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
1	DESCRIPTION OF PROCESS
2	CHANGE CONTROL INITIATED AND  APPROVED
3	CHANGE CONTROL DEPARTMENT WISE
4	CHANGE CONTROL INITIATED TYPE WISE
5	CHANGE CONTROL INITIATED CATEGORY WISE
6	STATUS OF PERMANENT CHANGE CONTROL
7	STATUS OF temporary CHANGE CONTROL
8	SUMMARY
9	CONCLUSION
10	APPROVAL

• 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 Control	Total No. of Change Control Raised
01	Permanent Change Control	25
02	Temporary Change Control	01
	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.	Department	Permanent Change Control
01	Production	14
02	Quality Control	07
03	Quality Assurance	03
04	Warehouse	00
05	Engineering	00
06	Technology Transfer	00
07	Information Technology	00
08	FRD and Artwork	00
09	Packaging Development	00
10	Human Resource and Administration	01
	Total No.	25

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

Sr. No.	Department	Temporary Change Control
01	Production	0
02	Quality Control	01
03	Quality Assurance	0
04	Engineering	0
05	Technology Transfer	0
	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 Wise	Permanent Change Control
01	Document	25
02	Facility	00
03	Material	00
04	Formulation	00
05	Instrument	00
06	Other (if any)	00
	Total No.	25

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

Sr. No.	Type Wise	Temporary Change Control
01	Material	01
02	Document	00
03	Facility	00
04	Formulation	00
05	Equipment	00
06	Other	00
	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 Category	Permanent Change Control
01	Minor	25
02	Major	00
	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 Category	Temporary Change Control
01	Minor	01
02	Major	00
	Total No.	01

• 5.0 Status of Permanent change control for Jan – Mar 2021:

Sr. No.	Year	Total CC Raised	Open	Closed
01	2021	25	00	25

• 6.0 Status of Temporary change control for Jan – Mar 2021:

Sr. No.	Year	Total CC Raised	Open	Closed
01	2021	01	01	00

• 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 By	Reviewed By	Approved By
Signature
Date
Name & Designation

• Uncategorized