Root cause analysis (RCA) is a structured method for identifying the main cause of a problem and implementing changes to the system. It’s an important part of CAPA (Corrective and Preventive Actions) management in the pharmaceutical industry. RCA is used to determine the underlying cause of a ...

The 5 Whys method is a root cause analysis tool that helps determine the root cause of a problem by asking the question “Why?” five times in a row. The answer to each question forms the basis for the next question. The goal is to dig deeper to ensure corrective action goes beyond addressing ...

Root Cause Analysis is a useful process for understanding and solving a problem. As an analytical tool, Root Cause Analysis is an essential way to perform a comprehensive, system-wide review of significant problems as well as the events and factors leading to them. Root Cause Analysis (RCA) is a technique ...

Root cause analysis is performed to determine the root cause of errors or problems during the process. Root causes of out-of-specifications, production time deviations, and market complaints must be determined. Various methods are used for root cause analysis in pharmaceuticals. 5 Why is a useful and ...

Root Cause Analysis is the most important factor in determining the quality of every organization, including the pharmaceutical industry, it is a method of knowing the first action that leads to the sequence that leads to the resulting problem and finding ways to solve this problem. Company auditors ...