VDA Band 06.3 EN

23.08.2010

10:07 Uhr

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6

Quality Managment in the Automotive Industry Process Audit

Part 3

Product Development Process / Serial Production Service Development Process / Providing the Service

VDA Volume 6 Part 3

Band_06_3_2nd_engl:Umschlag_rot

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Process Audit

Product Development Process / Serial Production Service Development Process / Providing the Service

2nd completely revised edition, June 2010 Verband der Automobilindustrie e.V. (VDA)

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ISSN 0943 9412 Printed 08/2010 Copyright 2010 by Verband der Automobilindustrie e.V. (VDA) Quality Management Center (QMC) Behrenstraße 35 10117 Berlin Germany Overall production : Henrich Druck + Medien GmbH Schwanheimer Straße 110 60528 Frankfurt am Main Germany Printed on chlorine free bleached paper

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Preface Greater demands in the whole chain of customer and supplier processes present the quality management of companies with new and ever more complex tasks. Higher expectations of products require robust processes which must be secure throughout the entire manufacturing and supply chain. The time between the concept of a new product and its manufacture is becoming ever shorter and this means that work processes in all the various areas of the company need to operate in parallel to an ever greater degree. This in turn places greater demands on the organisations involved, their work processes and their personnel. Organisational processes must therefore be continually monitored and improved so that they are secure and, if deviations occur, to use appropriate control loops to introduce corrective measures. An important instrument in the monitoring of processes is the process audit. This is an integral part of the VDA strategy : "Quality standard for the German automotive industry (VDA 6)" as can be seen from the following illustration. QUALITY STANDARD OF THE GERMAN AUTOMOTIVE INDUSTRY (VDA 6)

VDA 6

VDA 6 QM system audit VDA 6 QM system audit Part 1 Products Part 2 Services

Quality audit

VDA 6 Process audit Part 3 Serial production / Services

VDA 6 Part 7

VDA 6 QM system audit Part 4 Production equipment Process audit Production equipment

Fundamentals VDA 6 Product audit (material and non material) Part 5

There is agreement between automobile manufacturers and suppliers on the execution of audits in accordance with this publication.

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We thank the organisations involved and their employees for their contributions to the preparation of this publication. The following firms have cooperated in drawing up the publication :

Audi AG, Ingolstadt Continental AG, Ingolstadt Daimler AG, Stuttgart Dr. Ing. h.c. F. Porsche AG, Stuttgart Harman Becker Automotive Systems GmbH, Karlsbad Knorr Bremse Systeme für Nutzfahrzeuge GmbH, Münich Robert Bosch GmbH, Stuttgart Rollax GmbH & Co. KG, Bad Salzuflen Volkswagen AG, Wolfsburg ZF Sachs AG, Schweinfurt

Our thanks go also to all who have given us suggestions in the preparation and improvement of this publication.

Berlin, May 2010

VERBAND DER AUTOMOBILINDUSTRIE E.V. (VDA)

4

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Page

Contents Preface

3

1

Introduction

7

2 2.1 2.2 2.3

Guidance on the use of a process audit Area of application for a process audit Limits of a process audit – potential analysis Identifying process risks (risk analysis)

8 8 9 9

3 3.1 3.2

Requirements regarding auditors Auditor qualifications Code of behaviour for auditors

11 11 12

4 4.1 4.2 4.3 4.4 4.5 4.6 4.7

The audit process Audit programme Audit contract Preparation Execution Assessment Presentation of results Final evaluation and closure

13 14 16 19 24 27 29 32

5

Potential analysis ( Process element P1) Objective and purpose of the potential analysis Pre conditions Preparation Operational sequence of a potential analysis

35 35 35 35 36

5.1 5.2 5.3 5.4 6 6.1 6.2 6.2.1 6.2.2

Assessment Assessing the potential analysis Assessing a process audit for material products Assessing the individual questions Assessing sub elements in the process analysis of production and generic baselines 6.2.3 Overall assessment 6.2.4 Assessing product groups and process stages 6.3 Assessing service processes 6.3.1 Individual assessment of questions & process elements Dokument wurde bereitgestellt vom VDA-QMC Internetportal am 10.11.2010 um 14:27

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6.3.2 Overall assessment of the audit result 6.3.3 Classification 7

6

Using the questionnaire (process elements P2 to P7)

44 45 47

8 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8

Questionnaire Questionnaire overview Project management (P2) Planning the product & process development (P3) Carrying out the product & process development (P4) Supplier management (P5) Serial production (P6) Customer support, customer satisfaction, service (P7) Services (PD)

49 49 54 60 66 75 82 112 119

9 9.1 9.2 9.3

Assessment forms & overviews (examples) Process audit for material products Process audit for services Potential analysis

144 144 150 151

10 10.1 10.2 10.3

Best Practice / Lessons Learned Example of information provided by the supplier Assessment guidelines Data stores

161 161 170 172

11

Technical terms

175

12

Downloads

176

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1

Introduction

The established Audit Standard VDA 6.3 1998 has been completely revised. The objective was to re organize the process audit, making it more precise and adapting it to changing requirements in the automotive industry. Processes must be analysed in such a way that risks and weaknesses are detected in the work processes and in their interfaces. Part A of the 1998 issue has been fully revised and expanded to include further process elements such as potential analysis and project management. The contents of Part B of the 1998 issue have been made more precise and expanded with the aim of achieving maximum repeat recognition. The rules for determining classification levels have been extended, questions with particular product and process risks are identified by (*) and the classification levels have been reduced to A, B and C. In addition to the questions set out in this VDA 6.3 publication, it is recommended that databases be established in order to provide adequate support for relevant product and process specific requirements. Other assessment methods (such as software assessments using Automotive SPICE) are useful, depending on the product and can be used as supplementary systems. Explicit questions regarding environmental protection and health & safety at work are not covered, as these have their own monitoring systems, including standards covering requirements. A further objective in drawing up this new issue was to take account of existing VDA publications, in particular "Maturity level assurance for new parts" and "Robust production process (RPP)“.

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2

Guidance on the use of a process audit

2.1

Area of application for a process audit

Process audits can be used internally as well as externally throughout the entire product life cycle. The list of questions is constructed in such a way that it can be used for small and medium sized companies as well as for large concerns. As can be seen from Fig. 1, the way of looking at the product life cycle in the supply chain varies according to different phases. Issue contract Cutomer

Pre select suppliers; Potential analysis

Def. and Draft, Product & process development

SOP

Quotation process (contract review)

Def. and Draft, Product & process development

Serial production

Customer service (After Sales)

Receive Issue SOP contract contract

Supplier

Fig. 1:

Implementation Product / process development

Pre select suppliers; Potential analysis

Customer service After Sales

SOP

Issue contract

Receive contract Organisation

Serial production

Implementation Product / process development

Phases of the product life cycle in the supply chain

Fig. 2 shows how individual questions regarding process elements can be aligned with the product life cycle, independent of the position within the supply chain. This illustration may vary, depending on the specific organisation. Receive contract Quotation process (contract review)

Def. and Draft, Product & process development

Issue contract Pre select suppliers; Potential analysis

SOP

Implementation Product / process development

Serial production

Customer service (After Sales)

P1

Allocation of questions

P2 P3 P4 P5 P6 P7

P1: Potential analysis (new)

P5: Supplier management

P2: Project management (new)

P6: Process analysis / production

P3: Planning the product & process development

P7: Customer support, customer satisfaction, service

P4: Carrying out product & process development

Fig. 2:

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2.2

Limits of a process audit

potential analysis

As will be seen from Fig. 2, an analysis of potential (P1) can be carried out before a project is launched. In this, a process audit of reduced scope can be used to assess potential suppliers who are suitable as serial production suppliers. Because these are merely potential suppliers, the audit must be based on other processes / products which should be comparable with the product to be supplied. The analysis of potential can likewise be accepted by all parties, where the products and technologies are comparable (see Section 5). 2.3

Identifying process risks (risk analysis)

In a process audit, the effect of the individual processes on the product is decisive and the assessment must therefore be made from the stand point of the product risks involved. For this reason, the potential risks within the process must be determined as early as the preparations for the audit (see also Section 4.3), so that they may be assessed adequately in the process audit itself. One method of determining the product risk is the "turtle" model : see Fig. 3.

What functions / areas / persons support the process ?

What material facilities are used to carry out the process ?

Material resources

Process support

Equipment; facilities

Training, knowledge, ability, authority

What goes into the process ?

I

PS1

O

Input

What is the intended result of the process ?

Process PS2 stage stage

Output

Interface

PS3

O

Interface

How does the process operate ?

Work content

Control of execution : instructions, procedures, methods

Fig. 3:

I

How effectively is the process carried out ?

Level of effectiveness

Performance indicators

"Turtle" model

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Firstly an explanation is given of what "input" is converted into an "output" by the process. This is expanded by considering the following questions : how does the process operate ? (work content) what functions/areas/personnel support the process ? (process support) what means are employed to carry out the process " (material resources) how effectively is the process executed (level of effectiveness) In a second stage the potential risks arising from these questions are determined. These potential risks must then be evaluated in the audit, to ensure that they are assured to a reasonable degree.

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3

Requirements regarding auditors

3.1

Auditor qualifications

The quality of the results of an audit is influenced critically by the qualifications of the auditors. The qualification criteria for auditors are as follows : Internal process auditor Carrying out internal process audits with no interfaces to outside suppliers or customers : Technical requirements Basic knowledge of quality management (familiarity with current regulations and standards) and knowledge of the specific product/ processes. Certification of successful participation in a VDA 6.3 training course. Career experience At least 3 years' industrial experience, preferably in manufacturing companies in the automobile industry, including at least one year in quality and/or process management. Process auditor in the supply chain Carrying out internal and external process audits with interfaces to outside suppliers or customers. Technical requirements Well grounded knowledge of quality and process management, as well as knowledge of the specific product/ processes. Certification of an auditor qualification (e.g., based on EOQ systems). Certification of successful participation in a VDA 6.3 training course. Career experience At least 5 years' industrial experience, preferably in manufacturing companies in the automotive industry, including at least 2 years in quality and/or process management.

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3.2

Code of behaviour for auditors Process auditors must exercise their professional capabilities and their judgement, taking account of the law and maintaining the principles of honesty and plain dealing. Process auditors must continue to develop their technical expertise and maintain their knowledge of the latest developments. Process auditors must behave at all times in such a manner that the standing and reputation of the organisation (the company) are not placed in jeopardy. Process auditors must not accept contracts which represent a conflict of interests in regard to their contractual duties. Process auditors undertake to maintain strict secrecy regarding confidential information (for example, know how) which they have gained in the course of their professional activities. This duty of confidentiality does not apply where the law requires information to be divulged. Process auditors must not use in a dishonest manner the information they have gained in the course of their activities, neither to their own advantage nor to the advantage of third parties.

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4

The audit process

This section describes the procedure for carrying out internal and external audits, as well as the analysis of potential suppliers. Process oriented auditing Audit Audit contract

Preparation

Execution

Assessment

Presentation of results

Final evaluation and closure

programme

Internal audit External audit (suppliers) Potential analysis (suppliers)

Fig. 4:

Audit process

Details covering the execution of a potential analysis are set out in Section 5.

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4.1

Audit programme Audit Audit contract

Preparation

Execution

Presentation of results

Assessment

Final evaluation and closure

programme

Generate the audit programme from the audit requirements Input ! Audit requirements ! Time frame ! Auditor pool ! Current audit programme ! Experience from previous years

Rolling adjustments to the audit programme as new requirements emerge Process stage Generate the audit programme from the audit requirements

Output ! Audit programme

Objective Audits are planned in accordance with their priority and the company's in house requirements. Qualified auditors are used to achieve the objective. Responsibility The person responsible for the audit programme draws up an audit programme for a defined period. Description The number of audits is determined and prioritized by the person responsible for the audit programme. From this, this person works with the audit client (and, where appropriate, the operation to be audited) to set out the following details regarding the audit : ! ! ! !

The main emphasis of the audit The calendar week of the audit The number of days required for the audit Details of the auditors, in particular the process experts

In addition to technical qualifications and the necessary neutrality, the choice of auditors should also take account of a knowledge of language and inter cultural aspects. A process expert should be provided to assess process specific questions beyond the competence of the process auditor. This process expert need not necessarily be a VDA process auditor. Thereafter the audit programme is approved by the relevant management.

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Method / documentation Audit programme Input !

Process stage Events based need for an audit

Output

Rolling adjustments to the audit programme as new requirements emerge

Current audit programme Up dated resource planning

Objective The audit programme is always current as a result of continuous adjustment. Responsibility The person responsible for the audit programme continually adjusts the audit programme and plans resources accordingly. Description Current quality problems in production and / or at the supplier's premises, new product launches or changed priorities can create new audit requirements at any time. During the whole course of validity of the audit programme, the person responsible for the audit programme must ensure that these additional audits are included in the programme. The existing resources must be adapted to meet the new requirements. To achieve this, the person responsible for the audit programme up dates the existing programme and resource planning before agreeing them with the organisations to be audited and the body placing the contract for the audit. Management must be involved in up dating the audit programme. Method / documentation Up dated audit programme

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4.2

Audit contract Audit Audit contract

Preparation

Execution

Assessment Presentation of results

Final evaluation and closure

!"#!$%%&

Clarify initial situation with the client

Input Reason for audit Audit programme

Draw up the audit contract

Process stage

Output

Clarify initial situation with the client

Audit contract

Objective To implement the requirements set out by the body placing the contract in the form of a precisely detailed audit contract. Examples of audit contracts : determine / assess / approve the current status analyse / estimate risks qualify / encourage / improve check the effectiveness of actions from a prior audit escalation Responsibility Person responsible for the audit programme (audit leader) with the support of the client.

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Description The auditor must know the reason for drawing up the audit contract. Reasons for an audit can be :

Process audit

Potential analysis

X

X X

X X

X X

X

X

X X

X

Special audit (e.g.. technical revision)

External

X X

Internal

New supplier New technology New location (transfer of production) Requirements (client; standards; legislation) Changes to management, core and support processes Changes caused by outside processes To secure a product launch and process approval Organisational changes (change of company name, ownership, ..) Continuous monitoring of production and organisation Target criteria not achieved Customer complaints / rejects Production breakdown Escalation stages (e.g., red or yellow from VDA publication "Maturity level assurance for new parts") Periodic monitoring as part of current audit programme Continuous improvement process

Audit variant

Events based

Planned

Reason for an audit

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Method / documentation

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Input initial situation reason for audit

Process stage

Output

Draw up the audit contract

Audit contract

Objective Draw up an audit contract with all the information required for a structured execution of the audit Responsibility The audit client, with support from the person responsible for the audit programme Description The following factors must be taken into account in an audit contract : ! ! ! ! ! !

Reason for the audit Audit objective Audit variant Audit location Audit team (provisional) Extent of the audit

!

Client

! ! ! !

Audit date Date of the contract Comments Essential documents

!

History

see previous table Assessment; process release; status examination; etc. Internal/external audit, potential analysis, special audit Internal, external Auditor, process expert(s) Processes, products, manufacturing locations, interfaces, outside processes Person responsible for the audit programme, management, person responsible for the product Desired date; audit period; shifts Background information Test/inspection regulations; contracts; important agreements, cost stipulations, etc. Complaints; rejects; delivery performance; project status

Method / documentation Audit contract form

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4.3

Audit preparations

Audit Audit contract

Preparation

Execution

Assessment

Presentation of results

Final evaluation and closure

programme

Specify the audit team

Gather information

Input

Limit the Processes and set points of emphasis for the audit

Process stage

Audit contract Process documents

Draw up check lists and audit plan and agree these with the organisation

Output

Specify the audit team

Audit team

Objective Select a suitable audit team with appropriate qualifications Responsibility The audit leader specifies the final audit team and organises the audit. Description The audit team is appointed on the basis of the audit contract, any other relevant information and by the planning in the audit programme. In addition to the personal aptitude of the auditors and any technical experts (see Section 3.2 : "Code of behaviour for auditors") the qualifications for the audit must be taken into account, particularly technical knowledge. A process expert should be provided to assess process specific questions beyond the competence of the process auditor. This process expert need not necessarily be a VDA process auditor. Method / documentation Code of behaviour; audit contract

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Process stage

Input Audit contract Audit team Information

Gather information

Output ! Documents ! Assembled information

Objective The team of auditors obtain all the information required to plan the audit Responsibility Audit team with the support of the client and the organisation to be audited Description The information collected for the audit must be capable of displaying the process, as well as the interplay and interfaces between processes. The following documents can be taken into account : organisation charts process flow plans production control plans (internal audit) FMEAs (internal audit) Standards specifications customer specific requirements target requirements (ppm, for example) process descriptions quality control charts audit results action plan from the previous audit results of supplier quality assessments (quality performance) complaints / rejects layouts project plans etc… Method / documentation

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!"#$! &'! ()*+& ,(-* .($&+/)0($01 +- &'! /(2! #" !3&!$-(0 ()*+&24 +& 5)2& 6! !-2)$!* &'(&7 *)$+-8 &'! ()*+&7 &'! ()*+&#$2 '(9! (//!22 &# (00 $!0!9(-& +-"#$5(&+#-: ;'! .($&+/+.(&+#- #" ")$&'!$ .!$2#--!0 5)2& 6! (8$!!*: = 1,67 must be achieved. For long term process capability (Cpk) the minimum requirement is Cpk >= 1,33. Note must be taken of customers' regulations, requirements for proof of capability of significant characteristics. In the case of significant characteristics where no capability level can be demonstrated, 100% inspection is required.

P6.2.3

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Production processes are controlled and process capable. Quality records are specified for significant characteristics (type and duration of archiving) and are agreed with the customer. In the case of characteristics subject to special documentary and archiving requirements, customer specific requirements must be observed.

Product FMEA / Process FMEA Standardised production Production control plan system methods : Scrap/ separation of Quality records, statistical waste assessments Standardised equipment SPC assessments; quality Process security plan control charts VDA vol. 1 Proof of capability (Cpk, Cmk, VDA vol. 6 Part 5, production capability checks, …) Product audit Proof of suitability of inspection VDA vol. "Robust processes production process" Test/inspection results VDA vol. "Maturity level Results of product audits assurance for new parts " Independent of operators (Poka Yoke)

Are significant characteristics controlled in production ? *

Significant product characteristics and process parameters are identified in the production control plan and are monitored systematically (SPC). Control limits are defined and effective control action is taken in the event of deviations. Records are maintained of non compliances and corrective actions. Non compliances affecting the characteristics of the product must be approved by the customer.

P6.2.4

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The storage and retention of setting parts, reference parts and tools must be displayed and identifiable.

Non released parts, defective parts and/or parts with defective characteristics must be separated and documented. They must be securely removed from production operations. Containers for scrap and rework must be appropriately identified. Quarantine stores and quarantine areas must be clearly recognizable (unauthorized access must be prevented).

Identification of scrap, rework Standardised production and setting parts system methods : Separation of scrap and Identification of containers for waste scrap, rework and setting parts Standardised equipment Defined scrap/rework stations in Process security plan production Quarantine stores & areas Identification of internal residual VDA vol. 4 quantities, including storage Records of rework and scrap VDA vol. "Robust (sorted by characteristic) production process" VDA vol. "Maturity level assurance for new parts "

P6.2.5 Are scrap, rework and setting parts kept separate and identified ?

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Is the flow of materials and parts secured against mixing / wrong items ?

Internal residual quantities must be logged by quantity and suitably identified and stored.

Product / Process FMEA An appropriate and optimum flow of parts and materials must Poka Yoke actions ensure that mixing / confusion between similar items cannot occur. Poka Yoke or other methods may be used for this. The use Interrogation and checks in production equipment or fitment of an incorrect part or material must be immediately Parts identification detectable and must not proceed further in the value creation process. Suitable checks/actions must be carried out to guarantee Identification of work, inspection and usage status early detection and filtering out of items wrongly installed items. Batch identification, traceability Associated subjects and actions must be included and examined of use or production of batches in the Process FMEA and, if appropriate, in the Product FMEA. Use by dates for various materials There must be a clearly controlled process for handling residual Remove invalid identifications quantities, parts which have been separated out (for example, Work papers with master data stacked up because of a machine problem), re used parts from for parts/production. product audits, checking parts, etc. Design level of incoming Containers and parts must be adequately, appropriately and materials and finished products securely identified. Material flow analyses (value The process and/or inspection status must be clearly visible. flows) The use by date and longest storage time for materials must be observed.

P6.2.6

VDA vol. 4 VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"

Standardised production system methods : Marking, Identification, lettering Process security plan First In First Out (FIFO)

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Possible examples of requirements and evidence, depending on product risk

Notes (input output) and references

The quality consciousness of operators must be encouraged and maintained regularly by suitable means. All operators are trained in the consequences of carrying out work wrongly, as parts of product training (what tasks/functions does the product perform and what happens if these cannot be guaranteed because of incorrect assembly, etc.). A process must be implemented to determine to what extent personnel are aware of the significance and importance of their tasks. Employees regularly receive information on current quality levels achieved by the customers. Operators are engaged in the continuous improvement process. Feedback s provided on suggestions for improvements

Job descriptions and task Standardised production descriptions system methods : Job descriptions Participation in improvement Group tasks programmes Group work Operator self checks spokesperson Process release (setter release/ On site measurements checks on first off and last off Operator feedback parts Operator questioning Process control (interpretation of Recognition of operators control charts) Authority to quarantine products Assessment system Cleanliness & tidiness Team development Carry out or authorize repairs & activities maintenance Absenteeism Provide/store parts improvement Carry out/authorize setting up programme and alignment of inspection and Group discussions measurement equipment Group boards Product training Metrics boards Quality information (specified Continuous and actual figures) improvement workshop Zero defect programmes Improvement proposals VDA vol. "Robust production process"

Are operators given responsibility and authority to monitor the quality of product and process ?

A description must be provided of what responsibilities, tasks and authority the operators have in their individual areas of operation : who is responsible for process releases and checks on first off parts and who can distribute these. Checks carried out by the operators themselves must be described : when, how many, how often, with what, where, documentation. A description must be provided of who maintains the quality control charts and who has what authority in the event of non compliances (authority to quarantine parts, stop the line, etc...).

P6.3.1

Process analysis / production

What functions support the process ? (personnel resources)

Minimum requirements / assessment relevant

P6.3

Process element P6 :

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.

Voluntary special action (training, quality circles) Contribution to improvements in quality Self assessment Information flow, implementation in the organisation Workshops Product liability training

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Training/instruction is given and documented in the event of changes to the product/process.

Induction, training, qualification Standardised production certification system methods : Qualification Knowledge of the product and Induction training for defects which can occur Training in health & safety at work employees Selection process for and environment aspects employees Training in the handling and Qualifications matrix dealing with "components/ Learning groups products requiring special Continuous improve documentary evidence" ment workshops Certificates of suitability – e.g., Group spokesperson welder's certificate, eye test, Employee feedback driving licence for fork lifts) Employee questioning Training planning to cover Recognition of changes in process and employees technologies Assessment system Product training motivation Team development Product liability training activities Quality information (specified and Absenteeism actual results) improvement Zero defect programmes programme Improvement proposals Group discussions Voluntary special actions Group boards (training; quality circles) Metrics boards Low sickness rates Contribution to quality VDA vol. "Maturity level improvements assurance for new parts" Self assessment Information flow; organisational implementation Workshops

Are the operators able to carry out their allotted tasks and are their qualifications kept up to date ? *

There must be a job description for each work station, including a requirements profile. Training needs must be determined individually for each operator based on the task and an appropriate personnel development plan drawn up. A record must be kept of who is qualified for what tasks and activities. This documentation must be taken into account when planning the use of personnel. Employees are trained in the processes and know of production errors which can potentially occur. All employees are trained in the consequences of carrying out work incorrectly (e.g., product training, what happens if the product is wrongly assembled; using checking / inspection equipment, …). Training in health & safety at work and work related environment aspects is provided regularly. Instruction must be given to employees regarding the handling and dealing with "components/products requiring special documentary evidence". Training, instructions and qualification evidence must be documented. There must be evidence of suitability to meet requirements regarding activities (e.g., fork lift driver licence; welding certificate, soldering certificate, eye test, hearing test, etc.). Induction plans must be available for new employees, replacement and temporary personnel. Induction phases must be demonstrated.

P6.3.2

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Is there a personnel employment plan?

When planning the employment of personnel the qualifications of the employees must be taken into account (qualifications matrix). Absentee levels (sickness, holidays, training) are included in the employment planning. In the case of replacement personnel and personnel transferred on loan, it is important to ensure that they have the necessary qualifications. Rules regarding deputies are documented and are derived from the qualifications matrix for the relevant production operations.

P6.3.3 Shift plan (based on orders) Qualification certification (Qualifications matrix) Information flow; organisational implementation Documented rules regarding deputies

Standardised production system methods : Group spokesperson Group boards Rotation Qualifications matrix

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Process analysis / production

Clean working surroundings and work places are integral to an overall care for the facilities (GAB). A process has been effectively implemented to analyse and optimize down times, machine loadings and the life of tools.

Plant, equipment, machines and tools required for the problem free operation of key processes are identified and appropriate preventive maintenance intervals are allocated to them. Resources to carry out essential maintenance work are available. Essential maintenance work is systematically planned and carried out. Preventive maintenance of machines, plant and tools is carried out, documented and controlled (maintenance systems). Availability is assured for spares for production facilities, particularly for key processes reflecting the critical path.

Notes (input output) and references

planned/periodic maintenance Standardised production activities system methods : availability of spares/replacement Check lists & checks parts for production equipment Qualification covering key processes Qualification matrix comply with specified maintenance Overall plant and equipment support intervals (GAB, TPM) Planned and actual amount of work are the same VDA vol. 4 Documentation of maintenance VDA vol. : "Robust work completed Production Process" Qualifications of employees VDA vol. 19 involved Archiving of work certificates Regular plausibility checks on planned maintenance intervals Scheduling and availability of spares Contracts to external companies to carry out maintenance work

P6.4.1 Are the maintenance and overhaul of production facilities / tools controlled ?

Possible examples of requirements and evidence, depending on product risk

What facilities are used to achieve the process ? (material resources)

Minimum requirements / assessment / relevant :

P 6.4

Process element P6 :

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identification of usage status (OK / NOK / under repair) tool tracking card with all the changes made to the tool tool operating times protection from damage ownership details for the tool

Tools are covered by a tool management system containing the following points : Availability/use of associated technical documentation Facilities in the areas entrusted with maintenance work Preventive tool exchange programme for units subject to greater wear Quality of execution of maintenance work Logging, assessing & develop ment of maintenance targets Machinery to place items in or remove them from racking (for transport and storage, ....)

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Can the quality requirements be monitored effectively with the test, inspection and measurement facilities employed ? * Production control plan The test, inspection and measurement facilities employed are Standardised production Checks to demonstrate reliability, system methods : suitable for the purpose and for handling in production. They are Statistical process function and corrosion resistance included in the production control plan. control (SPC) Measurement accuracy / Systematic and random causes of measurement errors are Monitoring of inspection capability of inspection equipment eliminated. Employees are trained in the use of measurement equipment and its Proof of the capability of equipment (exclusion of measurement errors). capability / capability inspection processes Capability studies are carried out on the measurement devices studies of measurement Data logging and suitability of and measurement systems employed. The accuracy of this devices data for assessment equipment is appropriate for the purpose and for the Evidence of the calibration of characteristics to be checked. VDA vol. 5 / MSA inspection equipment Certification is available covering the calibration of the Alignment of inspection equipment VDA vol. "Robust inspection equipment (inspection plates). production process" and measurement processes with A process for the periodic monitoring of measurement and VDA vol. "Maturity level the customer inspection equipment is installed and implemented assurance for new parts" (responsibility for collection and return is defined). This process also takes into account the calibration of process integrated measurement technology with an influence on the product characteristics. There is an identification system for measurement and inspection equipment. Administration of this equipment is based on the identification. Measurement and inspection equipment accessories having an influence on measurement accuracy and the measurement result are monitored in the same way.

P6.4.2

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In addition, the work place layout is adapted ergonomically to the work to be carried out.

VDA vol. 4 VDA vol. 19 VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"

Standardised production Ergonomic work place layout system methods : Lighting Health & safety at work Cleanliness and tidiness and environmental Air conditioning awareness Clean rooms Standardised material Work place organisation stocks Surroundings / handling parts at Visual management the work place 5A Health & safety at work (national 7 ways of wasting legislation) 5 "why" Storage of parts at the work place Production system

Are the work stations and test/inspection areas suitable for requirements ?

Conditions for the work places and their surroundings (inc. rework areas) are appropriate for the products and the work carried out, in order to prevent / eliminate contamination, damage, mixing up of parts and misinterpretations.

P6.4.3

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Storage is provided where the equipment is protected against damage and environmental effects, and cleanliness and tidiness are ensured. The issue and use of this equipment is controlled, specified and documented.

Stored free from damage Cleanliness and tidiness Defined storage location Issues are administered Environmental influences Status identification Identification showing customer's property, products/tools/devices provided on loan Defined release status and change level Machinery to place items in or remove them from racking (for transport and storage, ....

Are tools, equipment and test / inspection facilities stored correctly ?

Even tools, equipment and test/inspection devices not in use and/or not yet released must be stored and managed in an appropriate manner. All tools, equipment and test/inspection devices are identified with their current status and change level (released; under maintenance; maintenance required; quarantined).

P6.4.4

VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"

VDA vol. 4

Standardised equipment

Standardised production system methods :

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Process analysis / production

Process and product metrics are defined and logged in order to control and monitor the organisation's processes. A regular comparison is made between specified and actual results. Target requirements are agreed and achievable; they are guaranteed to be up to date. Process specific targets are laid down, monitored and communicated (quantities produced; quality metrics such as failure rates, audit results, through times and process effectiveness figures (Cpk). Non conformances are analysed and subjected to suitable action leading to improvements to the product and process. Essential special action must be specified and implemented as necessary. The potential for improvement must be determined continuously from previous experience regarding quality, costs and service. Monitoring the metrics is ensured through regular management reviews and reported in associated committees.

P6.5.1 Are target requirements set for product and process ?

Notes (input output) and references

Presence & absence of personnel Standardised production Availability of plant and machines system methods : Target agreements Peak production figures under full Metrics boards production conditions and cycle Quality agreements times (some with escalation Scrap levels within the planned/ stages) estimated framework. Quantities produced Continuous Number of parts produced per improvement process time unit Rapid tool changes Rework; scrap Elimination of waste Run outs Six Sigma Quality metrics (e.g., failure rates, audit results) Throughflow times VDA vol. "Robust Non conformances (failure costs) production process" Process metrics (process VDA vol. "Maturity level capability). assurance for new parts" Cost improvements Criteria for establishing metrics Reduction of waste (e.g., scrap and rework, energy and process materials) Improved process security (e.g.,

Possible examples of requirements and evidence, depending on product risk

How effectively is the process carried out ? (effectiveness, efficiency, elimination of waste)

Minimum requirements / assessment / relevant :

P6.5

Process element P6 :

process sequence analysis) Improved tool change over times, increased machine availability Reduce throughflow times Reduce stock levels

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Types and frequencies of failures are logged and assessed and actions are derived. The effectiveness of the actions introduced is verified. Failures resulting in a change to the process or product are also documented in the relevant FMEA with the associated actions. Failure costs are logged against those causing them (amount of scrap; rework items & consequences) and actions are allocated

SPC Pareto analyses Cause & effect diagrams FMEA

Original data charts Cumulative reject charts Control charts Data logging significant characteristics Writing device for process parameters (temperature, time, pressure, ...) Production data logging (e.g., plant down times, power failures, programme error messages) Parameter changes Process capability data Failure types & frequencies Failure costs (non conformance) Process parameters Scrap / rework Quarantine announcements/ sorting actions Cycle times; throughflow times Reliability / failure patterns

Are quality and process data logged in such a way that they can be assessed ?

Full quality data and process data must be available to demonstrate compliance with requirements and targets. The data must be capable of assessment. Special events must be logged (in a log book). Events and problems must be allocated to the areas responsible, where the associated improvements are generated and implemented. Quality control charts and monitoring charts are in use and are maintained in accordance with requirements. Process data and parameters (SPC) are monitored and used for the control of processes. In the event of a problem or non conformance, corrections are made automatically and/or an associated report is issued. Essential actions (action plan) for process problems are known and are introduced and documented by the responsible personnel. Non conformance with approved/released processes with an effect on the characteristics of the product must be approved by the customer. Process capabilities are checked regularly.

P6.5.2

VDA vol. 6, Part 1 VDA vol. 3.1; 3.2 VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"

Standardised production system methods : Process description Standardised work place documentation On site measurements SPC (statistical process control) Quality control circles in production Analysis of causes Problem solving processes PDCA 5W 8D

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In the case of deviations from product and process requirements, are the causes analysed and the corrective actions checked for effectiveness ? * Additional dimensional material, If deviations from product and process requirements occur, Standardised production functional and endurance checks system methods : immediate containment actions must be taken to comply with Quality control circles in and tests the requirements, until the causes of failure are eliminated and production Cause & effects diagram evidence has been provided of the effectiveness of the Process FMEA Taguchi, Shainin corrective actions. PDCA FMEA / failure analysis Methods used for the analysis of causes are defined and in use. 8D Corrective actions are derived, their implementation is monitored Process capability analysis 5W Quality control circles and effectiveness is verified. 8D method In this, production control plans and FMEAs are taken into Analytical assessment methods VDA vol. 6, Part 1 account and are extended and up dated if required. VDA vol. 6, Part 5 Information flow to the customer Functioning quality control circles are implemented in production VDA vol. 14 5W method within the organisation. VDA vol. "Robust Problem downtime logging The status of the actions is transparent and communicated. production process"

P6.5.3

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Are processes and products audited regularly ? *

Deficiencies in engineering and production are displayed, assessed from the customer's standpoint and appropriate actions are introduced.

Product audits are carried out and documented in production after production operations have been completed. They are carried out periodically and examine the finished product. Account is also taken of customer requirements and relevant functions, including ease and security of fitment.

Deviation reports must be issued to those responsible and improvement actions must be tracked. If quality requirements are not met (internal / external) additional audits referring to the specific event(s) must be carried out.

Reasons for an audit are : New projects, processes and/or products To provide evidence of compliance with quality requirements To indicate the potential for improvements

Audit plans (process audits, product audits) must be available for the product and its production processes.

P6.5.4

The capacity of checking and inspection devices, current inspection instructions, specified traceability documentation and responsibilities must be clearly controlled.

Specifications Standardised production Significant characteristics system methods : Sectional checks / Function section audit Process parameters / capability System audit / Identification, packing certification Specified process and procedural Process audit operations PDCA Controlling actions and timings Audit plans (for all areas; for VDA vol. 6 Part 5 product and process audits) inc. VDA vol. 6 Part 7 identification of planned and event related audits VDA vol. "Robust Frequency of product audits production process" Requirements for product audits VDA vol. "Maturity level Audit results; audit reports assurance for new parts" Auditor qualifications Audit results in the management review Developing metrics before and after implementing actions

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Process analysis / production

Account must be taken of all requirements included in the customer's supplier assessment. Process specific targets (from the customer's requirements, if appropriate) must be laid down, including quantities produced, quality metrics such as failure rates, audit results, failure costs, throughflow times and process metrics (Cpk). Significant characteristics specific to the customer ("D" type characteristics) must be identified. Customer requirements must be audited in house (shipping audit, ...) A process is implemented, regulating the use of products supplied by the customer. This refers to products (setting parts), tools, inspection equipment and packaging. Test/checking/inspection instructions must be available (also covering endurance testing. Procedures must be agreed with the customer and documented accordingly. A process must be described and implemented, explaining how the areas of stores, scheduling, parts provision, shipping and the customer are informed in the event of a block on shipping.

Notes (input output) and references

Quality agreements with Standardised production customers system methods : Customer specific requirements Quality agreements (in (process requirements spec.) part with escalation Customer requirements for stages) identification of special, significant Customer quality sensor characteristics Quality control circle Shipping audits Production programme Endurance tests/long term trials planning (to determine failure reactions) Inspection regulations Storage/processing schedules/ VDA vol. 19 providing parts/shipping VDA vol. "Robust Function tests production process" Suitability of checking and VDA vol. "Maturity level measurement equipment assurance for new parts" Aligned checking procedures (measurement points, fixing concept, equipment, ...) Up to date specifications Target agreements to achieve

P6.6.1 Are the customer's requirements met in terms of product and process ? *

Possible examples of requirements and evidence, depending on product risk

What should the process produce ? (process result / output)

Minimum requirements / assessment / relevant :

P6.6

Process element P6 :

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Are quantities / production batch sizes aligned with requirements and are they forwarded to the next process stage in a targeted manner ? Adequate, appropriate means of Parts/components must be forwarded to defined storage/holding Standardised production transport points using suitable means of transport. In this, attention must system methods : Standardised material Defined storage points be paid to the order quantity/batch size so that only the required stock levels KANBAN quantity of parts/materials is moved to the next work station (the Marking, identification, Just in time “pull” principle). lettering Stores management Logging and assessing quantities (number of OK parts, parts to Smooth production Change status be reworked and scrap parts) must be controlled and traceable. “Pull” production Logging/assessing quantities/ Parts identification must be specified (OK parts, rework parts Flow line production volumes and scrap). The identification must also indicate the current Types of waste Stock levels change status. Production quantities tailored to Process FMEA the customer’s needs It must be ensured that NOK parts cannot be forwarded or ESD protection for electronic processed further. VDA vol. “Robust parts Customer requirements for the identification of reworked parts production process” must be implemented and documented (quantity/volume, VDA vol. “Maturity level identification, life history and usage). assurance for new parts”

P6.6.2

zero defect objective Shipping audits Implement customer's demands for production tests under peak production conditions

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Are products / components stored in an appropriate manner and are transport facilities / packing arrangements suitable for the special characteristics of the products / components ? Quantities in store Parts must be protected from damage by suitable storage and Standardised production Protection from damage packing. system methods : Positioning of parts Visual safety instructions Customer specific packing instructions must be available in Material stock levels shipping/goods outwards department and observed/implemented Cleanliness, tidiness, over filling Marking, identification, (storage points & containers) throughout (also in the various production operations). lettering Monitor storage periods The positioning of parts must ensure secure storage at the work Environmental and climatic place, including handling. influences Process FMEA Storage points/containers must meet essential requirements for Customer specific packing VDA vol. "Robust cleanliness & tidiness. This includes the parts at the work place instructions (inc. packing supplied production process" itself (no over filling). VDA vol. "Maturity level Specified storage times must be monitored (specified maximum, by the customer) assurance for new parts" minimum and intermediate storage times). Information on available stock Parts must be protected against environmental and climatic levels influences during storage and processing. Substitute packaging

P6.6.3

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Customer specifications Significant characteristics and customer's identification requirements Process descriptions Documentation matrix for storage times for various documents and records Customer's archiving requirements Archiving requirements/ regulations (EDI, paper, fire protection, legibility, ...)

Are the necessary records / releases carried out and stored appropriately ?

Releases for the shipment of products to the customer or the next process must be identifiable and documented. Special releases and releases under deviation must be traceable by appropriate identification and documentation. The documentation must cover the period and/or quantity of parts involved. These details must also be included in the parts life history, including the identification method. Traceability of releases, including documentation, must be generally guaranteed. Traceability of the parts produced must be ensured to a reasonable degree. The customer's requirements must be taken into account in determining archiving regulations and periods

P6.6.4

VDA vol. 1 VDA vol. 2 VDA vol. 19 IMDS VDA vol. "Robust production process"

Standardised production system methods :

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Process element P7 :

Notes (input output) and references

It must be ensured that the product conforms with legal regulations.

Product requalifications are carried out to the customers' requirements.

Packing must meet the customers' requirements regarding suitability, fixing, cushioning and identification.

Customers' requirements for the supply of spares before, during and after serial production must be implemented and observed, including the acceptance and recycling of returned parts. The supply of spares must be considered in addition to serial production, including variants and changes, in terms of the resources required.

Quality agreements with the customer Completed shipping audits/ product audits Function checks Endurance tests (to determine failure reactions) Storage, scheduling, providing parts, shipping ppm figures, targets to achieve zero defects Incorrect deliveries Up to date specifications Requalification concept (frequency, extent, ...) Suitability of checking and measurement equipment Aligned test/inspection procedures, reliability tests, COP Audit plan to cover "D" characteristics Specify and track improvement programmes Involve sub suppliers Supplies of spares

VDA vol. 1 VDA vol. 2 VDA vol. 4 VDA vols. 6.x

Are the customer's requirements satisfied regarding QM system, product (on delivery) and process ? *

Take account of all requirements, particularly those included in the supplier assessment system used by the customer. Take account of the certification of the QM system in accordance with the customer's requirements. If appropriate, include evidence of significant characteristics when carrying out audits.

P7.1

Possible examples of requirements and evidence, depending on product risk

Customer support, customer satisfaction, service

Customer support, customer satisfaction, service (P7)

Minimum requirements / assessment / relevant :

8.7

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Part shipments to provide spares/first fill before start of full production Duty to supply after end of full production Supply of spares to old levels following changes (tool management, ability to manufacture) Supply concept for small quantities of spares following changes / end of serial production Compliance with customer specific packing and identification regulations

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Is customer support ensured ?

It must be ensured that competent contact personnel are available for the various areas in the customer's organisation. Communication in a language which the customer understands is essential. Customer support is also a measurement of active creative cooperation. The supplier has the obligation to examine his products at all stages of the creation and implementation stages and to improve them in agreement with the customer. A procedure is agreed with the customer for ensuring the security of new product/process launches.

P7.2 Reports of visits to customers and, if relevant, generating actions from these Knowledge of the product application Knowledge of problems with the product and complaints regarding the product or transport Implement new requirements Advise of improvement actions Advise of changes to product and process / change of production location (inc. those of suppliers) Initial & repeat sample submissions (trials / serial production) Information on non compliance with requirements (including packing and transport) Customer support in other countries Quality of logistics data from the supplier (e.g., statements of account covering container stocks) Access to customer portals (by agreement with the specific customer) Ensure problem free launches

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Is the supply of parts ensured ? *

Concepts are in place, including security for emergencies to ensure supplies. These concepts must always be kept up to date in the serial production delivery phase. In this, consideration must be given to in house processes and also the suppliers' processes. Procedures must be in place which guarantee that the organisation informs the customer immediately when supply bottle necks are detected. The information must include the expected duration and extent of the bottlenecks and the actions which have been taken. The actions must be taken at the right time and in accordance with the customer's requirements

P7.3 Contingency plans (e.g., for alternative production, suppliers, transport) Capacity and reaction time for sorting actions Possible changes to equipment, special production facilities, tools, product specifications and sources of supply Use of external capacity Communication regarding supply bottlenecks Regulations covering authority to take decisions / escalation stages when introducing special actions Spares for assembly lines

VDA vol. "Standardized process for handing customers´ complaints "

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If there are deviations from quality requirements, are failure analyses carried out and corrective actions implemented effectively ? Analysis facilities (laboratory, Independent detection and analysis of deviations from quality inspection and test equipment, requirements, with the rapid introduction of corrective actions personnel) including evidence of effectiveness are requirements demanded PARETO analysis of failure of the quality control circle. characteristics (internal/external) Involvement of all areas affected Timings agreed with the customer following complaints or (internal/ external) rejects must be maintained. Non conformances must be Use of problem solving methods communicated. Resolve deviations detected in sample submissions Deviations and the associated corrective actions must be Revise specifications placed in order of priority and integrated in existing risk Checks on effectiveness analyses (e.g., FMEAs). Product observation and improvement Introduce special actions to ensure the supply of products Flow of information, as far as the correct to specification (e.g., 100% inspection). customer, if deviations occur Knowledge data base, "lessons learned"

P7.4

Product FMEA Process FMEA VDA vol. "Standardized process for handing customers´ complaints "

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Checking specification for analysing field failures, with classifications based on standard checks and checks involving debit charges NTF guidelines Test/checking equipment and specialist personnel for analysing failures in defective parts Metrics for analysing defective parts (e.g., by average detection time) 8D reports Quality reports (including Pareto diagrams, Paynter charts)

Is there a process which ensures that analysis of defective parts is carried out ?

The process for analysing defective parts from the field is implemented and described throughout the organisation. Customer specific requirements are agreed. Test/inspection planning must be carried out for standard checking and checks involving debit charges. Initiation criteria must be agreed with the customer for the "NTF" (no trouble found) process. The characteristics to be checked and the specification for the checks must be documented and agreed with the customer. Capable checking equipment and the associated resources must be planned. Communication must be maintained with the contact personnel involved in analysing field failure returns. Personnel responsible for the findings, the NTF process, the reporting system and for controlling the failure elimination process must be clearly defined. Metrics for the field failures analysis process must be tracked in order to measure effectiveness. The standard reporting system for reporting on analyses (8D) and quality reports must be agreed with the customer. The effectiveness of the failed parts analysis is ensured by a continuous improvement process.

P7.5

VDA vol. "Field failures analysis"

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P7.6

A job description, including requirements profile, must be provided for each function. Training needs must be determined for each person, depending on the task and appropriate personnel development planning must be drawn up and implemented.

Product / specifications / special customer requirements Standards / legislation Processing / usage Assessment methods (e.g., audits, statistics) Quality techniques (e.g., Pareto, 8D method, Ishikawa cause and effect diagrams) Knowledge of foreign languages in the following areas : Customer support Product checking Storage / transport Logistics Failure analysis

Evidence of knowledge of :

Are personnel qualified for the various tasks and are responsibilities defined ?

A description must be provided, setting out the responsibilities, tasks and authority of personnel in their respective task areas.

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D 1.1

No.

D1

8.8 Planning

The following must be taken into account : The type and extent of the service Timings; locations Extent of guarantees Customer support / satisfaction (service actions) Pricing; quality requirements Confidentiality / discretion Environmental aspects The supplier's performance specification Specifying significant characteristics and process parameters Translating documents into the relevant language Benchmarking / competitor analyses

Minimum requirements / assessment / relevant :

Possible examples of requirements and evidence, depending on product risk

Terms & conditions of trading Specifications such as drawings, standards, etc. Company standards Purchasing conditions (inc. legislation / regulations) Customer requirements specifications Order / contract documents

These requirements and expectations are set out in the following, for example :

Notes (input output) and references Are the customer's requirements and expectations for this process / service logged and analysed in a consistent manner ? It is essential to consider all customer requirements in Customer requirements and expectations can be determined, planning a service / process. This includes the tasks for example, by asking customers, performed by sub suppliers. The supplier retains market research, etc. responsibility.

Use in phase

Services

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D 1.2

Has a development plan been agreed with the customer for the services and service process and has this been implemented ? Up to date milestones, network plans or project plans The following points must be must be produced for the development plan. These must considered in planning the service : reflect all the activities involved, from the award of the Check the requirements to see if contract to the supply of the service itself. A person they are reasonable responsible for the project must be appointed and all the Clarity & comprehensiveness associated areas, with their respective tasks, must be Documentation of results known. A central, continuous monitoring function must Obtain and install the facilities be ensured. The monitoring must cover compliance with required for the services all the specified objectives, such as timings and Verify (check for compliance with qualifications (the type, extent and sequence of the requirements and expectations) service) with their costs. Approval/release in agreement with the customer Take account of changes and modifications Draw up operating and installation instructions. Flow of information to and from the customer during the planning of the services (regular meetings, conferences, remote data transmission) Work and process sequences (work sequence diagrams) Ensure compliance with timing requirements (milestones) Specifications (inc. tolerances) / extent of individual services Instructions Software / hardware, test facilities Extent of training (by supplier at customer's premises) Framework conditions

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Definition of interfaces to other departments Specify the customer's obligation to cooperation Specify publicity and information policy Personnel required / temporary exchange of personnel Personnel qualification / point of performance Deviations from plan – actions and informing the customer Risk analyses Capability studies Controlling communication and information

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D 1.4

D 1.3

The planned capacity must ensure that the contractually The following points should be specified customer requirements can be met. monitored, for example : Availability of production fixtures and facilities (information and communication facilities), buildings and documents Qualified personnel (training, capabilities, information) Health & safety at work; environment Release and guarantee the necessary investments.

Is sufficient capacity planned and is on time implementation ensured ?

The release stages can be traced, Release stages are to be planned in accordance with for example, in : the customer's requirements or the organisation's own Defined release stages and decisions. Release criteria and timings must be specified criteria for each release. The results must be documented. Milestones (release at the end of each phase) Review / verification / validation of contents and sequence of the service (test, comparison of performance; post calculations, Price comparison) Management of changes Risk assessment (compliance with future timing dates) Status report

Are release stages provided for all elements of the service at the time required ?

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D 1.5

In this the following points must be considered : Function Safety/ security Reliability Traceability Availability Environmental aspects Qualification check to confirm individual requirements Problem areas Inadequacies Corrective / preventive actions

At each stage where matters are made concrete, improvement programmes must be introduced and implemented for the services / processes, with the emphasis being on the prevention of failures and not their elimination.

The following are examples of the methods employed : Risk analyses (System, Design and Process FMEAs) Function checks Reliability checks Feasibility analyses Pilot projects

Is a quality assessment made of the service / process and are further developments derived from this ?

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D 2.1

No.

D2

Minimum requirements / assessment / relevant :

Possible examples of requirements and evidence, depending on product risk

Against what criteria are suppliers selected and are only approved / released suppliers used for this service / process ? Before suppliers are specified, an assessment must be Suitability can be demonstrated by, made by the customer. It must be ensured that only for example : suitable suppliers are used to provide the outside Supplier meetings / regular service. Experience gained from assessments of quality support performance must be taken into account. Assessments of quality capability (e.g., audit results) Assessments of quality performance Current results Preventive quality assurance actions.

Use in phase

Outside services Notes (input output) and references

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D 2.3

D 2.2 The following may be used to evaluate outside services : Agreed assessment scales Adequate checking facilities Internal / external checks Specifications (e.g., requirements set out in the order/contract) QA agreements Agreement on checking procedures and sequences Assessment of main failure areas

As a result of the findings from the assessment (inadequate quality performance / quality capability) are qualification actions introduced and carried out with suppliers ? The capabilities and performance of a supplier should Evidence can be provided, for be checked over defined time periods and recorded in example, by : Discussion of fundamentals a listing / supplier questionnaire. If results are negative, with QA management / top qualification programmes must be specified. Their management of problem suppliers implementation must be demonstrated. Reports / findings on the state of improvement programmes Action plans Improved service process Audit results

Significant metrics, capable of assessment, must be generated in order to evaluate outside services, so that a classification can be made regarding the suitability of the outside service.

Is it ensured that the agreed quality of the outside services is guaranteed ?

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D 2.5

D 2.4

A release procedure must be carried out for all services provided by a supplier before implementing new or modified services / processes

Release criteria include : Evidence of capability for significant characteristics Simulation checks Trial releases Results of preventive QA Compliance with regulations (e.g., legislation, standards, safety data sheets, EU standards).

Are the outside services to be used and their processes approved and released ?

Are target agreements / actions to improve processes and outside services agreed with the suppliers and implemented ? Improvements must be targeted towards objectives. The following points must be considered, for example : Continuous improvement Specified, measurable metrics Cost improvements

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Use in phase

D 3.1.1

Possible examples of requirements and evidence, depending on product risk

Are responsibilities and authority specified and implemented for personnel with regard to the quality of the service ? Responsibilities and authority must be defined in writing Responsibility / authority must be for employees involved in the service process specified for the following, for example : Cooperative work on improvement programmes Self checking Process release Process quarantining (release of quarantined units) Training on the significance and tasks associated with significant characteristics Process documents relevant to personnel include : Function description Authority matrix Description of task Job description Qualifications matrix (requirements profile) Information to and from managers (target agreement; process status).

Minimum requirements / assessment / relevant :

Personnel / Qualification

D3.1

No.

Service process All the following questions must be assessed for each process stage

D3

Notes (input output) and references

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D 3.1.2 Responsibilities / authority must be laid down and implemented for : Availability; maintenance System responsibility Operating instructions Work instructions Test/inspection instructions

Are responsibilities and authority for facilities and production equipment specified and implemented ?

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D 3.1.3

Are personnel involved in the service process put in a position where they can carry out the allotted tasks and are qualifications regularly monitored ? Evidence must be provided for all personnel involved in The following points are some of the the service process, showing that training in the relevant employee qualifications : Leadership ability activity is planned and carried out and its effectiveness Instruction/training and proof of is checked regularly . qualifications for the process and service Legislation and guidelines (evidence requirement, storage periods for documents) Instruction in health & safety at work / environmental protection Process / service sequence (e.g., conditions and equipment at the work place and surroundings) Physical suitability Illustrations of targets and levels of achievement Encouragement of quality consciousness Knowledge of employee satisfaction Further training / qualification actions

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D 3.1.4

Is the personnel requirement for the services / process determined / ensured and is alternative capacity secured ? The following are some of the The personnel required for each service must be aspects to be considered : determined and ensured. Risks regarding personnel Determine the personnel capacity must be determined and contingency plans requirement must be drawn up. Calculate the work involved Deputy arrangements for important positions

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D 3.2.1

D3.2 No.

D3

Providing the service Minimum requirements / assessment / relevant : Possible examples of requirements and evidence, depending on product risk

An on site approval / release must be issued for all services before the introduction of new or modified services / processes. The release checks must be carried out to clear criteria to ensure repeatability. These criteria can be general or related to the specific process or service. The release must be issued in writing by "authorised" employees, based on acceptance criteria.

The following are some of the points to be examined in the release of services : Check list with specified criteria Comprehensive in terms of function / execution Availability of installation and operating instructions On the hand over (performance transfer) After a new version / new change level Complete paperwork at the work place Up to date requirements and expectations Cleanliness and tidiness at the work place Time frame for the introduction phase Log non conformances in a form which can be assessed

Is the service approved / released and are deviations from requirements handled ?

Use in phase

Service process All the following questions must be assessed for each process stage Notes (input output) and references

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D 3.2.3

D 3.2.2

Improvement programmes from audits Information to the area causing the problem Interface discussions (internal/ external) Internal complaints, the principle of "the producer pays", logging costs Questioning customers Customers' complaints Risk analyses (FMEAs) Tracking actions

Corrective actions can arise from the following, for example :

The appropriate facilities and support must be available and the appropriate organisation must be selected in order to guarantee the specific quality requirements

Are the quality requirements applying specifically to the process guaranteed ?

This applies before and during the process.

Are corrective actions checked for implementation and effectiveness ?

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D 3.2.5

D 3.2.4 Monitoring can include the following : Efficiency metrics Simulation software Benchmarking (e.g., from data bank) Check lists (e.g., for audits) Measurement and inspection/ checking equipment Reliability / function checks Questioning customers Measurement accuracy / capability of checking/inspection equipment Logging and evaluation of data

If non conformances occur the actions taken must be documented

The relevant process requirements must be stated in descriptions of operations / process descriptions and similar documents.

Process requirements are factors which influence the process and which are used to control and regulate the process.

Service operations / process stages Process parameters / data Checking / inspection requirements (significant characteristics, checking and inspection equipment, methods, checking/inspection frequencies) Evidence of capability

Are the relevant requirements for the service process set out comprehensively at the work place and are they implemented in full ? Explanation of the term "requirements" in this context : Requirements can include :

Control mechanisms / systems must be introduced in order to monitor the effectiveness of the service process.

Is the effectiveness of the service process monitored ?

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D 3.2.6

Work places and their surroundings must be appropriate for the work content of the services.

Reasonableness can be assessed in terms of : Lighting Ergonomics Cleanliness and tidiness Health & safety at work .

Is it ensured that work places and their surroundings are appropriate for requirements ?

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D 3.3.1

D3.3 No.

D3 Communication, identification, information, data flow

Agreement must be reached between customer and supplier on ways and means of transmitting data and the exchange of information. The responsibilities and communication facilities to be used must be agreed. The service provider must ensure that confidentiality is maintained regarding the data / information provided to him and the services which he provides. Products used within the framework of service processes must always be current and available.

Minimum requirements / assessment / relevant :

Possible examples of requirements and evidence, depending on product risk

Notes (input output) and references Are the service products stored appropriately and is transport aligned with the special characteristics of the services in question ? It must be ensured that the service product is always stored and transported so that it is not damaged. In this connection there must be an effective system which takes account of the following aspects : Damage free storage (applies also to data carriers) Security against unauthorized access Effective protection against loss Appropriate transport and storage.

Use in phase

Service process All the following questions must be assessed for each process stage

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D 3.3.3

D 3.3.2

Information to the customer Information to those involved in the process Prevention of unauthorized use Ensure that corrections are made.

In the service process it must be ensured that, when non conformances are detected, information is given to the relevant locations and the non conforming products are separated and identified. In this the following must be observed :

Are non conforming products from services processes detected, separated carefully and identified ?

Is the extent of the service aligned with the demand and the process chain ? How have the interfaces to adjoining processes been taken into account ? The requirements which have been defined must be Points to be considered here taken into account in the service provider's planning include : tools. Business plan / marketing plan A regular check on implementation must be carried out Capacity planning and documented. Rights of access Interfaces / organisation plan.

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D 3.3.4

The supplier must draw up operating or user instructions if applicable for the introduction of the service.

It must be ensured that access to the products and data is available at all times, in a manner which prevents mix ups and false identification. An error free method of data and information transfer is essential for the introduction of the service. In this connection there must be an effective system which takes account of the following aspects : Clear identification Current (change) status Security against unauthorized access Traceability Operating and user instructions

Are the services and their results sufficiently secured against mix ups and false identification ?

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D 3.3.6

D 3.3.5

Defined contact points must be defined, which are responsible for the following aspects : Selection of suitable means of communication Up dating data Data protection Software safety copies Securing data against loss Transmission and comprehensiveness Archiving Changes Failure strategy.

It must be ensured that information arrives clearly and in full with the correct addressees.

Is the flow of information within the service process and to the customer controlled and ensured ?

It must be taken into account that, even after the introduction of new computer generations, access must still be provided to older data material.

Ways and means of storage must be agreed between customer and supplier. This includes agreement on the duration of the storage.

Facilities and applicable documents must be protected to a reasonable degree against ageing, damage and unauthorized access. Suitable storage areas must be selected for the purpose. Access which is not capable of being confused must be provided by clear identification.

Are facilities and applicable documents for the service process retained in an appropriate manner ?

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D 3.4.2

D 3.4.1

D3.4 No.

D3

Eliminating errors and continuous improvement Minimum requirements / assessment / relevant : Possible examples of requirements and evidence, depending on product risk

Notes (input output) and references

Additional data can be displayed, such as : performance levels / levels of use throughflow times availability

Use of management methods such as : Continuous improvement TQM

Evidence must be provided of the following activities : Problem analysis / preventive actions / responsibility / timings Work sequence analyses Immediate containment actions

Are process problems reported and analysed and are corrective actions implemented effectively ?

Comparisons between specified and actual results relating to agreed targets Personnel statistics (sickness levels, absenteeism, holidays) Punctual delivery Identification of systematic errors

The following must be available :

Are work / test results logged consistently and quality patterns displayed in an understandable form ?

Use in phase

Service process All the following questions must be assessed for each process stage

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