Magneti Marelli UM Electronic Systems Private Limited Doc. No.

: R&D-OI-01
Rev. No.: 01
Issue date: 19.05.10
Operative Instruction for Process FMEA
Rev date: 31.01.13
Page: 01 of 09

1.0 OBJECTIVE: To establish, implement and maintain control for FMEA

2.0 SCOPE: This procedure covers all Products FMEA generation, review & distribution.

3.0 RESPONSIBILITY: HOD R&D and Process Engg are overall responsible for implementation of this operative instruction.

METHODOLOGY APPLICATION
1) If the Customer expressly requests the use of a specific FMEA methodology, then that Customer’s approach
may be used.
2) In the absence of any specification by the Customer, potential failure mode and effects analysis in
manufacturing and assembly processes (Process FMEA) as per AIAG Manual.
3) The present Operative Instruction describes also the FIAT, PSA and ISO/TS 16949 (FORD, Chrysler, General
Motors and SAE) methodologies; the use of another methodology specified by the Customer must be supported
by documentation of the methodology itself
4) It is meant to be a “before-the-event” action, not an “after-the-fact” exercise. This isn’t opposite to the necessity
of updates when is arrived an unanalysed failure.
To achieve the greatest value, the FMEA must be done before a product or process failure mode has been
incorporated into a product or process, when product/process changes can be most easily and inexpensively
implemented, minimizing change crises due to the delay in preventive/corrective actions and reducing the risk to
have a urgent set of preventive/corrective actions and vehicle campaigns.
During the development of FMEAs, Communication and coordination should occur between all types of FMEAs
and all the involved teams (see figure with optimal interactions in the time between different FMEAs)

5) Project FMEA (DFMEA)

Process FMEA (PFMEA)

Machinery FMEA (MFMEA)

Project FMEA
of components
for tooling

ISO/TS 16949:2009 APPROVED BY ISSUED BY CONTROL STATUS

AIAG Manual Head R&D Management Representative CONTROLLED COPY

 Magneti Marelli UM Electronic Systems Private Limited Doc. No.: R&D-OI-01
Rev. No.: 01
Issue date: 19.05.10
Operative Instruction for Process FMEA
Rev date: 31.01.13
Page: 02 of 09
Definition of functions and requirements to respect (functional
FMEA DEVELOPMENT STEPSanalysis)

What can go wrong?

No Function

Degraded / out of range Function

Intermittent Function

Unintended Function

How can this be prevented? What are the causes?
(Worst Case evaluation, robust (Please, find the root
design, etc.) cause and don’t stop
---------------------------- to the first identified
cause)
How can this be detected?
(Simulation, test, Vehicle test,
etc.)
How often it’s happen?
(Similar product
behaviour, reliability)
What are the effects?
•System The function is under
•Vehicle Law constraints or has
•Persons effects on safety or is
•… related to a customer’s
Special Characteristic?
how bad is the effect?

How good are ours methods to

prevent or to detect the What can be done?
problem?
Project Changes

Process Changes

Special Controls

Internal Standard, Procedure and
Guidelines modifications

Implementation of controls for special
characteristic

PROCESS FMEA - GENERAL

A Process FMEA is an analytical technique utilized by a Process Engineer/Team as a means to assure that, to the extent possible,
potential failure modes and their associated causes/mechanisms have been considered and addressed. This technique is applied
under the Process Engineer Responsibility.
A PFMEA is a summary of the interfunctional team's thoughts (including an analysis of items that could go wrong based on
experience) as a process is developed, and supports Process Engineer/Team in the reducing the risks.

The Process FMEA:

b Identifies the process functions and requirements,

b Identifies potential product and process related failure modes,
b Assesses the effects of the potential failures on the customer,
Identifies the potential manufacturing or assembly process causes of failure and identifies process variables on
b which to focus controls for occurrence reduction or detection of the failure conditions,

b Identifies process variables on which to focus process controls,

Develops a ranked list of potential failure modes, thus establishing a priority system for preventive/ corrective
b action considerations
b Documents the results of the manufacturing or assembly process development.
ISO/TS 16949:2009 APPROVED BY ISSUED BY CONTROL STATUS

Head R&D Management Representative CONTROLLED COPY

 Magneti Marelli UM Electronic Systems Private Limited Doc. No.: R&D-OI-01
Rev. No.: 01
Issue date: 19.05.10
Operative Instruction for Process FMEA
Rev date: 31.01.13
Page: 03 of 09
1) This kind of evaluation can use a variety of methodologies depending on both the type of analysis and the
Customer requirements. Even presenting some different methods, in the present document the focus is on the
AIAG FMEA Manual that is the standard for PFMEAs.
2)
The basic methodology is always the same for the different methods (ISO, SAE, FIAT, PSA, etc.), but the starting
point for the analysis, certain quantitative indices, value assignment criteria and analysis data may vary.
3)
The best solution is to develop an analysis at the whole product/process level with an inter-functional approach
(Design, Technology, Suppliers, Testing, Quality aspects).
4) Depending on the Customer, on the other hand, a number of quantitative indices may vary, more or less
marginally or the value assignment criteria for certain apparently similar indices or certain data required for the
analysis.
5) All the methodologies in the present Operative Instruction (ISO, FIAT, PSA, and ISO/TS 16949) provide for the
determination of a Risk Priority Number (RPN) for each term analysed (Risk Priority Index (IPR) for FIAT,
Criticality (C) for PSA, Risk Priority Index (RPI, for the others).
6) The calculated values of this index must be compared with a critical threshold level beyond which corrective
actions must be implemented to reduce the associated risk to an acceptable level.
7) It is advisable to ask the Customer to specify, before doing the FMEA, the critical threshold values.
8)
If this information is not available it’s necessary an intervention when the RPN (or IPR) value is greater or equal
then 48 for severity from 1 to 7 and 27 for severity 8, 9 or 10..

PFMEA EXECUTION REQUIREMENTS

The Process FMEA should be initiated/ reviewed:
» Before or at the feasibility stage, » Prior to tooling for production, and
» Take into account all manufacturing operations, from individual components to assemblies.
1) The FMEA must also be done by members of the cross functional team (Designers, Technologies engineers,
Testing engineers, Quality, Environmental and Safety experts etc.) who are in possession of the information
required for running the analysis.
2) The Process Engineer is expected to directly and actively involve representatives from all affected areas.
3) The FMEA should be a catalyst to stimulate the interchange of ideas between the functions affected and thus
promote a team approach. Unless the responsible engineer is experienced with FMEA and team facilitation, it is
helpful to have an experienced FMEA Facilitator assist the team in its activities.
4) It is advisable to use the services of any further professional figures that might be able to improve the evaluation
of particular aspects of the analysis (even Supplier or Customer if necessary)
5) Before starting the analysis, all the required documentation must be available, even in draft or related to similar
products/process (Process flow chart, Manufacturing and assembly cycle product schematics, B.O.M., DFMEA,
Critical Characteristic definition, Quality objectives and results on similar products, etc.).
6) The scope of Process FMEA must be include also the raw material and components in input to the process.
These must be analysed as:
» Criticality (if it’s Non Conform and isn’t verified into the process)
» Occurrence (level of problems of Quality related to the supplier or the component)
» Detection (controls and probability of non detection with actual controls)
7) Actions that can reduce the occurrence of failures related to component / materials are:
» Selection of Qualified Suppliers
» Critical Dimension and Characteristics defined in the request for quotation
» In-Process/Supplier’s Process FMEA / control Plan approved by MM SE
» In -Process/Supplier’s Process with Ppk / Cpk > 1.67
» Supplier’s Self certification of Ppk / Cpk Level or delivered row materials for each Lot
» Additional Controls in incoming
» 100% of component controlled into the MM SE’s Lines
ISO/TS 16949:2009 APPROVED BY ISSUED BY CONTROL STATUS

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 Magneti Marelli UM Electronic Systems Private Limited Doc. No.: R&D-OI-01
Rev. No.: 01
Issue date: 19.05.10
Operative Instruction for Process FMEA
Rev date: 31.01.13
Page: 04 of 09
8) For internal made components (i.e.: pre-assembled circuits, …) is necessary a specific FMEA of the production
process of the component.
9) Must be considered also in the PFMEA all the external activity of the assembly / production process, as:
» Handling and transportation into the warehouse and to the lines
» Handling and transports between stations
» Reworking Phases and refused management
» Internal transport of finish product
» Packaging and labelling Phases
» Warehousing and Boarding Phases
» Transport to the Customer’s Plant and Delivery
10) Considering that product characteristics have been incorporated, the Process FMEA addresses the process
development intent and assumes the Product as designed, will meet the design intent.
11) Potential failure modes and/or causes/mechanisms that can occur because of a design weakness must not be
included in a Process FMEA.
12) The Process FMEA does take the technical/ physical limits of the designed product into consideration also.
13) The FMEA Report must be compiled on forms with the same content defined by the present Operative Instruction
(unless otherwise required by the Customer); and must be: dated and signed, with all graphic materials required to
explicate the Risk Indices, including the identification of the Critical Characteristics, Corrective Actions and
conclusions.
14) It must be updated as process changes occur or additional information is obtained throughout the phases of
process development (Prototypes, Pre-series, Mass production), and it’s necessary that the FMEA document be
fundamentally completed before the Start of Production.

PFMEA METHODOLOGIES AND WORK TABLES

The document must contain, generally at the beginning all the general data:
» The FMEA REFERENCES (identification, version, date) , which may be used for tracking.
» COMPONENT NAME AND CODE. Indicate the appropriate level of analysis (Preliminary, Pre-series, Mass
production) and enter name and identification code of the component for which the production process being
analysed.
» PROCESS RESPONSIBILITY Indicate the Production Plant and Business Area.
» WRITER Enter the name of the engineer responsible for preparing the FMEA final document.
» MODELS/PROGRAMS If known, indicate the intended models and programs that will utilize and/or be affected
by the design being analysed
» FMEA MODIFICATION HISTORY. Enter the modification history with version, writer, modification description
and version date.
» CORE TEAM List the names of the responsible individuals and departments which are involved in the analysis

» DOCUMENT REFECENCES Indicate if the FMEA is using a Customer Specific Form and refer to Customer
Standards about FMEA. Indicate also documents defining Engineering rules, Internal or External or Customer
Norms and Procedures if applicable.
» REGULAMENTATION OR SAFETY SYMBOLS if necessary (as defined in PRDIV2201 or Customer specifics if
requested)
FAILURE ANALISYS
1)
Referring to the standard MMSE PFMEA form in annex 2, indicate the PROCESS FUNCTION/REQUIREMENT.
Enter a simple description of the process and operation being analysed (e.g. welding, assembling, screwing, etc.).

2) Where the process involves numerous operations (e.g., assembling) with different potential modes of failure, it
may be desirable to list the operations as separate elements.
3) Define the POTENTIAL FAILURE MODE. Potential Failure Modes are defined as the manner in which the
process could potentially fail. It is a description of the non-conformity at that specific operation. It can be a cause
associated with a potential failure mode in a subsequent operation or an effect associated with a potential failure
in a previous operation. However, in preparation of the FMEA, the assumption may be made that the incoming
parts/materials are correct. The FMEA team can make exceptions where historical data indicates deficiencies in
incoming part quality.
ISO/TS 16949:2009 APPROVED BY ISSUED BY CONTROL STATUS

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 Magneti Marelli UM Electronic Systems Private Limited Doc. No.: R&D-OI-01
Rev. No.: 01
Issue date: 19.05.10
Operative Instruction for Process FMEA
Rev date: 31.01.13
Page: 05 of 09
4)
List each potential failure mode for the particular operation in terms of component and process characteristic. The
process engineer/team should be able to pose and answer the following questions:
5) How can the process/part fail to meet specifications?
6) Regardless of engineering specifications, what would a customer (end user, subsequent operations, or service)
consider not acceptable?
7) Typical failure modes could be, but are not limited to:
» Bent » Burred » Cracked » Deformed » Handling damage » Open Circuited » Mislabelled
» Hole Dirty/Missing/out position » Surface too rough/Deformed Surface » Short Circuited
Note: Potential failure modes should be described in “physical” or technical terms, not as a symptom noticeable by the
customer.
8) Define the POTENTIAL EFFECT OF FAILURE. Describe the effects of the failure in terms of what the customer
might notice or experience, remembering that the customer may be an internal customer as well as the ultimate
end user.
9) State clearly if the failure mode could impact safety or cause non-compliance to regulations (see PRDIV2201). The
customers in this context could be the next operation, subsequent operations or locations, the Car Maker Plant,
the dealer, the vehicle owner.
10) Each must be considered when assessing the potential effect of a failure.
11) For the End User, the effects should always be stated in terms of product or system performance, such as:
» Noise » Rough » Erratic Operation » Inoperative Regulatory » Non-Compliance
» Poor Appearance » Unstable Operation » Loss of function » Loss of feedback » Scrap
» Vehicle Control problems » Rework/Repairs » Customer Dissatisfaction ….
12) If the customer is the next operation or subsequent operation/locations (regarding also the Car Maker’s Lines)
the effects should be stated in terms of process/operation performance, such as:
» Can’t fasten » Doesn’t fit » Doesn’t connect » Can’t mount
» Doesn’t match » Causes Excessive tool wear » Damages equipment » Endangers operator
13) Define the SEVERITY (S) as in table 4. Use Criteria 1 for Customer effect and Criteria 2 for Assembly
Manufacturing Effects evaluation. The worst-case evaluation must be used.
14) Define the CRITICALITY CHARACTERISTICS using the PR DIV 2201 and Customer requirement. The criticality
Characteristics can be: Safety, Regulation, Critical for aesthetic or mounting and other Customer Classification. If
asked from the customer, in alternative:
15) Must use of customer classification symbols or must use of MMSE symbols, with a Cross Reference table annexed
to the final document
16) Define the POTENTIAL CAUSES/MECHANISMS OF FAILURE. Potential Cause of Failure is defined as how the
failure could occur, described in terms of something that can be corrected or can be controlled
17) List, to the extent possible, every potential cause and/or failure mechanism for each failure mode, even if the team
is sure that an error is impossible. The identified causes must be in the scope of FMEA. (i.e. a failure related to
Design causes can’t be indicate in PFMEA). If a cause is exclusive to the failure mode, i.e., if correcting the cause
has a direct impact on the failure mode, then this portion of the FMEA thought process is completed. Many causes,
however, are not mutually exclusive, and to correct or control the cause, a design of experiments, for example,
may be considered to determine which root causes are the major contributors and which can be most easily
controlled.
18) Typical failure causes may include, but are not limited to:
» Improper torque -over, under » Improper weld » Inaccurate gauging » Improper heat treat
» Inadequate or no lubrication » Part missing or mislocated » Worn locator
» Worn tool » Chip on locator » Broken tool » Improper machine set-up
» Improper machinery programming
» » Only specific errors or malfunctions (e.g., operator invert the capacitor) should be listed.
» » Ambiguous phrases (e.g., operator error, machine malfunction) should not be used.
ISO/TS 16949:2009 APPROVED BY ISSUED BY CONTROL STATUS

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 Magneti Marelli UM Electronic Systems Private Limited Doc. No.: R&D-OI-01
Rev. No.: 01
Issue date: 19.05.10
Operative Instruction for Process FMEA
Rev date: 31.01.13
Page: 06 of 09
19) Determine the OCCURRENCE (O) Occurrence is the likelihood that a specific cause/mechanism will occur. Use
the table 5 definitions to define the ranking.
20) Preventing or controlling the causes/mechanisms of the failure mode through a design change or process change
is the only way a reduction in the occurrence ranking can be effected.
21) Determine the PREVENTION CURRENT PROCESS CONTROLS. They are the controls that prevent the
cause/mechanism of failure or reduce the rate of occurrence.
22) Determine the DETECTION CURRENT PROCESS CONTROLS. They detect the cause/mechanism of failure or
the failure mode and lead to corrective actions.
23) The preferred approach is to first use prevention controls, if possible. The initial occurrence rankings will be
affected by the prevention standard controls. The initial detection rankings will be based on detection controls that
detect the failure mode.
24)
Define the DETECTION (D). Detection is the rank associated with the best detection process control from the list
in the previous activity. Detection is a relative ranking, within the scope of the individual FMEA. In order to achieve
a lower ranking, generally the planned process control has to be improved. Use table for evaluation of this ranking.

NOTE: After making the Detection Ranking, the Team should review the Occurrence Ranking and ensure that the
Occurrence Ranking is still appropriate
25)
Calculate the RISK PRIORITY NUMBER (RPN) as RPN = S x O x D. Within the scope of the DFMEA, this value
(between “1” and “1000”) can be used to rank the priority of intervention in the design (e.g., in Pareto fashion).

26)
Define the RECOMMENDED ACTIONS. Engineering assessment for preventive/corrective action should be first
directed at high severity,then occurence & detection.

i) » » The intent of any recommended action is to reduce rankings, in the following preference order: severity
occurrence, and detection rankings.
ii) » » In practice when the severity is a “9” or “10”, special attention must be given to assure that the risk is
addressed through existing design controls, process controls or design and process preventive/corrective actions,
regardless of the RPN value.
iii) » » In all cases where the effect of an identified potential failure mode could be a hazard to the end-user,
preventive/ corrective actions should be considered to avoid the failure mode by eliminating, mitigating, or
controlling the causes. A preventive action that mitigates the effect of failure is the only way to reduce the severity.
Only a design and process revision can bring about a reduction in the severity ranking .
iv) » » After special attention has been given to Severity Rankings of 9 or 10, the team then addresses other Failure
Modes, with the intent of reducing Occurrence and then Detection.
» To reduce the probability of occurrence, process and/or design revisions are required.
v)
» » An action-oriented study of the process using statistical methods could be implemented with an ongoing
feedback of information to the appropriate operations for continuous improvement and defect prevention
vi) » To increase the probability of detection, process and/or design revisions are required.
vii)
» Generally, improving detection controls is costly and ineffective for quality improvements. Increasing quality
controls inspection frequency should only be utilized as a temporary measure since permanent
preventive/corrective action is required.
viii) » In some cases, a design change to a specific part may be required to assist in the detection. Also changes to the
current control system may be implemented to increase this probability.
ix) » If no recommended actions for a specific failure are indicated, is suggested to enter a “NONE” in the action field
of module.
27) Define the RESPONSIBILITY FOR THE RECOMMENDED ACTION, entering the name of the organization and
individual responsible for the recommended action and the target completion date
28)
In no action is made the REVISED RATINGS field must be blank.

PFMEA REVIEW FREQUENCY

PFMEA is a live document which has to be reviwed on a frequency of every 6 month apart from the following:

i) Due to Customer claim corrective & preventive actions

ii) Due to internal defect correcetive & preventive actions

iii) Due to ECN/ new development/ layout change/ Inprovement Projects/ abnormality detected in the process.

iv) Due to change in RPN cut-off

ISO/TS 16949:2009 APPROVED BY ISSUED BY CONTROL STATUS

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 Magneti Marelli UM Electronic Systems Private Limited Doc. No.: R&D-OI-01
Rev. No.: 01
Issue date: 19.05.10
Operative Instruction for Process FMEA
Rev date: 31.01.13
Page: 07 of 09
» » After an action has been implemented, enter a brief description of the actual action and effective date in the
next PFMEA revision and revise in the specific Field the revised rating. All revised ratings should be reviewed. If
further action is considered necessary, repeat the analysis. The focus should always be on continuous
improvement.
» » Annexed to the FMEA a Synthesis table must be present with all the identified actions. The actions must be
listed ordering by decreasing RPN and if the RPN is the same by decreasing severity. In any case, even if actions
aren’t defined, indicate the 5 functions with higher RPN. Even in this case at same RPN give the priority at the
higher severity.
PFMEA QUALITY OBJECTIVES
Process Improvement » PFMEA drives the Process Improvement with emphasis on error proofing solution
High-Risk Failure Modes » PFMEA addresses all identified high-risk failure modes with an action plan
Control Plans » The Preseries and Production control plan consider the failure modes of PFMEA
Integration » PFMEA is integrated with Process Flow, Process Controls and DFMEA
Lesson learned » PFMEA consider all major lesson learned as input
Critical Characteristics » PFMEA identifies appropriate key characteristics in the process control point of view
» PFMEA must be made during the “window of opportunity” where is made with higher
Timing
impact on process design
» The right people participate at the team activity and they work in an Inter-functional
Team
manner
Documentation » PFMEA document is complete only including action made and new RPN values
Time usage » Time spent early is useful to made an affective and efficient action plan
Detection Ranking Table

ISO/TS 16949:2009 APPROVED BY ISSUED BY CONTROL STATUS

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