FMECA: when risk analysis defines the maintenance strategy
POMEX’s work at a biopharmaceutical site.
How do you choose the best maintenance strategy while balancing reliability, risk control and cost?
The maintenance expertise centre of a biopharmaceutical site asked POMEX to define an analysis tool to answer this question, equipment by equipment.
01. Context and challenge
The teams were asking practical questions, with no common tool to answer them:
- Can failures be anticipated?
- Do manufacturer recommendations match the real use of the equipment?
- How do you choose between corrective, time-based and condition-based maintenance?
- What is the impact of non-ideal operating conditions on reliability?
- Does the spare parts stock really add value?
02. Our approach
POMEX defined the expertise centre’s FMECA tool and rolled it out with the teams:
- workshops bringing maintenance, engineering, production, the manufacturer and HSE around the same table;
- a desk study based on the technical staff’s knowledge, confirmed by checks in the field;
- a full breakdown of machines and processes, so that everyone takes ownership of the production equipment.
03. Results
FMECA became a strategic tool and a daily help in the field:
- maintenance choices based on the criticality of each failure mode and its effects on safety, quality and productivity;
- a well-argued maintenance strategy that is easy to justify to the authorities;
- faster troubleshooting, as each observed effect is linked to its possible causes;
- a living document, enriched by feedback from the field.
Conclusion
With FMECA, maintenance choices no longer rely on habit or on manufacturer recommendations alone, but on a shared analysis of real risks.
