8/4/2019 01 Preventative Maintenance Procedure 1 P04

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Company Name Page 4 of 8

Department SOP No.+ Version No.

Supersedes: SOP No.

Attachments: 2 (2 pages)

Preventive Maintenance (PM)Procedure

Effective date: Date

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The Engineering Technician or designee assures that PreventiveMaintenance work is done according to the Preventive Maintenance Programand is completed by their due dates. If Preventive Maintenance work is notpossible the Engineering Technician or designee must inform the EngineeringHead or designee and the Quality Assurance for supervision.

The Engineering Technician or designee reviews the Preventive Maintenancedocumentation for:

Completeness

AccuracyGood Documentation Practice

The Engineering Technician or designee supports the Engineering head ordesignee by creating periodically maintenance trending reports.

4.3 Quality Assurance The Quality Assurance (QA) Manager approves the Preventive Maintenance

Program and planned Preventive Maintenance schedule. The Quality Assurance Manager must audit the Preventive Maintenance

Program and work including the corresponding documentation and raw dataregularly in the frame of the self inspection program at least once every 12

months.This includes but is not limited to:

Completeness Accuracy cGMP compliance Good Documentation Practice

Quality Assurance always needs to agree in case of skipping a PreventiveMaintenance work altogether (skip the Work Order) and rescheduling the work at anew date. The decision must be justified and documented cross-referencing the

Work Order number.

5. Procedure

5.1 Generate Preventive maintenance work orderEngineering head or designee is responsible for issuing the planned maintenanceaccording the maintenance schedule. He/she releases the Preventive MaintenanceWork Order from the PM System and schedules the PM in the production plan.If the Work Order does not require plant/equipment shutdown, or will have nooperational impact, the Engineering Head or designee schedules the PM accordingto the availability of engineering technician resources. He/she allocates the

engineering resources to the work orders and generates (prints) work orders out ofthe PM system.