Rather than just fixing problems on the surface, root cause analysis (RCA) reaches back with a methodology that solves problems at their root.
The benefits of RCA are that it uncovers relationships between causes and symptoms of problems, works to solve issues at the root itself and provides tangible evidence of cause and effect and solutions.
Root cause analysis is widely used in many industries including IT operations, telecommunications, industrial process control, accident analysis, medicine and the healthcare industry.
Another sector that has become a leading advocate of root cause analysis is the pharmaceutical industry. RCA helps pharmaceuticals identify market complaints, out of specifications (OOS) and deviations.
For the pharmaceutical industry, corrective and preventative
actions have become more important than ever since the Food and Drug
Administration (FDA) demands effective corrective and preventative actions
(CAPA) via the Quality System Regulation and the Quality Systems Approach to
Pharmaceutical Current Good Manufacturing Practice Regulations guidelines.
Successfully implementing and documenting CAPA is one of the critical processes in a medical device and pharmaceutical manufacturing company’s day-to-day quality operations. CAPAs carry significant implications for both product quality and compliance with FDA regulatory directives, and remain vital to any company’s ability to address incidents that inevitably arise in the manufacturing processes. In fact, around 30% of the warning letters issued by the FDA is due to pharmaceuticals failing to establish and maintain procedures for implementing corrective and preventative action.
Consequently, it is critical to take necessary steps to prevent errors from re-occurring, which is where RCA comes in.
Root cause analysis is a problem-solving process for conducting an investigation into an identified incident, problem, concern or nonconformity. Root cause analysis is a completely separate process to incident management and immediate corrective action, although they are often completed in close proximity.
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