Quality Made Simple: Getting Started with QMS

Establishing a compliant quality foundation can be a struggle for many small to mid-sized organizations...where do you start? How do you manage rollout? How do you create processes that are flexible, but fully compliant?

In this webinar, we cover how to: 

• Establish a compliant process for SOPs - from drafting to approval - with configurable workflows and integration eSignatures
• Manage Quality Events - including Deviations, CAPAs & Vendor Audits - with built-in templates for document & project management
• Stay on top of Training with easy course creation, team enrollment and training compliance reporting.

View the full session or read the transcript below.

Full Transcript:

Kevin Tate: Welcome to Quality Made Simple: Getting Started with QMS. We're so excited. This is going to be a lot of fun, and we have a very distinguished guest, our own Angella Hamilton. Just a couple of housekeeping notes before we get going.

Please ask questions in the chat or in the Q&A, either works. I'll be monitoring both and we'll have plenty of time at the end to answer questions. So please don't be shy. Also we will be sending around a recording of the presentation. Don't worry if you don't catch everything or you want to refer back to some slides, we'll send around a full recording to everyone who was here.

So without further ado, let's jump into Quality Made Simple.

Today, I'm going to tee up things a little bit with some context, talk about why quality is so interesting as a topic right now, and then I'm going to introduce Angella who leads our quality solutions and works with all of our customers and getting their QMS solutions set up.Then I'll be talking a little bit at the end about how we've tried to build features into Kivo that link back to some of what helps teams get started with QMS. 

With that, a little context. This is a pretty exciting time in the life sciences space. Probably don't have to tell folks on the call, investment is accelerating quickly. A lot of money's coming into drug discovery. And that's making for a lot more promising compounds.

We're also seeing timelines decrease. So it's faster and faster to discover and test and tee up compounds and opportunities for clinical trials. And that's leading to about a 10x increase in active trials, which is amazing when you think about it. To have a 10x increase in the volume of an industry, it's the kind of thing that requires new approaches.

If we look out to 2030, the estimates are that we'll have over 200,000 active trials globally by 2030. So that's the backdrop for what's happening in the companies and the industry that we all work in.

Partially because of those pressures, what we're seeing at Kivo is that life sciences teams are finding new ways of working.To look at that at the highest level, in the before times, big teams were working together, probably in all the same building, and they were trying to create a big pharma company that was ultimately headed toward a commercial launch. And, to the extent that's how things used to work, it's really not how they work today, right?

Most of the companies that we're working with are actually small distributed teams, and they're working with a bunch of different partners and experts. They're trying to get things done as quickly as possible to build a pipeline of products, and they're always looking for ways to monetize and advance that pipeline.

Ultimately, the end goal, may not be building a multi-thousand person pharma company that takes its products to market. It might be to have those assets be acquired or to find the right partner or to bring them to market in another way. That's a very different way of working together and it creates different opportunities and pressures and roles around the function of quality and what quality means for those teams and how they work together.

To put a finer point on that, as we work with teams in the quality function, there are some traditional ways that they're looking at that. Obviously maintaining regulatory and inspection readiness, figuring out how to balance efficiency with risk management. Something that Angella is going to talk about each different stage of a company's development and then making sure teams can work together in a way that maintains data integrity.

Those have always been key areas of focus for quality teams and the tools that they use. But maybe some of the newer lenses on quality that come from these new ways of working and these faster cycle times for companies might be... you've always got to be audit and diligence ready, even if something is really early in the pipeline or it's a new program, the companies we're working with see a lot of value in making sure that at any given point they can explore a partnership or a licensing opportunity or an acquisition opportunity.

The fact that teams are so distributed today and that people are working across time zones and systems and processes in a way that's so different from what was even five years ago, really changes the role of these systems and the workflows and the processes that they seek to manage and just really staying nimble and efficient.

A lot of the teams that we're working with are getting a tremendous amount done with very small teams, but rarely is the path to success a straight line, right? So being able to adapt to new market changes, add new opportunities to the pipeline, follow success, is key. And so making sure that quality becomes a strategic advantage and gives you that flexibility.

And not something that is holding you back because your system is getting in the way of that nimble efficiency. So with that as the framing, I'm super excited to introduce Angella. She runs our solutions here at Kivo, and works with all of our teams on how to get started with QMS.

And so I'm going to stop sharing and hand it over to Angella.

Angella Hamilton: Great. Thank you, Kevin. My name, of course, is Angella Hamilton. I have been doing this for over 10 years, so I've been helping people select QMSs as well as implementing QMSs for the last 10 years. So I've helped hundreds and hundreds, I have not counted, of companies transition from paper QMS to a different QMS.

So I have worked in large QMSs, and out of the box, completely configurable, you name it, we've worked on it. So many different systems. Based on all my experience over the last 10 years, we're going to share some of those tips and tricks that we've learned, especially five steps to help everybody get started.

Now, this isn't just starting from scratch and moving forward. This is a repetitive cycle that we go through that can help at any point of the journey that you're on . So let's get started with some of these five steps. The objective today is really to provide that five steps to help companies get started or grow their QMS.

We are going to be using the "Plan, Do, Check, Act" Continuous Improvement Cycle as we talk about this. It really helps us implement that into our daily quality activities because we're driving this as a business accelerator, to use that Plan, Do, Check, Act, model.

These are the five steps that, as I've worked with companies, I have found.

The first one is shifting our mindset that quality is now a business advantage. We're moving away from regulations; we still need them, but the focus is on the business advantage. Then we're going to plan. We're going to lay the foundation for that scalable QMS. So whether we're scaling up or we're starting brand new, we are going to lay that foundation.

Then  we are going to design the QMS processes and systems. It's a lot easier than most people think. Then we're going to check. We're going to monitor it. We're going to make sure things are working effectively. We're going to drive innovation from the things that we've learned. And then finally, we're going to act upon what we've learned.We're going to continually improve and scale our QMS more and more. And when we're saying QMS, we're talking about your quality program overall and your corporate culture as well as just a QMS.

Okay, so let's dive in real quick to shifting mindsets. A lot of times I have a lot of customers come to me and [ask], "How do I check off all the regulatory boxes?"

I have had customers frequently ask, "How do I just get quality set up? Regulatory is in place and never have to look at it again". And that's a great approach, except if you really want to drive your business as a competitive advantage, we have to start changing our mindset. And we're seeing that quality, and especially for all those clinical ops folks, you'll totally know what I'm saying. We start looking at Quality as a competitive advantage.

So with that, how do we develop a culture around quality? How do we make sure this is a mindset that's among everyone and not just those who are responsible for quality? One of the things I've noticed as we start talking about quality internally, we talk about the benefits of a quality driven company or a quality mindset. And that of course is greater efficiency. When we incorporate quality for output organization, companies are just more efficient. They are able to have greater process times, fewer risks, and they also have fewer risks so they're a lot faster in getting things done. They're always compliant. They're ready for audits, they're compliant, and they're ready at every stage. They also have greater data integrity, and of course that leads for better outcomes, whether that's faster times to market or easier transfer of knowledge as you are acquired or develop a partnership.

Everything is goes faster. With a solid foundation quality, your market value increases as well. Brand trust increases. So you're valued higher within the industry. That is really shifting, right? We are developing that culture of quality. We're shifting our mindset to see quality now as that business advantage. So it's not just about regulations anymore. It's about how can I have my company function as quick and efficiently as possible? How can I reduce my risk overall? And of course, how can I have that bigger payout in the end? And that really is through that innovation.

The next place we're going to look at is laying that foundation once we've shifted that mindset, right? Quality just isn't a concept. It's a commitment to doing something better every day. We are going to lay that foundation for a scalable QMS. And this is where I get the most questions as we start implementing customers is, "How do I really lay that foundation We're starting to build a culture of quality. What do I do? What's my first part in laying that foundation for a scalable QMS?"

First thing is to understand, this goes back to the mindset. We have to understand we're going to start small and then we're going to grow. Just like Kevin was talking about where [at] big companies, everybody tried to do everything all at once. We're now becoming more agile, where we're taking things in increments, and we're iterating upon those increments, and we're keeping our companies far more agile. We're going to focus just on what's critical. We're going to start to focus on critical, and then we're going to continually improve until we can flower and grow, and then we transition, whether that's through a partnership, acquisition, or you go to market.

Coming here, the first thing we want to do is we want to jump in right away and start writing our SOPs. So I see this a lot happen where people come and say, "okay, I'm going to hurry and start writing all of my SOPs. Can you give me a list?" Yes, we can. But a better way is to just start thinking through your business objectives.

Align your business objectives, because remember, this is now about a culture of quality. So we're going to align our business objectives with quality; now they become the focus. So all of our business objectives are going to have some type of quality focus. And quality is not just regulations, of course, it is leadership commitment, right?

This is what's in our quality policy. Our customer focus is in our quality policy. Our continuous improvement efforts are in our quality policy as well as that process management. We want all of those come together. We want to align those with our business goals, to make sure that culture equality leadership's on board, everybody's on board and seeing how quality is so important in driving patient safety reliability, but also internally as a company and a company culture.

And then, of course, from the policy, we're going to create our quality objectives and those are gonna be our smart goals, right? Specific, measurable, achievable, relevant, and time bound. So we are going to create those quality objectives.

And then it's going to drive all of our other doc processes and documentation that you're creating. A lot of people come to me and say, "How do I write my SOP on document control?" And I always say, "What is your focus and your quality policy and your quality objectives?" Then we can start talking about that, because this is what drives everything.

Okay. Once we understand what we're trying to achieve, we are going to identify those core processes. Now when we're building some of this out, it's really important to remember our stakeholders. Who are our stakeholders in all these processes? Customers are number one, always, or our patients are number one, their safety and the efficacy of the product is always number one.

But we have other stakeholders too. So in all of our processes, this is who we're thinking about as we design these core processes, regulatory agencies are also a stakeholder in our product. We are going to conduct a risk assessment, risk based approach to quality, your QMS can really help you make sure you're getting the right things at the right size, right?

We're not a big plant yet. We're still where we are, but we can start growing those processes and we can just really focus on what's critical. What are their critical processes? So we look at that risk assessment and we identify where the biggest risks in our quality program. And then we're going to consider those quality objectives again, and that quality policy.

We're going to go back to it and say, okay, driving my culture of quality, I have my stakeholders, I understand their requirements, we have done a risk assessment, now we're going to determine how we're going to measure and monitor those things. Customer success; how am I going to measure my customer success? How are we going to measure product efficiency? Especially in the development stage. Very important to really think through that, because it's not always going to be, we have it in the hands of the customer, but what about the potential?

I often get asked , "what are some of the core processes I should be looking at?"

So as we do this, people come to me and ask, "if I have 10 SOPs that I need written, what are those?" First I say, okay, let's look at your quality policy, and then of course we're going to then look at core processes. As we do this is ICH Q10, Q9, as well as 1345. They all have outlined very well what you need in your QMS as you grow.

This really comes from their guidance. A lot of it is that document and data control. How are you going to manage your documents? How are you going to manage your data? Are you going to make sure they are effective, efficient, and you can find the right document at the right time quickly?

Change control is another one. This is a big one with Part 11 compliance as well. Corrective and preventative actions are also important. How are we going to manage this? Your corrective and preventive actions will go into your continual improvement programs and things like that. How are we going to correct to prevent?

One thing I do like to point out here. It's also good to put something before your corrective and preventive actions, whether that's a deviation or an event, where you're just analyzing the event, making sure that we're not always just jumping to corrective actions if we don't need it. If we can immediately contain something, let's do that.That way you're not always doing corrective and preventive actions. It takes a lot of resources. And for small teams, it may be more efficient to be able to handle in an incident or a deviation.

Another thing is vendor and supplier management. Even as we develop, maybe it's equipment, maybe it's compounds. How are we going to manage those and build those successful relationships long term? This is great when you're doing a knowledge transfer to either a partnership or an acquisition, so they understand where your path along that journey for your suppliers and vendors.

The other thing, of course, is how are we going to train and prove competency of our employees? Training, corrective actions, those are the big things when you go through an audit. A lot of findings usually are around training and those corrective actions. And then internal audits and management reviews. A lot of them are like, "we don't really need to do them when we're young and growing."

One thing that's really nice about doing an internal audit and a management review annually, even when you're not distributing a product, is it's a great opportunity to learn! To look back at your QMS, evaluate it, and say, "how can we improve on it this next quarter or this next year?" Or however often you're determined to do it. These are not long meetings. They can be very easy.

I worked for a company a while ago. And they made Internal Audit and Management Review a huge event. Everybody came, they dressed up for this! It was a whole fun activity which usually resulted in lunch. Because quality was so important to their teams. But every year, we'd have this huge management review and everybody was invited. And top leadership would run it. And it was really fun for the half hour that we had it, and we just looked over everything. We saw great opportunities for improvement. We talked about what we learned, what we're going to improve on, what we're going to do over the next year, and management review became a key component of the culture, and it drove a lot of improvements and innovations throughout the organization.

Often overlooked, but very important, especially when we're talking about driving culture and including everybody in the management review that wants to be there. It was optional, but it was a lot of fun, so most people attended.

Okay, so we have shifted our mindset. Quality is a business advantage. We've laid a foundation through our quality policies, identifying our requirements, remembering our stakeholders. Now we're going to do some doing. We're going to design that QMS.

We've laid the foundation for all our design. We understand our requirements. We've even identified some of those core processes. So in doing the design , we're going to diagram first.

A lot of people want to go straight to writing. I always recommend diagramming it. If you can't diagram it, you may not understand it as well as you think you do. Diagramming is very critical because then you can see gaps, right? This goes back into your risk assessment. You can do a quick risk evaluation as you diagram and say, "Ooh, this section here, we need some continual improvement on. Maybe this isn't fully flushed out as we need to". So we're gonna diagram that critical process. So CAPA is a great one to do deviations. How does things flow into a CAPA? We can look at how things are, our approval processes. Diagram those, where can we see bottlenecks happening and how can we mitigate those. Diagramming can teach you a lot in how to do this.

Then we can start writing. Once we get these diagrams, you basically have it outlined and you're ready to write. Procedures and work instructions, your policies, we can start writing all of those. And I'll have some tips in a minute here on writing those policies.

Also important but often forgotten is designating process owners. And hopefully it's not just one person within your organization. Hopefully you can spread it out. I know small teams it's hard. And yet, still designating those process owners so we know, especially for CAPA, who's going to manage those, who's going to manage overall your quality documentation.It really helps just to identify who's going to be part of it because everybody needs ownership in some form or function if you're building that quality culture. We all want to have ownership into pieces of the quality components. Great.

Here's some quick tips:

Keep your SOPs and work instructions simple, eye level. You need to be able to follow it. This goes into the second one, avoid using specific language. It is not helpful when you have a growing team and you've set all these dates that you have to have stuff done in your SOPs because you have to meet those dates.

Keep it a little bit flexible. Use terms from the regulations themselves to help guide you on that because regulations really are guidelines here. Just avoid that specific language. Keep things high level. Don't say, " Kevin is going to be reviewing all my SOPs." we want to keep it high level. When we talk about who's going to be doing something, use roles. That way when people move in and out, you're not revising your SOPs.

Avoid screenshots. Avoid them in your SOPs at all because you will constantly revising your SOPs. That's a lot of work. Let's give you guys less work to do.

Promote a quality culture by making it really friendly. Think about your end users who are reading it. Make it reader friendly, but also use that regulatory language that makes it audit friendly.

Use templates. Keep it consistent. This is the best thing. I know all you experts in quality, you guys know templates are your best friend. Especially to get more and more people on board and you're letting them create some of their own procedures. Templates are amazing. Help guide them so everything is consistent.

And then always, when you're creating these, remember the quality policy and your quality manual. This is what's driving everything, so make sure we're always referring back to it to make sure we are in line with what we set out to do and our objectives.

Kevin Tate: Angella, maybe just to pause and underline this tip.

There's so much goodness on this slide, and I think as we go back to the theme of staying nimble and not getting hamstrung in the policies and the activities that keep us compliant. I have worked with so many customers who have found, either they were a little too restrictive or too specific, or they found that it was just requiring too much changing and updating of the SOPs as they tried to evolve. I feel like there's hours or days or weeks saved in every one of these bullets if you can keep it a little more flexible.

Angella Hamilton: Make it easy on yourself.

Kevin Tate: Yes.

Angella Hamilton: Because if you're an agile organization who is constantly innovating and growing and iterating, changing all your SOPs all the time is a lot of work on you, on your teams. And it eats up resources that you guys could be focused on committing quality within the organization.

So once you get those outlined and everything, and this can be in parallel, is when you start selecting that scalable QMS, right? It's fit for purpose. I worked at one of the larger QMSs, and a lot of people wanted to jump right into all of the features and all the modules all at once, and we're talking, we span the entire life cycle of the product, even into manufacturing, and they weren't manufacturing at the time. So make sure it's fit to purpose. If you're not commercialized yet, don't worry about it. You'll get there. Your QMS should also respect that.

When you're looking for that QMS, make sure that it is fit to your purpose. Your team's ability to innovate is not slowed down during this. Now I will have to say some of the ad hocs can also slow you down. So having hybrid systems and SharePoint and Box, depending on where you are in your quality journey, those will also slow you down, because of how hard and difficult they are to manage. So just make sure, whatever it is, it's fit for purpose.

Sometimes Box is great or SharePoint, but validated systems really do help speed up some of your quality efforts.

Okay, the next thing we're gonna do. So we have that quality culture. We have laid our foundation and then we started develop our processes and design our processes. So once we get them into, whether we're using fully functioning, validated QMS or SharePoint, we are going to check and monitor this for effectiveness. Like a CAPA that you're running where we're gonna monitor and check for effectiveness. We are gonna do data. We are gonna look at all of our data points, clinical trial data, development data, how things are progressing in our R&D. We're gonna look at everything. How are our vendors working? How are our CAPAs working? Is our documents getting stuck somewhere? Is everybody getting trained? We're going to look at all of our points and we're going to go back to how we designed our processes back in the other step and we're going to look at those points in our mapping of all of our processes and really evaluate where we are on all of those.Where can we improve?

One thing I do like to point out is continual improvement isn't jumping from 0 to 100 in a couple days. I did work for a quality company that said, "okay..." -and this was a focus for five years where they actually had the most growth- "Every day, just find 1 percent of your job that you can improve." Just 1%, right? That adds up over time. You're not trying to reinvent the wheel every day. You're just finding 1 percent that you can improve. And the next day, maybe another percent.  You go slowly. This is a gradual process. Quality is a process. It is a journey. It is something that is continuing to develop. We're always just looking for that 1 percent every day and how we can develop our quality and our company and even our jobs in our lives.

The next piece here is management review. This is a big part to check. I said it's often the most forgotten, but it's a great way to get together and discuss what's going on. Look at those results that we just monitored and then say, "Okay. We have all this data. What can we learn from this data?" Our risk and audit results. What about customer feedback? If you're in a clinical trial, what's the trial persistence saying? Process and product performance. How are we doing on developing our product? Continuous improvement, change control, QMS performance, objective and goals, CAPAs and events, QMS... all of these are all data points that we're looking at. And then we're going to discuss it, and we're going to celebrate our wins.

Here's the big thing with management review. This is why management review was such a big thing in one of the one of the previous companies I worked at. It's because we celebrated our wins during our management reviews. So not only are we looking for improvement, we looked at how we've improved that 1 percent every day. And we recognize that we did this 1 percent every day to get to where we are. And then we take that and we say, how do we innovate? How do we become better? How do we change things to make it even more exciting for us and challenging to work here. So all the employees love working here as well as our patients are safe, reliable and have quality products. We look at opportunities for improvement. Management reviews can be tons of fun guys!

The last thing that we can talk about today really is, now that we've shifted our mindset, we're laying that foundation. We designed all our processes and our systems. And then we're going to monitor it, and we learn, so think monitoring, learn. We are going to act upon what we've learned over the process. And we are going to improve yet again, because 1%, every day.

We're going to start scaling our QMS. When I look for QMSs too, one thing I always told clients that I was working with, is make sure that QMS can scale with you as far as you want to go. Whether you're being acquired or a partnership, or if you're going all the way to commercialization, make sure there's components of that QMS that can scale with you.

Five years ago, everybody was looking at handling everything in house. That's changing. We're using more contractors, CDMOs, and so on, CROs to handle everything. As that changes, how can that QMS connect all of those contacts? This really weaves in that quality culture even to your external partner saying this is really important to us. We all need to connect back into our quality system.

Okay, so act. This is where we begin to refine, right? We are going to expand our QMS. We're going to make those small improvements in our product. We're going to make those small improvements in our process. We're going to make those small improvements in our systems and our service. All that will help us reduce cost and it will help us increase our market share.

We're building trust. Even when product isn't in the hands of consumers, we're building brand awareness. We are building brand trust as things get developed, as news articles come out and the amazing things that you guys are doing, you're building that brand trust with all of the market. And it starts from the beginning. A quality culture and building a quality system and the scalable, starting where you're at and building to it is all part of that process.

Continuous improvement. Continuous improvement never ends. It is what keeps the company moving forward. It's what helps you iterate. It's what helps you become strong. And even when that transfer of knowledge, when you're transferring it to acquisition or even to a CDMO, if you're commercializing... you're making it simple enough that you can follow with your policies and procedures, making sure you're tracking that data and then having those continuous improvements.

This is what will excel your company forward. This is when quality becomes a competitive advantage now, because it's built into every department. It's built into every employee. And now you are always audit ready because everybody's thinking about "how do I improve 1 percent more? How am I producing quality results with everything that I'm doing. And that's what moves your company forward as a business accelerator.

This is what I've learned over the last 10 years when we start building out quality systems, and our quality programs. And that the biggest thing, always, my advice is: Start where you are and then build 1 percent every day and think about that plan, do, check, act as you go through the process.

Kevin Tate: Thank you, Angella. That was so great. That was excellent. Perfect.

I'll share now just a little bit, about how we've tried to take these principles in this new way of working and factor that into Kivo's QMS solution. A little bit about how we think about it. And I'll show you a three minute demo of some aspects of the system that we get a lot of good feedback on.

Just to set the stage here. A lot of the teams that we talked to, as Angella said, are in some version of do it yourself with their systems and their processes today. And so a lot of times it's the quality function and the need to standardize those processes that's driving them to look at a compliant and consistent system. But also a lot of the teams we talked to are very experienced and they've been there and done that in bigger companies. And they're saying to us "I don't need, I can't afford, or I don't want a system that is built for big pharma." Just the complexity and the time and the cost of that, doesn't suit their business. So what we've really tried to do with Kivo is create a scalable and compliant solution that's easy enough to use, and brings that flexibility and nimbleness to the business. That's a big part of how we've designed the QMS solution as well.

In terms of what we hear from customers for how we help them support this new way of working, I think the theme is bringing together the way documents are managed, processes are managed, and even projects are managed. This really constitutes the work of a team. How do you create a way for the team to work together around those in an efficient way? And it differs by team. So as you may know, Kivo has solutions for regulatory and for clinical as well. But when we talk about quality and how those three things come together, it really comes down to making sure that documents are managed organization-wide in a way that's part 11 compliant, and that gives you control over those documents and their lifecycle.That the processes that are key to quality, like managing vendors, managing quality events and activities, managing training, like Angella talked about, that those processes are managed in a consistent way. Finally, the ability for that quality leadership to monitor and report on team activities and projects and make sure compliance is maintained. So that's how we think about that stack when it comes to the quality solution.

Now I'll take a look at a three minute mini tour for how Kivo does those things. This is what Kivo looks like. And you can see right here on the home page, I can get to the quality area, where my controlled documents are stored. When it comes to storing and managing documents, we try to make it very easy to see where everything is. So familiar folders and names that follow the EDM reference model. And then if you're managing your SOPs in Kivo, then every SOP, and every document has its own homepage here where I can get to all the versions and see its effective date and manage metadata and so on.

I can also control how that document evolves. So you can see this one's in the process of being updated. These four people are involved in the drafting of that new SOP. And I have a prescripted workflow for draft, collaborative review, final review and approval. All these can easily be configured to match those SOPs and to match the way that you want to work around documents.

If you do end up updating those documents together, you can even do that in your own Microsoft Word applications with Kivo, which is really convenient. No check in or check out or anything like that. We manage it all directly. So that's documents and it brings a lot of consistency and control to the document side on the activity side.

You can manage any type of quality activity in Kivo. Here are some examples. When you define an activity like a deviation, you can capture all the key information about that activity, and that will allow you to automatically file it away in your QMS, even creating placeholders for expected documents or generating documents based on templates. So again, turning SOPs into activities and documents, Kivo can take those and turn them into templates to automatically generate those documents based on key information around, say a deviation or a change control.

Then finally, when it comes to projects and staying on top of that work, we have a built in project management tool.

So if I go over here to my vendor area. I might be conducting a vendor audit for pharmagenics here. In addition to capturing all that vendor information, I can create a project for that audit. Again, coming back to a consistent way of working, I can create a template for how vendor audit should work, what those steps should be and who's responsible for them.

Within each task, I can link those tasks to a document so that it's easy for me to automatically keep track of what documents have been created, which are under review, and which has been approved. I can even manage my project and watch things move across the Kanban board or have my Gantt charts line up as I manage that activity.

So really trying to bring together that concept of documents, process, and projects, and a way that supports the entire quality function, and that you can report on. If I'm looking at something like my training course report, I can easily see who's completed what courses, what version and when, and so I can generate my compliance reports across all quality activities.

So that's how we've tried to create a system that easily supports not just getting started with QMS, but also evolving through the steps that Angella talked about. With that, we've got some time for Q&A, and if you have more interest in more information or want to see more tours, please visit us, at Kivo.io. We've got a lot of great information there on the site.

But Angella, I want to get to a couple of questions that came up in the presentation. Maybe dig a little bit deeper. So, what is around the quality policy? You mentioned the importance of that upfront, and I strongly suspect that's an area that gets skipped sometimes, as companies are so focused on getting to the implementation. What advice would you have for helping put together a right sized quality policy to start?

Angella Hamilton: Yeah. Great question. It's one we do get often. Running your quality policy is very just focused on, and by the way, just before I say this- once this is done, communicate your quality policy! Put it on your website, put it on everything, make people understand what your quality policy really is.

It's a document that you're telling people that you are committed to quality and to how you're committed to it. It is basically stating those couple of things. Here are what we're trying to accomplish in this company, and this is our commitment to quality. That is your quality policy, and it's not long! This is short.

And then of course you have your quality statement in a part of that. That is what you're you're broadcasting. Just think through a business objective are always part of developing that quality policy. That's so key. And it gets to another piece you touched on. I loved your example of the quality management review event, people getting dressed up. I picture everyone putting on their suit and tie! But it gets to a really serious point, which is how do you keep everybody involved and caring and on the same page about quality. This is a long journey for a company, right? Not just quarters, but years on this path. And so how do you keep everybody in the quality tent, if you will?

It always starts with leadership. Making sure everybody on leadership's on board. If you have a company meeting, highlight something positive that's happened in quality! Reinforce that. Reward people for quality. I was talking to a friend and they told me a story. They had an employee who did everything. He was very consistent. He was in a manufacturing plant. So there's a little scrap work. But he was very slow, right? And so he was always getting told he needed to be faster and faster. One of his leaders actually went to him and said, "Hey, I am going to acknowledge that you are amazing. You have zero scrap work" and that changed everything for that employee.

Kevin Tate: A little goes a long way. Just a couple of questions back to our theme of getting started. I think, a lot of the companies that we talked to are using SharePoint or something like that today and trying to figure out when and how to make the move to a full QMS.

Based on all the things you've seen, what advice would you give in terms of how to think about when it's the time to move and how to make that move?

Angella Hamilton: When you've outgrown your current system or your current way of doing things, it's becoming a little bit harder to keep up with your day to day and not spend all your time managing quality. That can come very early for some companies, depending on how much documentation you're putting out, especially as you start developing your product.

A lot of companies [say] we're not there yet. We can't make that investment. But one thing that I've seen over and over again, working with both people and in out of basic systems as well as a full QMS is that risk evaluation. How many times am I missing approvals or how long is it taking me to get something done because I'm chasing something around via email? How many versions are missing? How's my collaborations going? Especially when you're creating all of your documents around your products. Reporting: where am I putting that reporting? How am I drawing that data from my reports? Am I doing it all together or can I find a system?

Then once you say, "my risks are too high"... risk based approach. I'm missing too many things. I go, okay, now how do I transfer over? And that's where we go back to. We plan, right? We look at our quality policy, we go back to our objectives. We say, this year, here is my objective, is to implement a QMS.

Then, I'm going to start thinking through what am I trying to achieve? What are my business concepts? Then I'm going to go into a quick design of what I want happening. And then I'm ready to talk with another QMS. I shop around, and I find those things, once again, fit for purpose. You're finding what is fit for your purpose.

Kevin Tate: Yeah. You learn a lot by looking at different systems and different ways of working and seeing how they've organized it. I love what you touched on there in terms of risk, and also just the pace of play. Back to the tee up for this conversation, the pace of play is accelerating in our space so significantly, and these are systems that can either help you accelerate or end up slowing you down.

Something we think about a lot, Angella, thank you so much for your time today.

Angella Hamilton: Always welcome.

Kevin Tate: Thank you everyone for joining us. We really appreciate it. And again, we'll send around a recording of the session today. If you have any other questions, please don't hesitate to come check us out at kivo.io. Thanks all.

Angella Hamilton: Thanks everyone.