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.
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, email@example.com, or medinstitute.com.
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