Operational Qualification of Aluminium Strip Defoiler

• PURPOSE
• To describe the Operational Qualification of Aluminium Strip Defoiler and to define the specification of the system in order to:

• ensure that the equipment meets the Operational/Design limits as per user requirements.
• ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices.

• SCOPE
• The scope of this document applies to the operational qualification of Aluminium Strip Defoiler.

• RESPONSIBILITIES:
  • It is the responsibility of the Manufacturer to prepare the Operational qualification protocol.
  • 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 Aluminium Strip Defoiler 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.

•  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 are 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

• Conclusions / Comments:

• 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 notes any adverse condition.

• Acceptance criteria:
  • At step 5.2.3.2 the equipment shall stop in safe and secure condition.
  • At step 5.2.3.4 the equipment should not start of its own after the power is restored without user permission
  • At step 5.2.3.5 the equipment can be restarted with no problems or adverse conditions observed.

• Power and Communication Failure Recovery test results

•  Conclusions / Comments:
• Operational Qualification Tests Status
• The table below lists the tests performed and related results.

• LIST OF STANDARD OPERATING PROCEDURES

• Data Analysis, Summary of OQ & Recommendations

• AMENDMENT RECORD

•  Note: Any changes made in the system must be recorded in this sheet.

• CONCLUSION

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