Best Practice for Documenting Design Reviews

[scnaugle]

Is it acceptable to combine some design phase review meetings (specification & verification) for medical devices?

 

[scnaugle]

Thank you!
My question is more specific. I have been trying to convince our design group to not combine multiple design phase reviews meetings at the same time. We use 8 phases in our product life cycle process;

Requirements, specifications, design, verification, validation, design transfer and obsolescense.

In some cases they have combined the requirement & specification or validation & design transfer phase review meeting at the same time. We document the phases seperatly but have performed the phase review meeting on the same day. Recently an auditor commented that this is not a good practice.

What's your take on this?

 

[Colin]

I don't know medical devices but ISO 9001 clause 7.3 has a note after clause 7.3.1 which states that 'Design and development review, verification and validation have distinct purposes. They can be conducted separately or in any combination, as suitable for the product and the organisation'.

So according to ISO 9001 - yes they can combine them.

 

[Ronen E]

It depends on the circumstances. For instance, in borderline cases, where the design validation outcomes are not so conclusive, I would have recommended a separate design validation review, to allow a thorough consideration of whether to move forward to design transfer, to repeat the validation with required adjustments, to redo the design, to update the requirements specification or otherwise. A separate design transfer review could later follow, for ensuring that the design was appropriately transferred and regular production is ready to commence.

Combining reviews along the design control flow is like stating that all but the last phase combined do not have critical exit gates. Otherwise the risk of redoing a phase is too big IMO.

Cheers,
Ronen.