4 Planning and preparation                                pdca p

 

4.1 Purpose

When to plan and initiate a FMECA

 4.1

By failing to prepare, you are preparing to fail. Benjamin Franklin

The purpose of the first step is to determine which FMEAfailure mode and effects analysis will be carried out for the project (productany outcome of a process or activity (see also ISO 9000, 3.4.2), processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) or other). Planning and preparation allows you to:

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4.2 Planning

Inputs of step 1, FMEA header, case studies, questions before starting

4.2 

The inputs in step 1 can be:

One of the first tasks to be undertaken is to complete the header of the design FMEAfailure mode and effects analysis (cf. DFMEA sheet, annex 02) and processactivities which transform inputs into outputs (see also ISO 9000, 3.4.1) FMEAfailure mode and effects analysis (see PFMEA sheet, annex 03), shown in figures 4 -1 and 4-2: rec

4-1

Figure 4-1. Design FMEA header

4-2

Figure 4-2. Process FMEA header

The only difference between design and process FMEA is in the appointment of the Design responsibility and Process responsibility.

A FMEAfailure mode and effects analysis is performed in the following cases:

Before starting a FMEAfailure mode and effects analysis, the following questions must be answered:

It's never too early to start the FMEA, it is sometimes too late to still present a real interest. Gérard Landy

FMEAfailure mode and effects analysiss on productsany outcome of a process or activity (see also ISO 9000, 3.4.2), processes and similar means already produced will be used as a knowledge base. The Quality Function Deployment - QFD tool can provide valuable help, cf. annex 09. rec 

Planning for FMEAfailure mode and effects analysis should be done early in product start-up. This is so as to allow the failure modes to be detected as early as possible in the industrialization schedule of a productany outcome of a process or activity (see also ISO 9000, 3.4.2). And therefore to provide a solution as much as possible before sending the quotation to the customeranyone who receives a product (see also ISO 9000, 3.3.5) (so that the costs of Poka-Yoké and other error-proofing systems specific to the productany outcome of a process or activity (see also ISO 9000, 3.4.2) are included in the quotation and paid by the customeranyone who receives a product (see also ISO 9000, 3.3.5)) .

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4.3 Preparation

FMEA team members, first meeting, FMEA documents, outputs from step 1

4.3

 

The person designated by top management as FMEAfailure mode and effects analysis leader is responsible for setting up the FMEAfailure mode and effects analysis multidisciplinary team which may include a:

The first team meeting (optimal number between 5 to 7 people) makes it possible to define:

If the leader is different from the facilitator, the latter will be responsible for the application in the field of the FMEAfailure mode and effects analysis, for meeting the deadline and cost. External people can be invited for advice or expertise.

The scope of FMEAfailure mode and effects analysis is defined, customeranyone who receives a product (see also ISO 9000, 3.3.5) requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.1.2) are clarified, and similar FMEAfailure mode and effects analysiss are reviewed.

All documents providing objective data on the productsany outcome of a process or activity (see also ISO 9000, 3.4.2) (processes) studied are an essential basis for the conduct of FMEAfailure mode and effects analysis, and it is therefore imperative that they are collected by the facilitator before the first meeting or brought by the participants during the meeting. 

Among these documents, we can note in a non-exhaustive way:

The outputs of step 1 can be:

smileyMinute of relaxation. Cf. joke "Gold contract"

The rest of the T 45v19 FMEA approach version 2019 training is accessible on this page.

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