Quality System Remediation and Root Cause Analysis

Regulatory Services

Successful quality system remediation relies on understanding why problems arose, generally referred to as “root cause analysis.”  There are several well-established tools in quality system root cause analysis, including “5 whys” and fishbone diagrams.  The fishbone diagram is particularly helpful, because it sorts for sources of problems (e.g., environment, methods, machines) and can be expanded or contracted in its number of categories (though five or six are the most common).  Our experience in serving MED Institute regulatory clients has shown that the root cause of many quality system problems lies outside the quality system and so are not as amenable to these methods.  In such cases, a different tool is needed.

We present here a different way to consider root causes, one that works both within and outside of quality systems.  At a high level, systems, like individuals, have three types of problems:  Capacity, capability, and motivation.

  • “Capacity” refers to having the available time and resources to perform the task. An imbalance here (too many tasks or too few resources), means that an otherwise effective system is suddenly not able to get things done or starts to do things poorly.  It’s often easy to assume that if more people were involved in a task or the team was given more time, the situation would improve.  It’s a good place to start, but it may not be true, because the other two factors may be at work.
  • “Capability” refers to the skill set of the team. Most work teams are constantly reforming, adding new members as the work grows, losing key members as those people move on to other tasks.  If the team doesn’t have the capabilities they need to get the work done, adding more people won’t fix the situation.  The team needs training, guidance, and perhaps new members to improve its capability.
  • “Motivation” is the deepest cause and is not easy to observe. Systems, like individuals, can have multiple motivations and those motivations can often clash.  A system may be operating at the right capacity with fully-capable team members, but still not achieve its goals.  Here’s a simple example:  Company A does its quality improvement work through cross-functional teams.  Year-end bonuses, however, are not tied to these cross-functional teams and are based only on individual achievement.

Problems of capacity, capability, and motivation can build up over time and eventually create major quality problems:  loss of productivity, product recalls, even FDA Warning Letters.  Sometimes you need outside help – a fresh set of eyes – to look at these problems.  Or you need urgent help because you have just received an FDA Warning Letter.  MED Institute has experience in all sorts of remediation and system improvement efforts and can help at any level.  We work with you to develop a custom quality improvement or remediation plan, with a timeline that meets reasonable expectations, based on your unique situation.

To learn more about our services and how we can partner with you, please contact us at 855.463.1633, askmed@medinstitute.com, or medinstitute.com.


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