Transcription: Quality in the Laboratory: It’s in the Details Expert Panel Discussion

The following transcription is taken from The Windshire Group’s webcast “Quality in the Laboratory: It’s in the Details Expert Panel Discussion:

Terri Melvin: Welcome everyone to today’s webinar Quality in the Laboratory: It’s it in the Details Expert Panel Discussion. I’m Terri Melvin and I will be today’s moderator. We have with us today two expert panelists, panelists will first tell us a little bit about themselves then address some talking points in their particular areas of expertise, and then we will dive into your questions live. Our hope today is to make new industry friends and acquaintances and to serve as an information resource for organizations by providing answers to some of their most pressing questions around this very important and timely topic. Just a couple of house rules before we get started. Please don’t ask anything that contains confidential information, also for today’s webinar we’re not offering any specific advice for anyone’s particular situation and we are not responsible in any way and for any use of the advice or opinions we express.

After self-introductions we will share a few personal thoughts about the quality in the laboratory, and then we’ll get started with questions. We will then close our expert panel with some concluding thoughts. Dr. Blackwell was going to be here but he to tend to a client’s needs. We’re hoping he can join us for the Q&A. later. Right now I will turn it over to our first panelist Deborah Miller for her self-introduction, Deborah?

Deborah Miller:  Thank You, Terri. I guess you would say that I’ve been working in laboratories since my 6th grade science class, but I’ve actually been in positions of responsibility in regulated environments for about the last 30 years. I have experience in pharma, biotech, clinical lab, forensic toxicology and specifically blood plasma and tissue. I’ve been in the trenches as an operations person, I’ve been a quality manager, I’ve been a lab director and through all of that I have been very much a proponent of laboratory quality and compliance. Dr. Gusack you want to take it from here?

Dr. Mark Gusack:  Yes, thank you good morning everyone. Basically I’ve spent forty-five years in one or other positions in the laboratory field starting with actually being a technologist in the nuclear medicine field, as well as a clinical engineer. I then went on to become a physician and became board-certified in anatomic and clinical pathology and I was introduced the concept of quality assurance in my first position as a chief of a multi-department laboratory in a hospital. From then on continued to develop experience and background in the field of quality assurance, as well as risk management and utilization review. And more recently I’ve been involved with the Clinical Laboratory Standards Institute as well as with A2LA, with ISO 5189 assessment.

Terri:   Okay excellent, and now we would go back to Deborah Miller for her points to consider slide, Deborah?

Deborah:   Thank you, Terri, as I was thinking about the broad subject of quality in the laboratory, I reviewed my experience with both being inspected and assessing laboratories for gap analysis and for formal audits, and one of the things that I noticed is that these experts in quality who can cite you regulations and standards and have vast amounts of documents talking about quality, still something goes wrong in these environments when you have deviations non-conformances and worse, release of wrong results. And I was thinking from the first introductions into the laboratory where we talk about quality, it’s in our vocabulary, it’s in our procedures, it’s in our processes. We don’t perform traditional measurement on certainty. We use our quality controls to define our assay limits. So what goes wrong? I thought about this a lot when interviewing people during audits I realized that since quality is so much a part of our vocabulary that we almost wear blinders to it on the day to day basis, we’re following quality principles but we end up being complacent about actually executing them.

I’ve seen instances where supervisors have been standing in a laboratory watching someone train another individual with no labels on any of the beakers, and when asked why aren’t there labels on the beakers? How do you know what’s in them? The person says, “Oh, this is just training”, and the supervisor allows that to continue. Simple things like you’re supposed to be wearing PPE and it’s supposed to be wore in a certain way and supervisors will be in the laboratory talking with individuals or coworkers will be working side by side, they’re not wearing their PPE as directed and no one says a word. So what is this? I think it’s a complacency or a familiarity that puts blinders on all of us. And that carries over into our policies, procedures and processes it’s the same thing. We think we know what our procedures say and we think we’re executing them but when you have a deviation and you go back and look at it, if you investigate it thoroughly, you’ll find that the procedure didn’t say what you thought it would say.

I just reviewed a deviation with a client and the root cause was that the technologist did not follow the SOP, but in looking at the SOP, we found out that the timing that was assumed to be in there was not in there, so again it’s in the details. And then when it comes to our training programs which leads us up to these failures at the bench, is it comprehensive or do we just say they read the procedure and they understand it and they watch somebody else do it and we watch them do it once so, therefore they’re signed off on the procedure? I actually was in an environment as a quality manager where they hired a person right out of college, taught her the procedure, gave her an unknown she passed it and they let her loose on the bench and there was no additional training on how to get your samples, how to manage your workload or how to manage your documentation. She had several failures when she was actually thrown into a routine workload.

So again, it’s in the details. It’s not about just documenting the training, it’s about ensuring that the training is effective and there’s feedback when something goes wrong and additional training and, I don’t mean just training out of a problem, but additional time spent in ensuring that they really understand it. And now I’ll pass this on to Dr. Gusack.

Mark: Thank You, Deborah. Good morning everyone. I’m going to talk about four points to consider and we’re going to kind of step back and look at things strategically, operationally and then technically. When you’re talking about quality management often there’s confusion as to what that means. What I found, it’s best to look at three things that really make up any activity that we carry out and that’s risk management. We’re trying to maximize product, service, safety and quality management. We’re trying to maximize our client satisfaction, their perception of us as being really good and being competent, and then resource management which maximizes the efficiency the value of whatever it is we’re doing, while minimizing costs.

And you have to really look at all three of these together in order to put quality management in the appropriate context, because they all affect each other and just one example can be that you may be driving for a certain level of quality for your client satisfaction, but in the process it may well be increasing the risk to their safety. In the clinical field I’ve seen this in clinics where for the convenience of the patient and the physician they will carry out point-of-care testing on instruments that really aren’t appropriate for the particular diagnostic workup that they’re dealing with. Instead of actually sending off the patient specimen to the laboratory for a more reliable result and the outcomes are increased patient unsafety, so it’s important to look at all three together.

The next is the operational level. We often look at one or maybe two areas. These are systems that are often looked at in personnel and we often don’t look at tools or the processes and how they all again interact with each other. So you want to look at the system that you’re running everything in and that’s the input of specimen or information. Some sort of an input could be other resources. If it’s a pharmaceutical company that’s using materials to make a particular drug, then the workflow itself. The decision points those are the points where you accept or not accept a batch, you accept or not accept the test results, that sort of thing. Then finally the output and making sure that output meets specifications. Tools – that’s the facilities, the equipment, the environment, instruments, reagents and consumables that are important. These have to be checked so if you bring in new reagents these need to be validated to make sure that they actually are producing the kind of results and are at a standard that the vendor has claimed.

Then the processing and this is what Deborah has been talking about procedures. Basically where you have tasks. They use the tools to run the system and finally the personnel issue that she has been really honing in on in her third point. That is, how do we train people well? Turns out, training is part of a greater kind of cognitive cascade where you have to orient the individual, prime them so they’ll see a lot of what’s going on before they actually get into the training. Training them properly, educating them as to what quality assurance is and what it means, and then allowing them to gain experience under supervision so that they can establish a level of competence that is doing it right and doing it reliably right and proficiency so they can carry out the task efficiently.

And then, finally, how do you investigate these problems that occur with quality where an event occurs? I recommend using something called the scientific method, which I’ll simply say is a superset of total quality management, the root cause analysis and Edward Demings approach to quality. Then finally you need to integrate the knowledge that you gain in evaluating these errors that occur and document them properly to have an integrated system there, that’s the foundation of quality systems. See, if you don’t capture it you really can’t benefit by it.

Terri:  Okay excellent, thank you panelist for your points to consider. We’ll now open it up for your questions live, please take advantage of these experts while you can, simply type your question into the question box on your control panel. We will answer all the questions we can in the time allotted. So now for our first question: Do you have suggestions or pointers on how to prevent the complacency you have described? I think they’re talking to you Deborah.

Deborah:  I’ll give it a shot, I kind of alluded to that in my first point there I would say the first thing is that you need to get into the mindset of supervising by walking around. I don’t just mean the supervisor but coworkers also. I can’t tell you how many times as I mentioned before where things have gone right under the noses of people in the laboratory and they just didn’t see it. I know we all know that an auditor is like a third set of eyes is not familiar with the environment so picks up on things that people working there every day might not, but these are simple things.

People not holding a pipette correctly. How many times have co-workers or supervisors seen that happen? I had an incident with an instrument that my staff, unbeknownst to me, because I wasn’t walking around, had spent a good part of a day turning it off and on opening new controls trying to get it to work and when I finally got a complaint and went looking to see what was going on. I heard the story and found a piece of paper had sucked up against the fan in the back and it wasn’t cooling properly. Just keeping your eyes open to the everyday opportunities and make sure people are doing what they’re expected to do. And, oh, by the way, if you’re posting pieces of paper on the wall with instructions you may want to look at your SOPs. The other thing is feedback. When something does go awry you need to give feedback to everyone on what you found, without blame without judgment, just as a learning lesson.

So many times we have something that is non-compliant or a deviation we rush to get it investigated and closed but we never really do like an after-action with folks to let them know what happened. Simple gatherings of maybe a 10-15 minutes tutorial on how it happened is really a great way to continue to give feedback with everyday happenings in the laboratory. And the other thing is in training you want to make sure the person understands what they’ve trained on. So a conversation about what they trained on and tell them if you were teaching me, what would you say the most important points are? When you do all of these things you’re showing the staff that you are interested in quality, that you support it and that you’re watching it so you’re putting them in the right mindset to do the same, thank you.

Mark:  I just like to add briefly to that, Deborah mentioned the feedback portion of this which has to do with the application of the scientific method. It really has to do with knowledge management. That feedback is usually from somebody who is more knowledgeable. They have more experience. They know how to troubleshoot and it’s important to capture that, document it and then be able to link that to the procedure that the technologist is carrying out. So that in the future they will actually have that knowledge right there in front of them that they can refer to and that’s really how you grow your quality system.

Terri:  Thank you. I think we have a follow up question to what you were just talking about, they want to know what things can we do to make sure that actual practices in the laboratory match the procedures?

Mark: Basically it’s been my experience that often procedures are pulled from secondary sources like the vendor or they’re written by someone who’s at a high level and they’re not really at the bench. What I found is that it has to be cooperative. Where the technologists who organize their work area and are the ones who are going to be doing it on a routine basis need to be very intimately involved with it, and often it’s best to design a form with a flow sheet and an area where information would be entered or a checklist so that basically they start off with a simple cheat sheet really and then from there, once the procedure has been developed, and any of the points that need to be smoothed out have been smoothed out, then the formal procedure can be written because now it’s validated. The procedure has been validated.

Often procedures are not validated and that means that when the technologist gets to the bench they’re going to end up doing it differently from the written procedure and that can have significant consequences, because they may not know what’s really the most important part of that procedure that needs to be maintained in order to get reliable results.

Deborah:  And I would add as a real-life example, I was doing a supplier audit in an infectious disease laboratory and I was watching the technologist actually perform the procedure and I couldn’t follow it with the SOP. Finally I asked him. I said, “how do you know how to do these steps they’re not in the SOP?” and he pulled out a folded piece of paper out of his pocket that had the steps on it and it was not a controlled document. I asked him what it was and he said oh he got that during training, which is okay it can be part of training but it was not a controlled document therefore it was not necessarily current. We don’t know if everybody was following the same one. But it had the detail needed to actually execute the procedure and it wasn’t in the aforementioned SOP.

One of the things that we’ve done in our laboratory is when you’re doing your internal audits you have someone who is not familiar, not trained on the procedure someone from the other part of the laboratory actually observe the procedure and the process with the SOP and actually audit it and see if the procedure leads them to actually be able to follow the SOP according to what they’re doing. So that’s just kind of a simple way to do it with your own internal auditing.

Terri: Okay, I think that answers that question. If you have a follow-up question let me know. Here’s another question about training, in our lab the trainee is observing the trainer as they are performing the assay, is it sufficient to document this training as quote “trained on the related SOP” unquote?

Deborah:   Well that’s a good question, I would not begin to tell you what is sufficient. You have to define your own training program, and I would hope that it’s more detailed and more comprehensive when you’re training someone on how to do an assay, than to just say read and understood. I know a lot with a lot of these automated training systems, when I audit them, the only thing I see is the SOP number and date that the person read and understood it. I have no idea if there was a didactic session, if there was an on-the-job training session. If there was a test. You need to consider all of those things when you’re developing your training program for someone who’s expected to do an assay. Frequently, if you have a trained person who is just new to your laboratory but has worked in a laboratory, sometimes you’ll take shortcuts, I hate to say this but the word assume comes in that they have the correct laboratory skills and you just show them the SOP one time.

Again from my life history, I was working with a company under consent decree and I was reviewing a deviation, where there was an out of spec result for the reconstitution of a final product. In the investigation, it was the first time this technologist had performed it on a live product and we went back through her training she had never passed that task. She had a no-go on that task yet somehow the trainer and the supervisor signed her off to go live. So it makes me wonder the rigor of the training program and the reasons that the people are going through these steps and if they really want to confirm that everybody is trained and performing the tasks as expected every time.

I attended a class at the University of Maryland, a master’s class on biotechnology and one of the new startup scientists asked the FDA, “do we have to document our training?” Just as the question said we just have them stand by us at the bench and we show them. Do we have to document that? Of course you have to document that, but more importantly it’s the depth that you train and the depth that you determine whether the training has gotten through, and the understanding has gotten through. So you design your training program. You decide how much is going to be curricula and how much is going to be on-the-job training and how much you’re going to document.

Mark: Can I add something to that?

Deborah:  Please do.

Mark:   Yes, and one other thing to remember is training shouldn’t be considered something that ends at a certain point in time. As soon as the basic training that you’re thinking about has been done then if at all possible the individual training should now for a period of time be monitored by someone who is knowledgeable and is competent in that particular test. Sometimes it’s not possible, but if it can be done it’s a good idea.

And then periodically many laboratories do some form of what is called proficiency training where they get an unknown and they carry out the procedure and then if their results deviate a certain degree from what is expected an investigation is done to look into what might have caused that. You would be surprised at the reality of what appear to be minor deviations that become systemic and can adversely affect the outcome of the testing.

Terri:  Excellent hopefully that answered your question. Again in the control panel if you have any questions just type them into the question box and we will get your question answered live, but I do have another one here. With integrated system management how do you prioritize the three areas of management?

Mark: Yes, and actually the whole purpose of integrated systems management isn’t necessarily to answer all the questions for you because when you look at any particular activity you are carrying out there will be differences of opinion within that activity by different people as to what even constitutes risk versus quality versus utility. In fact for decades we’ve had a problem regarding what is quality versus what is risk and that is made worse by the fact that in hospitals and in many pharmaceutical companies and elsewhere those three areas are run by three separate people who don’t generally talk to each other.

So it’s really important to understand that an artificial construct which forces you to take a look at what you’re doing and what I recommend is that risk really be prioritized at the top of that whole thing, then quality and then the resource management with the understanding that there will be a limitation of resources which will then feedback and limit what you can do in terms of quality and risk.

And that can then basically bring into focus what’s the difference in opinion between different people involved with the activity as to what risk and quality should be, and that alone could be very valuable. So especially if you’re starting up a new activity you know from the beginning where this conflict is and hopefully can resolve it before you actually go into planning and implementation of an activity or bringing in a new instrument or putting out a new product or service.

Terri:  Deborah do you have anything to add?

Deborah:  No, I think that Mark covered the prioritization quite well, thank you.

Terri: Okay great, well we’ll go back to Mark’s slide again. Where you mentioned FMEA, could you explain in more detail the difference between a system and a process?

Mark:  Yes, by the way FMEA stands for failure mode and effect analysis which was developed after World War II and then has been systematically applied to various industries and eventually to the service industries and now more recently in the last 15 to 20 years to the healthcare field. And basically people often talk about systems that they’re actually talking about processes or vice-versa, and it’s a good idea to understand that the systems are not the actual tasks they get you from point A to point B. Systems are point A to point B. In other words, it’s the path that you’re going to take to get an input via the specimen or be it information or some raw material and how does it come in, how is it handled at each point of the way. What is done to it, what transformation, how is it transmitted, where is it inspected and what do you do if your inspection indicates that there’s a problem. That’s where you get your branch points, your decision points.

And then eventually you have output and even then after you have output there may be retrospectively an evaluation of that output either on a continuous basis or with random sampling. So that’s your system which you define and you can actually draw that out. Often you’ll see those within industrial plants as well as in laboratories. The processes are the way in which you get from point A to point B. What tasks do you have to carry out when the specimen or the information comes in they’re usually organized chronologically and they’re self-limited at each point. In other words, it isn’t just one long process. There are separate processes that individuals do and then they hand off the information or the specimen or the intermediate product to the next step.

It can also be done by a computer and automated but regardless of that those processes have to be well-defined so that it minimizes deviation and most greatly assures that when you go from step A to step B and so on and so forth that it will be done in a highly reliable way as possible, so those are the differences between the two.

Deborah:  Mark I have a question, when you have your processes within a system can there be parallel processes or are they always in series?

Mark:  Yes, there certainly could be parallel processes so if you have a specimen that comes in it might be split and sent to two different areas of the laboratory. It might be sent to a chemistry and then just special chemistry and then it could become parallel and that’s a very good question. I kind of implied that it was just only serial, same thing with information technology in fact most computers nowadays I have multiple processors and they’re doing parallel processing behind the scenes.

Deborah: I’ve actually seen one supplier that I audited actually instead of having a list of SOPs and work instructions, they actually had a system map that included all of their SOPs and their work instructions and how they were linked. It was a little bit difficult for me to know what SOPs to ask for but it was really great in actually illustrating their systems and then the individual processes.

Terri:   Well, I think that answered that question, very good. Okay for those of us that forgot what we learned in junior high or middle school, I think this is for Mark, can you go over the steps of the scientific method again?

Mark:  Yes, basically I didn’t actually talk about those because timewise it would be very difficult but what we’re taught in high school and I actually got taught this when I was in ninth grade and it greatly affected my life. That’s one of my basic beliefs that if you can’t apply the scientific method then perhaps you’re just dealing with speculation or hypotheses you’re not really dealing with facts and being able to develop theories. So there are a number of steps. Generally the first thing is some sort of an event that we identify. Usually in our case and if the event is an error or some feedback from a client or a new regulation that has come down upon the laboratory or the pharmaceutical company or perhaps an inspection and a finding.

So once you have that event, that presentation you then need to search for a reason why that occurred. So you’re going to make observations. You’re going to take a history. Basically you’re going to be examining things physically. You’re going to be looking for signs and symptoms that will lead to the ability to identify what the root cause is, the problem. And you’re also often going to be doing research. That’s another step. That’s really the third step where you’re looking for people that you can consult with who have a fund of knowledge or you’re going to look to guidelines that are written that you can refer to, and then you put together your hypothesis which will either indicate a single problem that you think is present or maybe a list. Now you want to eliminate the ones to get it down to just one. In order to be able to actually test that you now need materials. Basically you need people to carry out this essential experiment. You need people to evaluate the results. You need equipment and funds. Often, a small amount of funds in order to get this done. Finally you need some sort of methodology in order to carry out this test.

And so if it’s something that has to do with quality control, your quality control reagents. You need a method to actually test your hypothesis. What went wrong with them. Finally you carry out that experiment and in order to benefit from it you need to take the results that you observe and you need to store them. That is where you need to document them. That’s the next step and finally there may be calculations that have to be done. Then eventually you go to interpretation. You analyze and interpret and you either rule in or rule out the particular problem you were considering.

And finally, you’re not done. So let’s say you’ve identified a problem and you’ve got a solution, well that’s really the check. If your solution works that’s great but often people simply impose the solution and then they kind of walk away from it. Instead you have to check and that means. You go all the way back to the beginning and you’re going to look at the event that is the outcome of your particular intervention and then do a final evaluation and conclude this is a correct solution. This is the correct problem that we’re addressing or it isn’t. Then start the whole process over. And depending on how complex or how deep-seated the problem is you may be able to skip some of these and that’s why you see things like total quality management and root cause analysis that have been used in the past in order to carry out these types of analyses.

Deborah:   I’d just like to add that sounds lengthy but in practice there’s a couple of key points. Back to my instrument that was not performing correctly and my lab staff were furiously opening new controls assuming that the control was the problem Dr. Gusack mentioned. Observe, take your time when you’re observing. Actually observe everything even the simplest things. We’re not looking at complicated processes here but really observe going back to what your SOP says and what’s actually happening. Observe what’s supposed to be happening. And the same holds true with the analysis that he mentioned. Do not jump to conclusions. Don’t get to the end because you think you know where it is. Actually analyze what you’ve carefully observed and in the case of this instrument the signs were there. They plug it in it would run the first control fine and then it wouldn’t run anymore. They turn it off it cooled down and they repeat the cycle only to find out that it was overheating because the fan was blocked.

They clearly were not thinking about what they were observing analyzing it and coming to a conclusion, and when I finally got into the act it was Friday afternoon at 4:30 and I didn’t want it to be a complicated problem, so I listened to what they said look behind and found the fan block. So take time to observe everything and take time to analyze it before you get to your conclusion, thank you.

Terri:  Excellent thank you, we have a question here about knowledge management, could you give some examples of knowledge management and how would that even get documented?

Mark:  Yes, knowledge management is a really interesting field. Basically what happens is that when people are doing something they are experiencing, and what we don’t realize is that we go through really internally a complex series of internal events. Some people have good memories. They’re able to integrate it into what they’re doing and that’s fine. The problem is that the person who is doing that often is not communicating with other people. And so, for example, Deborah mentioned she looked behind the instrument and saw the piece of paper. So the process by which she got to the end result is based on her knowledge, her experience. This is what needs to be documented. So when an investigation goes on, as it goes on, the whole process needs to be documented and then turned into what I call guidelines that can either be integrated right into the procedure as a subsection or be separate but linked to it.

So that when a technologist, someone who is working at the bench or someone who’s really at any level in in the particular facility, when they come to a point where they’re faced with an error, they’re faced with an event and they’re not quite sure what to do instead of splashing around like a fish caught on the end of a line, they can refer initially to these guidelines. And there will be a set of if this then that, if then, if then. And I just recently did an assessment and ISO 5189 assessment of a very large reference lab and integrated within all of their procedures are a series of if thens, if this happens then do that, if that happens then do this and it’s in a table so that while they’re doing the procedure they are benefiting from knowledge that has been gained by people before them and it’s not lost. Especially if those people go to another job or move to another section so that’s how you basically document that and integrate it into what it is you’re doing. So you have the knowledge attained and then you integrate it into your document system.

Deborah:  And those “if thens” frequently are things that as Mark said the experienced people know will happen.

Mark: Yes, absolutely correct.

Deborah: You’re just not inventing them, it’s life experience.

Mark:   Well also, I see all the time that the same problem recurs over and over and over again. For different people and instead of having a complete SOP, you don’t have to review it a second time and waste resources on it. Instead if it’s integrated into your documents you’re done there. Now there could be a variation so there will also be a statement, once you’ve gotten to the end of this, if then, if you still haven’t figured out what’s going on now you call for help. And here’s who you call you call your supervisor, you call this person in IT, or you call that person in quality systems to come in and help you, so that also integrates in a quality system process right there within the procedure.

Terri:  Okay, the instrument example was what really brought it to life Deborah, so I have a follow up question to that, as a subject matter experts, both of you, and as consultants, if you walk into a lab what is the first thing you’re going to do? Are you going to do risk assessment, are you going to look at SOPs? Can you just take us through a bit of a case study and your experience? Where do you start if you’re walking into a lab?

Deborah:  I walk around usually with the quality person or some management person or both and just have them walk me through and tell me about the place as they see it. While I’m observing the people going about their business. It doesn’t really take long to get a sense of the laboratory just by walking around.

I was a brand new manager of quality in a facility and the first week I was there we got a state inspection, it was an unannounced inspection. My associate came to me and said there’s inspectors here. I’m walking around with the director of the laboratory with the inspectors and they asked her a question and she answered it. It was wrong and apparently she saw the look on my face and eventually corrected herself but just walking around with the people that are directors, managers and having them define the lab and explain the lab and seeing how they interact with the people and just seeing how organized and neat and what the tone of the laboratory is gives me a really good foundation of what to expect.

If you see sticky notes and all kinds of information that’s not in a book or not in a procedure then that’s going to tell me look at their SOPs. Why do they have all these additional notes, instructions and don’t forgets and things like that around? Obviously, if you see a lot of disarray, like a lab that I just looked at then you’re going to be concerned about how under control it is. If you see a sign on a drying oven that says take the specimen out at 12:40 and it’s 12:40 and there’s no one in that lab that tells you a lot. So without even looking at documents you know a lot about the lab. Then you’re going to see how people are recording their actions. Are they recording them concurrently? How are they recording them? Are they interfacing with workstations? Are they paying attention to their instruments? There’s a lot that I just can assess just by walking around before I look at any records.

While I’m walking around I will look at records. I will look at labels on instruments. I will look at logs. And again, I can get a lot just from that, I can get everything from GMP annotations to if calibrations are within calibration specs and if they are filling out preventive maintenance logs on instruments. Mark you want to add to that?

Mark:   Yes, and basically I agree a thousand percent with what Deborah is saying. I use the Australian Aborigine term “walkabout” and whether I’m going to be medical director of a laboratory, a staff pathologist or I am assessing or inspecting I do the walkabout. I try to do the walkabout first and I have my systems, tools, process, personnel not naturally in that order because I’m just kind of walking about and I’m looking. I get a sense of the environment. Is it clean, well-lighted? How do people look? Are they well-groomed? Are they wearing clean outfits? Do they look like they know what they’re doing?

I can tell after a while simply from experience, if people are just milling about. They’re not really sure what they’re doing or whether they are very directed. I look at their workspace and how well organized it is. Is it disorganized? Is it dirty? Is it really highly organized? All these things kind of come together and I get a gestalt as to what I’m dealing with. Then I hone in. The first thing I like to do is I try to walk around with upper level management first, if at all possible, to get a sense of the culture of the day. That’s going to determine the kind of system and processes and really the cognitive capabilities of the people and how they’ve been developed through training and proficiency test in an oversight and so that’s kind of what I do.

And then I can look and see where I want to drill down. When one is inspecting, even if you’re just somebody coming in as a medical director, you don’t have a whole lot of time. There’s no way you can look at everything but you get a sense of where you want to look to see okay, let me look here because I kind of get a sense here. Maybe there is a problem. If you don’t find that problem most likely there aren’t going to be any. If you do find one then you begin to spread out and look for other issues that may be important. And this really has a big impact on the accuracy of any kind of inspection. You’re actually in the company, you’re in the laboratory and you’re part of it or you’re outside coming in to do an evaluation.

Deborah:   And to follow on with what Mark was talking about, doing this walkabout with upper management, I’ve more than once walked around with the quality manager, looked at a chart on a temperature-controlled box, that had religiously recorded the temperature everyday, but there was no acceptable range. When I turned to the quality manager and said how does the person who’s recording nine degrees centigrade know whether that’s in or outside of the acceptable range? The quality manager doesn’t know the answer to that. That’s where I’m going to drill down because that’s a problem. And that’s the kind of thing that when you’re doing your internal audits you should be thinking the same mindset.

Mark:   Yes, I actually had that kind of experience recently. I wondered if they’re properly calibrating their thermometers. It turned out they were, but what was interesting was that they were having a hard time finding the calibration documents. They didn’t quite have control over the whole process that they carried out in terms of documenting temperatures and making sure that they were properly calibrated at the appropriate time and that they were responding to any changes in temperature. And it was in their procedures but they didn’t quite have a handle on it, and an observation to make.

Terri:   Thank you, that was incredible insight that both of you do walkabouts in laboratories. I think that answers that question of what to look at first. Maybe that may help some of you out there with your labs to walk around and take a look. I think we just have some time for some concluding thoughts here, if there are not any more questions. I think we’ve answered all the questions in a timely manner but Deborah we’re going to talk about doing a part two of this webcast. Do you want to go into what part two of this is going to be?

Deborah: Well yes, keeping with the theme of it’s in the details. Part two will cover out-of- specification investigations and get drilled down a little bit into the details of how to go about that. Equipment lifecycle, purchased to retirement that’s everything from defining user specs to qualification of equipment and validation/verification, and those are pretty big subjects so I think we’ll have enough for our next webcast.

Terri:  Yes, we have one webinar on validation alone. So we’re going to get down into some more details and we’re going to try to get this done sometime in October, Mark I’d like to invite you back for that one?

Mark:  Thank you very much.

Terri:  Any concluding thoughts yourself Mark?

Mark:  Yes, just to really briefly conclude, I am a great proponent of basically taking the three areas of management that are strategic. Really kind of from high up looking at your activity that way so you can decrease conflict and increase the safety and the client satisfaction and efficacy of what you’re doing. And to use the operational tool that should break it down to the systems, tools, processes and personnel so you don’t miss anything. It helps structure what you’re doing and then to apply to individual events and problems at the technical level, the scientific method. And then take what you’ve learned and document it, integrate it into what you are doing so you don’t lose it, so you can progress.

Deborah:  And I just like to add that I know in the beginning it was kind of harsh to talk about this complacency when it comes to quality for experienced laboratory people, remind yourself of how close to the edge that you can come with that then that’s half the battle. Once you understand that you have to be more alert and do your walkabouts on a routine basis not just when you’re being inspected or audited, then you’ll will fine, once you’re aware of it then you’ll know how to remediate it.

Terri:    Excellent, those are some great observations and some tips hopefully you can utilize in your labs today. We’re going to go ahead and conclude this webinar. I just want to thank everyone for attending and I hope you came away today with some useful insights and a greater understanding of the challenges in laboratory quality. If anyone has any specific consulting needs on this or any other CMC, quality, regulatory, supply chain or operational excellence topic please reach out to us. Our contact information is on this slide. We’d love to hear from you and you’re all on our list if you’d like to participate in part two as soon as we nail down a date Deborah, I’ll let everybody know. Thank you everyone and have a great day!

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