Organization and personnel problems with quality

Tintypographer

Registered
I think I'm in a difficult situation. I'm working for a small undercapitalized medical device company. They have a CE Mark and an approved product for the USA. Manufacturing is contract and their suppliers are all compliant. The company is very lean on employees. One of the scientific founders does not work for and is not paid by the employee. This person essentially received a payout and is now in academia and has shown strong disdain for not wanting to be involved. The intellectual property, manufacturing and a lot of the technical questions for their product is very complex and some of it was written in this founders lab notebooks. The quality team often reaches a point where the tech team has to state, "we have no idea you will have to call Dr X". But Dr. x has categorically started he will not be involved in quality or risk analysis work and will only answer technical questions as he has time. He is not employed by the firm and has stated that with the exception of intellectual property he will not be involved with the company.

Evidently my predecessor and he had a significant falling out over risk analysis where he as the VP of R&D was very frustrated and made an offhanded sarcastic comment of "what if the product spontaneously combust?" And the QA manager wrote this down as a risk out of spite and it resulted in Dr X having to write a justification for removing that risk from the product. That was the beginning of the dissociation of Dr X from the firm.

We are no where close to being able to answer some of the questions without his expertise but he has stated he will only provide it if he is not paid, is not required to sign any legal documents and is not required to comply with any training in order to do the consulting. One of the questions in an audit deals with a set of equations that he personally developed in physical chemistry for rates of moisture vapor transpiration to answer questions about adhesion of the product to wounds. He says he will provide the response but wants his name and responsibility completely left out of it.

Is there even a way to develop this type of response without an author or his involvement?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Sounds like a minor or major finding will be made. You could let the process work its way through and receive the audit report. Summarize the audit report to senior management and the CEO. Tell them what's at risk. Ask for support to prevent that "result" from occurring. The CEO has responsibility for the QMS per the FDA. They can delegate the work to you but they ultimately answer the FDA. ISO 13485 has a specific requirement that all resources for the support of the product and QMS shall be made available. Not having some person here isn't acceptable.

As QA lead if the roof sprung a leak or the servers crashed or employees were drinking on the job would you, as QA guy, be responsible? The failure here is not QMS or QA-related. This "sounds like" engineering resources are not properly managed. Not having a complete design history file sounds like an accident waiting to happen.

Sounds like a horrible place to work. I hope you are being super compensated for it.
 
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Tintypographer

Registered
The people are nice, the former founder is just no longer associated with the company and we keep having to defer to him to answer questions. The original marketing brochure states that the product remains in place without an adhesive backing and somehow it does that via capillary forces which we said but the review by our notified body of the literature wants clarification for that of what documentation shows that the adhesion occurs if there is no adhesivem. Dr X is a physical chemistry at a local university and his notebooks are meticulous but it is almost impossible for a non physicist or mathematician to derive all of that stuff he did. He doesn't work for the company, he is not under contract and is very careful to not be paid and not want to be associated with it. Some of these capas go back a ways and they wind up being less about the quality system and more about study reports which I can't create without expertise but this guy is some sort of expert on diffusion physics.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Do you keep a trace matrix tying input requirements to output documents? How does "Adhesion" get filled in there?
 
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