1.0 Purpose
This SOP outlines the procedures for the calibration and maintenance of equipment to ensure accuracy, reliability, and compliance with regulatory standards.
2.0 Scope
This procedure applies to all equipment requiring calibration and maintenance within [Company Name]’s facilities.
3.0 Responsibilities
- Management: Responsible for providing necessary resources and ensuring compliance with the SOP.
- Quality Assurance (QA) Department: Responsible for overseeing the implementation of this SOP and ensuring adherence to regulatory standards.
- Equipment Users: Responsible for reporting any deviations or issues with equipment performance promptly.
- Maintenance Personnel: Responsible for conducting calibrations and maintenance activities as per this SOP.
4.0 Equipment Calibration
4.1 Calibration Schedule
- Establish a calibration schedule based on manufacturer recommendations, regulatory requirements, and historical data.
- Document the calibration frequency for each piece of equipment in a calibration schedule matrix.
4.2 Calibration Procedure
- Identify qualified personnel to perform calibrations.
- Ensure all necessary calibration standards and tools are available and calibrated.
- Follow manufacturer’s instructions and SOPs for calibration procedures.
- Record pre-calibration readings, adjustments made, and post-calibration readings in a calibration log.
- Label calibrated equipment with calibration date, due date, and technician initials.
4.3 Out-of-Tolerance Conditions
- If equipment is found to be out of tolerance during calibration, immediately quarantine the equipment.
- Notify management and QA department for further investigation and corrective action.
- Document the out-of-tolerance condition, actions taken, and any impacts on product quality or safety.
5.0 Equipment Maintenance
5.1 Maintenance Schedule
- Develop a maintenance schedule based on equipment type, usage, and manufacturer recommendations.
- Include preventive maintenance tasks such as lubrication, cleaning, and inspection in the schedule.
5.2 Maintenance Procedures
- Assign trained personnel to conduct maintenance tasks.
- Follow manufacturer’s guidelines and SOPs for maintenance procedures.
- Document maintenance activities including date, tasks performed, and any issues identified.
- Conduct periodic equipment performance checks to identify potential issues before they impact operations.
5.3 Spare Parts Management
- Maintain an inventory of critical spare parts for equipment maintenance.
- Ensure spare parts are stored properly and replaced as needed during maintenance activities.
- Document spare parts usage and replenishment to ensure adequate stock levels.
6.0 Documentation and Recordkeeping
- Maintain accurate and up-to-date records of all calibration and maintenance activities.
- Keep calibration certificates, maintenance logs, and other related documents in a designated location.
- Ensure records are easily accessible for audits and inspections.
7.0 Training
- Provide training to personnel involved in calibration and maintenance activities.
- Ensure personnel understand their roles and responsibilities as outlined in this SOP.
- Conduct periodic training updates to reinforce proper procedures and compliance requirements.
8.0 Revision History
- Maintain a revision history of this SOP to track changes and updates.
- Ensure all revisions are documented, approved, and communicated to relevant personnel.
9.0 References
- List any relevant standards, regulations, manufacturer’s manuals, and other documents used to develop this SOP.
10.0 Definitions
- Define any terms or acronyms used in this SOP for clarity and consistency.
11.0 Attachments
- Include any forms, checklists, or templates referenced in this SOP as attachments.
12.0 Approval
- Obtain approval from management and QA department before implementing this SOP.
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