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PEC-19-17 PROGRESSIVE ROOT CAUSE ANALYSIS FOR THE FDA REGULATED INDUSTRY

PEC-19-17 02/06/2019
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Ing. Carlos Urrutia

Root cause analysis (RCA) is a methodology for finding and correcting the most important reasons for performance problems.

“Root cause analysis is an approach for identifying the underlying causes of why an incident occurred so that the most effective solutions can be identified and implemented.”

It differs from troubleshooting and problem-solving in that these disciplines typically seek solutions to specific difficulties, whereas RCA is directed at underlying issues.

  • As a business process improvement tool, RCA seeks out unnecessary constraints as well as inadequate controls.
  • In safety and risk management, it looks for both unrecognized hazards and broken or missing barriers.
  • It helps target CAPA (corrective action and preventive action) efforts at the points of most leverage.
  • RCA is an essential ingredient in pointing organizational change efforts in the right direction.
  • Finally, it is probably the only way to find the core issues contributing to your toughest problems.

 

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