The Hidden ROI of Complaint Management

Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations.

The FDA mandates that medical device companies, for example, designate a formal unit for managing complaints, which is required to:

• Log all customer complaints received
• Establish procedures for reviewing and conducting investigations of complaints
• Conduct and document results of investigations
• Report certain adverse events to regulators in compliance with 21 CFR Part 803

Complaint management software simplifies this process with an automated, end-to-end workflow from intake to reporting, helping ensure compliance and maintain a state of audit readiness.

However, the benefits of complaint management go far beyond basic regulatory compliance. Furthermore, these benefits extend to companies in any industry, life sciences or not.

To understand more, let’s dig into the hidden ROI of complaint management, and what companies should pay special attention to when evaluating complaint management software.

Download a free brochure on AssurX Complaint Management to learn more

Improved Workflow Efficiency

The traditional complaint management process is rife with inefficiency, from time-consuming spreadsheet tracking to important information buried (or ignored) in email chains. The process can eat up a significant portion of employees’ time, while only increasing the likelihood of problems escalating.

Complaint management software, on the other hand, allows you to standardize and accelerate each step of the process, including:

• Intake: The quality management system (QMS) collects all relevant data for investigation and reporting, then routes it to designated parties for review.
• Review: Based on pre-defined criteria, the software determines whether the issue is a valid complaint and whether it’s reportable. From there, the complaint is routed to investigation or closed.
• Investigation: During the investigation phase, complaint management routes the issue through various tasks such as product return, root cause analysis, corrective action, and reporting. Users with assigned responsibilities are notified, with missed tasks escalated so problems don’t fall through the cracks.
• Reporting: Complaint reports are automatically generated and submitted to regulatory authorities such as FDA MedWatch 3500A adverse event reporting, as well as EU, Canada, and Australia.

Automation sharply reduces the hours needed to manage and document the complaint management process. That means fewer in-person meetings, less back-and-forth to collect approvals and signatures, and complete visibility into complaint status to keep the process on track. All in all, this can free up significant time, so teams can spend less time doing paperwork and more time finding the best way to correct problems.

Accelerated Root Cause Analysis

When a complaint pops up, every day that goes by without identifying the source of the problem represents an opportunity for it to affect other customers.

Complaint management software reduces this risk, accelerating root cause analysis by:

• Routing complaints to the appropriate investigation type (e.g., 5 Whys, 8D) based on pre-defined criteria such as complaint type or severity
• Allowing you to instantly access the results of previous investigations to compare similarities, causes and implemented actions
• Providing dashboards that show real-time status of complaints and help identify bottlenecks in the process or where more resources are needed
• Helping teams analyze data more effectively, such as generating reports showing patterns that can point to deeper underlying causes

Assessing Corrective Action Effectiveness

Tracking complaints systematically can help assess effectiveness of previous corrective actions and identify where additional measures are necessary. For example, by running reports on complaints, you can see where repeat issues are occurring, which may suggest where previous corrective actions weren’t effective.

Monitoring complaints can also include adding charts to configurable dashboards to increase visibility and keep mission-critical issues front and center. This improved visibility is essential to verifying that implemented corrections continue to be effective over time.

Reduce Organizational Risk

Reducing risk to patients is a primary driver behind FDA complaint management requirements. Complaint management software helps manufacturers do just that, with detailed insights that help prioritize action and reduce risk at the design stage.

First, adding a risk assessment to each complaint, such as with a risk matrix, allows you to evaluate each risk according to its severity and occurrence or likelihood. The resulting risk score can then be used to prioritize which complaints need to be addressed first, such as if a device failure has the potential to impact patient health.

Information from complaints can also be used in failure mode and effects analysis (FMEA) exercises. This could mean adding newly identified failure modes to the FMEA, then calculating a risk priority number (RPN) based on its severity, occurrence, and detection. This makes FMEAs themselves more complete and robust, so that organizations can further reduce risk starting with design.

Improved Product Performance

In addition to helping reduce product safety risks, manufacturers can leverage complaint data to identify areas of improvement for products. For example, using software to analyze complaint data can help companies:

• Identify design flaws to ensure future product versions meet customer expectations
• Reveal unmet customer needs and stimulate innovation with greater insights into desired features, functions, or improvements
• Pinpoint patterns relating to manufacturing processes or quality control, such as if certain lots are associated with certain types of complaints
• Determine when to discontinue products or release updated versions based on complaints and comments from customers

In this way, complaint handling goes beyond immediate product safety issues, also becoming a tool for continuous improvement in refining products and processes.

Enhanced Company Reputation

Every company will receive complaints over their products. The real question is, how do you use them as the opportunity they truly are?

Manufacturers that take the challenge seriously can turn complaint data to their advantage, using it to improve customer loyalty and brand reputation, and even build a competitive advantage.

Consider, for example:

• A customer who experiences prompt resolution of their complaint is more likely to buy from the company again.
• Many companies have built a reputation for addressing complaints professionally, leading to word-of-mouth recommendations and positive online reviews.
• The ability to quickly resolve customer concerns can become a unique selling point, providing a competitive advantage in the market.

Of course, this is harder to do if you’re relying on time-consuming manual processes such as spreadsheet tracking to manage complaints. These outdated tracking methods make it difficult to address issues in a timely manner, such that more problems are likely to fall through the cracks. Complaint management software takes paperwork out of the equation, speeding up the process to accelerate resolution.

Employee Engagement

Meeting customer expectations is the foundation of the quality movement, as well as standards such as ISO 9001. So how do you engage employees in fostering a customer-centric culture? Effective complaint management is one important tool.

Employees involved with the complaint management process gain valuable insights into customer challenges and expectations. When employees see firsthand how their work impacts the customer experience, that in turn influences their attitudes and behavior—two important ingredients of quality culture.

Recall Prevention

Recalls are costly no matter what industry you’re in, totaling millions—or even billions—in direct costs, to say nothing of the reputational damage involved.

Resolving complaints in a timely manner is key to preventing issues from escalating. Addressing problems at early stages can help better contain issues, as addressing them earlier is easier and carriers a lower likelihood of causing wider damage.

Consider, for instance, a string of complaints that reveals a problem with a component or material from a supplier. Identifying this early and segregating affected lots or batches can prevent other defective products from reaching customers, potentially avoiding a far more costly and damaging recall.

Moreover, companies can also use complaint data in the QMS to improve their predictive capabilities, analyzing patterns and trends in historical data to identify and prevent future quality issues.

What to Look for in a Complaint Management Solution

We’ve talked about many of the ways complaint management provides positive ROI for companies. Now let’s examine what companies should look for when evaluating complaint management solutions.

One critical function is the ability to configure complaint workflows. The reason why this is vital is that no two companies are the same, and thus no single process will work for every single company.

For example, if you get 15 complaints a week, your process is going to be a lot different than a company that gets 150 a week. The same is true if you are in a regulated industry such as medical device or pharmaceuticals.

Many organizations also designate different complaint workflows based on the source of the issue, for example when a problem arises in the manufacturing process versus from a supplier. You may also want to define your own criteria for opening a corrective action, or for how you’ll handle or escalate repeat issues.

Other key functions to look for are:

• Industry-specific reporting such as electronic medical device reporting (eMDR) for FDA Medwatch 3500A reports and EU manufacturer incident reporting (MIR)
• Integration with other QMS solutions such as risk management, corrective and preventive action (CAPA), and supplier quality management
• Built-in dashboards, reports, and metrics tracking that don’t require third-party tools
• 21 CFR Part 11-compliant audit trails and electronic signatures
• Cloud and on-premise software options, with all QMS modules included

Conclusion

While mandated in regulated industries such as medical device and pharmaceuticals, effective complaint management does far more than satisfy regulatory requirements. Effective complaint management benefits the entire quality process, from accelerating root cause analysis and corrective action to reducing risk and improving performance overall. Automation is the critical factor in eliminating the delays of manual processes and provides full visibility into complaints and the factors that surround them.

Download a free brochure to learn about AssurX eMDR solution for MedWatch 3500A submissions

About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.

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