Design Input - 820.30(c) - Addressing incomplete, ambiguous... requirements

M

Monica Lewis

According to 820.30(c). The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements.

If one would write in the SOP that incomplete,ambiguous or conflicting requirements are resolved with those responsible for imposing these requirements would this satisfy an FDA inspector
 
D

Don Winton

Monica,

If one would write in the SOP that incomplete, ambiguous or conflicting requirements are resolved with those responsible for imposing these requirements would this satisfy an FDA inspector

I would think so, but you should also consider the following in drafting your SOP.

From the FDA's Small Entity Compliance Guide:

The QS regulation requires that the input procedures shall address incomplete, ambiguous or conflicting requirements. Every reasonable effort should be made to collect all of the requirements from which designers can generate detailed design specifications that are clear, correct and complete.

Using the above, the FDA included the following guideline and question (among others) for FDA inspectors to follow in regards to § 820.30(c).

Question 3. Review the process for resolving incomplete, ambiguous, or conflicting requirements. For the design reviewed, determine whether any incomplete, ambiguous, or conflicting requirements were not resolved per the manufacturer's procedures.

See http://www.fda.gov (**Link Was /ora/inspect_ref/qsreg/dcrpgd.html**) - for additional information.

From these two references, be certain that your SOP includes record maintenance methodology when resolving incomplete, ambiguous or conflicting requirements.

For consideration:

Incomplete, ambiguous or conflicting requirements are resolved with parties responsible for imposing these requirements and records are maintained in accordance with §820.30(j).

Regards,
Don
 
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