Transforming Complaints in a Digital World

The U.S. Food & Drug Administration (FDA) has consistently regulated medical devices since 1976. Yet, management of complaint files continues to be one of the top 483 observations given.

Industry leaders are urged to stop viewing complaints as a burden and transform their current mindset on company culture, core values, strategic goals, and objectives because manufacturers are undertaking digital transformation at a rapid pace.

If industry leaders want to survive this digital transformation, one of their initiatives must be a successful movement to Quality 4.0. Quality 4.0 enhancements allow employees to be efficient, connect intelligent automated processes, shorten time-to-value, and improve data-based decision making. Industry leaders who take an in-depth look and rethink critical components of their quality management system (QMS), such as complaint management, will:

• Reduce variations
• Prevent defects
• Reduce rework
• Improve productivity, efficiency, and compliance 
• Reduce risk

Let’s look into how manufacturers can rethink their complaint process.

What Is a Complaint?

A high level of quality is necessary to protect an organization’s reputation and revenue and help ensure regulatory compliance. Complaints indicate that these areas are being threatened. A complaint could lead to repair, servicing, and changes in a manufacturer’s recommendations. More serious or recurring issues can lead to recalls and even product removal. A single complaint could lead to corrective actions—a few complaints could lead to a trend causing the company to revise product, labeling, packaging, or distribution.

In 21 CFR §820.3(b), a complaint is defined as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution.”

Rethinking Common Complaint Observations

When manufacturers get product complaints, they must adhere to reporting requirements set forth by the FDA and other regulators. They must also either initiate corrective action, put change controls in place, and/or require updated training. Having an integrated global complaint management system in place will allow medical device manufacturers to comply with the FDA and other regulatory requirements.

In fact, FDA 21 CFR Part 820 and GxP regulations dictate manufacturers should maintain complaint files and establish a sustainable complaint management process. Specifically, Part 820 Section 198 requires that a formally designed complaint unit ensures complaints are processed in a timely manner, evaluated to determine the necessity of a formal medical device report or internal formal investigation.
Having reliable quality processes, systems, and reporting infrastructures in place will facilitate effective and timely complaint management.

However, manufacturers seem to struggle with post-market surveillance. Using manual processes or a wrong-fit system can lead to incomplete complaint information, delays in investigations, adverse event reporting, and threaten data integrity. 

There are several ways a manufacturer can prevent common challenges.

Complaint Intake

Complaint handling is a crucial component of a successful QMS. A robust complaint handling system that receives sufficient information, triages, prioritizes, assesses, resolves, and communicates the complaints promptly will benefit the company by customer loyalty, patient safety, and total cost of quality. There are several methods to report a product complaint to the manufacturer, including through a phone call, email, online notification, verbal communication, or voluntary MedWatch report.

One of the roadblocks to a robust and beneficial complaint system is the complexity of a complaint intake system. Using a homegrown database with a time-consuming manual paper process to receive and categorize complaints becomes overcomplicated, which can lead to lack of data integrity, backlogs of complaints, poor use of employee time, and poor customer satisfaction.

Investigations

Part of an effective complaint system is understanding and completing a complaint investigation. If no investigation is required, an authorized person will document the reason. Using a systematic process to gather and establish the facts behind a complaint and document all parts of the investigation will tell a complete story that is easy to follow. When an investigation is thorough, there should be a known root cause and necessary actions. An enterprise quality management system (EQMS) can provide a simple, straightforward process coordinated among multiple departments, with action items and target dates, providing an automated connection with corrective and preventive actions (CAPA), remedial actions and failure modes, and effects analysis (FMEA). Many companies struggle with the complexity of risk management and, therefore, lose the value of the process. An EQMS takes the complexity of risk management and makes it obtainable for standard users. 

The FDA has taken steps to provide transparency to the public about adverse event reporting. By law under §803.20, manufacturers, importers, and device user facilities must investigate and report certain device-related adverse events and product malfunctions to the FDA through an electronic format that can be processed, reviewed, and archived.

Using complaint management systems that provide intelligent decision trees to standardize the reportability process and efficiently automate the electronic medical device reporting (eMDR) process will help companies identify and resolve product issues. 

Data Integrity

The FDA requires that medical device companies retrieve, track, and trend all complaints, claims, recalls, and failures through the effectiveness of the resolution. Relying on a paper-based system often forces companies to operate in silos. As a result, they miss the opportunity to review complaints system-wide, making it difficult and time-consuming to provide reliable data.

Trending complaints offer insight into customer satisfaction and product performance, allowing deficiencies to be adequately corrected.

Integration of a digital system will allow for trending across one or all sites, providing medical device companies with the ability to cross-collaborate and proactively monitor real-time data. The benefit of real-time visibility is the data enables manufacturers’ framework to include tangible productivity gains, customer loyalty, no duplicate investigations, and fast and appropriate reactions to obstacles.

Benefits of Transforming the Complaints Process

When manufacturers do not have a vital resource or processes, they will find themselves dealing with a backlog of complaints. How many times have you heard “It’s not in the budget” or “too much volume and not enough people”? It is time to consider the “do more with less” mentality and improve efficiency without overworking employees. Stop wasting time on broken processes and invest in understanding how to provide valuable data to enhance the complaint process.

Implementation of Quality 4.0 technologies will help reduce product risk. Providing the ability to recognize if a product issue is widespread or preventing additional future problems is significant. When companies stop looking at a complaint as a burden but rather as a vital part of providing a proactive quality system that prioritizes the voice of the customer, this will result in:

• A strong EQMS performance
• Positive customer relationship
• Reducing cost 
• Improving product design, manufacturing, and safety of devices
• Lowering chance of a recall and regulatory fines
• A streamlined compliant system with device regulations and consensus standards
• Positive employee morale

The data that companies capture as a result of complaint reporting and processing can be used to gain insight into production and quality. An effective complaint management system enables manufacturers to access a variety of data reports and trends, which are very useful to determine the difference between random errors and critical production issues.

Once a manufacturer has processed the complaints and trended the complaint data, they can analyze and discuss the data. Cross-functional quality teams can be utilized to provide solutions to reoccurring complaints or issues as provided by the data reports. This group can be responsible for discussing newly reported failure modes, trends, and the effectiveness of corrective actions.

Shift the Burden of Complaints with the Right Tools

Using a closed-loop EQMS that can seamlessly integrate critical processes will provide consistency and ensure a complete and adequate intake process, resulting in facilitating the process and product improvement. An EQMS offers the ability for automated complaint categorization and initial complaint review and risk assessment using precise supporting data.  Along with an EQMS, companies must provide vital training to field personal and complaint handling and the importance of meaningful information.

Ultimately, having a global complaint management system in place is critical to medical device companies to understand if there is a problem with a product and how to fix it. The ability for a company to recognize if a product issue is widespread can speed up process improvements to stop the recurrence of an issue. Being able to identify and address life threatening complaints can prevent other injuries, or even deaths. The ability for a complaint handling system to communicate with an EQMS is essential for identifying whether other facilities are having issues, communicating to leadership for continuous improvement, and trending to prevent additional problems from recurring in the future. 

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Zillery A. Fortner is the Product Advisor, QA/RA Life Sciences at Sparta Systems, a Honeywell company. She earned a bachelor’s degree in health science from South University. Fortner has 20 years of experience in the medical device arena related to quality assurance, regulatory affairs, and JACHO. She served 10 years in the military as a certified surgical technician. Fortner is an active member of ASQ and AAMI.