SOP for Change Control

1.0     Objective:

The objective of this SOP is to describe a procedure for permanent change or alteration in established system and testing activity.

2.0       Scope:

This SOP is applicable to all SOPs, specifications, facilities, layout, testing procedures.

3.0       Responsibility:

3.1       Head of department shall be:

Responsible to check the impact on the test results due to change.

Responsible for initiate the change control form as mentioned in the scope with justification.

3.3       GM Tech/ QA Manager shall be:

Review of the change control form and give the comment if any.

Responsible for Release or Rejection of the change(s).

4.0       Procedure:

4.1              Change: Any addition to, deletion of or modification to a system, materials or procedure.

4.2              Change can be categorized as follow.

a.       Minor

b.      Major

c.       Critical

Minor change: Those changes that are unlikely to have any detectable impact on the quality of test results.

Major change: Those changes that could have significant impact on the quality of test results.

Critical change: Those changes that are likely to have a significant impact on quality of test result.

4.3   Initiate change control form for any changes as mentioned in the scope.

4.4    Fill in details of proposed changes and justification for changes. Attach the supporting document, if any.

4.5  Take change control number from the Quality Assurance Department.

4.6  The initiator forwards change control form to Technical Manager for comments and Approval/ Rejection.

4.7   Forward change control form to Quality Assurance Manager for approval.

4.8   Quality Assurance Manager gives comments accordingly to its requirement.

4.9    After getting approval from QA Manager, QA department inform to initiating department about the approval of change control. QA department informs other department also, which are being affected for the change proposed.

4.10  Initiating department must change affected documents and concerned department must change other affected documents. Take approval of concerned responsible person.

4.11  Concerned QA must verify the changed details and sign the form.

4.12  QA Department must ensure that change is incorporated in all the affected documents and put change implementation date. 

4.13  QA Department retains original copy and issues photocopy of closed change control form to initiating department, and concerned department if necessary.

4.14   Implement the change and document all training given with respect to the implementation of changes.

5.0      Documents:

5.1      Annexure – 1         Format for change control register              XXX/FRM/000

6.0     History of Revision:

Revision No.	Effective Date	Revision details	Reason for revision

Change Control Register

Sr. No.	Proposed change	Change Date	Initiate by (Department)	Change control No.

SOP No.: XXX/SOP/000-00                                           Format No. : XXX/FRM/000-00