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Table of Contents
1.0 Purpose..........................................................................................................................................................2
2.0 Scope.............................................................................................................................................................2
3.0 Responsibility................................................................................................................................................2
3.1 Research and Development................................................................................................................2
3.2 Accounting.........................................................................................................................................2
3.3 Quality Assurance..............................................................................................................................2
4.0 References.....................................................................................................................................................2
5.0 Definitions.....................................................................................................................................................3
6.0 Procedure......................................................................................................................................................3
6.1 Design Change Request.....................................................................................................................3
1.0 Purpose
2.0 Scope
To identify, document, review, and approve all design changes and modifications prior to their
implementation. This procedure applies to design changes, in all products, which occur after the initial
design inputs have been approved.
Where appropriate, in lieu of this document, a contract facility may use their existing system that meets
the appropriate procedural and regulatory requirements.
3.0 Responsibility
It is the responsibility of the requester to complete the Design Change Request form when initiating a
design change and attaching the support documentation and data to the form.
3.2 Accounting
Is responsible for determining the cost of implementing the requested design change and
providing the information to the requester.
4.0 References
CFF 820.30(i)
Design Input “Documentation Requirements
Design Change Request Log
Design Change Request
5.0 Definitions
Design Change: a change to the initial approved design of a product or component, or a change to
correct deficient designs following design transfer.
6.0 Procedure
Document changes to the design of a product after initial design requirements have been approved.
Approve all product requirements. (Refer to the Initial Design Input Requirements form. Initiate a
design change as a joint responsibility of the requester, Research and Development and
Engineering.
Complete the following sections for requester, description of change, and reason for change.
The department initiating the change is responsible for presenting data to support the impact of the
change on the product.
Direct the addition, change, or deletion of Standard Operating Procedures, Records, Component
Specifications, and Bill of Materials (BOMs) to the Design Review Committee.
If appropriate, determine, with input and assistance from Accounting, an implementation cost.
Calculate any change to the standard cost as well as the quantity of the component(s) affected and
record on the Design Change Request form.
Ensure that FDA approval has been received, required reliability testing performed, and that a
second source has been qualified, if appropriate.
Once the proposed change has been properly initiated, attach supporting documentation (SOPs,
BOMs, supporting data, etc.) to the completed Design Change Request form and transfer the
documents to Quality Assurance for review.
Review the attached documents to ensure all documents requiring review are included.
If all documentation is in place, then return the request to the requester, R&D and/or Engineering.
R&D or Engineering assigns an initiation date and a Design Change Request number noting both
on the Design Change Request form and on the Design Change Request Log.