DISMANTLING VERIFICATION DOCUMENT FOR QC INSTRUMENT

DISMANTLING VERIFICATION

DOCUMENT FOR

QC INSTRUMENT

DEPARTMENT : Quality Control
LOCATION                : NA
Document No. Rev. No. Effective Date Reason for revision
NA 00   QC instrument transferred to Other department and other location as per requirement.

TABLE OF CONTENTS

Sr. No. Content Page No.
  Pre- Approval
  Objective
  Scope
  Verification team and Responsibilities
  Methodology for Dismantling verification
  Instrument Details
  Dismantling procedure
  Deviation or Non-conformance (If Any)
  Abbreviation(s)
  Attachment(s)
  Summary and Conclusion
  Post Approval
  1. Pre-Approval:
Prepared By:
Functional Area Name Designation Signature & Date
Quality Control      
Reviewed By:
Functional Area Name Designation Signature & Date
Head Quality Control      
Head Engineering      
Approved By:
Functional Area Name Designation Signature & Date
Head-QA      
Head-Operation        

 

Authorized By:
Functional Area Name Designation Signature & Date
Head Quality      
  • OBJECTIVE:

The objective of dismantling verification document is to ensure and verify that all the major and minor components of instrument dismantle and packed properly as per standard operating procedure, cGEP and same to be properly documented.

  • SCOPE:

This Document is applicable for dismantling and packing of QC instrument.

  • VERIFICATION TEAM & RESPONSIBILITY:

Verification Team:

Department Name Designation Sign. & Date
QC      
Engineering      
QA      

Responsibility:

Department Responsibilities
Quality Assurance   Preparation of document Execution of activity in co-ordination with QC & Engineering.
Engineering Dismantle the instrument as per cGEP. Provide technical support during execution of the Document.
Head QC & Head Engineering  Review of Document and verification activity Assist in resolution of deficiencies
Head Operation & Head QA Approval of Document and verification activity. Assist in resolution of deficiencies.
Head Quality Authorization of the Document for execution.
  •   METHODOLOGY FOR DISMANTLING VERIFICATION:
    • Dismantling of instrument.
    • Transfer of instrument from area.
    • Packing of dismantled instrument and Accessories.  

Remark: ……………………………………………………………………………………………………………….

……………………………………………………………………………………………………………………

…………………………………………………………………………………………………………………..

Checked  By Verified By
Quality Control (Sign. & Date)   Engineering (Sig. & date) Quality Assurance (Sign. & Date)
  • INSTRUMENT  DETAILS :
Sr. No. Instrument Name Instrument ID Location Quantity Remark
1.   as per requirement QC 01  

Remark: …………………………………………………………………………………………………………….….

…………………………………………………………………………………………………………………

………………………………………………………………………………………………………………….

Checked  By Verified By
Quality Control (Sign. & Date)   Engineering (Sig. & date) Quality Assurance (Sign. & Date)
  •    DISMANTLING AND PACKING PROCEDURE:
    • Dismantling of instrument:
      • Disconnect the main supply of instrument from panel.
      • Dismantle the instrument as per SOP separately and record the observation in Annexure.
  • Transfer of instrument from area:
  • Transfer all the instrument part one by one from the area.
  • Store the instrument in suitable place.
  • Packing of Dismantled Instrument and Accessories:
  •    Pack the instrument in wooden box and record the observation in Annexure.
  • Document Verification:
  • Check all relevant document of the instrument and record the observation in Annexure.
  • DEVIATION OR NON-CONFORMANCE (IF ANY):

Report any deficiencies from the acceptance criteria or from document instructions shall be defined in report. The actions planned / taken on the deficiency shall be recorded in report.

Sr. No. Description Deviation No. Checked By QC(sign./ date)
       
       

Remark: ………………………………………………………………………………………………………………….

……………………………………………………………………………………………………………………

Reviewed  By Verified By
Engineering  (Sign. & Date) Quality Assurance (Sign. & Date)
  • Abbreviation(S)
Abbreviation  Full form Abbreviation  Full form
Sr. Serial QA Quality Assurance
No. Number Eng. Engineering
Sign. Signature cGEP Current Good Engineering Practice
SOP Standard Operating Procedure    
  1. Attachments:
Sr. No. Annexure No. Detail of Document
  1. Summary and Conclusion:

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Prepared By
Name……………………..
Department …………………….
    (Sign. & Date)
  1. Post -Approval:
Executed By:
Functional Area Name Designation Signature & Date
Engineering      
Quality Control      
Quality Assurance      
Reviewed By:
Functional Area Name Designation Signature & Date
Head Quality Control      
Head Engineering      
Approved By:
Functional Area Name Designation Signature & Date
Head Quality Assurance      
Head Operation      
Authorized By:
Functional Area Name Designation Signature & Date
Head Quality      

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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