Overview
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Jérémy CICERO: Consultant, trainer, ICA auditor, Qualipole Languedoc-Roussillon
INTRODUCTION
You need to qualify a new process or a new product, and want to identify the risks of drift or non-control. FMEA (Failure Mode, Effects and Criticality Analysis) is a powerful analysis tool that enables you to make an exhaustive inventory of the risks of drift in a process, a product or a means of production.
FMEA is part of the risk management approach; its purpose is to implement preventive action plans aimed at eliminating or reducing risks related to user safety, non-quality, loss of productivity and customer dissatisfaction.
This sheet provides a step-by-step guide to conducting a FMEA analysis.
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Regulations
ISO 9001:2008 – Chapter 8.5.3 - Preventive action
ISO 9001:2008 – Chapter 7.5.1 - Control of production and service preparation
ISO 9001:2008 – Chapter 7.5.2 - Validation of production and service preparation processes
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