April 1, 2019
FDA & ISO DMR/MDF vs. “Design Output”
Remember that the DMR is intrinsically linked to the design control process. The DMR is by formal definition a design output (see my preceding blog post). It unequivocally lives and breathes in direct relationship to the design control process. A properly-maintained DMR never becomes decoupled from the design control process. Indeed, decoupling the DMR and the design control process is a certain recipe for an FDA 483.
As the product life-cycle evolves and DMR changes are needed, they by regulation are not allowed to happen apart from the design change requirements of the design control process. Even more eye-opening is that, if there is ever a change to design outputs (and thus the DMR), then it must always be paired with corresponding design verification and perhaps also design validation. Oftentimes, this in addition means there was a change in the underlying design inputs.
Another way to say all this is that if there is ever a change to the DMR, then it inherently means there was a “design change”. That is the reason FDA doesn’t permit us to maintain the DMR independent of the design control process. The associated use of a general (e.g., 21 CFR 820.40) document control process may create the impression that this is independent of 820.30 design controls; however, that is not the intent of the design control and DMR regulations.
For example, FDA has stated that “…Post-production design changes [which would include DMR changes] require the firm to loop back into the design controls of Section 820.30 of the regulation…[Emphasis added by ComplianceAcuity]. Similarly, FDA has also clarified that, “…The design change control section is linked to and is redundant with Section 820.70(b) Production and process changes of the regulation…” [though this particular citation focuses solely on the manufacturing section(s) of the DMR]. For additional insights about design changes and thus how the DMR must be maintained in direct correlation with design controls, check out my corresponding related blog post.