Best Practices for Conducting Quality Investigations in Manufacturing

Kim Wakeman, ETQ Group Product Manager, Applications

Medical device manufacturers are facing unprecedented challenges, from an evolving regulatory environment to the prolonged pandemic and supply chain disruptions. Their goals of improving patient outcomes while reducing costs, however, have not changed. From insulin pumps and defibrillators to inhalers, pacemakers, and artificial knees, products in highly regulated industries are held to a higher standard. And rightly so, considering patient lives and corporate reputations are on the line.

The accelerated pace of development in the medical device industry is making these challenges even more daunting. The global market for medical devices is projected to reach $523 billion in 2022, spurred by a record pace of investment and innovation. Against this backdrop of growth, the need for high quality in the design, manufacture, and distribution of devices is as strong as ever. Maintaining the highest levels of quality not only reduces patient risk and ensures regulatory compliance, but also improves brand reputation and customer loyalty, and can significantly reduce the many costs related to product defects and recalls.

But what happens when a quality event - a product defect, a process deviation, or a specification nonconformance - occurs, putting a halt to production, or worse, impacting patient safety? The manufacturer must take steps to quickly evaluate the issue and identify the root cause to determine if it is a one-time occurrence or if something more systemic is happening, requiring further investigation and corrective actions to be taken.

When quality events occur, the U.S. Food and Drug Administration (FDA) requires that manufacturers take immediate action. Yet, its constant oversight is no small task when you consider the number of new products produced annually. FDA reports that between 2017 and 2018, more than 18,000 manufacturers produced an estimated 190,000 distinct medical devices, all of which require monitoring. The FDA has established regulations that require manufacturers to investigate, identify, and report on the source of a problem and create a corrective action plan to ensure quality and efficacy standards are met and only safe products are made available to the public.

The investigation process is a thorough evaluation; root cause analysis involves a multidisciplinary team and numerous steps aimed at identifying the corrective and preventive actions that must be taken to ensure regulatory conformance. To be meaningful, investigations should be thorough, timely, unbiased, well-documented, and scientifically sound, and all materials, processes and finished products must conform to pre-defined specifications.

The investigations should involve all related departments (depending on the issue) that have a role in quality, including design, manufacturing, process development, procurement, and manufacturing. In cases where one aspect of production occurs off-site, all sites involved should be included in the investigation. It is crucial that each step in the investigation be fully documented and that all key stakeholders, including suppliers, are made aware of developing trends. If the criticality of the event is “high,” the event must be escalated to senior management to ensure the appropriate actions is taken, which could include a field action or recall.

While quality events occur in even the most advanced, state-of-the-art environments, there are proactive steps you can take to minimize their impact and increase the likelihood of a safe, successful outcome, and the return to full-capacity production. Consider the following preventive steps:

Automate Quality Processes
By automating quality processes, including quality event investigations or tracking and trending, medical device manufacturers not only have a ‘paper’ trail to document the steps they’ve taken to identify and investigate a problem; they can potentially prevent problems, and therefore the need for an investigation, by proactively flagging nonconformances, performing root-causes analysis, identifying trends that impact quality, and addressing supply chain quality issues. Automated quality systems also ensure quality processes are followed and the organization is freed up to focus on innovation and the core business instead of putting out fires.

Perform Quality Audits
Audits can be a valuable source of feedback to improve your manufacturing processes and, as a result, your products. According to the FDA’s quality system regulation (QSR), every medical device manufacturer must do internal audits regularly. Knowing this, manufacturers need to develop action plans to develop and implement proactive quality processes and protocols. Performing audits will highlight the processes that are functioning well, but it’s often the deviations that provide the most valuable insight into how to improve your processes and your end product.

Establish a Culture of Quality
A corporate culture of quality has significant benefits, including a strong brand reputation, increased revenue, and improved employee satisfaction. Regulatory compliance should not be the end goal. Compliance helps companies get over one hurdle but doesn’t help them build a sustainable quality culture, one focused on continuous improvement. To achieve this, companies need to take a holistic approach, supported by the highest levels and comprising all aspects of the company: people, processes, products, and services.

Summary
Building a safe, high-quality medical device requires major investments of time and resources, and any error, big or small, can have significant repercussions – for the company, as well as patients. As devices continue to become more complex, and the challenges facing manufacturers continue to increase, quality must keep pace to enable patients, clinicians, FDA, and the public to have complete confidence in the safety and efficacy of critical life-saving solutions.