Operational Qualification of Aluminium Strip Defoiler

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  • 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.
TEST  NUMBER CRITICAL FEATURE
5.1 Main Panel/Control Panel Testing
5.2 Power & Communication Failure Recovery 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 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
 

Input

  

Target

  

Actual

  

Test Done by

  

Date
Move the lever to the ‘FORWARD’ Guide rollers shall start moving in the forward direction.
Move the lever to the ‘REVERSE’ Guide rollers shall start moving in the reverse direction.
Move the lever to the ‘OFF’ Guide rollers shall stop.
  • 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
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  

 
  •  Conclusions / Comments:
  • 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
5.1 Main/Control Panel Testing
5.2 Power & Communication Failure Recovery Verification

 

  • LIST OF STANDARD OPERATING PROCEDURES
S. No Description SOP No Verified By Date
1 Operating Procedure of Aluminium Strip Defoiler
2 Cleaning Procedure of Aluminium Strip Defoiler
3 Preventive maintenance of Aluminium Strip Defoiler
  • Data Analysis, Summary of OQ & Recommendations
  • AMENDMENT RECORD

Sr. No.

Item Name

Remarks

Signature and Date
  •  Note: Any changes made in the system must be recorded in this sheet.
  • CONCLUSION

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