Independent Reviewer - Design Controls

[Ajit Basrur]

A quick question: I would love to hear from you on whom have you identified as an independent reviewer for Design Controls?

 

[shimonv]

hi Ajit,
Independent review is a noble thought but in reality it doesn't work very useful.
I have seen cases where the CFO, external consultant, or someone from another R&D project served as an independent reviewer.

Shimon

 

[yodon]

We frequently use members from the test team / quality.

Agree with @shimonv that the idea is more "academically inclined." I feel though, that our folks do add value to the review.

 

[Carol2015]

Ajit, at my tiny (9 people) my company, I'm using someone in Operations. Taken straight from the 21 CFR 820 horse's mouth:
"
(820.30(e)):

“Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).”

Since Operations has no direct responsibility for the design under review, the individual in this department makes a perfect candidate. In the larger scheme of things, anyone within your organization with no involvement in the design could fill in the 'independent reviewer' role. That's my two-cents!

 

[Ampein]

The purpose is to have another subject-matter-expert, who is not involved in the design development, to look at the design being completed to assess the correctness and without errors.

Depending on the complexity of design and size of company, the reviewer is assigned.