Operational Qualification Report
- 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 perform all the tests with respect to Operational qualification and compiling data in co-ordination with client.
- It is the responsibility of the client to check and approve the Operational qualification.
- 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
- Pushbutton / 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