VDA 6.3 en Yellow Volume 22-05-16
VDA 6.3 en Yellow Volume 22-05-16
VDA 6.3 en Yellow Volume 22-05-16
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Process Audit
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Potential Analysis
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Series Production
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Potential Analysis
Product and Production Process Development
Product and Production Process Implementation
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Series Production
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Copyright 2022 by
Exclusion of Liability
VDA volumes are recommendations available for general use. Anyone
applying them is responsible for ensuring that they are used correctly in each
case.
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This VDA volume takes into account state-of-the-art technology, current at
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the time of issue. Implementation of VDA recommendations relieves no one
of responsibility for their own actions. In this respect, everyone acts at their
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own risk. The VDA and those involved in VDA recommendations shall bear
no liability.
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If during the use of VDA recommendations, errors or the possibility of
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misinterpretation are found, it is requested that the VDA be notified
immediately so that any possible faults can be corrected.
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Copyright
This publication is protected by copyright. Any use outside of the strict limits
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of copyright law is not permissible without the consent of the VDA and is
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Translations
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This publication will also be issued in other languages. The current status
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Foreword
The VDA 6.3 process audit has been established for almost three decades as
an important method for identifying strengths and weaknesses.
It involves analyzing and evaluating process capability during the product de-
velopment and product implementation phase.
The characteristics of VDA 6.3 are:
- a structured approach to analyzing processes
- an evaluation and points system
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- clear downgrading rules
- identification of specific product and process risks (questions marked
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with an asterisk, i. e. *-questions)
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- a clear presentation of the results of the process evaluation (A, B or C)
- worldwide comparability of the results for similar products and pro-
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cesses
- potential analysis for evaluating the suitability of new suppliers, loca-
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tions, and technologies prior to awarding a contract
- a focus on the process and the product rather than on the system
The VDA 6.3 process audit is integrated into a company’s QM system and
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2.3 Differentiation between a potential analysis and a process audit 14
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2.4 Identification of process risks (risk analysis) 14
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3 Requirements for process auditors 16
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3.1 Auditor qualification 16
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3.1.1 Internal process auditors 16
3.1.2 Supplier auditors 17
3.1.3 Process auditors as external service providers 18
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4.4 Classification of the audit methods based on existing risk factors / influencing
factors 22
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6.7 Repeat audit 41
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7 Questionnaire 42
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7.1 Overview of questionnaire 42
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7.2 Project management (P2) 47
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7.3 Product and process development planning (P3) 52
7.4 Implementation of product and process development (P4) 60
7.5 Supplier management (P5) 69
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9 Downloads 103
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1 Notes on the revision
VDA 6.3 was published for the first time in 1998 and was revised in 2010,
2016 as well as 2022 (present edition).
What has changed compared to the 2016 version?
- Software-related aspects have been considered in the questionnaire.
- The content of this volume was harmonized with further VDA methods,
namely Automotive SPICE and maturity level assurance for new parts
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(VDA MLA).
- Requirements with regard to purchasing activities were added to P3
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and P4.
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- Notes on conducting remote audits were added.
- Chapter 4 (“Audit process”) was deleted, as its contents are included in
ISO 19011.
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- Chapter 8 (“Process audit services”) was completely deleted from the
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VDA Volume 6.3.
- Chapter 10 (“Best practice/lessons learned”) was deleted.
- The evaluation of transport and parts handling (EU7) was omitted.
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cated.
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During the revision, the distinction between process and system audits was
once again explicitly taken into account. The current IATF requirements have
been observed.
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For products with integrated (embedded) software, the interface between
hardware and software has been strengthened. However, for a detailed eval-
uation of the software development, the Automotive SPICE® method should
be used.
Due to the changes that have been made, the results of audits conducted ac-
cording to the present volume are not directly comparable to the results of au-
dits carried out in accordance with the previous edition from 2016.
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2 Instructions for use
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In general, this volume can be used throughout the entire product life cycle. In
this regard, a distinction is made between:
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- Potential analysis
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- Product and production process development
- Product and production process implementation
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- series production
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When conducting process audits, the selection of process elements and the
implementation period may vary.
During series production, the process audit serves to ensure regular monitor-
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ing of the series production processes and can also be used on an event-ori-
ented basis.
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are to be expected based on the audit findings, as well as to identify the asso-
ciated risks.
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If any questions are added or deleted, or if any changes are made to the eval-
uation method, an audit cannot be considered a VDA 6.3 audit anymore, as
the evaluation systems are not comparable any more.
Specific evaluation questions relating to sustainability, compliance with social
standards, environmental protection, the conservation of resources, etc. are
not included in the questionnaire. There are special audit standards as well
as statutory and normative specifications for this. However, should the auditor
identify obvious aspects which are not in compliance with the requirements of
this process audit standard and/or which have a lasting negative effect on the
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product characteristics, this should be documented and taken into account in
the evaluation.
Table 2-1: Differentiation between audit standards
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2.2 Integration into the product life cycle
The VDA 6.3 audit standard can be used throughout the entire product life cy-
cle, from the selection of potential suppliers (P1 potential analysis) and the
product and production process development (P2-P4) up to support during
series production and follow-up support after production (P5-P7). Thanks to
the modular structure of the volume, individual process elements can also be
audited depending on the scope to be considered.
Figure 2-1 shows the possible use of the individual process elements accord-
ing to VDA 6.3 and how they relate to VDA MLA and Automotive SPICE®
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standards.
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duction, process elements P5 to P7 can be used to regularly monitor the se-
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ries production processes and the processes after discontinuation of the se-
ries, or to support an event-based reactive process analysis.
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In principle, each organization has the right to adapt the use of the process
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elements so as to meet their needs during product and production process
development as well as production.
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2.3 Differentiation between a potential analysis and a
process audit
As can be seen from figure 2-1, a potential analysis (P1) can be carried out
before a contract is awarded. The questionnaire, with a reduced scope, can
be used to assess whether potential suppliers are suitable as series produc-
tion suppliers. Given that these are potential suppliers, the audit must (if nec-
essary) be based on other processes/products. However, these pro-
cesses/products should be comparable to the product to be supplied. This
procedure can be applied to the entire supply chain, taking into account the
lead time to SOP.
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2.4 Identification of process risks (risk analysis)
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The effect of individual processes on the product is essential in the process
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audit. Consequently, the assessment must be made from the perspective of
the relevant product risk. Potential process risks must therefore already be
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identified during the preparation for the audit in order to assess them ade-
quately in the process audit itself.
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A risk analysis can be carried out on the basis of the Turtle Model.
An example of the Turtle Model using process element P6 is shown below,
but the model can be used for all process elements.
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Firstly, it must be described what “input” (see questionnaire sub-element
P6.1) is converted into an “output” (see questionnaire sub-element P6.6) by
the process. In addition, the following questions are considered:
• How does the process work (work carried out, workflow, methods,
procedures, instructions – see questionnaire sub-element P6.2)?
• What areas, functions and personnel support the process (personnel
resources such as capacities, competencies, authorities, qualifica-
tions – see questionnaire sub-element P6.3)?
• Which tools are used to implement the process (material resources
such as machines, tools, test equipment, facilities, other equipment –
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see questionnaire sub-element P6.4)?
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• How effectively is the process carried out (effectiveness, performance
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indicators, efficiency – see process sub-element P6.5)?
As a second step, the potential risks in relation to the content of the Turtle el-
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ements are identified. The auditor as well as the audit team should make use
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of their process know-how to identify potential product and process risks that
could affect product quality. These risks must then be analyzed and evalu-
ated in the audit to ensures a reasonable degree of risk minimization.
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3 Requirements for process auditors
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maintenance and improvement of auditor qualifications (e.g. observation dur-
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ing audits/approval and witness audits).
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Specialized knowledge
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• Good knowledge of quality tools and methods (e.g. VDA MLA, DoE,
FMEA, FTA, PPA, SPC, SWOT, 8D Method)
• Knowledge of the relevant customer-specific requirements
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be audited
Professional experience
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3.1.2 Supplier auditors
Specialized knowledge
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dure)
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• Knowledge of the relevant customer-specific requirements
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• Knowledge of the relevant management system requirements (e.g.
IATF 16949, DIN EN ISO 9001, VDA 6.1)
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• Specific knowledge regarding the product and the process
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Evidence of specialized training
VDA Auditor qualification, 1st/2nd party auditor for DIN EN ISO 9001,
IATF 16949, or VDA 6.1)
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be audited
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Professional experience
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3.1.3 Process auditors as external service providers
External auditors are from independent, third-party organizations and carry
out audits as a service for the organization.
Specialized knowledge
• Excellent knowledge of quality tools and methods (e.g. SPC, VDA
Volume 5/MSA, FMEA, VDA MLA/APQP, VDA Volume 2/PPAP, 8D
Method)
• If required, knowledge regarding software development processes
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and methods
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• Auditor qualifications (negotiation, conflict management, audit proce-
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dure)
• Knowledge of the relevant customer-specific requirements
•
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Knowledge of the relevant management system requirements (e.g.
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IATF 16949, DIN EN ISO 9001, VDA 6.1)
• Specific knowledge regarding the product and the process
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VDA Auditor qualification, 1st/2nd party auditor for DIN EN ISO 9001,
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Professional experience
A minimum of 5 years professional experience (after 3 years’ professional ex-
perience in-house apprenticeship periods may be considered additionally),
preferably in manufacturing companies within the automobile industry, includ-
ing at least 2 years’ experience in quality management.
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3.2 Product/process-related knowledge of the auditors
The quality of an audit is determined to a large extent by the product/process-
related knowledge of the auditors. There are various ways to gain this
knowledge and to use it during an audit. This can for example be done by:
• Getting experts involved when evaluating product/process-specific
aspects if the process auditor doesn’t have the necessary expertise
• Auditors doing their own research prior to the audit, e.g. by consulting
specialist literature, online forums and industry standards as well as
knowledge databases
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• Coordination with internal and external experts
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• Drawing conclusions from previous audits
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In order to systematically capture and expand this “expert knowledge” and to
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make it available to the auditors, it is recommendable to build up a knowledge
database. The sources of such knowledge can for example be typical errors
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that have occurred or internal lessons learned. It must be ensured that infor-
mation (from the customer, from the supplier, or from within the organization)
remains confidential.
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In addition, it should be noted that the resulting questions do not lead to addi-
tional requirements that go beyond the contractually agreed requirements.
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Knowledge databases can for example be made available in the form of Wikis
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or process-related lists.
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integrity.
• Process auditors must continually develop their expertise. They main-
tain their knowledge and skills with respect to audit procedures, QM
systems, products and processes as well as specialized methods,
procedures and relevant standards. They must be familiar with the
quality requirements for products as well as the specific process risks
and the possible impact on the manufactured products.
• Process auditors must always behave in a way that does not endan-
ger the image and reputation of their own organization.
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• Process auditors must not accept assignments that would cause
them a conflict of interests.
• Process auditors must not accept assignments that they cannot carry
out properly because of a lack of expertise.
• Process auditors are bound to secrecy regarding confidential infor-
mation that they have acquired through their professional activities.
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4 Notes on conducting remote audits
Process audits according to the present VDA 6.3 audit standard are generally
conducted on site.
Taking risks factors/influencing factors for auditors, auditees as well as prod-
ucts and processes into account, remote audits can in individual cases be
carried out.
The organization conducting the audit bears overall responsibility for planning
the scope/the elements of the audit and selecting the audit method, provided
that the customer has not stipulated otherwise. It is recommendable to define
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a company-specific procedure for internal and external audits.
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4.1 Definition of a remote audit
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“Remote audits” are defined in the ISO 19011 and can be carried out inter-
nally as well as externally.
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4.2 Definition of a hybrid audit
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Hybrid audits are a combination of a remote audit and an on-site audit. In this
regard, chapter 4.6 “Suitability of individual process elements/questions for
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conducting remote audits (process elements P2-P7)” must be taken into ac-
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count.
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Generally, remote audits cannot constitute a full process audit (P2-P7) in ac-
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cordance with VDA 6.3. This is due to a lack of transparency during the audit
process and due to technical, legal as well as data protection issues. The
same applies to potential analyses (P1), which can only be carried out to a
limited extent without a visit to the supplier’s premises. However, provided
that risk factors / influencing factors are taken into account, hybrid audits can
be considered full audits.
The “2/3 rule” (see chapter 6.1) regarding the number of evaluation questions
is still applied.
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The privacy and confidentiality requirements remain the same, no matter
whether a remote audit or an on-site audit is planned and conducted. In par-
ticular, taking pictures or making videos/audio recordings is not allowed un-
less both parties have given their express consent.
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When selecting a suitable audit method (on-site audit, remote audit, hybrid
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audit), the criticality of the product as well as the development / production
process, the previous performance and aspects related to the location are
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particularly important. The following table provides an overview of the audit
methods, including a classification of the risk factors/influencing factors.
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Table 4-1: Overview of audit methods, including a classification of the risk
factors/influencing factors
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Remark: The most negative evaluation is the deciding factor when choosing the audit
method.
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4.5 Suitability of individual process elements/questions for
conducting remote audits within the scope of the
potential analysis (P1)
Table 4-2: Overview of the audit questions for the potential analysis (P1) and
their suitability for remote audits
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Question conditioally Question conditionally
suitable suitable
VDA 6.3 suitable VDA 6.3 suitable
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P2.1/P2.2*/P2.3
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/ X P6.4.1* X
P2.4/P2.6*
P3.2*/P3.4* X
A P6.4.2 (X)
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P4.1* X P6.4.3* X
P4.3/P4.4* X P6.4.4 X
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P5.5*/P5.6 X P6.5.4 X
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P6.1.1/P6.1.5* X P6.6.2 X
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P6.2.3* X P7.2 X
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P6.2.4* X P7.3* X
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4.6 Suitability of individual process elements/questions for
conducting remote audits (process elements P2-P7)
Table 4-3: Overview of the audit questions for process elements P2-P7 and
their suitability for remote audits
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P2 - P4 X P6.4.1* X
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P5.1/P5.2/
X P6.4.2 (X)
P5.3/P5.4*
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P5.5* X P6.4.3* X
P5.6 X
A P6.4.4 X
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P5.7 X P6.4.5 X
P6.1.1* X P6.5.1 X
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X P6.5.3* (X)
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P6.1.3
P6.1.4 X P6.5.4 X
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(X) P6.6.1 X
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P6.1.5*
P6.2.1 X P6.6.2 X
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P6.2.4* X P7.1 X
P6.2.5 X P7.2 X
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The analysis takes into account the supplier’s experience and skills regarding
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the development and production of the scope of products requested, as well
as their ability to fulfill customer-specific requirements for product and pro-
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cess implementation.
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The assessment is based on existing processes for comparable products.
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The result can be used as preparation for a decision to award a contract. It
provides a prognosis of the quality capability of the considered supplier/loca-
tion regarding the implementation of the product and process in the event the
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contract is awarded.
A potential analysis can also be carried out independently of a project in case
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uct development phase), the assessment is only based on the questions from
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5.2 Prerequisites
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Given that no contractual relationship exists between the customer and the
potential new suppliers during the inquiry and quotation stages, an agreement
should be made regarding confidentiality and access permission.
5.3 Preparation
Obtaining information in preparation for the potential analysis is of particular
importance. In addition to the customer’s own research, an essential way to
obtain information is to ask the prospective supplier to provide a self-assess-
ment.
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5.4 The process of conducting a potential analysis
The following diagram illustrates the process of conducting a potential analy-
sis (P1). The evaluation questions in P1 are selected from process elements
P2 to P7. An overview of the questions is provided in section 7.1.
The analysis of the supplier’s processes is based on a comparable prod-
uct/production process using the P1 questionnaire and, if required,
knowledge databases relating to the scope of delivery under consideration.
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A separate evaluation is required for the potential analysis because the objec-
tive here is less to arrive at a classification in percentage-terms and more to
decide on “suitable” or “not suitable”.
Each question is evaluated in terms of fulfillment of the respective require-
ment and the risk involved.
If a question is not evaluated (shown as n. e.), the reason for this must be
stated. A maximum of 3 questions may be marked n. e. Otherwise, the results
may no longer be comparable.
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The assessment result is based on the traffic light system (“red”, “yellow” or
“green”).
If a question is marked “red” or “yellow”, the findings and the relevant evi-
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dence must be documented.
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The overall assessment result of the potential analysis is calculated from the
number of questions rated as red/yellow/green:
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Evaluation based on questionnaire
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Classification
Yellow Red
Barred supplier
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Conditionally approved
supplier Y max. 12 none
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Interpretation of results
The supplier has the potential to meet the customer’s requirements to the ex-
tent required and may be considered for awarding a contract.
The customer can award a contract for the project, component or product
group without restriction.
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Yellow = conditionally approved supplier
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With regard to the scope of products requested, a contract can only be
awarded under certain conditions. In some cases, the supplier needs support
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from the customer in order to meet the requirements of the project. Under
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certain conditions, a limited approval for contract award may be given, e.g.:
• Restriction to a defined quantity (small-scale production)
• Restriction to a product/process with limited complexity
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Note: Conditions must be specified between the relevant quality and procure-
ment departments.
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5.6 Follow-up activities after contract award
The results of the potential analysis are used as input when planning the se-
lection or implementation of methods (e.g. process audit, VDA MLA).
Once a contract has been awarded, the implementation of measures accord-
ing to the action plan is mandatory.
The quality capability can only be validated (in terms of a release for series
production) by means of a PPA process covering the customer-specific scope
of delivery concerned. To achieve this, a process audit can be conducted
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within the scope of a process release.
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6 Evaluating a process audit for material products
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10 The requirements are fully met; conformity is ensured
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8 The requirements are mainly++ met; minor non-conformity
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6 The requirements are partially met; significant non-conformity
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The requirements are inadequately met; major non-conformity
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0 The requirements are not met
++)The term “mainly” means that there are only individual cases in which fulfillment of the
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The following table serves as a guideline for the appropriate allocation of
points when evaluating the questions:
Points
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are fulfilled
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8 Minor discrepancies in Some product defects
the process which do which do not influence
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not affect compliance the function, use or fur- Customer requirement
with the customer ther process steps is only met to a limited
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specifications or have degree
an effect on the follow-
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ing process steps
process steps
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If there are several findings for the assessment of a single question, the indi-
vidual assessment which is associated with the highest risk is decisive for the
assessment of the respective question.
The auditor may require immediate actions depending on the risk associated
with the findings.
If a question is not evaluated (n. e.), the reason for this must be stated.
At least 2/3 of the questions for each audited process element, sub-element or
process step must be evaluated. In order to ensure comparability, the entire
list of questions from the VDA 6.3 process element should be covered in full.
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If corrective actions from previous audits are not implemented, this can also
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be regarded as a case of non-conformity, e.g. in the “cause analysis”, “imple-
mentation of measures”, “meeting customer requirements” questions.
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Questions associated with a special product and process risk (*-ques-
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tion)
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In the process elements, questions associated with special risks product and
process risks are marked with an asterisk (*-question). These special risks
are already taken into account in the downgrading rules (see section 6.3).
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The evaluation is carried out in the same manner as for the remaining ques-
tions. Consequently, *-questions are not evaluated more harshly than other
questions.
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Process element
The compliance level EPn of a process element (P2, P3, …, P7) is calculated
as:
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Exception: If there is more than one evaluation for a question
In process elements P3, P4 (separate evaluation of product and process de-
velopment) and P6 (individual evaluation of each process step), there may be
several evaluations for a single question. In this case, the arithmetic mean of
all results for the question must be calculated first. In calculations following
this step, the average is rounded to two decimal places.
These averages replace the “points awarded” when calculating the level of
compliance of a process element.
For each question, the total number “possible points” is 10 – regardless of
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the number of results per question.
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Sub-elements of P6
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In the process element P6, the following sub-elements are evaluated:
EU1 Process input
EU2 Work carried out
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EU3 Personnel resources
EU4 Material resources
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EU5 Efficiency
EU6 Process output
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The evaluation of the sub-elements is carried out in the same manner as for
the process elements and the exceptional case: more than one evaluation for
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a question.
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Total points awarded for the relevant questions for the sub-
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element of P6
EUn [%] =
Total possible points for the relevant questions
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Total points awarded for the P6 questions for this process step
En [%] =
Total possible points for the P6 questions for this process step
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6.3 Overall level of compliance and downgrading rules
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Production process analysis (P6) EP6
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Customer care, customer satisfaction, service (P7) EP7
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The overall compliance level EG for the process audit is calculated as follows:
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Total points awarded for all evaluated questions from
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EP2, EP3, EP4 ,EP5 ,EP6 and EP7
EG [%] =
Total possible points for these questions
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For process elements P3 and P4, product development (EP3 product) and
process development (EP3 process) can be evaluated separately. To calculate
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the overall result for all process elements (e.g. P2 to P7), the mean values of
the respective questions in section P3 and/or P4 are used. The downgrading
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rules are applied to the entire process element P3 and/or P4 (joint evaluation
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If during a specific audit, individual process elements from the overall ques-
tionnaire are evaluated, the result is calculated only on the basis of the evalu-
ated process elements. It must be specified in the audit report which process
elements have been used in the evaluation.
Example P5/P6/P7
If process elements P5, P6 and P7 are evaluated (e.g. auditing of series pro-
duction), the result is calculated as follows:
Total points awarded for all evaluated questions from
P5, P6 and P7 (EP5 ,EP6 and EP7)
EG(P5P6P7) [%] =
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Total possible points for these questions
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Example P4
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If only process element P4 is evaluated (e.g. audit at the time of handing the
project over to series production), the result is calculated as follows:
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Total points awarded for all evaluated questions from P4 (EP4)
EG(P4) [%] = Total possible points for these questions
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The designations EG(P5P6P7) and EG(P4) are used to easily identify the process
elements evaluated.
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ments
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Level of compliance for partial audits
To classify the level of compliance of a partial audit, the calculated level of
compliance (e.g. EG(P5P6P7) or EG(P4)) is compared to the benchmarks as given
above (at least 80% for a “B” classification of conditionally quality capable or
at least 90% for “A” quality capable).
Downgrading rules
Results from the process elements, sub-elements of P6 or process steps
have to be considered in the following downgrading rules and documented in
the audit report.
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Reasons for downgrading from A to B even though the level of compli-
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ance is EG or EG(Pn) ≥ 90%
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• At least one process element (P2 to P7) or process step (E1 to En) is
evaluated as having a level of compliance EP or En < 80%
A
• A level of compliance EU1 to EU6 in one of the sub-elements of P6 is <
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80%
• 4 points are awarded for at least one *-question
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• 0 points are awarded for at least one question in the process audit
EG or EG(Pn) ≥ 80%
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• At least one process element (P2 to P7) or process step (E1 bis En) is
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cess steps), the individually calculated results EPn, EUn and En are rounded to
the nearest percentage point.
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Product group Possible process steps
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ated from the organization’s own knowledge databases.
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In the evaluation matrix, the relevant process steps are allocated to the prod-
uct group being evaluated.
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The overall level of compliance for each product group EG(PGn) is calculated as
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follows:
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Total points awarded for the questions for the evaluated
process elements Pn (for each question in P6, the average
value per question from the process steps for this PG is cal-
culated++)
by
EG(PGn) [%] =
Total possible points for the questions for the evaluated
process elements (++)
ht
++ for explanations of “points awarded” and “possible points” see section: 6.2: Exception.
ig
When evaluating product groups, the downgrading rules are applied specifi-
yr
38
6.5 Using the questionnaire (process elements P2 to P7)
The questionnaire forms the basis of the auditor’s work. The auditor selects
the relevant process elements for the audit depending on the phase of the
product life cycle (see section 2.2). Additional specific requirements can be
added to the questions depending on the product/process risks identified.
The questions can be used for processes for material products and products
with integrated (embedded) software as well as for auxiliary and process ma-
terials.
C
The questions for the process elements are structured as follows:
M
• Questions
Q
• Minimum requirements relevant for assessment
• Examples for implementation
A
VD
The “examples for implementation” provide a selection of potential applica-
tions. They should be selected on a product/process-specific basis and ex-
panded, analyzed and evaluated when necessary.
by
The evaluation is carried out based on the questions in the “Minimum require-
ments relevant for assessment” list.
ht
For the auditor, the audit consists of two mutually independent activities (see
ig
figure 6.1):
yr
39
C
M
Q
A
VD
Figure 6-1: Audit pyramid
that a knowledge database be created to store information about the risks as-
sociated with individual products and processes. The experience stored in the
op
Based on the risk analysis described in section 2.4, identified risks must be
checked against the questionnaire and integrated into the applicable ques-
tions.
40
6.6 Rules on conducting an audit
An audit can be stopped at the auditor’s discretion, for example in the follow-
ing cases:
• Refusal to disclose necessary information during the audit
• Obvious violations of the law
• Actively interfering with the auditor’s work or putting the auditor in
danger
• Refusal to grant access to areas that are relevant for the audit, de-
spite prior agreement
C
• Insufficient preparation of the audit on the part of the organization
• Providing evidently false statements
M
The reason for stopping the audit must be stated. Audit findings obtained up
Q
to the point the audit was interrupted must be documented.
A
The organization conducting the audit decides whether a new audit should be
carried out.
VD
6.7 Repeat audit
It must be specified in which cases a repeat audit is necessary. Reasons for
by
(0 points)
yr
The repeat audit must be carried out within a specified time frame. Within this
period of time, the audited organization must initiate measures to effectively
C
41
7 Questionnaire
Potential analysis**
P2 Project management
C
planned and available, and are changes reported?
M
2.3 Is there a project plan that has been agreed upon with the
X
customer?
Q
2.4 Are the quality-related project activities being imple-
X
mented and monitored for compliance?
2.5
A
Are the procurement activities of the project implemented
VD
and monitored for compliance?
ble?
yr
ments?
planned in detail?
3.5 Have the necessary resources been taken into account for
product and process development planning?
42
Potential analysis**
4.1* Are the activities from the product and process develop-
X
ment plans implemented?
C
4.4* Are the required approvals and releases for product and
X
process development available?
M
4.5 Have the planned procurement activities been imple-
Q
mented?
A
4.6 Have the manufacturing and inspection specifications
been derived from product and process development and
VD
are they implemented?
P5 Supplier management
5.1 Are only approved suppliers used who are able to meet
C
X
the quality requirements?
43
Potential analysis**
5.7 Are personnel qualified for their respective tasks and are
responsibilities defined?
C
6.1 What goes into the process?
Process input
M
6.1.1* Has the project been handed over from development to
Q
X
series production and is a reliable start guaranteed?
A
6.1.2 Are the necessary quantities/production batch sizes of pri-
mary materials available at the agreed upon time and at
VD
the correct storage location/work-station?
Process management
X
plan complete and are they fulfilled effectively?
44
Potential analysis**
C
M
6.3.3 Are the necessary personnel resources available?
Q
6.4 What equipment is used to implement the process?
Material resources
A
6.4.1* Is the manufacturing equipment suitable to meet the cus-
X
tomer’s product-specific requirements?
VD
6.4.2 Is the maintenance of the manufacturing equipment and
X
tools controlled?
by
X
ments?
yr
45
Potential analysis**
C
ucts/components?
M
6.6.3 Are the necessary records/releases retained? X
Q
6.6.4* Are customer requirements met upon delivery of the final
X
product?
A
VD
P7 Customer care/customer satisfaction/service
7.5 Are personnel qualified for their respective tasks and are
op
responsibilities defined?
C
46
7.2 Project management (P2)
C
ject leader and team members are defined. • Project interfaces in multi-site
M
The customer and the supplier have been informed projects
who the contact persons are. • Organizational chart for the
Q
The project organization and the associated escala- project
tion management meet the customer requirements. • Composition of the project
A
team
Escalation criteria (including escalation in supplier • Evidence of qualifications
VD
management) have been specified, and measures
• Special customer require-
are derived in case of non-compliance with the
ments regarding project man-
specifications.
agement
Roles are defined in accordance with the develop- • In case of an agile approach:
by
measures.
ments, including measures
C
47
P2.2* Are all resources required for project implementation planned and avail-
able, and are changes reported?
C
A review and (where necessary) an adjustment of
the resource planning is carried out when changes • Resource planning by the
M
occur (deadlines, scope of development performance Scrum Master
etc.). The critical path is given special consideration • Resource planning for inte-
Q
within the resource planning. gration and tests
A
equipment is planned and released.
VD
Changes to the project organization (interface with
customer) are reported.
The resources for software-specific activities have
by
been planned.
ht
ig
yr
op
C
48
P2.3 Has project management been implemented and is there a project plan
that has been agreed upon with the customer?
The project plan meets the specific customer re- • Project plan with milestones
quirements. • Specific customer require-
All internal and customer defined milestones are ments regarding technologies
fully incorporated in the project plan. xand/or product groups
• Customer project plan
A review is carried out at the milestones defined in
• Customer deadlines
the project plan to check that all planned activities
• Customer milestones
are carried out and that the required maturity level
C
• Targets set by the customer
is reached.
(measurements within the in-
M
If a statutory authorization procedure for a product dividual milestones)
is specifically required, the duration of this proce- • Milestone assessments (re-
Q
dure is included in the project plan. views)
In-house communication is ensured when changes • QM plan (e.g. from VDA MLA
A
are made to the project plan. Changes to the pro- or APQP)
• Country-specific certification
VD
ject plan which affect the customer are coordinated
with the customer. requirements (ECE, SAE,
DOT, CCC, INMETRO, KBA
Project changes that have an impact on the overall
etc.)
schedule have been taken in account in the escala-
by
and takes account of the associated delivery items. quirements, among other
Quality-related project activities as well as procure- things)
ig
ment activities must be part of the project plan. A • Release planning regarding
separate, detailed plan can be referred to in the basic functions and mile-
yr
49
P2.4 Have the quality-related project activities been planned, and are they
monitored for compliance?
C
The planning also addresses critical components • Specific software milestones
and supply items (internal and external suppliers). • Reviews, e.g. of code and
M
The planning is regularly monitored for compliance models
• Test case creation and
Q
and for target achievement.
validation (verification?)
The quality-related activities relevant to software
• KPIs relevant to software
A
have been taken into account.
(metrics, test coverage, level
VD
of test automation, rate of er-
ror reduction etc.)
• Software-specific assessment
planning and assessment lev-
by
els
• SW-Q release
• Risk assessments (special
ht
P2.5 Are the procurement activities of the project included in the project
op
planning?
C
The supplier selection process and the target dates • Project plan
for contract awards are contained in the project • Milestone plan
plan for all types of suppliers. • Make-or-buy decision
The suppliers of plants, machines, tools, measuring • Service providers (e.g. devel-
and inspection systems as well as the service pro- opment, laboratories, mainte-
viders are integrated in the planning. nance, software)
50
The deadlines for contract awards, supplier mile-
stones and release are included in the planning and
are coordinated so as to match the overall sched-
ule.
C
Changes (initiated by the supplier, internally or by
the customer) must be evaluated. If necessary, the • Change forms
M
project plan must be adapted. This evaluation must • Change history for the prod-
include the risk assessment for product quality as uct and the process
Q
well as the deadlines. • Evaluation of changes
• Approvals of changes
Suppliers are actively involved in change manage-
A
ment. • Software: Change request,
change management
VD
It must be ensured that specified design freezes are • Change due to fault elimina-
observed. Exceptions must be agreed upon be- tion, changes to the architec-
tween the customer and the supplier and must be ture and the requirements
documented.
by
51
7.3 Product and process
development planning (P3)
C
product (and software) to be developed as well as
and software (products with
to the production process have to be determined.
M
integrated/embedded soft-
The organization must identify and take into ac- ware)
Q
count the product and process requirements known • Inquiry and contract docu-
from previous experience. ments, including requirement
specifications
A
Special characteristics must be identified on the ba-
sis of the organization’s own requirements, cus- • Traceability concept
VD
tomer requirements, statutory and regulatory re- • Ordering and inspection re-
quirements, manufacturing technology and charac- quirements
teristics that arise from the purpose/use of the prod- • Catalog of characteristics/ref-
uct. erence samples
by
• Product/process characteris-
Customer requirements regarding the selection of
tics, including characteristics
suppliers or primary materials must be docu-
regarding functional safety
ht
mented.
• Purchasing conditions
In case of suppliers appointed by the customer (di- • Logistics requirements (pack-
ig
rected suppliers), interface agreements are availa- aging, JIT, JIS, on consign-
yr
ble. ment)
The customer’s requirements regarding the docu- • Quality agreements, including
op
on the Internet
• Lessons Learned
• Environmental aspects, recy-
cling requirements
• Capability requirements
• Requirements regarding re-
lease
Product development
• Specifications, drawings
52
Process element P3: Product and process development planning
• Software specifications
Process development
• Requirements regarding fa-
cilities, tools and inspection
equipment as well as work-
place and test station layout
C
• Requirements regarding
M
handling, packaging, storage
and identification
Q
• Requirements for identifica-
tion, configuration and ensur-
53
P3.2* Has the feasibility been comprehensively evaluated according to the
product and process requirements?
C
tion, environmental impact
Material and personnel resources must be con-
• Requirements from product liabil-
M
sidered in the feasibility study.
ity
The results of the feasibility study must be
Q
available before tendering. • Traceability concept
Product development
ig
• Laboratory/test equipment
• Parallel software development /
yr
prototyping
op
Process development
• Capacity monitoring
C
54
P3.2* Has the feasibility been comprehensively evaluated according to the
product and process requirements?
P3.3 Are the activities for product and process development planned in
detail?
C
When planning the product and process develop- Product/process development
ment, the level of detail depends on the component,
M
• Overall project plan including
software and complexity of the process.
all deadlines
Q
In the development phase, suitable risk mitigation
• Customer requirements
measures must be used for product and process
• Customer schedule
A
development assurance, so that the product meets
the required operational conditions when goes into • Lead times
VD
series production (function, reliability, safety).
• Risk mitigation measures (in-
In case of product and process innovations, there is
cluding backup strategy and
a fallback concept.
cybersecurity)
by
ning
dits and requalification.
• Regular status checks on the
ig
(reviews)
lines and duration, milestones according to the
overall project plan, performance testing, PPA date, • Project plans for investment
op
lease meet the customer requirements and clarifi- • Logistics planning for all
cation must be sought with the customer if non-con- phases of product and pro-
formities occur. cess development, including
The software engineering process has been speci- packaging
fied and meets the customer’s requirements. • Spare parts concept
The software development progress must also be Product development
taken into consideration in the planning, such that
• Reliability testing, functional
the required software functions are tested and
testing, trial plan
available at the required point in time.
55
P3.3 Are the activities for product and process development planned in
detail?
C
agement (product backlog,
M
sprint backlog, increment,
definition of ready, definition
Q
of done, sprint planning,
DevOps)
A
• Release planning
VD
Process development
• Tool deadlines (parts from
production tools),
by
56
P3.4* Have the procurement activities been planned, and are they monitored
for compliance?
Selection criteria are defined to ensure that the se- Product / process develop-
lected suppliers are able to meet the quality re- ment
quirements.
• Supplier selection criteria
A potential analysis has been planned or has been
• VDA 6.3 potential analysis
carried out for new suppliers not appointed by the
and/or comparable method
customer, new locations or new technologies.
for software
C
The scope of the planning activities after contract
• VDA 6.3 audit planning
award is based on the risk classification of the pur-
M
chased products/services. • Management (supplier devel-
opment, forwarding customer
There are clear rules for the communication of cus-
Q
requirements) of the suppli-
tomer requirements along the supply chain.
ers, PPA procedures, failure
Customer requirements also include requirements
A
analysis, quality, warranty,
arising from the drawing, the parts, software or communication
VD
component specifications, the delivery quantity, the
deadlines, QM agreements and applicable regula- • Interface agreement (ser-
tions. vices according to DIA or in-
terface agreement)
by
57
P3.5 Have the necessary resources been taken into account for product and
process development planning?
The required resources for the project have been Product/process development
determined and documented. • Planning of staff training, cus-
Capacity for the implementation of prototypes tomer service (0km and field),
and prototype construction, pilot production, per- among other things
formance tests and series production must be • Qualification matrix
planned. • CAx equipment
C
Resource planning is regularly adapted to • Availability of qualified person-
M
changes in the project and potential bottlenecks nel for the respective tasks
must be addressed.
• Budget, infrastructure, e.g.
Q
When introducing new technologies and prod- buildings, inspection equipment
ucts, consistent employee training must be (hardware and software), labor-
A
planned, and it must be ensured that the neces- atory equipment, machines,
sary infrastructure is created. plants etc.
VD
Means of transport for in-house transportation, • Capacity planning for all re-
such as packaging and special load carriers sources
have been planned and the relevant quantities • Performance test, Run@Rate,
by
development tools)
Product development
yr
• Test/inspection/laboratory facili-
op
ing bugs
• Resources for installing the
software on the hardware (e.g.
flashing, coding, programming)
Process development
• Production locations, tools, pro-
duction and inspection equip-
ment, infrastructure
58
P3.6 Have the activities for customer care/customer satisfaction/customer
service and field failure analysis been planned?
C
has been planned for the scope of delivery and the
supply chain. The customer requirements regarding • Access for diagnosis
M
field failure analysis are taken into account. • Access control lists
Interfaces to the complaints process have been
Q
Process development
planned.
• Inspection planning for
An access control concept for software has been
A
standard and stress testing
established and is maintained.
VD
• Triggering criteria are de-
An analysis of all stakeholders has been carried
fined
out. Communication and escalation paths have
been specified. • NTF process
by
59
7.4 Implementation of product and process development
(P4)
P4.1* Are the actions from the product and process development plans
implemented?
C
fined in the development planning are imple-
• Methods to minimize risk (e.g.
mented in such a way as to ensure that the oper-
M
FMEA, HARA, FTA)
ational conditions are met (function, reliability,
safety). • Design of experiments (e.g.
Q
DoE, Shainin, Taguchi…)
The risk analysis (e.g. FMEA, HARA) is con-
ducted on a multidisciplinary basis and is contin- • Poka-Yoke principles
uously revised in accordance with the progress
A
Product development
VD
of the project. Defined measures are imple-
mented in accordance with the planning and are • Test planning
checked for effectiveness. • Assembly test and system test
Special characteristics are defined and identified • A, B, C, D samples
by
planning
op
60
P4.2 Are personnel resources available and are the personnel qualified to
ensure product and process implementation?
Product/process development
• Customer requirements
A staff schedule must be available.
• Requirements profile for the
The employees’ tasks, responsibilities and authori- relevant jobs
zations are defined and allocated. This also applies • Determination of the need for
to the staff of external service providers. Appropri- training
C
ate evidence must be available.
• Evidence of training
M
It must be ensured that needs assessments is car- • Knowledge of methods
ried out regularly during product and process devel-
Q
opment with regard to potentially emerging bottle- • Knowledge of foreign lan-
necks and additional requirements. guages
A
• Software development: Qual-
Qualified personnel are available during all phases ified software testers, inte-
VD
of product and process implementation, and the re- gration managers, etc.
quirements regarding the series production person-
nel have been derived. • Agile development due to
qualified roles (DevOps Man-
by
Processes that have been outsourced must be ager, Release Train Man-
taken into account. ager, etc.)
ht
ig
yr
op
C
61
P4.3 Are the material/immaterial resources available and are they suitable to
ensure product and process implementation?
C
Processes that have been outsourced must be • Supporting processes, e.g.
M
taken into account. from logistics and IT
Regular needs assessment must be carried out Product development
Q
during product and process development with re-
• Resources for verification and
gard to potentially emerging bottlenecks and addi-
validation
A
tional requirements.
• Test setups, e.g. Hardware in
VD
Material/immaterial resources are available for all
the Loop (HIL), test boards,
phases of product and process implementation,
evaluation boards
and the requirements for series production have
been derived. • Development tools, provision
by
• Facility planning
ig
• Facility layout
yr
• Transport routes
• Transport, containers, storage
• Capacity before the start of
series production (initial stock)
62
P4.4* Are the required proofs of capability and releases for product and pro-
cess development available?
C
The material data has been confirmed and re- products and services
leased.
• Development releases from
M
The measures from the risk analyses (e.g. FMEA, customers
HARA) have been included in the product and pro-
Q
Process development
cess implementation, and their effectiveness has
been confirmed. • Process parameters and
A
their tolerances
In case of products with integrated (embedded)
VD
software, the software-related aspects according to • Confirmed logistics concept
VDA Volume 2 have to be taken into account. (e.g. suitability of packaging
The production process and product approval through sample shipping)
• Proofs of capability
by
Software
ig
63
P4.5 Have the planned procurement activities been implemented?
C
PPA procedure
The required proofs of capability and releases (pro-
M
cess and product release) for the purchased prod- • NTF process, triggering crite-
ucts and services are available in accordance with ria for stress tests have been
Q
the project schedule. The material data has been defined
confirmed and released.
• Spare parts supply concepts
The relevant project-specific customer require-
A • Contingency plans
VD
ments have been taken into account.
• Interface agreement (ser-
The processes for ensuring customer care/cus-
vices according to DIA or in-
tomer satisfaction/customer service as well as field
terface agreement)
failure analysis have been established.
by
• Sub-supplier management
by auditee for off-the-shelf
components, engineering as-
ht
64
P4.6 Are the manufacturing and inspection specifications derived from prod-
uct and process development and are they implemented?
C
The results of the risk analysis are considered (e.g. Process development
• Inspection instruction
M
FMEA, HARA).
A production control plan is available. • Work instruction
Q
It must be available throughout the prototype phase • Reaction plans
(if required by the customer), the pre-launch phase
• Production release (first and
A
and the series production phase.
last piece, repeat release)
VD
The scope and the elements of product audits and
requalification tests have been defined. • In-line inspections
The software functions required at the respective • Release criteria in the pro-
times are released. duction test
ig
yr
op
C
65
P4.7 Is a performance test carried out under series conditions for the series
release?
C
The installation of the software in the components • Customer requirements
M
must be taken into account when determining the
• Performance test,
cycle times/throughput times.
Q
Run@Rate
Note: Depending on the time of the audit, some
• Determination of minimum
parts of the relevant production test could still be at
A
quantities (production peak
the planning stage!
and agreed flexibility)
VD
The question is not relevant for product develop-
ment! • Series production maturity of
equipment and facilities
(measurement report)
by
Software
ig
ROM programming
op
C
66
P4.8 Have the processes for ensuring customer care/customer satisfac-
tion/customer service as well as the field failure analysis been estab-
lished?
C
are available. • Inspection plans for failure
analysis
M
The analysis process for 0-km and field com-
plaints is established for the scope of delivery. • NTF process
Q
The customer requirements regarding field failure Process development
analysis are taken into account.
• Qualification matrix and evi-
A
The requirements for the analysis capability at
dence of training
the site have been agreed with the customer.
VD
• Inspection equipment
If external sites are used for analysis, the inter-
faces are defined and evidence of the availability • Service agreements with exter-
of the required equipment and capacity is availa- nal analysis sites
by
67
P4.9* Is there a controlled method for the project handover from development
to series production?
C
ceptance reports
Successful internal release and customer release
M
is a prerequisite for a series delivery release. • Parts history
Measures resulting from internal and external re-
• Key production figures such as
Q
leases are implemented on time.
OEE, ppm, reject rate, etc.
Personnel are available in accordance with the
• Experiences from the ongoing
A
planning and are qualified.
project
VD
The material resources for series production are
• Personnel resources (produc-
available in accordance with the planning.
tion staff, process engineers,
Measures to secure the production start-up have maintenance, etc.)
been specified and introduced.
by
termediate results and their documentation) are load carriers, packaging, etc.)
recorded.
• Change log, Release Note
ig
68
7.5 Supplier management (P5)
P5.1 Are only approved suppliers used who are able to meet the quality re-
quirements?
In series production, it must be ensured that only • Defined criteria for the selection
approved suppliers are used. The relevant ap- of suppliers
C
proval criteria have been defined.
• QM agreements
When selecting suppliers and in order to assess
M
• In case of criteria that have not
their ability to meet quality requirements, a pro-
been met: evidence of
cess audit must be planned and carried out de-
Q
measures being implemented in
pending on the risk classification of the compo-
order to mitigate risks
nent.
A
• Assessment of the suppliers’
Evaluations of the quality performance of existing
VD
ability to meet quality require-
suppliers have been taken into consideration.
ments, e.g. by means of KPI
Risks in the supply chain (internal/external) have (ppm, delivery performance),
been identified, evaluated and mitigated using escalation level
by
suitable measures.
• Self-Assessment, audit results
In case of suppliers appointed by the customer of the suppliers
(directed suppliers), interface agreements are
•
ht
69
P5.2 Are the customer requirements taken into account in the supply chain?
C
taken into consideration. • Requalification requirements
• Forwarding of complaints, in-
M
cluding measures
Q
• Statutory and regulatory re-
quirements
A
VD
P5.3 Have targets for supplier performance been agreed upon, and is the
achievement of these targets regularly assessed?
by
mance must be made with all direct suppliers and quantity, punctuality, failure
must be implemented. rate, PPM, special deliveries,
yr
Supplier performance must be checked and evalu- rejects, lead times for com-
ated within defined periods and according to de- plaints
op
70
P5.4* Are the necessary releases available for purchased products and ser-
vices?
C
• Product and process
M
changes in the supply chain
• Release agreement for small
Q
series and individual needs
A
VD
P5.5* Is it ensured that the purchased products and services are of the agreed-
upon quality?
by
planning.
• Boundary sample
If the quality requirements are not met, a standard
yr
71
P5.6 Are incoming goods delivered and stored appropriately?
C
labeled protected against unauthorized access.
• Protection against dam-
M
FIFO/FEFO (shelf-life requirements) and batch age/contamination/corrosion
traceability must be ensured when the materials
• Order and cleanliness
Q
are further processed. This equally applies to resid-
ual quantities. • Precautions to prevent mix-
A
ing/mistakes
Material stock figures in the warehouse manage-
VD
ment system match the quantities actually in stock.
The storage conditions fulfill the product require-
ments.
by
ht
ig
yr
op
C
72
P5.7 Are personnel qualified for their respective tasks and are responsibilities
defined?
C
planned and carried out accordingly.
• Packaging requirements
M
Knowledge of previous complaints (including cor-
rective actions) is available for purchased products • Quality procedures
Q
and services. • Job description / description
of tasks and function
A • Qualification matrix
VD
• Qualification of supplier audi-
tors
by
ht
ig
yr
op
C
73
7.6 Production process analysis (P6)
P6.1.1 Has the project been handed over from development to series
production and is a reliable start guaranteed?
C
documented according to the specified criteria.
• Defined measures and im-
M
The responsibilities for the entire handover process plementation schedule
are specified and acknowledged. Unresolved is-
Q
• Production release report
sues are followed up on, and the necessary
measures are implemented on schedule. • Releases for all plant compo-
A
nents and tools in 6.1.2
A complete production process and product release
VD
(PPA) including the documentation required must • PPA documents, including
take place before the first production shipment. customer approval and refer-
Measures to secure the production start-up have ence parts regarding the
been implemented on the basis of a risk analysis. PPA procedure
by
essary quantities.
• Examples for securing the
Analysis options for failure analysis are available
ig
production start-up:
The product software corresponds to the latest re- Higher inspection frequency,
yr
74
P6.1.2 Are the necessary quantities/production batch sizes of production mate-
rials available at the agreed upon time and at the correct storage loca-
tion/work-station?
C
At the workplace, parts and primary materials are customer, operating, auxil-
M
provided as needed, taking into account the order iary and process materials
quantity/lot size in accordance with the logistics
• suitable means of transport
Q
concept.
• Defined storage locations
The reuse of residual quantities, separated parts,
and stock levels
A
reworked parts, reused parts from product audits,
inspected items, etc. and their traceability must be • KANBAN, Just in time/Just in
VD
clearly defined. sequence, FIFO/FEFO
Regulations for reintroducing parts from outsourced • Revision / change status of
processes (e.g. sorting service) must be available. materials and software
by
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P6.1.3 Are materials stored appropriately and are the means of
transport/packaging facilities suitable for the special characteristics of
the materials?
C
tion. to the material
M
Storage areas/work-stations/containers must be ap- • 5S
propriate for the tidiness and cleanliness required
• Over-filling (storage areas
Q
for the material. Cleaning cycles are defined and
and containers)
monitored.
• Maximum and minimum stor-
The supply of materials at the work-station/on the
76
P6.1.4 Are the necessary labels/records/releases available and allocated
appropriately to the materials?
C
Traceability from the sub-supplier to the customer
must be guaranteed according to a defined tracea- • Records of approvals
M
bility concept.
• Traceability system
Q
Customer requirements as well as statutory and
regulatory requirements regarding labeling are • Documentation of waivers
taken into account. (number, duration, type of
A
identification, etc.)
• Stock management systems
VD
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P6.1.5* Are product or process changes during series production tracked and
documented?
Changes to the product and the production pro- • Trigger matrix in accordance
cess are implemented in accordance with the with VDA Volume 2 or cus-
change management described. Changes to the tomer specifications
product and process are agreed upon with the • Documented release of a
customer, approved and released (including soft- change
ware changes) in accordance with customer re-
• Cross-functional evaluation
C
quirements. A PPA must be carried out. The his-
prior to changes
tory of change statuses must be fully traceable.
M
• Change history/parts history
The correct, released version of the material / soft- (also for software)
Q
ware must be used.
• Design and process FMEA
After changes have been made, it must be • Operation management in
A
checked whether the risk analyses need to be up- case of changes
dated.
VD
• Pre-production
• Unique software identifier,
software integrity (build num-
ber, hash key)
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Process element P6: Production process analysis
P6.2.1 Are the requirements in the production control plan complete and have
they been effectively implemented?
C
plan. tion methods, inspection fre-
M
The data relating to released machinery/tools/aids quencies, inspection cycles
must be noted in the production control plan and requalification
Q
and/or the manufacturing and inspection docu- • Data regarding ma-
ments. chines/tools/aids (identification
A
The documents must be accessible close to the numbers), process parame-
VD
work-station. ters and tolerances (pressure,
temperatures, times, speeds
Required measures (reaction plan) for process etc.)
disturbances are described in the production con-
trol plan and are implemented and documented. • Work instructions (including
by
reworking)
Process parameters influencing product character-
istics/quality must be fully stated. • Inspection instruction
ht
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P6.2.2 Are production processes released?
C
At the time of release, the necessary reference and • Possible triggering criteria
M
boundary samples must be available. for a repeat release:
Criteria for triggering a repeat release must be de- ○ Production interruption
Q
fined e.g. after an interruption of production. (e.g. night time
in two-shift operations,
If production is continued after the collection of in-
A
tool changes, material/
spection parts, these products must be accessible
batch/product change)
VD
until the inspection parts are released.
○ Repair, tool change,
○ changed setting data
• Release of reworked parts
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P6.2.3* Are special characteristics controlled in production?
C
Records regarding special characteristics are avail- • SPC evaluations
M
able. The duration and type of archiving of these
• Quality control charts
records are specified and meet the customer’s re-
Q
quirements. • Proofs of capability
• Proof of inspection process
A
capability
VD
• Inspection results
• Process parameter records
by
Suspect parts and defective parts must be sepa- • Labeling indicating the prod-
ig
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P6.2.5 Is the flow of materials secured against mixing/wrong items?
C
The reuse of residual quantities, separated parts, re- • Kanban
M
worked parts, reusable parts must be clearly de-
• Removal of invalid labeling
fined. Traceability is ensured.
• Value stream analysis
Q
Regulations for reintroducing parts from outsourced
processes must be available. • Sorting service
A
Setting masters, setup and reference parts must be • Unique software identifier,
VD
labeled and protected against accidental use. software integrity (build num-
ber, hash key)
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Process element P6: Production process analysis
Personnel resources
C
is not the case, a qualification scheme must be put • Initial training plan, including
M
in place. evidence
Instructions, trainings and inductions provided to • On-the-job training
Q
the employees as well as proofs of qualification are
• Qualification matrix
documented.
A
• Knowledge about the prod-
Proof of special qualifications required for the rele-
uct and failures that have oc-
VD
vant job must be provided.
curred
In case of changes to processes, trainings/instruc-
• Handling of measuring
tions are provided and documented.
equipment
by
• Training/instructions regard-
ing occupational safety
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istics
• Suitable evidence of qualifi-
op
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P6.3.2 Do the employees know what responsibilities and authority they have
regarding the monitoring of product and process quality?
C
Employees receive regular information on the cur- the process
rent standard of quality achieved and are informed • Escalation protocol
M
about customer complaints.
• Product training
Q
The requirements also apply to temporary employ- • Product safety/product liabil-
ees. ity training
A
VD
P6.3.3 Are the necessary personnel resources available?
There is a staff schedule for all shifts. The staff • Shift plan
schedule takes into account the required number of • Evidence of qualifications
ht
qualified employees.
• Qualification matrix
Rules exist for supporting areas that are not contin-
• documented absence man-
ig
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Process element P6: Production process analysis
C
quirements using the existing production facilities,
• Monitoring of key process
M
and that the resulting products meet the customer
parameters (e.g. pressure,
specifications.
time, temperature)
Q
The production facilities, machines and plants must
• Capability of replacement
be able to comply with the specified tolerances for
tools
A
the respective product and process characteristics.
• Feed and removal systems
VD
Parameters and software that influence the process
are protected against unauthorized access. • Reproducibility of gages, fix-
Process capability must be determined for selected tures etc.
product and process characteristics, and proof of • Cleanliness requirements
by
ments as well as customer requirements. The mini- ware in accordance with the
mum requirement for process capability is Cpk ≥ unique identifier, software in-
ig
1.33. In case of characteristics where a certain ca- tegrity (build number, hash
pability is required but proof of capability cannot be key)
yr
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P6.4.2 Is the maintenance of the manufacturing equipment and tools
controlled?
C
Maintenance
measures.
• Key processes and bottle-
M
Resources needed to carry out necessary mainte-
neck machines
nance activities are available.
Q
A process for the analysis and optimization of • Technical documentation
down-time, machine utilization and tool life is imple- provided by the manufac-
A
mented effectively. turer
• Preventative tool exchange
VD
The availability of replacement parts is ensured.
programs for units subject to
Tools undergo tool management which includes the increased wear
following:
• Tool operation sheet
by
index
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P6.4.3* Can compliance with quality requirements be effectively monitored with
the measuring and inspection equipment in use?
C
Inspection and measuring equipment is labeled. sticker, barcode, engraving,
M
The validity status is monitored. etc.)
• Reference parts
Q
A process for periodic monitoring of inspection
equipment and measuring systems is established
and implemented.
In case of non-conformity, an assessment of poten-
A
VD
tial risks in relation to the process, the product and
the customer is carried out. Measures have been
defined and are implemented effectively.
by
way.
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P6.4.4 Do the work and inspection stations fulfill the requirements?
C
The layout of the work station is adapted to the
work to be carried out. • Layout of the work station
M
• Surroundings/handling of
parts at the work station
Q
• Occupational safety
A
VD
P6.4.5 Are tools, devices and inspection equipment stored properly?
Tools, devices and test equipment must be stored • Stored in such a way as to
properly. be protected against dam-
ht
It is ensured that the equipment is stored in such a age, e.g. collision protection
way as to be protected against damage and envi- • 5S Method
ig
ronmental effects.
• Defined storage location, e.g.
yr
88
Process element P6: Production process analysis
Process-specific targets are defined, monitored and • Key production figures, e.g.
communicated. quantities produced; quality
Customer requirements are taken into account metrics, throughput times,
defect costs, process effec-
C
when setting targets.
tiveness figures, plant and
M
A regular comparison between specified targets machine availability)
and actual results is made and documented.
• First time trough quality, First
Q
pass yield
• Reduction of waste (e.g. re-
89
P6.5.2 Is quality and process data collected in a way that allows for analysis?
C
ble and archived as specified. Traceability require- rameter changes
ments are met.
• Shift/machine log
M
The collected data is analyzed, and appropriate im-
• Cycle times, throughput
provement measures are initiated.
Q
times
The potential for improvement must be continuously
• Fault message (e.g. plant
determined based on findings relating to quality,
A
standstill, power outage, pro-
costs, and services.
VD
gram error message)
• Output/availability
• Blocking message/sorting
by
actions
• Traceability
ht
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P6.5.3* If product and process requirements are not met, are the causes
analyzed and the corrective actions checked for effectiveness?
C
• Design and process FMEA
Repeat errors are recorded. A more detailed analy-
M
sis of the causes must be carried out accordingly. • Waivers/concessions
• Additional dimensional, ma-
Q
Corrective actions are derived, their implementation
is monitored and the effectiveness verified, terial, functional and endur-
ance testing
A
The production control plan and the risk analysis
are updated as needed.
VD
Non-conformities that affect the characteristics of
the delivered product are communicated to the cus-
tomer.
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P6.5.4 Are processes and products audited regularly?
C
rived, their implementation is monitored and the ef-
fectiveness is verified. action plans
M
Non-conformities that affect products which have • Auditor qualification
already been delivered are communicated to the
Q
• Scope of the audit, e.g.: P5,
customer.
P6, P7
• Labeling, packaging
92
Process element P6: Production process analysis
P6.6.1 Do the quantities/production batch sizes match needs and are they sys-
tematically directed to the next process step?
C
• JIT/JIS
The order quantity/batch size must be taken into
M
account, so that only the required quantity of prod- • Storage management
ucts is moved to the stipulated storage/holding
Q
• Production quantities tailored
point.
to the customer’s needs
The current state of the component (OK part, re-
A
• Technical cleanliness
worked part, reject, etc.) must be evident from the
VD
labeling (component, container etc.).
The change status must be clearly indicated.
It is ensured that only OK parts move on to the next
by
as further processing.
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P6.6.2 Are products stored in an appropriate manner and are the means of
transport/packaging facilities suitable for the special characteristics of
the products?
C
The storage areas/containers must meet the re-
over-filling (storage areas,
quirements with regard to cleanliness.
M
containers)
Specified storage times must be monitored.
• Monitoring of storage
Q
Products must be protected against environmental times/storage quantity (maxi-
and climatic influences during storage and ship- mum/minimum storage
A
ment. times, specified interim stor-
These requirements apply to the handling during age times)
VD
the production process as well as during shipment. • Specifications regarding the
It is ensured that there are no product risks in the cleaning of packaging
transport chain, e.g. due to parts handling, transport • Sufficient amount of packag-
by
94
P6.6.3 Are the necessary records/releases retained?
C
are fulfilled.
The traceability of products is ensured.
M
The customer’s requirements with regard to archiv-
Q
ing are fulfilled.
A
P6.6.4* Are the customer requirements met upon delivery of the final product?
VD
Minimum requirements relevant for assessment Examples for implementation
•
by
• Customer specifications
Products are labeled, stored and shipped in accord- regarding labeling (e.g.:
op
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7.7 Customer satisfaction/customer care/service (P7)
P7.1 Are all requirements related to the QM system and product conformity
fulfilled?
The internal and customer-specific requirements re- • Quality agreements with the
garding the QM-system and its further development customer
are fulfilled. The processes within the organization
• Requalification concept, e.g.
C
(including the outsourced processes) and along the
product audits carried out,
supply chain are taken into account.
M
functional tests, endurance
Requalification tests are carried out in accordance tests
Q
with the customer requirements
• Certification of the QM sys-
Customer requirements for the return of parts and tem
A
their recycling must be fulfilled.
• Proof of conformity, e.g.
Proof of conformity with necessary national and in-
VD
parts that are subject to type
ternational regulations is available. approval, CCC, ECE, DOT,
certificates, inspection re-
ports
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P7.2 Is customer service guaranteed?
C
customer-specific agreements is ensured, and the ments
required data is up to date/maintained. • Notification of improvement
M
measures
Q
• World-wide customer service
• The customer is informed in
97
P7.3* Is the supply of parts guaranteed?
C
taken into account. supply shortages
M
Procedures must be in place which guarantee that • Regulations covering author-
the organization informs the customer immediately ity to make decisions/escala-
Q
when supply shortages are detected. The infor- tion paths when introducing
mation must include the expected duration and ex- special actions
A
tent of the shortages, the reason and the measures
• Blocking of parts
which have been initiated.
VD
• Involvement of the suppliers
The customer’s requirements regarding the supply
in spare parts supply
of spare parts must be fulfilled during the series
production phase as well as afterwards. • Provision of software up-
by
dates
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P7.4* In case of complaints, are failure analyses carried out and corrective
actions implemented effectively?
A complaints process that meets the customer re- • Process for processing com-
quirements is followed in case of 0-km and field plaints and field failure analy-
complaints. sis process
Analysis procedures must be defined. The neces- • Internal/external analysis fa-
sary personnel and material resources are available cilities (laboratories, test and
to ensure punctual processing. The deadlines inspection facilities, person-
agreed upon with the customer must be met. In nel)
C
case of non-conformities, the customer has to be
• Use of problem-solving
M
informed.
methods (8D)
In case of field complaints, a field failure analysis
Q
• Flow of information to the
must be carried out according to the customer re-
customer in the case of non-
quirements (e.g. VDA Field Failure Analysis).
conformities
In case of suppliers appointed by the customer (di-
A
• Knowledge databases, les-
VD
rected suppliers), interface agreements are taken
into consideration. sons learned
• Quality control loop
• Risk analysis (e.g. FMEA,
by
HARA)
• Access to the necessary re-
ht
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P7.5 Are personnel qualified for their respective tasks and are responsibilities
defined?
C
the consequences of incorrect execution of work for • Standards/legislation (prod-
the supply of parts and the quality of the final prod- uct liability)
M
uct.
• Intended use
Q
• Failure analysis
• Evaluation methods (e.g. au-
A dits, statistics)
VD
• Quality techniques (e.g. Pa-
reto, 8D Method, cause and
effect diagram, “5 Whys”
method)
by
100
8 Glossary and list of abbreviations
Definitions and terms from the VDA publications are provided in the overarch-
ing online glossary of the VDA QMC:
https://vda-qmc-learning.de/module/glossar/glossar.php
Abbrevia-
Explanation
tion
C
aSPICE automotive SPICE (Software Process Improvement and Capability Determination)
M
CAx Computer-Aided x
Q
DIN German Institute for Standardization (Deutsches Institut für Normung e. V.)
A
EDn Compliance level of the service process element (D2, D3, …, D7)
VD
ESD electrostatic discharge
OK OK
NOK Not OK
101
Abbrevia-
Explanation
tion
C
P7 Process element: Customer care, customer satisfaction, service
M
REACH Registration, Evaluation, Authorization and Restriction of Chemicals
Q
SAE Society of Automotive Engineers
A
VDA Verband der Automobilindustrie e. V.
VD
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102
9 Downloads
Given that the tables and figures can only be presented to a limited extent in
the print form, we have provided you with PDF downloads under the following
link: www.vda-qmc.de/downloads
Login details:
C
Username: prozessaudit
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Password: vda_6.3
Q
A
VD
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103
Quality Management in the Automotive Industry
C
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Q
A
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Reference:
104
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