[Company Name]
[Company Group, Division, Location]
Document Title: Design Changes
Document Number:[Document Number]
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COMPANY PROPRIETARY AND CONFIDENTIAL
[Company Name]Design Changes
[Company Group, Division, Location][Document Number]
Rev x.xxDD/MM/YY
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[Document Filename]COMPANY PROPRIETARY AND CONFIDENTIALPage 1 of 3
[Company Name]Design Changes
[Company Group, Division, Location][Document Number]
Rev x.xxDD/MM/YY
Table of Contents
1.0Purpose
2.0Scope
3.0Responsibility
3.1Research and Development
3.2Accounting
3.3Quality Assurance
4.0References
5.0Definitions
6.0Procedure
6.1Design Change Request
1.0Purpose
2.0Scope
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.
3.0Responsibility
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.
3.1Research and Development
Is responsible for: initiating a design change, or assisting with the initiation, completing a Design Change Request Form (Attachment 2), and providing supporting documents or data the assignment and documentation of a Design Change Request number and initiation date timely routing of all Design Change Requests assuring that design changes are properly controlled and documented retention and maintenance of the Design Change Request Log (Attachment 1) Research and Development is responsible for the timely routing of the design change request after it is initiated, and the retention and maintenance of the Design Change Request Log. The Design Review Committee (DRC) is responsible for establishing and documenting requirements for each product design, and for the review and approval of all completed Design Change Requests.
3.2Accounting
Is responsible for determining the cost of implementing the requested design change and providing the information to the requester.
3.3Quality Assurance
Is responsible for reviewing all Design Change Requests and supporting documentation prior to assignment of a Design Request Number and initiation date, and for determining if the request is complete and all documentation is in place.
4.0References
- CFF 820.30(i)
- Design Input “Documentation Requirements
- Design Change Request Log
- Design Change Request
5.0Definitions
Design Change: a change to the initial approved design of a product or component, or a change to correct deficient designs following design transfer.
6.0Procedure
- 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.
6.1Design Change Request
After an initiation date and Design Change Request number are assigned, review the document and, if appropriate, have the document approved by the appropriate signatures. If the Design Change Request form is approved, return to R&D or Engineering for retention and maintenance.
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