Trends and Innovation in Supplier Quality

There is a significant change underway in the regulatory landscape for the medical device industry, particularly for supply chain relationships. These changes are spawning opportunity and there are novel solutions for supplier management ripe for implementation. Under EU Directive 93/42/EEC (MDD) and existing U.S. Food and Drug Administration (FDA) regulation, organizations have adopted some creative solutions for managing supplier quality efficiently. However, the evolving and increasing requirements for risk-based supplier controls bring challenges to existing systems. For small organizations participating in MDSAP, there will likely be increased audit time dedicated to supplier controls. The potential for the FDA to harmonize with ISO 13485:2016 also means new perspectives from the FDA when auditing to these requirements. Further to these changes, EU MDR (Regulation 2017/745) increases scrutiny for all organizations in the supply chain. In planning for these inevitable changes in auditor and customer expectations, customers and suppliers must implement new tools to maintain cost-effective supply relationships.

Existing Solutions
ISO 13485:2016 states a quality management system (QMS) must include criteria for evaluating, selecting, monitoring, and re-evaluating suppliers. These criteria must be risk-based and appropriate based on the supplier’s ability to provide the product or service, the supplier’s performance, the effect of the product or service on the quality of the medical device, and the risk profile of the medical device. There are numerous ways to incorporate these criteria into processes and work tools for practical application. Yet, where regulatory requirements fall silent, companies have the freedom to employ their own solutions for supplier quality. For example, no specific criteria in the aforementioned regulations reference specific methods, timelines, or processes for the selection and reiterative evaluation of suppliers. Many organizations have tailored the timing, depth, and methods of supplier evaluations to add value without overburdening resources. Such methods include alternating on-site and remote audits, basing audit recurrence on supplier performance, and combining on-site audits with product source inspections.

Networking and “cross-pollination” are perhaps the most readily available sources for identifying tools for supplier quality. Encourage employees to actively network with colleagues, participate in industry learning events, and seek various quality and regulatory certifications. Fostering employee growth in this manner also serves to demonstrate competence to auditors. Companies should survey employees who have recently been hired from other organizations (cross-pollination). Consider contacting a consultant or quality contractor; as they may provide helpful information even during an introductory discussion. Lastly, and as I explore in more detail later, medtech firms must be willing to adopt new technology to sustain operations with increasing regulatory requirements. Such an eclectic approach to QMS subsystems is the heart of best practices.

Supply Chain Relationships
As industry scandals have highlighted the risks of supply chain breakdowns, the focus on these relationships by regulators has increased and new requirements have been codified into regulation as a result. EU MDR in particular has applied an increased focus across the entire supply chain—from critical suppliers through distributors and importers in the EU. Manufacturers must demonstrate effective processes for controlling service providers who handle critical processes, distribution, and importation. A holistic approach with increased visibility is essential for managing the host of suppliers that manufacturers rely upon. In turn, suppliers will find they increasingly are expected to meet more stringent customer needs.

Some suppliers and service providers may not fully understand the new requirements headed their way. Manufacturers will need to adopt an active role in ensuring all suppliers are managed in accordance with new regulatory requirements and understand their roles in managing their own processes and downstream suppliers. Assuming supplier compliance and then simply verifying compliance through a normal auditing program may be a risky move resulting in supply interruption. Companies must consider the best ways to assist suppliers without bogging down their supplier quality programs and incurring expenses on their behalf.

Suppliers may already realize the impact of these changes on their organizations. If not, they should take the time now to investigate and develop a compliance strategy. Even with the most robust QMS, suppliers will be hosting additional audits, completing more paperwork, and possibly exerting more effort in managing their own suppliers. Consider this possible solution: Coordinate, comply, and consolidate. To remain successful in this new regulatory landscape, suppliers must meet customer requirements and comply with changing regulations. Doing so in a cost effective manner requires streamlining efforts and consolidating activities for maximum benefit.

Solutions
I discussed earlier how to leverage employee experience and education to maximize returns in supplier quality programs. I’d like to offer some additional solutions for adapting to new regulatory requirements with an eye on financial considerations.

Technological Solutions
There has been a rapid explosion in technology, particularly software and software-related tools. Medtech companies should not be reluctant to adopt new technology; after all, a good number of their competitors likely are doing so already. The device industry needs to acknowledge that the cost of poor quality and ways of managing regulatory requirements are becoming critical factors in competing for market share. Even when considering the costs of adopting technological solutions (e.g., 21 CFR Part 11 and data security), the money and time savings realized from employing technology will far outweigh the initial expenditure. Moreover, the internal team’s experience in deploying these solutions is readily leveraged toward future projects—for both new product development and QMS improvements.

While QMS software is one example, more disruptive technologies that carry enormous potential are virtual and augmented reality. Augmented reality provides a perfect combination of real-time observation with countless work tools. By providing procedures, audit resources, and reference materials at point of use and in a hands-free manner, significant reductions in business risk can be obtained. Other QMS tools can be leveraged through augmented reality for auditing suppliers and for giving customers greater visibility without tying up resources needed to host them at a facility. With the use of artificial intelligence on the horizon, implementing these tools provides a valuable experience and preparation for further technological innovation.

Auditing personnel can access automated and stepwise audit checklists without seeking out paper copies or a desktop for reference. Providing animated representations of production processes for auditors at the point of use increases the efficiency of the audit by instantly familiarizing the auditor. Or, consider the cost savings by sending associate and specialist level personnel for remote activities under the real-time supervision of seasoned employees and subject matter experts.

Suppliers can host auditors remotely with full visual and auditory access to their facility, under their control. This method for supplier evaluation increases the granularity of supplier control measures with an additional option for risk-based supplier evaluations. With technology, one employee can now harness the knowledge and experience of numerous auditors and subject matter experts with reduced travel cost.

Coordinate, Comply, and Consolidate
Companies should consider how they can coordinate efforts and resources to meet multiple requirements. For suppliers, customer audits of operations and facilities often cover the same elements with little or no value added for either party other than demonstrating compliance to regulatory requirements. How might companies provide general information to all customers to conserve their resources while allowing customers to focus on the unique aspects of the service or product they purchase? For example, a medtech firm that develops a supplier package encompassing information, video, or interactive media to substitute (or complement) other audit activities can supplement this data with more customized information, most of which can be provided remotely. Companies also can consider partnering with an independent third party to coordinate the supplier-customer relationship across multiple customers.

To ensure they comply with all applicable requirements without redundant activities, organizations might consider a modular gap analysis. Develop a list of common regulatory requirements that can be supplemented with individual customer, product, or regional requirements. This modular approach allows companies to readily adapt to new requirements while “deactivating” mandates that are no longer applicable based on changes in customer relationships, portfolios, or regulation.

Consolidate redundant or similar tasks with disciplined quality planning to conserve resources. Employ a risk-based approach and leverage supplier competence and performance to avoid unnecessary and expensive on-site auditing. Consider a weighting system to allow on-site audits of critical suppliers on an intermittent basis and to coordinate multiple supplier audits in one trip. The weighting system would account for the criticality of the product or service (effect on the device and the risk of the device), the supplier’s abilities and performance, and any other metrics the organization deems important. As organizations gain more experience operating under ISO 13485:2016, keep an eye on trends in managing a risk-based supplier program.

Summary
By coordinating efforts, consolidating potentially redundant activities, and holistically complying with regulatory requirements, companies can successfully navigate the ever-changing sea of medical device regulation. With this approach, suppliers can provide unparalleled customer service, which reduces costs for customers and themselves as well. Employing technological solutions will reduce the burden on human and financial resources, increase the expertise at the point of activity, and reduce the potential for human error or oversight. 

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Bryan Brosseau’s experience has been forged in almost 20 years in the medical device and biologics industries. With a varied and in-depth knowledge of quality and regulatory requirements, he hones in on the necessary requirements of a project to ensure quality and compliance without impeding progress. Brosseau Consulting LLC manages quality management systems for numerous companies and has obtained regulatory approvals for products across a wide range of therapy areas. Brosseau received his bachelor’s degree in biology from the University of Georgia, maintains a Regulatory Affairs Certification (U.S.) from the Regulatory Affairs Professionals Society, and is a certified ISO 13485:2016 Lead Auditor.