Iso 9001 Management Review Meeting Presentation Techniques
Lovisa Zahra
How efficient are your management reviews? Could improvements be made? It might be time to reevaluate and reconfigure your system processes to eliminate burdens and extract utmost value from these critical checkpoints while still satisfying compliance needs.
Jon Speer: Man, I just had a great time catching up with Taylor Brown, senior medical device guru on the customer success team at Greenlight Guru. She is a quality system nerd, folks. And I mean that with the highest of compliments. On this episode, we talked about management review. I mean, that was bananas. Who has that much fun talking about management review? Well, Taylor loves it. I had a great time. So, I hope you enjoy this episode of the Global Medical Device Podcast. Hello and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer, and joining me today is senior medical device guru from the customer success team at Greenlight Guru Taylor Brown. Taylor, welcome back.
Jon Speer: Absolutely. And we were just catching up a little bit beforehand, so and that fan it's going to come to a stop. I think so bear with us. We'll get there. You have a wealth of knowledge on a lot of things, or many things quality system related. And I reached out to you the other day like, "Hey, can we talk about management review?" And at first I'm like, "Is there a lot to talk about there?" And then the more I thought about I'm like, "Oh, yeah, nobody gets this right." So, yeah, let's dive in. So you just like started to share a little bit of a story, do mind being a little vulnerable for a moment and sharing one of your stories? You can say no.
Taylor Brown: Learn from my experience, dear listeners, heed this warning. So, I was sharing with Jon in my previous position, I was in medical device distribution and I was a quality engineer. And for whatever reason, I got put in charge of management review and I was so excited. This was going to be the world's best management review. We were going to set records with how good this presentation was, it was going to be bananas. But so I worked really hard and put these slides together, got my meeting minutes. I worked with an analytics team to pull charts and graphs and everything. Managements flying in, just the site, like lunch is on the way this is going to be awesome. And we put through, it was crazy like a four hour management review. I'm not even really sure what we talked about, but I came out of that meeting just, I was walking on air. It went so well, and we made really great decisions, cut to a couple of months later, looking at management review and our notified body audit for ISO 13485 and the auditor looking, and she asks for the slides and the meeting minutes. And she goes, "Where did you talk about your complaints?" We didn't really talk about complaints. We talked about how like nonconformances are doing, and customer surveys that we've put out, but no, there's really no complaint dated. She's like, "How are you supposed to report to management review the health of your customers and their happiness with the product and regulatory reporting if you're not talking about complaints?" I'm like, "Oh, man. Yeah, you're right." I really shouldn't have spent those 30 slides talking about like audit etiquette and the body audit we had coming up. I should have just gone through the standard and done what the standard told me to do. I went above and beyond as I tend to do, but it kind of bit me this time.
Jon Speer: So, I guess for those listening let's remind them where they can learn more about what are the must haves in a management review. And I think there are two sources here that are probably the most relevant. Certainly it's pretty well defined in 1345. I think it's also decently defined and FDA 820. So, do you mind reminding folks, these are the "thou shalts" from a management review perspective.
Taylor Brown: Right. And you're correct. The FR, and then also ISO 13485. I think ISO has, honestly, more of a checklist type of view. So it says your inputs they're in section 5. 6. 2, I have it up in front of me. I don't have it memorized. It's feedback, complaints, reporting, audit, all of that. So, the standard is pretty general on how often you should be doing management reviews. I think it says planned intervals, which, I mean, you could take once a month, you could take once every five years, I'd say industry standard is once a year. However, once a year that's every 12 months a lot could happen in 12 months. So I think here at Greenlight, we really recommend doing it twice a year, especially in the early parts of your business.
Jon Speer: Yeah. And from an FDA perspective, I think this is one of the areas. There are a lot of areas between 820, and 1345 where they're very much in sync. And I think there's a lot of similarities, or there's nothing that's an ISO that is not an FDA and vice versa. I think the FDA requirement, if I recall, and it's been a minute or two since I've read this, but I believe the expectation is that it's done at least annually. So, but to your point, the periodic, I think I've had quite a few experiences with management review and I've seen them done annually by a company, because that was the minimum criteria. And I've also seen companies that they just go through a checklist and I'm like, "Hmm, this isn't really getting it. I'm not..." This is just one of those moments. I think unfortunately, a lot of companies, they treat it as that checkbox while we got to do it, so schedule it in September or whatever. And we'll go through a little checklist and be done with it.
Taylor Brown: December 21st management review. I was going to say what are you talking about on December 21st? Like no one is mentally in the office at that point, I think internal audit and management review. Those are the two things that I bring up when I hear a company is going... Their stage one or stage two audit is coming up. I say, "Have you done your internal audit? Have you done your management review?" And I group both of those activities together, because it is a snapshot in time of the overall picture of the health of your QMS, right? Management review then is a bit different because management review is really a platform to escalate issues. If your director of quality is sitting in the management review, this is not their first time looking at the CAPA system. This is not their first time looking at it.
Jon Speer: Yeah. Let's maybe talk about some best practices or things that make the management review more effective. To your point, I think it is one of those forgotten activities, strangely, that right there with internal audits and I've seen it happen so many times. A company's like, "Oh, crap, it's December. We haven't done our management review yet this year." Got to squeeze that in. And then you get into the holidays and the end of the year and all that sort of thing. And it's like, it becomes a challenge which pulling off a management review last minute is a lot easier than trying to pull off all of your internal audits last minute, but we've talked about that, I think, before, and we can certainly talk about that in a different episode. But so you're saying at a minimum two times a year?
Taylor Brown: A minimum of two times a year. Yeah. And a lot of companies will say, "Let's do it monthly," Don't mistake, a management meeting for a management review. You can meet with management as much as you want, please by all means set up a meeting every Monday morning with management, but a management review, per ISO 13485 per the CFR has a very specific set of requirements. So, that's my first step is to create a meeting minute template that consists of those requirements. So, and you'll never hear us say it's a checkbox activity, but the agenda is kind of a check box activity. It's more of a list of things you need to talk about. There's a lot of conversation there, but don't be me and not talk about complaints because you didn't include it on the agenda.
Jon Speer: Yeah, so the agenda is cookie cutter, as far as the topics. Now, for example, you're going to talk about complaints. You're going to talk about CAPAs and nonconformances et cetera, et cetera, but within each of those topics that is not cookie cutter because you're going to talk about the new business from the last time that you had a management review to this time and make sure you're holistic and comprehensive regarding to that.
Taylor Brown: Exactly. And I think you talk about what your KPIs are, your key performance indicators, but also talking about what the goal is. I think sometimes companies say here's our CAPA closure data, and it's just this big bar chart. But what's your goal? What are you comparing that information to? Are you taking too long? Are you doing a great job of closing CAPA's? So typically it's in your analysis of data SOP, or your quality objectives to see what goals are you meeting, and that's really your threshold for analytics in your management review.
Jon Speer: You saying that reminded me, I'm pouring another cup of coffee, but you saying that reminded me of the time I got dinged an ISO audit. In ISO speak one of the key parts of management review, and frankly the health of your quality system is defining your quality objectives. And I got dinged because I don't remember specifically what the verbiage was, but they were like warm, fuzzy, ambiguous quality objectives. Like we need a good quality system, but we didn't put in any like KPIs or metrics to that. And so I encouraged those management representatives and heads of quality out there, evaluate your quality objectives and make sure that they are stated in such a way that they're measurable define those KPIs. I mean, there's a methodology that we use internally at Greenlight from time to time called OKR. So that's a way. O stands for objectives, KR, key result. But there's lots of other ways to do that too, but just make sure that you have criteria defined for specific key processes. And I think with that though, I think I see a lot of people make mistakes on the KPIs. Like you mentioned CAPA like they'll say close the CAPA in 30 days. And that's not really a great KPI.
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