Does a CDR (Critical Design Review) have to have a moderator that is unconnected to the team?

Mandy

Involved In Discussions
#1
Does a CDR (Critical Design Review) have to have a moderator that is unconnected to the team?
A colleague and I disagree on this: She claims that it is a regulatory requirement to have a moderator from a different group, or with a function unconnected to the project.
 
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Jean_B

Trusted Information Resource
#2
Does a CDR (Critical Design Review) have to have a moderator that is unconnected to the team?
A colleague and I disagree on this: She claims that it is a regulatory requirement to have a moderator from a different group, or with a function unconnected to the project.
While you do not specify industry (and the prefix critical is not common in my experience), within the Medical Devices Industry, for products intended for the USA market, the regulations specify
USA 21 CFR 820.30(e) ; QSR said:
(e) Design review. 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).
So while the role is not prescribe to be that of moderator, it must include an individual who is independent of the design stage being reviewed.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
From this old document, available online:

Independence. The formal design review should include at least one individual who does not have direct responsibility for the design stage under review. In a small company, complete independence is very difficult to obtain. Within the context of formal design reviews, the practical solution is simply to ensure a fresh perspective, based on the principle that those who are too close to the design may overlook design errors. Thus, reviewers will often be from the same organization as the developers, but they should not have been significantly involved in the activities under review.
 
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