Title Page
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Manufacturer
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Manufacturing Facility
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Equipment/System
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Protocol Author
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Conducted on
Process Validation Protocol - Performance Qualification Template
Performance Qualification Protocol
Objective
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To determine that the equipment/system perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that performance consistently meets pre-determined specifications under normal conditions and where appropriate, for worse case situations.
Scope
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To be performed after the Installation and Operational Qualification have been completed and approved. To be performed after installation, modification or relocation and for re-validation at appropriate intervals. Each piece of equipment must be validated before it serves another piece of equipment/system during validation of the latter (e.g. water system before steam generator; steam generator before autoclave, etc.)
Responsibility
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Person responsible for operating the equipment or system will perform the qualification and record the information. The supervisor will oversee the study, verify the completion of the records and write the Deviation Report and the Performance Qualification Report. Quality assurance will review and approve the Performance Qualification Report and Protocol.
Procedure
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Select all that apply
- Equipment
- System
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Run normal procedure three times for each use (configuration or load)
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Record all required data
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Are there any deviations to the procedure?
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Deviation
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Justification for Acceptance
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Impact on Operation, Function, or Process
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Run for 20 consecutive working days
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Record all required data
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Are there any deviations to the procedure?
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Deviations
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Justification for Acceptance
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Impact to Operation, Function, or Process
Evaluation
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Perform all required calculations and statistical analyses
Acceptance Criteria Vs. Performance Test Results
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Criteria
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Results
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Decision
Completion
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Date Study Initiated
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Date Completed
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Observations Made/Problems Encountered
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Do results meet acceptance criteria?
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Conclusions on the validity of the equipment/system
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Protocol Author & Signature
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Departmental Approval by
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Quality Assurance Approval by
