Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                
Scribd
Upload
641 views

Standard Operating Procedure For Change Control and New Procedure Implementation

This standard operating procedure outlines the process for managing changes and implementing new procedures. It defines responsibilities for reporting changes, and requires that all changes be submitted to the quality assurance department for review. The quality assurance manager is responsible for overseeing the process, and may require further technical review, approve, reject, or suspend proposed changes based on an impact assessment. Approved changes are implemented and then monitored to ensure the results match what was assessed. All activities are documented in change request forms.

Uploaded by

Solomon
Copyright
© © All Rights Reserved
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
641 views

Standard Operating Procedure For Change Control and New Procedure Implementation

This standard operating procedure outlines the process for managing changes and implementing new procedures. It defines responsibilities for reporting changes, and requires that all changes be submitted to the quality assurance department for review. The quality assurance manager is responsible for overseeing the process, and may require further technical review, approve, reject, or suspend proposed changes based on an impact assessment. Approved changes are implemented and then monitored to ensure the results match what was assessed. All activities are documented in change request forms.

Uploaded by

Solomon
Copyright
© © All Rights Reserved
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
You are on page 1/ 2

SOP Number:QA-006

Title: Standard Operating Procedure for change control and new procedure implementation
Revision Number 03 Supersedes 02

1.Purpose
The purpose of this SOP is to control any change that can possibly be made and may directly or indirectly alter
the quality of products and services.
2.Scope
This SOP is to be followed by all processes whenever they make any change to existing practice and/or
introduce any new one.
3.Validity
This SOP is valid up to the next revision date and only if it bears the control seal.

4.Responsibility
 It is the responsibility of all process owners to report any change or new procedure to be initiated in their
department to QA department.
 The QA manager is responsible for full implementation of the procedure.
5.Materials and Equipment
None
6. Procedure
6.1 Person issuing the change request should define; the data needed to raise the request, reason for change and
should evaluate the impact and/or consequences of change and define the party responsible to carry out the
change by filling Change/Implementation proposal Format.
6.2 The raised request is then submitted to the QA department.
6.3 The QA then reviews the change request form and based on the submitted document he/she may come out
with the following responses.
 Request further Technical Review
 Approve the change Request
 Reject the change request
 Suspend the change request
6.3.1 Technical Review
If the case requires further impact assessment, the QA manager initiates further review on the impact
and assigns a technical committee that assess the impact of the change.
6.3.2 Approve/ Rejection and Suspension of the Change Request
 Based on the impact assessment from technical review and/or submitted documents, the QA
manager fills the result of the assessment on the Change request form.
 Based on the comment and total assessment result, the plant manager Approves the change
request.
 Following approval of the request, the requesting party will carry out the change as per the
request.
 If the impact assessment shows problem with the critical parameters with regard to the product,
the QA manager rejects the request.
 However, if the request requires even further assessment, the QA manager suspends the request
and then again initiates further technical review.
6.4 After the change is initiated, it shall be followed and monitored for its full implementation.
6.5 If the monitoring and follow up results are the same to the assessed impacts and results, then the case will be
closed.
6.6 All filled information shall be filled in two copies, one retained in the QA department and the other to the
requesting unit.
7. Reporting
All performed activities shall be filled and recorded on the change request form.
8. Reference Documents: NIL

You might also like