Build a Proficient Operational Qualification.

Typically, the OQ considers the operation parameters of the system at the full range established by the equipment manufacturer recommendations.

The purpose of the OQ is to determine that equipment performance is consistent with the user requirement specification within the manufacturer-specified operating ranges.

Typically, the OQ is performed to the equipment offline, with no product, or empty of any valued material or data.

During OQ, all items in the test plan are tested and their performance is thoroughly documented. Since this is a prerequisite for acceptance of equipment and the facility.

Operational qualification (OQ) is performed after completed the execution and approval of the installation qualification IQ final report.

3 STEPS TO EXCEL IN ANY OPERATIONAL QUALIFICATION

Step 1. Prepare a protocol and obtain approval.

Step 2. Execute the execution as established in the protocol.

Step 3. Prepare the final report and obtain approval.

The requirements to properly operate the system are pre-defined in the Design Specification.

WHAT MAY INCLUDE THE OPERATIONAL QUALIFICATION PROTOCOL

The OQ protocol may include, but, is not limited to the following sections, (as applicable)

• Purpose
• Scope
• Background
• Hardware Description
• Infrastructure Identification
• Associated Documents
• Definitions and Acronyms
• Hardware Identification, and Operational Verification Instructions
• Test Steps for Operational Verification, as applicable.
• Temperature control and variations
• Servo motors and air flaps
• Temperature measuring and protection systems
• Card readers and access systems
• Pressure and vacuum controllers
• Temperature distribution
• Display units and signaling LEDs
• CO2, oxygen, nitrogen, and compressed air controls
• Humidity-measuring and control
• Fan and fan-speed controllers
• Verification that all loop installations;
• Insert a brief description of what part of the validated product process.
• Insert a brief description of the operational function.
• An integrated loop test verification.
• Testing of alarms.
• Testing of interlocks and permissive conditions.
• Testing of database or data storage integrity.
• Testing of report generation and event chronicle.
• Verification of the functionality of the equipment.
• Challenge of software, where required;
• Review of system functionality to verify compliance with 21 CFR Part 11.
• If the system must be 21 CFR Part 11 compliant, verification of audit trails and electronic signature
• Testing of security levels to prevent;
• Testing to verify and document ‘Power loss Recovery’.
• Testing of all interfaces
• Testing for Electromagnetic interference and compatibility.
• Analysis of Test Results
• Acceptance Criteria
• Incident Reports Summary
• Conclusions and Recommendations
• Final Resolution and Release
• Associated Reference Documents
• Appendices
• History of Change
• Document Approval

What makes OQ successful?

Successful OQ must demonstrate that the equipment and its subsystems will do what they are supposed to do as established in the Design Qualification documents, (URS and FRS).

Operational Qualification must be performed before completing the Performance Qualification.

Depending on the size of the system, Operational Qualification can be combined in one protocol, execution, and report with Installation Qualification or Performance Qualification.

Operational Qualification protocols should be approved before protocol execution to comply with the prospective validation approach.

A copy of the unexecuted protocol should be kept in the validation package.

The unexecuted protocol should be approved at least by the protocol author, system owner, and quality assurance representative.

The final report of the executed protocol should be signed at least by the tester and reviewed by the system owner and quality assurance representative.

The unexecuted protocol should be approved at least by the protocol author, system owner, and quality assurance representative.

The final report of the executed protocol should be signed at least by the tester and reviewed by the system owner and quality assurance representative.