Beyond SOPs – What is quality?

Interview with Gary Sullivan

During my early years, I was overwhelmed by so many trainings, SOPs, and processes. Only after my later years I learned what quality is really about. Gary fundamentally helped me and many others have a very different and more insightful/helpful/easy perspective about this topic.

Listen and learn while we talk about the following points:

  • During your first years in the industry – how did you think about quality? What did it mean to you?
  • What are the key parts of quality today for you?
  • How does this understanding of quality differ from being compliant to SOPs?
  • Have you seen an example where a person was compliant to SOPs but didn’t deliver quality?
  • How can we increase quality as defined in this episode in our organization?

References:

Demmings book “Out of the crisis!”

The 14 points of Demming!

Gary Sullivan, PhD

Gary Sullivan, PhD

Gary is currently consults as a Leadership Specialist and Statistical Scientist for my company Espirer Consulting since March, 2018. Before this, he was the Senior Director for Non-Clinical Statistics at Eli Lilly and Company, where he worked for 28 years.  He also worked as a technical statistician in Non-Clinical Statistics for the first half of my career at Eli Lilly.

He led the development and instruction of the first leadership course at the Joint Statistical Meetings (JSM) of the American Statistical Association (ASA) in 2014..  He has provided leadership training to over 500 statisticians and data scientists, both at Eli Lilly and within the ASA. In addition, he has authored several articles and a book chapter on leadership for statisticians.

He holds a Bachelor’s degree in Statistics from the University of Pittsburgh, and both a Master’s and Doctorate in Statistics from Iowa State University. 

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Transcript:

Alexander: Welcome to your new episode. And today, I’m talking with Gary about a topic that comes up again and again in our discussions, as we talk about leadership and it surely relates to leadership and that is quality. So for those of you who don’t know Gary yet and hopefully this is not so many, If you are longtime listeners and you have heard Gary speaking about leadership, quite a lot of different episodes, maybe Gary, you can very shortly, introduce yourself. 

Gary: Yeah. Sure. It’s great to be here Alexander. Like I said, quality is a topic. It’s probably the second topic that’s near and dear to my heart behind leadership. But yeah, I’m a longtime statistician who has been sort of in the business for over 30 years. I worked at Eli Lilly and Company for over 28 years. I retired from there at the end of 2017 and at the end of my career, as many people know. I developed a passion for leadership. And so what I do now is I have a business and Alexander and I work together and we have a leadership program and I’ve been doing that for about three plus years and working with other companies and doing training. So my focus is leadership development. But I am a trained statistician and worked in the business. Like I said, half that time as technical statistician, and the back half in various management roles, but my second passion maybe is quality. It’s something that I’ve thought long and hard about for probably as long as I’ve thought about leadership. So I’m happy to be able to join you in and talk about this topic because I think it is really relevant and connected to leadership. And it’s something that every statistician in the Pharma Industry should pay attention to. 

Alexander: Yeah. Absolutely. So speaking about the industry, when you joined the industry in your first years, how did you think about quality and what it meant to you at that time? 

Gary: Well, it’s interesting. I have a funny story because I really didn’t think about quality, my first exposure to Quality. I remember it was probably the second or third year in my career and there were some people that have been in our group longer in our manufacturing group and they were kind of excited about quality for those who push for quality. I think Six Sigma was just sort of taking off. And I remember our group, our small group went to a half-day quality conference. And frankly I was just disinterested. I was just, I was bored. I was like, I’m a statistician. I just want to design experiments, I don’t work with Scientists. What is this quality thing? And so I remember, almost like falling asleep at this thing. It was just so disconnected in some ways. But that changed, actually, this kind of connects to how you can communicate at the Top. Because a few years after that, one of the statisticians in our group brought in a consultant to do some training in the manufacturing area, to the Operators and Technicians, and some of the Frontline people and Engineers on control charting and they were going to do about three pretty big seminars. So they asked some Statisticians to come in and help facilitate because they were going to teach them how to do control charting. And they were going to have classes of about 40-50 people. So they wanted Statisticians to help the Instructor go around and make sure they were doing things right. So I was like, yeah, sign me up for a nice review and stuff. But this guy is gone by the name of John McConnell and he was a disciple of W. Edwards Deming. I mean one of the fathers of true quality and he just had a really great way of communicating quality and he weaved it into the importance of creating change in your organization. He talked about quality management. He talked about leadership and then I started to see, Wow, this is really relevant because being a statistician just goes beyond doing the technical stuff. This is a quality thing, it really does touch everything and one of the things that he did he does a masterful job of doing Deming’s Red Bead Experiment, and I won’t go into what the Red Bead Experiment is. If you’re not familiar with it, there’s recordings of it online, but it’s an exercise that you think like, okay. This just applies to manufacturing, but it doesn’t and it really teaches you the importance of understanding variability. It really teaches you the importance of understanding the capability of your systems and processes and any system and process. I think the fallacy sometimes is when people hear quality or Deming’s quality, they are associated with manufacturing, but it can be applied much, much broader than that. And so, I started to read more. McConnell had some books that I read. I read Deming’s book out of the crisis, I got familiar with his 14 points and really came to this sort of understanding of quality or the essence of quality being that from the Deming standpoint that, you know, all work is a series of interconnected processes. All processes are subject to variability, and if you can work to understand and reduce variability, you will improve processes and improve productivity. So it’s kind of that simple and that word process again isn’t specific just to manufacturing. It’s any process and we can come back to that later. But that was kind of my kick start into quality into my interest in the mid late 90s. 

Alexander: And for those who don’t know who Deming is, he had a major impact on the Japanese automobile industry and I think it’s really funny that that person shaped the high-quality coming from Japan and got lots of U.S. companies actually into trouble. 

Gary: And for a couple decades, I think the U.S. took note because they were losing the automobile war to Japan. And then they started embracing some of those ideas as well back in the 80s. So that’s one quality that started coming back to the United States. 

Alexander: Yeah, and lots of things like Six Sigma and these types of things came from that era and we have then applied it beyond manufacturing, and lots of different things. If I think back of my time, I think when people were talking about quality, when I first came into the industry, I was always thinking about having the right results. And then I said, oh, yeah, it’s all you also need to have validated other things and said, oh, so validated means that we have a process of making sure it’s right. No! Validation just means that it’s checked in a certain way. It doesn’t mean that right, and then all these kinds of things about quality became more and more as “read, all these SOPs”, make sure you have ticked them, you have kind of signed them and that way we track that everybody is trained and since and that’s quality. And there was a kind of “Yeah quality. We need to get out. We have these deviations and all these kinds of things” and “Oh that is quality”. 

Okay, and then we have “Oh, there’s another process”. We need to be more kind of descriptive and more of kind of detailed in all the SOPs and then you get longer and longer SOPs. And there’s another case that wasn’t really captured in the SOP. So we create yet another SOP. Then you start a new job, and the first thing that you do is you read SOPs for weeks and weeks to be compliant with the recent requirement. So I think this whole quality topic is kind of you know, lots of people hate actually because it’s just associated with long processes and lots of reading and in the end there might be an Auditor that may find. “Oh, you haven’t written the date on the signature page, according to our SOP and therefore that is a finding”. Which reminds me of a Funny Story, I once saw an SOP that was exactly about in which format on how to write the signature, how to write the date. And on the signature date, there were five different formats. So I said, “Hmm interesting”. So yeah. 

Gary: You bring up a really interesting point, this notion of how people view quality and it really ties into this notion of what people think of when you say quality and unfortunately, that’s what they think of that. Most people think of what quality is on the manufacturing side. They might think of its meeting specifications. Okay, and on the clinical side, they think it’s following SOPs. If we follow SOPs then we’ve achieved quality. Okay. Now, I’ve heard some people say quality is whatever the customer says it is. 

I think they’re not wrong but they’re just incomplete. It just shows, I think a small understanding of what quality is and what you said is true that when people read the SOP, we bring someone into a company and the first thing they do. I mean we hire them, you’re a good statistician. They come in, they’re excited to apply statistical techniques. And what’s the first thing we do? Well, you have to train these however, many procedures before you can do any actual work. That’s meaningful. Okay. So they read these procedures and they get this view of quality that, you know, so I need to follow these SOPs and if I don’t follow these SOPs, then that’s quality. Okay, and if that’s not you don’t have quality. And if you don’t abide by the SOPs, if you make a mistake, that’s a deviation. Deviation triggers an investigation, then we’re going to need to come back to you and we’ll need to take up your time to figure out why you deviated from the procedure. And, and oh, by the way, this deviation is a metric that gets rolled up to management and they don’t want any deviations. Okay. So you’ve created this, you’ve taken, an employee who comes in out of school as excited to work in the industry and you’ve just completely flipped around like, “Oh my gosh. Now I have to follow these SOPs to achieve quality”, and then they see it as a bad thing. So quality means SOPs, which has a negative connotation in their mind. 

And then they start to learn, well can we do this? You can’t do that. That’s against the SOPs. Okay, so it’s completely flipped. I mean, my understanding of quality is a good thing. Okay, but it’s a very different understanding I think than what most people have. Even what organizations have because they will, you know, quality is our number one priority. We don’t sacrifice quality. What do you mean by that? So what is quality? I mean, it’s a great question to start with. And I think most, if you ask 10 people, you’ll get 10 different answers, or at least, maybe five or six. 

Alexander: I love the thing about, whatever the customer says, it is. Yeah. And if you see just the Regulators as a customer and you see their Auditors as a customer, then it becomes this very, very kind of quality management system, documentation kind of thing. But I think we actually have some other customers as well. So for me, kind of ultimately, the customers are the patients. Yeah, and their loved ones, their parents or their caregivers, these are ultimately our customers. 

What, what do they expect in terms of quality? And I’m sure most of them never heard about SOPs, so I think they have completely different views on quality and then you know, we work with Physicians. What do they think about quality? Yeah, the prescribing Physicians. Or payers, what do they think about quality? So, I think there are many more customers than external customers. And of course, internal customers are yet another topic. Yeah, if you think about management, yeah, what do they see as quality? Yeah, when you present results to them, yeah. 

Gary: So yeah, I was going to say we had this conversation once I was doing some supervisor training and someone came in, and I forgot what their expertise was or what part of the team. But we got on to this discussion of, I think it was like a marketing type of person and patient-focused type of discussion and they were talking about the customer, the customer. I said, so who do we define as the customer? And they said the patient. I said, don’t we have other customers? Internal, external? And they kind of said, well, no, we just think of it as the patient and that’s not a bad thing. But you’re absolutely right. There are many different customers. And so before we kind of get too far down this I guess Rabbit Hole.

I do want to go back and kind of give people a definition of quality. And if you don’t like the definition, that’s fine, but I want to sort of provoke people’s thinking in terms of having them think what, what is quality in your mind? What is quality? And I would think this definition more fits with Deming’s quality, understanding and meeting the prioritized needs of your many customers. Okay, so, understanding, and meeting the prioritized needs of your many customers. So it does acknowledge a lot of those things that you’ve got multiple customers. Okay, it’s not just The Regulators. It’s not just the patients. Okay, and in all those customers have needs and sometimes they have competing needs. Because even if you look at the patient, okay, so what’s the need of the patient in most people’s view of quality and SOPs. Well, really, it’s probably more the safety of the patient. We want to protect the patient. We need to do these things right, so that we don’t make a mistake and at least that’s the notion in manufacturing. I think to some extent on the clinical side too, but the patient has another need, which is to get the medication sooner. Okay, so there’s a speed element to the patient. Yeah, they want safety but they want the new drug. Okay, because they’re sick, they want to improve their health. And then, as you said, you’ve got internal customers and I would even challenge people to say that, another customer is the employee. The employee who’s having to work with the quality system. If you want to call it that, I refer to it as a more compliance system because most mergers focus on SOPs, but the employee is also the customer. So again, I think that one of the first learnings is to challenge people here to think broadly about who the customer is. It will change your thinking a little bit or maybe a lot about what quality is.

Alexander: Going back to the patient. I think patients’ safety and getting the drug to the patient quickly is important. But also making sure that the patient together with a physician that is probably prescribing the drug has a good understanding of data, so that they can make it an evidence-based decision. I think this is also really important. Yeah, if you communicate your data in a way that nobody can understand it. It’s probably easy to tick all the boxes on the compliance side, but it’s a completely different thing on the quality side. Yeah. 

Gary: Yeah. That notion of connecting to the customer and thinking about the customer and what their needs are because the needs of the different customers are different and again competing. So you’ve got this notion of a kind of how people view SOPs that they view them sometimes as a barrier to Innovation or Improvement or letting me do things that are new and novel. Okay, so that’s why there’s this conundrum of, you know, quality. I don’t see it as a good thing because it keeps me from doing stuff that I think is ultimately going to be better for the business and better for the patient’s. So the challenge is, how do you remedy those things? And in the context of that definition, it’s a big Challenge. And I mean I have some ideas as to how well people do that. 

Alexander: Yeah, I think he has a point about, this huge compliance system is kind of, how you can really be well trained in everything else. So, how can you really have it completely in your mind, these hundreds of pages? Yeah, I think if you just see that as a big Library, kind of unstructured stuff. It’s really difficult to remember it and to also put it into action. So I really love to have something like quality principles, some kind of underlying fundamentals, that helps you to understand what is all about, and that kind of gives you a basis for how to read all the different documents. Yeah, to figure out the details. Because I think very often you read it and you think “What I’m exactly supposed to do here”. Yeah, and it’s really good to understand where this is coming from. 

Gary: So as I say, we should talk about principles. But before we get to that, I want to build up this notion of one, people read all these SOPs. And I want to tie this back to Deming because I think it’s important from a standpoint of Productivity in general. So as you said, people are starting to read these SOPs. And there’s like, well, how, how do I interpret this? Or I don’t understand the context of this, or how am I going to remember all these things? So what does that create? I mean, we talked about how it creates a sort of negative connotation, but it also creates uncertainty and fear. 

Okay, this is going back to little quick Deming lesson 1 of Deming’s 14, principles was drive out fear, okay. And you know, even thinking about that. It’s like you want your employees to be energized, empowered and confident. You don’t want them working under fear like that. I don’t know if I should do this because it might bail a procedure, let me check with someone. Let me ask on or let me not do it because I’m afraid. So that’s one reason. It’s like we need to create compliance systems or tie the SOPs into the business in such a way that people feel confident that they can execute on the SOPs or as you kind of said the quality principles and  I think one way to explain this notion of quality principles or how it work. I think it is good to use an analogy. Okay, or compare it to a different type of a business. One of the ones that stands out to Me and this is something I think most people can relate to is the Disney Corporation. Okay, so, and I think this is true mostly of Disney Parks, but the Disney parks, the employees, they have five principles that they have to follow. Okay, used to be formal. Think they had a fifth one last year, but those five principles are Safety, Courtesy, Show, Efficiency, and Inclusion. 

Okay, so think about how a person comes into Disney and they’re going to be working. I don’t know if they’re going to be working on a ride or they’re going to be working on the grounds or they’re going to dress up like a character or they’re going to work at your concession stand or whatever that is. Okay, I’m sure they have to go through training. All right, but I would guarantee you that the first thing they’re not doing is okay. Come we’ll put you out in the park for a month. First, you’re going to have to read all these SOPs. My guess is that they come in and they do something that says more of, we’ve got five principles for you to follow. Yeah, we’re going to do some training and we’re going to talk you through these but the five principles need to be executed when you’re out in the park, engaging with each other and engaging with customers. You want to keep people safe, and you want to be courteous, we’re here to put on a show. So, you know, whether you’re in character, whether your ride, we want to keep people entertained and happy. We pride ourselves on efficiency and we want to create an inclusive type of environment for both employees and for our customers, okay? Then it’s like that. That’s so empowering to say I don’t need to remember these 50 SOPs. I got these five things and I can go out and I can, you know, maybe hear some examples of those. But then I can use my own judgment and exercise my own thinking to put those into practice. Okay. So what a very different type of a model that then connects our quality back to our business. What a great thought.

Alexander: And also kind of clearly explains, what are the expectations of the customer? Yeah, its meetings. If you meet these five things, you’re pretty likely meeting the expectations of the customer.

Gary: All customers. You’re going to make the people in the park happy. The business is going to thrive. And the employees are going to be happy because they know how to execute their responsibilities. They know how to work on a day to day basis. 

Alexander: Yeah, and it’s also for the best. It is not Efficiency on the top, It is Safety at the top. 

Gary: Safety. Yeah. 

Alexander: Yeah. So if it’s costly but it’s safe. Go for safety. Not the efficiency. Okay, good. So, if these five are for Disney, what do you think are five good ones for our industry for Pharma and Healthcare? 

Gary: These are five that you could think about. Again, I think they’re pretty easy to follow. Okay. So the first one was Patient First, so again, pretty easy, put the patient first, the safety of the patient, the need for the patient to get a case, you know, maybe groundbreaking medication that improves their life. That’s pretty easy to understand. Alright, so that was one. Data Integrity, so we all know how important the data is. The data drives every decision about safety, efficacy, business decisions, moving drugs, forward submission, all that stuff. So data Integrity, very important. The third one was reproducibility. All right, as you said, we need to be able to when someone challenges us. We need to be able to go back and reproduce the information. I mean for good reasons. We can defend what our conclusions were but we can also learn from that. We can, we can generate analysis again and it shows that we’re confident in our internal processes. And then the last two, I think get to these other notions. So one was Appropriate Methodology. Okay. So, in a sense, it forces that balance of, if there’s a new method, a new idea that makes for a better analysis or an improved design. We need to be able to integrate that into our business. Okay, so it keeps that notion of we want to innovate, we want to implement new ideas that will speed, the cycle time or improve, our ability to discover drugs, or improve the efficiency in evaluating drugs as we manufacture them. And then the last one was Professional Integrity. Okay, so that gets to the notion of, you know, I have to make sure that I’m honest and transparent and I’m doing things in the best interest of all our customers tell people this is part of your core responsibilities as a statistician or statistical program, or even in management that we want to support and drive these five principles. You could have conversations that were sort of competing challenges, okay? Where does this sit from a Patient First stand point? Or do we stand from a Data Integrity standpoint? And Appropriate Methodology, is this going to speed things up? Or is it going to slow things down? Do we need to change the procedures so that we can incorporate this methodology? Which one do we need to change? And in the acknowledgement that that was possible. It was possible to do that. Okay, so that you didn’t feel like, the procedure won’t allow that. So that’s a, that’s a showstopper there. No. We can change the SOPs, if they’re becoming a barrier to Innovation as long as we can do it in such a way that it doesn’t compromise the other principles. So it creates a very sort of meaningful conversation and a path toward achieving what you want again for all customers. 

Okay, and again, getting back to this notion that the employee is the customer too. I could ask you, would you rather operate under a system like that? Or here’s five principles to follow. You have the, we’re going to train on all these SOPs, but they connect to these five principles and understanding and practicing these principles will basically get you to compliance as well as meeting the needs of different customers. Or, here’s 50 procedures, 60 procedures may be more than that. You have to read and sign, understand them all. Don’t violate them because we know the consequences of that. If they use that word or not. There are consequences. 

Alexander: Yeah, and that’s a lot of different discussions about, okay. This is written in the SOP and we just change the system and so, you know how it’s written in the SOP relates to the former system. How is it actually implemented now? 

Yeah, and then if you have these kinds of things in mind, it’s much easier to do it. Yeah, so we want to achieve reproducibility. Yeah, so you need to explain why you did it? What did you do? Make it traceable, these kinds of things. So, document it in such a way that another Statistician can also understand it. Yeah. A reasonably well trained statistician. You know anybody from the street that you pull in needs to understand.

Gary: Yeah, because, you know, like it could be years down the road where someone challenges something about drugs or the analysis of it and you can go back and here it is. We can easily get the data. This gets back to meeting the needs of the customer because later someone has to go back and we can’t reproduce it. So then you’re starting from scratch. So then you’re taking up resources. Okay, people’s time. All right, so there’s that efficiency piece that actually is a benefit to the business. It’s like, if you write the procedures in such a way that it fits in with what’s important to you within the business. If you look at the missions of a lot of pharmaceutical companies, they will say things like Innovation, you know, patient-focused, patient outcomes, delivering value to the patient and to the business and other stakeholders. So connecting your quality principles to all these things. Again, it makes it nice and neat and consistent. And, I would think it would empower an employee. I can do this. This is all good, this is a place I want to work. 

Alexander: Yeah. The other point is, if you create processes. You can think about these principles first before you start writing. And as you go along, you can maybe be much more consistent and much more concise in terms of how you do things. Because if you start with these principles, you don’t need to tear out every possibility because you can rely more on these principles. 

Gary: Yeah, it’s as you said, and I can think of specific examples back when I was in manufacturing, where something would happen in the knee-jerk reaction was, “Oh, we need to write a procedure so that doesn’t happen again”. And I remember sitting down with one of the directors and one of the pilot planners who is responsible for making the materials to support the clinical trials. And he described it as, you know, every time there’s something going wrong we do that, and what we’ve ended up with is this web of procedures that doesn’t connect. It’s just a tangled mess that sometimes they even contradict each other. So an employee is like thinking, “how can I do this and that?” So having this sort of consistent holistic approach from the top down again, easier said than done. I understand that. But acknowledging that. Maybe there is a better way to do this, that would really provide benefits to all of our customers and maybe, especially, so the employees would be a good thing. 

Alexander: In terms of achieving quality. I think it’s not just by writing more SOPs. Yeah, I’ve seen that quite a lot. Yeah, it’s kind of an automatic default reaction. “Oh, there’s something happening. So we need to write more SOPs, more lengthy SOPs or kind of more instructive SOPs or whatsoever. I think it only focuses on the Process always, but it never focuses also on the people. Yeah.

Gary: I can give an interesting sort of different perspective on that. One of the statisticians came to me and said “I’m designing this, this animal study”. Okay, and this was an animal study that was based on a very predictive animal model and they said we’re going to do this study. We’re going to invest quite a bit of time and money in it from a discovery standpoint. And the results are going to be used to drive a business decision to drive the decision around whether we take this molecule for okay. Now, we do lots of dozens of animal studies and dozens of other, you know, in vitro studies and we didn’t have the staff to do the things that you could do on the clinical side. I mean to double program and review everything. All right, but we would follow the sort of best practices. In Discovery, they had these great research practices which were sort of principles that people have to follow. But for this situation, we had a discussion and said, okay, maybe we need to ramp up how thorough and sure we are on this one. 

So, after you write the protocol. I want you to have this person review it. Okay. I want you to work with them and see what they think about the design before we move it forward. When you get the data, I want you to work with this programmer. Okay, who was a programmer on the Discovery side and I want you guys to make sure that the data has been transferred right. Okay, that is what it was, what they generated it to be, and then you can do the analysis, but I want to have someone else do the analysis. Okay. So in a sense, it was implementing what you might think about in a clinical program, but it was just for this situation. And we didn’t have to do it this way. But as we talked, it was like, this is the thing to do for the business. And sometimes that’s how people define quality. It’s doing the right thing. Okay. It was the thing from a standpoint of, you know, it gave him confidence that he wasn’t doing anything wrong because this was such a high-profile thing. It delivered a concise study design and Analysis to the business. Okay, so we met the business need and it met the needs of the downstream customers who are then going to take this product and move it forward. 

So, we essentially followed the definition of quality and did the thing with zero procedural overhead. Okay, so it is. This is I guess a concept or a definition that you can apply to any process. And I mean there, we talked about sort of the compliance based drug development processes on the clinical side, maybe the development manufacturing side, but there are a lot of business processes that are in place that may have little or nothing to do with compliance. You need to think about them the same way because sometimes those are the processes that are creating the inefficiencies that are creating the problems of the frustration and I can give you examples of those too. But yeah.

Alexander: I’m just thinking about, let’s say business data. Yeah, think about your organization, how is resource planning done? Yeah, and where the data for resources are stored and how much you need them and things like this. I’ve seen organizations where there’s, you know, on each level of the organization, there is another data set. There’s the Study of Statisticians that has their own data, how you plan things. There’s a Project Statisticians that has yet another data. There’s the kind of therapeutic area that has yet another data. And then there is I don’t know, VP or whatever, that is yet another data set. And doesn’t need a genius to conclude that most of the time, probably even all of the times these data are not in alignment. 

Gary: It begs the question like, okay, again thinking about understanding meeting the needs of our prioritized customers. Okay, who are the customers, the, we going to need this data in the future? How should we integrate this Data? Should we compare the data to make sure people have the same? Do we want to have a central storage place for this data? Okay. Now it doesn’t need to beat all the bells and whistles of clinical data. But again from a good business practice. What’s the right thing to do here? So that we can deliver on the needs of the many prioritized customers. Are we going to come back and rethink this data? Okay, so it does, it really sort of begs all those questions that allows you to have a conversation, that to them decide how much rigor do we want to apply here, too, you know, maybe putting a formal data structure in place or putting a more formal assessment process for this data or a process that we re-do this every year. So, do we want to write something up that says, here’s how we’re going to do it.

Okay, so I think again it doesn’t sort of force you, you only need to proceed. It just forces you let’s think about this. Let’s think about it from a standpoint of the different customers and how we can structure this approach, so it meets our business needs consistently and sustainably. 

Alexander: Yep. So we talked a lot about what kind of compliances? What kind of quality is?  We talked about Deming and I can only reiterate that this is a really, really good thing to have to look into these principles and I will also put them into a link to the season in the show notes.

And we talked about what it means to be, to have quality versus what it means to be compliant with the SOPs. And a couple of steps you can think about when you are maybe next time pulled into rewriting or updating an SOP and may think about it differently. And lastly. We also talked about, you know, quality and not just from a clinical delivery point of view or any other kind of, you know, medical data processing but more generally, how do we deliver good quality in our work and things? The five principles that we talked about here. From Patient First, Integrity of Data, Reproducibility, Appropriate Methodology, and Professional Integrity applies there as well. 

Any final call to action that you have for the listener? 

Gary: Yeah, so I think you summarized it really well, I would go back to this notion of Deming’s quality and not just think of it as, well that’s what they do in manufacturing on the physical process. But if you talk to any sort of Deming disciple, or anyone that studies Deming, you know that these principles can be applied anywhere in any business in any industry and any part of a business.

I would add that, you know, take a look and it’s usually some of the business processes that get in your way. Think of it like “gosh, this is such a pain. This just takes so much time and is so inefficient”. Well, maybe you should address it. Okay, and I guess one of the messages is to think about that notion of what I said at the start, in terms of all work, is a series of processes on process or subject of variability. Pick the process, that’s giving you headaches, or affecting your team, and go after it and try to fix it. Because that’s the thing is, whether it’s with Compliance Processes or Business Processes or Financial Processes. Those people that put those processes together, most of them probably aren’t coming to you and saying is this working for you? The customer. So if it’s not working for you, take it upon yourself to go to them and say we need to fix this. And here’s why and I want help, okay, because a lot of the time those are the things that make a difference. So in a sense, my call to action is to think about this, this notion of quality. This holistic notion of quality, think of how you can tie your quality, your true quality into the business. Okay? Gain a deeper understanding. I mean, look at Deming’s 14 points, they’re very sort of provocative, and you’ll find I think they’re very consistent with a good business model and then, you know, put these things into practice. Again, not just for the numerical quantitative processes that you work with, but this will make life better and easier for people around you. And that’s what people want. I mean, they want to work in an environment where they feel confident. They feel empowered. They feel that it’s their direction and a sense of simple enough that they’re not working and fear. Wouldn’t be a wonderful culture and a workforce to be a part of.

Alexander: Absolutely, very good. So stay tuned. There’s a future session with Gary coming up on a different topic and so stay tuned for that. And if you want to listen more to Gary’s insights and just scroll back into your podcast player. There are lots of further discussions that we had and I’m pretty sure that there will be many future ones as well. So, thanks a lot. 

Gary: Thank you. 

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