Project Planning Approval Board Approval signatures - FDA regulated medical device

[danpa]

I was wondering what Cove'ers opinions were on this:

If I define in my process that a Project Planning Approval Board makes planning decisions. I have been told that I need to either have the Project Planning Approval Board members each approve the minutes OR formally document a means of capturing the group approval, meaning I need to define quorum authority for the group in the procedure and I must formally identified the person by both position and name in the procedure who can sign.

I thought the approval authority was with the board and not the person taking the minutes. My plan was to have one member of the board take minutes of the decisions and sign-off on those minutes saying that the minutes accurately represent the board's approval of the planning decisions.

This is for an FDA regulated medical device.

 

[MIREGMGR]

Re: Approval signatures

My understanding is that it's the company that has responsibilities. It's up to the company how it defines its operations, including decision processes. As long as your process is defined, consistent and objective and its operation is appropriately documented, it's OK.

I would think that would mean that if the process is based on group consensus i.e. the finally adopted decision has everyone's approval, you need a mechanism to document that everyone did approve. If the process is based on majority vote or some similar approach, you need a mechanism to document the number of favorable votes that the decision received. If minutes are used as a formal record, you need to hold off on implementation of decisions until the subsequent meeting has passed so that the minutes containing the decision are formally accepted without objection.

My employer uses a consensus approach for those decisions that are group-made and are regulatorily significant. For instance, approvals of substantive product or process changes (as procedurally defined) require signatures from six department heads, senior management, and the initiator. Normal changes happen in a once-weekly meeting; hot changes get walked around by the Change Coordinator, and get approved in half an hour.

Product risk analyses require three signatures, including a VP.

We use a "minutes of the meeting" approach for a lot of intermediate-process actions, but not for anything that is regulatorily (i.e. legally) significant and is defined as a group decision...mostly because we want to move faster than a minutes-of-the-meeting approach supports.