4.2.5 - Study Report

Makes a report on the FMEA once the study is complete, to include: { A summary of the causes and purposes of the study, { A summary of the study specifications, { A summary of the way the study was carried out (composition of the work group, list of the sub-assemblies or components analyzed, the cost and duration of the study), { The results of the study: { Histogram of causes plus failure modes for each class of risk priority number (attach as an appendix): { Summary of the causes plus failure modes with the actions recommended (attach as an appendix): { The conclusion summarizing the main facts brought to light by the analysis. { The scale used to evaluate the risk priority number is attached to the report.

After agreement with the studys requester, the report is distributed to the members of the work group, their managers, the requester and the decider. It can also be commented on in a final summary meeting held within a few days of its distribution. This meeting marks the end of the original study.

The list of recommended actions will be used when compiling operational plans, depending on the objectives set out elsewhere.

4.2.6 - FMEA Dossier

The FMEA dossier includes: { A page on the administration of updates, { The study specifications, { The study report, { The reports on revisions, { The FMEA tables of all the sub-assemblies or components analyzed.

It is passed to the person delegated as being responsible for the dossier in the study specifications.

4.2.7 - Monitoring and Revision

In case of a non-conformity being detected or following modification of the model, the FMEA is revised.

Revision is carried out during work meetings by a work group gathering together the same expertise as for the original study and led by the FMEA leader, with the participation of the Project Leader.

The summary of the causes plus failure modes from the last update will be used as support material. For each cause plus failure mode, list the actions taken, the person responsible for each of them, the time frame and their date of application. Evaluate the new risk priority number, taking into account the actions taken, using the same scale as for the original study. Describe new recommended actions if those taken are not sufficient to achieve the risk priority number objectives. Use the old recommended actions when no measure has been taken. Where risk priority number thresholds fixed at the onset do not allow the purpose of the study to be achieved, or if additional progress has become necessary, set new thresholds and describe the resultant new recommended actions. List the increases in risk priority number in relation to the last update by carrying out a sub-assembly-by-sub-assembly or component-by-component examination in co-operation with the members of the work group.

Write a revision report (using the same basic outline as for the original study). The summary of causes plus failure modes with recommended actions (attached as an appendix) is replaced by a summary of causes plus failure modes with the actions taken and the new recommended actions . The histogram of causes plus failure modes for each class of risk priority number is updated and attached as an appendix to the revision report. Distribute this revision report and comment on it in a summary meeting (process identical to the original study).

Update the FMEA dossier by filling in: { The page on the administration of updates, { The FMEA tables for the study (measure taken, person responsible, time taken, dates of implementation of actions taken, new risk priority number, new recommended actions if appropriate).

Note: The FMEA studies are updated periodically and systematically, and the dates of update are given as described above including when there has been no change.