: Mr. Dr. Neuhaus Industrieverband Blechumformung e.V. Contact: Mr. Dannert Stabziehereien-Vereinigung e.V. Contact: Mr. Düppe Verband der deutschen Federnindustrie • Vehicle springs • Cold-coiled springs Contact: Mr. Dannert Wirtschaftsvereinigung Metalle e.V.
Contact: Mr. Lipps
226
Trough its training center estabished in 2001, the Quality Managment Center (VDA-QMC) offers a fund of knowledge covering the entire spectrum of quality in the automobile industry. The focus is on communicating this comprehensive quality know-how to users.
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