SMB Validation

What does an OQ contain?

Operation Qualification Protocols include (but are not limited to) the following common sections:

Identification of Writer, Approvers, Executors and Revision History:
Provides documented evidence on the personnel involved in preparing and executing the protocol complete with samples of signatures, initials and date formats. A revision history is maintained to record any changes to the document and the date they occurred.

Objective, Testing Rationale, and Scope:
Defines the intent and limitations of the protocol and specifies the quality critical functions of the equipment.

Acceptance Criteria and Identification of Test Equipment Required:
Specifies the criteria for a successful implementation and provides the customer with a list of test equipment to supply.

Equipment/Process Description:
A detailed written description of the entire system is included so as to provide the less-informed reader with the level of information required to gain comprehensive understanding of how the system as a whole is designed to operate.

Control Panel Functions - Identification and Testing:
All control features whether discrete components or touch-screen elements will be identified and tested for functionality. Control features for options not fitted will be tested to ensure that they will have no detrimental effects on the system.

Alarms, Error and Machine Status Messages Displays/Functions:
All possible alarm, error, or information messages will be verified for functionality and accuracy.

Interlock Challenges:
All interlock and safety devices will be tested for functionality.

Password Functions:
All password levels will be challenged for proper level accessibility.

Loss of Electrical and Compressed Air Tests:
Verifies that the system recovers from a temporary loss of electrical power and/or compressed air supply. Documents the nameplate information on the UPS system (if present) and verifies that the UPS system is activated immediately upon loss of electrical power and that no accumulated data pertaining to the run is lost upon transfer to the UPS backup system or upon restoration of the main electrical supply. Documents that, upon a loss of adequate air pressure, the system comes to a stop and that, upon return to sufficient air supply, the system recovers completely to full operation.

Machine Performance Functions - Operational Challenge of Equipment: Equipment challenge sheets using various product/packaging components combination are supplied to ensure that specific set-ups can be validated. These Equipment Challenge Sheets can also be used to bracket ranges of combinations thus allowing for more flexibility in production.

Note: This part of the Qualification is concerned with the actual performance of the equipment and is sometimes supplied as a separate Performance Qualification (PQ) protocol.

O.Q. Notes, Appendices, and Test Incidents:
These sections are provided to allow for proper documentation of any unforeseen occurrences during protocol execution.

Close Out and Sign Off:
Final approval of the executed document by authorized personnel is required in order to close out the document.