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Today on the podcast we're introducing a new type of episode: Quality Quick Tips.
Periodically we'll focus on specific aspects of quality management on the show since we love to nerd out on all things quality and compliance. Call us weird. Call us what you want, but quality management is what we love to do. And we do it well ...so why not have some fun along the way!?
Today, two of Qualio's QA experts, Kelly Stanton and Ezra Kelderman talk about how to maintain and improve your quality management while working remotely. It was a conversation that they had in the midst of the COVID 19 pandemic, but it still applies today as many organizations are still adjusting to a "new normal" of remote quality work.
They cover important aspects like:
- what questions to ask to better evaluate and prioritize tasks
- the what and how to communicate about quality issues remotely
- how to manage remote audits
- the importance of documentation
- much more
Building and improving a culture of quality at your company can be done remotely as effectively as if it was in person, and this episode can help you show how that's done.
Hi, everyone. Thanks for joining us for another episode of, from lab to launch. We're really glad you're here. If you haven't already, please hop on over and give us a positive review on iTunes or subscribe to the podcast. We'd love to have you following along. Today, we're introducing a new type of episode called quality quick tips.
We'll do these types of short episodes periodically that focus on specific aspects of quality management. Since we love to nerd out on all things, quality and compliance. Call us weird. Call us what you want, but it's what we love to do. And we do it well. And we like to have fun along the way.
Today, two of our QA experts, Kelly and Ezra talk about how to maintain and improve your quality management while working remotely. It was a conversation that they had in the midst of the COVID 19 pandemic, but it still applies today. As many organizations are still adjusting to a new normal of remote quality work, they cover important aspects like what questions to ask to better evaluate and prioritize tasks, the what and how to communicate about quality issues, how to manage remote audits, the importance of documentation all of these changes that are happening. Internal and external factors and a lot more. Building and improving a culture of quality at your company can be done either remote or in person, and this episode can help you show how that's done. So let's bring in Kelly and Ezra.
Kelly Stanton: [00:01:37] So hi everyone and we really do appreciate you taking some time out of your day to spend some time with us talking about some of the things about remote work and, managing a quality system from that perspective. It just in talking to some of our customers, as well as other colleagues in the field, it seems that the the impacts of this whole global pandemic have, varied pretty widely from some organizations just being completely shut down at the moment to other organizations where they're actually busier than normal because they're spinning up ways to help fight the pandemic I'm aware of other organizations who have pivoted to their whole manufacturing operation is now focused on trying to make hand sanitizer or, other PPE type products.
So, yeah it's, an interesting time to be in quality. The regulatory landscape is certainly a moving target at the moment as well. So that's another challenge to to be managed, but we wanted to spend a little bit of time today, just talking about ways to.
Continue to, operate your quality system per the regs in a way that's compliant. We don't necessarily have the luxury of, just setting everything down and walking away for the next month or two months or however long. So, some of the things to, to look at from a quality system perspective is, really what's critical internally and, how your operations have been affected.
Looking at the the ripple effect of those things. If you're a small startup and you're managing all of your products processes through a contract manufacturer, obviously there's a lot more communication that needs to be happening. We're personally experiencing that in some cases, That communication is actually very interrupted because the CMO has pivoted they're making hand sanitizer.
So they don't really care about developing our product right. This moment, because they're all focused on hand sanitizer. And asking ourselves what processes are still operating, what are broken And then applying some risk management some organized thinking about what are the impacts of, that process.
And then what are you doing to mitigate that? If you're a quality unit supporting an actual main like you have manufacturing in house, you know what processes are still running? What is broken some manufacturers, of course, in, in our efforts to enforce social distancing, for example, that might have an impact on your manufacturing floor and, people being in there at the same time and how close the, operations were.
All of that stuff is are things to consider And as you're going through those processes and, looking at resourcing and allocating those resources, obviously the production group, the operations type groups are are managing those decisions. And as a quality unit, your job is to support those decisions.
If, Processes and operations are having to change from a quality system perspective. How does that impact training for example are we having to throw together new procedures, get everybody trained quickly, or as. People get sick and can't come into work and operations is having to move resources around to keep manufacturing, operations running.
Are there new training needs that need to happen. And, in that in all of that vein, are you as the quality unit, are you still working on site? Are you working remotely? Or some hybrid thereof and just making sure that as these. Things happen and you react to these things that you're capturing all of that from a document perspective, because in the end when, this is over and we're all getting back to normal in our new normal, whatever that looks like if we didn't document it, it didn't happen.
That's our favorite saying from an FDA perspective. Just making sure that you're capturing all of these changes and if you need to set up a new risk management template form, for example, and say, okay here's the change that happened, obviously your change control process.
Comes into play, but how you justify or document there, the risk assessments and things behind some of that might might change, might need some more rationales and that sort of thing. So that's some of the, internal parts. And then we talked a little bit about external, but do you wanna spend a minute here talking about the external stuff?
Ezra Kelderman: [00:06:06] Absolutely. And Kelly said, you're going to have these internal changes and they could impact your external changes and vice versa. If you're a virtual manufacturer, you're obviously going to be impacted by your supply chain. And, obviously if you're doing your full operations in house, you're going to have supplier impacts as well.
You need to ask yourself what part of the supply chain is disrupted. What's the impact there? Are you going to have available parts as you predicted parts and components that were on schedule before? What's that look like now? Obviously it's likely going to lean towards delays in that area.
So how, can you balance that and manage that? How does that impact your internal scheduling and how you keep your day to day operations running? For a lot of folks it's going to look like operations are going to slow down. So do you shift some of those folks towards your quality efforts or have things sped up if you're working on COVID related products and do you have some of your quality team helping.
Over in operations or helping your suppliers meet their demands. So it's a lot of scattering around and Kelly said you really want to make sure you're documenting all these adjustments and making sure if you're remote, you have the ability to do also related is travel restrictions.
So if you have. With this going on you might've run into needing to audit a supplier. How are you able to do that? Do you need to visit your contract manufacturer to check on their operations, how they're getting by, with developing product. You may be fully adjusted to working remotely and.
And all the logistics that come with that. But you can only be as prepared as your supplier in some of these situations. So really coordinating with them if they're able to getting. Audit related activity set up zoom meetings whatever outlet you use can you take virtual tours of the facility?
Do you need to look at the manufacturing process over video? How are you, preparing for these things? So there's a lot to think about in terms of external preparations as well. And also, and I'm sure a lot of you thought of this as well as is what's the response from the regulatory bodies.
Are we still on audit schedule? What's should be expected audit. And, that's going to differ depending on are you manufacturing product already? If so, what's that mean? If you're in development? You may have submitted 510 Ks, or you're waiting for response from FDA or any regulatory body on any questions you have or submissions are we expecting 45 to 90 days on something on a response.
If you're not working on COVID products, you may have an extended Delay on response to that. So these are all things you'll want to consider is where am I at in the priority chain with, COVID going on? And what, should I expect from the regulatory bodies in terms of attention towards my operations?
It's likely you're not going to be audited right now, although I, I. We're in the same space as a lot of you where we're, not sure this is really unprecedented right now. It's really, important to consider these things in terms of how you prioritize your day to day operations right now.
Kelly Stanton: [00:09:49] Yep. So again, working remote's We can't just walk down the hall and pop into some of these cube, ask some questions about things keep those things off the record and then go back to our official system of record if you will.
And and document those conversations. Some, other things about managing your QMS, right? Communication is really, critical on, on lots of levels, but obviously in this situation It, takes on a whole new level of criticality. So one of the things that's really, important and this is true, whether you're in the office or working remotely please ensure all official communications related to quality issues are captured and channeled to the appropriate storage location.
The last thing you want to have is lots of let's say your operations are still running. You've got a problem on the floor. The, initial communication could be, Hey there's this problem on the floor emails happening. And then pretty soon it spins into everybody on the email thread.
Speculating about what might be happening on the floor, these shut that stuff down quickly. Anything that you communicate or put into writing can, is discoverable. And, so in the horrible event of an example I used to manage a complaint or a complaint group for a medical device organization.
And periodically customers like lawsuits would occur right over product issues or perceived product issues and everything in our complaint files. Is discoverable. And having to sit through depositions and be asked, are there any other communications related to this issue?
No, there's not. They're all in our complaint system. You need to be able to sit there and say that with with all confidence that there isn't some email threads somewhere that might come up later where there was speculation about problems that were happening. Ideally your personnel are trained in your Kappa process, your non-conformance process, your complaint process, the people who need to be involved continue to be involved, even though you're working remotely.
It's probably worth. A conversation and it could be an email to say, if there's any of these issues please pick up the phone, have a conversation follow up that conversation with the email iteration of what you just discussed, if it is something that needs to be part of those official records.
But the alternative is of course, to have people putting the conversations into those records directly. Assuming you have a robust electronic quality system. That's very possible. People can continue to work on these things no matter where they're located. But yeah, formal communications policy around quality issues is Again, it tends to go unsaid when we're all working together in a manufacturing facility.
For example, now that we're working remote this is, a very important consideration. If you're not sure, or if you see one of these email threads starting to spin out of control pick up the phone that's S wait, stop, full stop. Let's get on the phone. Let's talk about the issues.
It's not to say that those speculations, the troubleshooting, all of that shouldn't occur. It should. Absolutely. And everybody has their perspective on the issues as they happen. And that's important to capture, but it's very important to capture those appropriately so that you don't expose any UN inappropriate risk to your organization.
Ezra Kelderman: [00:13:22] Yeah. And I'll just add to it, finding what works for you is going to be different. Based on your organization. So if you're making the switch right now, or if you've already made it you may find yourself using Skype and teams and Slack and all these different applications thinking the more, digitally plugged in, I am the better where the better we are and the more efficient we are and you'll find pretty quickly If you're not organized in the digital realm, you're going to miss just as much stuff.
Whether it's catching a week later, Oh, marketing sent this advertisement out and QAR aid didn't even see it. How did that happen? It may have been sales and marketing may have blasted it on every channel and said, Hey, take a look at this. But if. If the way you're receiving those communications and the, group set up aren't well-organized or if there's if you've got a hundred groups set up yeah, that's a lot of groups and that's great, but he started getting in the weeds pretty quickly and it becomes less folk, less focused.
Just keep an eye on that. If you're remote More isn't better. Just keep trying to focus on what's efficient. What are the right channels for each process? And there's a lot of growing pains involved. I've never run into a perfect system yet for that. It's yeah, it's always a learning process.
Kelly Stanton: [00:14:47] Definitely. Audits. a reiteration, right? Our, normal business as usual for for your onsite audits we all have processes set up for this summer, more formal than others depending on the how your organization is run.
But obviously on site is, kinda. Out of the out the door right now. So on one hand, it's nice there's some logistical things that we don't have to worry about. Helping the customer that's coming in, find a hotel nearby or any of those kinds of things.
But again, the documentation piece, which is outside of the facility tour, what they're coming to look at. What we're experiencing in this, realm is, definitely a little more upfront scope asks, scope specificity, for example. It's, that normal audit process to request a copy of their quality manual and their procedures list.
And then you read and look through and start directing the things you're. In the thing, the flow, the things you're wanting to look at and we're finding that we're having to provide more of that information upfront so that the oddity Can prepare and figure out how they're going to make those records available to us to review if they have any QMS could be possible to, provide remote access to a system if they don't have that possibility, then it's a whole new challenge.
Some of those guys, whether they're having to have somebody go in and scan things or put things up in a, shared drive location and then obviously all the security and, things that go around that so there's, definitely some some interesting changes to this process as there a, did you have any other thoughts here?
Ezra Kelderman: [00:16:30] Yeah. Then you might just this is going to be another area where you might have to get creative and really rely on your communication with your supplier, whoever whatever the auditing situation is to, work something out. If you're scheduled to, to audit a supplier right now, but you've had operations shut down the last two or three months.
You really, you want to take that into consideration. Do I even need to audit at this time? Or as long as you have the proper justification for what's going on there's a whole lot to consider at this time if, it's really needed. So take all those things into account.
If you can work out with a supplier, like we mentioned earlier, if you can. Take a virtual tour. If you can get pictures of the process and attach that to an audit report with all the pertinent information and what you would normally report on it's really, a time to get use some creativity as long as you're capturing things with, risk and having these records documented in mind.
Kelly Stanton: [00:17:31] So, there are situations certainly where One might argue that QA is, least effected in terms of being forced to be remote, in many organizations you might have some of your quality folks that are very embedded in your manufacturing teams.
They're highly effected, and then you have. A whole lot of your quality organization, that's the behind the scenes just supporting from that documentation perspective and keeping, things going. Again, outside of the scenario where you have a paper system in place and your files are all stored in the office you can if you're, not.
Running your manufacturing and trying to keep that up and running. What, kinds of things can you, look at this is a good opportunity to really assess the complexity of your quality system. Change control looking at descriptions and references. Does your change control require nine people to sign off every time?
Is that. Is that really necessary? And, it's, sometimes it takes some of these sort of emergency use situations to really look at. The, system as a whole, how big and, structured has it gotten and is that really necessary to be compliant? It's, a good opportunity to look for some efficiencies in your processes.
Maybe isn't the time to make those changes, but it's sure a good time to look at that process from that perspective and say is everything in here really necessary? In this sort of shutdown mode where some core critical processes are still running, but everything else is on hold.
Maybe it's a good time to build in a little bit of flexibility to your processes, to account and allow for those things to happen. Training. It's another good place to to spend a little bit of time. If you find some time on your hands that other records up to date looking at effectiveness as a whole, right?
The regulators continue to scrutinize training effectiveness. And what does that mean? Is it a time to look at some of those riskier processes or if they're still running right now, obviously they're. Maybe they're more essential. What sort of additional controls might need to be in place or are there controls in place that aren't necessary?
It's a good time to look at some of the redundancy and see if you can trim things back from that perspective quality planning that sort of thing this is a good time to look at those. So you know, it's a good time to spend a little effort and focus on some of those objectives metrics. Development plans, et cetera. Azra anything else you might add in
Ezra Kelderman: [00:20:10] here? We all know training is exciting and, we've all been part of those organizations where everybody's read the docs that have been released and looked through them, but by the end of the year, nobody could tell you what they've read.
Use this time. If your organization has a lot of downtime to just. Hey, let's talk about design control. Let's go over the main points. Let's go over the main points of risk management, just some of the heavy hitters it's it might be one of your best times to get everyone's focus just depending on the situation you're in.
I know from personal experience training and really documenting the effectiveness. Of your training plan is just, it's one of those things that's really hard to stay on top of and really accurately gauge. Might be a good opportunity. I know of reached out to a family member who right now this he's in the medical industry and everything's shut down and he's just I'm on conference calls all day and they're really just about nothing.
I'm just trying to fill time, keep everybody communicating. So if you're in that situation setups and some light training material here and there and, keep keep, focused on this is what we do and, it might be just a good milestone to get that knocked out and, really everyone caught up to what they've been doing the last year or so.
Kelly Stanton: [00:21:36] Yeah, good opportunity to short cycle, that annual GMP training. So we all have to go through,