Modules

Determination of individual production steps and flows
Decision on in-house / outsourcing
Determination of production, storage and transport requirements between production sites
Spatial distribution of production steps and rationalisation of movement

For each of the steps, a FMEA should be carried out to assess what impacts it can have on the quality of the product if the process is carried out properly, or something deviates from the norm. The FMEA procedure is therefore carried out separately for each part of the production process and for the whole. It follows the standard FMEA procedure, which is part of the methodology but can be adapted by the organisation according to its needs.

The following sections briefly summarise the logic of each FMEA process step (details are given within each step within the methodology).

Start of FMEA

The FMEA is carried out either as part of the project (production preparation) or entirely separately.

FMEA in the project

If it is part of the project, it is a stage within the project – it is then planned as an optional part of the project with it being planned

For the development project itself (initial project FMEA)
for the product (product FMEA)
For the planned steps of the production process

Each corresponds to a step in the model project but its inclusion in the project is optional. For the production steps, it is planned separately for each proposed process.

FMEA separately – outside the project

If it is implemented separately (typically to solve a problem – see 8D report) an internal order is created for it and the sample procedure is applied to the order

FMEA Team

The team implementing FMEA is documented within the project for the task implementing it (and on the basis of which meetings are convened) within the internal contract the team is described within the contract.

In both cases, each member of the FMEA team is listed along with the competence on the basis of which they are nominated for the FMEA. It is therefore obvious to each member of the FMEA team why he was invited. Conversely, the team description allows you to revise whether all the necessary qualifications have been included in the FMEA team.

Analysis Subject Documentation

The FMEA is always implemented on the basis of the described analysis of the analysed product or procedure:

For a FMEA product, the basis of the analysis is directly the description of the product
For individual production steps, the basic object analysed is the individual tools and machines that will be used for production. These are described as products and the FMEA is carried out on them in the same way as the product.
For the production process itself, the basis is a description of the steps, activities and tasks. Their description is documented in the form of sample procedures in methodology of the production process. For clarity, it is advisable to create your own methodology for each product and to propose individual steps in it.
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Proposal for risk minimisation measures

The most important output of FMEA is rationally justified requirements for a product or production facility, new procedures or control mechanisms that are integrated into the production process (this includes control procedures). These requirements and procedures are part of the FMEA analysis.

FMEA Documentation

The FMEA is documented by final report, but no less important documentation is proof of its proper course:

Records of the meeting, which show when it took place and who attended
Recorded comments on individual properties analysed.
Documented settlement of these comments
Created product or process requests
Created new work steps within methodology
Documents of all tasks performed within the FMEA process, including a job statement from participants.

Remember that all documents keep information on who created them and when. The documentation therefore really documents the progress, and the system ensures that the progress cannot be simulated afterwards. The FMEA analysis therefore needs not only to be done, but also to be truthfully reported and documented.

FMEA documentation – in particular the progress records – is checked by an independent quality check before completion within the milestone. Only after this check can the entire FMEA stage be completed.