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Change Control SOP
Change Control SOP
Quality representative signs to confirm document complies with quality management system
Authorised by: Job title: Signature: Date:
Document is current only if front page has “Controlled copy” stamped in red ink Page 1 of 7
<Company Change Control
Name> Document ID: QP703 Revision No.: 01
Table of Contents
1. Purpose 3
2. Application 3
3. Responsibilities 3
4. Procedure 4
4.1. Proposing a change 4
4.2. Evaluating the effect of a change on product quality 4
4.3. Approval of a change before implementation 4
4.4. Implementing a change 5
4.5. Storage of completed change controls 5
4.6. Publication of change control status 5
4.7. Emergency change control 5
5. Heading 1 6
5.1. Heading 2 6
5.1.1. Heading 3 6
Heading 4 6
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<Company Change Control
Name> Document ID: QP703 Revision No.: 01
1. Purpose
This procedure describes the system to control and manage all changes that can impact
product quality and safety both developed and manufactured under the Quality
Management System (QMS) at <Company Name>.
It ensures these changes are clearly identified, documented, reviewed and approved.
2. Application
The procedure applies to changes to:
product quality
controlled documents
raw materials
specifications
analytical methods
facilities
support systems
equipment (including computer hardware)
processing steps
labelling and packaging materials
computer software
any other element that can impact product quality and/or safety.
3. Responsibilities
Amend to reflect company structure.
Role Responsibility
Department managers Identify and follow up actions to be taken to justify any change within their
area of responsibility.
Quality Manager Independent evaluation of proposed change controls.
Approve changes to the company QMS.
Management of the change control system.
All personnel Raise a change control request. Personnel are encouraged to make changes
that improve product quality, or reduce or remove the risk of non conforming
product or processes.
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<Company Change Control
Name> Document ID: QP703 Revision No.: 01
4. Procedure
Any change to the following must be approved before the change is made:
changes affecting company procedures and systems, referred to as the QMS
changes affecting manufacturing equipment performance
changes affecting product quality not managed by batch or process documentation.
Document is current only if front page has “Controlled copy” stamped in red ink Page 4 of 7
<Company Change Control
Name> Document ID: QP703 Revision No.: 01
Document is current only if front page has “Controlled copy” stamped in red ink Page 5 of 7
<Company Change Control
Name> Document ID: QP703 Revision No.: 01
Document Information
Revision History
Revision Modified by Description of Change
01
Complete the above fields for each revision of this document. Ensure that there is sufficient
description of changes so that the change history of this document can be followed.
Additional columns can be added to include document/change tracking numbers generated
by your company’s systems if required (eg. change control).
List all controlled procedural documents referenced in this document (for example, policies,
procedures, forms, lists, work/operator instructions
Associated records
Doc. No. Document Title
List all other referenced records in this document. For example, regulatory documents, in-
house controlled documents (such as batch record forms, reports, methods, protocols),
compliance standards etc.
DOCUMENT END
Sample styles follow. Delete all text to the end of the document, including this comment,
prior to publishing.
5. Heading 1
Normal
5.1. Heading 2
Subtle emphasis
5.1.1. Heading 3
HEADING 4
Bullet 1
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<Company Change Control
Name> Document ID: QP703 Revision No.: 01
- Bullet 2
6. Numbered step 1 (1, 2, 3 etc)
a) Number step 2 (a, b, c etc)
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