DQ IQ OQ PQ tec lab

Dq Iq Oq Pq Tec Lab-PDF Download

  • Date:14 Sep 2020
  • Views:4
  • Downloads:0
  • Pages:31
  • Size:441.59 KB

Share Pdf : Dq Iq Oq Pq Tec Lab

Download and Preview : Dq Iq Oq Pq Tec Lab


Report CopyRight/DMCA Form For : Dq Iq Oq Pq Tec Lab


Transcription:

8 2 4 DQ IQ OQ PQ Revision 0,Taylor Wharton,Taylor Wharton Germany GmbH Protocol Mowden. 11 12 2014,Mildstedter Landstr 1,25866 Mildstedt,I APPROVAL PAGE. The Owner User signature indicates this document has been reviewed to assure that it effectively docu. ments all customer requirements for Design Installation Operational Performance Qualification. System Owner Date, The signature of the Taylor Wharton Representative indicates that this for Design Installation Opera. tional Qualification package has been reviewed and approved for thorough testing of the freezer to ensure it. has met all manufacturing and performance requirements as specified by Taylor Wharton. Taylor Wharton Representative Date,Print name and title. Page 2 of 31 824 DQ IQ OQ PQ Protocol Mowden rev 0. 8 2 4 DQ IQ OQ PQ Revision 0,Taylor Wharton,Taylor Wharton Germany GmbH Protocol Mowden.
11 12 2014,Mildstedter Landstr 1,25866 Mildstedt,I APPROVAL PAGE 2. A Purpose 5,III RESPONSIBILITIES 6,A System Owner SO 6. C Manufacturer s Representative MR 7,IV SYSTEM QUALIFICATION PROCEDURE 7. A System Qualification Procedure 7,V DESIGN QUALIFICATION DQ PROTOCOL 8. VI INSTALLATION QUALIFICATION IQ PROTOCOL 9,VII OPERATIONAL QUALIFICATION OQ PROTOCOL 10.
VIII PERFORMANCE QUALIFICATION PQ PROTOCOL 11,B General Arrangement Drawing 12. LABS FUNCTIONAL TEST MOWDEN CONTROLLER 30, LABS FUNCTIONAL TEST MOWDEN CONTROLLER FEHLER TEXTMARKE. NICHT DEFINIERT,IX APPENDIX A DQ DOCUMENTATION 12,A Freezer Specification Sheet Appendix A. B General Arrangement Drawing Appendix A, C Manufacturing Process with Quality Check Points Appendix A. D Manufacturing Quality Traveler sample Appendix A. E Manufacturing Equipment Calibration Checklist and Certifications Appendix A. F ISO Certificate Appendix A,X APPENDIX B IQ DOCUMENTATION 13.
A Inspection of Condition of External Packaging 14. B Inspection of Condition of Freezer Internal and External Surfaces 15. C Inspection of Cleanliness of Equipment 16,D Confirmation that Unit is Properly Labeled 17. E Confirmation of Documentation Package 18, F Confirmation of Receipt of all Required Parts 19. G Confirmation that Freezer has Correct Power Supply 20. H Confirmation that Freezer is Level 21, I Confirmation Components are Leak Tight after Connection to LN2 Supply 22. XI APPENDIX C OQ DOCUMENTATION 23,A Operating and Maintenance Manual Appendix C. B Mowden Controller Function Checklist factory test Appendix C. Page 3 of 31 824 DQ IQ OQ PQ Protocol Mowden rev 0. 8 2 4 DQ IQ OQ PQ Revision 0,Taylor Wharton,Taylor Wharton Germany GmbH Protocol Mowden.
11 12 2014,Mildstedter Landstr 1,25866 Mildstedt,XII APPENDIX D PQ DOCUMENTATION 24. A Temperature Map Appendix D,B Normal Evaporation Rate Test 25. C Confirmation that Lid Opens and Closes Smoothly 26. D Confirmation that Lid Seal is Uniform and Level 27. E Confirmation that Turntable Rotates Freely if applicable 28. F Mowden Controller Function Checklist performance test Appendix D. Page 4 of 31 824 DQ IQ OQ PQ Protocol Mowden rev 0. 8 2 4 DQ IQ OQ PQ Revision 0,Taylor Wharton,Taylor Wharton Germany GmbH Protocol Mowden. 11 12 2014,Mildstedter Landstr 1,25866 Mildstedt,II INTRODUCTION. The intent of this DQ IQ OQ PQ protocol is to define and assure the implementation of. the organizational practices standards methods and documentation conventions to be. used for the requirements proper specification design and acceptance of the Taylor. Wharton Stainless Steel Cryogenic Freezer Serial Number 815 003 LL10. The purpose of this qualification protocol documentation package is to identify the mini. mum acceptance requirements to assure the complete and proper specification design. and acceptance of the Taylor Wharton Cryogenic Freezer specified in this document. Successful acceptance requires that the specifications and criteria are adequately ad. dressed managed tested and documented To this end evidence that this Taylor. Wharton Cryogenic Freezer will perform its functions repeatedly reliably and as ex. pected throughout the life of the system will include the following. Adherence to applicable standards codes practices and guides. Adherence to the specifications and design criteria listed in the DQ protocol section. Adherence to the initial condition of the Freezer system packaging documentation. and proper installation criteria is listed in IQ protocol section. Adherence to the Freezer s controller functional testing and operational criteria is. listed in the OQ protocol section, Adherence to the Freezer s mechanical functional testing and performance criteria is.
listed in the PQ protocol section,Records collection maintenance and retention. This qualification protocol document package pertains specifically to the Taylor Wharton. Stainless Steel Cryogenic Freezer which serve as a product storage container and com. Vacuum Insulated Product Storage Container,Control System. This document package is intended to serve as a guide during the Design Qualification. Installation Qualification Operational Qualification Performance Qualification protocol. It outlines how the freezers are to be tested and documented in order to conform to all of. the above requirements and acceptance criteria, Page 5 of 31 824 DQ IQ OQ PQ Protocol Mowden rev 0. 8 2 4 DQ IQ OQ PQ Revision 0,Taylor Wharton,Taylor Wharton Germany GmbH Protocol Mowden. 11 12 2014,Mildstedter Landstr 1,25866 Mildstedt,III RESPONSIBILITIES.
This section describes the organization tasks and responsibilities required for defining. developing implementing testing operating and maintaining the Cryogenic Freezer Sys. tems The following comprise the individuals required for this qualification protocol. These individuals are assigned specific responsibilities detailed in the paragraphs below. System Owner SO,A System Owner SO, The SO shall provide all documents and related functions listed In support of this work. the SO shall, 1 Provide information to support the creation of the qualification protocol package for the. Taylor Wharton Cryogenic Freezer and assure that any compliance issues are addressed. 2 Review an outline of the T W standard qualification protocol package and identify any. additional customer specific requirements before protocol is begun. 3 Provide technical guidance to assure that the system is in compliance with its specified. functional requirements and standards, 4 Understand the function and operation of the cryogenic freezers. 5 Oversee the installation of the systems, 6 Retain secure and maintain all system documentation. 7 Execute Operation and Maintenance O M Procedures as required. 8 Approve the Qualification Protocol Criteria,9 Issuing a controlled copy for use.
Page 6 of 31 824 DQ IQ OQ PQ Protocol Mowden rev 0. 8 2 4 DQ IQ OQ PQ Revision 0,Taylor Wharton,Taylor Wharton Germany GmbH Protocol Mowden. 11 12 2014,Mildstedter Landstr 1,25866 Mildstedt,C Manufacturer s Representative MR. The MR shall supply all facilities supplies and resources necessary to execute all system. testing In support of this protocol the MR is, 1 Responsible for the generation of this protocol and reporting the outcome of this. protocol in a final report, 2 Responsible for the procedures outlined in this protocol. 3 Responsible to ensure that all control instruments are calibrated and functional prior to. the start of the qualification,IV SYSTEM QUALIFICATION PROCEDURE.
A System Qualification Procedure, System performance shall be initially validated and initially qualified by the successful ex. ecution of the DQ IQ OQ PQ protocol procedures at the suppliers factory. System performance shall be formally approved and qualified by the successful review and. or execution of the DQ IQ OQ PQ protocol procedures at the system owners site. Page 7 of 31 824 DQ IQ OQ PQ Protocol Mowden rev 0. 8 2 4 DQ IQ OQ PQ Revision 0,Taylor Wharton,Taylor Wharton Germany GmbH Protocol Mowden. 11 12 2014,Mildstedter Landstr 1,25866 Mildstedt,V DESIGN QUALIFICATION DQ PROTOCOL. The DQ Protocol section of this qualification package defines and validates the Freezer. System design, The DQ Protocol section also defines and validates the manufacturer processes manufac. turing equipment and quality procedures used to manufacturer the design. And finally the DQ Protocol section defines and verifies that the Quality Certificates of the. facility equipment and components used to design and manufacture the Cryogenic Freezer. System design are current and within standards, The DQ Protocol documentation includes specification sheets component and material.
lists and drawings that define the basic Cryogenic Freezer and the completed Cryogenic. Freezer System which includes the controller solenoid valve and other pertinent compo. nents if applicable, The DQ Protocol documentation also includes a flow diagram of the Manufacturing Pro. cesses with Quality Check Points a Freezer Dimensional Checklist a Controller Checklist. and Manufacturing Traveler, And finally the DQ Protocol documentation includes Quality Certificates of the facility. equipment and components used to design and manufacture the Cryogenic Freezer System. The results and expectations of each section of the DQ Protocol is reviewed and signed by. Manufacture s Representative at the factory Each section of the DQ Protocol also has an. acceptance box for the System Owner,The DQ protocol documentation is in Appendix A. Page 8 of 31 824 DQ IQ OQ PQ Protocol Mowden rev 0. 8 2 4 DQ IQ OQ PQ Revision 0,Taylor Wharton,Taylor Wharton Germany GmbH Protocol Mowden. 11 12 2014,Mildstedter Landstr 1,25866 Mildstedt,VI INSTALLATION QUALIFICATION IQ PROTOCOL.
The IQ Protocol section of this qualification package defines and validates the cleanliness. the external and internal appearances the labeling and the overall workmanship of the. Cryogenic Freezer System, The IQ Protocol section also defines and validates that the complete Cryogenic Freezer. System is properly packaged for shipment and has all required documentation. The IQ Protocol documentation includes quality inspection reports and checklists of the. Cryogenic Freezer System labeling and documentation. The IQ Protocol documentation includes confirmation reports of basic mechanical func. tionality tests used to verify that the Cryogenic Freezer will perform its mechanical func. tions repeatedly reliably and as expected throughout the life of the system. The results and expectations of each section of the IQ Protocol is reviewed and signed by. Manufacture s Representative at the factory Each section of the IQ Protocol also has an. acceptance box for the System Owner,The IQ protocol documentation is in Appendix B. Page 9 of 31 824 DQ IQ OQ PQ Protocol Mowden rev 0. 8 2 4 DQ IQ OQ PQ Revision 0,Taylor Wharton,Taylor Wharton Germany GmbH Protocol Mowden. 11 12 2014,Mildstedter Landstr 1,25866 Mildstedt,VII OPERATIONAL QUALIFICATION OQ PROTOCOL. The OQ Protocol section of this qualification package defines and validates that the Cryo. genic Freezer System will perform its operational functions repeatedly reliably and as ex. pected throughout the life of the system, The OQ Protocol documentation includes confirmation reports of operational functionality.
tests used to verify that the Cryogenic Freezer will perform its operational functions repeat. edly reliably and as expected throughout the life of the system. The OQ Protocol documentation also includes the Operating and Maintenance Manual. The results and expectations of each section of the OQ Protocol is reviewed and signed by. Manufacture s Representative at the factory Each section of the OQ Protocol also has an. acceptance box for the System Owner,The OQ protocol documentation is in Appendix C. Page 10 of 31 824 DQ IQ OQ PQ Protocol Mowden rev 0. 8 2 4 DQ IQ OQ PQ Revision 0,Taylor Wharton,Taylor Wharton Germany GmbH Protocol Mowden. 11 12 2014,Mildstedter Landstr 1,25866 Mildstedt,VIII PERFORMANCE QUALIFICATION PQ PROTOCOL. The PQ Protocol section of this qualification package defines and validates that the Cryo. genic Freezer System will perform per the specifications repeatedly reliably and as ex. pected throughout the life of the system, The PQ Protocol documentation includes a Normal Evaporation Rate NER test report. and confirmation reports of operational functionality tests used to verify that the Cryogenic. Freezer will perform its operational functions repeatedly reliably and as expected. throughout the life of the system, The results and expectations of each section of the PQ Protocol is reviewed and signed by.
Manufacture s Representative at the factory Each section of the PQ Protocol also has an. acceptance box for the System Owner,The PQ protocol documentation is in Appendix D. Page 11 of 31 824 DQ IQ OQ PQ Protocol Mowden rev 0. 8 2 4 DQ IQ OQ PQ Revision 0,Taylor Wharton,Taylor Wharton Germany GmbH Protocol Mowden. 11 12 2014,Mildstedter Landstr 1,25866 Mildstedt, IX DESIGN QUALIFICATION DQ DOCUMENTATION APPENDIX A. Appendix A includes the following documentation,A Freezer Specification Sheet. B General Arrangement Drawing,C Manufacturing Process with Quality Check Points.
DQ IQ OQ PQ Design Installation Operating Performance Qualification Protocol for Taylor Wharton Cryogenic Freezers Serial ID Taylor Wharton Taylor Wharton Germany GmbH Mildstedter Landstr 1 25866 Mildstedt 8 2 4 DQ IQ OQ PQ Protocol Mowden Revision 0 11 12 2014 Page 2 of 31 824 DQ IQ OQ PQ Protocol Mowden rev 0 I APPROVAL PAGE The Owner User signature indicates this

Related Books