AMDEC inversée - FIEV · Since a process FMEA is a preventive analysis, it is conducted prior to any implementation of machines or means. In order to check the process FMEA outputs

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REVERSE FMEAAMDEC inversée

QualityCompetitiveness and markets

© Copyright - All rights reserved – SFEPA - 2019

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Table of Contents Background ............................................................................................................... 2

1. Objectives .......................................................................................................... 3

2. Scope ................................................................................................................. 3

3. Terms and Definitions......................................................................................... 3

4. Method description ............................................................................................ 4

4.1. What .............................................................................................................. 4

4.2. Why ............................................................................................................... 4

4.3. Who ............................................................................................................... 4

4.4. Where ............................................................................................................ 4

4.5. When ............................................................................................................. 4

4.6. How often ...................................................................................................... 5

4.7. How ............................................................................................................... 5

Summary of reverse FMEA steps ................................................................................ 9

Annex: Examples of templates ..................................................................................10

A. Schedule ................................................................................................................ 10

B. Checklist for on-site FMEA review ......................................................................... 10

C. Observation template ............................................................................................ 10

D. Activity report ........................................................................................................ 10

Normative references ...............................................................................................10

The FIEV is grateful to the members of the Reverse-FMEA working group for their help in producing this

guide: Ludovic CLAVIERE – FAURECIA

Fabien BRIERE – HOWA TRAMICO

Martin HE – LEAR CORPORATION FRANCE SAS

Serge FOURET - ROBERT BOSCH (France) SAS

Pierre WEYER - ROBERT BOSCH (France) SAS

Yves GEANT – SNOP

Farid AJAAOUN - SOGEFI Noyan ÖZKAN – VALEO

Philippe PICCIN – ZF Group

Maïlys NGO INYUMA – SFEPA

As well as Maxime PLUCHON – RENAULT SAS (for his involvement)

And Véronique DANGLA – MPSA (for her contribution)


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Background Reverse FMEA is a method of analysis increasingly requested by Original Equipment Manufacturers for continuous improvement of products quality.

Figure 1: Extract of PSA & RENAULT CSR (Source: IATF CSR website)

In view of this trend and to standardise such an approach, French automotive experts have put together this guide, presenting the best available knowledge and reflecting the state of the art at the time of publication.


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1. Objectives

This document describes the basic principles of the Reverse FMEA method and the necessary requirements for its implementation. It aims to provide a common foundation and to guide organisations that need to deploy and implement such a method. It is based on consensus among the various stakeholders.

2. Scope

This guide applies to all types of processes (technologies, etc.) and production sites in the automotive industry. It involves all levels of the industry (CUSTOMERS, suppliers, manufacturers, subcontractors, etc.). It is applicable whatever the Process FMEA Standard used.

NOTE: This document can also be used for other industry sectors.

3. Terms and Definitions

FMEA: Failure Modes and Effects Analysis.

A preventive method of analysis used to identify, assess and reduce the technical risks and design weaknesses related to a product, a process or a mean.

Process FMEA

FMEA focused on the technical risks and design weaknesses of a manufacturing and/or assembly process (and may include logistics-related risks).

Mean FMEA

FMEA focused on the technical risks and design weaknesses of means, tools and equipment.

Reverse FMEA

A tool for continuous improvement based on on-site observation for:

• Identifying new risks (quality) associated with real-life production situations • Enhancing and updating all the relevant process FMEA (new failure modes and/or re-rating)

and other resulting documents (e.g. control plan, work instructions)

“CUSTOMER”

An external organisation that receives a product.

Production event

An event that affects the production line.

Organisation

See ISO 9000: 2015


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Escalation process

Procedure used to highlight and notify the relevant parties of certain problems within an

organisation so that the competent personnel can tackle these situations and solve them.

4. Method description

Since a process FMEA is a preventive analysis, it is conducted prior to any implementation of machines or means. In order to check the process FMEA outputs against what is actually happening in production, a reverse FMEA must be carried out.

4.1. What A tool for continuous improvement based on on-site review and observation.

NOTE: Reverse FMEA is not a qualification tool for the manufacturing process.

4.2. Why To improve production robustness (to reduce and anticipate quality issues)

4.3. Who A multidisciplinary team with:

• A method leader (a trained and skilled person responsible for the respect of FMEA and reverse FMEA methodologies)

• Participants (e.g.: quality, maintenance, method, production, safety)

NOTE: It is recommended to include:

o Different hierarchical levels o Person having a fresh eye (new perspective)

4.4. Where On-site: Production line or workstation (incoming, production, dispatch).

NOTE 1: If reworks or degraded mode operations are existing in the process observed, these shall be analysed.

NOTE 2: risks between workstations shall be analysed.

NOTE 3: Presence and access to production lines shall be compliant with the rules defined by the site to ensure the safety of people, the integrity of means and the quality of products.

4.5. When During mass production

NOTE: Reverse FMEA can also be conducted:

o During ramp up. In this case, it is recommended that the multidisciplinary team includes at least one person from the project team.

o During production events (production change over, shift handover, maintenance, planned shutdown, etc.)


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4.6. How often The frequency at which Reverse FMEA are conducted is defined by the organisation and depends on its capacity. A scheduling shall be defined by the organisation.

Figure 2: Example of schedule

The scheduling could be affected by the occurrence of certain events.

Examples of such events (non-exhaustive list)

• CUSTOMER complaint

• Change in process/product

• New product

• Internal incident

• Increase in rejects

• Preparation/results of audits

4.7. How By identifying new risks (quality) associated with real-life production situations, in order to enhance and update all the relevant process FMEA (new failure modes and/or re-rating consistent with the real-life situations observed/data gathered) and other resulting documents (e.g. control plan)

The Reverse FMEA is conducted according to these steps:

1. Define the scope It contains:

a) Selection of the workstation(s) as identified in the organisation’s schedule. b) Verification of the need for an on-site FMEA review (required if non-existent or

obsolete)

2. Prepare the team The team shall be informed about the product (functional analysis, product presentation, etc.) and the process (flow chart, PFMEA, control plan, etc.).


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3. On-site FMEA review Depending on the organisation’s methods and CUSTOMER recommendations, this review could contain the following steps:

a) Comparison of real-life flow chart and the Process FMEA by checking: i. operations presence

ii. operations order

b) Verification of the presence and effectiveness of the preventive and detection actions for each failure mode identified in the Process FMEA.

c) Verification at the workstation that the failure modes are exhaustive, by

identifying possible new failure modes not defined in the Process FMEA. This

verification could be realised by testing:

i. creation of possible failure modes

ii. detection means effectiveness

NOTE 1: Tests should be performed by authorised persons to ensure the safety of people and integrity of means. NOTE 2: During these tests, all bad parts entered or created in the process shall be identified and scrapped.

The review could be conducted, if needed: • using a support document as checklist • using the Process FMEA in hand

Figure 3: Example of checklist for on-site FMEA review

The methodology document used remains the property of the company.

4. On-site open-minded observation

This observation follows steps below: • Observe flows and operations using locations allowing to have different perspectives and avoiding disturbing the production line • Identify the observed causes and (or) potential failure modes • Report the risks in a document (see Annex: Example of observation template)


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The duration of observation shall be consistent with the production rate at the observed workstation.

Figure 4: Example of observation template

NOTE 1: Stages 3 and 4 can be performed at the same time or separately. NOTE 2: The teams can be the same for stages 3 and 4. NOTE 3: Non-respect of Standards (control Plan or Work Instructions) shall be escalated to the sector manager.

NOTE 4: For any problem involving safety, the workstation shall be stopped immediately. The risk shall be reported and solved before re-starting the operation.

The document used remains the property of the company.

5. Debriefing of the observed risks and comparison with the Process FMEA The aim of this step is to identify any risk that is missing or underestimated in the Process FMEA.

6. Update the Process FMEA by: • Adjusting any ratings judged underestimated compared with the real-life

situation observed

• Adding any missing failure modes and completing their corresponding line(s)

(causes, actions, ratings)

• Defining a corrective action plan (with responsible and deadline) if the risk assessed by the FMEA is considered unacceptable.

NOTE 1: The Process FMEA is updated based on the rules established by the organisation when the FMEA has been created (no FMEA rules or procedure/guide versions shall be mixed up in the same analysis). A conversion method (e.g.: observed risks compared with the rating procedures) could be used for the update. NOTE 2: Depending on the risks observed, other documents may be updated. For example: Mean FMEA,

maintenance plan, contingency plan.

NOTE 3: Depending on the risks observed, design optimisations could be considered.

Containment measures shall be implemented while corrective actions are being carried out and shall be prioritised in line with the criticality of the risks (for example: impact on product safety and regulatory characteristics)


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7. Activity report An activity report shall be created and contain at least:

▪ Date ▪ Workstation(s) audited

▪ Audited product reference

▪ Participants

▪ Number of new risks and (or) re-rating

Figure 5: Example of report

It shall be recorded in accordance with the organisation’s or direct CUSTOMER’s rules. The report document shall remain available to the CUSTOMER and auditor (internal or external) if requested. Steps 5, 6 and 7 shall be performed by the whole team immediately after the observation and reported in accordance with the organisation’s rules

8. Update of control plan(s) and/or work instruction(s) Once the definitive corrective actions have been taken and effectiveness proved, the control plan(s) and/or work instruction(s) will be updated. It is recommended to inform all participants of the result obtained.

9. Knowledge capitalization In order to avoid any recurrence on similar products or processes, the risk control shall be capitalised and made available to the entire Organisation. For each organisation, it is recommended to applicate and verify the implementation of this capitalisation by tools or verified by the entities responsible for the deployment and application of "standards / best practices / lesson learns /...”.


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Summary of reverse FMEA steps

Scope

Figure 6: Reverse FMEA Steps

The organisation may use indicators (KPIs) according to the scheduling and activity reports.

Notes 1 & 2 in § 4.7.4

Update control plan, work instructions,

etc., with definitive corrective actions

2

4

5

No

8

On-site FMEA review conducted and up-to-date?

Team preparation

3

Debriefing and comparison Containment measures implementation

Process FMEA Update

6

Activity report recording

7

Yes

Team preparation

On-site open-mind observation

On-site FMEA review

1 Selection of the workstation(s)


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Annex: Examples of templates A. Schedule

Schedule

template.xlsx

B. Checklist for on-site FMEA review

On-site

FMEA_Checklist template.xlsx

C. Observation template

Open_observation

template.xlsx

D. Activity report

Activity report

template.xlsx

Normative references

IATF 16949:2016 - Quality Management systems -- Automotive industry” ISO 9001 :2015 - Quality management systems – Requirements” ISO 9000 :2015 - Quality management systems -- Fundamentals and vocabulary”

https://www.fiev.fr/jcms/prod_22239/fr/schedule-template

https://www.fiev.fr/jcms/prod_22237/fr/on-site-fmea-cheklist-template

https://www.fiev.fr/jcms/prod_22238/fr/open-observation-template

https://www.fiev.fr/jcms/prod_22236/fr/activity-report-template

Reverse FMEA

This guide describes the fundamental principles of the reverse

FMEA and the requirements for its application.

It was written on the basis of the consensus of the various

stakeholders in order to support the organisations in the

deployment and application of this method.

1st Edition – February 2019

© Copyright - All rights reserved - SFEPA - 201979, rue Jean-Jacques Rousseau, F 92158 SURESNES CEDEX

www.fiev.fr

http://www.fiev.fr/

AMDEC inversée - FIEV · Since a process FMEA is a preventive analysis, it is conducted prior to any implementation of machines or means. In order to check the process FMEA outputs

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