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Why Design Controls Are Good Business Sense for Any Product Company

Insights from Christopher Hill, Director of Regulatory and Quality Affairs, Organ Recovery Systems This blog is the final of our three-part series on design controls. The first explained why “Good Design Controls Are Critical to Avoid FDA Issues” and the second entailed Vis Ayer’s account of “How Nevro Achieved Design Controls Success. ” Here we encapsulate our discussion with Christopher Hill about his experience at Organ Recovery Systems, focusing on design controls from a quality assurance perspective. He addresses many of the pitfalls to watch out for when trying to organize historical design documents during the product development process and emphasizes following design controls as a good business practice for regulated and non-regulated companies alike.

Ann: It’s a pleasure, Christopher, to have you with us today. Can you tell us a little about Organ Recovery Systems?

Chris: Thank you, Ann. Organ Recovery Systems is the global market-leading provider of organ preservation products and services. We currently support over 290 leading transplant programs in 39 countries with our patented LifePort® Kidney Transporter and our gold standard organ preservation solutions, SPS-1® and KPS-1®.

Ann: Can you share a lesson learned from your career where design controls had a major impact on your validation, product launch, or production?

Chris: When I got started at Organ Recovery Systems, my first challenge was collecting and organizing historical design documents and then conducting a gap assessment. That was a several year project, and it’s still in process to some extent. Our documentation was spread across paper copies in binders, electronic files on our network, and files stored at contract manufacturing sites. We’re a small company, so we needed an efficient way to centralize everything and keep it current. To do that, we created an electronic device history file that linked all the required files, either scanned or native, into an electronic format. Since all the documents are now controlled electronically, our design history file always contains the correct version of every document with minimal upkeep.

Ann: Wow, several years to organize all those binders and electronic files at both sites! That’s certainly a big challenge and a big expense, especially for a small company.  Many medical device companies are still using paper or manual processes. What do you see as the biggest challenge you faced with this and how is a product-centric quality management system (QMS) helping?

Chris: Our products include electrical, mechanical, software, and chemical components. Cross-referencing of source documents can get complicated. A single document may capture data that satisfy multiple requirements. For instance, a risk analysis is an output of the design control process and linked to the design history file. But, it’s also a component of the risk management file (RMF) and a component of the usability/human factors engineering file. Instead of maintaining three separate binders with paper copies outside the document control system, we’ve been able to link individual electronic documents to multiple locations to cover the different standards. Plus, as I mentioned before, the electronic documents are linked and are always the current version. This makes it far easier to maintain and to present at audits. Ann: Maintaining design controls with design and manufacturing partners can add complexity when managing information for compliance. Do you outsource and how do you manage it?

Chris: We outsource all manufacturing and distribution. A few years back, we had an FDA 483 associated with our device master record and control of our subcontracted manufacturers. They argued that our device master record must contain the current device history record or batch record. Up until then, our contract manufacturers had controlled them. We were involved in any major changes that had the potential to impact compliance, but we didn’t approve every change to the documents. As part of our corrective action, we had to revise quality agreements with the contract manufacturers so we could approve every change to the product-specific manufacturing documents. Once we were in the approval routing, we were able to keep the current copies of the device history record electronically linked in the device master record. As part of the lot release, we now check the contract manufacturer’s device history record revision against what we control in our system. This is to ensure that they are using the current, approved instructions. The FDA approved of how this solution managed compliance and closed out the observation.

Ann: Based on what you’re saying, it’s apparent that a product-centric QMS solution supports the outsourced business model by helping with communication and collaboration.  How about challenges with risk management, which ensures that the product works as intended and causes no harm? Since risk management is a fact of all product development, particularly in the regulated medical device world, how has the way you approach design control helped risk management efforts?

Chris: With the release of ISO 13485:2016, risk management is now a part of nearly all our processes, including design control. When changes to a design are proposed, we know we need to assess the risk as part of the review process. At Organ Recovery Systems, our change management process requires a review of the RMF as part of any changes to device design, labeling, or manufacturing processes. The RMF contains separate risk analysis documents covering the design, the manufacturing process, cybersecurity, and user application. The documents are all linked in the system to make it easy for the engineer proposing the change to open the applicable risk analysis and decide if the design change will introduce a new risk or mitigate an existing risk. If the risk analysis needs to be updated as a result of the design change, we update the document and add it to the same change order as the design change.

Ann: Based on your extensive experience in the medical device industry, what advice or tips would you suggest as keys to successful compliant design controls?

Chris: First, I’d like to reiterate one point from your previous discussions about design controls. FDA design controls are required and are something we all must comply with. But design controls are also good business practices—from planning your project to identifying data sources, deliverables, responsibilities, and risks. Those are all good steps for any product launch whether you are a regulated device or not. At Organ Recovery Systems, we don’t just follow these practices to avoid FDA 483s, we follow them because we want our final products to be well-designed, well-controlled, and well-documented. We created our electronic design history files first, and then added electronic device master files, risk management files, and usability/human factor engineering files over the years. We’ve also implemented online workflows for complaints, nonconformances, corrective and preventive actions (CAPAs), and audit observations. If I could do it all over (and could see into the future), I would map out the processes and how they interact in advance. Organic growth can sometimes be very good, but I would have loved to have had a documented overall strategy before starting. It would have saved me a lot of time spent going back and tweaking processes and workflows to get everything connected. The backbone of product design and manufacturing is the bill of materials (BOM). So, product companies need a QMS solution that properly manages the BOM, design changes, and ideally integrates with the ERP system. What I figured out is that only a product-centric QMS does all this.

Ann: This is great advice, Chris. You mentioned you’ve also implemented online workflows for complaints, nonconformances, CAPAs, and audit observations. Do you have any additional tips for our readers on those

Chris: For the many CAPAs that include a product or document change, we’ve linked these two processes. It’s pretty easy in our system since we can link document updates, change orders, and investigations or upload external documents. For CAPAs in particular, it’s very handy to have the change order linked. This way, you can check the status or access content from within the CAPA while conducting effectiveness verification. For handling complaints or investigations with our system, we’ve built custom workflows using the quality module of Arena. We capture the critical data in the workflow and summarize the investigation, root cause, and corrective actions. We upload a PDF of the full investigation report for reference. Complaints are linked directly to the product just like we do for CAPAs or nonconformances. Basically, we can pull a list of all related complaints, CAPAs, or nonconformances from the system for any given product. During FDA, ISO, and customer audits, we’ve presented our design history files, device master records, and risk management files live on-screen. They were all impressed with the solution.

Ann: Thank you, Chris, for delivering such helpful design controls insights. In moderating this three-part series, it has become abundantly clear the importance of having design controls in place and implemented in the right way. Additionally, we appreciate that you’ve demonstrated how the deployment of a product-centric QMS can really help product development stay on track right through commercialization.    To our readers: If you’ve found this post helpful, we urge you to check out our other two posts in this three-part design controls series—Vis Ayer of Nevro encountered different challenges to that of Chris, and our initial post helped to set the design controls landscape for medical device manufacturers.