Quality Management

in the Automotive Industry

– Product Integrity –
Recommended actions for companies

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on product safety and conformity

1st edition, May 2018

Online Download Document
– Product Integrity –
Recommended actions for
companies on product safety and
conformity

© VDA QMC Gelbband 2018 | Free version | www.vda-qmc.de/publikationen/gelbdrucke

1st edition, May 2018

Online Download Document

Verband der Automobilindustrie e.V. (VDA)

 © VDA QMC Gelbband 2018 | Free version | www.vda-qmc.de/publikationen/gelbdrucke
ISSN 0943-9412
Online download document, May 2018
English edition released in June 2018

Copyright 2018 by

Verband der Automobilindustrie e.V. (VDA)

Qualitäts Management Center (QMC)
Behrenstr. 35
10117 Berlin, Germany
Non-binding VDA recommendation
The Verband der Automobilindustrie (Automotive Industry Association –
VDA) proposes that its members apply the following recommendations
when establishing and maintaining QM systems.

Exclusion of liability
This VDA volume is a recommendation which is free for anyone to use.
Anyone who implements it is responsible for ensuring that it is used
correctly in each case.

This VDA volume takes account of the latest state of the art at the time it
is issued. The application of the VDA recommendations does not in any

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way relieve the user of their own responsibility for the use of the docu-
ment. In this respect, everyone acts at their own risk. The VDA and
those involved in drawing up the VDA recommendations decline all lia-
bility in any circumstances.

Anyone using these VDA recommendations who identifies incorrect

information or the possibility of incorrect arrangements is asked to ad-
vise the VDA without delay, so that any deficiencies can be eliminated.

Copyright protection
This publication is protected by copyright. Its use outside the strict limits
of the copyright laws is prohibited without the permission of the VDA
and is punishable by law. This applies in particular to copying, transla-
tion, storing on microfiche, and storing or processing in electronic sys-
tems.

Translations
This publication will also be issued in other languages. The current sta-
tus must be requested from VDA QMC.

3
Preface to the first edition
Product innovation frequently results in increasing product complexity,
with simultaneous shorter development cycles. Combined with increas-
ing customer expectations in terms of the function and safety of prod-
ucts, this raises particular challenges for all companies involved.
Companies not only have to deal with new customers and their cultures,
but also with changing customer expectations and the country-specific
laws and requirements that apply to the products. Furthermore, the sen-
sitivity and connectedness of product users and authorities, and public
discussions on the issue of product integrity have increased significant-
ly.
In this context, the question arises as to which organization structures

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and processes must be established in a company and how a company
should react if a product is classified as potentially non-conform or as
potentially safety-critical due to discrepancies in one or multiple coun-
tries.
The answer to this question is subject to a certain level of complexity
that results, among other things, from the number of parties involved
(authorities, product users, OEM, suppliers) and their various require-
ments.
Reasonable safety expectations from customers, consumers, and unin-
volved third parties (the “general public”) need to be identified and taken
into account. If products prove to be “unsafe” in the market, the compa-
ny has an obligation to initiate the necessary measures to protect cus-
tomers, consumers, or the general public.
The resulting duty of care is the basis for appropriate handling of safety
and conformity-related issues.

4
From these insights, companies can develop preventive measures with
regard to internal processes, methods and tools, as well as the organi-
zation structure.
This volume provides recommendations for implementation. The ac-
companying VDA training provides a more in-depth look at the content
of this volume using real-world examples.
Conformity with these recommendations does not absolve a company
from consequences under product liability law. The requirements of this
VDA volume have no relevance in terms of liability or warranty towards
the relevant user with regard to the scope of liability and warranty.
The objective of this volume is to create a better understanding of prod-
uct safety and product conformity - combined under the term product
integrity for the purposes of this volume.

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The volume contains references to other VDA volumes that support and
detail these specific duties of care.

5
6
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Content
1 Introduction 9
1.1 Instructions for use 11
2 Organization of product integrity 13
2.1 Requirements for delegation of product integrity
duties 14
2.2 Qualification requirements 16
3 Product integrity over the product lifecycle 19
3.1 Determination of product integrity focus areas in the
company 23
3.2 Handling of PI requirements during the product
lifecycle 25
3.2.1 Requirements phase 26

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3.2.2 Development phase 27
3.2.3 Production phase 27
3.2.4 Usage phase 28
3.2.5 Product monitoring 29
3.2.6 Market monitoring 30
4 Recommended actions for product
discrepancies 31
4.1.1 Implementation of a recall management system in the
company 31
4.2 Communication and documentation of product
discrepancies 31
4.3 Information flow within the supply chain 33
4.4 Corrective measures 37
4.5 Circumstance analysis 37
4.6 Risk evaluation 39
4.6.1 Risk evaluation in the supply chain 39
4.6.2 Example method for RAPEX 40
4.7 Resolutions concerning further action 42
4.8 Examples 43
4.8.1 Example process for an SME 43
4.8.2 Example case 44
5 Examples of tools and methods 47
5.1 Sensitization of the organization to product integrity 47
5.2 Continuous monitoring of product integrity 47
5.3 PSB organization or PSR duties at a glance 49

7
5.4 Configuration management 50
5.5 Communication guidelines 51
5.6 Lessons learned 52
5.7 Special features 52
6 Glossary 53

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8
1 Introduction
Every company in the supply chain has an obligation to guarantee the
safety and conformity of its products. This means that the legal regula-
tions for product integrity applicable in the relevant countries and re-
gions have to be met, and also that reasonable safety expectations from
the general public have to be satisfied.
For products that are identified as “unsafe” in the market or whose con-
formity with legal requirements is not adequate, the economic agent has
an obligation to initiate the necessary measures.
The term “product integrity” is used in this volume to refer to this obliga-
tion to ensure product safety and product conformity (Figure 1).

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Figure 1: Definition of product integrity

The recommendations in this volume are intended to systematically

prevent or reduce product integrity related risks and discrepancies in
products in their development, manufacture, and use, until the end of
their intended usage.
In addition to the required activities, it addresses the responsibilities for
product integrity throughout the supply chain.

9
To aid readability, all roles outlined are described as functions and can
be performed by people of any gender.

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10
1.1 Instructions for use
The senior management of a company has a fundamental responsibility
for the product safety and conformity of products brought into circula-
tion. Therefore, the recommended actions in this VDA volume are initial-
ly assigned to the senior management of the company.

Responsibility extends over the entire product lifecycle and the entire
supply chain. The depth of the supply chain must be documented in
contractual arrangements.

The term product1 refers to any manufactured goods, including movable

objects, parts of other movable objects, or immovable objects. This ex-
plicitly includes integrated software, software and services (e.g. e-call,
sorting action, rework by third parties, development services).

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Duties that are necessary to ensure responsibility for product integrity
can be assigned to a PSR (product safety representative).

These duties can be delegated to one or more people or functions, at

each company’s discretion.

For example, secondary product integrity duties (e.g. product conformi-

ty) can be delegated to existing departments and/or experts (e.g. regula-
tory, Conformity of Production (CoP) or homologation experts, Func-
tional Safety Management or Quality Management).

These people must be appointed in line with specific company guide-

lines.

The purpose of this practical paper with its examples is to further

strengthen the collaboration between the automotive manufacturers and

1
The meaning of the term “product” as set out in this volume has been
agreed from the perspective of the consequences of any discrepancy in
terms of safety and conformity.

11
their suppliers in the field of quality.

In-depth practical examples for implementation, as well as detailed in-

formation on methods and tools, are provided in the accompanying VDA
training and communicated using clear exercises.

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12
2 Organization of product integrity
The fundamental responsibility of senior management cannot be dele-
gated, but duties designed to meet this responsibility can. Responsibility
for particular duties can be delegated, provided that the competences
(for decision-making and action) are verifiably defined (e.g. in writing),
the relevant person is carefully chosen and their qualifications can be
confirmed. This kind of delegation should take place explicitly, promptly
and effectively.

A company should identify people, qualify them and assign them the
required authority to formulate and implement preventive and corrective
measures. Senior management in the affected companies must guaran-
tee that the contact person for the employees’ contact in the company is

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kept up to date. The contact(s) for product integrity issues must be ap-
propriately designated and known in the company and at any relevant
locations.

Setting up an internal communication network - across relevant compa-

ny locations - for product integrity issues is recommended for sharing
early warnings and lessons learned.

A communication network for product integrity issues is also required

within the supply chain to ensure rapid exchange of information in the
event that a product warning becomes necessary. In these cases, the
relevant PSR in the supply chain is to be involved.

The company’s senior management is responsible for the fundamental

suitability and appropriateness of the specifications, procedures, meth-
ods, and tools used in the company in relation to product integrity.

Monitoring effectiveness of conformity with product integrity is the re-

sponsibility of the senior management in the supply chain. Internal audit-
ing, product and process audits, definition and review of compliance
guidelines can support in fulfilling this obligation.

13
2.1 Requirements for delegation of product
integrity duties
The following items must be ensured to achieve effective delegation:

 Careful selection of a suitable person for the duty to be delegat-

ed, based on their personality and technical expertise
 Description of the duties, authority and responsibilities of the del-
egate before delegation
 Verifiably adequate briefing (instruction) of the delegate in their
duties
 In case of personnel changes, the role of the delegate must be
reassigned by the delegator as quickly as possible. Until this re-

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assignment, the delegator retains responsibility.
 Provision of appropriate conditions and resources for the dele-
gate to perform the duties
 Monitoring effectiveness of the delegate by the delegator
The need for delegation is based on the extent of the company’s prod-
uct integrity related activities and follows the principle of a delegation
cascade.

Derived from the individual terms, a delegation cascade refers to a

“transfer of duties, authorities, and responsibility to a third party, or to
adjacent or subordinate hierarchy levels”.

As part of delegation, it must be ensured that duties are delegated to

people whose position in the company,
in terms of the corporate hierarchy, can be considered appropriate.
When assessing appropriateness
in terms of position in the company, two key criteria are the delegate’s
competence and the assigned decision making authority. This also limits
the scope for sub-delegation.

Sub-delegation to an appropriate level of responsibility is recommended.

14
Two examples of two-stage sub-delegation:

 Senior manager responsible for product delegates to develop-

ment manager for a product group (first level), who in turn dele-
gates to the development managers for individual products (sec-
ond level).
 Plant manager responsible for product delegates to plant quality
manager (first level), who in turn delegates to the quality manager
for a production segment (second level).
Appointment of PSRs supplements this sub-delegation by ensuring that:

 all employees are given a contact person to provide technical

support on product integrity related issues.

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 the role of the PSR is clearly communicated, along with the asso-
ciated duties and authorities.
Where necessary under applicable law, a formal legal adjustment of the
contract of employment or appointment corresponding to the duties
assigned may be required.

The recommendations specified for internal delegation can also be ap-

plied to external delegation.

Examples of external delegation:

 Performance of internal product and process audits by external

companies: The senior management or an internal PSR from the
commissioning company must conduct a review of effectiveness.
 Engaging a service provider to perform a sorting action in the
customer’s warehouse: Commissioning and monitoring are to be
carried out with the appropriate duty of care, as is the case for in-
ternal commissioning.

15
2.2 Qualification requirements
The company’s senior management is responsible for the content and
quality of the PSR qualifications. The qualification requirements and the
necessary qualification level is determined by the delegation cascade
throughout the product lifecycle.

The example qualification requirements listed in the following table do

not necessarily have to be satisfied by one person. However, to ensure
product integrity these issues must be covered in the company.

Table 1: Topics and content for PSR qualification

Topic Content

Obligation to comply with laws and directives, as well

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Compliance
as the corporate culture shaped by voluntary codes

Product knowledge related to the application-specific

Product liability legal framework in terms of use and foreseeable mis-
use

Basic knowledge of consumer protection legislation

Product safety
related to the application-specific legal framework

Basic knowledge of the relevant product approval laws

Product conformity and conformity requirements in the application-specific
legal framework

Company-specific product safety related knowledge in

Company-specific product
terms of development and production of the relevant
knowledge
product (standards, lessons learned, checklists, etc.)

Basic knowledge of prevention (FMEA, FTA, Haz-

ard&Risk, DRBFM, etc.)

Risk analysis and risk man- Handling of special characteristics

agement

Statistical methods (Weibull, etc.)

Evaluation of the hazard risk, e.g. RAPEX, ACC

16
Topic Content

Problem-solving methods 8D, Ishikawa, Kepner Tregoe, 5Why, etc.

Customer-specific (safety)
Internal company checklists
requirements

Management and storage of Basic knowledge of compilation and storage of devel-

documents opment- and production-related documents

Preventive quality assurance Basic knowledge (APQP)

Line walk, safety review, lessons learned, checklist

Product safety prevention
management, etc.

Product monitoring Field failure analysis

Evaluation and lessons learned from product recall

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Market monitoring portals and public consumer feedback on own and
competitor products

Product safety reporting

obligations in the supply Expert knowledge of reporting obligations related to
chain and, where necessary, the application-specific legal framework
to authorities

Identification of product
Internal company guidelines
safety related discrepancies

Management of safety
related product discrepan-
Internal company guidelines
cies including case conclu-
sion

Guidelines for internal and

external communication in
Internal company guidelines, legal requirements
case of product safety relat-
ed cases

Product traceability, verifica-

tion, disposal, and handling Basic knowledge
of counterfeit products

Basic principles of utilizing positive or negative expe-

Lessons learned
riences for continuous improvement

17
The VDA recommends training on product integrity, which will provide
participants with the knowledge to identify and implement the appropri-
ate product integrity measures for their company.

Based on this, a suitable, in-house training concept for qualification of

multiple product safety representatives as part of an internal PSR net-
work can be installed, provided comparable content is appropriately
communicated, understood, and documented.

Conformity with the content of this volume and completion of the corre-
sponding training also satisfies key requirements of IATF 16949 regard-
ing product safety and conformity.

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18
3 Product integrity over the product lifecycle
Companies are responsible for the integrity of their products over the
entire product lifecycle, including the continuous risk management re-
quired.

QMS standards, for example DIN EN ISO 9001 and IATF 16949, require
companies to have a risk-based solution for defining processes and
methods.

This must be taken into account along with the relevant product re-
quirements through the development phase (design), the production
phase (manufacturing), and
the usage phase. The usage phase covers the time from sale until the

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customary end of product life, including
recycling. It explicitly includes required documented instructions and
product and market monitoring (Figure 2).

Figure 2: Product integrity over the product lifecycle

Process and handling instructions for product integrity duties result from:

 Determination and assurance of legal product requirements and

the reasonable safety expectations of the
general public
 Product and market monitoring
 Response to product discrepancies

19
These three product integrity duties are key elements of the product
lifecycle and must be included in the relevant corporate management
system.

In a specific company, product integrity related duties can be performed

as part of continuous risk-based measures.

A company can apply these measures as required to the phase model

with testing and approval points (Figure 3) used for its products.

Below, the VDA maturity level model is used as an example, which has
milestones and testing points for particular phase sections.

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Figure 3: Example representation of the VDA maturity level
model over the product lifecycle,
ML=Maturity level

Over the product lifecycle, depending on the activity or after

certain events, PSRs are involved in decision-making processes
to maintain product integrity, according to their authority.

As a result of this involvement and based on defined requirements, re-

ferred to below as requirement lists, there are possible requests for ac-
tion in the product lifecycle, which are aimed at achieving or improving
product integrity (see Figure 7).

To continuously improve product integrity, evaluating the implementa-

tion status of PI measures periodically using suitable key performance
indicators is recommended.

Companies must determine the requirements relevant for the integrity of

their products by using a risk-based approach in line with legal or con-
tractual requirements, ensure transparent documentation and archiving
of these.

20
This determination is a risk assessment to be performed internally on
the company’s product range.

Indicators of specific risks relevant for product integrity (corresponding

to special requirements) could include:

Table 2: Examples of indicators relevant for

product integrity

Increase in product integrity related complaints

Number of product approvals with special conditions.

Increase in recalls of competitor products.

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Development of new business fields (products, markets, customers,
technologies, etc.).

Exceptional product or project complexity.

Recruitment of new employees with duties relevant for product integrity.

Engagement of suppliers with integrity related products.

Requirements for product marking for traceability purposes

Special safety characteristics, special approval characteristics, special

functional characteristics

Relocation of duties, e.g. production relocation

Change management

Particular risks relevant to product integrity in terms of:

 Risk of death or injury

 Non-conformity with legal requirements

21
Example information sources are set out in Figure 4.

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Figure 4: Sources of information to determine
indicators (examples)

22
3.1 Determination of product integrity focus areas
in the company
Because of their different product ranges,companies have different
product integrity risks. The risks are selected based on assemblies,
functional groups or specifically for individual products.

Examples:

 As part of its integration function for components and systems, an

OEM defines the PI relevance for individual assemblies or func-
tional groups and derives requirements for them.
 The OEM analyzes individual areas (e.g. wiring, brake system,
steering, etc.) from the end product, namely the entire vehicle.

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 A supplier selects corresponding products from its product range.
It is recommended that the company continuously monitor those param-
eters that contribute to product integrity (PI) using a risk-based method.
In addition to product specifics, other factors can influence PI relevance.

Examples of this:

 Automotive products with standard industry requirements and

non-automotive products
 Comprehensive product range (semiconductor component range)
 Variance at production sites (location, climatic conditions)
 Diverse usage scenarios (machine components such as screws,
bearings, rivets)
 Design and development process (change to legal
regulations, design of safety factors)
Selected areas of the product and process should be summarized in a
PI selection list. With a large product range, use of a database simplifies
monitoring of these products and their PI classification.

For the products included in this selection, the requirement lists for

23
evaluating product integrity (PI requirement lists) are created.

These selected areas and the associated parameters, are transparently

documented in line with the company’s risk-based approach and contin-
uously monitored in respect of product changes (derivatives, configura-
tions, etc.) over the lifecycle, up to the end of the usage period.

In the event of new findings/events, the PI requirements for these prod-

ucts are reviewed, assigned measures where necessary, and the result
determined is documented (see Figure 5).

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Figure 5: Product lifecycle supplemented with emphasized
product integrity measures

The PSR is responsible for performance and documentation. The rele-

vant specialist departments and their managers are involved.

This task extends over the entire product lifecycle, from design/develop-
ment through to the end of the usage period, including disposal.

Depending on the PI relevance, different activities and requirements can

24
be assigned to the products (Figure 6).

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Figure 6: Determination and continuous updating of product
integrity relevance

3.2 Handling of PI requirements during the

product lifecycle
Products or areas relevant for PI are monitored with reference to the
current status of the product in its lifecycle.

Monitoring means:

 Discussion of PI requirements at the beginning of the activity

 This is done by the PSR in conjunction with the specialist de-
partment/experts/project managers
 If necessary, the requirement list is updated based on new in-
sights, for example from a line walk, risk assessment or other ap-
plicable procedures or methods designed to ensure product in-
tegrity

25
  Presentation of results from the valid PI requirement list for ap-
proval after completion of the activity.
Result: Requirement has been fully implemented or not fully implement-
ed. If a requirement is not fully implemented, the PSR issues a request
for action to the specialist department / experts / project manager. If
these requirements are not feasible for a product approval in terms of
product integrity, the company must make a decision with support from
the internal or external experts that need to be involved.

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Figure 7: Checks on products relevant for PI using
PI requirements

3.2.1 Requirements phase

Depending on the company structure and products, there may be very
different methods of determining product integrity relevance down to the
level of individual work steps.

Meeting product integrity requirements for design and production ap-

provals must be verifiable at the time when the product is brought into
circulation. The risks caused by the product must not exceed the ex-
pected risks for the relevant maturity level (e.g. before prototype ship-
ping ). The sender must indicate unidentifiable risks for the customer or
anyone who will come into contact with the product in the supply chain.

26
During the requirements phase, the PSR supports the creation and in-
terpretation of functional and requirement specifications using lessons
learned. This ensures that insights relevant to PI are incorporated from
an early stage.

3.2.2 Development phase

Requirements and areas relevant for PI are incorporated into the devel-
opment phase according to the PI risk evaluation results.

If this results in new insights that indicate products used in a similar

context are particularly relevant to safety, these should be added to the
PI selection list and, if necessary, linked to requests for action to ensure
product integrity.

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The PSR coordinates and reviews conformity with requirements con-
sistently until completion of development.

At the milestones in development, the requirements can be fully or not

fully implemented. If requirements are not fully implemented, the PSR
issues a request for action to the specialist department/experts/project
manager. For product approval relating to product integrity, the compa-
ny has to make a decision with the support of the experts who need to
be involved.

3.2.3 Production phase

The PI related requirements for the manufacturing process are incorpo-
rated into the production phase in the same way as the design require-
ments in the development phase.

There may be additional PI related requirements in a specific production

plant and corresponding measures are to be defined by the responsible
PSR. Both the product safety and product conformity related requirements
have to be met. Depending on the scope, these requirements can be dealt
with by different people using separate requirement lists or, if the scope
of the checks is small, by one designated person, for example the PSR.

27
Examples:

 PSR line walk for product safety evaluation

 CoP inspections as verification of conformity
 PI inspections for simultaneous assessment of product safety
and product conformity
The frequency of line walks and CoP inspections is defined and, where
necessary, updated according to the maturity level.

Additional product integrity questions that cannot be addressed through

the PI requirements are to be clarified with the PSR during the PI in-
spections.

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If there are any discrepancies in the plant, the PSR issues a request for
action, up to and including a request for product block. To prevent a
product block, the company must make a decision with the support of
the experts who need to be involved. Approvals of any discrepancies
must be agreed within the supply chain.

3.2.4 Usage phase

Obligations to ensure product integrity extend over the entire customary
usage phase. The usage phase starts when the product is brought into
circulation and ends at the end of its intended use or with scrapping or
product recycling.

During the usage phase, the PSR observes any insights from product
and market monitoring and supports, coordinates or leads any neces-
sary corrective measures.

28
3.2.5 Product monitoring
Companies must guarantee product monitoring in the field. Product
monitoring can essentially be divided into
reactive and preventive components. Reactive product monitoring in-
volves obtaining information on complaints about the product in the field,
e.g. customer complaints, guarantee claims or inquiries from authorities.
Preventive product monitoring could include, for example, targeted
analysis of possible discrepancies in the manufacturing or safeguarding
process, demand for spare parts or media research on comparable
products.

A possible product discrepancy may be found during product monitor-

ing. Assessment of the discrepancy must take place in the course of the

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fault elimination process. If a possible safety issue or conformity dis-
crepancy is present, this topic must be integrated into the product integ-
rity process. Otherwise, the regular fault correction process applies.

The scope of the obligations for product monitoring may differ for the
parties involved in the supply chain. In particular, the production moni-
toring obligation for the OEM relates to the entire vehicle; for suppliers it
generally only refers to the supplied product.

The PSR is responsible for transparent selection of activities relevant for

PI and for implementing the derived requirements in the affected prod-
uct lifecycle phases and in terms of further use with PI requirements.
Work can be documented on a company-specific basis.

29
3.2.6 Market monitoring
As part of market monitoring, changed consumer expectations or habits
are monitored, along with changes in the behavior of competitors.

For example, changes in consumer habits or new technologies can lead

to a change in the safety perception of consumers or the general public.
Failure of a function that represents no direct hazard to the user can be
viewed as an unacceptable hazard due to causal links.

Significant improvements in product safety brought about by implement-

ing new insights in the market can raise the state of the art for competi-
tors. Consumer expectations to benefit from this improvement can lead
to a new, reasonable safety expectation (example: functional quality of
active/passive safety systems).

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Market monitoring depends on the feasibility of traceability and monitor-
ing in the market and may not be possible for all products.

Once again, the PSR is responsible for transparent selection of activities

relevant for PI and for implementing the derived requirements in the
affected product lifecycle phases, and in terms of further use in docu-
mentation of PI requirements.

30
4 Recommended actions for
product discrepancies
4.1.1 Implementation of a recall management system in
the company
If the safety or conformity of a product is not ensured, suitable measures
must be taken. Involving the PSR in this is recommended. For example,
this can include an obligation to report to the authorities, a product warn-
ing, rework or a recall of the product. The aim is to protect the product
user or third parties against possible harm caused by the product or its
usage or to ensure conformity with legal requirements.

For larger companies, it is currently advisable to set up an internal recall

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management system. Generally external suppliers can also perform
sub-tasks, e.g. legal advice, field data analysis, sorting activities, re-
work, modifications, etc.

4.2 Communication and documentation of

product discrepancies
If a potential discrepancy that is relevant to product integrity has been
identified by a party in the supply chain, the relevant parties involved,
both external and internal, must be informed about it. To this end, a
previously defined, reporting process should be used in order to ensure
that the necessary reports are made consistently.
If possible, the interfaces in the supply chain should be defined in ad-
vance and the responsible contact persons in the company should be
announced, in order to ensure smooth communication. Every report
should be neutral, purely fact-based, that is without subjective evalua-
tion of the effects. Relevant documentation is part of the reporting pro-
cess between the affected companies.

Where available at this time,

it should include the following content:

 Day - the discrepancy was identified

31
  Affected product
 Type of discrepancy
 Risk evaluation
 Reporter
 Number of parts identified with the product discrepancy
 Determination of the production volume potentially affected
The report must be made immediately when the product discrepancy is
identified, using the process defined in the company. If necessary, open
issues must be submitted promptly afterwards or updated.

It must be possible to refer to relevant information during each process

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step. Structured, consistent and appropriate documentation of the pro-
cesses is necessary for this purpose. Furthermore, all information rele-
vant for the decision should be documented in a comparable manner. In
doing so, it must be ensured that objective traceability of the process is
ensured.

32
4.3 Information flow within the supply chain
Implementation of PI measures is in the interests of the manufacturer, in
order to ensure that only safe and legally conforming products are being
used in the field. These PI measures include the company organization,
which must have clearly defined processes, duties, authorities and
competences to ensure product integrity. This approach not only relates
to the company itself, but also to the interfaces to process partners in
the supply chain.

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Figure 8: Schematic example of a reporting procedure

If possible discrepancies regarding safety or conformity are identified in

the course of product monitoring, this information must be promptly
passed on to the affected interface partnersin the supply chain for fur-
ther risk analysis. In the event of a discrepancy that has to be reported,
it is generally advisable for the OEM to submit the report to the authori-
ties and, if necessary, to the product users or dealers. The reason for
this is that the consequence of possible discrepancies in terms of a
risk evaluation on a component can only be evaluated in the overall
vehicle system. If thesupplier has its own reporting obligations, it must, if
necessary, also report individually to the authorities. However, this
should be done with the involvement of the affected OEMs. Further-
more, supplying or trading companies that also have direct contact with
end consumers (e.g. through direct marketing in the spare parts mar-
ket), must fulfill their obligations in the same way as an OEM.

33
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Figure 9: Example reporting process from the German-

Chinese product safety working group as part of the collabora-
tion between BMWi and AQSIQ from 2017.

34
Table 3: Explanation of the example reporting process in Figure 9.

Step Authority OEM Supplier Remark

1 R R Possible process triggered by:
 Tests or validation

 Analysis of field complaints

 Information from press or social media

2 R/S R/S Initial analysis can take place as follows:

 Overall vehicle system (OEM)

 Sub-system (OEM or supplier)

3 R/S R/S Verification of the potential product safety or conformity

discrepancy during initial analysis.

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4 I R If the supplier supplies the same or similar parts to more
than one OEM, the initial analysis must be carried out for
each OEM.
The analysis result may vary due to the influence of the
discrepancy on the various systems.

5 R S All relevant information is documented and the process is

finished.

6 R S The OEM carries out a risk assessment for the verified

discrepancy. This assessment is carried out at the overall
vehicle level. The suppliers support on individual sub-
systems where necessary.

7 R S Safety or conformity related product discrepancies are

identified based on the risk assessment.

8 R (I) If a potential risk cannot be ruled out, the OEM must report
it to the authorities and, if affected, to its suppliers.

9 R If the supplier and OEM’s joint assessment does not lead to

the OEM reporting to the authorities, the supplier must
check its own obligation to report to the authorities.

10 R The supplier checks whether the incident associated with

its product leads to safety or conformity related product
discrepancies or unacceptable risks with regard to people
or property.

11 I I R If safety or conformity related product discrepancies are

present, the supplier reports to the authorities and informs
the OEM.

12 R R S Recall measures are taken in accordance with instructions

from authorities.

R – Responsible, S – Support, I – Information

35
This reporting process can also be transferred to the n-tier supplier in a
similar form. Correspondingly, it reports to its respective higher-level
suppliers at all times.

The figures and procedures described in this chapter relate to the status
at the date of publication of this volume. The manufacturer must always
independently keep themselves informed of the current country-specific
reporting obligations and times.

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36
4.4 Corrective measures
In addition to the general requirements of IATF 16949 (International
Automotive Task Force), the rest of chapter four describes the specific
requirements for product safety and conformity in the
automotive supply chain in the event of product discrepancies.

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Figure 10: Process chart

4.5 Analyse facts of the case

Once circumstances concerning a product discrepancy have been re-
ported by a
company organization or by third parties, they must be analyzed, pre-
pared, and documented for the subsequent steps in the process se-
quence. The resulting facts regarding the situation forms the basis for
the subsequent evaluation of the circumstances, for deriving alternative
actions and the resulting decision made by the decision-makers or in the
decision-making committee.

The facts analysis includes all the findings from the

analysis process carried out by the divisions involved. The contents of
the facts analysis should follow a defined standard in order to ensure
that all relevant information is reproduced as completely as possible.
With this in mind, documentation should also be in a standard format.

37
The following points provide a guideline as to what contents should be
covered in the facts analysis.

 Reported discrepancy or complaint

 What discrepancy/complaint has been identified?

 Cause

 What can the discrepancy/complaint be ascribed to?

 What results are there with regard to analyses (compo-

nent, system, system environment)?

 Effect

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 What effect does the complaint/discrepancy have dur-
ing product use?

 Likelihood of occurrence and risk evaluation

 Determination

 Determinationof the affected components or vehicles

must be carried out (production batch, production peri-
ods, etc.)?

 Amount affected

 How many components or vehicles are affected?

 Country distribution

 To which countries were the affected components or

vehicles supplied?

 Measures

38
  Which measures have been (immediate measures) or will be
(long-term solutions) adopted to enable current series production
to be carried out with no product discrepancy?
What opportunities are there for correcting the components or
vehicles that have been manufactured and/or delivered?

 Is part correction in the supply chain (e.g. spare parts in

aftermarket, parts in plants) necessary?

The process cycle should take place in a period of time and to a level of
detail that is appropriate for the situation.

4.6 Risk evaluation

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Risk evaluation is a fundamental component of the product integrity
process.

The three key elements of a risk evaluation are:

 Severity
 Likelihood of occurrence
 Controllability of effect by affected parties.

4.6.1 Risk evaluation in the supply chain

A risk evaluation must be carried out by the parties involved in the sup-
ply chain with regard to their products. The vehicle manufacturer carries
out the final inspection of the overall vehicle system. Each of the parties
involved in the supply chain must individually determine which criteria
should be used for the risk evaluation in their own area of responsibility.
The legal regulations in the affected countries must be taken into ac-
count.

39
4.6.2 Example method for RAPEX
The guidelines for management of the community system for rapid in-
formation exchange “Rapid Exchange of Information System” (RAPEX)
were defined in the European Commission’s resolution of 16/12/2009
(reference number K (2009) 9843). The description of a guideline for
risk evaluation on consumer products is an integral component of the
resolution. This guideline applies to risk evaluation of issues in the au-
tomotive industry and is summarized in the following section.

The RAPEX risk evaluation has a relatively simple structure (see Figure
11).

First of all, a product’s consumer group is defined and a risk group is

derived from this. A potential injury scenario is now created using the

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consumer and risk groups defined. Both the injury’s possible level of
severity and its likelihood of occurrence is then identified.

The groups are defined using RAPEX help tables. A RAPEX table also
shows the resulting risk. The help tables can be found on the German
Federal Institute for Occupational Safety and Health (Bundesanstalt für
Arbeitsschutz und Arbeitsmedizin - BAuA) site.

40
 Figure 11: Schematic flow chart for a RAPEX risk evaluation

41
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4.7 Resolutions concerning further action
Decisions are made in the decision-making committee based on the
analysis of the specific issue. The range of options for decisions de-
pends on the role that the relevant company takes in the course of its
business activities. Examples of this are: Supplier for an OEM, supplier
with direct business (aftermarket sales), OEM, vehicle customizers. The
legal obligations of the relevant company must be considered here.

Possible common groups of measures are described in the following

section for the OEM and supplier roles, depending on the aforemen-
tioned risk evaluation.

The list makes no claim to completeness.

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Supplier for an OEM
 No measures required
 Introduction of an appropriate internal corrective measure
 Reporting of the circumstances to the affected OEMs in order to
agree further actions
 Report to the authorities

OEM
 No measures required
 Introduction of an appropriate internal corrective measure
 Quality improvement measure (customer service measure with-
out customer notification, during next service visit)
 Quality improvement measure (customer service measure with
customer notification)
 Recall with customer notification and information sent to the rele-
vant authority
 Report to the authorities

42
4.8 Examples

4.8.1 Example case for a Small Medium Enterprise (SME)

This section presents a case study for the overall organization for deal-
ing with PI related product discrepancies, including the notification as-
sessment.

 The company’s management has decided to delegate the deci-

sion-making process with regard to potential product discrepan-
cies to a committee.
 The delegation has been defined and established in a company
guideline.


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The decision-making committee is made up of the following func-
tions:
o Quality
o Production
o Product Safety
o Product conformity
o Product development
o Sales
o Customer services
o Law

 The chair is decided and in this example, is the quality manager.

 Proxy rules for all participants are defined.
 To this end, the job description for the employees affected has
been expanded accordingly. The employees are provided with
the resources, capacities and authority required to perform their
duties.

43
  The company guideline specifies that the decisions in the com-
mittee must be unanimous. If an agreement is not reached, the
decision is escalated to the company management.
 The committee can only take a decision if all competences are
represented. This is determined by the chair at the beginning of
each meeting.
 The decision-making committee meets as required.
 All documents required for this process are defined as standard-
ized forms and are stored centrally.
 Storage of data, with regard to protection against tampering and
access rights, is managed internally.


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The agenda topics are discussed and decided based on a
presentation that presents the specific issue in full.
 Each meeting must be documented with minutes. The minutes
are filed centrally by the chair of the committee.
 The internal reporting process is defined and is an element of the
quality management system andall participating employees are
aware of it. .
 The external reporting process is defined for the supply chain and
communication is standardized.
 The employees are continuously sensitized to the issue of prod-
uct integrity in the course of annual training.

4.8.2 Case study

A case study can be used to present the risk evaluation process and the
reporting path.

 In the course of its business activities, a supplier provides the

same liquid container to two different OEMs, referred to here as
OEM A and OEM B.

44
 OEM A receives leaky liquid containers in the course of its regu-
lar field monitoring and passes them to the supplier for detailed
analysis.
 In the course of its analysis, the supplier identifies that a different
starting material (granulate) has been used to manufacture the
component.
 The supplier verifies the results of its detailed analysis with its
subcontractors.
 The supplier compiles the following information in agreement with
the subcontractors:
o Which starting material was wrongly used?
o Why was it used (cause)?

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o Which production period is affected?
o Has the fault already been corrected?
o If yes, using which measure? If no, which measure will
correct the fault and when will it be implemented?
o Who in the supply chain is still affected?
o If yes, how does the correction take place and whose
responsibility is it? If no, when was the first OK delivery
and how will the correction be carried out?
 The supplier evaluates the effect of the incorrect starting
material being used on the component. The results show that the
temperature resistance of the incorrectly manufactured compo-
nents is only provided up to a lower value. This has an effect on
the strength of the component during vehicle operation. As a re-
sult, these components do not correspond to the originally de-
fined specification. A potential safety issue cannot be ruled out in
the case of a premature failure.
 The supplier informs both OEMs about the circumstances to al-
low evaluation of the component discrepancy in the relevant
vehicle system environment.

45
  In the course of its fault consequence analysis, OEM A deter-
mines that potential danger could result from vehicle operation. In
its analysis, OEM B comes to the conclusion that no
safety hazard could occur. Its component is in a different, non-
critical installation situation in comparison with OEM A.
 OEM B incorporates the circumstances into its regular fault elimi-
nation process.
 In the case of OEM A, the circumstance process is presented to
the decision-making committee with all available information. The
decision-making committee decides further action. In the example
case, OEM A prepares the steps for a safety recall and sends the
information to the relevant authorities.


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The entire supply chain is informed about the respective circum-
stances and the associated result.
 The whole process is communicated, documented and archived
in accordance with the internal company guidelines.
 Both OEM A and OEM B continue their field monitoring as part of
the regular fault elimination process. When doing this, OEM A al-
so includes the effectiveness check on the measure implemented
(safety recall).

A supplier with direct business takes on the role of an OEM in its obliga-
tions for the direct business.

If a measure is defined resulting from the decision-making process, it

must be implemented in the affected markets in a period of time appro-
priate for the circumstances. However, business activity does not stop
when the measures are implemented. Product monitoring must continue
to be carried out in the field in line with the regular fault elimination pro-
cess, in order to assure that the success of the measure implemented is
monitored.

46
5 Examples of tools and methods
5.1 Sensitization of the organization to
product integrity
The overarching company goal must be to ensure product safety and
conformity for all sales markets. In doing so, it is necessary to regularly
check that the established company guideline is up-to-date and, if nec-
essary, to modify it. Employees must be sensitized at regular intervals in
how to correctly deal with issues potentially relevant to product integrity
and the possible consequences of improper action. Figure 12 shows
examples of issues.

Figure 12: Examples of elements and factors influencing product integrity © VDA QMC Gelbband 2018 | Free version | www.vda-qmc.de/publikationen/gelbdrucke

5.2 Continuous monitoring of product integrity

Product integrity must be monitored over the entire product lifecycle. For
example, the measures adopted by the company can be evaluated us-
ing PI key performance indicators.

47
PI key performance indicators should be selected by the relevant com-
pany according to its needs and used to manage product integrity within
the company.

PI key performance indicators relevant for the company could

be:

 Number of employees in an organizational unit who are trained

on PI issues

 Product related (e.g. number of faults identified during devel-

opment phase as part of PI checks)

 Process related (e.g. number of discrepancies identified during

line walks)

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 Project related (e.g. number of discrepancy approvals
relevant for PI after SOP)

 Key performance indicator from product monitoring (e.g. number

of field complaints per product relevant for PI)

After evaluation and monitoring of the company-specific key perfor-

mance indicators, product integrity management should be optimized,
for example by adding to the requirement lists.

To improve the key performance indicators, the company can use appli-
cable established methods:

 Product related risks can be managed using methods such as

FMEA, FTA, DRBFM, etc.

 Process related risks can also be controlled with support from

FMEA, for example, but also using special characteristics, pro-
cess capabilities, machine capabilities, or Poka Yoke.

Examples of these and other methods are outlined in more detail in the
VDA PSR training.

48
5.3 PSB organization or PSR duties at a glance

 Support in product, assembly, or functional group selection from

a PI perspective

 Ensuring conformity with laws and regulations using appropriate

processes

 Creating PI requirements and adapting them for specific prod-

ucts

 Monitoring the product development process utilizing the PI re-

quirements

 Supporting product approval

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 Supporting production:

o Performing line checks according to PI requirements

o Performing/initiating Conformity of Production spot

checks

 Initiating measures in case of discrepancies

 In the event of discrepancies in delivered products, defining es-

calation process in advance, including response plans and re-
sponsibilities

 Deriving lessons learned

Determining and supporting PI knowledge and training requirements at

the location.

49
5.4 Configuration management

Generally speaking, comprehensive configuration management means

managing, dealing with and documenting changes in complex systems -
over the entire product lifecycle.

This includes continuous management and monitoring of adaptations,

corrections, and enhancements. The relevant system and all its compo-
nents should always be in a clearly defined condition, which can be
traced back to its origins.

Configuration management is therefore fundamental for a systematic

and fully transparent product history. Even very minor changes to the
process or product can have far-reaching consequences.

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Examples of proper configuration management could include:
 Version management (e.g. new revision in case of
design changes)
 Change management (e.g. transparency on when
the products underwent a change)
 Build and release management (e.g. transparency of software
adaptations)
 Process changes/adaptations (e.g. documentation of materials
and operating equipment used)

As part of continuous PI management in product development, the fac-

tors influencing the evaluation (see Table 2) must be taken into account
with the involvement of the PSR.

If issues affecting product integrity are raised in the context of configura-

tion management, the relevant PSR should be consulted.

Documenting and archiving any evidence created in line with the com-
pany-specific guidelines is recommended.

50
5.5 Communication guidelines
Communication must take into account the company’s internal commu-
nication guidelines. Country-specific regulations, technical conditions,
and locally applicable laws must be taken into account in specific cases
(see Figure 9).
 Issues relevant for product integrity are to be directed to the re-
sponsible PSR.
 If no direct PSR is appointed, the information should
go to the managing director of the company.
 Defining the communication partners (internal and external) is
recommended.

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Requirements for communication:
 objective, precise,
free of emotions, idiomatic phrases, lack of respect, or slang
 clear and unambiguous
 authoritative
a representation of facts and free of personal
evaluations
The PSR’s duties include sensitization regarding the content and means
of expressing circumstances relevant for product integrity.

It must be possible to refer to relevant information throughout the prod-

uct lifecycle. Structured, consistent and appropriate documentation of
the processes is necessary for this purpose.

Furthermore, all information relevant for the decision should be docu-

mented in a comparable manner. In doing so, it must be ensured that
objective traceability of the process is ensured.

Evidence of the entire product safety process,from identification of a

product discrepancy through to its elimination must be documented.

The recommended specifications for documenting evidence are de-

scribed in the VDA volume “Documented information and storage”.

51
5.6 Lessons learned
The product integrity related lessons learned process must be managed
by the PSR or the PSR organization throughout the product lifecycle as
part of their duty of care. The resulting insights are to be passed on to
the relevant responsible departments for implementation. The general
principles of the lessons learned process are set out in the detail in the
VDA volume on Lessons Learned.

One example method for a product integrity related

lessons learned process is the utilization of PI requirements using a
company-specific procedure.

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Figure 13: Lessons learned process
(Source: VDA volume - Lessons learned)

5.7 Special characteristics

Critical and significant product and process characteristics can be used
for a risk evaluation. Handling of these features should be clearly regu-
lated internally and the affected people must be fully aware of this.

Special characteristics are characteristics that require increased care

and are not covered by other processes (see VDA volume “Special
characters”, chapter 2).

52
6 Glossary

Compliance Adherence to laws and directives,

but also to voluntary codes in
companies

Conformity of Production Conformity of production with the

(CoP) legal requirements

Product liability Liability of a manufacturer for its

product

Product integrity Obligation to adhere to product

(PI) safety and product conformity laws

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Product safety Reasonable safety expectation of
the general public

Product conformity Satisfying legal verifications and

safety related specifications and
standards

Product safety representative Person who is nominated and

(PSR) competent in regard to
product integrity

Quality management system Measures for planning,

(QMS) managing and monitoring
the quality of the operational
service process or the
process result

53
 State of the art Generally recognized technical
rules are the totality of scientific,
technical, and trade experience,
that is broadly known and has
proven correct and usable. It rep-
resents the absolute minimum
level for a product. Falling below
this limit means that the product is
classed as faulty and unsafe.

The latest scientific and technical

knowledge is a collective term for
State of science and the latest generally recognized
technology expertise that is available in the
scientific and technical fields at the

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time of bringing a product into cir-
culation. It refers to the knowledge
that is objectively accessible. Any
patented specialist knowledge or
secret knowledge held by other
market agents is not relevant. It
represents the highest feasible
safety level.

PI management Management of issues relevant for

product integrity

Activities relevant for product in-

PI measures tegrity

PI selection list List of products flagged as being

relevant to PI

PI requirements Tasks relevant to product integrity

based on company-specific indica-
tors for PI related risks.
PI relevance determination Based on the company-specific
indicators for PI risks (see Fig. 6
sources cited)

54
Line walk Checking conformity of PI related
requirements in production

PI key performance indicators Can be defined on a company-

specific basis to manage PI

Bringing into circulation Bringing into circulation describes

the transfer of power of disposal
as part of a surrender for payment
or not for payment to legal or natu-
ral
persons not bound by instructions.
A product can be brought into cir-
culation at any time in its product

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lifecycle (e.g. it applies to sam-
ples/prototypes, series products,
traded products,
significantly modified products,
used products

Deviation approval A deviation approval is permission

for a deviation by the owner of the
risk based on a risk assessment

55
Quality Management in the Automotive Industry
The current version of published VDA volumes regarding
quality management in the automotive industry (QAI) can
be found at http://www.vda-qmc.de.

You can also place orders directly on this homepage.

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Reference:
Verband der Automobilindustrie e.V. (VDA)
Qualitäts Management Center (QMC)
Behrenstraße 35, 10117 Berlin, Germany
Phone +49 (0) 30 8978 42-235,
Fax +49 (0) 30 8978 42-605
E-mail: info@vda-qmc.de, Internet: www.vda-qmc.de

56
57
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