Defining Approvals Required for Design Control Documents

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C Jones

Associates,
I'm generating templates for design controls per ISO 13485:2016 and FDA 820.30, but am struggling to find any guidance on approvals necessary for different document types.

I know there's some flexibility in who the organization identifies as required signatories on documents per their defined colleague's responsibilities, but does the Agency expect specific representation on DHF documents?

For example, my HFE/UE should probably have a medical/clinical approver, and my pFMEA should have a manufacturing lead, but each likely doesn't require signing off on the other document. Is a QC and regulatory lead required for all design control documents? Author? Project lead? Senior director?

For what it's worth, we're a 3 person startup wearing a lot of hats.

Thank you in advance-
 

yodon

Leader
Super Moderator
Regs / standards don't prescribe who has to sign what. It's up to you; do what makes sense.

Do note that if changes are required, per 13485: "changes to documents are reviewed and approved either by the original approving function or another designated function that has access to pertinent background information upon which to base its decisions." (and there's something quite similar in 820).

I recommend that the document types be enumerated in the Design & Development Plan and the requirements for review and approval be listed there. Takes away any guess-work.
 
C

C Jones

Yodon, thank you for the timely response. It was precisely in drafting a DDP template that I noticed this gap in my understanding. Thank you for the confirmation.

In your experience, is it generally advisable to maintain a consistent approval list across all documents in a given DHF because of the 13485 context you cited and the linkages between documents -- and their impact as such.
 

yodon

Leader
Super Moderator
Not the same approvers for each document in the DHF, necessarily. For example, the Design and Development Plan typically has more approvers since it has the most stakeholders. The Risk Management Plan (and Report) pulls in someone from top management since they're signing up for the company on residual risk. Domain-specific documents (e.g., software architecture) generally are limited to the domain experts. I generally prefer to have quality sign off on most docs since they act as compliance monitor (in my situations) and have a quality eye.

It really depends on the situation. Small companies, like yours generally have fewer approvers and large companies seem to prefer to have more.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Auditors might as you how you deliberate which dept is impacted. It isn't important how you do it just that you do it. So we have an "impacted dept" checklist on our ECO request form for evidence.
 
S

snoopy2017

I have worked in very small startups. Sometimes the author may be the approver (e.g. the quality manager is the author of many documents but the quality manager also signs off on all the QMS documents), but at least get a second pair of eyes, e.g. another decision-maker. Hope it helps.
 

John Predmore

Trusted Information Resource
For what it's worth, we're a 3 person startup wearing a lot of hats.

You should identify document signers as roles for adequate design control, rather than individuals. As your management team grows or you have turnover, you will make fewer revisions to your forms.

Examples of a RACI chart (Responsibility assignment matrix - Wikipedia) may help identify different levels of responsibility/accountability/consultation/involvement, for projects of varying magnitude or complexity.
 
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