Proactive Risk Management to Reduce Recalls in the Life Sciences

Recalls are serious issues that plague the life sciences industry with many potential negative consequences. They can cost organizations large amounts of time and money, as well as negatively impact brand image and customer trust. At their worst, imperfect products can jeopardize the health and safety of an organization’s customers.

Even though recalls are devastating, they’re still a common occurrence in life science organizations. In the medical device industry alone, there are 4,000 to 5,000 recalls annually. In 2015, the U.S. Food and Drug Administration recalled an additional 9,178 products. A large portion of the market suffers from the immediate and long-term effects of even one recall.

If organizations understand the severity of recalls, why do they happen so frequently? The answer: many organizations lack the quality management skills and tools that can reduce the risk of a recall.

Challenges of Quality and Risk Management
Recalls are often caused by systemic quality management issues going undetected for too long. A 2014 survey showed that almost half of life science professionals cited quality management issues as their biggest challenge in new product introduction. Unless these issues are solved during the planning and introduction phases, they will remain in the product as it enters the market.

Without a reliable method for detecting and resolving these issues, recalls will continue to happen. However, this is not a simple process—without the proper tools and technology to help, the process requires a lot of effort. Learning to leverage proactive risk management tools will help significantly lower the risk of recalls.

The first step in successfully overcoming quality management challenges is changing the approach to addressing recalls. Most organizations have systems in place for dealing with recalls once they happen, but they’re not completely effective because the recalls still cause damage.

Rather than a reactionary response to recalls, the proactive mitigation of quality issues can reduce the risk of recalls happening in the first place. Taking control of quality systems will reduce recalls and other quality issues within an organization. Leveraging an effective quality management system that features proactive risk management tools is the best way to gain control and prevent recalls.

Building an Effective Risk Management System
A strong risk management system lays the foundation for reducing recalls. When an organization can identify, understand, and reduce its various risks, it can better prevent the undesired event from happening. Good risk management solutions contain a few essential traits that make them effective for reducing recalls and other quality issues.

Repeatability: An organization should be able to apply the same methodology for all possible events. Following a set procedure sets up a systematic approach that can be easily duplicated. Other methods—for example, e-mail chains and spreadsheets—vary from occurrence to occurrence with little or no repeatability. Using a proven risk management tool guarantees an organization is following a set procedure and will receive the most accurate results.

Objectivity: Many quality and risk issues result from some type of human error, like making a mistake inputting the data or interpreting it incorrectly. Risk management tools remove the human input and provide results based solely on numerical data. There are no assumptions, beliefs, or subjectivity to influence the interpretation of the results. The result is a more efficient, accurate process yielding results free from human error.

Consistency: An organization should have confidence that its risk management system produces accurate outputs reliable for making decisions. If results differ between incidents or products, there is no way to know which results are accurate.

If that’s the case, an organization can’t rely on any of the information for decision-making, and the system becomes useless. An organization should never doubt whether the outcome is correct, since an effective risk management tool will be consistently accurate each time. That way, all of the products an organization put into the market are fully in compliance.

Automation: The purpose of putting a risk management system in place is to avoid issues that can occur with manual processes or human error. Using automated risk tools eliminates those possibilities by leaving the data entirely in the hands of the software.

Automated software also helps keep up with the fast-paced quality management environment. As standards, regulations, and technology change and advance, it is important to have automated tools that can keep up with the shifts. Relying on manual processes would take too long; by the time current issues or changes were documented, they may have already become obsolete.

Leveraging Risk Management Tools to Reduce Recalls
The challenge then becomes finding risk management tools that put these principles into action while still meeting a specific organization’s needs. Fortunately, they do exist, and can help identify high-risk situations, prevent future risk of recalls, and turn data into important information to drive improvement.

The Risk Matrix is one of the most commonly used risk measuring tools in the life science industries. With this tool, an organization can analyze hazards to quantify risk with numerical values, with the added effect of visual presentation of the information.

Using tested assumptions, a possible event is plotted on an “x” and “y” axis. Typically, the “x” axis is frequency (i.e., probability of the event happening) and the “y” axis is severity (i.e., the potential negative impact of an event). The axes are assigned with numerical values, depending on the organization’s particular circumstances and acceptable risk levels for certain impacts.

Within the matrix, ranges of high severity and frequency will be given the label of “high risk,” while something with low severity and frequency will be labeled “low risk.” The middle ground is usually considered moderate risk—but that varies between organizations. The matrix is then color coded (usually with colors like green, yellow, and red for low, moderate, and high risk, respectively), to easily show whether the risk is acceptable, needs mitigation, or must be avoided. However, some events fall on the border between two risk levels. In those cases, it is important to analyze the events in the specific context of an organization.

The risk matrix is a useful tool for both decision-making and prioritizing actions within an organization. For example, it can be used to decide whether or not to employ a new production method based on its potential risk. It’s also a helpful tool for prioritizing actions—regardless of their chronological order, higher risk situations should be mitigated or resolved before attending to those with lower risk.

Corrective and Preventive Action (CAPA) is another systematic approach to reducing recall risk and improving overall quality. This approach analyzes an event based on what went wrong, why the issue happened, and what can be done to prevent it from happening again. Throughout this process, the team will ask a lot of “why” and “how” questions to drastically reduce the likelihood of a repeat undesired event.

The first stage of the process is corrective action, which begins with a Root Cause Analysis. One or more various tests help determine the systemic, underlying reason for the recall or adverse event, so the organization can make an action plan to resolve the issue. Then, the plan for the second stage, preventive action, can be developed. Here, steps are taken to ensure the issue doesn’t happen again. The final step is an effectiveness check, where the solution and controls are tested to make sure they are working properly, and adjusted if necessary.

This tool is helpful for adverse events that are unexpected, happen quickly, or need to be prevented from recurring. This systematic approach aids quick recovery from issues and prevents similar future issues. Preventive controls will help reduce the risk of recalls by fixing the systemic problems plaguing an organization.

Enterprise Reporting promotes a culture of improvement, reducing recall risk over time across the entire organization. This tool gathers data from quality operations and presents it to the team in a comprehensive manner. The data can also be exported to other programs, where it can be examined more closely and analyzed with different formulas, filters, or ranges.

Flexibility of the data makes this tool effective for risk reduction. Comprehensive reports give insight into overall trends and general areas of strengths and weaknesses, and data exporting lets an organization see the data under specific parameters to pinpoint exactly what influences quality and recall risk. Either way, the information can be used to see challenges, make decisions, measure improvement, and prioritize actions. Following this, improvements can be made and the data can be revisited, in order to track the impact on the organization.

Benefits of Risk Management for Recall Management
When used in a combination that best fits an organization’s needs, these tools provide a systematic approach for reducing recall risk. Implementing them as part of the quality management system has many benefits to a company’s overall risk management, and specifically for recall risk.

Proactive mindset: Rather than a reactionary response to recalls, an organization can use risk management tools to prevent them from happening in the first place. Taking a proactive approach prevents recalls and saves an organization a lot of time and money that would otherwise fund the recall process.

Increased visibility: Risk management tools provide valuable insight into many aspects of production. When a team is aware of the strengths, weaknesses, opportunities, and risks surrounding its operations, it can better prioritize tasks and notice the effects that decisions can have on the organization.

Constant improvement: The reporting feature provides organizations the advantage of making informed decisions based on data and seeing the impact of those decisions. In combination, those two benefits lead to continual improvement and drive recall risk down.

If used properly, leveraging risk management tools will mitigate recall risk. An effective risk management system fosters quick response times, improves product quality, and promotes recall prevention methods. Otherwise, an organization will spend so much time and effort recovering from the recall process that it will be unable to correct the underlying issues, and recalls will continue.

Put simply, building a strong quality management system, with a focus on risk management, is the best practice for reducing recall risk. Leveraging an automated quality management system with risk-based tools and features gives an organization the best chance of avoiding recall and producing quality products.