N Orma - AMDEC EN 0133200 - C

4444444444444
STANDARD
01 – 33 – 200 / - - C
DESIGN AND PROCESS FMEA
(FAILURE MODE, EFFECTS
AND CRITICALITY ANALYSIS)
Renault Automobiles Standardisation

RE-DS / Department 67210
Section Normes et Cahiers des Charges
RENAULT 01 - 33 - 200 / - - C
This document is to be considered as a whole; its parts must not be separated.
© RENAULT 2011.
Duplication is not permitted without the approval of the issuing department.
No communication permitted without approval from RENAULT.
FIRST ISSUE
December 1986 ---
REVISIONS
November 2000 - - A Complete revision.

This issue originates from draft NC 1999 0171 / - - B
December 2009 - - B Adjusting the standard so that it meets market requirements and
Company requirements.
• Contribution of information to definitions and method in which
risks are analysed and criticality is evaluated.
• Update of evaluation criteria related to Severity, Occurrence and
Design Control.
• Update of RPN thresholds.
• Addition of diagnosis grid to Appendices.
This issue originates from draft NC 2007 0704 / - - -
January 2011 - - C Conformation with the new V3P milestones
This issue originates from draft NC 2011 0084 / - - -
REFERENCED DOCUMENTS
CNOMO Standard : E41.50.530.N.
© RENAULT 2011 Page 2/47

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TABLE OF CONTENTS
Page
GLOSSARY 4
0. LANGUAGE 5
1. SCOPE AND FIELD OF APPLICATION 5
2. DEFINITIONS 6
3. BASIC PRINCIPLE 7
4. DETAILED PROCEDURE FOR THE PRODUCT OR PROCESS FMEA 10
4.1. STAGE 1: INITIALISE 10
4.1.1. Select subjects to be dealt with 10
4.1.2. Organising the FMEA study 10
4.2. STAGE 2: ANALYSIS 11
4.2.1. Preparing the FMEA 11
4.2.2. Identifying potential failures 12
4.3. STAGE 3: EVALUATE - DECIDE 17
4.3.1. Principle of evaluation: 17
4.3.2. Ranking indexes 18
4.3.3. Calculating criticality 20
4.3.4. Classification 20
4.3.5. Deciding corrective actions on a priority basis 21
4.4. STAGE 4: SEARCHING FOR SOLUTIONS 25
4.5. STAGE 5: FOLLOW UP 25
4.6. STAGE 6: APPLY 26
4.7. STAGE 7: CHECK – BUILD KNOWLEDGE 27
4.7.1. Principle of checking 27
4.7.2. Building knowledge based on experience 28
APPENDIX 1: NORMATIVE: SUMMARY SHEET 29
APPENDIX 2: NORMATIVE: LISTING SOURCE DATA AND FUNCTIONAL ANALYSIS TO BE
CARRIED OUT 30
APPENDIX 3: NORMATIVE: PRESENTATION OF THE ANALYSIS GRID 31
APPENDIX 4: NORMATIVE: RATING TABLES 32
APPENDIX 5: NORMATIVE: ADDITIONAL FLOW FMEA 41
APPENDIX 6.1: FOR INFORMATION PURPOSES: DESIGN FMEA DIAGOSIS GRID 44
APPENDIX 6.2: FOR INFORMATION PURPOSES: PROCESS FMEA DIAGNOSIS GRID 46

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GLOSSARY
ABVC : Agreement to Built Vehicle Check (Vehicle Engineering ; V3P logic).
ABPT : Agreement to Built Plant Trial (Mechanical Engineering ; JPOM5 logic).
AMS-lot : S-Lot Assembly Approval (Vehicle Engineering ; E=MC² logic).
AMEI : Approval to Build Initial Samples (Mechanical Engineering ; JPOM4 logic).
AMIOD : Approval to Build Definitive Off-Tool Parts (Mechanical Engineering ; JPOM4 logic).
DLI : Industrial Logistics Department.
DPLI : Manufacturing and Industrial Logistics Department.
Durability : In the dependability area, durability is the capacity of equipment to perform a function until
a limit state is reached (Standard NF X 60-500).
E‰ : is the result indicator of the 3-month Estel survey that polls customer / users of the product.
FMEA : Failure Mode, Effects and Criticality Analysis (FMEA).
Functional Specifications : Functional Specifications.
IOD : Definitive Off-tool Part (Mechanical Engineering ; JPOM4 logic).
K‰ : Warranty cases per thousand.
NCR : Non-Conformity Rate.
RPN : Risk Priority Number.
PIMOL : Vehicle off-road breakdown.
PC : Pre-Contract (Mechanical Engineering ; JPOM5 logic).
PPM : Parts per Million (1 % = 10 K ‰ = 10 000 PPM).
RO : Tooling Go Ahead (Vehicle Engineering ; E=MC² logic).
SdF : Operating Dependability.
S1 ‰ : SOFRES per thousand after the customer has used the product for 1 year.
S3 ‰ : SOFRES per thousand after the customer has used the product for 3 years.
TGA : Tooling Go Ahead (V3P and JPOM5 logics).
VPC : Vehicle Pre-Contract (Vehicle Engineering ; V3P logic).

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0. LANGUAGE
The FMEAs that are compiled for the RENAULT Group must be in French (as a priority) or in English.
1. SCOPE AND FIELD OF APPLICATION
Failure Mode, Effects and Criticality Analysis (FMEA) is a method used to analyse the potential
reliability of a product. This method contributes to the performance of the company.
FMEA favours spending time and cost on prevention so that less will be spent during
correction.
The FMEA is used to identify the potential failures and related consequences that would affect the
correct operation of the product, manufacturing process, production facilities or equipment being
studied. It assess the risks linked to the occurrence of such failures so that corrective actions can be
taken, if needed, at the design, implementation or operational (production, maintenance, monitoring)
phase of the product, manufacturing process, facilities or equipment.
This standard deals with Design FMEA and Process FMEA.
The FMEA applies to the AUTOMOBILE PRODUCT at the different design stages of the Engineering
Department. The scope of the study by system and/or element may cover the following:
• mechanical, hydraulic, electrical, mechatronics technology
• one unit, subset, component, characteristic of the product
• one main function and/or constraint with related value criteria
Note: The FMEA is not the ideal tool for evaluating software.
The FMEA applies to the industrialisation PROCESS of the product used by Production Engineering
departments. The scope of the study by system and/or element may cover the following:
• production process, rework process or inspection process of a product,
• manufacturing operation and/or inter-operation,
• one or n manufactured characteristics, etc.
The FMEA also applies to:
- PRODUCTION FACILITIES during the phase in which the facilities are designed (see Machinery
FMEA – CNOMO Standard E41.50.530.N).
- Physical and facilities WORKFLOWS during the phase in which operational modes are drawn up
(see § 5. ADDITIONAL INFORMATION: FLOW FMEA in this standard).
In the context of projects, FMEA progress and the results obtained are decision-making elements that
the Quality Department takes into consideration before issuing RECOMMENDATIONS and
APPROVALS at Project milestones ("Vehicle" or "Mechanical Unit").
It is the responsibility of the Technical Departments and Suppliers to assume ownership of this
standard.

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2. DEFINITIONS
FMEA
Failure Mode, Effects and criticality Analysis is a rigorous and preventive method that aims at listing
and then evaluating the potential failures of a system and/or element. This method of analysis leads to
the organisation of these failures into a hierarchy based on which the appropriate actions to be taken
can be decided. A schedule that is used to follow up these corrective or monitoring actions is set up.
Application of these measures is checked in the field.
The knowledge gained from every study is used as a diagnosis support and for future projects.
DESIGN FMEA
The scope of the analysis is the design and definition of the automobile product, which is examined in
the various stages of its development before the Part Tooling Development (TGA) stage. This is
undertaken in order to ensure that the technical solution decided upon meets specifications related to
quantified requirements as well as customer expectations and industrial constraints.
Consequences of potential failures must be related to the customer / user of the product (driver,
passenger, another road user, repair network, emergency organisations, recycler, etc.; it may also
relate to regulations).
PROCESS FMEA
The scope of the analysis is designing the industrialisation plan (production process, assembly
process, rework process or inspection process) of an automobile product, which is examined during
the different planned operations of production: manufacturing, inspection, handling, etc. to ensure that
as per the industrial process a product can be mass-produced in compliance with requirements
specified in plans.
Improvement may concern either the product or the process, or both.
Consequences of potential failures must be related to the customer / user of the product.
This standard is also used to indicate the effect that a single type of product non-compliance may
have on manufacturing/assembly, but without obligation (a Process FMEA, in which customer-side
manufacturing/assembly effects are indicated, would not replace a facilities or flow FMEA).
PRODUCTION FACILITY FMEA
The scope of the analysis is the production tool, machine, robot, machining fixture, tooling, etc., which
is examined during the design phase in order to ensure that during operation it will meet objectives
related to product compliance as well as Reliability, Maintainability, Availability, Safety of people and
equipment (FMDS), required in the specifications of the facility.
Consequences of potential failure are relative to the user of the facility: that is, the Manufacturer of the
automobile product.
Note: The production facility FMEA is carried out in compliance with CNOMO standard
E41.50.530.N. It has not been given in detail in this standard.
FLOW FMEA: see additional information in Appendix 5
The scope of the analysis is relative to the movement of parts of the product, its packaging and the
flow of information while the facilities are in operation.
Consequences of potential failures are relative to the Manufacturer and/or Operator as well as the
Industrial Logistics Department.
The FMEA is one of the Operating Reliability tools (see standard 01 33 204)

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Implementing Product, Process, Facilities and Flow FMEA optimises the robustness of the product-process
design on a priority basis and sets up, if needed, a monitoring plan that is adapted to risks.
Functional Requirements
Technical Functional Analysis Design FMEA
Drawing
Drawing
Manufacturing Process Plan Process FMEA
Facilities
Robustness of product/process definition
Facility requirement
Drawings of the facility Facilities FMEA
Logistics diagram Flow FMEA

Operating mode
3. BASIC PRINCIPLE
1) The FMEA is available to every one of us to construct quality and reliability measures that
prevent failures, to meet customer / user requirements and to contribute to the
performance of the industrial system.
In the context of Customer – Supplier relations, every person involved has a task to
accomplish, either on an individual basis or collectively:
. To accomplish task "n", quantified input data from the Supplier who has completed upstream
task "n-1" is necessary.
. While exiting this phase, we must provide results that are in compliance with the objective so
that the person responsible for downstream task "n+1" can complete it.
The FMEA is a tool used to construct quality and reliability that contributes to the completion of
task "n". By implementing the FMEA, it is possible to validate the task or optimise it before
sending it to "its direct Customer" (figure 1).
Added value
F
M
Task n-1 TASK n Task n+1
E
INPUT A OUTPUT
OPTIMISE
Figure 1 – Validate task by taking preventive action on potential failures
Examination of every task in this chain of activities takes place with a view to satisfying the
customer / user of the product.
FMEA studies are planned in a way that they are completed before key decision-making dates in
a project schedule.

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2) "IMAGINE NEGATIVE SCENARIOS", dysfunctional analysis: 3 stages (figure 2)
Stage 1:
A product, process or service is always designed with a positive outcome in mind. When we
speak about a service to be offered to the customer / user of the Product, we speak in terms of
customer satisfaction. This service is then broken down into technical solutions, components,
characteristics, etc. with the aim of making everything run so that the customer / user of the
product is satisfied.
Stage 2:
The FMEA procedure will be based on the critical or negative aspect: "what could possibly
happen to make this service unavailable and to what extent would the Customer / user of the
product be affected by it?" Therefore, here, we list the potential failures that make this service
unavailable.
Stage 3:
The FMEA procedure is definitely not just a critical review of the product or process design. With
this procedure, corrective solutions can be found that are used to optimise the future design of
the product and its industrialisation.
1 Design with a positive outcome in mind
2 Imagine the failures 1 2
3 Remedy the potential failures. _

+
Figure 2
3) EFFECTIVENESS OF THE FMEA IS BASED ON 3 QUALITIES: COMPETENCE, CREATIVITY

AND RIGOUR
Within a multidisciplinary group, the competence of the participants is used to explore the
subject being studied. Each member shares his/her experience and knowledge.
The creativity of the members of the group is put to the test when they have to go beyond their
experience and have to imagine potential failures and those that are the less probable.

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Rigour is developed by implementing the entire FMEA method in a systematic manner. The
FMEA method can be divided into 7 stages (see figure 3 below).
STAGES MEANING – SCOPE WHO

Formalise the subject on a summary • Coordinator
sheet that is made up of: • Requestor
• choice of subject and its limits • Decision-maker
1 INITIALISE • group composition
• planning • Engineering department
• follow-up of results (RENAULT, Partner or
Supplier)
• Present the FMEA and functional analysis of
the requirement and of the Technical Solution
• Imagine potential failures and their • Multi-disciplinary group
2 ANALYSE and coordinator
consequences for the customer-user of
the product by using the analysis sheet
EVALUATE • Evaluate and classify potential failures into a
3 hierarchy based on predetermined Rating • Multi-disciplinary group
DECIDE • Decide to start plans of action for RPN and coordinator
that exceed thresholds
REPORT
LOOK Look for corrective solutions.

FOR This action is undertaken outside the • Product and/or Process
4 CORRECTIVE FMEA group. However, it can be outlined designer
SOLUTIONS during FMEA meetings.
Analyse and evaluate the corrective

5 FOLLOW UP • Multi-disciplinary group
solutions that are being studied until the
and coordinator
RPN are lower than the thresholds.
REPORT
Apply the approved corrective solutions • Action leader (GFE
selected. This action is undertaken (part engineers),
6 APPLY
outside the FMEA group at the designer, etc.) internal
Engineering Dept; applied to industrialisa- or external to
tion methods and during manufacturing. RENAULT
Check the effectiveness of measures • Coordinator
CHECK taken • Multi-disciplinary group
7 KNOWLEDGE- End FMEA (signature) • Requestor, decision-
BUILDING maker
REPORT Build knowledge based on experience by
archiving the study in a database • Coordinator/Requestor
Figure 3

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4. DETAILED PROCEDURE FOR THE PRODUCT OR PROCESS FMEA
Implementing an FMEA consists in methodically rolling out the procedure in 7 stages. The aim of
methodically applying the FMEA is to make a list of potential failures which tends toward
exhaustiveness and resolving them on a preventive basis. Each stage is described below.
4.1. STAGE 1: INITIALISE
The aim of initialisation is to "present a problem” and manage it in time. This first step is fundamental
for the study to be a successful one. It materialises by way of documenting the summary sheet
(appendix 1).
4.1.1. Select subjects to be dealt with
Systematizing the FMEA will only serve to validate that which is already controlled. It would lead to
unnecessary added expenditure for the Company.
On the other hand, the FMEA must be used wherever there are anticipated or measured risks,
innovations, incomplete information or significant issues for the Company.
The project manager (vehicle, system, unit, industrial project, production facilities, etc.) and the Quality
manager draw up a list of subjects at risk as soon as general principles are approved at the design
and industrialisation stages.
INDUSTRIAL PRODUCT OR PROCESS SET

Known and reliable Industrial product or Industrial product or Innovation of the industrial
industrial product or process renewed with process where risks product or process, new Supplier,
process recurring problem are anticipated regulated function/safety
Feedback Failure or cause tree FMEA Tools and Reliability Procedure
Figure 4 – Principle on which subjects are chosen
4.1.2. Organising the FMEA study
It is obligatory for the requestor of the study (project or task "n" manager) who is internal or external to
RENAULT and the FMEA coordinator to document the “summary sheet”, which serves the purpose of
a contract between the requestor and the group. It is made up of the following information:
- FMEA type (product or process)
- Vehicle, unit, scope of the study and key dates: date of request of the FMEA, VPC/PC/Pre-
Contract, CO/Contract, TGA/RO/IOD, ABVC/AMS-lot or ABPT/AMEI.
Important point:
Design FMEA: risks must be cleared (stage 7) for TGA/RO/IOD.
Process FMEA: the action plan must be drawn up for TGA/RO/IOD and risks must be cleared for
ABVC/AMS-lot or ABPT/AMEI.
- The objective (E ‰, K ‰, S1 ‰, S3 ‰, PIMOL, durability, objective of rate of compliance etc.)

and the reason for the study (see appendix 1).
- The name of the requestor (subject manager) and decision-maker (manager of important choices
and decisions).
- The limits of the subject (references related to the product, process plan, etc.).
- Composition of the group (5 to 6 people):
. 1 coordinator proficient in FMEA

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. Participants (Engineering Department, Production Engineering, Manufacturing, etc.) who are
proficient in and are managers of the subject (specify the function in the summary sheet).
- Planning the FMEA over 7 stages according to project milestone dates.
- Resolution of potential risks can be seen in the report.
- Location where the FMEA in progress and the implemented FMEA are archived.
- Study progress:
. as per the schedule,
. as per clearance of potential risks (stage 5)
. as per verification of results (stage 7)
It is the responsibility of the requestor to manage the FMEA. The end of forecast studies (clearing of
risks) is certified by a signature on the summary sheet by the requester or by the decision maker.
4.2. STAGE 2: ANALYSIS
Analysis consists in studying risks that can be imagined and that are known from experience. This
search is always structured on the basis of functional analysis.
4.2.1. Preparing the FMEA
The aim of this first phase is to ensure that all the members of the work group have the same level of
knowledge on the subject and to get specialists to speak about the same scope.
This phase also serves the purpose of ensuring that the participants are familiar with the FMEA
procedure.
Functional analysis includes (see Appendix 2):
- the functional analysis of the requirement, which lists, characterises and develops all service
functions of the system to be studied as well as the phases in the life cycle. Functional analysis
of the requirement (stated in the functional specifications) is a prerequisite to the FMEA.
The FMEA group takes from it the elements necessary for the FMEA study (main and constraints
functions as well as related value criteria that fall within the scope of the study). These elements
are attached to the FMEA file.
- the technical functional analysis, which explains how the solution is supposed to operate, its
organisation, during all the phases of the life cycle that are studied. This analysis is presented in
the form of flow charts. Qualified and quantified operating conditions are listed. The flow chart is a
result of the design phase or is created by the FMEA group.
- the description of the industrial process that is planned for mass producing the product. The
industrial process is defined in the production and inspection process plan. Technical sheets and
the description of the operating mode provide input data. This data can be seen on a process
diagram (or manufacturing diagram or synoptic). Input and output conditions (Customer –
Supplier relationship) are drawn up.
Using functional analysis is mandatory so that the members of the group have the same vision of the
subject and can make a comprehensive list of all the potential failure causes, modes and effects that
are possible as well as Design Controls.

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4.2.2. Identifying potential failures
The aim of the second phase is to highlight all potential failures of the studied system that can be
imagined or that are known. Failures have the following qualitative and quantitative criteria:
Potential failure mode:
The potential failure mode is the manner in which the system will stop running or will run unusually.
To understand a potential failure mode ask yourself the following questions:
What are the potential failure modes that …

- no longer make the operation possible?
- no longer make the operation stop?
- disrupt the operation?
- make the operation unpredictable?
- make the operation …?
Deal with potential failure modes that may appear at 0 km and also those that are likely to appear
over time: reliability of the product (consider the entire product life cycle).
Does it occur…
- totally,
- partially,
- at 0 km,
- over time (e.g.: after 3 months, 7 years, 100 000 kms, above 25 000 cycles, etc.)
- …
Identify and quantify potential failure modes of a component or a set of components on

the basis of the 5 senses:
- touch: e.g.: hardness, seizure
- sight: e.g.: rough break/caused by fatigue, alteration in aspect
- hearing: e.g.: noise
- smell: e.g.: burnt smell, plastic smell
- taste: e.g.: chemical product taste
Remark:
The potential failure mode is expressed in physical terms:
- The potential failure mode arises from operating conditions (see flow chart).
- Wherever possible, quantified criteria will complement information on the potential failure mode
(e.g.: noise heard within the first few kilometres (fault occurs at "0 km"), progressive breaking of
the shaft under 50 daN, 100 000 kms onwards, bearing seizure 150 000 kms onwards, etc. (fault
occurs "over time").
To complement and add to potential failure modes, include failures proven on the replaced product in
the analysis.
Potential cause of failure:
The potential cause of failure is the initial anomaly that is likely to lead to the potential failure mode.
The potential cause of failure is always an unsuitable or non-compliant characteristic of the product:
- as regards the Design FMEA, characteristics of the product that are estimated, unsuitable,
missing, superfluous, etc. must be considered.
- as regards the Process FMEA, characteristics of the product that are manufactured and are
estimated to be non-compliant must be considered.

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When the potential causes of failure are being looked for, it is essential to describe and
formalise the entire causal chain in the analysis grid. This is the potential failure scenario.
Potential failure MODE CAUSE of failure
Manner in which the system stops · initiale cause

running (totally, partially, …) - causal chain
-…
-…
+Remarks:
- Design FMEA:
• to imagine the potential modes and causes of failure, systematically explore the entire body,
contacts and the design and service flows of the flow chart.
• for a given technical function, imagine, for example, 5 to 7 potential failure modes.
• for a potential failure mode, imagine, for example, 5 to 7 potential causes.
• for every potential failure mode, search for the characteristic(s) of the product at the
source of the potential failure (explore: material, geometry, dimensioning, thermal treatment,
appearance, assembly conditions, etc.); always go back to root causes; prohibit causes
related to “incorrect design, incorrect wiring route, etc.”.
- Process FMEA:
• It is necessary to imagine that the product-cause (product characteristic to be manufactured

that is non-compliant or altered by the process even though it was compliant at the time of
input) may lead to a potential failure mode. Then, the causal chain relative to process-causes
must be searched for: "what are the process parameters that are likely to lead to a product-
cause"
• For a product-cause, imagine, for example, 5 to 7 process-causes.
Indication of the potential cause of failure in the grid:
In the analysis grid, the potential cause of failure must be given in the following manner:
Design FMEA: "product-causes" are given in the "cause” column
• Example:
Effect Mode Cause Prevention Detection S O D RPN

Effect E1 Mode A Product-cause A1 Prevention PA1 Detection DA1 S1 OA1 DA1 RPN1
Product-cause A2 Prevention PA2 Detection DA2 S1 OA2 DA1 RPN2
… S1 OA… DA… RPN3
Product-cause An Prevention Pan Detection DAn S1 OAn... DAn RPN4
Effect E2 Mode B Product-cause B1 Prevention PB1 Detection DB1 S2 OB1 DB1 RPN5
Product-cause B2 Prevention PB2 Detection DB2 S2 OB2 DB2 RPN6
… S2 … … RPNn

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Process FMEA: indicate "product-causes" (non-compliance during manufacturing) in the "cause"

column, then, under each product-cause indicate “process-causes”, which lead to the appearance of
the non-compliance. Product and process-causes are given in the “cause” column.
• Example:
Effect Mode Cause Prevention Detection S O D RPN

Effect E1 Mode A • Product-cause A1 Prevention PA1 Detection DA1 S1 OA1 DA1 RPN1
- Process-cause A1p1
- …
- Process-cause A1pn
• Product-cause A2 Prevention PA2 Detection DA2 S1 OA2 DA2 RPN2
- …
• Product-cause An Prevention PAn Detection DAn S1 OAn DAn RPNn
- …
Potential effect of failure:
In the Design and Process FMEA:
The effect of a potential failure is defined by 2 parameters:
- on the one hand, it is related to a disrupted service function,
- on the other, it states the potential consequences for the final user of the vehicle.
Note: If necessary, this standard is also used to indicate the effect that product non-compliance can
have on manufacturing/assembly. In this case, the effect on the customer / user of the product must
also be indicated.
It is the potential failure mode that leads to the disruption of a service function.
Potential EFFECT of failure Potential failure

Potential consequence for the Disturbed service function Mode
customer / user of the product
Dissatisfaction of the customer Service function totally, Manner in which the system/the component
/ user of the product partially, etc. disturbed stops operating (immediately, over time, etc.)
Remarks:
- The wording of the disrupted service functions is chosen on the basis of the potential failure mode
and the functional analysis of the requirement.
- In order to be as thorough as possible, imagine:
. no service function,
. loss of service function,
. unpredictable triggering of the service function,
. degraded service function (over time, at 0 km, etc.),
. service function that is misinterpreted, etc.
- For the Design and Process FMEA, the consequences for the customer / user of the product are
stated on the basis of the table that appears in Appendix 4.
In the flow FMEA, the manufacturer and central production departments are the Customers: DLI (see
appendix 5)

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Design Control:
Design Control is an action planned, in progress or already implemented so as to prevent the potential
failure cause (and/or potential failure mode) from appearing and affecting task N+1.
Design Control is an activity that is carried out by the designer of the product or process to check
whether the design of the product or manufacturing process is in compliance in relation to the
imagined potential failure scenarios.
* Remark:
The later non-compliance is detected, the more considerable business consequences are.
Therefore, for business reasons and as the responsibility of each department, in a Design and
Process FMEA, all potential non-compliance must be detected before going to the next stage in the
design/industrialisation/manufacturing process. This next stage is called “Task N+1” in the rest of the
document.
Task N+1 is the stage which comes immediately after (downstream from) the analysed activity. So, it
does not yet relate to the customer / user of the product (see figure 1).
Examples:
- In the Design FMEA, Task N+1 is an activity that falls under the Industrialisation Methods
Dept (manufacturing process engineering dept).
- In the Process FMEA, Task N+1 is an activity that falls under the Manufacturing sector,
downstream from the studied process.
"Do not generate a defect, do not accept a defect, do not deliver a defect."
Potential failure MODE Potential CAUSE of failure Design Control

Manner in which the • Initial cause: That which is planned, in progress or
system has stopped - causal chain already implemented to prevent the initial
operating (totally, over - ....... potential cause of failure (and/or the
time, etc.) - ....... potential failure mode) from appearing or
affecting task n+1.
There are 2 types of Design Control:
- Actions related to Prevention that aim to prevent the potential cause or failure mode from
appearing; give priority to theoretical Prevention actions. From among the different Design
Controls, certain actions can also be qualified as Prevention actions when they are implemented
with a view to optimising a technical solution so that the potential cause or failure mode does not
appear. They work towards lowering the Occurrence index O:
Example for the Design FMEA:
. analytical study (calculations, chain of dimensions, etc.)
. simulation program at limit states, digital simulation, digital mock-up design review (DMDR),
etc.
. test campaigns (design of experiments)
. correlation of calculations/testing
. "Robust Engineering" study
. compliance with proven design rules, etc.

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Example for the Process FMEA:

. digital simulation, digital mock-up design review (DMDR), etc.
. transformation of functional tolerance into manufacturing tolerance based on chains of
dimensions
. operator training
. increasing the capability of the process
. setting up an anti-error device (poka yoke), etc.
- Actions related to Detection that aim to detect the potential cause or failure mode that is
supposed to have occurred; give priority to theoretical Detection actions. Detection actions
aim to detect the potential cause or failure mode that is supposed to have occurred and work
towards lowering the Detection index D.
Example for the Design FMEA:
. Chain of dimensions to detect interference in a theoretical manner
. Creating a mock-up of a solution to check whether it is operating correctly
. Functional testing at limit states
. Bench testing, durability testing during operation at limit states, etc.
Example for the Process FMEA:
. Simulating the injection of a plastic part to detect areas to which the material has not spread
in a theoretical manner
. Checking the compliance of a characteristic, 100% checking or by sampling
. Checking a process parameter
. Functional testing, etc.
Distinction made between Prevention actions and Detection actions in the analysis grid:
- Prevention actions are entered in the "Prevention" column
- Detection actions are entered in the "Detection" column
Remarks on Prevention and Detection actions:

- In the "Prevention" and "Detection" columns, enter actions that are planned, in progress or
already implemented (those that have to be planned will be described in the action plan
column, if needed).
- In the Design FMEA as well as in the Process FMEA, in order to reduce costs, give priority to
“theoretical” actions (calculations, chains of dimensions, simulations and digital design review,
project reviews, recommendations from Technical Departments and experts, etc.) as far as
possible, over “physical” actions (prototypes, bench or vehicle testing, 100% inspection, etc.).
- Document actions in the most complete manner as possible (qualify and quantify parameters).
Analysis grid:
The following can be saved by using the analysis grid:

- references of the subject, names of analysts, dates of analysis, evaluation and follow-ups.
- subject data to be processed.
- list of potential failures and Design Controls for Prevention and Detection.
Note: The grid is compiled on A3-size paper or online (see Appendix 3).

RENAULT 01 - 33 - 200 / - - C
Summary Design = “Design with a positive outcome in mind”
Service Technical Solution : Components :
to be Characteristics (to be
provided Operating conditions specified, manufactured)
Satisfied
Customer
Composants :
Service Solution characteristic that is
not malfunction unsuitable or manufactured
provided outside tolerances
Unsatisfied
Customer
Potential Potential Cause
Potential Effect of the failure Failure mode of failure
FMEA = "Imagine negative scenarios"
4.3. STAGE 3: EVALUATE - DECIDE
Evaluation consists in quantifying the level of risk of each potential failure in order to help the
requestor, decision-maker and participants of the study to define corrective actions that have to be
given priority.
Evaluation is conducted once the entire analysis (effects, modes, causes and design controls) has
ended. A ranking table lays down the limits that define acceptable risks and those that are not.
4.3.1. Principle of evaluation:
Evaluation is based on the sequence of events that leads to the customer / user of the product
perceiving a failure and to consequences that impact him/her (see figure 5).
For a potential cause of failure to lead to a potential failure mode that impacts the customer / user of
the product, the 3 following conditions need to be fulfilled:
1. The potential cause of failure is supposed to

have appeared. Probability P1 may be attached
P1 Cause Prevention to this event.
P2/1 2. If the potential cause of failure has appeared

then it must necessarily lead to the potential
failure mode that is considered. The probability
Mode attached to this event is conditional probability
Task P2/1.
N
3. The potential cause-mode pair of failure that is
Detection supposed to have appeared will have to have
passed Detection for it to affect Task n+1. Non-
detection probability is called P3. P3
XXXXX
characterises the permeability level of
Customer P3 Detections that are planned or set up by the
Effect person in charge of task N.
Final Task
Customer N+1
User
Figure 5 – Chain of events

RENAULT 01 - 33 - 200 / - - C
Remarks: it is necessary to consider that after task N, there is no more Detection.

Due to this, as regards a Process FMEA for example, even if the potential failure can be detected
because assembly by the Manufacturing sector has been made impossible at the stage that is
downstream from the studied process stage (N+1 or N+2, etc.), this downstream Manufacturing sector
will suffer the consequences in the form of production losses, line stoppage, vehicle blocked in plant
stock before delivery, etc. because it is assumed that the parts in the manufacturing sector process
concerned are compliant.
However, it is possible to have a contract drawn up between the person in charge of task N and the
person in charge of the downstream task (N+1 or N+2, etc.) so that Detection is officially set up and
included in the scope of the person in charge of the downstream task, who then becomes responsible
for it.
If P is the probability that the customer / user of the product is affected by, it can be expressed in the
following manner: P = P1 x P2/1 x P3
4.3.2. Ranking indexes
Ranking is based on 3 indexes and on predetermined ranking, namely:
- Severity index S: is the ranking of the consequences of each potential failure perceived by the
customer / user of the product (see Appendix 4).
In the Process FMEA, it is also possible to indicate in a timely manner the effect of product non-
compliance has on manufacturing/assembly. In this case, for every potential failure that has an
effect on manufacturing/assembly, the consequences for the customer / user of the product must
also be indicated and both will have to be dealt with.
- Occurrence index O: corresponds to the probability that the product cause appears and leads to
the mode. It arises from predetermined ranking and is a function of the product P1 x P2/1. When
an Occurrence index is attributed, it is necessary to include these 2 probabilities (see tables in
Appendix 4).
Design FMEA: the Occurrence index should be estimated based on Prevention actions which
were identified during analysis, the Occurrence ranking table given in Appendices, and on:
• feedback in the case of a reused technical solution
• feedback and knowledge in the case of a solution based on basic solution elements that are
already known and implemented (as in the case of improvements or innovations)
• experience gained in the case of inventions, during design, through mock-up creation, testing,
design of experiments, durability testing conducted in an environment that represents mass
production of the vehicle.
Process FMEA: the Occurrence index should be estimated based on Prevention actions which
were identified during analysis, the Occurrence ranking table given in Appendices, and on:
• probability P1 for appearance of the cause defined by:
o process dispersion related to a characteristic when the manufacturing process has already
been implemented in a similar context,
o or estimating dispersion when the manufacturing process is new.
o P1 is estimated for each product cause-mode pair: it takes into account the impact of each
process cause on the product cause.
• and, probability P2/1 for appearance of the potential failure mode (same for Design FMEA)

RENAULT 01 - 33 - 200 / - - C
- Detection index D:
• it corresponds to the probability that the product cause (and/or mode) that is supposed to have
appeared affects task n+1:
o In the Design FMEA, it is inferred from the risk percentage that is estimated during product
design that a product characteristic, which may lead to a potential failure, has not been
identified and intercepted before affecting Product/Process design task N+1.
o In the Process FMEA, it is inferred from the risk percentage that is estimated during
manufacturing process design that a manufactured product characteristic that is not in
compliance with the drawing, has not been identified and intercepted before delivery to the
manufacturing sector following the studied process.
D is estimated for every product cause-mode pair and takes into account the impact of
each process Detection on process causes (if such Detection exists).
• Detection is estimated using ranking (given in Appendix 4) and corresponds to P3.
Design FMEA: the Detection index should be estimated based on Detection actions which were
identified during analysis, the Detection ranking table given in Appendices; and on:
• Technical department rules, feedback, recommendations from experts, etc.
• application of robust engineering, dimensioning calculations, functional chains of dimensions,

integration of production dispersion and off-centring (e.g.: Cam/Cap and Cpk, etc. that have
been forecast so that the distribution of tolerances is optimised, project review, digital
simulation, digital mock-up creation, physical prototypes, etc.
• results of a testing plan, validation in compliance with Technical department’s

recommendations (validation plan), compliance with regulations and safety norms, etc.
• testing in compliance with the usage of the product by customers
• correlated results from calculation/bench testing/actual operation, etc.
Process FMEA: the Detection index should be estimated based on Detection actions which were
identified during analysis, the Detection ranking table given in Appendices; and on:
• transformation of functional tolerance into manufacturing tolerance, capability studies, 100%

or frequency-related inspection, Statistical Process Control, inability to assemble, impossible
to continue production process, unit testing or end of the line, etc.
• Technical department rules, feedback, recommendations from experts, etc.
• Note: detection encompasses a larger area than inspection (a 100% inspection may prove to
be entirely ineffective in terms of detection. E.g.: 100% functional inspection to detect a failure
mode that appears over time, after 100 000 kms/5 years).
Ranking tables for S, O and D:
- Design and Process FMEA: ranking varies from 1 to 10; see appendix 4.
Note 1: during evaluation, it is very important to define ranking values related to Severity, Occurrence
and Detection up to the most precise value; however, in case doubt exists between the 2 values (e.g.:
doubt between S = 7 or S = 8), the higher value must be considered so as to prioritise the protection of
the customer / user of the product.
Note 2: a common error is to assume that because a phenomenon is not going to occur, the Severity
to be associated with it must be low: do not confuse failure criticality indicated by the Risk
Priority Number (RPN) with the Severity level indicated by S.
Note 3: as regards evaluating P2/1, this probability is always of interest: it contributes to the
evaluation of the Occurrence index O, up to the most precise value. It may so happen that a

RENAULT 01 - 33 - 200 / - - C
probability cannot be associated with this event (P2/1). In this case and even though it may be
penalising, it is possible to consider this value equal to 1, that is, the cause always leads to the mode.
Note 4: The robustness of product design is a quality of product definition that is applied to the
technical drawing. This makes it more or less sensitive to non-compliance that appears during
manufacturing. If the characteristic is within the tolerance, no failure mode will appear.
But, by way of example, one may say that:
- for a so-called robust solution, even if the characteristic exceeds the tolerance, no failure
mode will appear before deviating for example from 1x, 2x, 3x, Nx, etc. the tolerance. In this
case, it can be said that the product definition that is applied to the drawing is robust since
Non-Compliance does not lead to a failure mode. In this case, the opportunity to increase the
tolerance value might have to be examined. In FMEA (product and process alike), in this case,
if the potential cause of failure appears but does not lead to the failure mode: P2/1 is
considered to tend towards 0.
- conversely, if we imagine that as soon as a characteristic exits the tolerance, the failure mode
appears, this would mean that the tolerance value is at the maximum. This could also mean
that the product definition applied to the drawing is very sensitive to Non-Compliance. In the
FMEA (product and process alike), in this case, if the potential cause of failure appears, it
immediately leads to the failure mode: P2/1 is considered to tend towards 1.
Note 5: certain design controls may have an incident that simultaneously occurs on the Occurrence
index and the Detection index. Take these cases into consideration when evaluating O and D. E.g.:
• in the Design FMEA, a chain of dimensions may lower the Occurrence index so as to
have dimensions that do not cause interference between the parts and the
mechanism. It is also made up of theoretical Detection that is efficient in finding the
interference risk.
• in the Process FMEA, simulation of plastic part injection to ensure no areas on the
injected part are free from materials will enable similar action to be taken on the
Occurrence of these areas without material appearing and their Detection.
4.3.3. Calculating criticality
Every time "potential effect of failure, potential failure mode, potential cause of failure and Detection"
are associated, multiply the 3 ranking values: Severity, Occurrence and Detection.
The result is the Risk Priority Number that is also called Criticality.
RPN = S x O x D.
Evaluation is assessed by the members of the group based on databases and by default, on their
knowledge and experience.
Probabilities P1, P2/1, P3, ranking values and RPN are saved and kept on analysis sheets.
4.3.4. Classification
To obtain an overall image of the level of risk of the studied system, the RPNs are represented in the
form of a bar graph.
This representation makes it easier to follow up improvements that will be made later.

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Design and Process FMEA
SEVERITY
S
1 to 4
5 to 8 CORRECTIVE ACTIONS
9 and 10
RPN
1 1000
36 50 100
THRLD THRLD THRLD
Figure 6
4.3.5. Deciding corrective actions on a priority basis
The purpose of this decision is to implement everything that would make it possible to:
- meet objectives related to compliance, quality, reliability, durability (refer to the FMEA summary
sheet).
- optimise the Cost of Quality.
Decision in terms of thresholds:
Corrective actions are undertaken for all RPNs that exceed the threshold set by this standard.
TYPE OF FMEA CORRECTIVE ACTION FOR:
Product and process RPN > 36 when S = 9 and 10
RPN > 50 when S = 5 to 8
RPN > 100 when S = 1 to 4
A lower RPN can be obtained by acting on the indexes: O or D or both.
- Acting on O as priority in such a way that the potential failure does not occur (Prevention is
better than cure).
- Acting on D, as a complement, if needed: the potential failure that is supposed to have

appeared, what has been planned to identify and intercept it before it affects task N+1.
Index and Design and Process FMEA

probability
It is rare to be able to directly act on consequences for the customer / user of the
S
product unless the technical solution is modified in such a way that the effect
produced by the failure mode on the customer is minimal.
Examples:
- before the technical solution is modified, it is impossible to close the sunroof because part
P is broken.
- after the technical solution is modified, breakage of the same part P makes it impossible
to open the sunroof, not close it.

RENAULT 01 - 33 - 200 / - - C
Index and DESIGN FMEA

probability
O Act on Occurrence as a priority, that is:
P1 - Reduce potential causes of failure.
- Act on product design, optimise the functional characteristics of the product (dimensions,
geometry, material, thermal treatment, aspect, protection, etc.)
P2/1 Increase robustness of the product design: the solution should not be very sensitive to
variations in tolerances or add redundancy, etc.
P1 & P2/1 Combine both actions
D Secondly, act on detection only if needed.
Set up or improve Detection (calculations, chain of dimensions accompanied by a review of
dispersions, digital simulation that is correlated with physical tests, design of experiments,
P3
application of Technical Dept rules, constraint/resistance diagram, recommendation from an
expert, producing prototypes, representative durability tests: vehicle, unit or component, in
the laboratory, on the bench or in the vehicle, etc.).
Note: in complex scenarios, set up progression that goes from the theoretical to the physical
as regards Detection. Vehicle or unit testing is only planned to demonstrate compliance.
Example 1 for progressive Detection:
1. dimensioning calculations
2. chains of dimensions
3. drawing review
4. digital simulation
5. mock-up creation
6. physical prototype that is representative of mass production or not
7. unit testing, destructive testing, etc.
8. vehicle testing
Example 2 for progressive Detection:
1. digital simulation
2. recommendations from technical departments and experts
3. physical prototype
NOTE: In complex and exceptional scenarios, when the result can only be obtained with
components made during a process that is representative of mass production, the result will
be planned in accordance with the project milestone.
Index and PROCESS FMEA

probability
O ACT ON OCCURRENCE AS A PRIORITY, THAT IS:
P1 Reduce potential causes of failure:
1. Act on process causes by controlling parameters related to production facilities
and processes (tooling design, operating mode, cutting speed, etc.) or by
optimising the manufacturing process plan.
2. If this is not sufficient, act on Product causes (characteristics of the product) by
optimising the functional tolerancing and the manufacturing tolerancing.
Increase robustness of the product design: the solution should not be very sensitive to
P2/1
production dispersions or add redundancy, etc.
P1 & P2/1 Combine both actions
D SECONDLY, ACT ON DETECTION ONLY IF NEEDED.
Improve or set up Detection (digital simulation, design of experiments, capability of
production facilities, error-proofing devices, intensified monitoring plan, 100% sorting,
P3
functional testing, random auditing of processes, etc.).
In complex or critical scenarios for task N+1 or for the customer / user of the product, set up
mass production Detection to lower P3.

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Optimising the cost of quality:
The cost objective is brought up at this stage in the FMEA, in 2 respects:
- Reduce costs due to over-quality.
- If a choice has to be made between 2 solutions having the same predicted level of quality, opt for
the less costly one while taking into consideration investment and operation.
Solution S O D RPN
A 1 1 1 1
P2/1 = 1 ; P1 = 0 P3 = 0
B 7 10 1 70
P2/1 = 1 ; P1 = 0.3 P3 = 0
C 7 1 10 70
P2/1 = 1 ; P1 = 0 P3 = 1
Remarks:
Solution A: Isn’t the solution too robust? Why plan 100% effective Detection for a failure that has very
low probability and has no impact on the customer / user of the product?
Solution B: manufacturing the product with non-compliance estimated at 30% and 100% efficient
Detection (no potential non-compliance will affect task n+1).
Solution C: manufacturing the product with 100% compliance and no planned Detection.
With regard to predicted quality where there is equivalence between B and C, only a business study
that considers operational investment and operating cost must make it possible to select the most
economic solution without forgetting the risk to the customer / user of the product.
For all corrective actions that have been decided upon, an action plan needs to be formalised
on the analysis sheet:
- Write down measures that are recommended to reduce the RPN (act on P1 and/or P2/1 and/or P3).
- Write down the name of the person in charge of the action (his/her department) and the date on
which the studied corrective solution is presented.
Action plan
Recommended Manager
measure Technical dept
Target Completion Date

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Examples:
DESIGN FMEA:
Manager
Recommended measure Technical dept
RPN
Target
Completion Date
RPN > • Reduce P1: e.g.: M. Durant

threshold
o add geometric tolerances in boring Dept …
o add a cylindricity tolerance of 0.01… Date on which

presentation is
• and reduce P2/1: e.g.: made: ….
o study a solution with roller bearings instead of a

solution with ball bearings…
• and reduce P3: e.g.:
o calculate constraint on the bearing
o conduct intensified bench testing for durability: 200

000 cycles subjected to stress (10 DaN) at 80°…
PROCESS FMEA:
RPN Manager
Recommended measure Technical dept
Target
Completion Date
RPN > • reduce P1: e.g.: M. Durand

threshold
o define min and max parameters for adjusting Dept …
welding progress
Date on which
o optimise tolerance of manufactured dimensions: corrective solutions
±0.15 instead of ±.0.2 were presented: …
• and reduce P2/1: e.g.:

rd
o study the possibility of placing a 3 support in
position to limit part sagging
• and reduce P3: e.g.:
o inspect (once every hour) welding torch progress
o save and analyse parameters
o conduct a destructive test (once per shift), analyse

and save results, etc.
Important point: The RPN must not be re-evaluated at this stage but at stage 5.
The FMEA group can estimate the potential gain in relation to the RPN threshold to be reached by
considering that the action plan will be implemented with positive results. However, at this stage in
FMEA progress, do not place expected results in the “Measure taken” column: the action that
is actually taken is not yet known.
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4.4. STAGE 4: SEARCHING FOR SOLUTIONS
Looking for corrective solutions is generally carried out outside the FMEA group, especially when
major modifications must be made to the product and process. However, it may be outlined within the
FMEA group.
From the action plan drawn up at the previous stage, the designated manager makes sure that
resources are used to construct and formalise corrective solutions; examples:
o a new technical solution is tracked
o functional definition of the product is optimised on the drawing,
o chains of dimensions are produced and are compliant,
o results of simulations are in accordance with expectations,
o the manufacturing process plan is modified,
o parameters of facilities are defined based on quantified data,
o the monitoring plan is formalised…
IMPORTANT POINT:
Corrective solutions must be constructed and formalised in order to be presented to the FMEA
group at stage 5.
4.5. STAGE 5: FOLLOW UP
Follow up consists in analysing and evaluating the proposed corrective solutions (figure 7), as given
previously (§ 4.2. and 4.3.).
Looking for
corrective solutions
Stage 4
Follow-up date Present corrective solutions
Analyse the potential failures

(add to or change the content of the analysis grid)
Evaluate the new risks

Remove previous rating
Indicate new probabilities and rating
Calculate the new indicators
> threshold
RPN
≤ threshold
Stage 6
Figure 7 - Procedure

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This stage in which potential failures are corrected continues until all RPNs at risk reach a level that is
lower than the set thresholds (figure 8).
Number of
RPN >
threshold
Calendar
Initial Follow- Follow- Milestone
state up 1 up n
Figure 8 – Resolution curve
IMPORTANT NOTE:
Following up corrective actions is an aspect of paramount importance in the effective clearing

of identified risks.
The requestor of the study is responsible for ensuring regular FMEA progress and the clearing
of risks.
4.6. STAGE 6: APPLY
Corrective solutions that were validated during the follow-up are applied.
Examples:
- specification of the new technical solution
- application for modifying the definition
- validation of calculation, simulation results
- validation of a positive testing result
- modification of a manufacturing process plan, procedure, tooling, etc.
- specification of a provisional monitoring plan
- modification of operating modes
- ...
A
E
F
F M E A
?
Prior to …………………… and after corrections

Highlighting Implementing the measures taken
potential and obtaining a product in compliance
failures with customer expectations
Figure 9

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4.7. STAGE 7: CHECK – BUILD KNOWLEDGE
4.7.1. Principle of checking
Checking ensures that the objectives that were set when the "summary sheet" was drawn up are met.
It is carried out on 2 occasions, for Purchased Parts and Internally Worked Parts:
1- During the design phase, at every quality review at milestones and especially:
• for the Design FMEA: at TGA/RO/IOD ; risks must be cleared (stage 7) for this milestone.
• for the Process FMEA:
at the ABVC/AMS-lot (Vehicle Engineering perimeter)
at the ABPT/AMEI (Mechanical Engineering perimeter)
in order to ensure that the corrective actions are in place and effective ; risks must be cleared
(stage 7) for these milestones.
2- During mass production phase, to estimate the efficiency of the FMEA study in relation to
failures proven during manufacturing and at the customer-site.
4.7.1.1. Verification on the basis of a diagnosis grid at the time of every quality review at milestones
Based on the study, members of the FMEA group:
- check, in practical terms, whether the corrective solutions are in place,
- confirm with measurements, every time it is possible, hypotheses accepted during provisional
evaluation.
For example: implement capability of the facility to determine the actual P1 level, check the accuracy
of the chain of dimensions and related calculations, check flow time, in-process materials, etc.
Note: The group takes ownership of the FMEA. Every member must comply with FMEA
commitments and modifications made to the FMEA file must be a result of a concerted effort.
Results of the check are recorded in a summary note that is attached to the FMEA file. It is a part of
the Quality Assurance file.
When one project milestone goes to the next one, a diagnosis (see appendix 6) is strongly
recommended so that FMEA compliance can be attested in relation to the present standard (or in
relation to a standard that is deemed to have equivalence: at this stage, formalise deviations with
regard to the criteria used for clearing risks and criteria in the RENAULT standard).
The requestor of the study, or the decision-maker if needed, decides on the end of the FMEA and
clearing risks by signing the summary sheet after checking the results presented by the group.
At the milestone where risks should be cleared (stage 7), 2 cases appear:
• Case 1: if all RPN are lower than the thresholds: the requestor signs the summary sheet so
as to close the forecast study after having checked whether all potential risks have been
cleared (no RPN exceeds threshold); evidence is based on facts.
• Case 2: if certain RPN exceed thresholds: the decision-maker (project team) must be
informed about the potential risks that have not been cleared or that cannot be cleared by the
FMEA team contingent on proof of confidence provided by the FMEA team (level to which a
risk has been cleared, proof presented) and project issues. This will help him/her make
recommendations as regards continuing the project:

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- if the level of risk is considered to be acceptable by the decision-maker or the project
team, the decision-maker signs the summary sheet to certify that the risks have been
taken into account. An additional action plan is decided upon if necessary.
- if the decision-maker or the project team considers the level of risk to be

unacceptable, the decision-maker does not sign the summary sheet. An additional
action plan is decided upon or the project is stopped.
4.7.1.2. Checking during mass production phase
- During manufacturing: the FMEA file is included as a part of the process audit repository.
On the one hand, the sustainability of corrective actions can be checked and on the other hand,
effectiveness of the FMEA study, by comparing the deviation between potential failures and
failures proven on the process.
4.7.2. Building knowledge based on experience
The contents of an FMEA are a written record for the Company:
- that can be used for future projects (as is or to provide additional information),
- that can be used during process audits in the operation phase,
- that can be used when the product or process undergoes changes (phase II, increase in the
number of production centres, etc.),
The FMEA standard is reviewed on a regular basis in order to include changes made to Company
requirements and strategy.
The FMEA study must be archived in a place where it can be accessed for future use (examples:
intranet, BMIR, IG database, E-Room, etc.). It constitutes one of the elements that contribute towards
proving that the designed product is reliable.
In addition to this, a FMEA file must be compiled and archived in paper or electronic format and will
include the following:
FMEA: product process

Summary sheet. X X
Data from the studied subject and modifications:
- specifications or its reference, X X
- drawings, diagrams or their references (modified drawings), X X
- manufacturing process plan or reference (the modified manufacturing X X
process plan and monitoring plan)
Functional analysis:
- study on functions, X X
- flow chart updated with modifications made X X
- process diagram updated with modifications made, X
Sheets related to analyses, evaluation and corrective actions. X X
Summary notes. X X

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Appendix 1: normative: Summary sheet
SUMMARY SHEET Design FMEA

FMEA Process FMEA
Other FMEA:
Vehicle: Request date:
Unit: Milestone date (TGA, ABVC/AMS-lot or ABPT/AMEI):
Production date:
Scope:
Objectives of the study:
Causes of the study:
REQUESTOR: M. Dept DECISION-MAKER: M. Dept

Limits of the study:
PARTICIPANTS: Permanent members Temporary members

MM. Dept and function MM. Dept and function
COORDINATOR: M. Dept
P Weeks
L
A
N Forecast
N
I Completed
N
G Key Meeting: M Follow up: F Check: C Milestone date: Mil
stages 2 and 3 stage 5 stage 7
Initial Follow up Number of RPN > threshold
Date:
R TOTAL
E S 9 to 10:
P RPN RPN > 36
O
R
S 5 to 8:
T No. RPN > 50 Dates
S 1 to 4:
RPN > 100 Initial state Follow-up 1 Follow-up n Milestone
Archive location:
Decision to end study: Date:

Signature of the Requester
or Decision Maker:

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Appendix 2: normative: Listing source data and functional analysis to be carried out
INPUT DATA TYPE OF ANALYSIS TO BE FMEA

USED
PRODUCT PROCESS
Functional analysis of
requirements (function related to
Requirement or YES YES
use, adaptation, assessment,
functional specifications
constraint function and value
criteria)
Drawings of the studied Technical functional analysis of YES YES
system the design (Flow Chart, analysis
of kinematic links, Table of
Technical Functional Analysis:
TAFT)
Process plans:
Process diagram (or
- manufacturing
manufacturing and inspection YES
- inspection
diagram)
- ...
with references

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Appendix 3: normative: Presentation of the analysis grid
Design FMEA, Process FMEA, Flow FMEA
Failure Modes, Effects and Criticality Analysis

Unit … Vehicle … FMEA Analysts: Dates:
1 2 3 4 5
References :
Function Potential failure Design Controls Action plan
No. and/or Effect Mode Cause Prevention Detection S O D RPN Recom- Manager. Result
mended Dept.
process Customer Disturbed (P2/1) (P1) (P3) measures Target Action S O D RPN
consequence function Completi taken
on Date
6 7 8 9 10 11 12 13 14 15 16 17
Caption:
1. Product name
2. Specify: Design, Process or Flow FMEA
3. Names of FMEA participants and coordinator
4. Source dates, and dates on which changes were made to the document
5. Page no.
6. N°. which helps locate the line for each potenti al cause of failure
7. Studied functions (Design FMEA) or descriptions of manufacturing operations (Process FMEA) or flow
management points (flow FMEA)
8. Disturbed function and consequences for the customer / user of the product or manufacturing/assembly
9. Potential failure mode: states the manner in which the system no longer functions.
Also write down the probability value in this column: P 2/1.
10. Potential cause of failure relative to the product: initial anomaly that may produce the potential failure
mode.
The causal chain is the cascade of events that is of importance when the product-cause appears.
Also write down the probability value in this column: P 1.
11. Prevention control: provisions planned in order to prevent the cause or mode from occurring
12. Detection control: planned provisions for preventing the cause (and/or mode) that may appear from
affecting task n+1. Also write down probability value P3 in this column.
13. Quantify indexes related to Severity, Occurrence and Detection on the basis of ranking tables and
calculate criticality level (RPN):
• S: Severity index: see Severity ranking.
• O: Occurrence index: see Occurrence ranking and see product of probabilities P1 x P2/1.
• D: Detection index: see Detection ranking and see probability P3
• RPN = S x O x D
14. Write down the measures that are planned to reduce the RPN (act on P1 and/or P2/1 and/or P3).
15. Name of the person in charge of the action and the Target Completion Date for presenting the
proposed corrective solution.
16. Record of the corrective measure presented at the time of analysis and evaluation (stage 5).
17. Calculation of the new RPN after the proposed corrective solution has been analysed and evaluated.

RENAULT 01 - 33 - 200 / - - C
Appendix 4: normative: ranking tables
Design and process FMEA – severity index S

Criteria to be used in Design and Process FMEA
General
S defect types Effect on the customer / user of the
Disturbed service function
product
The customer does not notice the defect. No obvious deterioration in vehicle or
tolerated or not
the customer
perceived by
1 equipments performance.
Defect
The customer tolerates the defect. No obvious deterioration in vehicle or

2 equipments performance.
The defect, which the customer considers The failure leads to a very minor
Minor defect leading
to product approval
to be minor, leads to a defect impacting the deterioration in vehicle or equipments

comfort defect
3
driving comfort; the cost of repair is very performance.
low and can wait until standard service.
The defect, which the customer considers The failure leads to minor deterioration in
to be minor, leads to a defect impacting the vehicle or equipments performance.
4
driving comfort; the cost of repair is low and
can wait until standard service.
The customer considers the defect to be The failure leads to major deterioration in
Major defect leading to a
5 major; repair that does not cost much must vehicle or equipments performance.
loss of performance
be carried out before standard service.

The customer considers the defect to be The failure leads to major deterioration in
major; costly repair must be carried out vehicle or equipments performance.
before standard service.
6 The defect leads to major deterioration in
perceived quality, which has an impact on
the way the customer views the brand
image of RENAULT.
The failure makes the driver stop the The customer feels that the failure makes it
breakdown or
vehicle with the possibility of delaying the impossible to use the vehicle (e.g.: "very
confidence
7
Off-road
stop; the customer can no longer rely on loud noise"), but the customer could use
loss of
the vehicle. the vehicle in complete safety.

The failure immediately leads to an off-road The failure makes it impossible to use the
8 breakdown (the customer cannot delay the vehicle: e.g.: "does not start", "stopping the
stop while driving). engine while driving”.
The extreme nature of the consequences Disturbed function leads to non-compliance
as regards the customer / users of the with regulations or with an EIC-PS
Potentially related to
9 vehicle is relative to individuals’ safety (Undesirable Customer Event that is

and/or to non-compliance with regulations. “Potentially related to Safety”), with warning
(1)
safety
.
The extreme nature of the consequences Disturbed function leads to non-compliance
as regards the customer / users of the with regulations or with an EIC-PS
10 vehicle is relative to individuals’ safety (Undesirable Customer Event that is
safety and/or to non-compliance with “Potentially related to Safety”), without
(1)
regulations. warning .
(1)
Warning:
- A change is perceived and is considered abnormal by one of the senses or unusual behaviour is
noticed, the nature of which and/or intensity and/or development will be perceived without a doubt
by most customer / users of the product/manufacturing/assembly as an anomaly that is likely to
become a more serious undesirable event;
(2)
- This anomaly must encourage the customer to decide upon the appropriate instinctive action ,
in a reasonable frame of time that will allow the customer to execute this action for the safety of
all users;
- The time it takes for the undesirable event to appear must be long enough;
- The time it takes for a more serious undesirable event to appear is given a value. The
reproducible aspect of the warning is validated either by simulation or by physical tests, etc.
(2)
this implies that the designer would have identified beforehand the "appropriate instinctive”
reactions that the customer would naturally adopt when a warning is noticed.
RENAULT 01 - 33 - 200 / - - C
Examples of warning, as information only, to evaluate the Severity of the effect on the customer /
user of the product:
Sight oil leakage / smoke that the customer / user can see, warning light on the dashboard, misaligned
steering wheel, etc.
Touch vibration perceptible in steering wheel/pedals, abnormal gearshift lever oscillation, hot point, etc.
Smell odours related to heat/fuel inside the cabin, etc.
Hearing sound alert from the on-board computer, loud metal on metal sounds (e.g.: loose link that will not
break in the short term), clanking/squeaking, etc.
Unusual cold starting the vehicle becomes more and more difficult, right/left play on the wheel, degraded
behaviour straight-ahead ability, erratic acceleration noticed, no response to a command or unusual
response, etc.
For information purposes: table of equivalence between FMEA, HCPP and NISSAN Grade severities:
Severity in Renault FMEA Severity in HCPP NISSAN grade

10 S or R A
9 S or R A
8 1 B1
7 1 B2
6 2 C
5 2 C
4 3 D
3 3 D
2 3 or 4* D or E
1 3 or 4*
Note: FMEA Severities 1 and 2 correspond to HCCP Severity class 4 when the latter is used.

RENAULT 01 - 33 - 200 / - - C
Criteria to be used only in the Process FMEA:

S
Effect that product non-compliance has on manufacturing/assembly
1 Product non-compliance leads to, at the most, a minor problem related to operation or for the operator.
Product non-compliance leads to minor facility failure; no noticeable deterioration of material: as information,
Repair Time < 3 min.
2
Production sequence is not disrupted.
Products may be reworked on the line and at the workstation (less than 100% of production); no scrap.
Non-compliant products may be reworked on the line but not at the workstation (less than 100% of production);
3
no scrap.
Non-compliance of the product leads to average facility failure. This requires short-term repair work of the
facility. For information: 3 min < Repair Time < 20 min.
Production sequence is slightly disrupted.
4
Non-compliant products must be sorted. No scrap. A part (less than 100% of production) is reworked on the line
but not at the workstation.
Loss of production is negligible.
100% of production must be reworked, or the vehicle/unit must be repaired off line but is not sent to the repair
5
workshop.
Product non-compliance leads to significant facility failure. This requires long-term service. For information: 20
min < Repair Time < 60 min.
Production sequence is moderately disrupted.
6
Less than 100% of production must be scrapped (sorting not necessary), or the vehicle/unit must be repaired in
the repair workshop; the time taken for repair will be less than half an hour.
Loss of production is moderate.
Less than 100% of production must be scrapped after sorting, or the vehicle/unit must be repaired in the repair
7
workshop; the time taken for repair will be between half an hour and one hour.
Product non-compliance leads to serious facility failure or significant damages to material. For information: 60
min < Repair Time < 180 min.
Production sequence is severely disrupted.
8
100% of production is scrapped or the vehicle/unit must be repaired in the repair workshop; the time taken for
repair is greater than one hour.
Loss of production is significant.
Product non-compliance leads to critical failure of the facility. This requires Repair Time > 180 min.
9 The potential failure of the product may endanger manufacturing and maintenance personnel; with warning
(1)
.?
Product non-compliance brings production to a halt.
10 The potential failure of the product may endanger manufacturing and maintenance personnel; without warning
(1)
.
Examples of warning indicators, as information only, to evaluate the Severity of the effect product
non-compliance has on manufacturing/assembly:
Sight oil leakage / smoke that the manufacturing/assembly personnel can see, warning light on the
console, rotating light activated, etc.
Touch unusual vibration, hot point, etc.
Smell heat-related odours, chemical odours, etc.
Hearing console sound alert, loud metal on metal sounds (e.g.: loose link that will not break in the short
term), clanking/squeaking, air leak from HP pipe, etc.
Behaviour robot stops in unusual position, etc.
Note: for every potential failure where an effect on manufacturing/assembly is mentioned, the
effect on the customer / user of the product will have to be mentioned and must appear
in the FMEA. Risks must be cleared in both cases.

RENAULT 01 - 33 - 200 / - - C
Design and Process FMEA – Severity Index S (summary table provided for information purposes)
Severity Criteria to be used in Design and Process FMEA: Criteria to be used only in the Process FMEA:
Effect on the customer / user of the Disturbed product service function Effect that product non-compliance has on manufacturing/assembly
General
defect
types
Nissan*
product
HCPP*
FMEA
The customer does not notice the defect. No obvious deterioration in vehicle or Product non-compliance leads to, at the most, a minor problem related to operation or for the operator.
1
tolerated or
perceived
equipments performance.
3
by the
D The customer tolerates the defect. No obvious deterioration in vehicle or Product non-compliance leads to minor facility failure; no noticeable deterioration of material: as
not
or
or equipments performance. information, Repair Time < 3 min.
2 4
E Production sequence is not disrupted.
E Products may be reworked on the line and at the workstation (less than 100% of production); no scrap
The defect, which the customer The failure leads to a very minor Non-compliant products may be reworked on the line but not at the workstation (less than 100% of
product approval comfort
Minor defect leading to a
considers to be minor, leads to a defect deterioration in vehicle or equipments production); no scrap.

3 impacting the driving comfort; the cost of performance.
repair is very low and can wait until
standard service.
defect
3 D The defect, which the customer The failure leads to minor deterioration in Non-compliance of the product leads to average facility failure. This requires short-term repair work of the
considers to be minor, leads to a defect vehicle or equipments performance. facility. For information: 3 min < Repair Time < 20 min.
impacting the driving comfort; the cost of Production sequence is slightly disrupted.
4
repair is low and can wait until standard Non-compliant products must be sorted. No scrap. A part (less than 100% of production) is reworked on
service. the line but not at the workstation.
Loss of production is negligible.
The customer considers the defect to be The failure leads to major deterioration in 100% of production must be reworked, or the vehicle/unit must be repaired off line but is not sent to the
Major defect leading to a
major; repair that does not cost much vehicle or equipments performance. repair workshop.
5
loss of performance
must be carried out before standard

service.
The customer considers the defect to be The failure leads to major deterioration in Product non-compliance leads to significant facility failure. This requires long-term service. For
2 C major; costly repair must be carried out vehicle or equipments performance. information: 20 min < Repair Time < 60 min.
before standard service. Production sequence is moderately disrupted.
6 The defect leads to major deterioration in Less than 100% of production must be scrapped (sorting not necessary), or the vehicle/unit must be
perceived quality, which has an impact repaired in the repair workshop; the time taken for repair will be less than half an hour.
on the way the customer views the brand Loss of production is moderate.
image of RENAULT.
The failure makes the driver stop the The customer feels that the failure Less than 100% of production must be scrapped after sorting, or the vehicle/unit must be repaired in the
Off-road breakdown or
vehicle with the possibility of delaying the makes it impossible to use the vehicle repair workshop; the time taken for repair will be between half an hour and one hour.
loss of confidence
7 B2 stop; the customer can no longer rely on (e.g.: "very loud noise"), but the
the vehicle. customer could use the vehicle in
complete safety.
1 The failure immediately leads to an off- The failure makes it impossible to use Product non-compliance leads to serious facility failure or significant damages to material. For
road breakdown (the customer cannot the vehicle: e.g.: "does not start", information: 60 min < Repair Time < 180 min.
delay the stop while driving). "stopping the engine while driving”. Production sequence is severely disrupted.
8 B1
100% of production is scrapped or the vehicle/unit must be repaired in the repair workshop; the time
taken for repair is greater than one hour.
Loss of production is significant.
The extreme nature of the consequences Disturbed function leads to non- Product non-compliance leads to critical failure of the facility. This requires Repair Time > 180 min.
as regards the customer / users of the compliance with regulations or with an The potential failure of the product may endanger manufacturing and maintenance personnel; with
related to safety
warning (1). ?
Potentially
9 vehicle is relative to individuals’ safety EIC-PS (Undesirable Customer Event

and/or to non-compliance with that is “Potentially related to Safety”),
S
regulations. with warning (1).
or A
R The extreme nature of the consequences Disturbed function leads to non- Product non-compliance brings production to a halt.
as regards the customer / users of the compliance with regulations or with an The potential failure of the product may endanger manufacturing and maintenance personnel; without
10 vehicle is relative to individuals’ safety EIC-PS (Undesirable Customer Event warning (1).
and/or to non-compliance with that is “Potentially related to Safety”),
regulations. without warning (1).
© RENAULT 2011
RENAULT 01 - 33 - 200 / - - C
Ranking tables (continued)
Ranking used in Design FMEA: Occurrence index O
Design FMEA: Occurrence index O

O • Technical solution Environment, use, internal Probability
• Reliability interactions or inter-system P1 X P2/1
• Functional characteristics interactions
1 • Known and robust solution Known, integrated with the [0 à
Very low
-6
• Proven and compliant reliability technical solution and under 10.10 [
• Defined characteristics control
-6
2 • To a large extent known and robust To a large extent known, [10.10 à
-6
solution integrated with the technical 100.10 [
Low
• Reliable in relation to the purpose but solution and under control

-6
3 proven in a slightly different environment [100.10 à
-6
• Defined characteristics 500.10 [
-6
4 • The solution generally corresponds to Partially known or integrated [500.10 à
-6
vehicles in production with the technical solution 1 000.10 [
Moderate
• Reliability: failures appear occasionally in -6

5 [1 000.10 à
reduced numbers -6
2 000.10 [
• Partially defined characteristics
-6
6 [2 000.10 à
-6
5 000.10 [
-6
7 • Not very known or robust solution Very partially known or [5 000.10 à
-6
• Reliability estimated but not in relation to integrated with the technical 10 000.10 [
High
8 the purpose solution [10 000.10 à

-6
• Characteristic: partially adapted -6

20 000.10 [
-6
9 • Solution, new or not robust Unknown or not integrated with [20 000.10 à
-6
• Unknown reliability the technical solution 50 000.10 [
Very high
• Characteristic: not defined or adapted

-6
10 [50 000.10 à
-6
100 000.10 ]

RENAULT 01 - 33 - 200 / - - C
Ranking used in Process FMEA: Occurrence index O
PROCESS FMEA: Occurrence index O

O P2/1: Probability that the P1: Probability of the product-cause P1 X P2/1
product-cause (product non- appearing (product non-compliance
compliance) that has appeared due to the process)
leads to a potential failure mode
1 Technical solution insensitive to Very low probability of having a non- [0 à
-6
the dispersion of product compliant product characteristic: 10.10 [
characteristics:
Very low
P2/1 tends towards 0 P1 tends towards 0

The product-cause does not lead to Controlled process or procedure.
failure mode. Controlled Dispersion of production that
is significantly low in relation to
Tolerance.
-6
2 Technical solution that is slightly Low probability of having a non- [10.10 à
-6
sensitive to the dispersion of compliant product characteristic: 100.10 [
-6
3 product characteristics. [100.10 à
-6
Controlled process or procedure with a 500.10 [
Low
It is not very probable that the margin, which can appear low.
product-cause will lead to failure Controlled Dispersion of production that
mode. is significantly low in relation to
Tolerance, but exceptional random
defect.
-6
4 Technical solution that is Moderate probability of having a non- [500.10 à
-6
moderately sensitive to the compliant product characteristic. 1 000.10 [
Moderate
-6
5 dispersion of product [1 000.10 à
-6
characteristics. Controlled process or procedure that is 2 000.10 [
6 occasionally unstable. -6
[2 000.10 à
It is fairly probable that the product- Controlled Dispersion of production but -6
5 000.10 [
cause will lead to failure mode. risk of unexpected drift.
-6
7 Technical solution that is very High probability of having a non- [5 000.10 à
-6
sensitive to the dispersion of compliant product characteristic 10 000.10 [
-6
8 product characteristics. [10 000.10 à
High
-6
Partially controlled process or 20 000.10 [
It is very probable that the product- procedure.
cause will lead to failure mode. Dispersion of production that is partially
controlled and high in relation to
Tolerance.
-6
9 Technical solution that is directly Very high probability of having a non- [20 000.10 à
-6
influenced by dispersions of compliant product characteristic: 50 000.10 [
-6
10 product characteristics: [50 000.10 à
Very high
-6
P2/1 tends towards 1 P1 tends towards 1 100 000.10 ]
It is practically certain that the Uncontrolled or unstable process or
product-cause will lead to failure procedure.
mode. Dispersion of uncontrolled production
that is significantly high in relation to
Tolerance.
Note: depending on the analysis ratio as regards qualitative evaluation, take the highest corresponding
O index. As regards quantitative evaluation, take the corresponding O index.

RENAULT 01 - 33 - 200 / - - C
To estimate the Occurrence index O in the Process FMEA, the indicative values given below can also
be used:
Process FMEA: Occurrence index O if P2/1 is

considered to be equal to 1
(1)
O Indicative values of centered Cpk
1 [∞ à 1,46[
2 [1,46 à 1,30[
3 [1,30 à 1,16[
4 [1,16 à 1,10[
5 [1,10 à 1,03[
6 [1,03 à 0,93[
7 [0,93 à 0,86[
8 [0,86 à 0,77[
9 [0,77 à 0,65[
10 [0,65 à 0]
(1)
Centered Cpk => Cap = Tolerance / Dispersion and no off centering*: P1*P2/1 can be directly
deducted from this value when P2/1 = 1
*for centered distribution only: in that case, mean of the sample equals to nominal value.

RENAULT 01 - 33 - 200 / - - C
Ranking used in Design FMEA: Detection index D
Design FMEA: Detection index D
Detection is the action planned in order to prevent the potential cause and/or Probability
D failure mode that is supposed to have appeared from affecting task N+1. P3
1 No potential failure will affect task n+1. [0 à 0,1%[
Examples:
• the product validation process is complete and appropriate as regards S/R
(Safety/Regulation) requirements
• tests related to the component, system, unit, vehicle, etc. are representative of
usage by customers and the product is representative of mass production
• opinions of Technical experts are convergent
• sequence of planned Detection is optimal (calculation, simulation, prototypes,
etc.)
2 It is not very probable that a potential failure affects task n+1. [0,1 à 0,2%[
Examples:
• the product validation process is complete and appropriate to a large extent as
regards S/R requirements
• tests related to the component, system, unit, vehicle, etc. are representative of
3 usage [0,2 à 0,3%[
• digital simulation or calculation methods are tested (constraint-resistance
diagram, etc.)
• provisions taken are in compliance with Technical department standards
• the sequence of Detections is practically optimal, etc.
4 It is slightly probable that a potential failure affects task n+1. [0,3 à 0,5%[
Examples:
• the product validation process is partial and does not integrate all variables as
regards S/R requirements
5 • tests related to the component, system, unit, vehicle, etc are partially [0,5 à 1%[
representative of usage (all elements related to the environment are not
integrated)
• digital simulation or calculation methods are partial (dynamic aspects, chain of
6 dimensions in 1 dimension instead of 2 dimensions, etc. not considered) [1 à 2%[
• the Technical department standard does not integrate all parameters
• the sequence of planned Detection is partial, etc.
7 It is fairly probable that a potential failure affects task n+1. [2 à 3%[
Examples:
• the product validation process is not very appropriate as regards S/R
requirements
8 • tests related to the component, system, unit, vehicle, etc are not really [3 à 5%[
representative of usage (no integration from the environment, etc.)
• calculation or digital simulation is not totally appropriate (in nominal
configuration, etc.)
• drawing review, etc.
9 It is highly probable that a potential failure affects task n+1. [5 à 10%[
Examples:
• the product validation process is not appropriate as regards S/R requirements or
it is not planned at all
10 • tests related to the component, system, unit, vehicle, etc. are not representative [10 à 100%]
• calculations or digital simulations are not appropriate or are not planned
• detection is not planned or is not effective

RENAULT 01 - 33 - 200 / - - C
Ranking used in Process FMEA: Detection index D
Process FMEA: Detection index D
Detection is the action planned in order to prevent the potential cause and/or P3
D failure mode that is supposed to have appeared from affecting task N+1.
The failure has a very low probability of affecting task N+1: P3 => 0 [0 à 0,1%[
1 The different inspection procedures or the events that make it impossible to continue
the manufacturing or assembly process can be expected to detect the failure with
certainty.
Examples:
• 100% automatic inspection + process for calibration and isolating non-compliance
in an efficient manner
• POKA-YOKE, where it is absolutely impossible to continue the manufacturing
process
• functional characteristic that is obviously detectable (no steering wheel, vehicle
non-ignition, etc.)
2 The failure has a low probability of affecting task N+1: [0,1 à 0,2%[
The different inspection procedures or the events that make it impossible to continue
the manufacturing or assembly process can probably be expected to detect the failure.
Examples:
3 • statistical product or process control + maintenance plan of the installation [0,2 à 0,3%[
• simple unit inspection by an operator
• the nature of the impossibility to make the assembly can let a few failures pass
• the fault locator may let a few failures pass, etc.
4 The failure has a moderate probability of affecting task N+1: [0,3 à 0,5%[
5 The different inspection procedures or the events that make it impossible to continue [0,5 à 1%[
6 the manufacturing or assembly process do not detect the failure effectively. [1 à 2%[
Examples:
• inspection with an appropriate frequency, with production monitoring.
• 100% manual inspection where Detection is difficult (measure, appearance, etc.).
• the manufacturing or assembly process allows defects to pass rather easily, etc.
7 The failure has a high probability of affecting task N+1: [2 à 3%[
The different inspection procedures or the events that make it impossible to continue
the manufacturing or assembly process do not detect the failure.
Examples:
• control by sampling, incorrectly adapted
8 [3 à 5%[
• subjective control of the non-compliant characteristic
• non-conformity that cannot be easily detected
• ineffective detection: inspection might work correctly, but non-compliant parts run
the risk of being mixed with compliant parts, etc.
9 The failure has a very high probability of affecting task N+1: P3 => 1 [5 à 10%[
The defect is not detected during manufacturing, assembly or control.
Examples:
• detection deals with a potential failure mode, which affects the life cycle of the
10 component (mode cannot be detected at 0 km) [10 à 100%]
• the defect cannot be detected easily (incomplete electrical connection, visual
inspection in a difficult environment, etc.)
• the characteristic that is considered to be non-compliant is not controlled
• the non-compliant characteristic that is controlled is not identified as being non-
compliant

RENAULT 01 - 33 - 200 / - - C
Appendix 5: normative: Additional Flow FMEA
The FLOW FMEA is designed in the same way as the Design and Process FMEA.
The most significant differences are defined below. Supplementary information to the FMEA standard is
expected.
Potential EFFECT of failure
In the flow FMEA, the manufacturer and central production departments (DLI) (see below) are the
Customers.
DETECTION
Detection is the action planned in order to prevent the cause (and/or mode) from affecting the manufacturer
and the Industrial Logistics Department.
RANKING TABLE
Flow FMEA: Ranking varies from 1 to 4 for O and D and from 1 to 5 for S (see below).
ORGANISING INTO A HIERARCHY AND DECISION-MAKING THRESHOLDS
To obtain an overall image of the level of risk of the studied system, the RPNs are represented in the
form of a bar graph.
Severity S
1 to 4
CORRECTIVE ACTIONS
5
RPN
1 80
5 16
Threshold Threshold
Figure 10: Flow FMEA
Flow FMEA file
Compile a file and archive it, in paper or electronic format. It will include the following:
Flow FMEA
Summary sheet. X
Data from the studied subject and modifications:
- operating modes. X
Functional analysis:
- study on functions, X
- flows diagram. X
Sheets related to analyses, evaluation and corrective actions. X
Summary notes. X

RENAULT 01 - 33 - 200 / - - C
Ranking tables
Ranking used in Flow FMEA: Severity index S
S Consequences for users

Product and/ or Volume and/ or Order
1 No consequence OK OK OK
2 Annoyed Non-compliant; rework on Small loss of Order slightly disturbed (indicator of
the line volume vehicles in the cycle (1))
3 Dissatisfied Non-compliant; rework off Moderate loss Order moderately disturbed (indicator
the line of volume of vehicles in the cycle (1))
4 Very dissatisfied The non-compliance affects Significant loss Order significantly disturbed (indicator
the internal Customer (a of volume of vehicles in the cycle (1))
manufacturing sector that is
downstream from the
studied process)
5 Catastrophic The non-compliance may Production stop
affect the customer / user of
the product
(1) The loss of volume % and vehicles-in-cycle indicator are to be defined at the beginning of the
FMEA by the manufacturer and the Central Production Department (DPLI).
Occurrence index O:
O Probability of appearance (P1 x P2/1)

Note: in the absence of P1 and P2/1, appearance is stated in number of days.
1 Less than once per month
2 Once per month
Once in [6 to 20 days]
3 Once per week
Once in [2 to 5 days]
4 Once or n times per day
Detection index D:
Probability P3 where the cause or mode may affect a downstream Manufacturing sector
D Practical provision
P3 Flow level measure Alert Reactivity Measur
e
1 Effective detection YES YES YES YES
P3 tends towards 0
2 Moderately effective YES YES YES NO
3 Slightly effective YES YES NO NO
P3 tends towards 1
4 NO NO NO NO
Detection is ineffective or no Detection

RENAULT 01 - 33 - 200 / - - C
CHOICE OF SUBJECTS TO BE DEALT WITH IN THE FLOW FMEA:
PERFORMANCE (volume to be IMPLEMENTATION OF A

STATUS produced, production order, FLOW FMEA
product compliance) Decision Objective
Known and compliant to the NO
Carryover of an existing objective
Operating mode (for a future Unknown YES To improve the
vehicle, a future unit or a new planned operating
F production facilities) mode.
New operating mode YES To validate the
L
planned operating
O mode.
W Modified operating mode YES To analyse the
modified part.
Mode that runs the risk of YES To analyse the part
production being blocked that runs the
potential risk.
LISTING SOURCE DATA AND FUNCTIONAL ANALYSIS TO BE IMLEMENTED BY A TYPE OF

FMEA:
INPUT DATA TYPE OF ANALYSIS TO BE FLOW FMEA

USED
Operating mode Functional analysis of flows YES

and
Use existing flow diagram or draw YES
it if one does not exist

RENAULT 01 - 33 - 200 / - - C
Appendix 6.1: For information purposes: Design FMEA diagnosis grid
Vehicle or project: Unit:

Subject:
Requestor (Name, department, company):
Coordinator:
KEY POINTS Y N RECOMMENDATION

E O (in case the response is no)
S
SUMMARY SHEET: DATA
1 1. Deadlines are met:
In relation to the milestone date, (TGA) analysis, follow-up and
verification dates are observed.
2. The reasons for creating the FMEA are defined:
Product: innovative, prone to risk, new, etc.
ANALYSIS
2 In relation to planned limits, the processed perimeter is complete:
Design FMEA: - functions
- components
- product characteristics, etc. are integrated
3 1. Input data is quantified:

- service functions: handling force 15 daN ± 2, etc.
- component Dimensions 20 ± 0,1, material, etc.
2. Quantified input data is included in documentation related to
potential failures:
- cause: dimensions > 20.1; dimensions < 19.9, etc.
- mode: part breaks after 100000 kilometres, etc.
- Detection: durability testing No. 5.5. 1944, ...
4 Analysis of potential failures tends towards completeness:

- There are for ex. from 5 to 7 modes for a given function
- There are for ex. from 5 to 7 product causes for a given mode
- Every mode has an effect on the customer-motorist
- Detection is documented for every cause-mode pair
EVALUATION
5 The Renault evaluation table is used or the ranking table that is
applied is correlated:
- The Severity (S) index is adapted to the customer / user-effect
- Occurrence index (O):
• cause-mode pairs are evaluated
- Detection index
• all Detection is evaluated
DECISION-MAKING: ACTION PLAN

6 “Who will do what and when?” is defined:
Reminder about thresholds:
S = 9 and 10 : RPN ≤ 36
S = 5 to 8 : RPN ≤ 50
S = 1 to 4 : RPN ≤ 100
With regard to RPNs that exceed the threshold:
1. corrective measures to be studied are put forward
2. manager of the resolution is identified
3. Target Completion Date for presenting the corrective solution is
defined
FOLLOWING UP CORRECTIVE SOLUTIONS
7 1 – On the planned date, corrective solutions that have been
formalised are presented:
- product and/or modified characteristics
- Created or improved detection, calculation results, testing are in
accordance with the objective

RENAULT 01 - 33 - 200 / - - C
- all documents are present

2 – New RPNs are calculated after corrective solutions have been
analysed and evaluated:
1. the follow-up date is given on the summary sheet
2. analysis contents are modified
3. Severity (S) index does not change (else, explain).
4. Occurrence (O) and Detection (D) indexes change according to
the contents of the analysis
5. RPNs that exceed thresholds are resolved
VERIFY RESULTS
8 Potential failures are cleared:
1. a summary report certifies whether the corrective solutions that
have been set up and are effective
2. when the FMEA requestor signs at the bottom of the summary
sheet, s/he certifies that the potential failures have been cleared
Evaluation grid of the Design FMEA
Analysis and Action plan Results at TGA/RO/IOD

evaluation
Analysis and Planned before All RPN > Results shown Results applied Indicator
prioritisation of TGA/RO/IOD threshold are for all RPN > to the product (put a cross in the
failures included threshold and proven box that
validation corresponds to
the result)
OK OK OK OK OK K-0
Non-compliance exists, but making the product compliant is compatible with project time
K - 10
constraints.
Action plan not defined or One or several RPNs > threshold
incomplete and/or Target still remain, or all corrective
Not carried out K - 50
Completion Dates are incompatible actions have not been applied.
with project constraints Incompatible timelines
DECISION-MAKING
K - 0 Design FMEA study accepted
K - 10 Design FMEA study accepted subject to making the product compliant
K - 50 Design FMEA study rejected. Start an action plan.
REMARKS
Name: ............................... Date: ....................... Signature:

RENAULT 01 - 33 - 200 / - - C
Appendix 6.2: For information purposes: Process FMEA diagnosis grid
Vehicle or project: Unit:

Subject:
Requestor (Name, department, company):
Coordinator:
KEY POINTS Y N RECOMMENDATION

E O (in case the response is
S negative)
SUMMARY SHEET: DATA
1 1. Deadlines are met:
In relation to the milestone date, (TGA/RO/IOD and ABVC/AMS-lot
or ABPT/AMEI) analysis, follow-up and verification dates are met.
2. The reasons for creating the Process FMEA are defined:
Process: innovative, prone to risk, rate of non-compliance, PPM to
be reduced, etc.
ANALYSIS
2 In relation to planned limits, the processed perimeter is complete:
Process FMEA: - operations, inter-operations
- planned rework
- device for inspection, etc. are analysed
3 1. Input data is quantified:

- service functions: handling force 15 daN ± 2, etc.
- operation: clamping torque 21 Nm ± 15 %, manufactured dimension:
20 ± 0,1, manufacturing parameters: temperature 200 ° ± 15°…
2. Quantified input data is included in documentation related to
potential failures:
- product cause: dimensions > 20.1; dimensions < 19.9, etc.
- mode: part breaks after 100000 kilometres, etc.
- Detection: monitoring plan No. 5.5. 1944, Occurrence, ...
4 Analysis of potential failures tends towards completeness:

- there are for ex. from 5 to 7 modes for a given function
- there are for ex. from 5 to 7 product causes for a given mode
- there are for ex. from 5 to 7 process-causes for every product-cause
(product non-compliance that is supposed to have appeared)
- every mode has an effect on the customer-motorist
- detection is documented for every cause-mode pair
EVALUATION
5 The Renault ranking is used or the ranking table that is applied is
correlated:
- the effect on the customer / user of the product has to be indicated;
manufacturing/assembly effect on the customer may be indicated
- in both cases, the Severity index S is adapted to the customer-effect
- Occurrence index (O):
• cause-mode pairs are evaluated
• P1 probabilities (and P2/1, preferably) are put forward
- Detection index (D):
• all Detection is evaluated
• P3 probabilities are put forward preferably
- all RPNs are calculated
DECISION-MAKING: ACTION PLAN

6 “Who will do what and when?” is defined:
Reminder about thresholds: S = 9 and 10 : RPN ≤ 36
S = 5 to 8 : RPN ≤ 50
S = 1 to 4 : RPN ≤ 100
With regard to RPNs that exceed the threshold:
1. corrective measures to be studied are put forward
2. manager of the resolution is identified
3. Target Completion Date for presenting the corrective solution is

RENAULT 01 - 33 - 200 / - - C
defined
FOLLOWING UP CORRECTIVE SOLUTIONS

7 1. On the planned date, corrective solutions that have been
formalised are presented:
- modified manufacturing process plan, procedure, facilities,
workstation layout, etc.
- improved product, process monitoring plan, inspection equipment
and responsiveness, etc.
- product is modified, if necessary
2. New RPNs are calculated after corrective solutions have been
analysed and evaluated:
1. the follow-up date is given on the summary sheet
2. analysis contents are modified
3. Severity (S) index does not change (else, explain).
4. Occurrence (O, P1, P2/1) and Detection (D, P3) indexes change
according to the contents of the analysis
5. RPNs that exceed thresholds are resolved
VERIFY RESULTS
8 Potential failures are cleared:
1. a summary report certifies whether the corrective solutions that
have been set up and are effective
2. when the FMEA requestor signs at the bottom of the summary
sheet, s/he certifies that the potential failures have been cleared
Evaluation grid of the Process FMEA
Analysis and Action plan at TGA/RO/IOD Result at ABVC/AMS-Lot or

evaluation ABPT/AMEI
Analysis and The action plan is All RPN > Results shown Results applied Indicator
prioritisation of planned threshold are for all RPN > to the process (put a cross in the
failures included threshold and monitoring box that
plan corresponds to
the result)
OK OK OK OK OK K-0
Non-compliance exists, but making the product compliant is compatible with project time K - 10
constraints.
Not carried out Action plan not defined or One or several RPNs > threshold K - 50
incomplete and/or Target still remain, or all corrective
Completion Dates are incompatible actions have not been applied.
with project constraints Incompatible timelines
DECISION-MAKING
K - 0 Process FMEA study accepted
K - 10 Process FMEA study accepted subject to making the product compliant
K - 50 Process FMEA study rejected. Start an action plan.
REMARKS
Name: ............................... Date: ....................... Signature:

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DESIGN AND PROCESS FMEA

(FAILURE MODE, EFFECTS

AND CRITICALITY ANALYSIS)

Renault Automobiles Standardisation

December 1986 ---

November 2000 - - A Complete revision.

CNOMO Standard : E41.50.530.N.

© RENAULT 2011 Page 2/47

© RENAULT 2011 Page 3/47

ABVC : Agreement to Built Vehicle Check (Vehicle Engineering ; V3P logic).

ABPT : Agreement to Built Plant Trial (Mechanical Engineering ; JPOM5 logic).

AMS-lot : S-Lot Assembly Approval (Vehicle Engineering ; E=MC² logic).

AMEI : Approval to Build Initial Samples (Mechanical Engineering ; JPOM4 logic).

DLI : Industrial Logistics Department.

DPLI : Manufacturing and Industrial Logistics Department.

FMEA : Failure Mode, Effects and Criticality Analysis (FMEA).

Functional Specifications : Functional Specifications.

IOD : Definitive Off-tool Part (Mechanical Engineering ; JPOM4 logic).

K‰ : Warranty cases per thousand.

NCR : Non-Conformity Rate.

RPN : Risk Priority Number.

PIMOL : Vehicle off-road breakdown.

PC : Pre-Contract (Mechanical Engineering ; JPOM5 logic).

PPM : Parts per Million (1 % = 10 K ‰ = 10 000 PPM).

RO : Tooling Go Ahead (Vehicle Engineering ; E=MC² logic).

SdF : Operating Dependability.

TGA : Tooling Go Ahead (V3P and JPOM5 logics).

VPC : Vehicle Pre-Contract (Vehicle Engineering ; V3P logic).

© RENAULT 2011 Page 4/47

1. SCOPE AND FIELD OF APPLICATION

This standard deals with Design FMEA and Process FMEA.

• mechanical, hydraulic, electrical, mechatronics technology

• one unit, subset, component, characteristic of the product

• one main function and/or constraint with related value criteria

• production process, rework process or inspection process of a product,

• manufacturing operation and/or inter-operation,

• one or n manufactured characteristics, etc.

The FMEA also applies to:

© RENAULT 2011 Page 5/47

Improvement may concern either the product or the process, or both.

PRODUCTION FACILITY FMEA

FLOW FMEA: see additional information in Appendix 5

© RENAULT 2011 Page 6/47

Logistics diagram Flow FMEA

Figure 1 – Validate task by taking preventive action on potential failures

© RENAULT 2011 Page 7/47

2) "IMAGINE NEGATIVE SCENARIOS", dysfunctional analysis: 3 stages (figure 2)

1 Design with a positive outcome in mind

2 Imagine the failures 1 2

3 Remedy the potential failures. _

3) EFFECTIVENESS OF THE FMEA IS BASED ON 3 QUALITIES: COMPETENCE, CREATIVITY

© RENAULT 2011 Page 8/47

STAGES MEANING – SCOPE WHO

LOOK Look for corrective solutions.

Analyse and evaluate the corrective

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4. DETAILED PROCEDURE FOR THE PRODUCT OR PROCESS FMEA

4.1. STAGE 1: INITIALISE