Trending of Change Control


Trending of change controls shall be performed on quarterly basis and here i have given one example and Template to explain you about the Trending of change control. In order to prepare chart you have to use Excel sheet and according to your requirement you can use different types of charts. The below mentioned departments and figures are given for reference purpose only and based upon your organizations SOP requirement you can redesign the things. Hope you read it and gain some new knowledge or learn something new

Review of Change Controls (Jan – Mar 2021)

Index

Sr. No.Contents
 1DESCRIPTION OF PROCESS
 2CHANGE CONTROL INITIATED AND  APPROVED
 3CHANGE CONTROL DEPARTMENT WISE
 4CHANGE CONTROL INITIATED TYPE WISE
 5CHANGE CONTROL INITIATED CATEGORY WISE
 6STATUS OF PERMANENT CHANGE CONTROL  
 7STATUS OF temporary CHANGE CONTROL  
 8SUMMARY
 9CONCLUSION
 10APPROVAL
  • 1.0 DESCRIPTION OF PROCESS :
  • Change Control – A planned alteration which is documented and considered before implementation and is either permanent or for a fixed validity period (temporary).
  • All changes shall be handled as per SOP on “Change Control Management”, SOP XYZ.
  • Change control shall be initiated by concerned or initiator department and login shall be done by Quality Assurance.
  • After categorisation and comment from all concern departments, Quality Assurance shall approve or reject the change control.
  • Status of approval / rejection shall be communicated to initiator department and implementation of changes shall be done respectively.
  • Change controls shall be categorised as “Major” and “Minor” as per the impact analysis of changes on Safety, Identity, Strength, Purity and Quality of product / Material / Documents.
  • All major and product related change control shall be approved by CQA.
  • Inclusion of the requirement for the verification of the old document invalidation before issuance of the revised document.
  • This change control review includes,
  • Total no .of change control initiated approved and closed.
  • Total no. of change control raised department wise.
  • Change control initiated type wise (i.e. Permanent, Temporary, Facility, Document, Material, Equipment and Other )
  • Change control initiated category wise (i.e. Major or Minor).
  • Any specific highlight for change control review.
  • 2.0 CHANGE CONTROL INITIATED AND APPROVED (Jan – Mar 2021) :
  • Total  26  change controls were raised for the January – Mar 2021
Sr. No.Type of Change ControlTotal No. of Change Control Raised
01Permanent Change Control25
02Temporary Change Control01
 Total No.26
  • 3.0 CHANGE CONTROL DEPARTMENT WISE (Jan – Mar 2021) :
  • Total 25 permanent change controls were raised, out of them 05 for Packing Department, 03 for Quality Assurance Department, 07 for Quality Control Department, 09 for Manufacturing Department, 01 for Human Resource and Administration Department, Nil for FRD Department, Nil for Technology Transfer/Art work Department, Nil for Engineering Department and Nil for Information Technology Department.
Sr. No.DepartmentPermanent Change Control
01Production14
02Quality Control07
03Quality Assurance03
04Warehouse00
05Engineering00
06Technology Transfer00
07Information Technology00
08FRD and Artwork00
09Packaging Development00
10Human Resource and Administration01
 Total No.25

01 Temporary change controls were raised from the Review period between Jan to Mar.2021.

Sr. No.DepartmentTemporary Change Control
01Production0
02Quality Control01
03Quality Assurance0
04Engineering0
05Technology Transfer0
 Total No.01
  • 4.0 CHANGE CONTROL INITIATED TYPE WISE (JANUARY – MARCH 2021) :
  • Total 25 Permanent change controls were raised, out of them 25 for Document Type, Nil for Facility Type, Nil for Material Type, none for Formulation Type, none for Instrument Type and none for Other Type.
Sr. No.Type WisePermanent Change Control
01Document25
02Facility00
03Material00
04Formulation00
05Instrument00
06Other (if any)00
 Total No.25

01 Temporary change controls were raised from the Review period between Jan to Mar.2021.

Sr. No.Type WiseTemporary Change Control
01Material01
02Document00
03Facility00
04Formulation00
05Equipment00
06Other00
 Total No.01
  • 5.0 CHANGE CONTROL INITIATED CATEGORY WISE (JANUARY – MARCH 2021) :

Total 25 Permanent change controls were raised, out of them 25 for Minor category and none for Major category for review period of Jan-Mar 2021.

Sr. No.Type of CategoryPermanent Change Control
01Minor25
02Major00
 Total No.25

Total 01 Temporary change controls were raised, out of them 01 for Major category and none for Minor category for review period of Jan-Mar 2021.

Sr. No.Type of CategoryTemporary Change Control
01Minor01
02Major00
 Total No.01
  • 5.0 Status of Permanent change control for Jan – Mar 2021:
Sr. No.YearTotal CC RaisedOpenClosed
012021250025
  • 6.0 Status of Temporary change control for Jan – Mar 2021:
Sr. No.YearTotal CC RaisedOpenClosed
012021010100
  • 8.0 SUMMARY
  • All change controls were login, reviewed and approved as per SOP.
  • Total cumulatively 06 change controls were raised in period of Jan – Mar 2021.
  • Out of 26, 25 are Permanent change controls and 01 is temporary change controls.
  • Out of 26 change controls, All 25 Permanent change controls are closed and 01 Temporary change controls is in open stage.
  • For Permanent change controls, There are 14 change control raised by Production Department which are related to Document
  • There are 07 Change Controls raised by Quality control  Department which are related to Document
  • There are 03 change controls raised by Quality Assurance which  are related to Document.
  • There are 01 change controls raised by Human Resource and Administration Department
  • Which is related to Document
  • There are none change controls raised by Engineering Department.
  • There are none change controls raised by FRD Department.
  • There are none change controls raised by Warehouse Department.
  • 9.0 CONCLUSION
  • All Change Controls are handled as per procedure described in SOP “Change Control Management”.
  • 10.0 APPROVAL
 Prepared ByReviewed ByApproved By
Signature   
Date   
Name & Designation   

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