SMT007 Magazine

SMT007-Dec2019

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72 SMT007 MAGAZINE I DECEMBER 2019 rence, and preventing or minimizing device failures. One of the most important quality sys- tem elements is the corrective and preventive action subsystem." Having established the requirements, it's time to look at the 8D approach. This approach has been used by many organizations over the years and is widely recognized as best-in-class by top-tier OEMs in the aerospace, computing, automotive, and life science industries. The "8D" represents the eight disciplines in a CAPA system. The approach provided in this column is what I have used to train quality organiza- tions in contract manufacturing. This is spe- cific to product non-conformances. D1: Establishing a Team The 8D CAPA should not be drafted and implemented in a silo by a single individual. Preparing and implementing a CAPA is a team approach and effort. I recommend that you identify representatives from functional areas impacted by the corrective action request. Treat a CAPA as a small project that requires team collaboration and due diligence. D2: Problem Statement Be very specific in describing the problem. The best approach is to create a table that gathers the necessary information to help you define the problem in its entirety. Table 1 can help achieve this objective. D3: Immediate Containment Stop the bleeding of the non-conformity reported. For product quality-related correc- tive actions, consider using this table to ensure containment actions have successfully been addressed (Table 2). Table 2: D3 example. Table 1: D2 example.

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