Medtech Snapshot - Debate: New Job Compliance Shortfalls in Medical Device

Medtech Snapshot returns with an enticing debate as RAQA MedTech industry experts Stephanie Rallis-Daw, RAC, CQE, CMDA and Robert Lahaderne, MBA spar on the topic of "When starting a new job/ project, what is the most common MedTech compliance shortfall you can expect to encounter at your new company?"

Transcript:

Travis:
Welcome back to another MedTech Snapshot. Today we're doing something a little different. So we have two colleagues of mine, 2 good friends. We're here to have a little bit of a debate on a recent poll that came out online where we were talking about and we've all been there.  

You've entered a new environment, a new workspace and you're coming in as the RAQA person and you immediately see issues within the company. As the poll had kind of covered, there were some interesting discussions on areas where those issues might come up, everything from training to documentation.  

And two folks joining me today, we have Stephanie Rollis Doll and we also have Robert Laudern, both experts in the field. I'm curious to hear from both of you today on your position as it relates to what are the most common issues we're going to come across where compliance is deficient in an organization.  

So Steph, we're going to let you go first. We'll give you 45 seconds and I'm looking forward to hearing your perspective on it.  
Stephanie: 
Thank you, Travis. 
So the reason behind my choice of inadequate documentation over deficient training as the biggest compliance issue when starting a new company is you first need strong standardized documentation in order to allow for provision of appropriate training. Otherwise you can inadvertently create tribal knowledge to compensate for that procedure. The root cause of deficient training a lot of times leads back to the documentation being inadequate, missing a step, leaving too much to interpretation. 

And I feel in general, people want to do the right thing and do their work correctly. So without adequate documentation to guide them, mistakes are inevitable. Many times with people blaming the person rather than the process. And you've seen that from common root causes of operator error and inadequate training. 

I feel though, if you did just a touch deeper, you're going to find more times than not corrective action is going to require update to a procedure followed by training. To remedy this, the first thing I do when entering an organization is do thorough process and system audits to help identify any potential gaps. 

Travis: 
Strong response. Robert, give us your perspective. 

Robert: 
Yeah, I, I completely agree with Stephanie's point. And I think kind of at the end there, she started to see it from my point of view of deficient training. 

More often than not, especially for new hires, whether it's a consultant or a full time employee, what's happening is this person's being brought on board and it's, 'I want this person training to be just like Joe, just like James.' Well, there hasn't been much revision of training requirements or how things have changed in the organization. And in those instances, often people are starting out of the gate with a misconception of what their responsibilities are.  

In addition, in manufacturing environments, more often than not, they do a good job of both documentation and managing and training.  

But it's the ancillary of the design: the other team members that are outside of the manufacturing environment that have contributions to the state of quality with an organization that their training tends to get a little bit less well documented.  
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And you'll find that they're doing jobs. They're doing them right. But if you go and investigate, either it's not on their training matrix or they've never been properly trained to it. 

So I really, if you look at the survey that came out, it feels like we're arguing two sides of the same coin because where, where my argument stops, Stephanie's then comes along and, and, and compliments it. ​

And I think for what's fair is given the two arguments in your positions here, might also be a good idea when you're in that stage--whether it's an interview stage or you're discussing with a client--as a consultant to come in and provide support to ask these exact questions. That way when you step in on day one, you have a good perspective of what the system is like and how the employees are interacting with that system. That way you're not bogged down with kind of the sticker shock of walking into a system that perhaps is not operating. 

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