When cobbling together a team to discover the root causes of a product or process problem, medical device and pharmaceutical companies must be sure they don’t include employees who don’t want to be a part of the group and aren’t interested in solving such matters, an expert says.
QualityHub Principal Consultant John Flynn further urges manufacturers to develop a root cause team of volunteers who are either “directly involved with the issue or have a specific expertise that would be needed, like an engineer if it’s an engineering problem, or a manufacturing engineer or manufacturing technician.”
But just because a subject matter expert, or SME, is on the team doesn’t mean it will be a success.
“Sure, the root cause team needs somebody that’s an SME, but everyone on the team must be people who actually want to be on it,” Flynn said. “The deadliest thing for any team that is doing root cause analysis is a person who doesn’t want to be on it. The teams that are most successful aren’t necessarily the ones that have the smartest people or the most qualified; rather, it’s the teams that have people who want to be there. They like doing it and they want to solve problems.”
That, he told QualityHub in an interview, is the “most important thing” for a root cause team but is often “missed” when such a group is formed.
“It can be a people problem,” Flynn said. “Having a good team doesn’t mean having the best expert on it. Instead, it means having the best people involved. Those are the kind of teams that want to solve a problem so bad that if they need an expert to be added to the group, they’re going to ask for one. They’re not going to sit around and just wait and eventually say, ‘Oh, we don’t have a proper expert.’”
He added that if a company “wants people to do a good job, then they need to include people who want to do a good job finding the root cause or root causes. A manufacturer shouldn’t want someone who says, “Oh, I have to get this done and get this monkey off my back.”
Finding Root Causes Must Be Company Priority
Having an adequate process for finding a problem’s root cause and making sure employees are trained to it are key ingredients that assist manufacturers in truly solving an issue.
“There are companies out there today that will show you a corrective and preventive action [CAPA] process but they’re not really making sure their employees know what ‘root cause’ means,” QualityHub’s Flynn said. “Without a foundational type of training on root cause – which isn’t that big of a deal, we’re talking a couple of hours, maybe three hours at the most – a company will likely fail, even when its employees are good people who want to solve problems.”
He went on: “There needs to be a basic understanding of how far they’re supposed to go in a root cause investigation, because many people learn to solve the most obvious or most direct issue, which is not the root cause, and they don’t know to go further than that to get to the point where they’re truly eliminating the problem and making sure that from a consumer’s point of view, it’s eliminated.”
Flynn says there are a “couple of companies that seem to understand that,” including Toyota Motor Co. In a 2018 story published by industry publication Medtech Insight, Edwards Lifesciences, maker of a slew of medical devices including heart valves, said it benchmarked the maturity of its various processes against Toyota’s standards for organizational maturity. It wasn’t the only company to do so – Toyota’s Total Quality Management approach has been adopted by many private and public organizations, including some in healthcare.
“Toyota’s belief is that they’re allowed to try to fix things, and that’s more important than the volume of production,” Flynn said. “They don’t just willy-nilly stop production, but they know that solving a problem is of high importance to the company. Finding root cause must be of high importance because even when a team has good people and a reasonable process, if management gets in the way, it can be a hindrance.”
At companies where management can be a roadblock, they’ll say, “‘Oh, this person is too important to be involved in this root cause team. They don’t have time to do that,’” Flynn noted. “So, what happens is, the problems just go on forever.”
[Editor’s Note: If your FDA-regulated company is having trouble finding the root cause of product or process troubles, then reach out to QualityHub today – our stable of trusted quality and compliance consultants, project managers, and regulatory experts can help.]
