Last year the ASA recorded 41 Repeat Findings during audits. What behaviors (or lack thereof) contribute to the likelihood of new or repeat findings?

I was recently in a hotel listening to the local news broadcast. An area leader was celebrating the now wide-spread availability of Narcan in the community, Narcan being the medication used to help save those who are experiencing an opioid overdose. Narcan has been very successful in bringing down the rate of deaths due to opioid overdoses. In the news story there was plenty of high fives and back slapping for admittedly the good news of the availability of this important lifesaving medication, but there was nary a word about the community’s epidemic of opioid addictions, and what, if anything, was being done to address it’s causes. This issue, as with most social issues, are glaringly devoid of Root Cause Analysis.

Regarding Root Cause Analysis, herein RCA, a common quote goes like this:

As an auditor of various Quality Systems, it has been observed that many Corrective Action Procedures contain a provision for Root Cause Analysis, but upon examination the RCA section appears superficial - the person(s) processing the NCR (Non-Conforming Report) or CAR (Corrective Action Report/Request) is mostly focused on fixing the noted discrepancy but not on the Root Cause. That’s disappointing because it is well known that failure to fix the Root Cause greatly increases the chances that the noted issue will repeat itself.

To be clear, the intent of this article is not to teach you about all the RCA methods, because literally many books and training courses address this in detail, but to bring to your attention the usefulness of this technique to really crush those troubling NCRs which may or may not be repeat offenders. Nonetheless, a quick primer on the topic follows.

So, what exactly is RCA?

According to the ASQ¹:

“A root cause is defined as a factor that caused a nonconformance and should be permanently eliminated through process improvement. The root cause is the core issue—the highest-level cause—that sets in motion the entire cause-and-effect reaction that ultimately leads to the problem(s).”

“Root cause analysis (RCA) is defined as a collective term that describes a wide range of approaches, tools, and techniques used to uncover causes of problems. Some RCA approaches are geared more toward identifying true root causes than others, some are more general problem-solving techniques, and others simply offer support for the core activity of root cause analysis.”

If you were a full devotee of the topic, you would have been introduced to the many methods available to perform the analysis such as:

Notice the 5 Whys method. For firms seeking an easy to use and understand method, the 5 Whys seems to be popular. On the ASA website for ASA-100 audits is an example of how to perform and enter Root Causes on intelex responses. This one is for a self-life part which was not on the self-life tracking listings²:

The key to successful 5 Why analysis is to be brutally frank and do not stop the ‘why’ questions until the answers have been exhausted; it may be more, or it may be less than 5.

An organization held in the highest regard for root cause identification is the National Transportation Safety Board, NTSB. They perform their analysis and investigations with the singular focus of identifying the root causes of the accidents. There can be no question that their stalwart analyses have made significant and profound contributions to the level of safety we enjoy today. Indeed, they perform this in an atmosphere usually charged with external parties exhibiting emotions, and who have parochial interests, and who wish to protect their constituencies from criticisms or other actions, but the NTSB remains neutral and focused. Bravo NTSB…

Over ‘n out

Roy ‘Royboy’ Resto

www.AimSolutionsConsulting.com

1 - https://asq.org/quality-resources/root-cause-analysis

2 - https://www.aviationsuppliers.org/ASA/files/ccLibraryFiles/Filename/000000001743/ASA-100NCRSample-ShelfLifeIdentification.pdf