SOP for Operational Qualification

PURPOSE

• The purpose of this procedure is to define the process with which to establish, through documented testing, that all critical components and direct impact systems are capable of operating within established limits and tolerances. 
• This procedure defines the content and format of Operational Qualification (OQ) protocols and the process by which they are developed and executed. 
• This procedure also specifies the responsibilities for the writing, execution, and closeout of OQ protocols.

SCOPE

• This procedure governs all OQ Protocols used for the qualification of direct impact systems/equipment utilized in the manufacture of products at XYZ Ltd.
• The OQ is performed on systems, which may consist of facilities, utilities, and/or process equipment; and involves testing parameters that regulate the process or have an effect on product quality.

RESPONSIBILITIES

Quality Assurance Manager: 

• Review and approve OQ protocols. This review and approval includes an assessment of testing methods, procedures, and acceptance criteria.
• Review and approve Nonconformance Reports in response to OQ protocol deviations.
• Provide technical assessment of product quality impact.
• Review and approve test data, completed protocols, and summary reports.

Engineering/Validation Team:

• Develop and approve OQ protocols including testing methods and procedures, acceptance criteria, approval of forms and documentation.
• Coordinate with the Project Manager to identify and schedule OQ activities.
• Provide personnel and applicable technical support for scheduled validation activities and coordinate the execution of OQ protocols.
• Review and approve Deviation and Nonconformance Reports in response to OQ protocol deviations.
• Develop, review, and approve OQ summary reports.
• Provide technical input for equipment and process validation parameters.
• Provide operator training, as required.
• Provide technical input during design and qualification activities.

Manufacturing Manager:

• Provide trained personnel and designated manufacturing equipment for support of scheduled OQ activities.
• Provide technical input for the design, operation, and validation parameters.

DEFINITIONS

• Deviation: any data or conditions that fall outside of the acceptance criteria as defined in the approved protocol.
• Direct Impact: having a direct effect on the quality, safety, and/or efficacy of the product.
• Operational Qualification: documented verification that all key aspects of a system perform as intended throughout the approved operating range; establishing, by objective evidence, process control limits and action levels that result in a product that meets all predetermined requirements.
• Non-conformance Report: documentation of the identification, evaluation, corrective action and disposition of a nonconforming product.
• Worst Case Conditions: a set of conditions encompassing upper and lower processing limits and circumstances, which cause or create the greatest potential for process or product failure.

SAFETY REQUIREMENTS

• Before the initial startup and operation of equipment and systems, all personnel involved in the operation will receive a safety orientation and training on appropriate safety features and procedures.
• Only personnel who are properly trained in the operation and maintenance of the applicable equipment and systems will operate the system/ equipment.

PROCEDURE

• If so desired, the Installation Qualification (IQ) and Operation Qualification (OQ) protocols may be combined into one document, an Installation, and Operation Qualification (IOQ) protocol.

1. In an IOQ protocol, the Purpose, System Description, Scope, and References sections will apply to both the IQ and OQ activities.
2. The prerequisites, procedures, and verifications will remain unique to either the IQ or OQ activity.
3. During execution of an IOQ protocol, IQ activities must be completed before proceeding with OQ activities.

• Documentation Required to Write an OQ Protocol:

1. The following documentation is typically required to write an OQ protocol:
2. Validation Master Plan
3. Functional Requirements Specifications
4. P & ID’s
5. Equipment Operations Manuals
6. Drawings and Specifications including:
7. Equipment Data Sheets
8. Equipment List
9. Instrument List
10. Alarm/Interlock Schedule
11. Operation Manuals
12. References for local, national and international codes and standards

Writing the Protocol:

• The OQ protocol will identify and describe the system/equipment and its intended usage, and provide an overview of the operation of the system/equipment.
• The OQ protocol will describe the operational tests, measurements, and control tolerances of the parameters that are critical to the proper operation of the system. Test objectives, methodologies and acceptance criteria will be outlined in each protocol.
• The OQ protocol should include challenges to the system to demonstrate acceptable performance under worst-case conditions.
• In the OQ protocol, the acceptance criteria must be clearly defined. These will be the criteria that must be met in order to successfully complete the operational qualification.

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• Operational Qualification protocols should include the following sections:

1. Table of contents:
2. Purpose: defines the reason for performing the qualification on the equipment/system with an indication of the expected outcome of the qualification.
3. System Description: briefly describes the system/ equipment; identifies the usage and location of the system, including how the system is controlled. Note that the location of equipment during the OQ should be the same as the intended location during manufacturing.
4. Scope: details the boundaries that the testing encompasses.
5. References: indicates the name and applicable document number of any support information used in the creation of the OQ. This list may include validation SOPs, engineering specifications, design drawings and specifications, vendor manuals or other appropriate drawings.
6. Pre-requisites: identifies actions that must be performed prior to OQ protocol execution.
7. Procedure: describes the procedure or methods to be used to conduct the testing; includes instructions for completing the OQ test data sheets and an execution signature log.
8. Functional tests: identifies and describes testing of each function, alarm, interlock, or other operational features. In some cases, factory acceptance testing, site acceptance testing, or commissioning testing, may be referenced to demonstrate the specific function operates as required. Each test case should contain detailed procedures and specify acceptance criteria.
9. Operational performance tests: identifies and describes testing of certain operational performance requirements (temperature uniformity, pressure control, etc.), including appropriate challenges. Some of these types of tests may be performed during the Performance Qualification (PQ) instead. Each test case should contain detailed procedures and specify acceptance criteria.

• Test equipment/instruments list – identifies and lists all critical measuring and monitoring devices such as timers pressure indicators and temperature sensors used during the qualification.

1. Calibration and Preventive Maintenance (PM) Program Verification: verifies that a PM program has been established for the system, and all critical instruments have been entered into a calibration program; verifies the PM and calibration activities have appropriate, associated work instructions.
2. SOP Verification: verifies that final drafts of SOPs have been created based on OQ execution information and that the drafts have been submitted for approval.
3. Training Documentation: verifies that operator training has been completed, and includes the location of training documentation.

• A Deviation Report Form should be included as an attachment to the protocol. The form should provide space to document and explain each deviation, the resolution and required action, and a means to identify the deviation as critical or non-critical.
• The OQ protocol must be reviewed and approved prior to the initiation of any testing. At a minimum, the protocol must be approved by Validation and Quality Assurance.

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Documentation Required to Execute an OQ Protocol

• The following is a list of documentation typically required to execute an OQ protocol:

1. P & IDs
2. Instrument list
3. Equipment list
4. Instrument calibration certificates
5. Approved IQ protocol

Executing the Protocol

• Prior to beginning OQ protocol execution, the IQ should be completed, reviewed, and approved, and all deviations corrected. OQ protocol execution may commence prior to the closeout of the IQ if incomplete items or open discrepancies have been verified by Engineering, Validation, and Quality Assurance not to impact the outcome of the OQ.
• Prior to the execution of the OQ protocol, computer IQ and OQ activities should be complete and all deviations corrected or verified not to impact operational qualification.
• Prior to the execution of the OQ protocol, all critical instruments should be calibrated.
• OQ execution involves extensive operation and testing of systems, utilities, and/or equipment. Only personnel trained in equipment/system operation and safety features should perform operations.
• During OQ execution, if a situation arises where the system/equipment responds in an unexpected manner or if the testing creates a situation where a question of safety arises, immediately cease all testing and return the system/equipment to a ‘safe’ condition. Consult with the Project Manager prior to proceeding with protocol execution.
• The OQ protocol shall be kept on location during execution. Data, including initials and dates, shall be entered in the OQ Protocol as it is executed. All data must be entered in accordance with XYZ Ltd.
• Each page of the executed portion of the protocol shall be signed by the person responsible for conducting the inspection/ test, reviewed and signed by a second person, and verified and signed by a QA representative.

Deviations / Discrepancies

• If a deviation is encountered during protocol execution (i.e. acceptance criteria is not met), contact the Project Manager and evaluate the exceptional condition and its potential impact on product safety and/or quality.
• Record and explain the deviation, resolution, and required corrective action on the deviation report form supplied in the protocol.
• Number each deviation as follows: protocol section number where the deviation occurred followed by a sequential number for each deviation observed, etc.
• Minor changes to a system required to meet acceptance criteria that do not require a change to the design of the system may be documented in the applicable comments section of the Operational Qualification protocol. Document the scope of the change and the justification for the change. Once the change is complete, testing may continue.

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• A critical deviation that may impact product quality must be resolved before proceeding with the Performance Qualification (PQ).
• A non-critical deviation (errors in the protocol, missing documentation, etc.) may be resolved after the commencement of the PQ.
• All deviations must be addressed and resolved.
• When the corrective action has been completed, the failed portion of the OQ protocol may be re-executed. If a change in the test procedure or a new procedure is required, a protocol addendum will be required and must be approved by all persons responsible for the initial approval of the protocol.
• During retrospective qualification, if deviations occur and a change in the system design or a change to the protocol acceptance criteria or test procedure is required that could potentially adversely impact the product, complete a Nonconformance Report in accordance with SOP.

Summary Report

• Upon completion of the operational qualification of a system/equipment, an OQ summary report may be prepared.
• Alternatively, a report may be prepared to combine the results from the IQ and OQ.

• The OQ Summary Report should include the following sections:

1. Purpose – defines the reason for performing the qualification.
2. System/equipment description – briefly describes the system/equipment, including major components and controls; identifies the usage and location of the piece of equipment or system; briefly describes the system operation.
3. Scope – details the boundaries of the qualification.
4. Responsibilities – outlines the responsibilities of the departments involved in completing the OQ.
5. Definitions – defines significant terms and/or abbreviations.
6. Equipment/System Location – Identify the location of the equipment; include room number, building number, and address as applicable.
7. Functional Requirements – lists the functional requirements of the equipment and/or process.
8. Documentation Requirements – lists the documentation that was required to complete the OQ and the location of the documentation.
9. Qualification Results – describe the steps taken during the execution of the OQ Protocol (e.g. alarms and interlocks function properly, regulators accurately regulate pressure, etc.); include an evaluation of the results; identify deviations, resolutions, corrective actions, and recommendations (if any).
10. Acceptance Criteria – describes the general acceptance criteria; includes a statement of adherence to the acceptance criteria.
11. Summary – briefly summarizes the qualification; identifies the status/condition of the system/equipment.
12. Re-qualification Requirements – Identify the requirements and schedule for re-qualification.
13. Completed Test Data Sheets – attach the completed sheets.
14. Deviations and Resolutions – attach the completed and approved Deviation Report Forms.
15. Final Approval - includes spaces for signatures and dates of each of the original document approvers; these signatures verify that the protocol execution has been successfully completed and that all acceptance criteria have been met.

Completion of the Operational Qualification

• The Operational Qualification is considered complete when all test cases have been executed and verified; Quality Assurance and Validation have approved all deviation resolutions; and a Summary Report has been written and approved by the original signing departments.

Commencement of PQ

• The OQ should be completed and approved before the commencement of the PQ.
• Before completion of OQ, PQ protocol execution may begin provided a documented engineering assessment of the state of OQ is performed to verify any incomplete items or open discrepancies will not affect the outcome of PQ testing. This assessment shall be documented via signature either at the end of the OQ protocol or as a pre-requisite listed in the PQ protocol. It must be approved by Validation and Quality Assurance.

RECORDKEEPING REQUIREMENTS

• Protocols will be processed per SOP.
• Upon approval, a working copy of the protocol may be printed and utilized during the execution portion of the process.
• Upon completion of the OQ, a final report should be written and approved.
• The original protocol, recorded data and final report should be kept in Document Control.

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