Standard Operating Procedure for Maintenance Work Order Management

1) Purpose

The purpose of this SOP is to establish the procedures for managing maintenance work orders to ensure timely and effective maintenance activities in the pharmaceutical industry.

2) Scope

This SOP applies to all maintenance work orders issued for the maintenance of equipment and systems in the pharmaceutical manufacturing process.

3) Responsibilities

The Maintenance Department is responsible for implementing and adhering to this SOP. All relevant personnel must be trained on the procedures outlined in this document.

4) Procedure

1. Creation of Work Orders
   1. Generate a work order for each maintenance task based on the maintenance schedule or identified maintenance needs.
   2. Include detailed information in the work order, such as equipment ID, description of the task, priority level
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      , and assigned personnel.
   3. Assign a unique identification number to each work order for tracking purposes.
2. Approval and Distribution
   1. Submit the work order to the Maintenance Manager for review and approval.
   2. Distribute approved work orders to the assigned personnel.
   3. Ensure all relevant personnel have access to the necessary tools, parts, and documentation to complete the task.
3. Execution of Maintenance Tasks
   1. Perform the maintenance tasks as specified in the work order.
   2. Document the completion of tasks, including date, time, and any issues encountered.
   3. Report any additional maintenance needs identified during the execution of the work order.
4. Review and Closure
   1. Review completed work orders to ensure all tasks were performed satisfactorily.
   2. Document any deviations or corrective actions taken.
   3. Close the work order in the maintenance management system and update equipment maintenance records.

5) Abbreviations, if any

None

6) Documents, if any

Work Order Forms, Maintenance Logs, Equipment Manuals

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements.

8) SOP Version

Version 1.0