Addressing Nonconformance in Design Review Documentation for Early-Stage Product Development for 13485

[Sowmya G]

Hi,

I have been tasked with resolving a nonconformance—"the design review process was not fully effective because reviews conducted during product development were not documented in a controlled QMS location, and the design review records were retained informally and lacked traceability"

This design review and changes occurred during the early phases of product development (it's a product from a PhD project).

How to justify the nonconformance for lack of documentation and how to incorporate the old changes into the device history record now.

Any suggestions would be greatly appreciated.

 

[Tidge]

Do you have an established process for design reviews? If not: establish some. Do a gap assessment of the work that was done against the newly established process, and close the gaps... most straightforwardly will be to follow the new (or current, if compliant) process.

 

[Sowmya G]

Do you have an established process for design reviews? If not: establish some. Do a gap assessment of the work that was done against the newly established process, and close the gaps... most straightforwardly will be to follow the new (or current, if compliant) process.

Process was established recently and no design review meetings were conducted after process implementation so the auditor asked to retrieve the old review meetings but unfortunately those were done informally and there are no records to it. So What would be the best action point for informal records retrieval

 

[Sidney Vianna]

I am surprised this issue has not been discussed during a stage 1 audit, where no nonconformities are issued but the readiness aspect for a stage 2 certification audit is assessed.

Is this the case of a small organization with only a single medical device being offered?

 

[ChrisM]

Let me see if I have got this right:
"Process was established recently and no design review meetings were conducted after process implementation "
So when the product went through the design process, there was no requirement for formal, documented design reviews. By the time your system was updated to include this requirement, the product was at a stage where no further design reviews were required.
So there cannot be a NCR against this product, but against the QMS for not having a formal design review process in place when it needed one to meet whatever Standard you were operating to at that time. You will need to look at all relevant products and determine what needs to be done - and when I say "you", I mean the responsible people in your organization. it may be that photocopying pages of people's project books, scanning them into an electronic record system (if you have one) etc is what is required, so that as much evidence as can be retrospectively obtained as possible is collated and filed - then reviewed to determine if any additional work/testing is required to address any identified gaps. This should also be documented in the DHR.

 

[Jean_B]

Not wholly irrelevant. What are the region(s) and classification(s) of the device in each market? The extent and detail of design controls is managed by interaction with those aspects.

Second to that, what is the stage of the company? Are you a start-up in research, design prototyping, development, or already have finished devices (even if not cleared for market access); or perhaps you are already on market in one country and heading into a new one?

With that information in mind, seek out consultancy report appropriate to your market and device types (sterile, sw, etc.) or hire a Regulatory Affairs professional from the product field you are entering. If the RA person does not have area specific expertise hire appropriate coach(es)/support consultant(s) for them to overcome roadblocks more swiftly.

If you ended up in an audit where a body such as BSI could write NC's, and you use device history record (DHR) for questions that indicate a Design History File (DHF), and you established a process but did not do any design review before your audit, you lack management awareness of where your company's quality and regulatory competence should be at (both now, as back then) and appropriate resourcing and training. This likely started due to the very different nature of evidence needed in academia versus market access.
Sad to say, but this is not a minor gap to be addressed by separate topics on Elsmar. You need guidance which will require intimate knowledge - of product, company, and strategy - which you shouldn't share here.

 

[Enternationalist]

Informal records ain't records. Practically speaking, the ship has sailed - 13485 is a standard covering design and development, but it was not used for those design and development activities. Unequivocally, those activities weren't done under a 13485 system and were not fully effective.

Your problem isn't really how to get old records, it's how to bring this development into a 13485 system.

The most honest way of dealing with this would be to establish a quality plan that forces the product, at this stage, through all the necessary points of review and oversight, and record the lot of it. Pretend someone handed you a pile of garbage and that you need to do your due diligence checking everything - it wasn't under a 13485 system and now it has to be.