The Great Escape: Are Your Corrective Actions Yielding Unnecessary Cost and Risk?

We all know the drill … a problem occurs that may warrant a corrective and preventive action (CAPA) or, worse yet, land you on the U.S. Food and Drug Administration’s (FDA) radar. A SWAT team is deployed to address the issue (regardless of the cost), a procedure is modified or developed, steps are added, and another set of eyes is assigned to perform additional inspections presumed to prevent the problem from recurring.

At this point, a review is performed, and the company concludes that the action it’s taken will mitigate the risk of another “quality escape.” The corrective action is declared effective, and resources are deployed to solve the next issue.

This scenario plays out throughout the medical technology supply chain on a daily basis. We understand the need to react swiftly; documentation, labeling, procedural, and product issues can be especially dire and should elicit immediate action. However, while mitigating the risk of quality escapes is an appropriate first step, medical technology companies too often stop there. There’s little or no attention paid to identifying and eliminating the true root cause. While efforts to problem solve are well intended, they’re not effective beyond containing the initial fire, resulting in added cost and the risk of recurrence.

Cost Savings and Risk Mitigation Opportunities

Many medical technology companies do a very good job deploying resources to contain a problem when it occurs. They analyze the issue and subsequently take steps to prevent it from happening again. Those actions in themselves are appropriate. Where opportunity exists is in taking steps beyond containment—steps commonly absent in the execution of corrective and preventive action.

In organizations where problem solving is highly effective, these steps are the beginning and represent “containment” actions—containing the problem and taking steps to mitigate the risk that the problem will “escape.” High-performing companies have learned that containment actions are costly and only should be a temporary fix until the root cause can be identified and permanent corrective and preventive actions are put in place and verified to eliminate recurrence. Once cause for recurrence is eliminated, the cost associated with non-value-added steps to “contain” the problem and reduce the risk of escape can be
eliminated, too.

Why Is This So Important?

Organizations that don’t consistently perform root cause analysis and implement verified permanent corrective and preventive actions are missing significant opportunities:

1. Because the primary effort is aimed at containment, the root cause of the problem may not be identified; thus, recurrence of the problem is likely. Problems may resurface as the same identifiable issues or manifest as other issues. In this case, the company is dependent upon the ongoing containment actions to prevent the problem from “escaping” the system. The problem still exists … steps have been simply put in place to “catch” the problem. It’s remarkable how many times we talk with industry leaders and quality professionals about problems, and they comment on how they seem to address the same issues over and over again. This is because the true root cause never has been addressed.

2. A common corrective action for containment is to add an inspection step or modify the inspection activity. Inspection is an imperfect technique—it’s been found to be 80-94 percent effective depending upon the source and the context of the inspection activity. Still, these modified inspection steps all too commonly are accepted as appropriate corrective actions for quality issues and the completion of the problem-solving effort.

3. While inspection has its place in quality assurance, dependence upon inspection and the accumulation of additional inspection activities in medical technology companies builds non-value-added cost. Moreover, in many instances, it leaves the root cause of the issue unaddressed and builds an organizational culture that allows others to abdicate ownership for quality, as they’re conditioned to depend upon others to “catch” issues.

The Discipline of Problem Solving

Ask leaders in any organization about how they solve problems, and chances are they’ll use words such as “cross-functional,” “teams,” “data,” and “root cause.” Probe further, and you’ll find that differences between companies that excel in problem solving and eliminating recurrence have a number of common characteristics:

1. Leadership’s commitment to making robust problem solving a core competency and activity in the organization. This means continuous personal participation in conducting problem-solving review meetings and holding direct reports accountable for conducting similar reviews. Organizations that effectively have institutionalized robust problem solving and consistently eliminated causality have accomplished this because leadership is fluent in the use of, and regularly conducts, problem-solving reviews.

2. Establishing a company-wide standardized methodology for problem solving throughout the organization. The steps in the process are clear and repeatable, and containment action is a “mid-step” in the process. People throughout the organization are trained in the methodology, which establishes a common language and understanding within the organization and throughout its supply chain. The standardized methodology reinforces a culture of discipline, accountability and relentless pursuit of elimination of cause, not simply containment and prevention of escape.

3. A robust problem-solving toolkit. It’s critical that individuals in the organization master these tools so they’re able to diagnose the situation throughout the process and apply the appropriate problem solving tool. There are dozens of tools commonly used (Pareto charts, Ishikawa diagrams [a.k.a. fishbone diagram, cause/effect analysis], etc.), most of which are highly visual and graphic in nature. Organizations that have mastered problem solving and root cause analysis also establish advanced quality planning activities for both products and services; quality planning tools (failure mode analyses, control plans, etc.) are a source of rich analysis and action throughout the problem-solving process.

4. Problem solving is not the responsibility of RA/QA. Rather, it’s the responsibility of the function or area where the problem occurred. Because problems are considered quality issues, too many companies look to RA/QA to solve problems. While RA/QA may have a key contributing role during the problem-solving process, so do research and development, manufacturing, supplier management, finance, marketing and sales.

Why is Effective Problem Solving so Elusive?

Effective problem solving is not overly complex; in fact, applying the tools and following a prescribed methodology is quite simple. So why don’t more medical technology companies master it? Time and expectations.

The medical technology field is a dynamic and fast-paced environment. When issues occur, the tendency is to react quickly, contain the fire, and move on to the next issue. While this is understandable, it’s not a long-term solution.

Going beyond containment to identify the true root cause and, ultimately, change processes that will prevent recurrence, ultimately will reduce cost and mitigate risk. It’s a matter of setting expectations, establishing the standardized methodology, training your people, and having the drive and discipline to execute. You just have to decide it’s important enough to do it.

Jeff Jenkins is a partner at Plante & Moran, where he leads the Operations & Supply Chain Management practice. For the past 10 years, Jeff and his team have focused on helping medical device OEMs and suppliers in the areas of supply chain management including supplier development and low-cost country sourcing, product commercialization and launch, inventory management, manufacturing, lean, project management, problem solving, logistics and transportation, strategy, and quality systems.