Operational Qualification Protocol for Implant Inspection System

Document Number: OQ-001

Version: 1.0

Effective Date: 2023-10-01

Reviewed By: [Reviewer Name]

Approval Date: [Approval Date]

Objective

The objective of this Operational Qualification (OQ) protocol is to ensure that the Implant Inspection System operates according to predefined specifications and meets the requirements set forth in the User Requirements Specification (URS) Annex 11.

Scope

This protocol applies to the validation of the Implant Inspection System used in the production area for inspecting implant integrity. It is intended for use by validation personnel and quality assurance teams.

Responsibilities

Validation Team: Responsible for executing the OQ protocol and documenting results.
Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
Production Team: Responsible for providing access to the equipment and any necessary support during testing.

Prerequisites

Installation Qualification (IQ) must be completed and approved.
All personnel involved must be trained on the use of the Implant Inspection System.
Test materials must be available and meet specifications.

Equipment Description

The Implant Inspection System is designed to inspect the integrity of drug-eluting and biodegradable implants. It is equipped with advanced imaging technology to ensure high inspection accuracy and includes features for reject logic and audit trail documentation.

Test Plan

Test ID	Procedure	Acceptance Criteria	Evidence
OQ-01	Verify inspection accuracy	Accuracy within ±5% of specified value	Calibration records
OQ-02	Test reject logic functionality	All defective implants must be rejected	Test report
OQ-03	Audit trail verification	All actions logged correctly	Audit trail report

See also Slitting Machine – IQ Protocol

Detailed Test Cases

Test Case OQ-01: Verify Inspection Accuracy

Objective: To confirm that the system’s inspection accuracy meets the specified criteria.

Procedure: Run a series of known standard implants through the system and record the inspection results. Compare against the expected outcomes.

Acceptance Criteria: Accuracy must be within ±5% of the specified value.

Expected Results: Documented accuracy results must meet acceptance criteria.

Test Case OQ-02: Test Reject Logic Functionality

Objective: To verify that the system correctly identifies and rejects defective implants.

Procedure: Introduce known defective implants into the system and monitor the rejection process.

Acceptance Criteria: All defective implants must be rejected.

Expected Results: A report indicating all defective implants were successfully rejected.

Test Case OQ-03: Audit Trail Verification

Objective: To ensure that all actions taken by the system are properly logged.

Procedure: Review the audit trail logs after conducting several inspections.

Acceptance Criteria: All actions must be logged correctly.

Expected Results: An audit trail report that accurately reflects all actions taken.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.

Approvals

_________________________

Validation Team Lead