How to Define and Scope Problems: A Primer for Medical Device Manufacturers

January 18, 2019
This is the second post in a 4-part blog series on medical device root cause analysis. In our first post we covered the basics and in subsequent posts we will talk about formulating a plan, and root cause verification. We’ve combined all four posts into one easy-to-read PDF, plus added some extras. Download it here.

If I had an hour to solve a problem I’d spend 55 minutes thinking about the problem and 5 minutes thinking about the solution.”

Define_Scope_RootCauseAnalysisPretty smart advice from Albert Einstein. Too often we jump immediately into problem-solving mode without fully understanding the problem itself. Frequently a problem seems unsolvable because it is really multiple problems and each requires its own solution. A well-defined problem statement is objective and based in data. It presents the problem but not a cause or solution. It clearly defines a performance gap and focuses the team, and it can be understood by people who are not directly involved.

Well-written problem statements must be able to answer two questions.

  1. What is the thing that is wrong? (e.g., the connector…)
  2. What is wrong with the thing? (e.g., it contains cracks…)

Problem statements should:

  • Be measurable (where possible)
  • Be concise
  • Be specific

Consider the following problem statements:

  • Poorly written: Hypodermic needles are defective.
  • Better: Hypodermic needles, Gage 25, show too much variation in their inner diameter, beyond specification limits.

It is important that you do not confuse symptoms, problems, and causes. If you are feeling achy, weak, or tired, those are symptoms. But the problem may be that you have a fever, and the cause may be an infection.

Now that you have defined the problem, you need to scope it

Some problems quite obviously need to be solved, but others are not clear-cut. For instance, do you need to solve the “problem” that your company is losing 4% of a specific component to damage during warehouse handling and transit? That depends on several factors. Do not expect a problem statement to make its own case – it must be backed up with the reasons why the problem should be solved.

A frequent pitfall in problem solving is that the wrong problem – one that doesn’t matter or does not advance the organization’s strategic business plan – is solved. To make good decisions, you should think “business case” and examine problems with three things in mind:

In the problem statement example given above (hypodermic needles), the impact could be serious. If the inner diameter of the needles is too small, it could cause undesirable constriction. If it is too large, it might cause a patient’s blood pressure to drop.

In many situations the original problem statement might be quite broad, but “general” problems are very hard to solve and it’s even harder to measure your success in solving them. The better you define and focus the problem, the easier it will be to verify the solution. There are no rules that tell you when a problem is focused enough. Narrowing a problem allows you to localize the problem definition and use time and resources most efficiently. Developing a focused problem statement is a balancing act – you have to focus so that you have a clear path forward, but you don’t want to get bogged down.

Going back to the problem statement example concerning hypodermic needles, a more focused problem statement would read: Hypodermic needles, Gage 25, supplied by vendor A, lot #123, in October 2018, show too much variation in their inner diameter, beyond specification limits.

Making the case for solving problems

Once you have recognized a problem and determined it is worth addressing, you need to make a case for doing so. As we said before, many problems make their own case and it will be obvious to almost everyone that they should be solved. Sometimes, though, what may seem obvious to you could be viewed differently by others. Recognize the differing priorities of your internal audience in making your case. Engineers speak the language of measurement, while management speaks the language of money. For instance, you could say that a reduction in product defects by 50% will “reduce scrap, improve customer satisfaction, and reduce the labor needed for rework.” However, it will be much better if you make the case that doing so will “cut material costs by $275,000 per year, increase sales by 1-2%, and reduce labor costs by $150,000 per year.” That’s specific, measurable, and impactful. By crafting a clear problem statement and making a compelling business case, you can articulate how you will measure success.

After that, the next step is to prioritize the problems. Projects should be meaningful and manageable. To help evaluate them, create a matrix and weight the projects, as shown below.

Root Cause Analysis Problem Solving

Remember, as amazing as you are, you are not a superhero. Success is measured by victories, not by the size and number of battles. It’s better to achieve success one small problem at a time than fight ongoing battles on multiple fronts. Doing so will also reduce your stress level and make your work more meaningful.

Want to learn more?

Continue reading the next blog post on how to assemble your team and create a plan. We have addressed a small part of what there is to learn about medical device root cause analysis. If you enjoyed this article and want to take the next step in advancing your knowledge, consider Oriel STAT A MATRIX’s training class on root cause analysis.

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