Title: OPERATIONAL QUALIFICATION REPORT TEMPLATE / Revision:[INSERT REV]
This document is to be used as a template for generating Operation Qualification (OQ) reports. As such, use only the sections that are applicable to the equipment being qualified. Add sections which are specific for the equipment being qualified, as needed. Use the attachments (report sheets) to summarize OQ data and information. They can be amended to create forms that are directly relevant to the documented activities. Remove all gray sections. “N/A” any section that is not applicable. Fill out the header section. Remove these instructions.
- PURPOSE
The purpose of this report is to summarize and analyze the data collected during the operational qualification (OQ) of the process validation for [Insert Product Name] for [Insert Company Name] in accordance with the Validation Master Plan (XXXX).
For each Deviation Report that was generated during testing, a description and issue resolution is provided in this document.
- SCOPE
This document summarizes the OQ manually executed validation activities for[InsertProductName]
The following protocols were executed in support of OQ activities for this system:
Form / Document ID- DATA AND ANALYSIS DOCUMENTS
Document/Form/Record / Document ID / Record #
Enter All Relevant Documents / Insert Document ID / Insert Record #
- TEST RESULTS
- Test Conduct
Each trial was conducted by [InsertCompany Name]representative [Insert Tester Name], referred to as Tester for the remainder of the document. The tester followed each protocol task, recorded results and signed the Tester signature space on each page. The results of each trial were reviewed by an authorized [Insert Company Name]employee Reviewer for completeness and accuracy and signed in the Verifier signature space on each page.
Printouts or screen prints were marked with the document number, step number, pagination and a notation to the relevant pare or applicable section in the protocol. Recording errors made by the Tester or Reviewer were corrected using the single-line correction method. Minor protocol errors were corrected on the protocol page using the single-line correction method. If the reason for the correction was not to clear a brief statement was added for clarification. This approach only applied to obvious errors, such as spelling or obviously contradictory instruction and expected results. Protocol errors that affected Expected Results or required more extensive explanation are noted herein.
4.2.Results
State the results of the protocol, including all measurement data. If applicable, include the results for each run group and indicate whether or not each passed. If any test failures occurred, describe what failed and what is required to fix the failure. State whether or not the results meet the acceptance criteria.
4.2.1.Describe all the protocol deviations and observations and how they do or do not affect the results using the table below. Duplicate table for multiple deviations or observations.
Observation Type: E=Equipment Issues, P=Protocol Issues, D=Documentation Issues, C=Configuration Issues
Protocol Test # / Description / E / P / D / CObservation:
Corrective Action:
- CONCLUSION
Testing was performed from [Trial Initiation Date] to [Trial Completion Date] at [Insert Company Name],[Insert CompanyAddress] by [Validation Team or Person], results were verified by [Insert Company Name] Quality Assurance, Sales Operations, Production Supervisor and Engineering.
Select the appropriate description of the OQ outcome.
Based on the test results the equipment and process passed all acceptance criteria for operational qualification without exception.
Based on the test results the equipment and process passed all acceptance criteria for operational qualification with exception. The exceptions were approved, and the process passed all acceptance criteria.
Based on the test results the equipment and process did not pass all acceptance criteria for operational qualification. The overall process must be evaluated and retested.
Testing generated a total of [Insert Number] observations of which [Insert Number] was/were identified as deviations and documented in section 4.2.1. Original observations are documented within the executed protocol(s).
- DATA RETENTION
Document/File # / Reference Location / Date
Insert Document Number / Storage Location / Insert Date
- APPENDIX N/A [if this section does not apply]
Appendix 1 – [appendix 1 title]
[Enter description / title of Appendix]
[Include any referenced tables, forms, or figures.]
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