Justifying every maintenance task to the authorities
POMEX’s work with a pharmaceutical group.
After an observation during a regulatory inspection, a pharmaceutical group had to prove that the maintenance of its equipment guaranteed consistent production quality.
The deadline was tight and the business stakes were high. POMEX supported the plants in reviewing all maintenance plans with a risk-based approach.
01. Context and challenge
The client had committed to the authorities to review the maintenance plans of all its equipment. The challenge was both technical and organisational:
- tens of thousands of pieces of equipment spread across many plants on two sites;
- less than a year to complete the work;
- every task had to be justified, proving the absence of contamination or particles;
- access to a key export market depended on meeting this commitment.
02. Our approach
A risk analysis covering 100% of the equipment ranked each item by criticality and applied the right method:
- Critical equipment: full FMECA (Failure Mode, Effects and Criticality Analysis);
- Major equipment: reverse RCM, comparing current plans, manufacturer recommendations and breakdown history;
- Minor equipment: follow-up of actions from inspection rounds and root cause analysis of breakdowns.
A team of POMEX consultants supported the plants. Standard analysis models were built once, then adapted by each building to the equipment actually installed.
03. Results
Pooling the effort allowed the whole group to reach its objectives:
- the commitment to the authorities was met on time;
- central teams analysed the most complex systems once, for the benefit of every plant;
- every maintenance task is now linked to an identified risk and can be justified at future inspections.
Conclusion
By linking every maintenance task to an identified risk, POMEX turned an inspection observation into a stronger, clearer maintenance system that stands up to the authorities.
