VDA6.3-2010.pdf
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Quality Managment in the Automotive Industry Process Audit
6
Part 3
Product Development Process / Serial Production Service Development Process / Providing the Service
2nd comp letely revised editio n, June 2010
Process Audit
Product Development Process / Serial Production Service Develop ment Process / Providing the Service
2nd completely revised edition, June 2010
Verband der Automobilindustrie e.V. (VDA)
ISSN 09439412 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 chlorinefree bleached paper
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
Quality audit
VDA 6 Part 1 VDA 6 Part 3
QMsystem audit VDA 6 QMsystem audit Products Part 2 Services Process audit Serial production / Services
VDA 6 Part 7
VDA 6 QMsystem audit Part 4 Production equipment Process audit Production equipment
Fundamentals VDA 6 Product audit (material and nonmaterial) Part 5
There is agreement between automobile manufacturers and suppliers on the execution of audits in accordance with this publication.
3
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 KnorrBremse 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
Contents
P ag e
Preface
3
1
7
Introduction
2 2.1 2.2
Guidance on the use of a process audit Area of application for a process audit Limits of a process audit – potential analysis
2.3
Identifying process risks (risk analysis)
3 3.1 3.2
Requirements regarding auditors Auditorqualifications Code of behaviour for auditors
4 4.1 4.2 4.3 4.4 4.5 4.6 4.7
Theauditprocess Auditprogramme Auditcontract Preparation Execution Assessment Presentationofresults Final evaluationand closure
5
Potential analysis (ProcesselementP1) Objective and purpose of the potential analysis Preconditions Preparation Operational sequence of a potential analysis
5.1 5.2 5.3 5.4
6 Assessment 6.1 Assessing the potential analysis 6.2 Assessing a process audit for material products
8 8 9 9 11 11 12 13 14 16 19 24 27 29 32
35 35 35 35 36 37 37 39
6.2.1 Assessing the individual questions 6.2.2 Assessing subelements in the process analysis of production and generic baselines 6.2.3 Overallassessment 6.2.4 Assessing product groups and process stages 6.3 Assessing service processes 6.3.1 Individual assessment of questions & process elements
39 40 41 42 43 43
5
6.3.2 Overall assessment of the audit result 6.3.3 Classification 7
Using the questionnaire (processelementsP2toP7)
8 Questionnaire 8.1 Questionnaireoverview 8.2 Projectmanagement(P2)
44 45
47 49 49 54
8.3 Planning the product & process development (P3) 60 8.4 Carrying out the product & process development (P4) 66 8.5 Suppliermanagement(P5) 75 8.6 Serialproduction(P6) 82 8.7 Customer support, customer satisfaction, service (P7) 112 8.8 Services(PD) 119 9 9.1 9.2 9.3
Assessment forms & overviews (examples) Process audit for material products Processauditforservices Potentialanalysis
10 Best Practice / Lessons Learned 10.1 Example of information provided by the supplier 10.2 Assessmentguidelines 10.3 Datastores 11
Technicalterms
12 Downloads
6
14 4 144 150 151 161 161 170 172 1 75 1 76
1
Introduction
The established Audit Standard VDA 6.3 1998 has been completely revised. The objective was to reorganize 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 processspecific 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 mediumsized 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
Def. and Draft, Product & process development
Preselect suppliers; Potential analysis
SOP
Quotation process (contract review)
Def. and Draft, Product & process development
Serial production
Customer service (AfterSales)
Receive Issue SOP contract contract
Supplier
Fig. 1:
Implementation Product / process development
Preselect 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 Preselect suppliers; Potential analysis
SOP
Implementation Product / process development
Serial production
Customer service (After Sales)
P1 Allocation of questions
P2 P3 P4 P5 P6 P7
P 1 : P ote nti a l a na l ys i s (ne w )
P 5: S uppl i e r ma na geme nt
P 2 : P r o j e c t m a na g e m e nt ( ne w )
P 6: P r oc es s a nal ys i s / pr oduc ti on
P3 : Planning the produc t & pr oces s development
P7: Customer support, customer sa tisf ac tion, servic e
P4: Carrying out product & process development
Fig. 2: 8
Allocation of process elements to the product life cycle
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 standpoint 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 i s the "turtle" model : see Fig. 3.
What material facilities are used to carry out the process ?
What functions / areas / persons support 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 stage stage PS2
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
9
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 ou t 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 potentialtorisks must then be evaluated in the audit, to ensure that they are assured a reasonable degree.
10
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 Wellgrounded 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.
11
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 continu e 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 contra cts which represent a conflict of interests in regard to their contractual duties. Process auditors undertake to maintain strict secrecy regarding confidential information (for example, knowhow) 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 use of in their a dishonest manner information they have gained must in thenot course activities, neitherthe to their own advantage nor to the advantage of third parties.
12
4
The audit process
This section describes the procedure for carrying out internal and external audits, as well as the analysis of potential suppliers. Processoriented 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.
13
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 ! Timeframe ! Auditor pool ! Current audit programme ! Experience from previous years
Rolling adjustments to the audit programme as new requirements emerge Processstage Generate the audit programme from the audit requirements
Output
! Audit programme
Objective Audits are planned in accordance with their priority and the company's inhouse 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 intercultural aspects. A process expert should be provided to assess processspecific 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. 14
Method / documentation Audit programme Input
Processstage
! Eventsbased need for an audit
Rolling adjustments to the audit programme as new requirements emerge
Output Current audit programme Updated 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 updates 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 updating the audit programme. Method / documentation Updated audit programme
15
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
Processstage Clarify initial situation with the client
Output
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.
16
Description The auditor must know the reason for drawing up the audit contract. Reasons for an audit can be : Reason for an audit d e n n a l P
Audit variant s t n e v E
l a n r te n I
d e s a b
New supplier X New technology X New location X (transfer of production) Requirements (client; X standards; legislation) Changes to management, core and support X processes Changes caused by X outside processes To secure a product launch and process X approval Organisational changes
XX X X X X X
(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
X
X X X
part of current audit programme Continuous improvement X process
X
X
l a n r te x E
s s e c o r
ti d u a
P
l a it n te o P
s i s ly a n a
l ia c e p S
.. g . e ( ti d u a
l a c i n h c te
) n o i is v e r
XX X XX X
X
X
X X X X
X
X X X
X
XX X
X
X XX X
X
X XX X
X
X XX X XX X
X X
X X X X X X
Method / documentation
17
Input initial situation reason for audit
Processstage
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 see previous table ! Audit objective Assessment; process release; status examination; etc. ! Audit variant Internal/external audit, potential analysis, special audit ! Audit location Internal, external ! Audit team (provisional) Auditor, process expert(s) ! Extent of the audit Processes, products, manufacturing locations, interfaces, outside processes
! Client ! Audit date ! Date of the contract !Comments ! Essential documents ! History
Method / documentation Audit contract form
18
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
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
Processstage
Audit contract Process documents
Specify the audit team
Draw up checklists and audit plan and agree these with the organisation
Output 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 processspecific beyond the competence of the process auditor. This process expert need notquestions necessarily be a VDA process auditor. Method / documentation Code of behaviour; audit contract
19
Input
Processstage
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
customerspecific 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
20
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< .$#/!22 +2 /$!(&!* 61 &'! 0+->+-8 #" +-*+9+*)(0 .$#/!22 2&(8!2
!"#$ % &
'(")*"+,- ./ ,")0-1 +(.*-22-2
!"#$! &'! ()*+& ,(-* .($&+/)0($01 +- &'! /(2! #" !3&!$-(0 ()*+&24 +& 5)2& 6! !-2)$!* &'(&7 *)$+-8 &'! ()*+&7.!$2#--!0 &'! ()*+&#$2 (//!22= 1,67 must be achieved. For longterm process capability (Cpk) the minimum requirement is Cpk >= 1,33. Note must be taken of customers' regulations, requirements for proof of capability of signific ant characteristics. In the case of significant characteristics where no capability level can be demonstrated, 100% inspection is required. Cleanliness requirements for production are defined and implemented by reference to the product risk. There is sufficient production capacity, taking into account levels of scrap and rework.
Evidence of machine/process capability for special character istics/ processdetermining parameters Compulsory control of important parameters Ishikawa cause & effect analysis Warning of deviations from limit requirements/parameters (e.g., a lamp, horn or automatic shutdown) Feed and removal systems Poka Yoke solutions Inspection process capability Measurement equipment capability Measurement reports Inspection reports (e.g., measurement reports) Results of product audits Replacement tools Reproducibility of fixtures and
Standardisedprodu system methods : Failure prevention Failure avoidance SPC Machine stop if specified requirements are not achieved
... fittings, Maintenance/overhaul level of tools/plant/machines (including planned maintenance) Planning for emergencies
production VDA vol. "Robust process" VDA vol. "Maturity level assurance for new parts "
MSA, manufacturing capability study "5W" method 8D method Ishikawa fishbone diagram Pareto analysis SPC Six Sigma Poka Yoke VDA vol. 5 VDA vol. 6 Part 7 VDA vol. 19
P6.2.4
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 noncompliances and corrective actions. Noncompliances affecting the characteristics of the product must be approved by the customer. Production processes are controlled and processcapable. 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, customerspecific requirements must be observed.
9 1
Product FMEA / Process FMEA Production control plan Quality records, statistical assessments SPC assessments; quality control charts Proof of capability (Cpk, Cmk, production capability checks, …) Proof of suitability of inspection processes Test/inspection results Results of product audits Independent of operators (Poka Yoke)
Standardisedprodu system methods : Scrap/ separation of waste Standardised equipment Process security plan VDA vol. 1 VDA vol. 6 Part 5, Product audit VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts "
9 2
P6.2.5 Are scrap, rework and setting par ts kept sepa rate and id entified ? Nonreleased 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). The storage and retention of setting parts, reference parts and tools must be displayed and identifiable.
Identification of scrap, rework and setting parts Identification of containers for scrap, rework and setting parts Defined scrap/rework stations in production Quarantine stores & areas Identification of internal residual quantities, including storage Records of rework and scrap (sorted by characteristic)
Standardisedprodu system methods : Separation of scr waste Standardised equip Process security
VDA vol. 4 VDA vol. "Robust production process" VDA vol. "Maturity assurance for new pa
P6.2.6
Is the flow of materials and parts secured against mixing / wrong items ?
An appropriate and optimum flow of parts and materials must ensure that mixing / confusion between similar items cannot occur. Poka Yoke or other methods may be used for this. The use or fitment of an incorrect part or material must be immediately detectable and must not proceed further in the value creation process. Suitable checks/actions must be carried out to guarantee early detection and filtering out of items wrongly installed items. Associated subjects and actions must be included and examined in the Process FMEA and, if appropriate, in the Product FMEA. There must be a clearly controlled process for handling residual quantities, parts which have been separated out (for example, stacked up because of a machine problem), reused parts from product audits, checking parts, etc. Containers and parts must be adequately, appropriately and securely identified. The process and/or inspection status must be clearly visible. The useby date and longest storage time for materials must be observed. Internal residual quantiti es must be logged by quantity and suitably identified and stored.
9 3
Product / Process FMEA Poka Yoke actions Interrogation and checks in production equipment Parts identification Identification of work, inspection and usage status Batch identification, traceability of use or production of batches Useby dates for various materials Remove invalid identifications Work papers with master data for parts/production. Design level of incoming materials and finished products Material flow analyses (value flows)
Standardised production system methods : Marking, Identification, lettering Process security plan First In First Out (FIFO) VDA vol. 4 VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"
9 4
Process element P6 : P6.3
Process analysis / production
What functions support the process ? (personnel resources)
Minimum requirements / assessmentrelevant P6.3.1
Possible examples of requirements and evidence, depending on product risk
Notes (inputoutput) and references
Are operators given responsibility and aut hority to monitor the qualit y 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 firstoff 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...).
Job descriptions and task descriptions Participation in improvement programmes Operator selfchecks Process release (setter release/ checks on firstoff and lastoff parts Process control (interpretation of control charts) Authority to quarantine products The qualityconsciousness of operators must be encouraged and Cleanliness & tidiness maintained regularly by suitable means. Carry out or authorize repairs & All operators are trained in the consequences of carrying out maintenance work wrongly, as parts of product training (what tasks/functions Provide/store parts 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
Carry out/authorize setting up and alignment of inspection and measurement equipment Product training Quality information (specified and actual figures) Zerodefect programmes Improvement proposals
Standardisedprodu system methods : Job descriptions Group tasks Group work spokesperson Onsite measurements Operator feedback Operator questio Recognition of op Assessment syst Team developme activities Absenteeism improvement
programme Group discussion Group boards Metrics boards Continuous improvement workshop
VDA vol. "Robust production process"
.
9 5
Voluntary special action (training, quality circles) Contribution to improvements in quality Selfassessment Information flow, implementation in the organisation Workshops Product liability training
9 6
P6.3.2
Are the operators able to carry out their allotted tasks and are their qualifications kept uptodate ? *
There must be a job description for each workstation, 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., forklift driver licence; welding certificate, soldering certificate, eye test, hearing test, etc.).
Induction, training, qualification certification Knowledge of the product and defects which can occur Training in health & safety at work and environment aspects Training in the handling and dealing with "components/ products requiring special documentary evidence" Certificates of suitability – e.g., welder's certificate, eye test, driving licence for forklifts) Training planning to cover changes in process and technologies Product training motivation Product liability training Quality information (specified and actual results) Zerodefect programmes Improvement proposals Voluntary special actions
Standardisedprodu system methods : Qualification Induction training for employees Selection proces employees Qualifications ma Learning groups Continuous improv ment workshops Group spokesper Employee feedba Employee questio Recognition of employees Assessment syst Team developme activities Absenteeism improvement programme Group discussion
Induction plans be available for new employees, replacement andmust temporary personnel. Induction phases must be demonstrated.
(training; quality circles) Low sickness rates Contribution to quality improvements Selfassessment Information flow; organisational implementation Workshops
Group boards Metrics boards
Training/instruction is given and documented in the event of changes to the product/process.
VDA vol. "Maturity level assurance for new parts"
P6.3.3
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.
9 7
Shift plan (based on orders) Qualification certification (Qualifications matrix) Information flow; organisational implementation Documented rules regarding deputies
Standardisedprodu system methods : Group spokesperson Group boards Rotation Qualifications matrix
9 8
Process element P6 : P 6.4
Process analysis / production
What facilities are used to achieve the process ? (material resources)
Minimum requirements / assessment / relevant :
Possible examples of requirements and evidence, depending on product risk
Notes (inputoutput) and references
P6.4.1 Are the maintenance and overhaul of production facilities / tools controlled ?
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. Clean working surroundings and workplaces are integral to an overall care for the facilities (GAB). A process has been effectively implemented to analyse and optimize downtimes, machine loadings and the life of tools.
planned/periodic maintenance activities availability of spares/replacement parts for production equipment covering key processes comply with specified maintenance intervals Planned and actual amount of work are the same Documentation of maintenance work completed Qualifications of employees 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
Standardised production system methods : Checklists & checks Qualification Qualification matrix Overall plant and equipment support (GAB, TPM) VDA vol. 4 VDA vol. : "Robust Production Process" VDA vol. 19
Tools are covered by a tool management system containing the following points : 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
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, ....)
9 9
1 0 0
P6.4.2
Can the quality requirements be monitored effectively with the test, inspection and measurement facilities employed ? * The test, inspection and measurement facilities employed are Production control plan suitable for the purpose and for handling in production. They are Checks to demonstrate reliability, included in the production control plan. function and corrosion resistance Systematic and random causes of measurement errors are Measurement accuracy / eliminated. Employees are trained in the use of measurement capability of inspection equipment equipment (exclusion of measurement errors). Proof of the capability of Capability studies are carried out on the measurement devices inspection processes and measurement systems employed. The accuracy of this Data logging and suitability of
Standardisedprodu system methods : Statistical process control (SPC) Monitoring of inspection equipment and its capability / capability studies of measurement
equipment is appropriate for the purpose and for the data for assessment devices characteristics to be checked. Evidence of the calibration of Certification is available covering the calibration of the inspection equipment VDA vol. 5 / MSA inspection equipment (inspection plates). Alignment of inspection equipment VDA vol. "Robust A process for the periodic monitoring of measurement and and measurement processes with production process" inspection equipment is installed and implemented the customer VDA vol. "Maturity level (responsibility for collection and return is defined). This process assurance for new parts" also takes into account the calibration of processintegrated 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.
P6.4.3
Are the workstations and test/inspection areas suitable for requirements ?
Conditions for the workplaces and their surroundings (inc. rework areas) are appropriate for the products and the work carried out, in order to prevent / eliminate contamination, damage, mixingup of parts and misinterpretations. In addition, the workplace layout is adapted ergonomically to the work to be carried out.
Ergonomic workplace layout Lighting Cleanliness and tidiness Air conditioning Clean rooms Workplace organisation Surroundings / handling parts at the workplace
Health & safety at work (national legislation) Storage of parts at the workplace Production system
Standardised production system methods : Health & safety a and environmental awareness Standardised mat stocks Visual management 5A 7 ways of wasting 5 "why"
VDA vol. 4 VDA vol. 19 VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"
1 0 1
1 0 2
P6.4.4
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).
Stored free from damage Cleanliness and tidiness Defined storage location Issues are administered Environmental influences Status identification Identification showing customer's
Storage is provided where the equipment is protected against property, products/tools/devices damage and environmental effects, and cleanliness and tidiness provided on loan are ensured. Defined release status and The issue and use of this equipment is controlled, specified and change level documented. Machinery to place items in or remove them from racking (for transport and storage, ....
Standardisedprodu system methods :
Standardised equipment VDA vol. 4
VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"
Process element P6 : P6.5
Process analysis / production
How effectively is the process carried out ? (effectiveness, efficiency, elimination of waste)
Minimum requirements / assessment / relevant :
Possible examples of requirements and evidence, depending on product risk
Notes (inputoutput) and references
P6.5.1 Are target requir ements set for pro duct and proc ess ?
1 0 3
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 uptodate. Processspecific targets are laid down, monitored and communicated (quantities produced; quality metrics such as failure rates, audit results, throughtimes and process effectiveness figures (Cpk). Nonconformances 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
Presence & absence of personnel Availability of plant and machines Peak production figures under full production conditions and cycle times Scrap levels within the planned/ estimated framework. Quantities produced Number of parts produced per time unit Rework; scrap Runouts Quality metrics (e.g., failure rates, audit results) Throughflow times
Standardisedprodu system methods : Target agreements Metrics boards Quality agreeme (some with escalation stages)
from previous regarding quality, costs and service. Monitoring theexperience metrics is ensured through regular management reviews and reported in associated committees.
Nonconformances (failure costs) Process metrics (process capability). Cost improvements Criteria for establishing metrics Reduction of waste (e.g., scrap and rework, energy and process materials) Improved process security (e.g.,
VDA vol. "Robust production process"
Continuous improvement process Rapid tool chang Elimination of wa Six Sigma
VDA vol. "Maturity level assurance for new parts"
1 0 4
process sequence analysis) Improved tool changeover times, increased machine availability Reduce throughflow times Reduce stock levels
P6.5.2
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 nonconformance, 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. Nonconformance with approved/released processes with an effect on the characteristics of the product must be approved by the customer. Process capabilities are checked regularly. 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
1 0 5
Standardisedprodu system methods : Process description Standardised work place documentation Onsite measure SPC (statistical proc control) Quality control cir production Analysis of causes Problemsolving processes PDCA 5W 8D
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 downtimes, power failures, programme error messages) Parameter changes Process capability data Failure types & frequencies Failure costs (nonconformance) Process parameters Scrap / rework Quarantine announcements/ sorting actions Cycle times; throughflow times Reliability / failure patterns
SPC Pareto analyses Cause & effect diagrams FMEA
VDA vol. "Maturity level assurance for new parts"
VDA vol. 6, Part 1 VDA vol. 3.1; 3.2 VDA vol. "Robust production process"
1 0 6
P6.5.3
In the case of deviations from product and process requirements, are the ca uses analysed and the corrective actions checked for effectiveness ? * If deviations from product and process requirements occur, Additional dimensional material, Standardisedprodu immediate containment actions must be taken to comply with functional and endurance checks system methods : the requirements, until the causes of failure are eliminated and and tests Quality control circles in evidence has been provided of the effectiveness of the Cause & effects diagram production corrective actions. Taguchi, Shainin Process FMEA Methods used for the analysis of causes are defined and in use. FMEA / failure analysis PDCA Corrective actions are derived, their implementation is monitored Process capability analysis 8D and effectiveness is verified. Quality control circles 5W In this, production control plans and FMEAs are taken into 8D method account and are extended and updated if required. Analytical assessment methods VDA vol. 6, Part 1 Functioning quality control circles are implemented in production Information flow to the customer VDA vol. 6, Part 5 within the organisation. 5W method VDA vol. 14 The status of the actions is transparent and communicated. Problem downtime logging VDA vol. "Robust production process"
P6.5.4
Are processes and products audited regularly ? *
Audit plans (process audits, product audits) must be available for the product and its production processes. 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
Specifications Significant characteristics Function Process parameters / capability Identification, packing Specified process and procedural operations Controlling actions and timings Audit plans (for all areas; for product and process audits) inc. identification of planned and eventrelated audits Frequency of product audits Requirements for product audits Audit results; audit reports Auditor qualifications Audit results in the management review Developing metrics before and after implementing actions
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. 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. Deficiencies in engineering and production are displayed, assessed from the customer's standpoint and appropriate actions are introduced. The capacity of checking and
inspection instructions, devices, current inspection specified traceability documentation and responsibilities must be clearly controlled.
1 0 7
Standardisedprodu system methods : Sectional checks / section audit System audit / certification Process audit PDCA VDA vol. 6 Part 5 VDA vol. 6 Part 7 VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"
1 0 8
Process element P6 : P6.6
Process analysis / production
What should the process produce ? (process result / output)
Minimum requirements / assessment / relevant :
Possible examples of requirements and evidence, depending on product risk
Notes (inputoutput) and references
P6.6.1 Are the customer's requirements met in ter ms of product and pr ocess ? * Account must be taken of all requirements included in the customer's supplier assessment. Processspecific 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 inhouse (shipping audit, ...) A process is implemented, regulating the use of products supplied by the customer. This refers to produc ts (setting parts), tools, inspection equipment and packaging. Test/checking/inspection instructions must be available (also covering endurance testing. Procedures must be agreed with the
Quality agreements with customers Customerspecific requirements (process requirements spec.) Customer requirements for identification of special, significant characteristics Shipping audits Endurance tests/longterm trials (to determine failure reactions) Inspection regulations Storage/processing schedules/ providing parts/shipping Function tests Suitability of checking and
customer and documented accordingly. measurement equipment A process must be described and implemented, explaining how Aligned checking procedures the areas of stores, scheduling, parts provision, shipping and the (measurement points, fixing customer are informed in the event of a block on shipping. concept, equipment, ...) Uptodate specifications Target agreements to achieve
Standardisedprodu system methods : Quality agreemen part with escalation stages) Customer quality s Quality control c Production progr planning
VDA vol. 19 VDA vol. "Robust production process" VDA vol. "Maturity level
assurance for new parts"
zerodefect objective Shipping audits Implement customer's demands for production tests under peak production conditions
P6.6.2
Are quantities / produc tion batch sizes aligned with requirements and ar e they forwarded to the next process stage in a targeted manner ? Parts/components must be forwarded to defined storage/holding Adequate, appropriate means of Standardisedprodu points using suitab le means of transport. In this, attention must transport system methods : be paid to the order quantity/batch size so that only the required Defined storage points Standardised material quantity of parts/materials is moved to the next workstati on (the KANBAN stock levels “pull” principle). Just in time Marking, identificat Logging and assessing quantities (number of OK parts, parts to Stores management lettering be reworked and scrap parts) must be controlled and traceable . Change status Smooth production Parts identification must be specified (OK parts, rework parts Logging/assessing quantities/ “Pull” production and scrap). The identification must also indicate the current volumes Flowline produc change status. Stock levels Types of waste Production quantities tailored to It must be ensured that NOK parts cannot be forwarded or the customer’s needs Process FMEA processed further. ESD protection for electronic Customer requirements for the identification of reworked parts parts VDA vol. “Robust must be implemented and documented (quantity/volume, production process” identification, life history and usage). VDA vol. “Maturity level assurance for new parts”
1 0 9
1 1 0
P6.6.3
Are products / compon ents stored in an app ropriate manner and are transport facilities / packing arrangements suitable for the special characteristics of the products / components ? Parts must be protected from damage by suitable storage and Quantities in store Standardisedprodu packing. Protection from damage system methods : Customerspecific packing instructions must be available in Positioning of parts Visual safety instructions shipping/goods outwards department and observed/implemented Cleanliness, tidiness, overfilling Material stock levels throughout (also in the various production operations). (storage points & containers) Marking, identification, The positioning of parts must ensure secure storage at the work Monitor storage periods lettering place, including handling. Environmental and climatic Storage points/containers must meet essential requirements for influences Process FMEA cleanliness & tidiness. This includes the parts at the workplace Customerspecific packing VDA vol. "Robust itself (no overfilling). instructions (inc. packing supplied production process" Specified storage times must be monitored (specified maximum, by the customer) VDA vol. "Maturity level minimum and intermediate storage times). Information on available stock assurance for new parts" Parts must be protected against environmental and climatic levels influences during storage and processing. Substitute packaging
P6.6.4
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
1 1 1
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, ...)
Standardisedprodu system methods : VDA vol. 1 VDA vol. 2 VDA vol. 19 IMDS VDA vol. "Robust production process"
1 1 2
8.7
Customer support, customer satisfaction, service (P7) Process element P7 :
Customer support, customer satisfaction, service
Minimum requirements / assessment / relevant : P7.1
Possible examples of requirements and evidence, depending on product risk
Notes (inputoutput) and references
Are the customer's requirements satisfied regarding QM system, product (on delivery) and process ? *
Take account of all requirements, particularly those included in
Quality agreements with the
the supplier assessment used by theincustomer. Take account of the certificationsystem of the QM system accordance with the customer's requirements. If appropriate, include evidence of significant characteristics when carrying out audits.
customer Completed shipping audits/ product audits Function checks Endurance tests (to determine Customers' requirements for the supply of spares before, during failure reactions) and after serial production must be implemented and observed, Storage, scheduling, providing including the acceptance and recycling of returned parts. The parts, shipping supply of spares must be considered in addition to serial ppm figures, targets to achieve production, including variants and changes, in terms of the zerodefects resources required. Incorrect deliveries Uptodate specifications Packing must meet the customers ' requirements regarding Requalification concept suitability, fixing, cushioning and identification. (frequency, extent, ...) Suitability of checking and Product requalifications are carried out to the customers' measurement equipment requirements. It must be ensured that the product conforms with legal regulations.
Aligned test/inspection procedures, reliability tests, COP Audit plan to cover "D" characteristics Specify and track improvement programmes Involve subsuppliers Supplies of spares
VDA vol. 1 VDA vol. vol. 4 2 VDA VDA vols. 6.x
Partshipments 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 customerspecific packing and identification regulations
1 1 3
1 1 4
P7.2
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 implementa tion 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.
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 noncompliance 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 problemfree launches
P7.3
Is the supply of parts ensured ? *
Concepts are in place, including security for emergencies to ensure supplies. These concepts must always be kept uptodate in the serial production delivery phase. In this, consideration must be given to inhouse processes and also the suppliers' processes. Procedures must be in place which guarantee that the organisation informs the customer immediately when supply bottlenecks 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
1 1 5
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 "
1 1 6
P7.4
If there are deviations from quality requirements, are failure analyses carried out and corrective actions implemented effectively ? Independent detection and analysis of deviations from quality Analysis facilities (laboratory, requirements, with the rapid introduction of corrective actions inspection and test equipment, including evidence of effectiveness are requirements demanded personnel) of the quality control circle. PARETO analysis of failure characteristics (internal/external) Timings agreed with the customer following complaints or Involvement of all areas affected rejects must be maintained. Nonconformances must be (internal/ external) communicated. Use of problemsolving methods Resolve deviations detected in Deviations and the associated corrective actions must be sample submissions placed in order of priority and integrated in existing risk Revise specifications analyses (e.g., FMEAs). Checks on effectiveness Product observation and Introduce special actions to ensure the supply of products improvement correct to specification (e.g., 100% inspection). Flow of information, as far as the customer, if deviations occur Knowledge data base, "lessons learned"
Product FMEA Process FMEA VDA vol. "Standardized process for handing customers´ complaints "
P7.5
Is there a process which ensures that analysis of defe ctive parts is ca rried out ?
The process for analysing defective parts from the field is implemented and described throughout the organisation. Customerspecific 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
Checking specification for analysing VDA vol. "Field failures field failures, with classifications analysis" based on standard checks and checks involving debit charges NTF guidelines Test/checking equipment and specialist personnel for analysing failures in defective parts
agreed with the customer. Capable checking equipment and the Metrics for analysing defective parts associated resources must be planned. (e.g., by average detection time) Communication must be maintained with the contact personnel 8D reports involved in analysing field failure returns. Personnel responsible Quality reports (including Pareto for the findings, the NTF process, the reporting system and for diagrams, Paynter charts) 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.
1 1 7
1 1 8
P7.6
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. 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.
Evidence of knowledge of : 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
8. 8
Services
D1 No.
D 1.1
1 1 9
Planning Use i n phase
Minimum requirements / assessment / relevant :
Possible examples of requirements and evidence, depending on product risk
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 planning a service / process. This includes the tasksin performed by subsuppliers. The supplier retains responsibility.
Customer requirements and expectations can be determined, for example, by asking customers, market research, etc.
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
These requirements and expectations are set out in the following, for example :
Translating documents into the relevant language Benchmarking / competitor analyses
specifications Order / contract documents
Terms & conditions of trading Specifications such as drawings, standards, etc. Company standards Purchasing conditions (inc. legislation / regulations) Customer requirements
1 2 0
D 1.2
Has a development plan been agreed with the customer for the services and service process and has this been implem ented ? Uptodate 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
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
1 2 1
1 2 2
D 1.3
Ar e reetapas lease stde ageliberación s provided previstas for all eleme nts oflos theelementos service at th e tiservicio me require ? momento requeridos Son todos del end el Release stages are to be planned in accordance with The release stages can be traced, Etapas de publicación planificado de con in : the customer's requirementses or ser the organisation's ownacuerdo for example, decisions. Release criteria and timings must be specified Defined las necesidades del cliente o la organización de la propia release stages and for each release. The results must be documented. criteriosy tiempos dec isions.Releas e debe n espec ificarse criteria Milestones (release at the end of para cada versión. Los resultados deben ser each phase) Review / verification / validation documentados of contents and sequence of the service (test, comparison of performance; postcalculations, Price comparison) Management of changes Risk assessment (compliance with future timing dates) Status report
D 1.4
Is sufficient capacity planned and is ontime implementation ensured ? The planned capacity must ensure that the contractually specified customer requirements can be met.
The following points should be 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.
D 1.5
Is a quality assessment made of the service / pr ocess and are further developments derived from this ? 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. 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
1 2 3
The following are examples of the methods employed : Risk analyses (System, Design and Process FMEAs) Function checks Reliability checks Feasibility analyses Pilot projects
1 2 4
D2 No.
D 2.1
Outsideservices Use in phase
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 service. Experience gained from assessments of quality performance must be taken into account.
Supplier meetings / regular support Assessments of quality capability (e.g., audit results) Assessments of quality performance Current results Preventive quality assurance actions.
Notes (input output) and references
D 2.2
Is it ensured that the agreed quality of the outside services is guaranteed ? Significant metrics, capable of assessment, must be generated in order to evaluate outside servic es, so that a classification can be made regarding the suitability of the outside service.
D 2.3
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 : a listing / supplier questionnaire. If results are negative, Discussion of fundamentals qualification programmes must be specified. Their with QA management / top implementation must be demonstrated. management of problem suppliers Reports / findings on the state of improvement programmes Action plans Improved service process Audit results
1 2 5
1 2 6
D 2.4
D 2.5
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
Are the outside services to be used and their processes approved and released ? A release procedure must be carried out for all services Release criteria include : provided by a supplier before implement ing new or Evidence of capability for modified services / processes significant characteristics Simulation checks Trial releases Results of preventive QA Compliance with regulations (e.g., legislation, standards, safety data sheets, EU standards).
D3
Service process All the following questions must be assessed for each process stage
D3.1
Personnel / Qualification
No.
D 3.1.1
Use in phase
Minimum requirements / assessment / relevant :
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 Selfchecking 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
1 2 7
Authority matrix Description of task Job description Qualifications matrix (requirements profile) Information to and from managers (target agreement; process status).
Notes (input output) and references
1 2 8
D 3.1.2
Are responsibilities and authority for facilities a nd production equipment specified and implemented ? Responsibilities / authority must be laid down and implemented for : Availability; maintenance System responsibility Operating instructions Work instructions Test/inspection instructions
D 3.1.3
1 2 9
Are personnel involved in the service pro cess put in a position wher e they can carry out the allotte d 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 : activity is planned and carried out and its effectiveness Leadership ability is checked regularly . Instruction/training and proof of 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 workplace and surroundings) Physical suitability Illustrations of targets and levels of achievement Encouragement of quality consciousness Knowledge of employee satisfaction Further training / qualification actions
1 3 0
D 3.1.4
Is the personnel requirement for the services / process determined / ensured and is alternative capacity secured ? The personnel required for each service must be The following are some of the determined and ensured. Risks regarding personnel aspects to be considered : capacity must be determined and contingency plans Determine the personnel must be drawn up. requirement Calculate the work involved Deputy arrangements for important positions
D3
D3.2 No.
D 3.2.1
Service process All the following questions must be assessed for each process stage
Use i n phase
Providing the service Minimum requirements / assessment / relevant : Possible examples of requirements and evidence, depending on product risk
Is the service approved / released and are deviations from requirements handled ? An onsite 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 : Checklist with specified criteria Comprehensive in terms of function / execution Availability of installation and operating instructions On the handover (performance transfer) After a new version / new change level Complete paperwork at the work place Uptodate requirements and expectations Cleanliness workplace and tidiness at the Timeframe for the introduction phase Log nonconformances in a form which can be assessed
1 3 1
Notes (input output) and references
1 3 2
D 3.2.2
Are corrective actions checked for implementation and effectiveness ? This applies before and during the process.
Corrective actions can arise from the following, for example : 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
D 3.2.3
Are the quality requirements applying specifically to the process guaranteed ? The appropriate facilities and support must be available and the appropriate organisation must be selected in order to guarantee the specific quality requirements
D 3.2.4
Is the effectiveness of the service process monitored ? Control mechanisms / systems must be introduced in order to monitor the effectiveness of the service process.
D 3.2.5
Are the relevant requirements for the service process set out comprehensively at the workplace and are they implemented in full ? Explanation of the term "requirements" in this context : Requirements can include : Process requirements are factors which influence the process and which are used to control and regulate the
Service operations / process stages
process.
Process parameters / data Checking / inspection requirements (significant characteristics, checking and inspection equipment, methods, checking/inspection frequencies) Evidence of capability
The relevant process requirements must be stated in descriptions of operations / process descriptions and similar documents.
1 3 3
Monitoring can include the following : Efficiency metrics Simulation software Benchmarking (e.g., from data bank) Checklists (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 nonconformances occur the actions taken must be documented
1 3 4
D 3.2.6
Is it ensured that workplaces and their surroundings are appropriate for r equirements ? Workplaces and their surroundings must be appropriate for the workcontent of the services.
Reasonableness can be assessed in terms of : Lighting Ergonomics Cleanliness and tidiness Health & safety at work .
Service process All the following questions must be assessed for each process stage
D3
D3.3 No.
D 3.3.1
Communication, identification, information, data flow Use in phase
Minimum requirements / assessment / relevant :
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 : Damagefree storage (applies also to datacarriers) Security against unauthorized access Effective protection against loss Appropriate transport and storage. 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.
1 3 5
Possible examples of requirements and evidence, depending on product risk
1 3 6
D 3.3.2
D 3.3.3
Is the extent of the serv ice aligne d with the deman d and the proc ess chain ? How have the inter faces 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.
Are nonconforming products from services processes detected, separated carefully and identified ? In the service process it must be ensured that, when nonconformances are detected, information is given to the relevant locations and the nonconforming products are separated and identified. In this the following must be observed :
Information to the customer Information to those involved in the process Prevention of unauthorized use Ensure that corrections are made.
D 3.3.4
Are the services and their results sufficiently secured against mixups and false identification ? 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 errorfree 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 The supplier must draw up operating or user instructions if applicable for the introduction of the service.
1 3 7
1 3 8
D 3.3.5
Are facilities and applicable documents for the service process retained in an appropriate manner ?
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. Ways and means of storage must be agreed between customer and supplier. This includes agreement on the duration of the storage. It must be taken into account that, even after the introduction of new computer generations, access must still be provided to older data material.
D 3.3.6
Is the flow of information within the service process and to the customer controlled and ensured ?
It must be ensured that information arrives clearly and in full with the correct addressees. Defined contact points must be defined, which are responsible for the following aspects : Selection of suitable means of communication Updating data Data protection Software safety copies Securing data against loss Transmission and comprehensiveness Archiving Changes Failure strategy.
D3
D3.4 No.
D 3.4.1
Service process All the following questions must be assessed for each process stage
Use in phase
Eliminating errors and continuous improvement Minimum requirements / assessment / relevant : Possible examples of requirements and evidence, depending on product risk
Are work / test res ults logged consistently and quality patterns displayed in an understandable form ? The following must be available : Comparisons between specified and actual results relating to agreed targets Personnel statistics (sickness levels, absenteeism, holidays) Punctual delivery Identification of systematic errors
D 3.4.2
1 3 9
Notes (input output) and references
Use of management methods such as : Continuous improvement TQM Additional data can be displayed, such as : performance levels / levels of use throughflow times availability
Are process problems reported and analysed and are corrective actions implemented effectively ? Evidence must be provided of the following activities : Problem analysis / preventive actions / responsibility / timings Work sequence analyses Immediate containment actions
1 4 0
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1 4 4
9
Assessment forms & overviews (examples)
9.1
Process audit for material products
A c c e s s c h a p te r 1 2 .
a ll fo rm s o f th is c h a p tr e w il l b e m a d e a v a il a b le a s P D F d o w n lo a d .
1 4 5
1 4 6
1 4 7
1 4 8
1 4 9
9.2
150
Process audit for services
9.3
1 5 1
Potential an alysis (P1 ) as an extr act fro m the VDA 6.3 qu estionnaire
1 5 2
Note:
Ladies and Gentlemen, the layout of the questionnaire was simplified by the working group VDA 6.3, after publishing the German edition in July 2010
1 5 3
1 5 4
1 5 5
1 5 6
1 5 7
1 5 8
1 5 9
1 6 0
_________________________________________________________________________ Qualification timing plan Contract: PY Timing plan : Supplier / tenderer Activities Improvementprogramsreceived
T im in g 03.02.2010
I.
17.02.2010
Finalisation and agree timings for the improvement programme (14 days)
II. Carry out the improvement programme (2 weeks from award of contract) III. Se lfaudit to VDA 6.3 (only if contract awarded on the basis of a "GREEN" or "YELLOW" status)
Open 12 wks before SOP
Explanatory notes The actions must be implemented without delay. In the case of largescale improvement programmes this can be split into implementation phases. Selfaudit : In order to make a wellfounde d assessment of the selfaudit we would ask you to advis e the amount of time taken in mandays and the time required for qualification of the auditors involved. We assume that the time for the selfaudit is at least equivalent to that of a certification audit. The selfaudit must be carried out in the 0production phase of the project (parts from serial production tools and facilities). After we have received and checked these documents and provided that this results in an "A" status we shall agree with you on the date for our audit. If the result is a "B" status, please advise us of a realistic date when you expect to achieve an "A" status. We shall then expect you to send us the audit report at that time, covering the internal followon audit, without our having to request this. Improved qualification agreement Controlled suppliers / tenderers undert ake to cooperate with an approved consultant organis ation within the framework of an agreement to achieve improved qualifications. The costs of this will be borne by the supplier.
_________________
________________________
________________________________________
Auditor
Auditor
Signed for and on behalf of the supplier / tenderer
10
Best Practice / Lessons Learned
10.1 Example of information provid ed by the supplie r
Information provided by the supplier
Customer
Date: Contact person Name Phone Email Fax General supplier information Supplier code Commodity/product of interest for customer Technology of interest for customer DUNS (Dun & Bradstreet) Code Company name Legal form Year of foundation
Address of headquarters Street City State Country Post code Phone Fax 161
Access to supplier portal for customer Name Phone Email Supplier Contact Name Phone Email Fax Languages spoken
Electronic data information (EDI) facilities Location System in use Communication standard Name of contact person Phone Email Products Main product groups
Current maximum capacity for each product
1. 2. 3. 4. 5. 6. 1. 2. 3. 4. 5. 6.
Tooling Percentage of inhouse tooling design
%
Percentage of inhouse tooling manufacturing
%
Tooling suppliers
%
162
Customers (by volume)
All your customers (list names only) 4 biggest customers Industry (passenger cars, commercial vehicles, ...) Unit volume per year Sales per year Percent of total sales
%
%
%
%
Percent of sales exported
%
%
%
%
Production capacity utilization
%
%
%
%
Main Suppliers (by purchase volume)
Supplier name
Product group
Product
Location/ country of srcin
Distance to your plant
Annual quantity (€/$)
% of total purchasing volume (€/$)
163
Product quality
Commodity/product of interest Internal ppm Internal scrap rate First time capability (no rework) External ppm Ontime delivery For electric/electronic: Which statistical methods for early detection of failures (e.g. Part Average Analysis PAA) do you apply?
Location
Name of location Total number of employees shopfloor/office Management R&D Engineering (Product) Engineering (Process)
164
Overall
Production Service Sales Purchasing Quality Toolshop and Maintenance Others Total f acility area size Manufacturing Laboratory Engineering Administration Others possible expansion
Manufacturing facilities (only for processes used for commodity/product of interest)
Type of machinery
Producer
Year of construction
Utilization
% % % % % %
165
Manufacturing work pattern Shift model Working hours per shift Working days per week Union affiliation Working days per year Extra time possible
Competitors Companyname
MarketShare
1. 2. 3. 4. 5. 6.
% % % % % %
Quality Management Description
QM certificates
ISO TS 16949
Environmental management certified
ISO 14001
Registration / certification body
Inhouse laboratory certification Software development: ISO 15504 (SPICE) level?
166
Expiry date
Software development: CMM/CMMI level? List the laboratories used for validating commodity/product of interest: List supplier activities during customer ramp up
Ownership
Parentcompany
1. 2. 3. 4. 5.
Mainowners
Participations
1. 2. 3. 4. 5. 1. 2. 3. 4. 5.
JointVentures
Cooperations / Alliances
List the parties from which you have received licenses for product and/or processes.
List the parties you have given licences to for product and/or processes.
1. 2. 3. 4. 5. 1. 2. 3. 4. 5. 1. 2. 3. 4. 5. 1. 2. 3. 4. 5.
167
Research & Development
For commodity/product
Overall
Current customers during product creation phase Products in focus of R&D activities
Brief description of prototype facilities Brief description of testing facilities CAD data processing
Business development (please attach your latest annual report)
For each year listed (last four years) Total turnover Production utilization Market share Number of employees Export percentage Volume of purchased materials Expenditure on tooling/equipment
168
% %
% %
% %
% %
Expenditure on research and development
Expenditure on wages/salaries
Explain your current logistics methods – (local / export) Delivery modes (JIT, Just in Sequence, Logistics centre, etc.)
Percentage of use for main customers
Percentage of use regarding parts supplied
% % % % % IT processing
% % % % % Production
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Contingency plan exists ?
yes no
yes no
Transport
Qualified
interruptions
personnel
yes no
yes no
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an uptodate organisation chart
a list of your suppliers (names, product, evaluation status)
a complete list of all your manufa cturing facilities a complete list of external developers/engineers
169
10.2 Assessment guidelines Points 10
8
Product risks
Product is free from complaints and meets technical requirements
Complaints regarding the product (no effect on function, use or
Process risks
further processing operations). Improvements required.
Technical requirements / specifications covering product and process are met Minor problems in the production process Process weaknesses are present but are detected & eliminated immediately
QM system relevance
6
4
170
Complaints regarding the product (no effect on function but defect leads to problems in use and/or further processing operations) Process capability (significant characteristics) is not achievedare reworked in Defects followon processes Defects are detected by monitoring, non conforming items must be securely removed from production operations, separate rework required Complaints regarding the product (defect affects function, leads to restrictions in use and has a significant negative effect on further processing) Agreed process capability (special characteristics) is not achieved Defects lead to serious process difficulties Defects are not guaranteed to be detected, sorted or
Products cannot be made in a secure process; however, significant characteristics are within specification Significant characteristics are not monitored systematically Sorting action required Rework required Risk of damage to parts Process problems in overall flow of materials Inspection & measurement equipment not suitable for detecting the defect Employees have not been adequately informed Products cannot be made in a secure process; significant characteristics are in part outside tolerance Characteristics are not monitored systematically Sorting action required Rework required Risk of damage to parts Mixedup parts/ incorrect assembly leads to process problems Inspection &
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