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As organisations continually strive to improve quality and reduce risk, many are beginning to understand the benefits of preventive action.
The International Organisation for Standardisation (ISO) defines preventive action as “action to eliminate the cause of a potential nonconformity or other potential undesirable situation”. ISO also notes that there may be more than one cause of nonconformity.
Historically, organisations have performed root-cause analyses after an adverse event occurred in an attempt to understand why the event happened. With a focus on quality, safety, and risk-reduction, it is important to analyse products, processes and services to see what could go wrong before the adverse event occurs. Such analysis requires a rigorous methodology.
FMEA, or Failure Mode Effects Analysis, is an efficient method of identifying the cause of an adverse event before it occurs and can be the foundation of an effective prevention and improvement programme. Creating the opportunity to see potential errors and mistakes at the design stage saves time, money and, in extreme circumstances, lives. FMEA should not be a chore; it should be a voyage of discovery.
Introduction to FMEA
Types of FMEA
Product Design FMEA
Forming the Team
Points to consider
Completing the FMEA Chart
Conducting the FMEA
Rating the Effects
Case Study: Where is it?
Before the FMEA
Annex 1 – FMEA chart
Annex 2 – Severity rating criteria
Annex 3 – Probability rating criteria
Annex 4 – Detection rating criteria
Annex 5 – Corrective action report
Anthony Wilkinson, RQA