Design Control Guidance - Food and Drug Administration

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Historically, shortcomings in the production specifications tend to be manifested late in theproduct life cycle. When the design is new, there is often intensive interaction between thedesign and production teams, providing ample opportunity for undocumented informationflow. Later, as production experience is gained, some decoupling often occurs betweendesign and production teams. In addition, key personnel may leave, and their replacementsmay lack comparable training, experience, or institutional knowledge.Particular care should be taken when the product involves new and unprovedmanufacturing processes, or established processes which are new to the manufacturer. Itmay not be possible to determine the adequacy of full-scale manufacturing on the basis ofsuccessfully building prototypes or models in a laboratory and testing these prototypes ormodels. The engineering feasibility and production feasibility may be different because theequipment, tools, personnel, operating procedures, supervision and motivation could bedifferent when a manufacturer scales up for routine production.No design team can anticipate all factors bearing on the success of the design, butprocedures for design transfer should address at least the following basic elements.• First, the design and development procedures should include a qualitativeassessment of the completeness and adequacy of the production specifications.• Second, the procedures should ensure that all documents and articles whichconstitute the production specifications are reviewed and approved.• Third, the procedures should ensure that only approved specifications are used tomanufacture production devices.The first item in the preceding list may be addressed during design transfer. The secondand third elements are among the basic principles of document control and configurationmanagement. As long as the production specifications are traditional paper documents,there is ample information available to guide manufacturers in implementing suitableprocedures. When the production specifications include non-traditional means, flexibilityand creativity may be needed to achieve comparable rigor.Section H. Design Transfer 3/11/97 Page 38
SECTION I. DESIGN CHANGESI. REQUIREMENTS§ 820.30(i) Design changes.• Each manufacturer shall establish and maintain procedures for the identification,documentation, validation or where appropriate verification, review, and approvalof design changes before their implementation.Cross-reference to ISO 9001:1994 and ISO/DIS 13485 section 4.4.9 Design changes.II. DISCUSSION AND POINTS TO CONSIDERThere are two principal administrative elements involved in controlling design changes:• Document control—enumeration of design documents, and tracking their statusand revision history. Throughout this section, the term “document” is used in aninclusive sense to mean all design documents, drawings, and other items of designinput or output which characterize the design or some aspect of it.• Change control—enumeration of deficiencies and corrective actions arising fromverification and review of the design, and tracking their resolution prior to designtransfer.For a small development project, an adequate process for managing change involves littlemore than documenting the design change, performing appropriate verification andvalidation, and keeping records of reviews. The main objectives are ensuring that:• corrective actions are tracked to completion;• changes are implemented in such a manner that the original problem is resolvedand no new problems are created; or if new problems are created, they are alsotracked to resolution; and• design documentation is updated to accurately reflect the revised design.For projects involving more than two persons, coordination and communication of designchanges become vitally important. In other words, manufacturers should take steps toavoid the common situation where, for example, Jon and Marie agree to a make a changebut neglect to inform Pat of their decision.Medical device manufacturers are usually quite comfortable with the processes ofdocument control and change control with respect to managing manufacturing documents.The principles of these processes are reviewed in the following paragraphs. Subsequently,we will explore how these may be applied to design activities.Section I. Design Changes 3/11/97 Page 39
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Design Control Guidance - Food and Drug Administration

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