Standard Operating Procedure for Periodic Review of Equipment Performance
1) Purpose
The purpose of this SOP is to establish procedures for conducting periodic reviews of equipment performance used in the manufacturing of dental dosage forms, including pastes, gels, and mouthwashes. The goal is to assess equipment reliability, efficiency, and compliance with operational standards to identify opportunities for improvement and ensure continued product quality.
2) Scope
This SOP applies to all manufacturing equipment within the pharmaceutical industry used in the production of dental dosage forms. It includes procedures for scheduling, conducting, and documenting periodic reviews of equipment performance.
3) Responsibilities
The Engineering Department is responsible for coordinating and conducting periodic reviews of equipment performance. The Quality Assurance (QA) Department is responsible for reviewing review reports, assessing compliance, and ensuring corrective actions are implemented as necessary. All personnel involved in equipment operation and maintenance are responsible for providing input and observations during reviews.
4) Procedure
4.1 Schedule and Preparation
4.1.1 Develop a schedule for conducting periodic reviews of equipment performance based on equipment criticality, usage frequency, and regulatory requirements.
4.1.2 Identify review criteria and performance metrics, including uptime, efficiency, maintenance records, and compliance with operating parameters.
4.1.3 Prepare review checklists and forms to document observations, findings, and recommendations during equipment performance reviews.
4.2 Review Process
4.2.1 Gather data and performance records related to the equipment under review, including maintenance logs, calibration certificates, and performance reports.
4.2.2 Inspect the physical condition of equipment, including cleanliness, wear and tear, and adherence to safety standards.
4.2.3 Evaluate equipment performance against predefined metrics and operational requirements to identify deviations or areas for improvement.
4.3 Documentation and Reporting
4.3.1 Document observations, findings, and recommendations from the equipment performance review using the prepared checklists and forms.
4.3.2 Prepare a performance review report summarizing the review process, findings, identified deviations, and recommendations for corrective actions.
4.3.3 Review and approve the performance review report by relevant stakeholders, including QA, engineering, and management.
4.4 Implementation of Corrective Actions
4.4.1 Develop corrective action plans (CAP) based on identified deviations and recommendations from the performance review.
4.4.2 Assign responsibilities for implementing corrective actions and establish timelines for completion.
4.4.3 Monitor and verify the effectiveness of implemented corrective actions through follow-up reviews and assessments.
4.5 Continuous Improvement
4.5.1 Use findings from equipment performance reviews to identify opportunities for continuous improvement in equipment reliability, efficiency, and compliance.
4.5.2 Incorporate lessons learned and best practices into ongoing equipment maintenance and operational procedures.
4.5.3 Foster a culture of continuous improvement by encouraging feedback, collaboration, and knowledge sharing among personnel involved in equipment operations.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
CAP – Corrective Action Plan
6) Documents, if any
Equipment Performance Review Checklists and Forms
Performance Review Reports
Corrective Action Plans (CAP)
Follow-up Review Reports
7) Reference, if any
Regulatory guidelines for equipment performance reviews in pharmaceutical manufacturing
Industry best practices for equipment reliability and maintenance
Manufacturer’s recommendations for equipment performance monitoring and assessment
8) SOP Version
Version 1.0
