REVERSE FMEA. Guideline. AMDEC inversée. Quality. Competitiveness and markets

Transcription

1 Guideline REVERSE FMEA AMDEC inversée Quality Competitiveness and markets

2 Table of Contents Background Objectives Scope Terms and Definitions Method description What Why Who Where When How often How... 5 Summary of reverse FMEA steps... 9 Annex: Examples of templates...10 A. Schedule B. Checklist for on-site FMEA review C. Observation template D. Activity report 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) Copyright - All rights reserved SFEPA / 10

3 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. Copyright - All rights reserved SFEPA / 10

4 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 Copyright - All rights reserved SFEPA / 10

5 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 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 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 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.) Copyright - All rights reserved SFEPA / 10

6 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.). Copyright - All rights reserved SFEPA / 10

7 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) Copyright - All rights reserved SFEPA / 10

8 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) Copyright - All rights reserved SFEPA / 10

9 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 /.... Copyright - All rights reserved SFEPA / 10

10 Summary of reverse FMEA steps Scope 1 Selection of the workstation(s) Yes On-site FMEA review conducted and up-to-date? No 2 Team preparation Team preparation 4 On-site open-mind observation Notes 1 & 2 in On-site FMEA review 3 5 Debriefing and comparison Containment measures implementation Process FMEA Update 6 7 Activity report recording Update control plan, work instructions, etc., with definitive corrective actions 8 Figure 6: Reverse FMEA Steps The organisation may use indicators (KPIs) according to the scheduling and activity reports. Copyright - All rights reserved SFEPA / 10

11 Annex: Examples of templates A. Schedule Schedule template.xlsx B. Checklist for on-site FMEA review On-site FMEA_Checklist templa C. Observation template Open_observation template.xlsx D. Activity report Activity report template.xlsx Normative references IATF 16949: Quality Management systems -- Automotive industry ISO 9001 : Quality management systems Requirements ISO 9000 : Quality management systems -- Fundamentals and vocabulary Copyright - All rights reserved SFEPA / 10

12 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. 1 st Edition February 2019 Copyright - All rights reserved - SFEPA , rue Jean-Jacques Rousseau, F SURESNES CEDEX