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effective root cause analysis and corrective action process

effective root cause analysis and corrective action process

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effects of the nonconformities encountered. Corrective <strong>action</strong> <strong>process</strong> should reviewnonconformities, determine the <strong>cause</strong>s of nonconformities, evaluate the need for <strong>action</strong> to ensurethat nonconformities do not occur, determine <strong>and</strong> implement <strong>action</strong> needed, record the results oftaken <strong>action</strong>, review taken <strong>corrective</strong> <strong>action</strong>, flowdown the <strong>corrective</strong> <strong>action</strong> requirements ifrequired to the place of problem’s origin, <strong>and</strong> take a specific <strong>action</strong>s where timely <strong>and</strong>/or <strong>effective</strong><strong>corrective</strong> <strong>action</strong>s are not achieved. In other words, CA is a <strong>process</strong> of identification <strong>and</strong>elimination of the <strong>root</strong> <strong>cause</strong>s of a problem, thus preventing its re-occurrence.Establishing a <strong>corrective</strong> <strong>action</strong> <strong>process</strong> includes also steps how to <strong>effective</strong>ly determine where<strong>action</strong> is needed, how to quickly assemble a knowledgeable <strong>and</strong> capable team to work on the case,<strong>and</strong> predictably produce results <strong>and</strong> improvements within the imposed or acceptable time frame(Ingram S. T., 1997)2. ROOT CAUSE ANALYSISIt’s very hard to precisely define the term <strong>root</strong> <strong>cause</strong>. There is a substantial debate on the definitionof the <strong>root</strong> <strong>cause</strong>, but these four cover all aspects of this phenomenon (Rooney <strong>and</strong> Heuvel, 2004):1. Root <strong>cause</strong>s are specific underlying <strong>cause</strong>s of observed problem;2. Root <strong>cause</strong>s are those that can reasonably be identified <strong>and</strong> therefore fixed;3. Root <strong>cause</strong>s are those states that depend on management <strong>and</strong> management has control tofix them;4. Root <strong>cause</strong>s are those for which <strong>effective</strong> recommendations for preventing recurrences canbe generated <strong>and</strong> hence eliminate the effect that they produce.1. Root <strong>cause</strong>s are underlying <strong>cause</strong>s of observed problem. The investigator’s goal should be toidentify specific underlying <strong>cause</strong>s called <strong>root</strong> <strong>cause</strong>(s). The more specific the investigator can beabout why an event occurred, the easier it will be to arrive at recommendations that will prevent reoccurrence.2. Root <strong>cause</strong>s are those that can reasonably be identified <strong>and</strong> therefore fixed. Occurrenceinvestigations must be cost beneficial. It is not practical to keep valuable manpower occupiedindefinitely searching for the <strong>root</strong> <strong>cause</strong>s of occurrences. Structured RCA helps analysts get themost out of the time they have invested in the investigation. The good representative of thisapproach is Kepner-Tregoe’s technique, when not the best but optimal <strong>root</strong> <strong>cause</strong> is sufficient <strong>and</strong>the most economical way to resolve the problem.3. Root <strong>cause</strong>s are those states that depend on management <strong>and</strong> management has control tofix them. Analysts should avoid using general <strong>cause</strong> classifications such as operator error,equipment failure or external factor. Such <strong>cause</strong>s are not specific enough to allow management tomake <strong>effective</strong> changes. Management needs to know exactly why a failure occurred before <strong>action</strong>can be taken to prevent recurrence. It is also important to be identified a <strong>root</strong> <strong>cause</strong> thatmanagement can influence.4. Root <strong>cause</strong>s are those for which <strong>effective</strong> recommendations can be generated.Recommendations should directly address the <strong>root</strong> <strong>cause</strong>s identified during the investigation. If theanalysts arrive at vague recommendations such as, “Improve adherence to written policies <strong>and</strong>procedures,” then they probably have not found a basic <strong>and</strong> specific enough <strong>cause</strong> <strong>and</strong> need toexpend more effort in the <strong>analysis</strong> <strong>process</strong>.The RCA is a four-step <strong>process</strong> involving the following:1. Data collection.2. Causal factor charting.3. Root <strong>cause</strong> identification.4. Recommendation generation <strong>and</strong> implementation.44

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