3 minute read
Yesterday was the first day of our latest 4-day (virtual) BlueDragon Critical Thinking and Complex Problem Solving Workshop for Practitioners. The very first learning objective in this workshop is to understand the regulations (laws) that require root causes analysis.
I was taken aback by how many of the participants in the workshop, even experienced root cause practitioners, did not realize that root cause analysis has been codified into our Code of Federal Regulations. In the commercial nuclear power industry where I spent time as an inspector for the Nuclear Regulatory Commission and also as a Site Quality Manager, I grew up enforcing and auditing to 10CFR Part 50, Appendix B, Criterion XVI, “Corrective Actions,” which states:
- “Measures shall be established to assure that conditions adverse to quality such as failures, malfunctions, deficiencies, defective material and equipment, and non-conformances are promptly identified and corrected.
- In the case of significant conditions adverse to quality, the measures shall assure that the cause of the condition is determined, and corrective action taken to prevent recurrence.”
The implications and legal ramifications of this language are that, in order to prevent recurrence of the significant conditions or events, we must conduct a sufficiently detailed analysis so as to uncover their deepest-seated causes (i.e. the root causes). Because only by addressing these root causes can we give ourselves a better chance of preventing their recurrence.
You will find similar language in many of the industries that have laws to protect human life. Sometimes directly, sometimes using more subtle language. Here are just a few:
- Title 10 – Energy
- Title 14 – Aeronautics and Space
- Title 21 – Food and Drugs
- Title 23 – Highways
- Title 32 – National Defense
- Title 33 – Navigation and Navigable Waters
- Title 34 – Education
- Title 36 – Parks, Forests, and Public Property
- Title 40 – Protection of Environment
- Title 42 – Public Health
- Title 44 – Emergency Management and Assistance
- Title 49 – Transportation
We have millions of passengers flying around the world every day, so you would expect to find strict laws that are intended to prevent such accidents as the two recent Boeing 737 Max airlines that crashed, killing 364 people; and there are. In Title 14 (Aeronautics and Space) we find the following language.
14 CFR Chapter III, Subchapter C, Part 437, Subpart C,
§437.73 Anomaly recording, reporting and implementation of corrective actions.
a) A permittee must record each anomaly that affects a safety-critical system, subsystem, process, facility, or support equipment.
b) A permittee must identify all root causes of each anomaly and implement all corrective actions for each anomaly.
Similar language exists in Title 21 (Food and Drugs) for obvious reasons:
21 CFR Subpart J: 21CFR820.100(a) – Corr./Preventive Action
(A) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:
(2) investigating the cause of nonconformities relating to product, processes, and the quality system;
(3) identifying the action(s) needed to correct and prevent recurrence of non- conforming product and other quality problems;
There are many ways that the different industries and organizations are complying with these laws; most through Quality Assurance Programs and the procedures that implement their Corrective Action Programs, which include Root Cause Analysis. Although most industries have these programs in place, in my opinion, there are few industries whose Root Cause Analysis programs have evolved to the level of those in commercial nuclear power. Perhaps after the big push that industry received after the highly visible Three Mile Island incident in 1979.
In recent years, I have noted more awareness of root cause programs and their benefits to preventing recurring events and improving overall safety cultures. For example, in a July 2020 article from the Pew Charitable Trust about the Food and Drug Administration’s (FDA) blueprint for improving food safety over the next decade, they noted that: “root cause analysis is core component of food safety.”
If you would like additional information on dramatically improving the effectiveness of your root cause analysis, visit us at: https://bluedragon1-ips.com/