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FMEA Development Procedure Overview

The document describes Magneti Marelli Electronics' FMEA process, which is a structured approach used during design to identify potential failures, their causes and effects, and establish prevention and detection controls to reduce risks. It provides definitions, responsibilities, and outlines the steps to perform a Design FMEA (DFMEA) and Process FMEA (PFMEA) including establishing a Risk Priority Number and recommended actions. The FMEA process must be applied during early conceptual design and continued through the life of the product.

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0% found this document useful (0 votes)
89 views10 pages

FMEA Development Procedure Overview

The document describes Magneti Marelli Electronics' FMEA process, which is a structured approach used during design to identify potential failures, their causes and effects, and establish prevention and detection controls to reduce risks. It provides definitions, responsibilities, and outlines the steps to perform a Design FMEA (DFMEA) and Process FMEA (PFMEA) including establishing a Risk Priority Number and recommended actions. The FMEA process must be applied during early conceptual design and continued through the life of the product.

Uploaded by

Najib Rtili
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ELECTRONICS

DIVISIONAL PROCEDURE

FMEA Development approach


PREDVP2008_

Rev.00

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PUBLICATION COMMITTEE*
FUNCTION NAME FUNCTION NAME

Quentin Gimel
Methodologies
Daniele Negri

* This section shall be updated any time a modification Is performed, to ensure that the author of the last version is included in the Publication Committee.

VERSION HISTORY
REV DATE CHANGE
00 06/02/2018 First issue.

APPROVALS
FUNCTION NAME DATE SIGNATURE

Engineering Yannick HOYAU (signature or mail for approval)

Quality Gerhard HENKEL

Methodologies Daniele NEGRI

Quality System Luca FERRANDI

Functional Safety Harald GEIGER

ELECTRONIC COPIES DISTRIBUTION PAPER COPIES DISTRIBUTION


The electronic version of the document is published on internal Note:
Technical Database or Intranet website. Distributing the documents within plant functions is Plant Quality
Note: Manager’s responsibility.
Printed copies could be not aligned to the last updates.
Checking for the last available version on the DBT/intranet
website is User’s responsibility.

Template ID: MDEDVM2000A rev0

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SUMMARY

1. Purpose .................................................................................................................................................... 4
2. Application Field ..................................................................................................................................... 4
3. References ............................................................................................................................................... 4
4. Definitions and acronyms ...................................................................................................................... 4
5. Responsibilities....................................................................................................................................... 4
6. Process Description ............................................................................................................................... 5
7. Architecture Process .............................................................................................................................. 6
7.1 FMEA ............................................................................................................................................... 7
7.1.1 Perform DFMEA ......................................................................................................................... 7
7.1.2 Perform PFMEA .......................................................................................................................... 8
7.1.3 Roles Responsibility Table (RASIC) ........................................................................................ 9
8. Process Measure(s) .............................................................................................................................. 10
9. Tailoring Guidelines ............................................................................................................................. 10
10. Process Roles Definition ...................................................................................................................... 10

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1. Purpose
The purpose of this document is to describe the FMEA Process and rules institutionalized in Magneti Marelli
Electronics organization.

2. Application Field
This document is applicable to all development projects of the Electronics business line starting after the
date of approval of this document.

3. References
Internal References

[1] PREDVP2000_ PDH: Product and Process Development Handbook

[2] MQEDVM2000_ Magneti Marelli Electronics QUALITY MANUAL

[3] PREDVP2014_ Magneti Marelli Standard Glossary P2_Glossary

[4] PREDVP2015_ Magneti Marelli Standard Acronyms P2_Acronyms

[5] PREDVP2018_ PMO Gates based product and process development handbook

[6] IOEDVS1004A Organization Roles Definition

[7] IOEDVP2008C System FMEA

[8] IOEDVP2000A Failure Mode Effect Analysis

[9] PREDVP2S01_ Functional Safety Management

External References

[10] Capability Maturity Model Integration (CMMI) for Development Ref: CMMI V-1.3

[11] Automotive SPICE Process Reference Model Ref: Auto SPICE V-4.5

4. Definitions and acronyms

For a complete list of Definitions and Acronyms see the MAGNETI MARELLI Standard Glossary [3] and
Standard Acronyms [4].

5. Responsibilities
Area Managers are the Process Owners, Methodology Manager is responsible for the editing and the
updating of this document and Quality System Manager is responsible for the approval process.

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6. Process Description
The Failure Mode and Effects Analysis (FMEA) is a structured step-by-step approach to discovering all
failures modes that may exist within the design of a product or process starting from functionalities.
FMEA is used during design to prevent failures. Later it’s used for control, before and during ongoing
operation of the process. FMEA should start during the earliest conceptual stages of design and continues
throughout the life of the product or service.
For each potential failure mode, all the consequences (potential failure effects) have to be identified on the
system, related systems, process, related processes, product, service, customer or regulations.
For each failure effect the severity (S) rating has to be identified.
For each failure effect all the potential root causes (failure causes) have to be identified.
For each cause the occurrence (O) rating has to be determined. This rating estimates the probability of
failure occurring for that reason during the lifetime of your scope.
For each cause the prevention controls have to be identified.
For each control the detection (D) rating has to be determined. This rating estimates how well the controls
can detect either the cause or its failure mode after they have happened but before the customer is affected.
For each item identified the Risk Priority Number (RPN, which equals SxOxD.) and Criticality (which equals
SxO) have to be calculated, These numbers provide guidance for ranking potential failures in the order they
should be addressed.
Based on the RPN threshold or Criticality threshold recommended actions have to be identified to improve
the detection (this means reduce the rating) and/or improve the occurrence (this means reduce the rating).
Overall target is to decrease the RPN value and reach the acceptable target value
The FMEA must be done before a failure mode has been incorporated into the product or process, when
changes can be easily introduced, reducing the need for urgent actions.
Even if the responsibility is assigned to an individual, the FMEA is the result of an inter-functional team: a
team with skilled individuals must be put in place (Hardware, Software, Mechanical, Testing, Manufacturing,
Technologies experts, Quality…) for the purpose. The FMEA is a multi-disciplinary process that is composed
of two different activities:
 The Design FMEA (DFMEA) : explores the possibility of product malfunctions, reduced product life,
critical characteristics, and safety and regulatory concerns derived from:
o Material Properties
o Geometry
o Tolerances
o Interfaces with other components and/or systems
o Engineering Noise: environments, user profile, degradation, systems interactions
 The Process FMEA (PFMEA) discovers failure that impacts product quality, reduced reliability of the
process, customer dissatisfaction, critical characteristics, and safety or environmental hazards
derived from:
o Human Factors
o Methods followed while processing
o Materials used
o Machines utilized
o Measurement systems impact on acceptance
o Environment Factors on process performance
During these two activities the owners of the Design FMEA have to be involved in the Process FMEA and
vice versa.
This cross functional team has knowledge about the process, product or service and customer needs.
Each step of the FMEA should be approved by a specially appointed role in case of product-safety related
products.

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7. Architecture Process
The following chart describes process interactions within the FMEA process area.

Figure: FMEA Process Architecture

The Severity rating associated to each input/output of FMEA sub-processes have to be maintained at the
same value for each step.

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7.1 FMEA

7.1.1 Perform DFMEA


The Design FMEA methodology can be applied in different phases of the lifecycle and focusing of different
perimeters. The following type of design FMEA can be identified:
 System FMEA
 Software FMEA
 Hardware FMEA: at hardware blocks level and, if requested (Functional Safety, Regulatory,
Customer) electronic elements level (qualitative)
 FMEDA: at electronic elements level (quantitative)
 Mechanical FMEA

Due to the analyzed perimeter, Software, Hardware and Mechanical FMEA depend hierarchically on the
System FMEA; for the same reason, the FMEDA depends hierarchically on HW FMEA.

SYSTEM FMEA

SW FMEA HW FMEA MECHANICAL


FMEA

FMEDA

The coherence among the different types of design FMEA is achieved respecting the hierarchical
dependency between the architectural blocks and ensuring the correct creation of function and failure nets:
 All the blocks of the highest level of SW, HW and Mechanical FMEA shall be hierarchically
connected to one of the blocks of the lowest level of the System FMEA.
 All the blocks of the highest level of FMEDA shall be hierarchically connected to one of the blocks of
the lowest level of the HW FMEA.
 All the functions belonging to the blocks of the highest level of SW, HW and Mechanical FMEA shall
be connected to the corresponding functions belonging to the blocks of the lowest level of the
System FMEA ensuring coherence and consistency (for “Function” definition see ref [7] and [8])
 All the functions belonging to the blocks of the highest level FMEDA shall be connected to the
corresponding functions belonging to the blocks of the lowest level of the HW FMEA ensuring
coherence and consistency.

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 All the failures belonging to the blocks of the highest level of SW, HW and Mechanical FMEA shall
be connected to the corresponding failures belonging to the blocks of the lowest level of the System
FMEA ensuring coherence and consistency, inheriting the Severity value.

7.1.2 Perform PFMEA


The PFMEA must be initiated when making the feasibility analysis for a new production process, and should
be completed before the tooling launch.

The PFMEA must be done by the process development team (Designers, Technology and Testing
engineers, Quality, Environmental and Safety experts etc.) that has every information needed for the
analysis, see ref[8].

The Process Engineer involves the representatives from every involved technical area.

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7.1.3 Roles Responsibility Table (RASIC)

Process Roles ►

SW Solutions

Testing Team
Quality Team
Safety Team
Architecture

Mechanics

Functional
HW Team

Engineer
Process
System

Team

Team

Team
Process Steps ▼

DFMEA

SYS FMEA R C C C C C C C

SW FMEA C R C C C C C C

HW FMEA C I R C C C C C

FMEDA C I R C C C C -

MECHANICHAL FMEA C I C R C C C C

PFMEA
PFMEA C C C C C R C C

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8. Process Measure(s)
The Process measures details should be defined at DFMEA and PFMEA process.

9. Tailoring Guidelines
In case of project derived, the FMEA could be performed as delta starting from the FMEAs of the derivation
project.

10. Process Roles Definition


The roles identified in this procedure are described in the Organization Roles Definition [6].

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