What is Your Biggest Compliance Frustration?
What is your biggest compliance frustration? This is the question I recently asked on LinkedIn. I posted it on my own LinkedIn profile and in a number of groups of which I am a member. I didn’t get as many responses as I expected (and some I only received privately) but I promised to share the ones I received and that’s exactly what I’m going to do here. My hope is that we can all learn something from each other and work to reduce or eliminate those frustrations that cause us stress and a lot of wasted time.
Ok, I’d like to start with the shortest response I received. “Meaningless activities …” Yes, I agree. We all hate to spend our time on meaningless activities that are a waste of time. So, let’s see if we can use a simple quality tool to extract more from this comment and, hypothetically of course, be able to narrow it down to something we can work on and measure. Let’s try the “5 Why’s” for this exercise. The first question we need to ask is “Why are you working on meaningless activities?” Let’s suppose the answer is, “because my management team is reactive and often creates work that doesn’t make sense for the long term.” Ok, so “why do you think your management team is reactive?” Maybe the answer is, “because they are overwhelmed with the number of CAPAs and just want them closed quickly.” Ok, now we’re getting somewhere. “Why are there so many open CAPAs?” “Because the company opens a CAPA for every single issue that arises and now there are so many that it has become a checklist activity rather than a value-added process that leads to improvements.” Ah, so “why do you think the company has that policy?” “It is the result of past audits that revealed CAPA’s were not being opened appropriately for issues.” And “Why were CAPAs not being opened when they needed to be?” “Because there is not enough expertise and understanding of the different Quality System elements and how they work together. So, management is constantly reacting to different feedback given in audits instead of taking the time to get educated on the real requirements. Ah-ha! We’ve reached the 5th “Why” in our hypothetical situation and we have a real problem that we can solve to help the organization stop working in reactive mode which will help reduce or possibly eliminate some of the meaningless stuff I have to do. Which of course, means less stress for my life! Now, in our hypothetical situation, what’s next? Armed with this information, I can now go spend productive time looking for ways to educate the management team in this area. I could create the training myself and get support for implementing it for management. I could reach out to a consulting expert to do the training for the organization. Or maybe, we have someone else in the company that I can partner with to help me create and deliver the training. So, here’s a challenge, perform a little “5-Why” experiment with yourself and see if you can narrow this down to something that is actionable and adds value to the organization. By doing this, you’ll likely reduce your own personal stress and frustration. I hope this helps!
The next two responses were, (a) “Personnel not following procedures and Management not understanding medical device requirements” and (b) “My biggest frustration is with companies whose managers approach this topic from a purely reactive viewpoint. Or even worse, who see this as some kind of paperwork exercise.” Yeah, those are big ones for me too and for those of us who know the value we bring to the organization, it can be frustrating when that perceived value isn’t shared by our management, peers, and/or subordinates. The first part of (a) might be a good one to use those famous “5 Whys” again. The issue with Management not understanding medical device requirements is a common one and extremely frustrating. Intuitively, we know the answer … educate them! But that’s not the problem. The real problem is getting enough buy-in and financial support for the education program and then making sure management attends and learns. For the leadership and accountability piece, I would recommend checking out Partners in Leadership. Roger Connors, Tom Smith, and their team do an incredible job working with executive and mid-level leadership teams to help build a culture of accountability. Then, you may have a shot at bringing in the education they need to execute their duties responsibility. Hope this gives you some ideas!
This next and last one that I didn’t think of right away but one that I’ve definitely experienced. Here it is, “Incorrect EU Notified Body audit reports and due to the NB’s status, manufacturers accept their judgement as being correct. In many cases it is incorrect; causing no end of problems, increasing cost and reducing quality.” There was some ongoing discussion on this one with regard to inconsistency in interpretation or variation or maybe a little of both. Having worked in the Medical Device Industry a long time prior to working as a consultant, I’ve been on the receiving end of these kinds of Notified Body audit findings before and it always feels icky to me. Now, I must pause to apologize to all the purists out there for using such a vernacular term that, quite possibly, isn’t even a real word in the English language. But admit it, you all know exactly what I mean when I say “icky.” You know, that creepy feeling you get when someone with presumed authority is handing down a verdict as if it’s law when it really just smacks of arrogance and self-promotion? I’m a consultant and I get it. We all need to promote ourselves to stay in business but the NB giants (and you know who I’m talking about) are far from struggling and, even if they were, it doesn’t give them the right to use their power to promote consulting services on the side. Does anyone else see this as a conflict of interest like I do? If so, please let me know in the comments below. This may not be the case in the example given by the person responding to the question but I think it’s worth exploring for a couple of sentences. Here’s an example from my consulting practice. Clients often call us in to help with remediation efforts following some type of regulatory action (483, warning letter, consent decree, etc.). Then, because they don’t fully understand the conflict, they also ask us to perform a post-implementation audit. Most of you reading this post can immediately see the problem. We cannot audit our own work. So, we advise them to bring in another group to handle the audit even though that means lost revenue for us. It is the right and ethical thing to do. So, now I ask you why Notified Bodies should be any different from MBCA? I have heard horror stories from my clients about NB findings that are nothing more than thinly disguised promotion of their own consulting services. To be fair to all the NB’s out there … not all of them engage in this kind of self-promotion but it happens enough that it worth mentioning. Ok, so back to the response … there may be a little of all three going on (variation, interpretation, self-promotion) but the key for me is to remember that they are all “For Profit” organizations. You pay them. I’ve found that if you are confident in your level of compliance and can explain why the finding is erroneous, you will win the day. All this takes is an escalation of the issue, which gives you a forum to present your case and puts them in a defense position. If all they can come up with is, “that’s not what we prefer our clients to do.” Then, call them on it. Any decent auditor will tell you that your processes must be compliant with the requirements and that’s it. It doesn’t matter if you do it differently than what the auditor would recommend. If you are compliant, the discussion is over.
Thank you all for taking the time to respond. I plan to do more of these questions on LinkedIn to hopefully spawn some beneficial discussions. If you have further feedback and would like to see more of this, please let me know below by leaving a comment.