Transcription: Conducting Proper Deviation Investigations Expert Panel Discussion

The following transcription is taken from The Windshire Group’s webcast Conducting Proper Deviation Investigations: Expert Panel Discussion – Live FREE Webcast

Terri Melvin: Welcome everyone to today’s webinar on Conducting Proper Deviation Investigations Expert Panel Discussion. I’m Terri Melvin and I will be today’s moderator. We were going to have with us today two expert panelists that will first tell us a little bit about themselves and then address the talking points in their particular areas of expertise, then we will dive into your questions live. However, Dr. Blackwell had a client emergency that he had to attend to. Perhaps he can join in a little bit later in the Q and A portion. He wanted me to tell everyone “Hello.” He is the president and principal consultant for The Windshire Group. 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 are not offering any specific advice for anyone’s particular situation and we are not responsible in any way for any use of the advice or opinions we express. So after the self-introductions, we’ll share a few personal thoughts about conducting proper deviation investigations and then we’ll start with the questions. We will then close out our expert panel webinar. So Danielle, I’m going to send it over to you for yourself introduction and everyone can review Dr Blackwell’s bio. Danielle it’s all yours.

Danielle Delucy: Hello everyone and welcome to today’s webinar on conducting proper deviation investigations. I’m Daniel DeLucy, I work with The Windshire Group as an independent consultant, I’ve had about fifteen to sixteen years now of Quality Systems experience. I started my career as a QA microbiologist, I’m definitely a lab rat at heart but I’ve kind of climbed the ladder at different companies in the Quality Systems arena. So my expertise really is developing and defining quality systems such as change control, deviations, investigations, all that good stuff that we deal with on a daily basis. I also help different companies if they run into any issues with 483 observations, consent decrees, warning letters, you name it.

Basically my role in industry at this time is to utilize all of the experiences that I have had and to help and share them with a lot of my clients in order to make your quality system that much more robust. Hopefully today you’ll take away some good tips and tools on conducting proper deviation investigations. So thank you very much.

Terri: OK Danielle, we’re going to go straight to your talking points for people to consider prior to the Q&A.

Danielle: Deviation investigations are a very common topic to be reviewed during FDA investigations. You can scroll over to FDA.gov and on their warning letter page you can pick anyone that they have there for observations and find any type of comments or observations about deviations. Really to have a successful audit, having a solid deviation system and very good, robust write-ups is key. When you have inadequate investigations, as you all know, this could cause some severe issues for the company. I have worked with and consulted with some firms that really fell down in this area and wound up with warning letters, recalls, and consent degrees. What it comes down to is that proper root-cause analysis of the issue. It is one of the most important things you can focus on in a deviation investigation. Really focusing on what went wrong and then developing a very strong Corrective and Preventative Action (CAPA) is really key to making sure that that deviation investigation is resolved and that you will not see that issue happening again.

One of the other things I like to highlight is having a very solid Standard Operating Procedure (SOP) with enough explanation that your end user and your operators understand how deviations are identified and classified. Classification is something that some companies tend to look towards to make their deviation process more robust and more efficient. Maybe classify the deviations in the major, minor, or critical category. It helps quality professionals that are in the quality unit gage how important these deviations are. If they can close them out maybe in a few days or maybe the more critical ones need to be elevated to upper management or potentially some regulators. Then also how long they need to work on investigating the cause. Having that information contained in that standard operating procedure can really help the operator and the end user have that strong deviation write-up. Root-cause analysis again is key. I do one webinar specifically on root cause analysis because it is so important. Many firms actually chose to do workshops on root-cause analysis because that is one of the pinnacles of the deviation investigation system. Making sure your are really getting into down to at least a potential root cause. Really aiming for that probable root cause and then really developing those strong corrective and preventative actions so that issue does not happen again.

Terri: Thank you so much Danielle for those talking points and maybe that spurred some questions. Like she’s mentioned before, The Windshire Group does have a webinar on-demand just on root-cause. But now we are now open for questions. We have a couple of questions that were submitted previously, but if you have a question now is the time to ask, just type into your question functionality on your control panel and Danielle will get to your questions. Our goal is to answer any and all questions today. If we don’t get to your question or if you think of one later, our information is on this slide, just send it to us, we’d be happy to answer any questions. So here’s a question that was sent in ahead of time, Danielle, to get us going: How long should deviations be open?

Danielle: That’s a great question, and it has probably no official answer that I can actually give to a person, but basically when you set up your deviation investigations system, you should have a certain amount of steps that you go through or an approval processes and your closure dates really should match up with what your change actually is. What I mean by that is if you’re implementing a very simple change such as may be changing the reagent in an assay or if you’re changing a piece of gowning, let’s say as you’re going into any septic area, those relations stay open quite a long time. As opposed to something that maybe requires construction or facility changes. The way you want to deal with closure of change control is to really set up a system so that your action items that are required to close the change control are very specific, you don’t want to put four or five different things into one action item because then that action item stays open longer, what I’ve seen to be more efficient and effective at handling closures is again to make the action items as distinct as possible. Like if you need a document updated that would be one action item, if you need to visit a supplier and do a supplier audit, that would be another action item. If you need to do a validation study that would be its own action item.

Sometimes when I do visit firms, they kind of lump everything together into one giant end product and it becomes very difficult to manage. If you cut them down into smaller action items I believe they get done quicker. To answer the specific question of how long they should stay open again, it really is up to you. It is up to your firm, how long they’re going to require you to have it open or to close it. As I said, a typical document update would probably only take maybe a few weeks if you’re implementing something with your assay that would take maybe a month or two because there is some validation involved but it really is dependent on how much work is involved. Once you have all of this action items completed, that record is then sent to a quality assurance group and then is reviewed holistically to make sure that all the action items were taken care of according to the due dates and then they mark it as closed and that change has been successfully implemented.

So I’ve never visited a firm where they’ve actually had a hard date when your change controls need to be closed within thirty days. That’s more for the deviation system or investigation on conformant systems, the change controls really vary based on the amount of work that you need to put into getting them closed, so hopefully that helps.

Terri: Thank you Danielle, I think that answered the question. We now we have a live question; I think he’s trying to say – Should a required procedure or SOP define the process or procedure to handle the emergency changes?

Danielle: So I think the question is, Do you need a procedure upfront to handle emergency change control? Hopefully I’m understanding the question correctly, but I guess to answer that question, you should have at your firm a standard operating procedure related to all things change control. That would be emergency changes, routine changes, even what we call “like for like changes,” which are let’s say you have a PSI. gage on a tank and your swapping it out for the exact same PSI gauge, same manufacturers, same specification, etc. That would be a like for like change. Within that document, you should definitely define all of the different types of changes that could potentially exist. You can have emergency changes, equipment changes, facility changes, laboratory changes, specification changes, I can go on and on, but there should be a little section in your standard operating procedures that is typically for emergency changes. Many times firms will actually make concessions for emergency changes because of the limitations of either their hard copy system or their software system. Many firms use a software system or maybe a spread sheet or a computer system to actually handle and track their change controls. Many times emergency changes don’t really fit in very well in the process and therefore they need to be documented in a standard operating procedure, so that both the initiator and the quality assurance representative know what to do. Basically the emergency change really should only be implemented when a person safety is being compromised, if there’s going to be an issue with public safety with the product potentially if there’s a marketing issue that quality can get their head around and agree to saying “yes,” this is an emergency change.

So it really is up to your quality unit to approve that the situation that you’re bringing to them is definitely an emergency and then when you deal with it, you can deal with it outside of the computer system or the software system as long as they are on official forms and then route them around for approved signatures as opposed to an e-signature and then eventually once that change has been approved and implemented it can then go into the electronic system after the fact but there needs to be a lot of justification for stating that your change is an emergency.

So make sure that is definitely a part of your write up, there’s a lot of information that goes into a change control and especially with an emergency change control, that justification is going to be key to getting your quality unit to actually agree that “yes,” what you’re presenting to me is an emergency and to kind of just tie that all together. All of that should be in an already established standard operating procedure. If you don’t have that in your change control procedure, I suggest that you could put in a section specifically on how you handle emergency changes. So hopefully that answers the question.

Terri: Thank you Danielle, Yes, I think that was the intent of the question. If she did not answer the question please let me know if you have a follow up question. We now have another question: How many reviewers or approvals are needed for a change control?

Danielle: So that’s a good question. I have been exposed to many different firms and everyone does that kind of differently. Really what needs to happen is anyone who has a vested interest in your change control or any department that it will affect, really should be a reviewer of that change. I worked at a few companies that utilized electronic software system to manage our change controls and basically what we would do is if it was a laboratory, each team’s would certainly would get a laboratory assessment or review, we’d get a validation assessment or review and we would get quality, of course.

So you really have to look out for the big picture and take a look at the change and take a look at all the different departments that you deal with and think if this change going to affect my interaction or my relationship with that department and my recommendation is if you answer yes to that, they really should take a look at the change. I’ve seen so many times that changes are implemented kind of in a vacuum and when they’re implemented and it effects a certain group and they didn’t really know about it then that causes them a deviation. So there isn’t really a specific number that I can say that should review and approve, but I would say that you definitely need to have the correct people reviewing and approving your change controls. Again, that’s something that you would have to take a look at your firm. Again, using that interaction, how do I interact with this group, that group, will my change affect planning, will it affect the warehouse, will affect manufacturing, etc. Always kind of think about that and you can even set up your hard copy forms or your change control software system to ask you those questions, even as an official piece of documentation, maybe as soon as you write down what your change is, there is maybe a checklist to say that these affect this department, that department, just so that you don’t forget anyone and it’s out there just for you to take a look at and certainly make sure that you don’t forget anyone.

So hopefully will be that answer that question, that’s a difficult one because you don’t want to exclude anyone and basically a lot of people could say to me well let’s just have every department review it. I’ve gotten that feedback as a quality professional before and that’s really not the intent, it’s really just making sure that no one gets left out in the interest of transparency that everyone knows the different changes that are that are going on.

Terri: Thank you Danielle, we have a follow up question about emergency changes: would you recommend documenting emergency changes under change control or as a deviation, also what are your thoughts on temporary change?

Danielle: Now I have seen this done both ways actually for the first part of the question. Some firms actually utilize emergency changes as “quote-unquote” planned deviations. A lot of times you get a little bit of a difference of opinion between quality groups. I worked at a biological firm for quite some time where our V.P. of quality really despise that definition, really thought it was totally out of compliance, would rather use the change control system. But I worked at another company that the V.P. of quality would rather do a planned deviation. So it really is up to your quality unit, I hate to say that, but I’ve seen it done both ways and I think it was presented both ways to the FDA.

In my opinion, if you’re going to do an emergency change, you can do it either way. I like both systems, if you do a planned deviation, it is something that you are documenting in your deviation system, you’re saying, “alright, I’m going to purposely going to go against my procedure.” This is what I’m going to do, this is what’s going to be different, this is how we’re going to handle it, this is the root cause, this is how we’re going to correct it and this is when we’re going to go back to normalcy or putting everything back the way it was. So you can certainly do it like that if you’re going to do emergency changes as planned deviations, please specify that in your standard operating procedure.

If you are doing it as an emergency change in your change control system, again document that in your standard operating procedure and make sure that you again specify the same information. This is what we are changing, this is why it is an important change, this is why we need to get it done ASAP that justification is it’s going to go a long way when you’re sitting across from an investigator or perhaps your quality unit professionals are reviewing it for them to help you out with that and then to agree with you that this certainly is a change.

When it comes to temporary changes, you can certainly utilize the change control system for a temporary change, I have really only ever seen this done in the event of like a construction issue or something that needed to be fixed. One of the things that I had a personal experience with was we had a ceiling leak in our own material manufacturing area, we needed to close off one part and reroute the way people would enter and exit the area. So the traffic flow procedure needed to be temporary we changed and also the amount of gowning that they would wear was changed as well because they were coming from a “dirtier area.” So that was instituted as a temporary change. We had a lot of different action items that we needed to show QA as we got everything back into normal, back into regular operating mode, they needed to come back and take a look to make sure that everything was put back the right way before they would actually close out the change.

So you can certainly utilize change control for a temporary change that certainly what it’s there for, but let’s just make sure that the temporary change doesn’t become permanent. If you see it going that way, that the temporary change is really kind of going to be our process going forward, amend or update that change control to change it from temporary to permanent and again add that specific justification as to why it’s becoming now a permanent change as opposed to temporary. Those are great questions, thank you.

Terri: Thank you. We’ve a follow up question about a change control SOP; Would you recommend one change control SOP or different ones for workflows like validation changes, engineering change orders, computer system changes, critical changes, CMO changes, etc?

Danielle: Well, how you handle changes really shouldn’t be that different. I would say two different change control standard operating procedures. So your change control system for your GMP activities and then maybe an IT system for informational technology changes, your hardware, your software, they kind of go through a different type of review. So I would say that if you have that many different workflows for your change control, you can certainly have appendices at the end of your change control procedures to say this is how you handle the CMO change, this is how you handle a method validation change but they really shouldn’t be that different.

You want to have your change control system kind of friendly to all different types of changes. Again you’re going to have different topics that you’re going to discuss. If you’re doing a facility change, obviously you’re going to talk a lot about construction and utilities and equipment and things like that as opposed to if you’re doing a laboratory specification change, you’re going to be talking about more of QA, validation and maybe changing the regulatory filings. So your change control should be general enough that they can handle really almost any change, it gets a little bit different again as they said when there’s an emergency change.

So you want to make sure that that’s highlighted, but my recommendation would really only be the two change control procedures one for IT, one for your GMP activities and then again maybe putting those flow charts or something like that at the end of the document as an appendix, just to kind of maybe help new users along as to how they can potentially get that change to the system efficiently.

Terri: OK, great. I have someone just making an observation or an interpretation. They just want to know what you think about their interpretation. They think a planned deviation is a deviation from a procedure and emergency change is some kind of improvement that is not necessarily a deviation.

Danielle: Yeah, I agree with that, I can say that a planned deviation is deviating from a certain procedure. That is correct, you have a method that you’re supposed to do or a procedure that you’re supposed to follow and you say “OK, I’m not going to follow that, I’m going to do X. instead,” that is what was in the context of our actual change, our emergency change. So think about it that way, I guess if you’re going to do it, a planned deviation, you are purposely saying what I have is this emergency, I’m going to purposely deviate from it because I need to, because of a safety issue, or this is a threat to public health, or that I can’t even think of the amount of things that could be justification for an emergency change.

So that’s why I said I could see it kind of going both ways, you can do the planned deviation or you can utilize the change control system, just because it has been my experience over and over again for years. I do kind of prefer the change control system to manage my emergency changes. Think about when the FDA swoops in on your site or another regulator comes in and they ask for that all-important list of deviations that they want to see, maybe for the past two years since they’ve been there. If you use the deviation system, all of your planned deviations will be in that report that you give them. So it’s kind of intermingling the two systems together, it kind of brings out the conversation as to “Oh well, how do you do this?” Is this really a change? Is it a planned deviation?

Kind of what we’re doing right now, kind of going back and forth with how they think about it or how your firm would think about it. So think about that as you’re making your decision as to whether the emergency changes should be harboured in the deviation system or the change control system. If they ask for a list of change controls, then your emergency changes will be in there. It’s not going to be a surprise to the investigators. They’re going to expect to see changes that may have potentially been an emergency that you needed to react to rather quickly. So I always think of kind of how I would defend it in front of an internal auditor, corporate auditor or investigators.

So I always think of those lists and that request that they want and always think “Well, do I want my emergency changes to really be called a planned deviations because then I’m going to have to deal with that issue across the table from them and they’re asking different questions about it” So that’s kind of my opinion on it, again, it’s just an opinion, certainly there’s really no regulation as to how you need to handle them but it’s just the way I have dealt with it in my career in the industry.

Terri: OK, great. We were talking about change control and some kind of improvement usually, but here’s a follow up question: What if my change does not improve the system or process? How do I address that?

Danielle: So that’s happened quite a bit in my career. You do the change control, or you go through the process, you get your approvals, you implement it and it really kind of falls flat. That happens with change control, that happens with corrective and preventive action. What you need to do is, as you’re closing it out and looking at all your action items, one thing that quality assurance and FDA actually require you to do now for CAPA’s, which is a little bit different than change controls, is to do an effectiveness check and I actually like to do this with my clients when they’re doing their change controls. When you’re closing out a change control that should be one of the things that quality assurance is asking themselves, alright this department has implemented this change, I see that they’ve closed out effectively, they’ve met all the due dates, they’ve met all their action items and deliverables, but really did the change work? Or was it beneficial? If you go and you take a look at that and say “What? No, it really wasn’t.”

You can certainly you open a new change, referencing the old one. I wouldn’t necessarily say it was a deviation because you didn’t deviate from anything, you’re just saying that this change wasn’t as great as I thought it was or it didn’t give me the process improvement I had originally thought it would. So either amend the old one or the initiating one. If it’s already closed you, can’t reopen them. I don’t usually like to reopen closed documents. So I would just initiate a new one, certainly with some discussion with quality or a department that could help you implement a change that you will think will be successful and then make sure that they do reference each other. You can put in the new change control like “Change Control 2018 ABC” was implemented on these dates. We went out to review it and the change wasn’t as effective as originally thought. Therefore, a new change control was instituted and you can say the step that you took in order to make the process a little bit better with your new controls. So again, just make sure that linkage is there. I’ve seen it happen time and time again, not only with change controls but even with your CAPA plans. Sometimes you think it’s a great idea and it’s going to work great and then you get it into actual production mode and it’s not as beneficial as you thought. So you can certainly open a new one, hopefully that answers that question.

Terri: OK, you talked about effectiveness checks in your previous answer. I just want to make sure this question gets answered: Do all changes need an effectiveness check?

Danielle: Not necessarily, I as a quality professional always do that check, whether or not I go out and actually go on the shop floor and take a look to make sure the change is actually successful. I wouldn’t say that I do that all the time but as a quality professional who is reviewing a change control for closure and you do want to ask yourself the question or ask the initiator the question; was this change beneficial? Some companies that I’ve worked with and for have actually had that as the last question that they asked themselves before the quality group can sign off on it. Was this change beneficial, successful, etc.? Before they check “yes or no” and of course if you check “no,” you have to explain why and then reference either a new change control or some other document. So you can certainly do it that way, as long as everything is documented and you can certainly justify your actions. That is all we can really ask you when you’re dealing with your change control. So documentation and justification really go a long way when you’re dealing with a situation such as that.

Terri: Here’s an interesting question: How do you typically classify and/or categorize change control?

Danielle: That can be done in a variety of ways. So you can typically classify your change controls by either criticality or their type. So basically what you can do is to do minor, major or a critical change and then you can also do a sub-classification such as laboratory change, equipment change, facility change, emergency change, like for like change, etc. So they can be a little drop down or check boxes on your change control form.

So certainly you can put this in your standard operating procedure. What you would define a minor change to be, a major change should be and a critical change to be. A lot of the times, folks will use those classifications for deviations which the criticality really actually works better with deviations. In my opinion, it’s difficult to say if a change is critical or not, I would say a critical change would be something that you are implementing. I hope that answers your question.

Terri: Thank you Danielle. I think we answered all the questions in the timely manner. So, we’re going to wrap it up here unless anyone else has another question. No? OK. Thanks everyone for joining us today. If anyone has any specific consulting needs on this or another topic, please know that we’re here to help and reach out to us at any time we’d love to hear from you. The Windshire Group looks forward to sharing our expertise with you in the future. Bye everyone.

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