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DECEMBER 2019 I SMT007 MAGAZINE 73 D4: Investigation and Root-cause Analysis Before you initiate a root-cause analysis exercise, make sure to gather all the facts with a thorough investigation. A common flaw dur- ing the root-cause analysis stage is to make assumptions and jump to conclusions without evaluating all factors. You can use Table 3 as a reference to evaluate all potential factors that could be contributors (this table a derivative of the fishbone diagram). Once you have established the highest risk factor(s) that contributed to the non-confor- mance, you can use a traditional "five whys" approach to help you drill down to the root cause (Table 4). There are other methods you can use to complete the root cause analysis, but the "five whys" approach is practical to implement. D5: Developing Permanent Corrective Actions Once the team has identified the root cause(s), then appropriate corrective action plans need to be drafted. Keep in mind that each corrective action plan needs to be verified for effectiveness. Corrective actions should not be ambiguous or general in context. Be spe- cific on what specific procedure, process, sys- tem, equipment, or method will be adjusted or improved (Table 5). D6: Implementing and Verifying Corrective Actions This discipline is what differentiates good CAPAs from average systems. A corrective action system is only effective when the verifi- cation phase has successfully been completed. Successful implementation requires that the Table 5: D5 example. Table 4: "Five whys" approach. Table 3: D4 example.