VDA Volume Product Safety and Conformity - February 2018
VDA Volume Product Safety and Conformity - February 2018
VDA Volume Product Safety and Conformity - February 2018
ISSN 0943-9412
Published: February 2018
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Copyright 2018 by
Germany
Non-binding VDA recommendation of standards
The German Association of the Automotive Industry (VDA) recommends
that its members apply the following standard for the implementation
and maintenance of QM systems.
Exclusion of liability
This VDA volume is a recommendation that is freely available for
general use. Anyone who implements it is responsible for ensuring that
it is used correctly in each case.
Copyright protection
This publication is protected by copyright. Any use outside of the strict
limits of copyright law is not permissible without the consent of the VDA
and is punishable. This applies in particular to copying, translation,
microfilming, and storing or processing in electronic systems.
Translations
This publication will also be issued in other languages. The current
status must be requested from VDA QMC.
3
Preface
Increasing globalization is accompanied by both new business opportu-
nities and risks. The opening up of new markets offers the opportunity of
gaining new customers. However, organizations therefore do not just
have to deal with the new customers, but also with their cultures and the
country-specific laws and requirements that apply for products. Fur-
thermore, the sensitivity and connectedness of product users and au-
thorities as well as the public discussions concerning the topic of prod-
uct safety and conformity have increased significantly.
The present VDA volume sets out recommendations for action. Terms
and approaches are explained using examples.
The purpose of this practical paper with its examples is to further strengthen
the collaboration between the automotive manufacturers and their sup-
pliers in the field of quality.
4
Contents
Preface 4
Introduction 6
4 Examples 29
4.1 Example presentation of an organizational process in a medium-
sized organization 29
4.2 Example case 31
5
Introduction
Each organization is obliged to ensure the safety and conformity (valid
laws and regulations) of the goods it produces. Product safety means
that products must not endanger people’s health and safety. This ap-
plies to both the intended use and foreseeable misuse of the products.
Conformity means that the products comply with the legal requirements
in the relevant sales region.
The question of when a product is safe and conform is not uniformly
defined in the various legal systems in the different sales regions. Never
the less almost all legal systems agree on one thing – only safe and
conform products may be introduced to market. Product conformity
The purpose of the present VDA volume is not to outline the individual
obligations for all parties involved within the supply chain or provide
them in the various country-specific legal systems. The publication is
rather intended to give recommendations to all parties involved in the
product manufacturing process concerning collaboration in the event
that a product nonconformity is identified regarding product safety or
conformity. Product nonconformity is understood to be non-conformity
6
with the agreed upon characteristics or functions of a product. Further-
more, this VDA volume also gives recommendations concerning swift
internal processing and evaluation of the circumstances. In doing so, the
objective is to allow a timely and appropriate implementation of
measures, where necessary.
The following explanations may be relevant for each of the parties in-
volved in the supply chain (from the smallest organizations to large cor
7
porations), whereby the required scope and implementation has to be
individually customized on a case-by-case basis. The present VDA vol-
ume therefore makes no pretense of being complete.
8
1 Product safety system
For manufacturers in the supply chain (e.g. software suppliers, service
suppliers, and parts suppliers up to overall vehicle manufacturers) dif-
ferent obligations and tasks arise. This is the case when product non-
conformities with regard to product safety or conformity could be present
in products that have already been supplied.
The aim is that relevant circumstances are quickly, efficiently, and com-
prehensively processed and a decision is taken. This can be achieved
by establishing an appropriate structure within the organization and by
defining relevant processes.
9
1.1 Structure of an organization for product
safety and conformity
Product monitoring and the obligations derived from it are a fundamental
and legally-prescribed requirement of product manufacturers and dis-
tributing organizations.
In order that swift and precise action can be taken in the case of rele-
vant product nonconformities, it is necessary that the responsibilities
and approach are clearly structured within an organization.
10
1.2 Implementation of a recall management sys-
tem in the organization
If the safety or conformity of a product is not ensured, suitable measures
must be taken. For example, this can include an obligation to report to
authorities, a product warning, reworking, 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.
Behörde
n-tier/ 1st-tier/
OEM Produktnutzer
Supplier Supplier
Händler
11
If possible nonconformities relevant for safety or conformity are identi-
fied in the course of product monitoring, this information must be
promptly passed on to the affected interface partners in the supply chain
for further risk analysis. In the event of a nonconformity that has to be
reported, it is generally advisable for the OEM to submit the report to the
authorities and, if necessary, to the product users or dealers. The rea-
son for this is that the consequence of possible nonconformities on a
component concerning the risk assessment can only be appropriately
and comprehensively evaluated in the overall vehicle system. However,
if the supplier has its own reporting obligations, it must, if necessary,
also individually report to the authorities. This should take place with the
involvement of the OEMs affected. Moreover, suppliers with direct cus-
12
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1. Incident reported
(OEM, supplier,
or other sources)
2. Initial analysis by
OEM (vehicle system)
and/or supplier (sub-system)
3. Incident
No
determined
based on initial
analysis?
5. Documentation
(End)
6. Risk assessment
by OEM on vehicle level
(if applicable w/ supplier)
Yes
8. OEM reports to authorities
(and informs supplier- if applicable)
10. Potential
unreasonable safety No
risk on vehicle level or
violation of regulations /
standards?
Yes
14
Table 1: Explanation of the example reporting process in Figure 2.
2 R/S R/S The initial analysis can be performed on two different levels:
-on the overall vehicle level by the OEM
-on the sub-system level by the OEM or the supplier
5 R S All relevant information will be documented and the process will be closed.
6 R S OEM performs risk assessment for the verified incident. The assessment is
performed on overall vehicle level. The supplier provides support on sub-
system-level if requested.
7 R S Based on the result of the risk assessment to determine whether there are
non-conformities with state standards or industrial standards regarding
protection of personal or property safety or any other unreasonable risks to
personal or property safety.
8 R (I) If a potential risk cannot be excluded, the OEM shall report to the authorities
within 5 working days. If applicable, the supplier is to be informed by OEM as
well.
9 R If the joint risk assessment performed by OEM and supplier does not lead to a
report to the authorities through OEM, the supplier has to check his own
reporting responsibility.
10 R The supplier shall further evaluate whether the incident related to his product
could lead to nonconformities with state standards or industrial standards
regarding protection of personal or property safety or any other unreasonable
risks to personal or property safety in the vehicles in China market use this
product.
15
This reporting process can also be transferred to the n-tier in a similar
form. It correspondingly reports to its respective higher-level suppliers at
all times.
The figures and approaches described in this chapter relate to the sta-
tus 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.
16
2 Organizational structure
17
This decision-making process must be clearly described in terms of
responsibilities within the organization and, if necessary, the internal
and external supply chain. Internal suppliers must be dealt with in line
with the relationship with external suppliers. This also includes docu-
mentation and communication.
Quality
Production
Sales, Aftersales
Legal
18
If possible, it should include the following content:
Affected product
Type of nonconformities
19
2.4 Sensitization of the organization to product
safety and conformity
The overarching organization 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 organization guideline is up-to-date and, if
necessary, to modify it. At least the employees involved must be made
aware of the correct handling of topics potentially relevant to product
safety and conformity at regular intervals, and the possible conse-
quences of improper handling.
20
3 Product safety process
Among the general demands of the IATF 16949 (International Automo-
tive Task Force) this chapter describes the special requirements for
product safety and product conformity in the automotive supply chain.
no
Possible
Product monitoring safety/legal
in the market issue
21
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 overall vehicle; for suppliers
it generally only refers to the supplied product.
The statement of facts includes all the findings from the analysis pro-
cess carried out by the parties involved. The contents of the statement
of facts should follow a defined standard in order to ensure that all rele-
vant information is reported as completely as possible. With this in mind,
documentation should also be in a standard format.
22
Containment
Narrowing down of the affected components or vehicles (produc-
tion batch, production periods, etc.)?
Amount affected
How many components or vehicles are affected?
Country distribution
To which countries were the affected components or vehicles
supplied?
Measures
23
3.3 Risk assessment
Risk assessment is a fundamental component of the product safety
process.
24
The RAPEX risk assessment is structured relatively simply (see Figure
4). 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
consumer and risk groups defined. Both the injury’s possible level of
severity and its likelihood of occurrence is then identified from this. 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.
25
26
Figure 4: Schematic flow of the RAPEX risk assessment
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3.4 Resolutions concerning further action
Decisions are made in the decision-making committee based on the
analysis of the facts. The range of options for decisions conforms to the
role that the relevant organization takes in the course of its business
activities. Examples of this are: Supplier for an OEM, supplier with direct
business (aftermarket sales), OEM, vehicle conversion or modification.
The legal obligations of the relevant organization must be considered
here.
OEM:
No measures required
Introduction of an appropriate internal corrective action
Quality improvement measure (customer service campaign
without customer notification, during next repair shop/ gar-
age/dealer visit)
Quality improvement measure (customer service campaign with
customer notification)
Recall with customer notification and information sent to the rel-
evant authority
Report to the authorities
27
A supplier with direct business takes over the role of an OEM in its obli-
gations for the direct business.
28
4 Examples
29
The committee can only make decision if all skills are repre-
sented. 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.
The agenda topics are discussed and decided by means of a
presentation that presents the circumstances in full.
30
4.2 Example case
The risk evaluation process and the reporting path is presented as a
whole with an example case.
31
These components thereby do not correspond to the originally
defined specification. A potential safety issue cannot be ruled
out in the case of a premature failure.
32
Quality management in the automotive industry
The current version of published VDA volumes regarding quality man-
agement in the automotive industry (QAI) can be found at
http://www.vda-qmc.de.
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
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