Operational qualification
Documented verification that the system or subsystem operates as intended overall anticipated operating ranges as per WHO TRS 1019-annex3.
The OQ should furnish documented proof that utilities, systems, or equipment are functioning in compliance with operational specifications. The tests should be formulated to exhibit satisfactory performance within the typical operating range, as well as under extreme operating conditions.
The testing may encompass worst-case scenarios. It is imperative to test the operation controls, alarms, switches, displays, and other operational components. The measurements conducted using a statistical approach should be thoroughly explained.
Operational qualification protocol cum report
Consist of minimum contents but not limited to.
- Pre Approval
- Overview
- Purpose
- Background
- Responsibility
- Requalification
- System Description
- Operational Qualification Procedure
- Training Date
- Calibration Review
- Key Functionality
- Safety Features
- SOP verification
- Preventive maintenance procedure verification
- Operational testing
- Deficiency (if any) and Corrective Action Report
- Acceptance criteria
- Summary
- Post Approval
- Appendix -Abbreviations, List of Documents
For operational Qualification Protocol cum report writing concerning activity
Pre Approval: It is described above.
Overview: under this section purpose, background about the installation qualification responsibility, requalification, and system description is come.
Operational Qualification procedure: Under this section training, calibration review, Key functionality, challenge test, safety feature, SOP verification, and Operational testing.
Deficiency (if any) and corrective action report: Under this section the Deficiency if any shall be reported.
Acceptance criteria: under this section check the acceptance criteria for operational qualification.
Summary: This section summarizes all the operational qualification activities.
Conclusion: this section gives the result of all the qualification activity and data that should be mentioned that it undergoes for performance qualification activity.
Post approval signatures: after the operational qualification, all the data is reviewed by the head of the engineering, production, and quality head and the certification of its approval.
Appendix: Under this section mention the abbreviation and list of the document
Performance qualification
Before the release of utilities, systems, or equipment, it is essential to conduct performance qualification. This process should be carried out under conditions that replicate the intended use, to establish documented proof that they can consistently perform by the specified requirements during routine use.
Operation cum performance qualification protocol cum report
Consist of minimum contents, but not limited to.
- Pre Approval
- Overview
- Purpose
- Background
- Responsibility
- Requalification
- System Description
- Operational Qualification Procedure
- Training Date
- Calibration Review
- Key Functionality
- Safety Features
- SOP verification
- Preventive maintenance procedure verification
- Operational testing
- Performance Qualification Results
- Deficiency (if any) and Corrective Action Report
- Acceptance criteria
- Summary
- Post Approval
- Appendix -Abbreviations, List of Documents
Appendix: Under this section mention the abbreviation and list of the document.
Post approval signatures: after the operation cum performance qualification all the data is reviewed by the head of the engineering, production, and quality head and take the certification of its approval.
Conclusion: this section gives the result of all the qualification activity and data that should be mentioned that it undergoes for operational use.
Summary: this section summarized all the operation cum performance qualification activity.
Acceptance criteria: under this section check the acceptance criteria for performance qualification.
Deficiency (if any) and corrective action report: Under this section the Deficiency if any shall be reported.
Written reports on the qualification and validation performed are essential. These reports should accurately reflect the protocols and procedures followed during the study. They should include important details such as the title and objective of the study, reference to the protocol, reference to the appropriate risk assessment, details of materials, equipment, programs, and cycles used, procedures and test methods employed, data collected, any changes and deviations encountered, out-of-specification and non-conformance results with proper traceability, and a conclusion.
Qualification and validation reports
The results recorded in the reports must comply with good data and record management practices. Therefore, the results should be thoroughly reviewed, analyzed, and compared against predetermined acceptance criteria. If necessary, statistical analysis should be conducted to interpret the results accurately. The results must meet the acceptance criteria, and any out-of-specification or out-of-limit findings should be carefully documented and investigated following the appropriate procedures. If these findings are accepted, a justification should be provided. Additionally, if further studies are deemed necessary, they should be considered.
The conclusion of the report should clearly state whether the outcome of the qualification and/or validation was considered successful or not. Furthermore, the report should provide recommendations for future monitoring and the establishment of alert and action limits, where applicable.
The completed report should be approved by the departments responsible for the qualification and validation work. In cases where it is appropriate, the quality assurance department should also approve the report. The criteria for approval should align with the company’s quality assurance system.
