FMEA analysis of production processes

1. FMEA objectives. FMEA as a method of continuous quality improvement and as a method of risk analysing or management.

2. Organization of a FMEA analysis, resources required, role and team composition.

3. The “part-family / generic PFMEA” concept, linking to the PDCA cycle.
4. FMEA for structure (DFMEA) and process (PFMEA) – differences and relationships.
5. Preparation of input data for the PFMEA (product and process requirements/specifications, process flow chart, characteristics matrix, non-conformity records).
6. Formulation of functions, requirements, defects, causes and effects of defects, identification of control measures in the production process; distinction between detection and prevention.
7. Identification and description of special properties (characteristics) in the PFMEA.
8. Supporting tools in the PFMEA: characteristics matrix, flow chart, Pareto analysis, Ishikawa diagram, nWhy.

9. Selection of risk indicators: S (Severity), O (Occurrence), D (Detection) according to the AIAG 4th Edition 2008 / SAE J1739:2009 guidelines. Critical interpretation of the RPN (Risk Priority Number).

10. Design of improvement actions – decision-making based on other considerations than the RPN – new indicators (SOD, SD), hazard rankings, risk matrices.
11. Versions of improvement actions – defect-addressed vs. cause-addressed actions, preventive vs. detective actions.
12. Versions of PFMEA forms.

Exercises:

1. Criteria for decision-making on production process improvement – a case study.

2. Performing a PFMEA for a selected product/process – working in teams:

• process identification: flow chart, functions, quality requirements;
• assessment of the current state of risk for the selected operation/defect (identification of potential defects, consequences, causes, measures such as detection and prevention, risk indicator assessment);
• designing preventive actions, evaluating their hypothetical effectiveness;
• discussion of the results.

A pre-test/post-test (only at the Customer’s request for closed training courses; training time: + 0.5 h/day).