Q: I’m struggling with developing our unit’s risk management plans, especially when it comes to hazard analysis.
Can you help me better understand the differences between a cause, an effect, and a hazard?
A: The short but complicated answer is — it depends. It often depends on how you frame the description of the problem.
Here’s a simplified example:
If there’s an exposed sharp edge on an instrument case, and I receive a cut from it, it’s clear that something harmed me. So what is the cause, and what is the hazard?
I’d analyze it like this — I received a cut because I came in contact with a sharp edge. The cause was that I made contact with the hazard (the sharp edge) and the effect was a cut (an injury).
Then let’s look for underlying causes. Why was there an exposed sharp edge? Perhaps the case was damaged in shipment. The sharp edge (the hazard) happened because the equipment was damaged in shipment (the cause).
Why was the case damaged in shipment? Perhaps because the packaging failed to protect the case from damage (the cause).
In a hazard analysis, define the hazardous situation first, then start drilling down to the root cause.
The bottom line is that you need to frame very carefully the way you identify causes, effects, hazards, and harm. In a hazard analysis, define the hazardous situation first, then start drilling down to the root cause.
There’s an investigational method known as the “Five Whys”. In brief, when investigating a hazard, a failure mode, or other issue, you pose the question, “Why?” five times (or more, if the root cause isn’t pinned down in five tries).
Usually five to seven iterations will lead you to the root cause.
Answered by Janis Olson, Vice President of Regulatory and Quality Services for EduQuest, who served 22 years at the U.S. FDA as an expert field investigator and was the Director of Information Management Resources for FDA’s Atlanta regional office. Jan is the developer of EduQuest’s 1.5-day training class, Quality Risk Management for FDA/ISO/ICH Compliance.