Standard Operating Procedure for Contractor Management in Maintenance

1) Purpose

The purpose of this SOP is to establish guidelines for managing contractors involved in maintenance activities within pharmaceutical manufacturing facilities to ensure compliance with safety, quality, and regulatory requirements.

2) Scope

This SOP applies to all contractor activities related to maintenance within the facility premises.

3) Responsibilities

The Facilities Management Department and Procurement Department are jointly responsible for implementing and adhering to this SOP. Facility Managers and designated personnel are responsible for overseeing contractor activities.

4) Procedure

1. Contractor Qualification
   1. Establish criteria for contractor selection based on qualifications, experience, safety record, and regulatory compliance.
   2. Verify contractor licenses, insurance, and certifications before engagement.
2. Work Planning and Authorization
   1. Define procedures for requesting and approving contractor work, including scope of work, timelines, and safety requirements.
   2. Issue work permits or authorizations specifying work details, safety precautions, and site access protocols.
3. Contractor Safety
   1. Ensure contractors adhere to facility safety rules and regulations, including wearing appropriate personal protective equipment (PPE) and following safety protocols.
   2. Conduct safety orientations or training sessions for contractors before commencing work.
4. Work Execution and Supervision
   1. Supervise contractor activities to ensure work is performed according to approved procedures and quality standards.
   2. Monitor progress and provide necessary support or guidance to contractors as required.
5. Documentation and Compliance
   1. Maintain comprehensive records of contractor qualifications, work authorizations, safety orientations, work performance evaluations, and any incidents or deviations.
   2. Review and assess contractor performance periodically to ensure continuous improvement and compliance with contractual obligations.

5) Abbreviations, if any

SOP: Standard Operating Procedure, PPE: Personal Protective Equipment

6) Documents, if any

Contractor Qualification Criteria, Work Authorization Forms, Safety Procedures for Contractors, Safety Orientation Materials, Performance Evaluation Reports

7) Reference, if any

Regulatory requirements for contractor management, industry guidelines for contractor safety and performance, and local safety regulations.

8) SOP Version

Version 1.0