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SOP - QA.019 Change Control

The document outlines a standard operating procedure for a change control process to define how changes to products or processes that could impact food safety or quality must be approved. It establishes that a change control board must approve any changes to facilities, equipment, or systems that could affect product quality. The board is responsible for evaluating proposed changes submitted by any personnel requiring a change. The procedure details the steps for submitting a change request form to the board for review and approval or request for modification before a change can be implemented. Records of board meetings and approved change requests are maintained by the food safety manager.

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Muhammad Zain
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96 views

SOP - QA.019 Change Control

The document outlines a standard operating procedure for a change control process to define how changes to products or processes that could impact food safety or quality must be approved. It establishes that a change control board must approve any changes to facilities, equipment, or systems that could affect product quality. The board is responsible for evaluating proposed changes submitted by any personnel requiring a change. The procedure details the steps for submitting a change request form to the board for review and approval or request for modification before a change can be implemented. Records of board meetings and approved change requests are maintained by the food safety manager.

Uploaded by

Muhammad Zain
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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Standard Operating Procedure Document Number: SOP.QA.

019
Change Control Revision 0
QA Approval By Page 1 of 2
Dept. Approval By: Issue Date:

1.0 Purpose: To define the process for controlling changes to product or process that
could potentially effect food safety or quality.
2.0 Scope
2.1 The change control process must be followed if the proposed change has
the potential to impact the quality or integrity of the final product.
2.2 The change control board must approve all changes to the facility,
equipment and systems which have the potential to affect product quality.
2.3 Routine maintenance, repairs using identical parts, and replacing
equipment with a functionally identical piece are excluded from this
Change Control procedure.

3.0 Responsibility: The change control board has the responsibility of evaluating and
approving changes. Proposals may be submitted by anyone that has the need for a
change in process, packaging, or ingredients.

4.0 Procedure.
4.1.1 When a change/maintenance is needed while members of the
Change Control Board are on site.
4.1.2 Review potential changes with the appropriate people (General
Manager, Plant Manager, Maintenance Manager, and Food Safety
Manager) to determine feasibility.
4.1.3 If feasible, complete the Change Request Form and submit to the
Change Control Board
4.1.3.1 The Change Control board will consist of the following:
4.1.3.1.1 General Manager
4.1.3.1.2 Plant Manager
4.1.3.1.3 Maintenance Manager
4.1.3.1.4 Food Safety Manager
4.1.4 The Change Review Board will verify all areas of risk are
represented and revise the Change Request Form as necessary to
include any missing areas.
4.1.5 The Change Control Board then reviews and verifies that the
change is approved by all.
4.1.6 If it is not approved it will be returned to the originator to be
modified.
4.1.7 If it is conditionally approved it will be returned to the originator to
verify the conditions can be met.
Standard Operating Procedure Document Number: SOP.QA.019
Change Control Revision 0
QA Approval By Page 2 of 2
Dept. Approval By: Issue Date:

4.1.8 When the change is approved it will be returned to the originator


indicating approval to move forward and the customer notified
when required.
4.1.9 The change control process will be scheduled to make the desired
changes as expeditiously as possible, with the timeline depending
on the complexity of the change.
4.2 When an emergency repair is required on an off shift
4.2.1 Determine potential impact
4.2.2 If the potential impact is high, notify the Change Control Board
4.2.3 If the potential impact is low, continue running, document the
change, and notify the change control board in writing as soon as
possible
5.0 Record Control:
5.1 Records of Change Control Board meetings and completed change request
forms, FORM.QA.019, will be maintained by the Food Safety Manager.

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