Vipsit has experience in leading workshops and working with engineering departments for identifying critical systems and defining a risk informed maintenance systems strategy and supporting schedules. The GMP regulations have very rigid requirements here, however the way maintenance is being done is up to the production facility itself.

The maintenance strategy must be defined in the late design phase and the maintenance system designed during the construction phase. Whether a reactive (deferred/emergency) or preventive (time/failure/risk/condition based, or predictive) strategy is selected (or a mix) and whether the institution will depend on in-house skills or service contracts depends on the complexity of the individual facility and staff skill-set. Bottom line is, the minute the commissioning phase ends, maintenance begins.

Depending on the criticality of the systems and available budget, most facilities/companies will benefit of a mixture of maintenance strategies. This can sometimes be difficult to defend and explain to regulatory bodies in charge of issuing new operational authorizations. On the other hand if you can explain, defend, and document that there is logic to the strategy and approach, most often inspectors will buy the rationales and accept the approach.

The performance indicators (PIs) identified in an impact assessment (IA) are the measurable numbers for which you will keep a trend log. It will also help you decide from which type of maintenance strategy you will gain the most:

• REACTIVE MAINTENANCE: Run it until it breaks
• PREVENTATIVE MAINTENANCE: Actions based on a time or machine based schedule
• PREDICATIVE MAINTENANCE: uses Performance Indicators (PI’s) to detect the onset of degradation