![]() The DMAIC root cause investigation process follows a sequential five steps question and answer pattern. The five steps to DMAIC root cause investigation ![]() Sometime, facts need to be gathered from other manufacturing sites such as Crookwell operations and relevant third party contractors, if required. The investigation might be extended to other batches of the same product, other products, related processing areas and equipment that may be associated with the specific failure or incident as required. The DMAIC investigational process gathers facts from interviewing colleagues, batch record review, complaint files, retain samples, procedures and instructions, quality control testing, in-process monitoring, stability data, trends in deviations, previous investigations, change control, product quality reviews, equipment and utility maintenance programs etc. Rather, the tool should be used as an extended investigation and findings are attached with corresponding deviation.Īs the root cause is determined, corrective and preventative actions (CAPA) are implemented to stop recurrence of similar incidents or defects. We should be careful that a DMAIC Investigation exercise does not need to be carried out for every unplanned minor deviation situation as this exercise involves wider resources to be deployed and contributions from cross functional teams.Īs a rule of thumb a DMAIC root cause investigation should be raised when one or more of the following occur:Īlso, A DMAIC root cause investigation is not a substitution of usual unplanned deviation investigation. Typically, a DMAIC Investigation tool is used if the root cause of a deviation is not known and there is a necessity to perform an in-depth investigation with an effort to identify root cause/s which are hidden beneath the process and not so apparent. DMAIC Investigation toolĪnother popular tool for root cause investigation is based on DMAIC (Define – Measure – Analyse – Implement – Control) principle which involves thorough inspection of wider aspects of the facility and processes. The tool was named after its creator Kaoru Ishikawa hence also familiar as Ishikawa diagrams. It is also called Cause and Effect diagram as the process starts from the mouth of the fish (which is the Effect and the pursuit is to identify the exact root causes that have resulted or contributed to the Effect. Identification of root cause is the final step of an investigation followed by implementation of suitable, long-term preventative actions as a permanent fix.Ī very popular and widely used tool for root cause investigation is Fish Bone analysis. Such exercise includes major deviation investigations, complaint investigations, incidents, repeat incidents, defects, QC out of specification results investigation, etc. Throughout the GMP facility root cause investigations are carried out in order to control quality concern issues methodically.
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