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Planning for the Unpredictability of Change

Design Changes

Changes to a design element are controlled by having each manufacturer establish and maintain procedures for identification, documentation, validation or, where appropriate, verification. The review and approval of design changes before their implementation into the manufacturing phase is a cross-functional phenomenon involving the players that will be affected by the change.


That makes sense. Most of the details of the change control system are left to the manufacturer to develop, document and implement.


After design activities are put into motion and the physical design evolves into an accepted entity, subsequent changes to the device specifications are commonly proposed, evaluated, reviewed, summarily approved and documented as such. The addition and revision of these design inputs in relationship to defined and anticipated outputs will affect the current design requirements in accordance with the procedures for design control, design change control and document control. These changes could affect ongoing choices that have to be made concerning the proper essential requirements and, ultimately, the validated confirmation of intended use supported by a safe and efficacious product.


The impact of making changes becomes a critical path destined to amble into manufacturing where, again, changes can be realized during and after production and distribution. The puzzle starts coming together—until you can’t find the reason why a puzzle piece is missing. Something could have changed.


As the design activity progresses toward the final stage, it is expected that the degree of change control will increase. A design change control procedure should at least address under what conditions change control is required, documenting the reason for the change, any differences in the change control process when outside parties are involved, analysis of the design to identify other elements that are impacted by the change, and, for significant changes (including any change requiring verification and/or validation), placing the reason for the change in the design history file along with the required design verification, validation and review documentation.


Post-production changes to the design can emanate from complaints, corrective actions, preventive actions, medical device reporting, non-conforming product trends, customer feedback, service reports, adverse event trends, etc. Failure can be one instigator of change, especially if you are determined to succeed. These changes are serendipitous in nature, should be based upon trends rather than aberrant results and, for the most part, are fairly unpredictable. Clues to possible design changes can be initially realized during the early stages of hazard determination and risk analysis.


There is a fine line drawn between robustly-presented design outputs and outputs that have their origins cradled between mitigated intent and failure. All of these types of changes should be presented to and filtered through a cross-functional group of people such as a Quality Review Board to make decisions as to scope, risk and ultimately, disposition. The ramifications of design changes, post-production, in comparison to design changes made during the actual design process are far different in scope and in documented intensity. Re-initializing a product into the design process can mean a regulatory resubmission (e.g., a 510(k)), the revalidation of both product (for example, a clinical study) and process, etc.



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