20 EXAMPLES

OF POTENTIAL
NONCONFORMITIES
IN IATF 16949
AUDITS
RELATED TO
FMEA AIAG-VDA
IN AUTOMOTIVE INDUSTRY

Prepared by
Agata Lewkowska Ph.D.
 Disclaimer &
copyright
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Any convergence of the described situations with people, organizations, companies
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No part of this e-book may be reproduced or transmitted in any form or by any

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Qualitywise®.

This e-book contains excerpts from:

IATF 16949: 2016 Requirements for quality management systems in serial
production and the production of spare parts in the automotive industry,
1st edition, 2016
FMEA AIAG-VDA, 1st edition, 2019
ISO 9000:2015 Quality management systems — Fundamentals and
vocabulary
ISO 9001:2015 Quality management systems — Requirements

Photography copyright:
Agata Lewkowska Ph.D.
FMEA Akademie GmbH

June 2023
Meet the author
OF THIS E-BOOK

AGATA LEWKOWSKA PH.D.

THE FOUNDER OF QUALITYWISE ®

Since 2007 Agata has been working with "quality" in

production organizations in the automotive supply chain.

Agata provides:
Trainings in quality management i.e. ISO 9001 and IATF
16949, VDA 6.3, core tools, auditing.
Consulting in the field of quality management in the
automotive industry.
1st and 2nd site audits for compliance with ISO 9001
and IATF 16949.
VDA 6.3 audits.
Rediness audits for ISO 9001 and IATF 16949
certification.
Quality management system implementation and
maintanance.
Supplier evaluation / development.
Lectures in the discipline of management and quality
sciences

"I hope this e-book will help you to understand basic

quality management system requirements related to work
with risk management such as FMEA. However, in this e-
book strong emphasis was put on FMEA according to
AIAG-VDA due to more OEMs/customer pressure to use
this approach."
Best regards,

LEARN MORE ABOUT

QUALITYWISE ®
About this
e-book
EUROPEAN FMEA
CONGRESS IN VIENNA
was an event in which I hold a lecture
about "20 examples of wrongly
implemented FMEA AIAG-VDA causing
nonconformities in IATF 16949 audits".
The interest of this topic was so big that
I decided to create this valuable e-book
for you to avoid future nonconformities
in your organization.

I wish you good luck with your FMEA

AIAG-VDA!
 Just before you will start
reading this e-book...
The first aim of this e-book is to help your organization in quality and risk
awareness increase relevant for work with FMEA. This method is
supporting "risk-based thinking" strongly incorporated in automotive
industry and is connected to certain requirements in IATF 16949. However,
bare on mind that there is no approach indicated in those requirements.

Due to stronger pressure from OEMs for FMEA acc. to VDA-AIAG

implementation the second aim of this e-book is to make you aware which
nonconformities may be obtained during an audit. This may help you to
investigate the probability of them in your organization. But before you will
read the potential nonconformities, please make sure you understand what
audit criteria means.

Read this short explanation how to read this e-book.

On the top of each page
you will find
potential nonconformity

FMEA AIAG-VDA: POINT 1.3.2

"Senior anagement carriers the responsibility for the
Audit criteria with application of FMEA."

the requirements
you will find here. ISO 9001:2015 P. 5.1.1.D)
LEADERSHIP AND COMMITMENT
Bare on mind that
"Top management shall demonstrate leadership and

in this e-book you commitment with respect to the quality management system by:
(...)
d)promoting the use of the process approach and risk-based
will find those - not thinking;
(...)."

full - criteria as an
excerpt of whole ISO 9001:2015 P. 5.1.2 1
CUSTOMER FOCUS
requirement which
"Top management shall demonstrate leadership and

are FMEA/ risk commitment with respect to customer focus by ensuring that:
(...)

analysis relevant
b)the risks and opportunities that can affect conformity of
products and services and the ability to enhance customer
satisfaction are determined and addressed (...)."

only.
 Source of
the nonconformity

Have you ever felt a feeling of insecurity and stress hearing that an audit is coming?
Moreover, you must take part in it as an auditee? Unfortunately, it is not well remarked
because it means a verification/control. Consequently, it may reveal a non-compliance
with the requirements against which it is carried out.

But is it really to be feared? In fact, only then it can be appreciated as an effective tool
to prevent any nonconformity and to help top management achieve the
organization’s goals which is aligned with audit definition:

AUDIT IS A SYSTEMATIC, INDEPENDENT AND DOCUMENTED PROCESS OF

OBTAINING OBJECTIVE EVIDENCE AND EVALUATING IT OBJECTIVELY TO
DETERMINE THE EXTENT TO WHICH AUDIT CRITERIA ARE MET.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary, p.3.13.1

SO...WHAT ARE AUDIT CRITERIA THEN?

AUDIT CRITERIA – A SET OF POLICIES, PROCEDURES, OR REQUIREMENTS
THAT ARE REFERENCED FOR OBTAINING OBJECTIVE EVIDENCE (I.E. DATA
THAT CONFIRMS THE EXISTENCE OR TRUTH OF SOMETHING) FROM AN
AUDIT.
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary, p.3.13.7

In this e-book it is IMPORTANT to understand that audit criteria in connection to

FMEA AIAG-VDA may come from 2 sources:

1. ISO 9001:2015 and IATF 16949:2016 STANDARD ....and Customer Specific

Requirements connected to this standard
2. Internal organizational requirements connected to implementation of FMEA
AIAG-VDA (thus requirements derived from this method itself).

Based on it in this e-book the potential nonconformities are presented according to

these 2 sources.
 1.No top management
commitment for risk
analysis.

FMEA AIAG-VDA: POINT 1.3.2

"Senior anagement carriers the responsibility for the
application of FMEA."

ISO 9001:2015 P. 5.1.1.D)

LEADERSHIP AND COMMITMENT
"Top management shall demonstrate leadership and
commitment with respect to the quality management system by:
(...)
d)promoting the use of the process approach and risk-based
thinking;
(...)."

ISO 9001:2015 P. 5.1.2 1

CUSTOMER FOCUS
"Top management shall demonstrate leadership and
commitment with respect to customer focus by ensuring that:
(...)
b)the risks and opportunities that can affect conformity of
products and services and the ability to enhance customer
satisfaction are determined and addressed (...)."
 2. No moderator
formally assigned.

FMEA AIAG-VDA: POINT 1.5.3.

"FMEA Team:
The FMEA team consists of multi-disciplinary (cross-functional)
members who encompass the necessary subject matter
knowledge. In this point we will find also an indication of
suggested DFMEA and PFMEA team meambers.

Facilitator is laways a part of each team and leads to the success

of the efficient FMEA analysis management. This role was also
indicated by QualityWise society as a crucial for a success of
FMEA analysis.

FMEA facilitator responsibilities are described in point 1.5.3.3.3

i.e.:
"x Coordination and organization of the workflows in the FMEA
x Method competence (FMEA) and familiarization of participants
in the FMEA method
x FMEA Software documentation competence (as necessary)
x Social skills, able to work in a team
x Managing execution of the 7 steps of FMEA method
x If necessary, Preparation or wrap-up of FMEA meetings
x Moderation of the FMEA workgroup

IMPORTANT: Any team member with the relevant competence

and training may fulfill the role of facilitator."
 2. No moderator
formally assigned.

ISO 9001:2015 P.7.2

COMPETENCE
"The organization shall:
a)determine the necessary competence of person(s) doing work
under its control that affects the performance and effectiveness
of the quality management system;
b)ensure that these persons are competent on the basis of
appropriate education, training, or experience;
c)where applicable, take actions to acquire the necessary
competence, and evaluate the effectiveness of the actions
taken;
d)retain appropriate documented information as evidence of
competence."

IATF 16949:2016, P.7.2.1

COMPETENCE – SUPPLEMENTAL
"The organization shall establish and maintain documented
processes for identifying training needs including awareness
(see section 7.3.1)* and achieving competence of all personnel
performing activities affecting conformity to product and
process requirements. Personnel performing specific assigned
tasks shall be qualified, as required, with particular attention to
the satisfaction of customer requirements.

ISO 9001:2015 p.7.3 Awareness

"The organization shall ensure that persons doing work under
the organization’s control are aware of:
(...)
c)their contribution to the effectiveness of the quality
management system, including the benefits of improved
performance;
(...)."
 3.No
multidisciplinary
approach.
FMEA AIAG-VDA: POINT 1.5.3.
"FMEA Team:
The FMEA team consists of multi-disciplinary (cross-functional)
members who encompass the necessary subject matter
knowledge.

The success of the FMEA depends on active participation of the

cross-functional team as necessary to focus on the topics of
discussion."

IATF 16949:2016, P. 8.3.2.1

DESIGN AND DEVELOPMENT PLANNING
– SUPPLEMENTAL
"The organization shall ensure that design and development
planning includes all affected stakeholders within the
organization and, as appropriate, its supply chain. Examples of
areas for using such a multidisciplinary approach include but are
not limited to the following:
(...)
c) Development and review of product design risk analysis
(FMEAs), including actions to reduce potential risks;
d) Development and review of manufacturing process risk
analysis (for example, FMEAs, process flows, control plans, and
standard work instructions)."
 4.No meeting CSRs
regarding using FMEA
acc. to AIAG-VDA.

IATF 16949:2016, P.4.3.2

CUSTOMER-SPECIFIC REQUIREMENTS
"Customer-specific requirements shall be:
evaluated
included in the scope
of the organizations quality management system."

*LET'S REMEMBER ABOUT REVERSE FMEA AS WELL!

 5.No reference to risk
analysis in process audit
or too small risk-based-
thinking approach
applied.
IATF 16949:2016, P.9.2.2.3
MANUFACTURING PROCESS AUDIT
"(…)
The manufacturing process audit shall include an audit of the
effective implementation of the process risk analysis such as
(PFMEA), control plan, and associated documents."

Informative only:

FMEA AIAG-VDA: POINT 1.5.4 FMEA TASKS

"The FMEA may also be audited by an internal auditor, customer auditor, or third-
party registrar to ensure each task has been fulfilled."
 6.No linkage to FCh and
CP and between DFMEA
and PFMEA itself.
FMEA AIAG-VDA: POINT 1.4.3
COLLABORATION BETWEEN FMEAS
"(...) A good starting point for a manufacturer is to make sure the
severity in the DFMEA and PFMEA are the same when the failure
effects are the same. If the “product” failure effects to the end user
(vehicle-level) are not included in the PFMEA then the correlation
between the DFMEA and PFMEA is not possible. A correlation needs
to be made so that a failure of a feature in design that leads to a
certain failure effect is also captured in the PFMEA for the same
feature (product characteristic)".

FMEA AIAG-VDA: POINT 3.4.8

RELATIONSHIP BETWEEN PFMEA AND DFMEA
"A design failure of a feature (product characteristic) can cause a
failure for one or more product functions. The corresponding process
failure is the inability of the process to manufacture the same feature
as designed.
The failure to conform to a product characteristic alone leads to the
Failure Effect. Only in this case is the Failure Effect in the Design
FMEA the same as in the Process FMEA. All Failure Effects which are
caused by a failure of the processes and which are not identified in
Design FMEA have to be newly defined and assessed in the Process
FMEA.
The Failure Effects related to the product, system, and/or end user
and their associated severities should be documented when known,
but not assumed. The key to the dentification of Failure Effects and
associated severities is the communication of the involved parties
and the understanding of differences and similarities of the analyzed
failures in DFMEA and PFMEA."
 6.No linkage to FCh and
CP and between DFMEA
and PFMEA itself.

IATF 16949:2016, P. 8.5.1.1

CONTROL PLAN
"(...)
The organization shall have a control plan for pre-launch and
production that shows linkage and incorporates information from the
design risk analysis (if provided by the customer), process flow diagram,
and manufacturing process risk analysis outputs (such as FMEA).
(...)."
 7.Missing special
characteristics in
FCh, FMEA, CP.

IATF 16949:2016, P. 8.3.3.3

SPECIAL CHARACTERISTICS
"(...)
a) Documentation of special characteristics in the product and/or
manufacturing documents drawings (as required), relevant risks
analysis (such as Process FMEA), control plans, and standard
work/operator instructions; special characteristics are identified
with specific markings and are documented in the manufacturing
documents which show the creation of, or the controls required, for
these special characteristics;
(...)."
 8.Too optimistic
scoring, especially
detection.
FMEA AIAG-VDA: POINT 2.5.9
DFMEA DETECTION (D)
"The Detection rating (D) is an estimated measure of the
effectiveness of the detection control to reliably demonstrate the
failure cause or failure mode before the item is released for
production. The detection rating is the rating associated with the
most effective detection control.
Detection is a relative rating, within the scope of the individual
FMEA and is determined without regard for severity or
occurrence. Detection should be estimated using the criteria in
Table D3.(...)
The detection rating is initially a prediction of the effectiveness of
any yet unproven control. The effectiveness can be verified and re-
evaluated after the detection control is completed. However, the
completion or cancellation of a detection control (such as a test)
may also affect the estimation of occurrence."

FMEA AIAG-VDA: POINT 3.5.8

PFMEA DETECTION (D)
"Detection is the rating associated with a prediction of the most
effective process control from the listed detection-type process
controls. Detection is a relative rating, within the scope of the
individual FMEA and is determined without regard for Severity or
Occurrence. Detection should be estimated using the criteria in
Table P3. (...)
The intent of the term “control discrepant product” used in Table
P3 Ranks 3 and 4 is to have controls/systems/procedures in place
that controls the discrepant product in such a manner, that the
probability of the product escaping the facility is very low.
The controls start from when the product is identified as
discrepant to the point of final disposition. These controls usually
exceed controls that are used for discrepant products with higher
Detection Ranks."
 9.Missing knowledge
how to designate
special characteristics.

FMEA AIAG-VDA: D ADDITIONS

D1 SPECIAL CHARACTERISTICS
"Special Characteristics are intended to provide information
regarding design characteristics which require particular attention
to process controls. Characteristics which lead directly to a failure
of a product function in regard to safety, fit, form, performance,
further processing of the product, or compliance to government
regulations and industry standards may be identified as Special
Characteristics.
(…) Special Characteristics are marked with abbreviations or
symbols* in documents such as Product documents (as required),
Process FMEA (Special Characteristics column) and Control Plans.
(…) The Design FMEA is one of several inputs to the selection of
Special Characteristics. The team may use the Design FMEA to
highlight when process controls may be needed to ensure
conformance to specifications. The Design FMEA Form Sheet
column named “Filter Code (Optional)” may be used to document
that information.
To properly identify Special Characteristics, the Process FMEA team
considers how variation in the manufacturing process can affect
the functionality of the product. In other words, characteristics may
be sensitive to manufacturing/assembly variation (Special
Characteristic) or not sensitive to manufacturing/assembly
variation (Standard Characteristic).
The Process FMEA contains the column titled “Classification”. This
column may be used to specify Special Characteristics (e.g. critical,
key, major, significant) that require additional process controls."
 9.Missing knowledge
how to designate
special characteristics.
IATF 16949:2016, P. 8.2.3.1.2 CUSTOMER-
DESIGNED SPECIAL CHARACTERISTICS
"The organization shall conform to customer requirements for
designation, approval documentation, and control of special
characteristics."

IATF 16949:2016, P. 8.3.3.3

SPECIAL CHARACTERISTICS
"The organization shall use a multidisciplinary approach to
establish, document, and implement its processes to identify
special characteristics, including these determined by the
customer and the risk analysis performed by the organization (...)."
 10.Discrepancy on the
shopfloor and in FMEA.
IATF 16949:2016, P. 9.1.1.1
MONITORING AND MEASUREMENT OF
MANUFACTURING PROCESSES
"(...)
The organization shall verify that the process flow diagram, PFMEA,
and control plan are implemented, including adherence to the
following:
a) measurement techniques;
b) sampling plans;
c) acceptance criteria;
d) records of actual measurement values and/or test results for
variable data;
e) reaction plans and escalation process when acceptance criteria
are not met."
11.Lack of understanding
Failure Chain: missing
FM with FE/FC.

FMEA AIAG-VDA: STEP 4

Step 4 in the Function Analysis begin building the Failure Chain.
The very good understanding of these 3 definition plays here a
crucial role for creation of a good Failure chain:

1. Failure Effects (FE):

"The effect of failure associated with the “Next Higher Level Element
and/or End User” in the Function Analysis."
2. Failure Mode (FM):
"The mode (or type) of failure associated with the “Focus Element” in
the Function Analysis."
3. Failure Cause (FC):
"The cause of failure associated with the “Next Lower Element or
Characteristic” in the Function Analysis."
11. Lack of understanding
Failure Chain: missing
FM with FE/FC.
ISO 9001:2015 P.7.2
COMPETENCE
"The organization shall:
a)determine the necessary competence of person(s) doing work
under its control that affects the performance and effectiveness
of the quality management system;
b)ensure that these persons are competent on the basis of
appropriate education, training, or experience;
c)where applicable, take actions to acquire the necessary
competence, and evaluate the effectiveness of the actions
taken;
d)retain appropriate documented information as evidence of
competence."

IATF 16949:2016, P.7.2.1

COMPETENCE – SUPPLEMENTAL
"The organization shall establish and maintain documented
processes for identifying training needs including awareness
(see section 7.3.1)* and achieving competence of all personnel
performing activities affecting conformity to product and
process requirements. Personnel performing specific assigned
tasks shall be qualified, as required, with particular attention to
the satisfaction of customer requirements.

ISO 9001:2015 p.7.3 Awareness

"The organization shall ensure that persons doing work under
the organization’s control are aware of:
(...)
c)their contribution to the effectiveness of the quality
management system, including the benefits of improved
performance;
(...)."
 12.Missing FE from
end user perspective.

FMEA AIAG-VDA: POINT 2.4.4

DFMEA FAILURE EFFECTS
"Describe effects on the next level of product integration (internal
or external), the end user who is the vehicle operator (external),
and government regulations (regulatory) as applicable.
Customer effects should state what the user might notice or
experience including those effects that could impact safety. The
intent is to forecast the failure effects consistent with the team's
level of knowledge. A failure mode can have multiple effects
relating to internal and external customers.
Effects may be shared by OEMs with suppliers and suppliers with
sub-suppliers as part of design collaboration."

FMEA AIAG-VDA: POINT 3.4.4

PFMEA FAILURE EFFECTS
"Failure Effects are related to functions of the process item (...).
Failure Effects are described in terms of what the customer
might notice or experience.
Customers could be:
Internal customer (next operation/subsequent
operation/operation tar-gets)
External customer (Next Tier Level/OEM/dealer)
Legislative bodies
Product or Product end user/operator."
 12.Missing FE from
end user perspective.

FMEA AIAG-VDA: POINT 3.4.4

PFMEA FAILURE EFFECTS
"Failure Effects are given a Severity rating according to:
1. Your Plant: the effect of the failure mode assuming the defect is
detected in the plant (what action will the plant
take, e.g., scrap)
2. Ship-to plant: the effect of the failure mode assuming the defect
is not detected before shipping to the next plant
(what action will the next plant take, e.g., sort)
3. End user: the effect of the process item effect (what will the end
user notice, feel, hear, smell, etc.)"

FMEA AIAG-VDA: POINT 3.5.6

PFMEA SEVERITY (S)
"Severity is a rating number associated with the most serious effect
for a given failure mode for the process step being evaluated. It is a
relative rating within the scope of the individual FMEA and is
determined without regard for Occurrence or Detection.
For process-specific effects, the Severity rating should be
determined using the criteria in evaluation Table P1. "

*Table P1 contains 3 perspectives of severities of the Failure Effect.

 13.Missing auditors'
competencies/
knowledge about
FMEA AIAG-VDA.
IATF 16949:2016, P. 7.2.3
INTERNAL AUDITOR COMPETENCY
"(…) Quality management system auditors shall be able to
demonstrate the following minimum competencies:
(...)
d) Understanding of applicable core tool requirements related
to the scope of the audit;
(...).

At a minimum, manufacturing process auditors shall

demonstrate technical understanding of the relevant
manufacturing processes to be audited, including process risk
analysis (such as PFMEA) and control plan. (...)"

IATF 16949:2016, P. 7.2.4

SECOND-PARTY AUDITOR COMPETENCE
"The organization shall demonstrate the competence of the
auditors undertaking the second-party audits. Second-party
auditors shall meet customer specific requirements for auditor
qualification and demonstrate the minimum following core
competencies, including understanding of:
(….)
d) Applicable manufacturing processes to be audited, including
PFMEA and control plan;
(...)."
 14.Missing
information taken
from the
requirements in
FMEA.
IATF 16949:2016, P. 8.7.1.4
CONTROL OF REWORKED PRODUCT
"The organization shall utilize risk analysis (such as FMEA)
methodology to assess risks in the rework process prior to a
decision to rework the product. If required by the customer, the
organization shall obtain approval from the customer prior to
commencing rework of the product. (...)"

IATF 16949:2016, P. 8.7.1.5

CONTROL OF REPAIRED PRODUCT
"The organization shall utilize risk analysis (such as FMEA)
methodology to assess risks in the repair process prior to a
decision to repair the product. The organization shall obtain
approval from the customer before commencing repair of the
product. (...)"
 14.Missing
information taken
from the
requirements in
FMEA.
IATF 16949:2016, P. 8.5.6.1.1
TEMPORARY CHANGE OF PROCESS
CONTROLS
"(...)
The organization shall document the process that manages the
use of alternate control methods. The organization shall include
in this process, based on risk analysis (such as FMEA), severity,
and the internal approvals to be obtained prior to production
implementation of the alternate control method.
(...)"

IATF 16949:2016, P. 10.2.4

ERROR-PROOFING
"The organization shall have a documented process to determine
the use of appropriate error-proofing methodologies. Details of
the method used shall be documented in the process risk
analysis (such as PFMEA) and test frequencies shall be
documented in the control plan. (...)"
 15.Not meeting
management review
inputs.
IATF 16949:2016, P. 9.3.2.1 J)
MANAGEMENT REVIEW INPUTS –
SUPPLEMENTAL

"(...)
identification of potential field failures identified through risks
analysis (such as FMEA),
(...)."

Be aware that during management review in your organization it

shouldn't be a discussion about i.e. status of the work in FMEA,
number of FMEA updated etc.
This requirement says strainght: identification of potential field
failures!!!
 16.Missing changes in
FMEA after problem
solving actions taken.

IATF 16949:2016, P. 10.2.3

PROBLEM SOLVING

"The organization shall have documented processes for problem

solving, which prevent(s) recurrence, including:
(...)
f) reviewing and where necessary, updating the appropriate
documented information (e.g. PFMEA, control plan).
(...)."
 17.FMEA not used in
documented process
for continual
improvement.
IATF 16949:2016, P. 10.3.1
CONTINUAL IMPROVEMENT – SUPPLEMENTAL
" The organization shall have a documented process for continual
improvement. The organization shall include in this process the
following:
(...)
c)risks analysis (such as FMEA);
(...)."

FMEA AIAG-VDA: POINT 2.6.5

DFMEA CONTINUAL IMPROVEMENT
"The DFMEA serves as an historical record for the design.
Therefore, the original Severity, Occurrence, and Detection (S, O,
D) numbers need to be visible or at a minimum available and
accessible as part of version history. The completed analysis
becomes a repository to capture the progression of design
decisions and design refinements."

FMEA AIAG-VDA: POINT 3.6.5

PFMEA CONTINUAL IMPROVEMENT
"The PFMEA serves as a historical record for the process.
Therefore, the original Severity, Occurrence, and Detection (S, O,
D) numbers need to be visible or at a minimum available and
accessible as part of version history. The completed analysis
becomes a repository to capture the progression of process
decisions and design refinements."
 18.Project phase goes
to serial production:
missing lessons
learned collected.

FMEA AIAG-VDA: POINT 1.3.6

FOUNDATION AND FAMILY FMEAS
"Foundation and family FMEAs are recommended to be created
and used as a basis for new analyses. These optional practices
provide the greatest opportunity to leverage past experience and
knowledge and ensure that knowledge is accumulated over
product lifecycles and that prior performance issues are not
repeated (lessons learned)."
=> Identification of baseline FMEA with lessons learned update

IATF 16949:2016, P. 6.1.2.2

PREVENTIVE ACTION
"The organization shall establish a process to lessen the impact of
negative effects of risk including the following:
(...)
f) Utilizing lessons learned to prevent recurrence in similar
processes (see ISO 9001, Section 7.1.6.)."
 18.Project phase goes
to serial production:
missing lessons
learned collected.
ISO 9001:2015 POINT 7.1.6
ORGANIZATIONAL KNOWLEDGE
"The organization shall determine the knowledge necessary for the
operation of its processes and to achieve conformity of products and
services.
This knowledge shall be maintained and be made available to the
extent necessary.
When addressing changing needs and trends, the organization shall
consider its current knowledge and determine how to acquire or
access any necessary additional knowledge and required updates.
NOTE 1 Organizational knowledge is knowledge specific to the
organization; it is generally gained by experience. It is information
that is used and shared to achieve the organization’s objectives.
NOTE 2 Organizational knowledge can be based on:
a) internal sources (e.g. intellectual property; knowledge gained
from experience; lessons learned from failures and successful
projects; capturing and sharing undocumented knowledge and
experience; the results of improvements in processes, products and
services);
(...)."

IATF 16949:2016, P. 8.3.3.1

PRODUCT DESIGN INPUT
"(...) The organization shall have a process to deploy information
gained from previous design projects, competitive product analysis
(benchmarking), supplier feedback, internal inputs, field data, and
other relevant sources for current and future projects of a similar
nature."
 19.Missing "look
across" at other
comparable products
and processes.
ISO9001: 2015
10.2 NONCONFORMITY AND CORRECTIVE
ACTION
10.2.1 REACTION TO NONCONFORMITIES

"When a nonconformity occurs, including any arising from

complaints, the organization shall:
(...)
b) evaluate the need for action to eliminate the cause(s) of the
nonconformity, in order that it does not recur or occur elsewhere,
by:
1. reviewing and analyzing the nonconformity;
2. determining the causes of the nonconformity;
3. determining if similar nonconformities exist, or could potentially
occur;
(...)."
 20.Abuse of generic
FMEA without
adjustment to the
current product and
process.
FMEA AIAG-VDA: POINT 1.3.6.
FOUNDATION AND FAMILY FMEAS
"(...)
When using the family or foundation FMEA approach for the new
product or process under development, the team should identify
and focus the analysis on the differences between the existing
and the new product, process or application. The information
and ratings carried over from the family or foundation are to be
critically examined with regard to the respective use case and
experiences from the known application."
 Look which of these
20 potential NC were
proven as the biggest
troublemakers!
This statistic comes from a survey performed between February and April 2023 in
QualityWise® networking. The results were obtained from 230 professionals who work
with FMEA in their organizations.

Do you confirm this order from your experience?

Use it as your Lessons Learned!

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