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Root Cause Analysis as a Tool for CAPAs

September 12th, 2014 by

CAPA Root Cause AnalysisCAPAs, or Corrective and Preventive Actions, are largely designed to help GxP-regulated firms handle non-conformity problems. In order to deal with undesirable occurrences in manufacturing processes, consumer feedback and compliance trends, firms analyze what went wrong with a given situation and the results.

It’s essential to scrutinize existing data, such as facility operating statistics and measured product characteristics, to quantify problems accurately. Nonetheless, firms must also focus on root cause analysis to find out more about the issues they discover and how to improve their quality management going forward.

Getting to the Source

Root Cause Analysis (RCA) attempts to pinpoint what prompted errors. Under this system, a factor that is defined as a root cause is one that would prevent the undesirable outcome from happening if it were eliminated from the situation. This unassuming definition is actually vital to fighting a problem effectively instead of simply dealing with a symptom.

Some issues can be confusing, especially with complex manufacturing processes. For instance, if a pharmaceutical company notices that some of the pills it manufactures are lacking in the required color, changing the amount or composition of food dye might seem like an obvious fix. Of course, such a measure may appear to result in a correction, but if the discoloration was actually caused by improper humidity levels in the curing environment, the same issue could crop up again later.

Without a thorough assessment methodology, such as RCA, you could end up wasting time and money on solutions that don’t actually produce the desired results in the long run.

Improving Methodologies

RCA also helps firms create CAPA systems that let them meet future goals and manage deviations. Learning as much as possible about past deficiencies could potentially assist companies that want to make ongoing improvements or target new compliance guidelines.

RCA strategies have demonstrated applications across a range of fields, and their versatility makes them suitable for GxP-regulated firms. Although RCA methods vary based on the type of production, safety, process, failure or systems analysis required for a specific application, the adaptability of these philosophies ensures that they can be used for many custom problem-solving tasks.

Taking a Systematic Approach

RCA may require your firm to adopt a new approach to dealing with deficiencies and their outcomes. In order to reach a state of near-zero problem recurrence, your response methodology must facilitate a systematic investigation of all the potential factors that could have contributed to the end state you identified as unacceptable.

Depending on the scope of the irregularity, some RCA efforts will require collaborative assessment efforts or outside assistance. Remember that in addition to identifying a single cause, firms often want to investigate diverse possible solutions and evaluate the cost efficiency of each. As such, many are forced to implement newer, more effective quality management systems overall instead of simply dealing with lone outstanding issues.

Although RCA is an important tool for correcting and preventing issues, a range of adaptable methodologies and problem-solving tools can make it difficult to adopt a workable system without prior familiarity. Trusted GxP-CC consultants possess the experience needed to adapt RCA and CAPA methods to the needs of diverse GxP-regulated firms. Contact them today to learn more about applying root cause analysis strategies efficiently.

 

About this author:

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For over 15 years Mr. Francum has worked in regulated environments directing and orchestrating the various components involved in assuring compliance of the most stringent regulatory requirements. He is an internationally recognized expert and has extensive experience in over 25 countries including, but not limited to, the regions of North America, Latin America, Europe and the Middle East.

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