“TrackWise solves a lot of problems that we have. Having an integrated quality management system, at the same time good reporting structure, good dashboards, and query management in such a way that we can get answers to all our metrics and management reviews. They understand what we need, and they come up with a solution to that.”

The post Voice of Customer: Suruchi Sharma, Regional Quality Manager @ Abbott | Experience with TrackWise Quality appeared first on Honeywell.

“TrackWise helped us to implement all the modules easily along with required IT infrastructures and helped us to harmonize the process across sites.”

The post Voice of Customer: Jagdish Meghrajani, Senior Manager IT @ Zydus, | Digital Transformation Journey with TrackWise QMS appeared first on Honeywell.

“People have to change their thinking on CAPA. They can’t think that CAPAs are burdensome or take too much time. They have to see how powerful, how proactive this tool is and how it can shape the future of quality in your company.” 

Zillery Fortner, Product Advisor, QA/RA Life Sciences, Sparta Systems, a Honeywell company

Welcome to Forging Connections, a podcast from Honeywell about the convergence of IT and operational technology for industrial companies. We’ll talk about the future of productivity, sustainability, safety and cybersecurity. Let’s get connected.

Michelle Dawn Mooney (00:20):

Hello and welcome to Forging Connections, a Honeywell podcast. This is another installment of the series, Shaping the Future of Quality. I am your host, Michelle Dawn Mooney, and I am thrilled to bring on our two guests. We’re talking about flipping CAPA on its head with prevention and understanding the root cause. To bring more information to that topic, it is my pleasure to bring on Bethany Kearney. She is the Director of Enablement for Sparta Systems, a Honeywell company; and Zillery Fortner, who is product advisor, QA/RA, Life Science for Sparta Systems, a Honeywell company. Thank you both for joining me.

Zillery Fortner (00:54):

Thank you for having us.

Michelle Dawn Mooney (00:56):

So, before we dive right in, let’s get a little bio. Bethany, Zillery—can you give people a little bit of a background?

Bethany Kearney (01:03):

I’ll start with my bio. I’m a life sciences expert. I started in pharma and quality systems, in quality control specifically, and progressed through quality assurance in compliance roles. In clinical, in working with medical devices, I’ve worked with multiple quality systems across my over 15 years of experience and most recently joined Sparta in 2019. I help our customers move from TrackWise to TrackWise Digital, using SaaS solutions and offer my expertise in life sciences to really make sure that the customers get what they need. I most recently joined the services team as a Director of Enablement to make sure that they’re trained appropriately on our software as well.

Zillery Fortner (01:51):

And I am Zillery Fortner. I’m the Product Advisor for the QA/RA life sciences at Sparta Systems. I got my bachelor’s degree in Health Science from South University, and I have over 20 years of experience in the medical device arena related to quality assurance, regulatory affairs, surgical arena and JACHO. In addition, I also served 10 years in the military as a certified surgical tech. I’m actively involved in groups including RQA, RAPS, PDA and ASQ. That’s me in a nutshell.

Michelle Dawn Mooney (02:38):

Very, very lengthy resumes there. A lot of numbers Zillery you’ve got going on and I am really excited to have you both here because you obviously know a lot about the topic at hand. And before we get into that, I guess we could say this is kind of that old saying “an ounce of prevention is worth a pound of cure.” We never want problems to happen, but unfortunately they are often inevitable. And before we go into some ways to hopefully prevent them, let’s take a look at some examples and how costly they can be, not just from a monetary standpoint.

Zillery Fortner (03:10):

So, I can give an example from the medical device side on not looking at the preventive measures and not determining the true root cause of what was going on. We had some products that were constantly getting complaints. A CAPA was opened. There were nonconformances because the product wasn’t wearing well. It was a reusable medical device, like a gown you would wear in surgery to protect you during surgery. The gown would just rip. If it was repaired, patches wouldn’t stay on. They were supposed to last 100 lifecycles. So, it should have been able to be used a hundred times approximately. We were getting like 30 to 40 uses out of this when they would try to repair it, the barrier, which makes it a certain level gown would not meet those criteria anymore. Once we finally took the time to dig into truly what was going on, truly what was happening, we noticed that the complaints or the MDRs that were reported for safety with patients that they really stopped at a high level. They didn’t dig down deep to truly find out what was going on. It was human error, human error, human error. They didn’t inspect something right. They didn’t repair it right. It was never truly looked at, to see what was going on. And there wasn’t a global communication between the different facilities. There were multiple issues going on multiple times. It was closed with CAPA saying it was fixed. And when it actually came down to it, the true root cause was a chemical reaction. So, the chemical was reacting with the material, which degraded in, in the barrier and wouldn’t allow you to repair it. This could have saved millions of dollars if we would’ve just taken six months and done it right and truly, truly understood the problem.

Bethany Kearney (05:25):

I have an example like that from the pharma industry where human error was determined to be the root cause time and time again. The background is that it’s a similar kind of issue with the product itself, but the analytical staff was initially blamed for not mixing the product properly. So, there were OS results that were found and the root cause was determined to be human error, human error, human error. And it wasn’t until it went through manufacturing to the full OS investigation, and then they pushed it back to R&D and they figured out that our API in the product is inadequately distributed. So, it really mattered the way they were collecting the sample from the packaging itself. So, the affinity of the product to the packaging was the true root cause.

And there were numerous human error OS investigations prior to that. Finding the true root cause is very complex. It’s easy to blame a human. And if the firm is a hundred percent focused on metrics, then finding the true root cause is going to be very challenging because in some cases it is costly. But it’s much more costly to not know that true root cause. So, I understand that it’s a paradigm shift for organizations but putting in the time to do it right is really where the value is.

Michelle Dawn Mooney (07:04):

Yeah. Not just costly as we talked about from a monetary standpoint, obviously you mentioned millions of dollars there in that particular example, but just the time and the stress level of trying to figure that out and in hitting your head against the wall of why isn’t this working. I mean, that really takes its toll on your mental state as well. So, let’s move on to how we can reduce these issues to have better safety, better quality, and prevent these things from happening. Is that even possible?

Zillery Fortner (07:35):

It’s very possible. And it’s all about prevention. It’s all about constantly continually improving something. You know, when I look at myself every day, how can I make one improvement, one adjustment to make myself better. Right? You take that same mentality. There’s a simple thing that’s been out there for a while. It’s called plan, do, check, act (PDCA). You have to have support—or like you were saying, you would beat your head against the wall. If you have no support, no involvement from the key and the right stakeholders, you’re going to struggle. They have to promote quality, strong quality, and they have to prioritize improvement plans. And it also has to be cross-functional. Everything might sound great to me. It’s my fault. It’s my plan. Yeah, it’s perfect. But does it sound great to the other team members? To people that actually have to put this in place and not playing the blame game? When you look at CAPAs it’s very easy to point a finger. You can’t do that. You can’t blame Bethany for this problem. I, I really need to understand why it happened and fix it. And you also have to make sure that you’re ensuring what you fixed worked, and that doesn’t mean for a week. That means you kind of stand there and watch and make sure that this isn’t happening yet again, because if it’s happening again, you didn’t figure it out and you need to start over.

Bethany Kearney (09:08):

Yeah, that resonates a lot with me too. And I do want to dig in further with that effectiveness piece that you were just mentioning, because you really do need to ensure effectiveness, making sure that you not only have the right time allocated for an effectiveness check, but your sample size. And is that appropriate to identify when those failures occur? Don’t be so close minded to think that this can only happen for a single product. If it could be something that’s happening that you didn’t initially take into account in your CAPA, but it, it could be across your portfolio. So, yeah, I think one of the things that are challenging to the teams that I work with across different organizations is what to do when your CAPA is not effective. And what I would, what I guide them is don’t hesitate. Don’t delay opening a new CAPA.

You see that there’s a piece of your effectiveness check that failed. Then you don’t have your right root cause, or you didn’t appropriately respond in your actions. So, it’s okay to do it again. And I know there is a big metrics game, but if your effectiveness check didn’t go as expected then open a new CAPA, do new actions that are more meaningful as far as finding resolution to that true root cause. I do get pushback on that sometimes. So, I’m open to feedback on that. I guess the only other thing here is that culture piece that you mentioned with effectiveness checks, you make sure there happen and you have those right stakeholders involved because there is going to be bias. So, if it happens in your manufacturing site, at your lab and your team completed those CAPA actions, make sure you’re accounting for some of that bias. And everyone knows that you want things to work out great and do it right the first time. Sometimes it doesn’t happen. You have to be open to know that the effectiveness check might not pass, and you need to have that clear criteria in that effectiveness check. So, you trust, but you also need to verify.

Michelle Dawn Mooney (11:28):

Yeah, and effective being the key word, because if it’s only 50% or 75%, or even 95%, there’s still that 5% that’s going to come showing its ugly head in there and is, is going to be not what you want to have happen. So, let’s dive a little deeper into this. What specific elements are needed for an effective CAPA process?

Zillery Fortner (11:50):

On paper? This is easy. I mean, and Bethany can kind of dig into them further, but on paper there’s considered to be seven steps to a CAPA process. The first is identify—how did this happen? I’m identifying my problem. Next, I’m evaluating this. I’m basing this on data on history, on the impact of the problems, costs, quality, safety of customers. That’s huge to determine the risk. Then, number three is develop and investigate. Four, analyze the problem. Five, I create my action plan. Six, I implement it. Seven, analyzing the effectiveness. That’s our perfect seven steps to a CAPA. But you know, you have your companies, you have to believe in true quality. They have to promote this. They have to live and breathe these seven steps.

Bethany Kearney (12:52):

Yeah, it’s great that’s on paper. And we like to apply what’s on paper to our electronic systems too. And thanks for covering that, Zillery. I love that it’s the Greenfield’s perfect world version. And we do adapt our quality systems to what it could be. And of course, there’s the differences between pharma and medical device as well. So, I just wanted to kind of backtrack a little bit with the initiation part where some of the initial CAPA steps are determined, or perhaps your predecessor, like you’re out of specification investigation of a quality event or complaint that is capturing your initial information. So, you can expedite through those initial steps of your CAPA process, given that maybe some of that root cause is already determined and jump into CAPA planning and execution. In pharma, this is your typical use case for that, where your investigation step occurs on that initial event.

And what we see in the SaaS solution world is that those will be automated for your CAPA to really make those steps abbreviated so you can jump right into your action once your root cause is known. The other way that we see folks influencing the CAPA process and abbreviating it where possible, is using that Make CAPA Cool program from the MDIC group that was sponsored by the FDA and they’re creating this fast track CAPA. So that’s typically where the product is internally controlled, low risk issues that occur. So internally controlled, meaning didn’t escape to market. So, would it be a customer complaint? And they’re able to get through the process and sometimes justify not having an effectiveness check. So, there we’ve seen different adaptions on the CAPA process depending on risk. So, it’s pretty interesting and dynamic, although we have the regulatory requirements to push us to always to do the right thing and make sure that there isn’t recurrence where possible.

Michelle Dawn Mooney (15:05):

Let’s talk about the flip side for a moment, what happens when CAPA goes wrong? So, what factors contribute to basically the opposite of outcome of what we are hoping to see?

Bethany Kearney (15:19):

So, I see that where issues persist when the quality teams don’t conform or don’t confirm the root cause. So, they can’t address the root cause in the CAPA actions. They’re just not finding the true root cause. So that’s going back to our example with blaming people and this kind of mentality, or issue with the CAPA process that can cause catastrophic harm to a patient and to your product by issuing a recall and causing brand damage to your company. In the case where I talked about earlier, where human error was blamed, this was a major issue in the lab itself that caused people to go on the improvement plans. And they just wanted to leave the company because they knew they were doing it the right way. They were following the procedure and they were still being blamed for something that ended up being a product issue. And that really tarnishes their relationship and their trust with the company. And we’ve lost a lot of great talent from that.

Zillery Fortner (16:22):

And you also have smaller companies that won’t survive. Some of these major CAPAs that have been opened, not finding the true root cause, going through a recall, and suffering from brand damage. They just can’t bounce back like a larger company can. And some CAPAs are very simple and then some of them are very complex. It can be as simple as poor documentation, but then they can come to not tracking and tracing. Maybe you didn’t validate something, your effectiveness plan was poor and you continued, you used that thinking of “I already know the problem.” So, you didn’t look at it deeper. And I go back to the one with poor top management, the understanding true quality.

Michelle Dawn Mooney (17:16):

When we talk about CAPA, obviously every facet of what we’ve discussed here today, involved a lot of time. There’s thinking, there’s planning, there’s replanning, there’s trying to do problem solving repeatedly and bringing the cases up and closing them and bringing more cases up. It’s very, very time consuming. But what is the payoff for taking that time to make sure that CAPA is done right?

Zillery Fortner (17:44):

I think it’s always interesting when people understand how much a recall actually costs. And a recall is just one part of doing something wrong or, or not really truly understanding the problem. And it is a little hard to estimate, but McKinsey gave a statement last year that states a single recall process can cost up to 600 million dollars. We’re not including lawsuits, we’re not including legal. We’re just including fixing that situation. The medical device industry spends around 5 billion dollars a year on recalls. It is expensive. And this expense, we can’t ignore it because lives are literally at risk. Every minute that a defective product stays out on that market is another opportunity for somebody to be injured. I always tell people to think if that was your loved one, would you be quick to act, would you want to do this right? So, the payoff to get a CAPA right? I don’t think you can measure it. It’s huge. It might be time consuming in the beginning, but once you get on this cycle of plan, do, check, act and that continuous improvement, your CAPA should go down, right? You should just be preventing things, finding things you can always do better.

Bethany Kearney (19:25):

The numbers are startling, and I totally agree with you. Consider if that was a device that was implanted. So, I’m not sure how to put a price on sanity or a life for that matter. I guess from my experience, I wanted to just offer that there are so many hidden costs unless you’ve been through it. I was just astonished by all the intricacies and the steps of a recall. When I had to go through this process with the company I was with, where you have your receiving of the recall materials, your processing, you have another team processing refunds, you’re shipping your recalled material, you’re reconciling that material.

And then you have all these other complexities. If the material is DEA controlled well, who’s with it? And when you run out of space in your containment area you have to ship it somewhere for deconstruction. So, it’s very complex. And I can see how these figures are easily in that seven-figure range, just thinking downstream as well. If your inspection didn’t occur already and that might have attributed to why you’re having a recall, you better get ready because this is cause for shutdowns and fines. And of course, once this is on the news, you have brand impact when you your public announcement is launched. So, when the organization moves from that reactive mode to being preventive, there’s a lot of impact with your manufacturing, your lab, your overall supply chain, to make sure that you have materials and products available. So, it really does matter when it comes to that customer experience with your product.

Michelle Dawn Mooney (21:31):

It reminds me of that, I think it was a credit card commercial, that had baseball tickets or an experience and the impact was priceless. And I think about the last answers that you both gave. That’s what we’re really talking about. We’re talking about human lives, potentially. We’re talking about not even just from a business standpoint, but just a real impact from a human standpoint. And then on top of it, you’ve got a huge payout with the business side of things and recovery costs. So, any final thoughts as we wrap this up today?

Bethany Kearney (22:03):

I I’ll just start with saying that simply whatever level you find yourself in, in any position, because there are lives at stake, because you are your company’s livelihood, all of this is at stake. Just make sure you’re doing the right thing. And I think the folks in quality like myself and Zillery, we’re here for the right reasons. If you’ve been in the industry long enough, you’re there for the right reasons. You’re going to do the right thing. It’s hard at lower levels to escalate things. And if you’re being blamed for issues, you don’t want to point the finger at management. I know that’s a tough situation, but it’s worth it. It’s worth flagging that. And calling your compliance helpline or whatever you have in your back pocket to support you to do the right thing. Don’t hesitate to do that. If, if your management team is pressuring you to get through an investigation, as fast as possible to keep their numbers green, that’s not doing the right thing. You need to do it the right way. So, challenge that and then throw the flags when you need to.

Zillery Fortner (23:11):

And then I’ll just add on with something we haven’t said yet—Quality 4.0. Quality 4.0 has to be there for companies to survive in the future. They’re going to need to be able to leverage their analytics, not just quality data, but data from all systems. They’re going to need that connective capability across their organization. And that’s how they’re going to get the transparency that they need. When it comes to Quality 4.0, I think it’s important for people to also remember that it doesn’t replace your traditional methods. The whole point is to harmonize the people, the culture, the technology, and your processes to achieve what your company’s goals are. And the other thing is that people have to change their thinking on CAPA. They can’t think that CAPAs are burdensome or take too much time. They have to see how powerful, how proactive this tool is and how it can shape the future of quality in your company. You have to use your CAPA system for the gains, not just flaws. So you have to look at it for improvement reasons also, not just for the mistakes. And then you remember that a successful corrective and preventive action system is not one size fits all. So, what worked for me, isn’t going to work for Bethany or anything like that. It’s not a reactive, overburdensome process.

Michelle Dawn Mooney (24:49):

A lot of information there. And as Bethany said, once you do the right thing for the right reason, you get the right results. And pretty much every time that happens. And that’s really what the discussion is about. We’re talking about flipping CAPA on its head with prevention and understanding the root cause. And I want to thank you both for joining me today. Bethany Kearney, who is the director of enablement for Sparta Systems, a Honeywell company, And Zillery Fortner, who is product advisor, QA/RA life sciences for Sparta Systems, a Honeywell company. Thank you both for joining me today.

Zillery Fortner (25:22):

Thank you.

Bethany Kearney (22:24):

Thank you.

Michelle Dawn Mooney (25:24):

And thank you so much for listening to Forging Connections, Honeywell podcast, and this is another installment in the series, Shaping the Future of Quality. And of course, if you’d like to learn more about Honeywell and its affiliated businesses and companies, you can go to honeywell.com. I’m your host, Michelle Dawn Mooney. Thanks so much for joining me and we’ll see you soon.

Closing (25:46):

This has been Forging Connections, a podcast from Honeywell. You can follow Honeywell Forge on LinkedIn and download new episodes from our website honeywellforge.ai. Thanks for listening.

Resources About Root Cause Analysis:

• Blog: 5 Steps to Performing an Effective Root Cause Analysis
• On-Demand Webinar: Root Cause Analysis – Getting to the Root of the Issue and Getting it Right
• Blog: Uncovering the Root Cause and Overcoming Challenges Along the Way
• Blog: Root Cause Essentials: Unleash the Power of Your Mind with Mind Mapping
• Blog: Root Cause Essentials: Using the PDCA Approach to Support Continuous Improvement

The post Flipping CAPA on its Head with Prevention and Understanding the True Root Cause appeared first on Honeywell.

While the term “root cause” implies a single cause for a problem, often, the RCA will discover multiple causes that triggered the problem. The RCA should identify potential causes to ensure the undesirable effect does not recur. 

Why a Root Cause Investigation Is Important  

There are multiple benefits to a robust RCA process. The main benefit is it allows an employer to discover the underlying or systemic, rather than the generalized or immediate, causes of an incident. Correcting only an immediate cause may eliminate a symptom of a problem, but not the problem itself. 

Understanding the true root cause can resolve and prevent similar issues and:  

• Enables Faster Product Release: Production slows down when an incident occurs which reduces the organization’s ability to get products to market  
• Reduces Costs: Nonconformances are costly especially if the product has shipped to the customer  
• Improves Safety and Reliability: By understanding the true root cause of an occurrence, it allows for changes to occur which can prevent the incident from recurring

Top Challenges to Effective Root Cause Analysis  

Some of the key challenges faced in root cause analysis include:  

• Poor quality culture: Lead by example; quality must be everyone’s responsibility 
• Lack of guidance on root cause analysis: Ensure resources are trained in completing root cause analysis, there are multiple courses available 
• Not using a cross-functional team approach: To understand the full picture and provide outcomes that solve the concern you must use a team of diverse individuals 

A 5-Step Approach to Root Cause Analysis  

A 5-step approach to effective root cause analysis includes:  

1. Define event 
2. Find causes 
3. Find the root cause  
4. Find solution 
5. Act and measure  

Download the eBook to get insight into each of these steps and get access to customizable root cause analysis resources like cause and effects analysis, force field analysis and more.  

Resources About Root Cause Analysis:

• Ebook: Uncovering the Root Cause
• Blog: 5 Steps to Performing an Effective Root Cause Analysis
• Podcast: Flipping CAPA on its Head with Prevention and Understanding the True Root Cause
• On-Demand Webinar: Root Cause Analysis – Getting to the Root of the Issue and Getting it Right
• Blog: Root Cause Essentials: Unleash the Power of Your Mind with Mind Mapping
• Blog: Root Cause Essentials: Using the PDCA Approach to Support Continuous Improvement

The post Uncovering the Root Cause and Overcoming Challenges Along the Way appeared first on Honeywell.

To reduce harm to patients and users, proactively detect signals and trends, and continuously improve quality and safety of medical devices through real-world evidence, quality risk management must successfully integrate with the quality management system.

In this article, we’ll consider the benefits of integrating quality risk management with the quality management system (QMS).

Why Risk Management is Getting Harder

New regulations are bringing more scrutiny from regulators on the risk management processes for medical devices and combination products. The European Union Medical Device Regulation (EU MDR) and ISO 14971:2019 requirements are bringing the full burden of risk management to medical devices and combination products.

Risk management in the new era is a big undertaking that spans all lifecycles of product development and means tracking practically every system and process in your enterprise, from product planning, design and changes to manufacturing activities, and more through to post-market surveillance.

A Better Approach to Risk Management

To be effective, all your risk management efforts must be interconnected. Information must be handed off between departments in a way that keeps complexity from leading to confusion. These teams include personnel from quality, regulatory affairs, clinical affairs, and many more that all speak about similar topics in different ways. It’s a lot to ask of cross-functional teams from every part of your organization to coordinate so much data frequently enough to be useful when they are working in siloes.

An integrated risk management approach will:

• Reduce harm to patients using your products
• Detect signals and identify trends for effective root cause analysis and decision making
• Improve quality and safety continuously
• Ensure acceptable quality
• Resolve process and product deviations and nonconformances quickly
• Expedite approvals and market authorization
• Comply with standards and regulations

Transform Your Risk Management Process

The constantly evolving expectations of risk management over the years have resulted in many manufacturers developing complex, ineffective risk management processes. These changes span over three decades and include the European Directives, ISO 14971-1:1998, ISO 14971:2000 and more. The EU MDR and ISO 14971:2019 have added to the burden of manufacturers staying on top of changing regulatory expectations for medical device risk management. Compliance with the EU MDR and ISO 14971:2019 from planning to production and post-product information collection requirements will take a lot of resources and will fail to deliver high quality for those relying on outdated risk management methods.

Manual risk management methods are simply not good enough anymore—they consume resources, slow down decision making, and don’t deliver the quality improvement and risk reduction that organizations need to compete.

Are you ready to take your risk management process to the next level? Download the white paper below to learn how to take a data-driven approach to risk management.

The post Beyond Compliance: The Benefits of Integrated Risk Management appeared first on Honeywell.

Supplier quality management systems can help manufacturers ensure high-quality processes across an increasingly complex supply chain. These systems help address supplier selection and evaluation, nonconformances, risk and product deviations.

It’s up to the manufacturer to maintain quality procedures as it is the one that will be held accountable by the FDA and the consumer if there is an issue with the product. Manufacturers must not only find partners that can provide the materials and components necessary for production; they must also find partners who are trustworthy and pose as little risk as possible to the final product.

Here’s why managing risk, quality, safety, and compliance begins with an effective supplier quality management system.

The Rise of Outsourcing

Medical device companies are becoming more global, sourcing more and more in raw materials and components from countries all over the world. The need to manage the complex supply chain is a crucial component to a company’s business strategy. A major challenge is not the lack of supply, delivery, inventory or critical supply data, but rather the visibility of critical information to perform proactive tasks or to make impactful decisions.

Companies use multiple suppliers that are “out-of-the-four walls” of their own IT environment, so it is imperative to provide near real-time access to a common system so there is no delay when using data to make both minor and major product decisions.

Managing Supply Chain Risk

With many suppliers both in the U.S. and abroad working under different regulatory bodies or requirements, having access to the same set of real-time data can be very challenging. In many cases, recalls are caused by supplier-related issues.  

Considering the cost and resources it takes to remediate, replace, repair and recall a product, it is critical that proactive measures of supplier quality metrics are in place to mitigate as much risk as possible.

Learn How to Improve Supplier Quality

Ultimately, manufacturers will have to keep accurate records of every aspect of its relationships with suppliers, including transactions and communications. It must also implement best practices. These include a comprehensive selection and evaluation process, supplier audits, supplier scorecards and supplier risk files.

The post How to Ensure Supplier Quality in Medical Devices appeared first on Honeywell.

These 20-minute sessions included quick demos of each quality process area using TrackWise Digital and live Q&A with a solutions engineering expert.

The post TrackWise Digital Success Series: An Overview of Key Processes appeared first on Honeywell.

In a previous article, we talked about the challenges to effective quality management, including use of siloed or homegrown systems.  But quality doesn’t have to be hard—in fact it shouldn’t be. With solutions pre-packaged to fit the needs of regulated industries, it isn’t.  

A good quality management solution is intuitive, simple to use and encourages user adoption. This is the basis of Sparta’s Quality Process Accelerators (QPA), which can help streamline and speed up your path to quality.  

Backed by Industry Experience and Influence   

Your organization can simplify and standardize your quality management processes with Sparta’s QPAs. Sparta’s intelligent, pre-validated quality processes are built on almost three decades of industry best practices. Our leading processes are backed by decades of feedback from customers and regulators—in short, we know the industry and the quality drivers your organization needs to be successful.  

Related article: FDA raising quality technology expectations

Plug and Play: Achieve Rapid Time to Value  

With Sparta’s QPAs, you can get your system up and running quickly, resulting in rapid time to value. This process standardization and simplification drives significant value and time savings for the end user.  

Simplicity in a Digital Quality Solution 

Our QPAs, developed in conjunction with Sparta’s Quality Best Practices Council, assure that change is managed at both the site and corporate and global level, with the appropriate personnel involved in change assessment, planning, approval, implementation and deployment. 

Sparta’s QPAs include: 

• Nonconformances: The nonconformance QPA records data about situations in which a product or device has not conformed to standards. This provides insight into which devices don’t conform, how they go against standards, where they are produced and how customers are impacted. It enables users to identify, record, assess and investigate deviations and nonconformances in a consistent and harmonized process.  

• Corrective and Preventive Action (CAPA): Complaints, audits and adverse events often lead to compliance events that must be addressed through a company’s CAPA process.  The CAPA QPA enables organizations to track and manage the process of carrying out CAPA plans, automate verification of effectiveness over time, and provide seamless traceability to related quality processes, including change control and training.   

• Audit Management: The audit management QPA helps companies monitor critical processes, identify gaps and improve quality. This solution drives efficient management of resources, workflow, data and records associated with company internal audits of all levels as well as with audits relevant to suppliers and company regulatory inspections. This process allows manufacturers to take a best practices approach to compliance and risk management.  

• Change Management: The change management QPA manages change at every level of the supply chain to ensure quality and compliance requirements are not affected. It enforces a standardized change control process across the enterprise while allowing the flexibility to meet specific workflow steps, making it the only solution designed to be flexible enough to manage all types of changes using one centralized system. 

• Out of Specification: Document and track results of in-process or finished product testing falling out of specified limits using the Out of Specification (OOS) QPA. OOS records contain information on situations when lab results come back out of the range in which they were expected. 

• Intake:  The intake QPA enables users to capture critical information using a simple, browser-based interface and share it with quality and compliance teams from anywhere, on any device.  

• Extension Request: Use the extension request QPA when a time-sensitive record cannot be completed on time. It contains information on the record, the original due date, a suggested new due date and reason for the delay. 

• Quality Events: Respond to adverse events faster with the quality events QPA and reduce the amount of time it takes to act on quality and safety issues. Quality events contain information on an event that has occurred regarding the quality of a product, as well as the actions that should be taken to minimize the negative impact of the event.  

• Batch Release:  The batch release records contain information on a grouping of products that are being manufactured together. 

• Complaint Handling: Track, triage, escalate and share records in a centralized and validated platform. The complaint handling QPA provides the ability to log, respond to and investigate complaints. It enables monitoring of developing trends through integrated tracking and reporting.   

• Risk Management: Risk Management enables companies to seamlessly link the risk process to other quality management processes. It facilitates the implementation and maintenance of a risk management program in accordance with ICH Q9 and ISO 14971. 

• Supplier Quality Management: Effectively manage and collaborate with suppliers and contract manufacturers across your supply chain. Supplier quality management allows quality teams to manage supplier relationships from onboarding to auditing and scorecard analytics. 

• Product Registration Tracking: Product Registration Tracking (PRT) significantly reduces the time, cost and resources needed to track product submissions with regulatory agencies around the globe.  

Sparta’s QPAs help simplify the process of quality management and drive success for regulated industries. Start improving productivity and reduce the chance of errors by enabling quality teams with the best practice processes, automation and collaboration that a digital quality management solution provides.  

Interested in learning more?  Request a demo and see firsthand how Sparta’s QPAs can benefit you.   

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