Part 3

Quality Management in the Automotive Industry

Process Audit

Potential Analysis
Product and Production Process Development
Product and Production Process Implementation
Series Production

4th revised edition, January 2023

Process Audit

Potential Analysis
Product and Production Process Development
Product and Production Process Implementation
Series Production

4th revised edition, January 2023

Verband der Automobilindustrie e.V. (VDA)

ISSN 0943- 9412

Copyright 2023 by

Verband der Automobilindustrie e.V. (VDA)

Qualitäts Management Center (QMC)
10117 Berlin, Behrenstr. 35
Non-binding VDA recommendation
The Association of the German Automotive Industry (VDA) recommends its
members to apply the following standard for the implementation and
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found, errors
it is requested that theor the be
VDA possibility
notified of
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must be requested from VDA QMC.

3
4
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
- clear downgrading rules
- identification of specific product and process risks (questions marked
with an asterisk, i. e. *-questions)
- a clear
clear presentation of the results of the process evaluation (A, B or C)
- worldwide comparability of the results for similar products and pro-
cesses
- potential analysis for ev
evaluating
aluating the suitability of n
new
ew suppliers, lloca-
oca-
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
contributes to the fulfillment of the requirements according to IATF 16949.

The VDA 6.3 process audit is part of the VDA 6.x family:

Figure 0-1: Overview of the volumes of the VDA 6.x family

5
Contents
Foreword 5
Contents 6

1 Notes on the revision 8

2 Instructions for use 10

2.1 Scope of the volume 10
2.2 Integration into the product life cycle 12
2.3 Differentiation between a potential analysis and a process audit 14
2.4 Identification of process risks (risk analysis) 14

3 Requirements for process auditors 16

3.1 Auditor qualification 16

3.1.1 Internal process auditors 16

3.1.2 Supplier auditors 17
3.1.3 Process auditors as external service providers 18
3.2 Product/process-related knowledge of the auditors 19
3.3 Code of conduct for auditors 19

4 Notes on conducting remote audits 21

4.1 Definition of a remote audit 21
4.2 Definition of a hybrid audit 21
4.3
Instructions for use 21
4.4 Classification of the audit methods based on existing risk factors / influencing
factors 22
4.5 Suitability of individual process elements/questions for conducting remote
audits within the scope of the potential analysis (P1) 24
4.6 Suitability of individual process elements/questions for conducting remote
audits (process elements P2-P7) 25

5 Potential analysis (P1) 26

5.1 Definition of a potential analysis 26
5.2 Prerequisites 26
5.3 Preparation 26
5.4 The process of conducting a potential analysis 27
6
5.5 Evaluation of a potential analysis 27
5.6 Follow-up activities after contract award 30

6 Evaluating a process audit for material products 31

6.1 Evaluation of the individual questions 31
6.2 Detailed evaluation and downgrading rules 33

6.3 Overall level of compliance and downgrading rules 35

6.4 Evaluation of product groups 37
6.5 Using the questionnaire (process elements P2 to P7) 39
6.6 Rules on conducting an audit 41
6.7 Repeat audit 41

7 Questionnaire 42
7.1 Overview of questionnaire 42
7.2 Project management (P2) 47

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
7.6 Production process analysis (P6) 74
7.7 Customer satisfaction/customer care/service (P7) 96

8 Glossary and list of abbreviations 101

9 Downloads 103

7
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 2023.
What has changed compared to the 2016 version?

- Software-related aspects have been considered in the questionnaire.

- The content of this volume wwas
as harmonized with further VDA methods,
namely Automotive SPICE and maturity level assurance for new parts
(VDA MLA).
- Requirements with regard to purchasing a activities
ctivities were added to
to P3
and P4.
- Notes on conducting remote audits were added.
- Chapter 4 (“Audit process”) was deleted, as its contents are included in
ISO 19011.
- Chapter 8 (“Process audit
audit services”) was completely deleted from the
VDA Volume 6.3.
- Chapter 10 (“Best practice/lessons learned”) was deleted.
- The evaluation of transport and parts handling (EU7) was omitted.
- In some cases, questions with special significance (*-questions) were
redefined.
- Some of the questions regarding the potential analysis were reallo-
cated.
- A comprehensive online glossary for all VDA volumes is established.

What has remained the same?

- The classification system (A, B
B,, C)
C) for the ov
overall
erall assessment
- The structure of the questionnaire
- The evaluation model for the individual questions (10-8-6-4-0)
- The applicability of p
process
rocess eleme
elements
nts P2-P7 according to figure 2-1
- The Turtle Model
- Previous downgrading rules

During the revision, the distinction between process and system audits was

once
been again explicitly taken into account. The current IATF requirements have
observed.

8
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.

9
2 Instructions for use

2.1 Scope of the volume

A process audit is a method for impartial analysis and evaluation of product

development and implementation processes as well as their effectiveness.
Process audits can be used internally as well as externally throughout the en-
tire product life cycle and fulfill the requirements specified in IATF 16949. Pro-
cess audits are suitable for small or medium-sized companies as well as
large corporations.
In general, this volume can be used throughout the entire product life cycle. In
this regard, a distinction is made between:
- Potential analysis
- Product and production process development
- Product and production process implementation
- series production

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-
ing of the series production processes and can also be used on an event-ori-
ented basis.
The aim of the process audit is to determine whether the processes/process
steps fulfill the process and product requirements and specifications. Any dis-
crepancies detected are evaluated in accordance with a points system with
regard to the process/product risk and are documented as audit findings. The

objective is to determine
are to be expected basedtoon
what
the extent potentially
audit findings, as non-compliant products
well as to identify the asso-
ciated risks.

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
st andard and/or which have a lasting negative effect on the

10
product characteristics, this should be documented and taken into account in
the evaluation.

Table 2-1: Differentiation between audit standards

11
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®
standards.

Figure 2-1: Possible use of the individual process elements

P1: Potential analysis
P2: Project management
P3: Product and production process development planning
P4: Implementation of product and production process development
P5: Supplier management
P6: Production process analysis
P7: Customer care, customer satisfaction, service

For explanations regarding the potential analysis, see chapter 5.

The use of process elements P2 to P4 focuses on the phase of the product

and production process development. Ideally, both process element P2 and
process element P3 are used after contract award to analyze the planning ac-
tivities.

12
Process element P4 can be used at a later time to analyze and evaluate the
implementation of the planning activities in accordance with process element
P3.

The breakdown of the process elements provides the opportunity to assess

the planning activities as well as the implementation/realization in accordance
with the requirements. From the contracting stage including SOP, the use of
process elements P2 to P4 serves to identify maturity level and process risks
early on.

Process elements P5 to P7 are ideally used at the time of the milestone SOP.
This corresponds to maturity level ML 6 from VDA MLA. As part of series pro-
duction, process elements P5 to P7 can be used to regularly monitor the se-
ries production processes and the processes after discontinuation of the se-
ries, or to support an event-based reactive process analysis.

In principle, each organization has the right to adapt the use of the process
elements so as to meet their needs during product and production process

development as well as production.

13
2.3 Differentiation between a potential analysis and a
process audit

As can be seen from figure 2-1, a potential

potent ial 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.

2.4 Identification of process risks (risk analysis)

The effect of individual processes on the product is essential in the process

audit. Consequently, the assessment must be made from the perspective of

the relevant product risk. Potential process risks must therefore already be
identified during the preparation for the audit in order to assess them ade-
quately in the process audit itself.
A risk analysis can be carried out on the basis of the
t he 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.

Figure 2-2: The Turtle Model

14
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,
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 –
see questionnaire sub-element P6.4)?

 How effectively is the process

process carried out (effectiveness, performance
indicators, efficiency – see process sub-element P6.5)?
As a second step, the potential
potent ial risks in relation to the content of the Turtle el-
ements are identified. The auditor as well as the audit team should make use
of their process know-how to identify potential product and process risks that
could affect product quality. These risks must then be analyzed and
evaluated in the audit to ensures a reasonable degree of risk minimization.
Based on the applied Turtle Model, it is possible to set priorities in a targeted
manner.

Figure 2-3: Schematic diagram of interlinked processes

The interfaces of the process steps have a significant influence on possible

risks and therefore require a more in-depth analysis.

15
3 Requirements for process auditors

3.1 Auditor qualification

Auditor qualification is of vital importance when it comes to achieving the au-

dit objectives. The quality and comparability of audit results are greatly influ-
enced by the qualification of the auditors. In addition to the qualification crite-
ria of each organization, the following minimum requirements, the require-
ments according to ISO 19011 as well as customer-specific and further exter-
nal requirements should be taken into account. The organization determines
and documents the procedure for auditor evaluation including the approval,
maintenance and improvement of auditor qualifications (e.g. observation dur-
ing audits/approval and witness audits).

3.1.1 Internal process auditors

Specialized knowledge


Good knowledge
knowledge of quality tools and m
methods
ethods (e.g. VDA MLA,
MLA, DoE,
FMEA, FTA, PPA, SPC, SWOT, 8D Method)

 Knowledge of the relevant customer-specific requirements

 Knowledge of the rel

relevant
evant m
management
anagement system req
requirements
uirements (e.g.
IATF 16949, DIN EN ISO 9001, VDA 6.1)

 Specific knowledge regarding

regarding the product and the process

Evidence of specialized training


Successful participation in a VDA 6.3 training course (passing a
test/obtaining a certificate of qualification)

 Knowledge of required quality tools and methods in the technology to

be audited

Professional experience

A minimum of 3 years’ professional experience (after 2 years’ professional

experience, in-house apprenticeship periods may be considered additionally),
preferably in manufacturing companies within the automotive industry, includ-
ing at least 1 year of experience in quality management.

16
3.1.2 Supplier auditors

Specialized knowledge

 Excellent knowledge
knowledge of quality tool
tools
s and methods (e.g.
(e.g. SPC, VDA
Volume 5/MSA, FMEA, VDA MLA/APQP, VDA Volume 2/PPAP, 8D
Method)

 If required, knowledge regarding software development processes

and methods

 Auditor qualifications (negotiation, conflict management, audit proce-

dure)

 Knowledge of the relevant customer-specific requirements

 Knowledge of the rel

relevant
evant m
management
anagement system req
requirements
uirements (e.g.
IATF 16949, DIN EN ISO 9001, VDA 6.1)

 Specific knowledge regarding

regarding the product and the process

Evidence of specialized training

 Qualification as an auditor on the basis of DIN EN ISO 19011 (e.g.

VDA Auditor qualification, 1st/2nd party auditor for DIN EN ISO 9001,
IATF 16949, or VDA 6.1)

 Knowledge of required quality tools and methods in the technology to

be audited

 Successful participation
participation in VDA 6.3 training (successfully passing a
written and an oral
or al exam)
 Evidence of ability to apply the theoretical knowledge in practice (e.g.
observation during audits/approval and witness audits)

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.

17
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. S

SPC,
PC, VDA
Volume 5/MSA, FMEA, VDA MLA/APQP, VDA Volume 2/PPAP, 8D
Method)

 If required, knowledge regarding software development processes

and methods

 Auditor qualifications (negotiation, conflict management, audit proce-

dure)

 Knowledge of the relevant customer-specific requirements

 Knowledge of the relevant management system requirements (e.g.

IATF 16949, DIN EN ISO 9001, VDA 6.1)

 Specific knowledge regarding the product and the process

Evidence of specialized training

 Qualification as an auditor on the basis of DIN EN ISO 19011
19011 (e.g.
VDA Auditor qualification, 1st/2nd party auditor for DIN EN ISO 9001,
IATF 16949, or VDA 6.1)

 Knowledge of required quality tools and methods in the technology to

be audited
 Successfully passing an exam and obtaining a certificate within the
scope of a VDA 6.3 training course

 Evidence of ability to apply the theoretical knowledge in practice (e.g.

observation during audits/approval and witness audits)

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.

18
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

 Coordination with internal and external experts

 Drawing conclusions from previous audits

In order to systematically capture and expand this “expert knowledge” and to

make it available to the auditors, it is recommendable to build up a knowledge

database. The sources

that have occurred of suchlessons
or internal knowledge can It
learned. formust
example be typical
be ensured thaterrors
infor-
mation (from the customer, from the supplier, or from within the organization)
remains confidential.

In addition, it should be noted that the resulting questions do not lead to addi-
tional requirements that go beyond the contractually agreed requirements.
Knowledge databases can for example be made available in the form of Wikis
or process-related lists.

3.3 Code of conduct for auditors

 Process auditors must uuse

se their professional s
skills
kills and judgment,
judgment,
while respecting the law and upholding the principles of honesty and
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 alw
always
ays behave in a way that does not endan-
ger the image and reputation of their own organization.
19
  Process auditors must no nott accept assignments that would cause
them a conflict of interests.

 Process auditors must no

nott 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

ac quired through their professional activities.

20
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
a company-specific procedure for internal and external audits.

4.1 Definition of a remote audit

“Remote audits” are defined in the ISO 19011 and can be carried out inter-

nally as well as externally.

4.2 Definition of a hybrid audit

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
conducting remote audits (process elements P2-P7)” must be taken into ac-
count.

4.3 Instructions for use

Generally, remote audits cannot constitute a full process audit (P2-P7) in ac-
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.

21
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.

4.4 Classification of the audit methods based on existing

risk factors / influencing factors

An audit may not lead to danger of life and limb (health) of the auditors/audi-
tees because of conditions on site, which are known in advance.

When selecting a suitable audit method (on-site audit, remote audit, hybrid
audit), the criticality of the product as well as the development / production
process, the previous performance and aspects related to the location are
particularly important. The following table provides an overview of the audit
methods, including a classification of the risk factors/influencing factors.

22
Table 4-1: Overview of audit methods, including a classification of the risk
factors/influencing factors

* Remote-Audits are possible as an alternative to an on-site audit

Remark: The most negative evaluation is the deciding factor when choosing the audit
method.

23
4.5 Suitability of individual process elements/questions for
conducting remote audits within the scope of the
potential analysis (P1)

Table 4-2: Overview

their suitability of theaudits
for remote audit questions for
f or the potential analysis (P1) and

Question conditioally Question conditionally

suitable suitable
VDA 6.3 suitable VDA 6.3 suitable

P2.1/P2.2*/P2.3
/ X P6.4.1* X
P2.4/P2.6*

P3.2*/P3.4* X P6.4.2 (X)

P4.1* X P6.4.3* X

P4.3/P4.4* X P6.4.4 X

P5.1 X P6.5.3* (X)

P5.5*/P5.6 X P6.5.4 X

P6.1.1/P6.1.5* X P6.6.2 X

P6.2.1 X P6.6.3/P6.6.4* (X)

P6.2.2 (X) P7.1 X

P6.2.3* X P7.2 X

P6.2.4* X P7.3* X

P6.3.1 (X) P7.4* (X)

(x) = suitable/suitable to a limited degree, depending on product and process risks

24
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

f or process elements P2-P7 and
their suitability for remote audits

Questions conditionally Questions conditionally

suitable suitable
VDA 6.3 suitable VDA 6.3 suitable

P2 - P4 X P6.4.1* X

P5.1/P5.2/
X P6.4.2 (X)
P5.3/P5.4*

P5.5* X P6.4.3* X

P5.6 X P6.4.4 X

P5.7 X P6.4.5 X

P6.1.1* X P6.5.1 X

P6.1.2 X P6.5.2 (X)

P6.1.3 X P6.5.3* (X)

P6.1.4 X P6.5.4 X

P6.1.5* (X) P6.6.1 X

P6.2.1 X P6.6.2 X

P6.2.2 (X) P6.6.3 (X)

P6.2.3* (X) P6.6.4* (X)

P6.2.4* X P7.1 X

P6.2.5 X P7.2 X

P6.3.1 (X) P7.3* X

P6.3.2 (X) P7.4* (X)

P6.3.3 (X) P7.5 X

(x) = suitable/suitable to a limited degree, depending on product and process risks

25
5 Potential analysis (P1)

5.1 Definition of a potential analysis

A potential analysis
anal ysis is used tto
o evaluate potential
potenti al new suppliers. For existing

suppliers, the potential analysis can be used in case of new locations, an in-
troduction of new technologies or new products.

The supplier’s potential to meet the requirements regarding the requested

products and corresponding processes is assessed.

The analysis takes into account the supplier’s experience and skills regarding
the development and production of the scope of products requested, as well
as their ability to fulfill customer-specific requirements for product and pro-
cess implementation.

The assessment is based on existing processes for comparable products.

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
contract is awarded.

A potential analysis can also be carried out independently of a project in case

of supplier changes or relocations.

In the event of relocations (components in series production, completed prod-

uct development phase), the assessment is only based on the questions from
process elements P2 to P4 related to the process development and P2 for the
relocation project.

5.2 Prerequisites

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.
26
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.

Figure 5-1: Process of conducting a potential analysis

5.5 Evaluation of a potential analysis

A separate evaluation is required for the potential

potent ial 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.

27
The assessment result is based on the traffic light system (“red”, “yellow” or
“green”).

Assessment of individual questions

The requirement of the question is not met. R

Y
The requirement of the question is partially met.
The requirement of the question is met. G

If a question is marked “red” or “yellow”, the findings and the relevant evi-
dence must be documented.

The overall assessment result of the potential analysis is calculated from the
number of questions rated as red/yellow/green:

Evaluation based on questionnaire

Classification
Yellow Red

Barred supplier R more than 12 one or more

Conditionally approved
supplier
Y max. 12 none

Approved supplier G max. 6 none

A positive potential analysis result (“green”, “yellow”) does not necessarily

lead to a contract being awarded.

A negative potential analysis result (“red”) excludes a contract award.

28
Interpretation of results

Green = Fully approved supplier

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.

Yellow = conditionally approved supplier

With regard to the scope of products requested, a contract can only be
awarded under certain conditions. In some cases, the supplier needs support
from the customer in order to meet the requirements of the project. Under
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 w
with
ith limited complexity

 Restriction to only a part of the requested scope of supply

 The supplier is in
included
cluded in a supplier dev
development
elopment program

Note: Conditions must be specified between the relevant quality and procure-
ment departments.

Red = barred supplier

It is not possible to award a contract covering the project, component
or product group in question.

Note: In individual cases (e.g. if there is no alternative supplier), the manage-

ment board can make the decision to award a contract. In this case, qualifica-
tion measures must be initiated, and safeguarding measures must be initiated
and implemented.

29
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
within the scope of a process release.

30
6 Evaluating a process audit for material products

6.1 Evaluation of the individual questions

Each question is evaluated in terms of fulfillment of the respective require-

ments and the risk involved. For each question, 0, 4, 6, 8 or 10 points can be

awarded. The number of points awarded is based on proven fulfillment of the

requirements as well as the risk assessment regarding the product and the
process.

Points Assessment of compliance with the requirements

10 The requirements are fully met; conformity is ensured

8 The requirements are mainly++ met; minor non-conformity

6 The requirements are partially met; significant non-conformity

4 The requirements are inadequately met; major non-conformity

0 The requirements are not met

++
) The term “mainly” means that there are only individual cases in which fulfillment of the
requirements could not be proven, and there are no special risks.

31
The following table serves as a guideline for the appropriate allocation of
points when evaluating the questions:

Points

Perspective of the Perspective of the

Perspective of the
process/process product
customer
step
10 Technical require- No product defects, the
ments and specifica- product meets the tech- Requirements are com-
tions for the process nical standards pletely met
are fulfilled

8 Minor discrepancies in Some product defects

the process which do which do not influence
not affect compliance the function, use or fur- Customer requirement
with the customer ther process steps is only met to a limited
specifications or have degree
an effect on the follow-
ing process steps

6 The process does not Product non-conformi-

always meet the de- ties do not affect the
fined requirements. function; however, the Requirements are par-
This has an impact on failure has a negative tially met; complaints
the following process impact on the use of the are possible
steps product or on further
process steps

4 The process does not Product non-conformi-

meet the defined re- ties have an impact on
quirements. This has the function. The failure Requirements insuffi-
a significant impact on leads to usage re- ciently met; customer is
the customer or on the strictions and has a sig- dissatisfied
following process nificant impact on the
steps following process steps

Not acceptable from

0 The process is not Product non-conformi-
the customer’s point of
suitable for ensuring ties, no function, the use
view
compliance with the of the product is consid-
defined requirements erably limited, further
process steps are not
possible

32
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.

If corrective actions from previous audits are not implemented, this can also
be regarded as a case of non-conformity, e.g. in the “cause analysis”, “imple-
mentation of measures”, “meeting customer requirements” questions.

Questions associated with a special product and process risk (*-ques-

tion)
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).
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.

6.2 Detailed evaluation and downgrading rules

Evaluation of the process elements, the sub-elements of P6 and the individ-

ual process steps.

Process element

The compliance level EPn of a process element (P2, P3, …, P7) is calculated
as:

Total points awarded for the relevant questions

EPn [%] =
Total possible points for the relevant questions

33
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

the number of results per question.

Sub-elements of P6

In the process element P6, the following sub-elements are evaluated:

EU1 Process input

EU2 Work carried out

EU3 Personnel resources
resources
EU4 Material resources
EU5 Efficiency
EU6 Process output
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
a question.

Total points awarded for the relevant questions for the sub-
element of P6
EUn [%] =
Total possible points for the relevant questions
for this sub-element of P6

Individual process steps

The questions from P6 are used for the evaluation of the individual process
steps. All questions from P6 can be answered for each process step. The
compliance level En of each process step can be calculated as follows:

Total points awarded for the P6 questions for this process step
En [%] =
Total possible points for the P6 questions for this process step

34
6.3 Overall level of compliance and downgrading rules

Process elements for material products

Project management (P2) EP2

Planning of product and process development (P3) EP3

Implementation of product and process development EP4

(P4)

Supplier management (P5) EP5

Production process analysis (P6) EP6

Customer care, customer satisfaction, service (P7) EP7

The overall compliance level EG for the process audit is calculated as follows:

Total points awarded for all evaluated questions from

EP2, EP3, EP4 ,EP5 ,EP6 and EP7
EG [%] =
Total possible points for these questions

For process elements P3 and P4, product development (EP3 product) and
process development (EP3 process) can be evaluated separately. To calculate
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
rules are applied to the entire process element P3 and/or P4 (joint evaluation
of product and process development).

35
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) [%] =
Total possible points for these questions

Example P4
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:

Total points awarded for all evaluated questions from P4 (EP4)

EG(P4) [%] = Total possible points for these questions

The designations EG(P5P6P7) and EG(P4) are used to easily identify the process
elements evaluated.

Overall level of compliance

The overall result is rounded to the nearest percentage point.

Classifica- Level G G(Pn)

tion [%] of compliance E or E Description
tion of the classifica-

A EG or EG(Pn) ≥ 90 able to meet quality require-

ments

B 80 ≤ EG or EG(Pn) < 90 able to meet quality require-

ments to some extent

C EG or EG(Pn) < 80 not able to meet quality re-

quirements

36
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.

Reasons for downgrading from A to B even though the level of compli-

ance is EG or EG(Pn) ≥ 90%

 At least one process element (P2

(P2 to P7) or process step (E1 to En) is
evaluated as having a level of compliance EP or En < 80%


A level of compliance EU1 to EU6 in one of the sub-elements of P6 is <
80%

 4 points are awarded for at least one *-question

 0 points are awarded for at least one question in the process audit

Reasons for downgrading to C even tthough

hough the level of compliance is
EG or EG(Pn) ≥ 80%

 At least one process element (P2

(P2 to P7) or process step (E1 bis En) is
evaluated as having a level of compliance EP oder En < 70%.

 0 points are awarded for at least one *-question

When applying the downgrading rules (process element, sub-element or pro-

cess steps), the individually calculated results EPn, EUn and En are rounded to
the nearest percentage point.

6.4 Evaluation of product groups

If required, the overall assessment of quality capability can be broken down

into product groups on the basis of individual process steps. Car manufactur-
ers mainly use this procedure to classify the suppliers’ quality capability. The
evaluation of the suppliers’ quality capability is thus restricted to product
groups. This forms part of the preconditions for future contract awards.

37
 Product group Possible process steps

Pressed and Stamping, Galvanic plating Painting

stamped parts drawing,
forming

Plastic injection Plastic molding Painting

moldings

Control devices Fitting compo- Soldering Assem- Functional check

nents bling

Note: To evaluate process steps, additional process requirements should be gener-

ated from the
t he organization’s own knowledge databases.

In the evaluation matrix, the relevant process steps are allocated to the prod-
uct group being evaluated.

The overall level of compliance for each product group EG(PGn) is calculated as
follows:

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++)
G(PGn) =
Total possible points for the questions for the evaluated
process elements (++)

++
for explanations of “points awarded” and “possible points” see section: 6.2: Exception.

When evaluating product groups, the downgrading rules are applied specifi-
cally to the product group concerned.

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.

Structure of the questionnaire

The questions for the process elements are structured as follows:

 Questions

 Minimum requirements relevant for assessment

 Examples for implementation

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.

The evaluation is carried out based on the questions in the “Minimum require-
ments relevant for assessment” list.

For the auditor, the audit consists of two mutually independent activities (see
figure 6.1):

1. The auditor asks the auditee open questions to a

assess
ssess compliance
with the requirements. The risks identified in the preparations for and
during the audit are taken into account.

2. Based on the audit findings, the auditor uses closed questi

questions
ons to as-
sess compliance with the requirements.

39
Figure 6-1: Audit pyramid

Process elements P3 and P4 can be audited either together or separately

when evaluating the product planning/implementation and process plan-
ning/process implementation. This depends on the audited organization.

If process element P6 (“series production”) requires a breakdown into pro-

cess steps, each step must be specified and evaluated separately.

In addition to the VDA 6.3 questions listed in this volume, it is recommended

that a knowledge database be created to store information about the risks as-
sociated with individual products and processes. The experience stored in the
knowledge databases can be used in addition to the requirements relevant for
the evaluation.

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,

d iscretion, 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
• Insufficient preparation of the audit on the part of the organization
• Providing evidently false statements

The reason for stopping the audit must be stated. Audit findings obtained up
to the point the audit was interrupted must be documented.

The organization conducting the audit decides whether a new audit should be

carried out.
6.7 Repeat audit

It must be specified in which cases a repeat audit is necessary. Reasons for

conducting a repeat audit can include, for example:

• A specified level of compliance is not reached

• Critical process that is associated with risks
• The requirements according to one or more *-questions are not met
(0 points)
• Potential analysis results in “red light”

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
rectify the shortcomings.

The scope of the repeat audit must be the same as for the previous audit. Re-
ducing the scope of the audit to a mere test of the effectiveness of the imple-
mented measures is not permissible.

41
7 Questionnaire

7.1 Overview of questionnaire

Potential analysis**

P2 Project management

2.1 Has a project management strategy (including a project X

organization) been established?

2.2* Are all resources required for project implementation

implementation X
planned and available, and are changes reported?

2.3 Is there a project plan that has been agreed upon with the
X
customer?

2.4 Are the quality-related project activities

activities being imple-
X
mented and monitored for compliance?

2.5 Are
and the procurement
monitored activities of
for compliance? of the project implemented

2.6* Is change management within the project ensured by the

X
project organization?

P3 Planning product and process development

3.1 Are the specific product and process

process requirements availa-
X
ble?

3.2* Has the feasibility been comprehensively evaluated ac-

cording to the identified product

pr oduct and process require- X
ments?

3.3 Are the activities for product and process

process development
planned in detail?

3.4* Have the procurement activities been planned, and are

X
they monitored for compliance?

3.5 Have the necessary resources been taken into account for
product and process development planning?

3.6 Have the activities related to customer care/customer sat-

isfaction/customer service and field failure analysis been
planned?

42
 Potential analysis**

P4 Implementation of product and process development

4.1* Are the activities from the product and process

process develop-
X
ment plans implemented?

4.2 Are personnel resources available and are the personn

personnel
el
qualified to ensure the start of series production?

4.3 Are the material resources available

available and suitable to en-
X
sure the start of series production?

4.4* Are the required approvals and

and releases for product and
X
process development available?

4.5 Have the planned procurement activities been imple-

mented?

4.6 Have the manufacturing and inspection specifications

been derived from product and process development and

are they implemented?

4.7 Is a performance test carried out under series conditions

for the series release?
r elease?

4.8 Have the processes for ensuring customer care/customer

satisfaction/customer service as well as field failure analy-
sis been established?
establi shed?

4.9 Is there a controlled method for the project handover from

development to series production?

P5 Supplier management

5.1 Are only approved suppliers

suppliers used who are able to meet
X
the quality requirements?

5.2 Are the customer requirements taken

taken into account in the
supply chain?

5.3 Have target agreements for supplier performance been

agreed upon and implemented?

5.4* Are the necessary releases available

available for purchased prod-
ucts and services?

43
 Potential analysis**

5.5* Is it ensured that the purchased products and services are

X
of the agreed-upon quality?

5.6 Are incoming goods delivered

delivered and stored appropriately? X

5.7 Are personnel qualified for their respective tasks and are
responsibilities defined?

P6 Production process analysis

6.1 What goes into the process?

Process input

6.1.1* Has the project been handed over from

fr om development to
X
series production and is a reliable start guaranteed?

6.1.2 Are the necessary quantities/production

quantities/production batch sizes of
of pri-
mary materials available at the agreed upon time and at
the correct storage location/work-station?

6.1.3 Are primary materials stored appropriately and

and are the
means of transport/packaging facilities suitable for the
special characteristics of the incoming materials?

6.1.4 Are the necessary identifications/records/releases

identifications/records/releases availa-
ble and allocated appropriately to the primary materials?

6.1.5* Are changes made to the product

product or process during series
X
production tracked and documented?

6.2 Are all production processes controlled?

Process management

6.2.1 Are the requirements specified in the production

production control
X
plan complete and are they fulfilled
fulfil led effectively?

6.2.2 Does a repeat release of production processes take

X
place?

6.2.3* Are special characteristics managed

managed in production? X

6.2.4* Are non-released and/or defective

defective parts managed? X

44
 Potential analysis**

6.2.5 Is the flow of materials and parts secured against mix-

ing/wrong items?

6.3 What functions support the process?

Personnel resources

6.3.1 Are the employees able to fulfill their given

given tasks? X

6.3.2 Do the employees know their responsibilities and authori-

zations regarding the monitoring of product and process X
quality?

6.3.3 Are the necessary personnel

personnel resources available?

6.4 What equipment is used to implement the process?

Material resources

6.4.1* Is the manufacturing equipment suitable to meet the cus-

X
tomer’s product-specific requirements?

6.4.2 Is the maintenance of the manufacturing equipment and

X
tools controlled?

6.4.3* Can the fulfillment of quality requirements be effectively

monitored with the measurement and inspection equip- X
ment in use?

6.4.4 Do the work and inspection stations fulfill the require-

X
ments?

6.4.5 Are tools, equipment and inspection

inspection equipment stored
properly?

6.5 How effectively is the process being carried out?

Effectiveness and efficiency

6.5.1 Have targets been set for the manufacturing process?

6.5.2 Is quality and process data collected in a way that allows

for analysis?

6.5.3* In case of non-compliance with product and process re-

quirements, are the causes analyzed and the corrective X
actions checked for effectiveness?
6.5.4 Are processes and products
products audited regularly? X

45
 Potential analysis**

6.6 What should the process accomplish?

Process result (output)

6.6.1 Do the quantities/production batch sizes meet the needs

and are they systematically directed to the next process

step?
6.6.2 Are products/components
products/components stored in an appropriate man-
ner and are the means of transport/packaging facilities
X
suitable for the special characteristics of the prod-
ucts/components?

6.6.3 Are the necessary records/releases

records/releases retained? X

6.6.4* Are customer requirements met upon

upon delivery of the final
X
product?

P7 Customer care/customer satisfaction/service

7.1 Are all requirements related to the QM system,

system, the prod-
X
uct and the process fulfilled?

7.2 Is customer service guaranteed? X

7.3* Is the supply of parts

p arts ensured? X

7.4* If quality requirements are not met or if there are com-

plaints, are failure analyses carried out and are corrective X
actions implemented effectively?

7.5 Are personnel qualified for their respective tasks and are
responsibilities defined?

Explanatory Highlighted marking indicates: *-questions

notes:

** Questions from the questionnaire that must be audited at a mini-

mum within the framework of the potential analysis (P1)

46
7.2 Project management (P2)

Process element P2: Project management

P2.1 Has a project management strategy (including a project organization)

been established?

Minimum requirements relevant for assessment Examples for implementation

There is a project management process.  The roles, tasks, compe-

An interdisciplinary project organization
organization is specified. tences and responsibilities of
the project manager/technical
The responsibilities and authorizations of the pro- experts have been defined
ject leader and team members are defined.  Project interfaces in multi-site
The customer and the supplier have been informed projects
who the contact persons are.  Organizational chart for the
project
The project organization and the associated escala-
tion management meet the customer requirements.  Composi
Composition
tion of the project
team
Escalation criteria (including escalation in supplier  Evidence of qualifications
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 ca
case
se of aan
n agile approach:
ment method or collaboration model (agile or not Definition of the escalation
agile). mechanism (e.g. the Scrum
Master escalates to the Prod-
Experiences (especially lessons learned) from on-
uct Owner)
going or previous projects with a comparable scope
of products are taken into account.  Contact persons/decision-
makers in the escalation pro-
Project risks have been identified, assessed, and cess have been defined
have been mitigated by means of appropriate
measures.

Records of milest
milestone
one assess-
ments, including measures

47
P2.2* Are all resources required for project implementation planned and avail-
able, and are changes reported?

Minimum requirements relevant for assessment Examples for implementation

The resource planning takes the customer require-

 Evidence of resource plan-
ments into account and is based on the project
ning (taking other projects
agreement. into account)
Resource planning for project team members has  Resource planning for
been established and implemented. The staff work- equipment (e.g. develop-
load is taken into account. ment test stand, inspection
A review and (where necessary)
necessary) an adjustment of and laboratory facilities)
the resource planning is carried out when changes  Resour
Resourcece planning by the
occur (deadlines, scope of development performance Scrum Master
etc.). The critical path is given special consideration  Resource planning for inte-
within the resource planning. gration and tests

The necessary project budget for personnel and

equipment is planned and released.
Changes to the project organization (interface with
customer) are reported.
The resources for software-specific activities have
been planned.

48
P2.3 Has project management been implemented and is there a project plan
that has been agreed upon with the customer?

Minimum requirements relevant for assessment Examples for implementation

The project plan meets

m eets the specific customer re-  Project plan with milestones
quirements.  Specific customer require-
ments regarding technologies
t echnologies
All internal and customer defined milestones are xand/or product groups
fully incorporated in the project plan.
 Customer project plan
A review is carried out at the milestones defined
defined in
 Customer deadlines
the project plan to check that all planned activities
 Customer milestones
are carried out and that the required maturity level
 Targets set by the customer
is reached.
(measurements within the in-
If a statutory authorization procedure for a product dividual milestones)
is specifically required, the duration of this proce-  Milestone assessments (re-
dure is included in the project plan. views)
In-house communication is ensured when changes  QM plan (e.g
(e.g.. from VDA MLA
are made to the project plan. Changes to the pro- or APQP)
ject plan which affect the customer
customer are coordinated 
Country-specific certification
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 tthe
he escala-
 Legal and regulatory approval
tion process (risk management).
processes relating to critical
The critical path is generated from the project plan systems (environmental re-
and takes account of the associated delivery items. quirements, among other
Quality-related project activities as well as procure- things)
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-
project plan. stones
 Software project plan
The plans must take prototypes and pre-launch
 Software milestones
parts into account.
 Basic Rollou
Rolloutt Plan
The scope of software required at the respective (BROP)
times has been planned.  Feature Rollout Plan
(FROP)
 Planning of the ASPICE as-
sessment, including the defi-
nition of levels and the scope
in accordance with the
agreed customer require-

ments

49
P2.4 Have the quality-related project activities been planned, and are they
monitored for compliance?

Minimum requirements relevant for assessment Examples for implementation

The quality-related project activities meet the spe-  Project plan

cific customer requirements.  Customer milestones

Both product and process assurance measures are 

Customer requirements with
part of the quality-related activities. regard to quality plans
 Quality plan (audits, reviews
Verification and validation of the product and pro-
and VDA MLA)
cess requirements are included in the planning.
 Customer specifications
The planning also addresses critical components  Specific software milestones
and supply items (internal and external suppliers).  Reviews, e.g. of code and
The planning is regularly monitored for compliance models
and for target achievement.  Test case creation and
validation (verification?)
The quality-related activities relevant to software
 KPIs relevant to software
have been taken into account.
(metrics, test coverage, level
of test automation, rate of er-
ror reduction etc.)
 Software-specific assessment
planning and assessment lev-
els
 SW-Q release
 Risk assessments (special
characteristics, cyber secu-
rity)

P2.5 Are the procurement activities of the project included in the project
planning?

Minimum requirements relevant for assessment Examples for implementation

The supplier selection process and the target dates

da tes  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.

P2.6* Is change management within the project ensured by the project

organization?

Minimum requirements relevant for assessment Examples for implementation

Change management within the project meets the  Change management

customer’s specific requirements.  Process description
Changes (initiated by the supplier, internally or by  Schedules
the customer) must be evaluated. If necessary
necessary,, the  Change forms
project plan must be adapted. This evaluation must  Change history for tthe
he prod-
include the risk assessment for product quality as uct and the process
well as the deadlines.  Evaluation of changes
 Approvals of changes
Suppliers are actively involved in change manage-
 Software: Change request,
ment.
It must be ensured that specified design freezes are change management
 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.
All changes must be documented.
documented.
The persons responsible for change management
are defined for the customer, internally and to sup-
pliers.
 51

7.3 Product and process

development planning (P3)

Process element P3: Product and process development planning

P3.1 Have the product/process-sp

product/process-specific
ecific requirements been specified?

Minimum requirements relevant for assessment Examples for implementation

The functional and non-functional requirements, in- Product/process development

cluding the customer’s requirements as well as stat-
 Requirements regarding the
utory and regulatory requirements that apply to the
interfaces between hardware
product (and software) to be developed as well as
and software (products with
to the production process have to be determin
determined.
ed.
integrated/embedded soft-
The organization must identify and take into ac- ware)
count the product and process requirements known  Inquiry and contract docu-
from previous experience. ments, including requirement
Special characteristics must be identified on the ba- specifications
 Traceability concept
sis of the organization’s own requirements, cus-  Ordering and inspection re-
tomer requirements, statutory and regulatory re-
quirements, manufacturing technology and charac- quirements
teristics that arise from the purpose/use of the prod-  Catalog of characteristics/ref-
uct. erence samples
 Product/process characteris-
Customer requirements regarding the selection of
tics, including characteristics
suppliers or primary materials must be docu-
regarding functional safety
mented.
 Purchasing conditions
In case of suppliers appointed by the customer (di-  Logistics requirements (pack-
rected suppliers), interface agreements are availa- aging, JIT, JIS, on consign-
ble. ment)
The customer’s requirements regarding the docu- 
Quality agreements, including
mentation and release of Free and Open Source QM-specific requirements
Software (FOSS) must be taken into account.  Schedules
 Portals/information platforms
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

P3.1 Have the product/process-sp

product/process-specific
ecific requirements been specified?

Minimum requirements relevant for assessment Examples for implementation

 Software specifications

Process development
 Requirements regarding fa-
cilities, tools and inspection
equipment as well as work-
place and test station layout
 Requirements regarding
handling, packaging, storage
and identification

 Requirements for identifica-

tion, configuration and ensur-
ing correct installation of the
software
 53

P3.2* Has the feasibility been comprehensiv

comprehensively
ely evaluated according to the
product and process requirements?

Minimum requirements relevant for assess-

Examples for implementation
ment

An interdisciplinary procedure for evaluating

evaluating Product/process development

feasibility (including potential production loca- 

Customer requirements and
tions) must be used. standards
All determined product/process-specific
product/process-specific require-  Schedules, time frame
ments (technology, function, quality, logistics,
software, etc.) must be checked for feasibility.  Regulations, standards, legisla-
tion, environmental impact
Material and personnel resources must be con-
sidered in the feasibility study.  Requirements from product liabil-
ity
The results of the feasibility study must be
available before tendering.  Traceability concept

The feasibility of critical purchased parts must  Buildings, premises

be ensured. 

CAM, CAQ
If customer requirements cannot be fulfilled, the  Product/process innovation
customer must be notified or non-conformities
approved by the customer prior to the contract  Interdisciplinary feasibility analy-
being awarded. sis (for example, sales, develop-
ment, purchasing, production
A flash concept is available for
for programming at planning, production, QM plan-
the plant and updates in the field (if required). ning, logistics)
Product development
 Laboratory/test equipment
 Parallel software development /

prototyping
Process development
 Capacity monitoring
 Availability of primary materials

 Manufacturing options, manufac-

turing locations

 Equipment, tools, production/in-

spection equipment, auxiliary
materials, laboratory facilities,
means of transport, containers,
storage
54

P3.2* Has the feasibility been comprehensiv

comprehensively
ely evaluated according to the
product and process requirements?

 Variant management, flash con-

cepts

P3.3 Are the activities for product and process development planned in
detail?

Minimum requirements relevant for assessment Examples for implementation

When planning the product and process develop- Product/process development

ment, the level of detail depends on the component,
 Overall project plan including
software and complexity of the process.
all deadlines
In the development phase, suitable risk mitigation
m itigation
 Customer requirements
measures must be used for product and process
development assurance, so that the product meets  Customer schedule

the required
series operational
production conditions
(function, when
reliability, goes into
safety).

Lead times
 Risk mitigation measures (in-
In case of product and process innovations, there is cluding backup strategy and
a fallback concept. cybersecurity)
Risk analyses are part of the planning.
 (QFD, FMEA, HARA etc.)
The inspection planning concept includes the re-
 Prototype/pre-launch plan-
quirements regarding series production, product au-
ning
dits and requalification.
 Regular status checks on the
The schedules contain all information regarding
progress of the development
product and process development (including dead-
de ad-
(reviews)
lines and duration, milestones according to the
overall project plan, performance testing, PPA date,  Project plans for investment
software standards…). items (facilities and equip-
ment)
The methods and evidence for development re-
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
packaging
The software engineering process has been speci-
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?

 Deadlines for development

phase samples

 Requirement analysis


Architecture design
 Implementation

 Test

 Artifacts of agile project man-

agement (product backlog,
sprint backlog, increment,
definition of ready, definition
of done, sprint planning,
DevOps)
 Release planning
Process development
 Tool deadlines (parts from
production tools),

 Inspection planning, inspec-

tion equipment planning,
maintenance planning in-
cluding spare parts manage-
ment
56

P3.4* Have the procurement activities been planned, and are they monitored
for compliance?

Minimum requirements relevant for assessment Examples for implementation

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
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
The scope of the planning activities after contract
 VDA 6.3 audit planning
award is based on the risk classification of the pur-
chased products/services.
pr oducts/services.  Management (supplier devel-
opment, forwarding customer
There are clear rules for the communication of cus-
requirements) of the suppli-
tomer requirements along the supply chain.
ers, PPA procedures, failure
Customer requirements also include requirements analysis, quality, warranty,
arising from the drawing, the parts, software or
component specifications, the delivery quantity, the communication
 Interface agreement (ser-
deadlines, QM agreements and applicable regula-
vices according to DIA or in-
tions.
terface agreement)
Agreements regarding suppliers
suppliers appointed by the
 List of suppliers for the pro-
customer (directed suppliers) are defined on a pro-
ject, including service provid-
provid-
ject-specific basis.
ers (e.g. development, labor-
The activities in terms of purchasing plants, ma- atories, maintenance, soft-
chines, tools, measuring and inspection equipment ware)
as well as services have been determined and
planned (selection, contract award, verification and  Risk classification for the
approval). scope of supply of the pro-
ject and the activities derived
derived
The progress of the supplier activities (such as con- (VDA MLA)
tract awards, deadlines, customer and supplier
milestones) is monitored.  Third-party software

 Criteria for the release of

FOSS
 57

P3.5 Have the necessary resources been taken into account for product and
process development planning?

Minimum requirements relevant for assess-

Examples for implementation
ment

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
Resource planning is regularly adapted to  Availability of qualified person-
changes in the project and potential bottlenecks nel for the respective tasks
must be addressed.
 Budget, infrastructure, e.g.
When introducing new technologies and prod- buildings, inspection equipment
ucts, consistent employee training must be (hardware and software), labor-
planned, and it must be ensured that the neces- atory equipment, machines,
sary infrastructure is created. plants etc.
Means of transport for in-house
i n-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,
have been determined. 2-day production, stress test
 Provision and distribution of
software
 Tool chain planning (software
development tools)
Product development


Test/inspection/laboratory
ties (internal and external) facili
facili--

 Resources for planning and

conducting tests as well as fix-
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?

Minimum requirements relevant for assessment Examples for implementation

The customer requirements are taken into account Product/process development

in the concept for parts supply across the product
 Investment planning
life cycle, including spare parts supply. Product development
Contingency plans to continually ensure series sup-
ply must be included in the concept.  Interfaces to analysis centers
for customer complaints, in-
The analysis process for 0-km and fieldf ield complaints
cluding the relevant software
has been planned for the scope of delivery and the
supply chain. The customer requirements regarding  Access for diagnosis
field failure analysis are taken
ta ken into account.  Access control lists
Interfaces to the complaints process have been Process development
planned.
 Inspection planning for
An access control concept
concept for software has been standard and stress testing
established and is maintained.  Triggering criteria are de-
An analysis of all stakeholders
stakeholders has been carried
fined
out. Communication and escalation paths have
been specified.  NTF process

 Spare parts supply concepts

 Contingency plans
 59

7.4 Implementation of product and process development

(P4)

Process element P4: Implementation of product and process development

P4.1* Are the actions from the product and process development plans
implemented?

Minimum requirements relevant for assess- Examples for implementation

ment

Product and process development activities de- Product/process development

fined in the development planning are imple-
 Methods to minimize risk (e.g.
mented in such a way as to ensure that the oper-
FMEA, HARA, FTA)
ational conditions are met (function, reliability,
safety).  Design of experiments (e.g.
DoE, Shainin, Taguchi…)
The risk analysis (e.g. FMEA, HARA) is con-
ducted on a multidisciplinary basis and is
i s contin-  Poka-Yoke principles
uously revised in accordance with the progress
of the project. Defined measures are imple- Product development
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
in the relevant documents (FMEA etc.), and
 Endurance tests
measures are implemented to ensure conformity.
 Environmental simulation test
(e.g. salt spray test)

 Automotive SPICE assess-

ments in accordance with the
planning

 Code, software release man-

agement

 Traceability, fallback concept

 Variant management

 Analysis of requirements, archi-

tecture design, implementation
and test in accordance with the
planning
Process development
 Control plan/inspection plan
60

P4.2 Are personnel resources available and are the personnel qualified to
ensure product and process implementation?

Minimum requirements relevant for assessment Examples for implementation

Product/process development

 Customer requirements
A staff schedule must be available.
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
ate evidence must be available.
 Evidence of training
It must be ensured that needs assessments is car-  Knowledge of methods
ried out regularly during product and process devel-
opment with regard to potentially emerging bottle-  Knowledge of foreign lan-
guages
necks and additional requirements.
 Software development: Qual-
Qualified personnel are available during all phases ified software testers, inte-
of product and process implementation, and the re- gration managers, etc.
quirements regarding the series production person-
 Agile development due to
nel have been derived.
qualified roles (DevOps Man-
Processes that have been outsourced must be ager, Release Train Man-
taken into account. ager, etc.)
 61

P4.3 Are the material/immaterial resources available and are they suitable to
ensure product and process implementation?

Minimum requirements relevant for assess-

Examples for implementation
ment

A process to determine resources

resources has been imple- Product/process development

mented. 
Customer requirements
The provision of resources refers to the availability
 Technical interface to the cus-
of buildings, measuring and inspection equipment,
tomer and suppliers
laboratory equipment, machinery, plants, IT sys-
tems and infrastructure as well as their utilization.  ERP systems

Processes that have been outsourced must be  Supporting processes, e.g.

taken into account. from logistics and IT

Regular needs assessment must be carried out Product development

during product and process development with re-  Resources for verification and
gard to potentially emerging bottlenecks and addi- validation
tional requirements.
Material/immaterial resources are available for all

Test setups, e.g. Hardware in
the Loop (HIL), test boards,
phases of product and process implementation,
evaluation boards
and the requirements for series production have
been derived.  Developm
Developmentent tools, provision
of the tool chain for software
Equipment for in-house transport, such as packag-
development
ing and special load carriers, has been defined
and is available in sufficient quantities. Process development

 Facility planning
 Facility layout
 Release of plants and ma-
chines, line clearance
 Quantities and throughput
times

 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?

Minimum requirements relevant for assessment Examples for implementation

The releases and proofs of capability are available Product/process development

for all items, assemblies, software versions and
 PPA results, in particular
purchased products/services in accordance with confirmation of conformity
development schedules.
with statutory and regulatory
The capability of the measuring and inspection requirements
equipment has been proven.
 PPA results for purchased
The material data has been confirmed and re- products and services
leased.
 Development releases from
The measures from the risk analyses (e.g. FMEA, customers
HARA) have been included in the product and pro-
Process development
cess implementation, and their effectiveness has
been confirmed.  Process paramet
parameters
ers and
their tolerances
In case ofthe
software, products with integrated
software-related (embedded)
aspects according to  Confirmed logistics concept
VDA Volume 2 have to be taken into account. (e.g. suitability of packaging
through sample shipping)
The production process and product
pr oduct approval
(PPA) must be available on the agreed date. The  Proofs of capability
tolerances of process parameters forf or the production
 Capacity studies
of special characteristics have to be verified.
 Plant and tool releases
Software

 Recommendations for use

(release notes) for each re-

lease
 Release of third-party soft-
ware and FOSS in accord-
ance with customer require-
ments

 Provision of test results and

test evaluations
 63

P4.5 Have the planned procurement activities been implemented?

Minimum requirements relevant for assessment Examples for implementation

The planned procurement activities have been im-  PPA release

plemented. This includes risk assessments, the
 FMEA, HARA
project plan, the maturity level, releases and ob-
serving deadlines. 
VDA 6.3 audit, potential ana-
lysis etc.
The planning activities according to the risk classifi-
cation have been implemented; measures have  Releases, evidence and per-
been derived and their implementation is moni-
mon i- formance tests in accord-
tored. ance with the coordinated
PPA procedure
The required proofs of capability and releases (pro-
cess and product release) for the
t he purchased prod-  NTF process, triggering crite-
ucts and services are available in accordance with ria for stress tests have been
the project schedule. The material data has been defined
confirmed and released.
 Spare parts supply concepts
The relevant project-specific customer require-


ments have been taken into account. Contingency plans

 Interface agreement (ser-
The processes for ensuring customer care/cus-
vices according to DIA or in-
tomer satisfaction/customer service as well as field
f ield
terface agreement)
failure analysis have been established.
 Sub-supplier management
by auditee for off-the-shelf
components, engineering as-
signments (no personnel
leasing)

 Reference to the ASPICE

Acquisition Process Group,
ACQ2, ACQ.3, ACQ.4
64

P4.6 Are the manufacturing and inspection specifications derived from prod-
uct and process development and are they implemented?

Minimum requirements relevant for assessment Examples for implementation

The manufacturing and inspection specifications Product/process development

contain all inspection characteristics from product
 Risk analyses
and process development (including special char-
acteristics). These must take into account all the Product development
components, assemblies, sub-assemblies, and ma-  Product audit plan
terials, including the processes for manufacturing
the products.  Requalification planning

The results of the risk analysis are considered (e.g. Process development
FMEA, HARA).  Inspection instruction
A production control plan is available.
available.  Work instruction
It must be available throughout the prototype phase  Reaction plans
(if required by the customer), the pre-launch phase
 Production release (first and
and the series production phase.
The scope and the elements of product audits and last piece, repeat release)
 In-line inspections
requalification tests have been defined.
Software
Maintenance specifications are available.
All test cases are described in accordance
accordance with the  Requirements for ensuring
test levels and the customer requirements (e.g. V- correct installation of the
Model). software

The software functions required at the respective  Release criteria in the pro-
times are released. duction test
 65

P4.7 Is a performance test carried out under series conditions for the series
release?

Minimum requirements relevant for assessment Examples for implementation

A performance test must be carried out under

under se- Process development
ries conditions to confirm that the required quantity
 Series production conditions:
can be produced for the customer with the re- e.g. tools, plants, cycle time,
sources used, within the specified period of time
personnel, production and in-
and in accordance with the specifications.
spection specifications,
If the performance test fails to confirm this,
thi s, measuring and inspection
measures must be defined. equipment
The installation of the software in the compo
components
nents  Customer requirements
must be taken into account when determining the
 Performance test,
cycle times/throughput times.
Run@Rate
Note: Depending on the time of the audit, some
 Determination of minimum
parts of the relevant production test could still be at
quantities (production peak
the planning stage!
and agreed flexibility)
The question is not relevant for
f or product develop-
 Series production maturity of
ment!
equipment and facilities
(measurement report)

 Staff concept for series pro-

duction

 Packaging requirements
Software
 Flash times, including test,
ROM programming
66

P4.8 Have the processes for ensuring customer care/customer satisfac-

tion/customer service as well as the field
fiel d failure analysis been estab-
lished?

Minimum requirements relevant for assess-

Examples for implementation
ment

The customer requirements regarding the supply Product/process development

Product/process
of parts throughout the product life cycle are es-
 Inspection equipment for
tablished in the processes.
standard and stress tests
The planned processes for the
t he continuous se
series
ries
 Triggering criteria are defined
supply including safety margins for emergencies
are available.  Inspection plans for failure
analysis
The analysis process for 0-km and field com-
plaints is established for the scope of delivery.  NTF process
The customer requirements regarding field failure Process development
analysis are taken into account.
 Qualification matrix and evi-
The requirements for the analysis capability at dence of training
the site have been agreed with the customer.
 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
ble.  Spare parts supply concepts
New technologies and products are also taken  Contingency plans
into account in customer support.
The employees designated for these processes
are qualified. The infrastructure is available.
Processes for product monitoring in the
t he field have
been specified.
There must be processes for error analysis and
diagnosis (embedded software in control unit).
If agreed, processes for over-the-air (OTA) soft-
ware updates have been specified.
 67

P4.9* Is there a controlled method for the project handover from development
to series production?

Minimum requirements relevant for assess-

Examples for implementation
ment

There is a process for transferring work results Product/process

Product/process development

from the project to series production.  Customer requirements

The activities specified in the project plan have
 PPA records
been implemented. Deadlines have been set for
aspects that are still to be clarified, and responsi-  Handover protocols/checklists
ble persons have been appointed. with handover criteria, ac-
ceptance reports
Successful internal release and customer release
is a prerequisite for a series delivery release.  Parts history
Measures resulting from internal and external re-  Key production figures such as
leases are implemented on time. OEE, ppm, reject rate, etc.
Personnel are available in accordance with the
 Experiences from the ongoing
planning and are qualified.
project
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.
 Material resources (machines
For products with integrated (embedded) soft- and plants, buildings, access
ware, the results from development (including in- routes, inspection facilities,
termediate results and their documentation) are load carriers, packaging, etc.)
recorded.
 Change log, Release Note
The industrialization is ensured.
 Industrialization of software: in-
cludes flashing software onto
the control unit in series pro-
duction and coding
68

7.5 Supplier management (P5)

Process element P5: Supplier management

P5.1 Are only approved suppliers used who are able to meet the quality re-
quirements?

Minimum requirements relevant for assess- Examples for implementation

ment

In series production, it must

m ust be ensured that only  Defined criteria for the selection
approved suppliers are used. The relevant ap- of suppliers
proval criteria have been defined.
 QM agreements
When selecting suppliers and in order to assess
 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
carr ied out de-
measures being implemented in
pending on the risk classification of the compo-
order to mitigate risks
nent.
 Assessment of the suppliers’
Evaluations of the quality performance of existing 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)
(i nternal/external) have (ppm, delivery performance),
been identified, evaluated and mitigated using escalation level
suitable measures.
 Self-Assessment, audit results
In case of suppliers appointed by the customer of the suppliers
(directed suppliers), interface agreements are
 ASPICE assessment results
taken into consideration.
 VDA 6.3-Process Audit
 VDA 6.3-Potential Analysis
 69

P5.2 Are the customer requirements taken into account in the supply chain?

Minimum requirements relevant for assess- Examples for implementation

ment

The communication of customer requirements  Requirements from: drawings,

must be regulated and traceable. components, software or com-
Change management must also be taken into ponent specifications, mile-
account during series production. stone plans, QM agreements or
other valid standards
In case of suppliers appointed by the customer
(directed suppliers), interface agreements are  Special characteristics
taken into consideration.  Requalification requirements

 Forwarding of complaints, in-

cluding measures

 Statutory and regulatory re-

quirements

P5.3 Have targets for supplier performance been agreed upon, and is the
achievement of these targets regularly assessed?

Minimum requirements relevant for assess- Examples for implementation

ment

Target agreements regarding delivery perfor-  Measurable targets: Delivery

mance must be made with all direct suppliers and quantity, punctuality, failure
must be implemented. rate, PPM, special deliveries,
Supplier performance must be checked and evalu- rejects, lead times for com-
ated within defined periods and according to de- plaints
fined criteria.  Escalation criteria according
If the agreed targets are not met, measures must to QM agreements
be defined and their implementation including  Evidence of measures (devel-
deadlines must be monitored. opment programs) being im-
In case of suppliers appointed by the customer (di- plemented in case of suppliers
rected suppliers), interface agreements are taken that do not meet the required
into consideration. delivery performance
70

P5.4* Are the necessary releases available for purchased products and ser-
vices?

Minimum requirements relevant for assessment Examples for implementation

Prior to using new or changed products/proces

products/processes
ses  Report regarding the coordi-
in series production, a release must be available for nation of the PPA procedure
all purchased products and services as agreed  PPA reports
upon with the customer.
 Reference parts for the PPA
In case of suppliers appointed by the customer (di-
procedure
rected suppliers), interface agreements are taken
into consideration.  Boundary sample

 Product and process

changes in the supply chain

 Release agreement for small

series and individual needs

P5.5* Is it ensured that the purchased products and services are of the agreed-
upon quality?

Minimum requirements relevant for assessment Examples for implementation

To monitor the quality of purchased products and  Released inspection proce-

services, inspections are carried out, documented dure
and evaluated in accordance with the inspection
 Sample size (e.g. Skip Lot)
planning.
 Boundary sample
If the quality requirements are not met, a standard


complaints process is followed. PPM evaluations, 8D reports

Inspection and measuring equipment for purchased  Improvement programs
products and services must be sufficiently available
 Material certificates in ac-
and must be stored appropriately. Inspection sta-
cordance with DIN EN 10204
tions must be laid out appropriately (e.g. climate
control, lighting conditions, cleanliness, and protec-  Gauges/fixtures
tion against damage and contamination).  Drawings/specifications

 Ordering and packaging

specifications
 71

P5.6 Are incoming goods delivered and stored appropriately?

Minimum requirements relevant for assessment Examples for implementation

Primary materials and load carriers must be stored  Packaging
in accordance with their release status so that they
 Labeling (traceability/inspec-
cannot be damaged or mixed.
tion status/use status)
For materials that could be damaged by tempera-  Quarantine stores; quaran-
ture, humidity, vibration, etc. and affect the quality
tine areas
of the final product, the transport and storage con-
ditions must be defined and evidence shown.  Batch-related use

“Suspicious”/quarantined materials must be clearly

“Suspicious”/quarantined  Climatic conditions
labeled protected against unauthorized access.
 Protection against dam-
FIFO/FEFO (shelf-life requirements) and batch age/contamination/corrosion
traceability must be ensured when the materials
 Order and cleanliness
are further processed. This equally applies to resid-
ual quantities.  Precautions to prevent mix-
ing/mistakes
Material stock figures in the warehouse manage-
ment system match the quantities actually in stock.
The storage conditions fulfill the product require-
ments.
72

P5.7 Are personnel qualified for their respective tasks and are responsibilities
defined?

Minimum requirements relevant for assessment Examples for implementation

The responsibilities, tasks and authority the em-  Knowledge of specifications,
ployees have in their relevant work areas must be product characteristics, cus-

specified. tomer requirements and pro-

The employees are qualified in accordance with the duction processes
job profile.  Standards
Qualification requirements must be determined in  Statutory and regulatory re-
relation to the tasks, and qualifications must be quirements
planned and carried out accordingly.
 Packaging requirements
Knowledge of previous complaints (including cor-
 Quality procedures
rective actions) is available for purchased products
and services.  Job description / description
of tasks and function

 Qualification matrix
 Qualification of supplier audi-
tors
 73

7.6 Production process analysis (P6)

Process element P6: Production process analysis

P6.1 What goes into the process?

Process input

P6.1.1 Has the project been handed over from development to series
production and is a reliable start guaranteed?

Minimum requirements relevant for assessment Examples for implementation

The project handover to series production

pr oduction has been  Handover reports
documented according to the specified criteria.
 Defined measures and im-
The responsibilities for the entire
entir e handover process plementation schedule
are specified and acknowledged
acknowledged.. Unresolved is-
 Production release report
sues are followed up on, and the necessary
measures are implemented on schedule.  Releases for all plant compo-
nents and tools in 6.1.2
A complete
(PPA) production
including process andrequired
process
the documentation product must
release  PPA documents, including
take place before the first
f irst production shipment. customer approval and refer-
ence parts regarding the
Measures to secure the production start-up have
PPA procedure
been implemented on the basis of a risk analysis.
 Waivers
Tools, transport and series packaging, inspection
and measuring equipment are available in the nec-  Released software versions
essary quantities.
 Examples for securing the
Analysis options for failure analysis
analysis are available production start-up:
The product software corresponds to the latest re- Higher inspection frequency,
lease versions. additional inspections, Resi-
dent,
 Safe launch concept
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?

Minimum requirements relevant for assessment Examples for implementation

The production material must be of the agreed  Production material includes,

quality and must be provided in the correct quantity for example:
and the correct packaging, with the correct docu-
 Software, packaging, load
mentation, at the agreed time and at the agreed
carriers, parts and compo-
place. Parts/components must be available at de-
nents, raw material, series
fined storage areas/work-stations.
packaging for delivery to the
At the workplace, parts and primary materials are customer, operating, auxil-
provided as needed, taking into account the order iary and process materials
quantity/lot size in accordance with the logistics
 suitable means of transport
concept.
 Defined storage locations
The reuse of residual quantities, separated parts,
and stock levels
reworked parts, reused parts from product audits,
inspected items, etc. and their traceability must be 
KANBAN, Just in time/Just in
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

 Special requirements regard-

ing components and contain-
ers (e.g. ESD protection, hu-
midity, temperature, residue)
 75

P6.1.3 Are materials stored appropriately and are the means of

transport/packaging facilities suitable for the special characteristics of
the materials?

Minimum requirements relevant for assessment Examples for implementation

Packaging requirements must be consistently taken  Stock quantities

into account/fulfilled.  Storage conditions
During manufacture and in-house transport and
 released special and stand-
also when being transported to and from
f rom service
ard transport containers
providers, suitable transport units must be used to
protect the products from damage and contamina-  Protec
Protection
tion against damage
tion. to the material

Storage areas/work-stations/containers must be ap-  5S

propriate for the tidiness and cleanliness required
 Over-filling (storage area
areas
s
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
assembly line must allow for safe handling. age times, specified interim
storage times, FIFO/FEFO
Specified storage times and use-by dates for spe-
cial materials must be monitored by means of ap-
propriate methods
Operating and auxiliary materials for plants and ma-
chinery that have a direct effect on the prod-
uct/product quality must be monitored accordingly.
Materials, operating and auxiliary materials must be
protected against environmental and climatic influ-
ences.
76

P6.1.4 Are the necessary labels/records/releas

labels/records/releases
es available and allocated
appropriately to the materials?

Minimum requirements relevant for assessment Examples for implementation

Released materials must be clearly identifiable. The  Customer requirements re-

release identification on bundles/batches/load carri- garding labeling and tracea-
ers/parts must be defined. bility
It must be ensured that only released materi-  Labeling of released
als/parts are forwarded to production/the
p roduction/the next pro- parts/materials (stickers, la-
duction stage and used. bels, issue slips, VDA label,
Traceability from the sub-supplier to the customer DMC, etc.)
must be guaranteed according to a defined
def ined tracea-  Records of approvals
bility concept.
 Traceability system
Customer requirements as well as statutory and
 Documenta
Documentationtion of waivers
regulatory requirements regarding labeling are
(number, duration, type of
taken into account.
identification, etc.)

 Stock management systems

 77

P6.1.5* Are pr
product
oduct or process cha
changes
nges dur
during
ing series production tracked and
documented?

Minimum requirements relevant for assess- Examples for implementation

ment

Changes to the product and the

t he production pro-  Trigger matri
matrixx 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
quirements. A PPA must be carried out. The his- prior to changes
tory of change statuses must be fully
f ully traceable.
 Change history/parts history
The correct, released version of the material / soft- (also for software)
ware must be used.
 Design and process FMEA
After changes have been
been made, it must be  Operation management in
checked whether the risk analyses need to be up- case of changes
dated.  Pre-production
 Unique software identifier,
software integrity (build num-
ber, hash key)
78

Process element P6: Production process analysis

P6.2 Are all production processes controlled?

Process management

P6.2.1 Are the requirements in the

the production
production control plan complete and have
they been effectively implemented?

Minimum requirements relevant for assess- Examples for implementation

ment

The production and inspection documents are  Inspection characteristics, in-

complete and are based on the production
p roduction control spection equipment, inspec-
plan. tion methods, inspection fre-
The data relating to released machinery/tools/aids quencies, inspection cycles
must be noted in the production control plan and requalification
and/or the manufacturing and inspection docu-  Data regarding ma-
ments. chines/tools/aids (identification
numbers), process parame-
The documents must be accessible close to the
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
reworking)
Process parameters influencing product character-
istics/quality must be fully stated.  Inspection instruction

Tolerances must be stated for process parameters

and inspection characteristics.
The control limits in process control charts are de-
fined, identifiable and plausible.
Non-conformities and initiated measures
m easures regarding
process requirements and inspection characteris-
tics must be documented.
Conditions governing rework are specified, assess
as part of the risk analysis and secured within the
process (parts identification; repeat inspection
etc.).
 79

P6.2.2 Are production processes released?

Minimum requirements relevant for assessment Examples for implementation

A process-specific release
release inspection for first  Release of a batch, includ-
piece/last piece and repeat release was carried out ing repeat release
and documented.
 First piece /last piece and
A release is necessary for the product and the pro- repeat release
cess and must be carried out and documented by
 Tooling diagrams/reference
authorized employees using acceptance criteria.
parts/installation parts (e.g.
Non-conformities and initiated measures are docu-
defect identification)
mented.
At the time of release, the necessary reference and  Possible triggering criteria
boundary samples must be available. for a repeat release:

Criteria for triggering a repeat release must be de- ○ Production interruption

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-
tool changes, material/
spection parts, these products must be accessible
until the inspection parts are released. batch/product change)
○ Repair, tool change,
○ changed setting data

 Release of reworked parts

80

P6.2.3* Are special characteristics controlled in production?

Minimum requirements relevant for assessment Examples for implementation

Special product characteristics specified by the cus-  Drawings

tomer and the organization as well as defined pro-
 Labeling indicating the cus-
cess parameters are marked in the production con-
tomer-specific special char-
trol plan and systematically monitored. acteristics, e.g.: D/TLD,
D /TLD, DS,
Records of non-compliances and corrective actions DZ, R, S, F
are maintained. Non-compliances affecting the
 Process FMEA
characteristics of the product must be approved by
the customer.  Production control plan

Records regarding special characteristics are avail-  SPC evaluations

able. The duration and type of archiving of these
 Quality control charts
records are specified and meet the customer’s re-
quirements.  Proofs of capability
 Proof of inspection process
capability

 Inspection results

 Process parameter records

P6.2.4* Are non-approv

non-approved
ed a
and/or
nd/or defective parts controlled?

Minimum requirements relevant for assessment Examples for implementation

Suspect parts and defective parts must be sepa-  Labeling indicating the prod-
rated, labeled, recorded or (when
( when necessary) safely uct status
removed from the production process.


These parts must either be directly marked or defined scrap/rework-sta-

tions in production
marked on their container.
 Quarantine stores and quar-
Authorized personnel decide
decide on the further use of antine areas, clearance ar-
potentially defective products. eas
The scope (including inspection and release) of  Documentation regarding re-
permissible rework is described in work instruc- jects, rework and repair
tions.
 Authorizations
Quarantine stores and quarantine areas must be
clearly labeled. Accidental or unauthorized use of
restricted parts must be excluded.
 81

P6.2.5 Is the flow of materials secured against mixing/wrong items?

Minimum requirements relevant for assessment Examples for implementation

A mix-up of materials or the use of wrong materials,  Process FMEA

software or components must be ruled out.
o ut.
 Poka Yoke actions

Appropriate
any mix-ups measures
of parts ormust be taken
be
any use to ensure
of wrong that
parts/in-

Checks and inspecti
inspections
ons in
production facilities
correct installation of parts is detected early on.
 Traceability of batches
The process and/or inspection status of parts must
be clearly visible.  FIFO/FEFO
The reuse of residual quantities, separated parts, re-  Kanban
worked parts, reusable parts must be clearly de-
 Removal of invalid labeling
fined. Traceability is ensured.
 Value stream analysis
Regulations for reintroducing parts from outsource
outsourced
d
processes must be available.  Sorting service

Setting masters, setup and reference parts must be  Unique software identifier,
labeled and protected against accidental use. software integrity (build num-
ber, hash key)
82

Process element P6: Production process analysis

P6.3 With which personnel resources is the process implemented?

Personnel resources

P6.3.1 Are the employees able to fulfill their given tasks?

Minimum requirements relevant for assessment Examples for implementation

For each task/job, the corresponding requirements  Evidence of qualifications

profile has been specified. The employees’ qualifi-
 Training plan
cation is in line with the requirements profile. If this
is not the case, a qualification scheme must be p put
ut  Initial training plan, incl
including
uding
in place. evidence

Instructions, trainings and inductions provided to  On-the-job training

the employees as well as proofs of qualification are  Qualification matrix
documented.
 Knowledge about the prod-
Proof of must
vant job special
bequalifications
provided. required for the rele- uct and failures that have oc-
curred
In case of changes to processes, trainings/instruc-
 Handling of measuring
tions are provided and documented.
equipment
The requirements also apply to temporary employ-
 Interpretation of contr
control
ol
ees.
charts

 Training/instructions regard-
ing occupational safety

 Training in special character-

istics

 Suitable evidence of qualifi-

cation (e.g. welding certifi-
cate, vision test results,
hearing test results)
 83

P6.3.2 Do the employees know what responsibilities

responsibilities and authority they have
regarding the monitoring of product and process quality?

Minimum requirements relevant for assessment Examples for implementation

The employees’ responsibilities, duties and author-  Work/inspection instructions

ity are described and implemented.  Job descriptions
The employees know the consequences of incor-  Setup release, first piece in-
rect execution of work. The tasks/functions of the spection, last piece inspec-
product are known. It is also known what happens tion
when they are no longer
l onger guaranteed.
 Authority to stop and start
Employees receive regular information on the cur- the process
rent standard of quality achieved
a chieved and are informed  Escalation protocol
about customer complaints.
 Product training
The requirements also apply to temporary employ-  Product safety/product liabil-
ees. ity training

P6.3.3 Are the necessary personnel resources available?

Minimum requirements relevant for assessment Examples for implementation

There is a staff schedule for all shifts. The staff  Shift plan
schedule takes into account the required number of  Evidence of qualifications
qualified employees.
 Qualification matrix
Rules exist for supporting areas that are not contin-
 documented absence man-
ually in use (e.g. laboratory, measurement room).
agement rules
Fluctuations in customer orders and workforce ab-
 Staff schedule
sences (e.g. illness, holidays, training) are taken
t aken Mentors
into account in the staff schedule. 

The requirements also apply to temporary employ-

ees.
84

Process element P6: Production process analysis

P 6.4 What material resources are used to implement the process?

Material resources

P6.4.1* Is the manufacturing equipment suitabl

suitable
e to meet the customer’s p
prod-
rod-
uct-specific requirements?

Minimum requirements relevant for assessment Examples for implementa-

tion

It must be demonstrated that the processes are im-  Proof of machine/process

plemented in accordance with the customer re- capability
quirements using the existing production facilities,
 Monitoring of key process
and that the resulting products meet the customer
parameters (e.g. pressure,
specifications.
time, temperature)
The production facilities, machines and plants must
 Capabil
Capability
ity of replacement
be able to comply with the specified tolerances for
tools
the respective product and process characteristics.
Parameters and software that influence the process
 Feed and removal systems
are protected against unauthorized access.
a ccess.  Reproducibility of gages, fix-
tures etc.
Process capability must be determined for selected
product and process characteristics, and proof of  Cleanliness requirements
capability must be provided.
 Configuration management,
The process capability must meet internal require-
r equire- ensuring provision of soft-
ments as well as customer requirements. The mini- ware in accordance with the
mum requirement for process capability is Cpk ≥ unique identifier, software in-
1.33. In case of characteristics where a certain ca- tegrity (build number, hash
pability is required but proof of capability cannot be key)

obtained, 100% inspection is required.

 85

P6.4.2 Is the maintenance of the manufacturing equipment and tools

controlled?

Minimum requirements relevant for assessment Examples for implementation

Preventive and/or predictive maintenance activities  Production-related logistical

(maintenance, inspection and repair) are defined equipment, such as forklift
and implemented for all installations, equipment, trucks
machines and tools based on the risk.
r isk.
 Maintenance and servicing
Scheduled and unscheduled maintenance activities schedules
that have been carried out are documented and an-
 TPM Total Productive
alyzed with regard to potential improvement
Maintenance
measures.
 Key processes and bottle-
Resources needed to carry out necessary mainte-
neck machines
nance activities are available.
 Technical documentation
A process for the analysis and
and optimization of
provided by the manufac-
down-time, machine utilization and tool life is imple-
turer
mented effectively.
 Preventative tool exchange
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
 Tool history including all changes and tool life
 Operational status of tools,
 Operational status e.g. operational, not opera-
 Labeling of tools tional

These requirements also apply to external service  Labeling of tools, e.g. prop-
providers. erty of the customer, tool no.,
index
86

P6.4.3* Can complianc

compliance
e with quality requirements be effectively monitored with
the measuring and inspection equipment in use?

Minimum requirements relevant for assessment Examples for implementation

The inspection equipment and measuring systems  Measuring system analysis

used are suitable for the intended purpose and han-


dling in production. They are included in the pro- Test process capability
duction control plan.  Replacement measuring
equipment
Confirmed results of capability studies are available
for the inspection equipment and measuring sys-  Software integrity check
tems used.
 Calibration status (inspection
Inspection and measuring equipment is labeled. sticker, barcode, engraving
e ngraving,,
The validity status is monitored. etc.)
A process for periodic monitoring of
of inspection  Reference parts
equipment and measuring systems is established
and implemented.

In case of non-conformity, an assessment

a ssessment of poten-
tial risks in relation to the process, the product and
the customer is carried out. Measures have been
defined and are implemented effectively.
Auxiliary equipment for inspection
inspection equipment and
measuring systems that have an influence on the
measurement result are monitored in the same
way.
 87

P6.4.4 Do the work and inspection stations fulfill the requirements?

Minimum requirements relevant for assessment Examples for implementation

Workplace and ambient conditions are appropriate  Cleanliness and tidiness, 5S

for the products and the work carried out, in order
 Lighting
to prevent or eliminate
eli minate contamination, damage,
mix-ups of parts and the use of wrong parts. 
Noise pollution
This also applies to rework,
r ework, sorting and inspection  Climate control
stations that have been permanently or temporarily  Clean rooms
set up.
 ESD
The layout of the work station is adapted to the
work to be carried out.  Layout of the work station

 Surroundings/handling of
parts at the work station

 Occupational safety

P6.4.5 Are tools, devices and inspection equipment stored properly

properly?
?

Minimum requirements relevant for assessment Examples for implementation

Tools, devices and test equipment must be stored  Stored in such a way as to
properly. be protected against dam-
It is ensured that the equipment is stored in such a age, e.g. collision protection
way as to be protected
p rotected against damage and envi-  5S Method
ronmental effects.
 Defined storage location, e.g.
Cleanliness and tidiness are ensured. markings on the floor
The issue and use of this equipment is controlled  Transparent warehouse
and documented. management
88

Process element P6: Production process analysis

How effectively is the process being carried out?

Effectiveness and efficiency

P6.5.1 Have targets been set for the production process?

Minimum requirements relevant for assessment Examples for implementation

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,
when setting targets. defect costs, process effec-
tiveness figures, plant and
A regular comparison between
between specified targets machine availability)
and actual results is made and documented.
 First time trough quality, First
pass yield

 Reduction of waste (e.g. re-

jects and rework, energy and

and
process materials)
 89

P6.5.2 Is quality
quality and process data collected in a way that allows for analysis?

Minimum requirements relevant for assessment Examples for implementation

The quality and process parameters required to  Control charts

demonstrate product conformity (target values) are
 Check sheet
defined and documented. The actual data is rec-
r ec-
orded and evaluated. 
Types of errors/error fre-
quencies
Special incidents are documented.
 Rejects/rework
The recorded data can be allocated to a product
and process, the data is available, legible, accessi-  Process data sheet with pa-
ble and archived as specified. Traceability require- rameter changes
ments are met.
 Shift/machine log
The collected data is analyzed, and appropriate im-
im -
 Cycle times, throughput
provement measures are initiated.
times
The potential for improvement must be continuously
 Fault message (e.g. plant
determined based on findings relating to quality,
standstill, power outage, pro-
costs, and services. gram error message)

 Output/availability

 Blocking message/sorting
actions

 Traceability
90

P6.5.3* If product a
and
nd proces
process
s requirements are not met, are the causes
analyzed and the corrective actions checked for effectiven
effectiveness?
ess?

Minimum requirements relevant for assessment Examples for implementation

If product and process requirements are not met,  8D method

immediate actions are taken to fulfill the require-


ments, until it has been proven that the corrective Cause and effects diagram
actions have been effective. The employees are fa-  Taguchi, Shainin
miliar with these immediate corrective actions.  5W method
Suitable methods are implemented to analyze the  Process capability analysis
causes.
 Design and process FMEA
Repeat errors are recorded. A more detailed analy-
sis of the causes must be carried out accordingly.  Waivers/concessions

Corrective actions are derived, their implementation  Additional dimensional, ma-

is monitored and the effectiveness verified, terial, functional and endur-
ance testing
The production control plan and the risk analysis
are updated as needed.
Non-conformities that affect the characteristics of
the delivered product are communicated to the cus-
tomer.
 91

P6.5.4 Are processes and products audited regularly?

Minimum requirements relevant for assessment Examples for implementation

The audit program for process and product audits is  Specifications

based on customer requirements as well as specific
 Special characteristics
risks. And is implemented.
The process and product audits carried out are suit-

Audit program including
scheduled and event-based
able to identify specific risks and
an d weaknesses.
audits
If non-conformities are detected during an audit, the
 Frequency of audits
causes are analyzed. Corrective actions are de-
rived, their implementation is monitored and the ef-  Audit results, audit reports,
fectiveness is verified. action plans
Non-conformities that affect products which have  Auditor qualification
already been delivered are communicated to the
 Scope of the audit, e.g.: P5,
customer.
P6, P7
 Labeling, packaging
 Change status of individual
parts and software
92

Process element P6: Production process analysis

P6.6 What should the process accomplish?

Process result (output)

P6.6.1 Do the quantities/production batch sizes match needs and are they sys-
tematically directed to the next process step?

Minimum requirements relevant for assessment Examples for implementation

Products must be forwarded to defined stor-  KANBAN

age/holding points using suitable means of
 FIFO/FEFO
transport.
 JIT/JIS
The order quantity/batch size must be taken into
account, so that only the required quantity of prod-  Storage management
ucts is moved to the
t he stipulated storage/holding Production quantities tailored


point. to the customer’s needs

The current state of the component (OK part, re-
 Technical cleanliness
worked part, reject, etc.) must be evident from the
labeling (component, container etc.).
The change status must be clearly indicated.
It is ensured that only OK parts move on to the next
production process step.
Rules are put in place for returning residual quanti-
ties, including the recording of the quantities as well
as further processing.
 93

P6.6.2 Are products stored in an

an appropriate
appropriate manner and are the means of
transport/packaging facilities suitable for the special characteristics of
the products?

Minimum requirements relevant for assessment Examples for implementation

The products must be protected from damage by  Protection from damage

suitable storage and packaging.
 For electronic components:
Internal and customer-specific packaging instruc- ESD protection
tions are known and are implemented. This also ap-
 Technical cleanliness
plies to released replacement packaging.
 Cleanliness, tidiness, 5S,
The storage areas/containers must meet the re-
over-filling (storage areas
areas,,
quirements with regard to cleanliness.
containers)
Specified storage times must be monitored.
 Monitoring of storage
Products must be protected against environmental times/storage quantity (maxi-
and climatic influences during storage and ship- mum/minimum storage
ment. times, specified interim stor-
These requirements apply to the handling during age times)
the production process as well as during
du ring 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-
routes, commissioning, outdoor storage areas (in- ing
ternal/external).
94

P6.6.3 Are the necessary records/releases retained?

Minimum requirements relevant for assessment Examples for implementation

The release of the products as well as the relevant  Customer specifications

evidence is documented.
 Customer’s requirements for
Waivers/concessions are documented. The docu-
mentation must cover the period and/or quantity of archiving time limits
 Archiving requirements/regu-
parts involved.
lations (e.g. EDP, paper, fire
Internal specifications and customer req
requirements
uirements protection, legibility)
regarding the documentation of rework and repair
 Parts history
are fulfilled.
The traceability of products is ensured.
The customer’s requirements with regard to archiv-
ing are fulfilled.

P6.6.4* Are the customer requ

requirements
irements met u
upon
pon delivery of the final product?

Minimum requirements relevant for assessment Examples for implementation

The customer-specific requirements regarding the  Quality agreements with

final product (delivery reliability, quality targets, the customer
quality performance etc.) are known. The fulfillment
 Packaging specification
of these requirements is continuously monitored,
assessed and documented.  Target agreements

In case of non-conformities, the causes are ana-  Shipping audit

lyzed, and measures are defined and implemented.  Customer specifications
Products are labeled, stored and shipped in accord- regarding labeling (e.g.:
ance with the customer requirements. VDA label)
In case of waivers/concessions, products and pack-  Labeling in cases of waiv-
aging are labeled accordingly. ers
Internal specifications as well as customer require-
ments regarding the labeling of reworked or re-
paired products are observed.
The handling of supplied products is regulated.
r egulated.
Customers should be informed of delivery stops
which affect them, and the further procedure should
be coordinated with them.
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7.7 Customer satisfaction/customer care/service (P7)

Process element P7: Customer care/service

P7.1 Are all requirements related to the QM system and product conformity
fulfilled?

Minimum requirements relevant for assessment Examples for implementation

The internal and customer-specific requirements re-  Quality agreements with the
garding the QM-system and its further
fur ther development customer
are fulfilled. The processes
pr ocesses within the organization
 Requalification concept, e.g.
(including the outsourced processes) and along the
product audits carried out,
supply chain are taken into account.
functional tests, endurance
Requalification tests are carried out in accordance tests
with the customer requirements
 Certification of the QM sys
sys--
Customer requirements for the return of parts and tem
their recycling must be fulfilled.
 Proof of conformity, e.g.
Proof of conformity with necessary national and in- 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?

Minimum requirements relevant for assessment Examples for implementation

It must be ensured that competent contact persons  Knowledge regarding prod-

are available for the various areas in the customer’s uct use
organization.


Communication is ensured in accordance with the Knowledge

the product of
andproblems with
complaints
customer specifications. regarding the product or
Product monitoring in the field is ensured. transport

Access to customer portals

portals in accordance with the  Fulfillment of new require-
customer-specific agreements is ensured, and the ments
required data is up to date/maintained.  Notification of improvement
measures

 World-wide customer service

 The customer is informed in

the case of non-compliance
with the requirements
 Required data (e.g. Certifi-
cates, contact data)
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P7.3* Is the supply of parts guaranteed?

Minimum requirements relevant for assessment Examples for implementation

Concepts (including contingency concepts to en-  Contingency plans (e.g. al-

sure that products/parts can continue to be sup- ternative production, suppli-
plied) are available and up to date. The processes ers, packaging, transport)
within the organization (including the outsourced Capacity and reaction tim
time
e

processes) and along the supply chain must be
for sorting actions
taken into account. This also includes immaterial
products such as software, etc.  Use of external capacity

Risks and their impact on the customer have been  Communi

Communication
cation regarding
taken into account. supply shortages

Procedures must be in place which guarantee that  Regulations covering author-

the organization informs the customer immediately ity to make decisions/escala-
when supply shortages are detected. The infor- tion paths when introducing
mation must include the expected duration and ex- special actions
tent of the shortages, the reason and the measures
 Blocking of parts
which have been initiated.
 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-
dates
98

P7.4* In case of complaints, are failure analyses carried out and corrective
actions implemented effectively?

Minimum requirements relevant for assessment Examples for implementation

A complaints process that

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
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)
case of non-conformities, the customer has to be
 Use of problem-solving
informed.
methods (8D)
In case of field complaints, a field failure analysis
 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 casesuppliers),
rected of suppliers appointed
interface by the customer
agreements (di-
are taken
 Knowledge databases, les-
sons learned
into consideration.
 Quality control loop

 Risk analysis (e.g. FMEA,

HARA)

 Access to the necessary re-

lease documents (e.g. PPA)
 99

P7.5 Are personnel qualified for their respective tasks and are responsibilities
defined?

Minimum requirements relevant for assessment Examples for implementation

It must be determined which responsibilities, duties  Organizational chart and es-

and authorizations each employee has in their re- calation procedures
spective field of work.
 Evidence of knowledge of:
Training needs must be determined and imple- the product/the specifica-
mented individually, based on the tasks. tions/ special customer re-
The employees are familiar with the
t he product and quirements
the consequences of incorrect execution of work for  Standards/legislation (prod-
the supply of parts and the quality of the final prod- uct liability)
uct.
 Intended use

 Failure analysis

 Evaluation methods (e.g. au-

dits, statistics)
 Quality techniques (e.g. Pa-
reto, 8D Method, cause and
effect diagram, “5 Whys”
method)

 Knowledge of foreign lan-

guages
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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

AIAG Automotive Industry Action Group

aSPICE automotive SPICE (Software Process Improvement and Capability Determination)

CAx Computer-Aided x

CMMI Capability Maturity Model Integration

DIN German Institute for Standardization (Deutsches Institut für Normung e. V.)

EDn Compliance level of the service process element (D2, D3, …, D7)

ESD electrostatic discharge

EG Overall compliance for the Process Audit

EG(PGn) Overall compliance for each product group

En Compliance level of a process step

EPn Compliance level of a process element (P2, P3, …, P7)

EU1 Sub-element of P6 or D6: Process Input

EU2 Sub-element of P6 or D6: Work carried out

EU3 Sub-element of P6 or D6: Personnel resources

EU4 Sub-element of P6 or D6: Material resources

EU5 Sub-element of P6 or D6: Efficiency

EU6 Sub-element of P6 or D6: Process output

OK OK

IEC International Electrotechnical Commission

Inmetro National Institute of Metrology, Standardization and Industrial Quality

ISO International Organization for Standardization

n.e. not evaluated

NOK Not OK
 101

Abbrevia-
Explanation
tion

P1 Process element: Potential analysis

P2 Process element: Project management

P3 Process element: Product and process development planning

P4 Process element: Implementation of product and process development

P5 Process element: Supplier management

P6 Process element: Production process analysis

P7 Process element: Customer care, customer satisfaction, service

REACH Registration, Evaluation, Authorization and Restriction of Chemicals

RoHS Restriction of Hazardous Substances

SAE Society of Automotive Engineers

VDA Verband der Automobilindustrie e. V.

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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

The downloads are available free of charge.

A supplier self-assessment form is also available on the download page.

Login details:

Username: prozessaudit
Password: vda_6.3
 103

Quality Management in the Automotive Industry

The current versions of the VDA publications covering quality management in

the automotive industry (QAI) can be found on the Internet under
http://www.vda-qmc.de.

You may also order via this homepage.

Reference:

Verband der Automobilindustrie e.V. (VDA)

Qualitäts Management Center (QMC)
10117 Berlin, Behrenstr. 35
Phone +49 (0) 30 89 78 42-235, Fax +49 (0) 30 89 78 42-605
Email: [email protected], Internet: www.vda-qmc.de
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