Investigating Cause – Drilling down to the root cause

In any nonconformance investigation, identifying the root cause is an integral part of the process. Identifying the root cause enables one to:

*Implement effective corrective actions
*Accurately trend data for process monitoring
*Implement effective preventive actions
* Develop effective strategies for continuous improvement

With so many different benefits of identifying the root cause of a nonconformance, it is imperative that the investigator does his/her due diligence to ensure that appropriate measures are taken.

One of the biggest challenges that various pharmaceutical / medical device companies face is that oftentimes, investigations stop at the first, immediate cause and fails to drill down further to address the systemic underlying cause(s). Or, their investigation may identify several contributing causes but fails to identify the root cause of a nonconformance. How can you tell the difference between a contributing cause and a root cause? Experience, Experience, Experience!

Experience is a critical factor in any comprehensive root cause investigation of an identified nonconformance. The key to differentiating between a contributing cause and a root cause lies with:

1. Experienced Investigators—they are an integral part of the process in that they are able to bring rational, sound judgment to the table. They have intimate knowledge of what works, what does not work and what requires improvement. They are not prone to “shoot at the hip” and stop the investigation after they have answered the first “why” an event occurred.

2. Experienced Mentors—coupled with an experienced investigator, experienced mentors are crucial in bringing unbiased, thorough, and systematic approach to a nonconformance investigation. They help the experienced investigator drill down even further into their process and to identify potential gaps and areas for process improvement.

3. Experienced Quality Oversight—The Quality dept. must give final approval of any nonconformance investigation and this individual must possess the necessary education, knowledge and experience in order to effectively carry out this quality function. Quality is the final reviewer of the investigation and as such, an experienced Quality reviewer will bring to the table a fresh viewpoint that ensures the comprehensiveness of the investigation.