Medical device startup and culture of quality

[snoopy2017]

Hi everyone,

What is the best way to promote a culture of quality at a small startup medical device company? The company is getting device approvals and passing audits but at the expense of regulatory and quality department. Over the years, the regulatory/quality department has been responsible and competent. However top management does not treat the company like it's in a regulated industry, leading to turnovers in the regulatory/quality department. This is the third RA/QA team in 3 years. They push through changes without going through change control or push through quality documents without going through QMS; using suppliers without evaluating them first as well as making design changes without going through approvals. And it's the regulatory and quality who then take responsibility for these actions and answer to these issues during an audit. Can somebody provide advice as to how we can fix these issues at the small startup company? How do we drill into top management that once a product is approved, there is a host of issues they need to deal with? For example, process validation, good record keeping and documentation of changes to the devices? The employees are constantly under pressure to meet deadlines, and there is always tension between management and Regulatory and Quality. How can we make them understand it's a regulated industry? Thank you.

 

[William55401]

Influence and education is the key. Quality and Regulatory professionals must be patient and capable influencers to explain (not lecture) WHY we must do certain things. Telling someone we do it "because it is a regulatory requirement" is not a recipe for success. Get their attention by finding a relevant Warning Letter (FDA share's these) related to your item of interest. This is the Fear approach. Is your company doing the same thing that the FDA is enforcing per the WL? Maybe that will get their attention. Hope is another way to message. The things we do from a QMS perspective help us to run the business better. We need to be compliant to the regs not because it's required but because it makes good business sense. Let's validate processes so that we don't have issues post launch. Let's solve problems using a good CAPA process so that we fix issues permanently. Messaging is key. To be a successful quality professional, you need to pick your moments to influence and engage your peers. How you message matters!

 

[Edward Reesor]

I have also used FDA recalls based on poor regulatory practices as examples for staff education. There are a few of those out there as well.

 

[Mark Meer]

...They push through changes without going through change control or push through quality documents without going through QMS; using suppliers without evaluating them first as well as making design changes without going through approvals. And it's the regulatory and quality who then take responsibility for these actions and answer to these issues during an audit...

I agree with advice given thus far.

But curious: these are pretty glaring issues. Do these not get identified in your ISO surveillance/re-certification audits, or in internal audits? If so, does management not see how proceeding this way may put your certification (and, presumably, market access) in jeopardy? Not to mention the cost involved in dealing with such issues that could have been avoided in the first place?

 

[sagai]

All great advices so far.

Reading all of this, first impression was that what else would we expect from top management other than to line up a QA/RA team, let them work independently and to give them all necessary authority without any distruption to accomplish there key goal to pass audits and product approvals. And QA/RA team does help to pass audits and to get product approvals.

So, all looks okay.

I am hoping that you do not get it wrong, sounds all these like that the QA/RA team is an accomplice of the management team in this sense.
It behaves as expected and gets the role model that is expected and had been seen so far by the management team.

I would be more on to somehow enhance the level of involvment of the management for decisions that they should take or that they also should be aware of.
It sounds like a small incremental process, due to the face that their recollection of how thing should work evolved a wee differently over that last three years.
Vast majority of the regulatory requirements are based on business benefits too, those benefits however not really elaborated in written form. I would think of to package regulatory requirments into business benefits for the management to make it more palatable for them.

Hope this may help.
Cheers