Template for Operational Qualification Protocol

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Operational Qualification Protocol

  • PURPOSE
  • To describe the Operational Qualification of Name of the Equipment and to define the specification of the system in order to:
  • Ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices
  • Ensure that the equipment meets the Operational/Design limits as per user requirements.
  • SCOPE
  • The scope of this document applies to the operational qualification of Name of the Equipment.
  • RESPONSIBILITIES:
  • It is the responsibility of the Manufacturer to prepare the Operational qualification protocol and identify the test parameters to be studied for qualifying the Name of the Equipment
  • It is the responsibility of the client to check and approve the Operational qualification protocol.
  • It is the responsibility of the Manufacturer to perform all the tests with respect to Operational qualification and compiling data in co-ordination with client.
  • PROCEDURE
  • The following requirement / practices apply to Name of the Equipment Operational Qualification activities:
  • To verify the components design parameters.
  • Review the preventive maintenance procedures, cleaning procedures and general operational procedure to ensure that they are comprehensive for reliable performance of the equipment.
  • OPERATIONAL QUALIFICATION TESTS
  • The table below lists the tests to be performed as part of the Operational Qualification phase.
TEST  NUMBER CRITICAL FEATURE
Main Panel/Control Panel Testing
Power & Communication Failure Recovery Verification
Main Operational Parameter. (Eg. RPM Verification)
  • Main Panel / Control Panel Testing.
  • Purpose :
  • To verify that the response of the equipment at the input from various
  • Push button / Switches on control or main panel is as per the system design.
  • Test equipment – None Required.
  • Procedure –  Give inputs from various Push buttons & Switches on Control Panel / Main Panel & observe the Response from the machine.
  • Acceptance Criteria :
  • The equipment will respond as mentioned in the target column of the table given below.
  • Take dry run of the equipment to ensure that all controlling parameters &functions are reproducible.
  • Test Results
Input Target Actual Test Done by Date
Control OFF/ON switch on control panel switched ‘ON’ Control ON indicating lamp will glow.
‘ON’    push button is pressed. Machine starts working
‘OFF’ push button is pressed. Machine stops working
  • Conclusion:
  • PASS                                    FAIL
  • Checked by:                                                                                       Verified by:
  • Date:                                                                                                    Date

 

  • Power & Communication Failure Recovery Verification
  • Rationale – To verify that in the event of a power loss or communications failure, the equipment will stop in safe condition.
  • Test equipment – None Required.
  • Procedure for Power and Communication Failure Recovery test –
  • Operate the equipment as directed in the User Manual.
  • While the equipment is operating, shut down the power to the main control panel. Record if the equipment stops in a safe and secure condition.
  • Wait for 5 minutes then restore power to the equipment.
  • Check whether system is start running once the power is restored
  • The system is not starting of its own, restart the equipment and note any adverse condition.
  • Acceptance criteria –
  • the equipment shall stop in safe and secure condition.
  • the equipment should not start of its own after the power is restored without user permission
  • the equipment can be restarted with no problems or adverse conditions observed.
  • Power and Communication Failure Recovery test results
Test Results Meets Test

(Yes / No)

 Test Done by Date
Main Power Shut Down Equipment stops in a safe and secure condition.
 

 

Main Power Restored

 Equipment is not starting of its own without user permission
Equipment can be restarted with NO problems or adverse conditions observed  

 
  • Conclusion:
  • PASS                                    FAIL
  • Checked by:                          Verified by:
  • Date:                                    Date:

 

  • Main Operational Parameter. (Eg. RPM Verification)
  • Purpose – To verify the RPM of blade roller.
  • Test equipment – Digital Tachometer.
  • Procedure :
  • Start the equipment as per user manual.
  • Observe the rotation of the equipment for ‘1’ minute (Note down the value in respective trial column) using tachometer.
  • Continue the procedure for totally ‘3’ times.
  • Acceptance Criteria – The average RPM of the blade roller should match with the specified RPM.
  • RPM verification test results
 

Acceptance Criteria

  

Trial-1

No of Revolution

  

Trial-2

No of Revolution

  

Trial-3

No of Revolution

  

Average RPM

 

 Test Done by Date
20±1 rpm
  • Note:   Average RPM = (Trial-1 + Trial-2 + Trial-3) / 3
  • Conclusion:
  • PASS                                            FAIL
  • Checked by:                                  Verified by:
  • Date:                                            Date

 

  • Operational Qualification Tests Status
  • The table below lists the tests performed and related results.
Test Number

 

 Critical Feature

 

 Pass / Fail Deviation Found
Pass Fail Yes No
Main/Control Panel Testing
Power & Communication Failure Recovery Verification
Main Operational Parameter. (Eg. RPM Verification)

 

  • LIST OF STANDARD OPERATING PROCEDURES
S.No           Description           SOP No Verified By      Date
1 Operating Procedure of Name of the Equipment
2 Cleaning Procedure of Name of the Equipment
3 Preventive maintenance of Name of the Equipment
  • Data Analysis, Summary of OQ & Recommendations:

 

  • CONCLUSION

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