Based on the qualification studies, a program for preventive maintenance of all major manufacturing equipments and critical support systems should be developed and implemented to maintain production systems in proper working condition and reduce equipment malfunctions.
it is to ensure that the equipments & systems continues to work under controlled conditions and maintained in the “validated state of control”.
The Preventive maintenance program should define the method, frequency, equipment specific checklist, and documentation .
The following shall be considered when developing a preventive maintenance schedule:
- Supplier / contractor recommendations
- Company history and experience with the component in critical applications
- Costs for performing the maintenance or calibration
- The documentation required for these activities
Preventive Maintenance shall be routed through separate SOP. The records of preventive maintenance shall be maintained. Preventive Maintenance Program considers the followings:
- Well established preventive maintenance procedures are defined for all equipments in related SOPs.
- Preventive maintenance program is scheduled weekly, fortnightly, monthly, quarterly, half-yearly or yearly as applicable to all equipments.
- Engineering department will be responsible for scheduling tracking and excusing of preventive maintenance program.
Preventive Maintenance Documentation
- Preventive maintenance schedule
- Preventive maintenance Checklist
- Preventive maintenance Record
- Equipment History cord
- Preventive maintenance SOPs