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Protocol · VAL-P06

Operational Qualification Protocol Template

OQ template covering functional tests, alarms, ranges, worst-case challenges.

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Purpose

To provide a template operational qualification (OQ) protocol establishing documented evidence that installed equipment operates as intended throughout its anticipated operating ranges, including controls, alarms, safety features and, for temperature-controlled equipment, empty-chamber temperature (and humidity) distribution, before it is used with product.

What is inside

12 sections, about 3 pages when printed.

  1. 1. Purpose
  2. 2. Scope
  3. 3. Responsibilities
  4. 4. References
  5. 5. Definitions
  6. 6. Prerequisites
  7. 7. OQ tests
  8. 8. Execution and reporting
  9. Deviations
  10. Data integrity
  11. Report
  12. Approval

How to complete it

  1. 1.Execute each test on VAL-F04 with expected and actual results, attachments (logger files, VAL-F06) and deviations (VAL-F09).
  2. 2.Summarise results and conclude whether the equipment is operationally qualified for the tested range; state any restrictions.
  3. 3.QA approves the OQ; PQ (VAL-P07) proceeds with product or surrogate load.

Before you use it

  • Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
  • Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
  • Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
  • Record the document in your own document register and set its review date.

Related documents

This is an original template published by ValiTrac. It does not reproduce the text of ISO/IEC 17025 or of any accreditation body publication, and it does not by itself confer or guarantee accreditation. Customise, review and approve it before use.