Last month, we talked about demystifying the root cause process- specifically with respect to the problem statement. The key takeaway from that clip was that you should take the necessary steps to fully understand the problem statement before investigating it.

This month, we’ll discuss the importance of fact gathering and common issues that get in the way of good investigations. Specifically:

I see many investigators who don’t want to appear like they mistrust their witnesses. So they don’t challenge the meaning of words, and they often accept vague or general statements. They attach a meaning to the words and move on.

My advice: Don’t be afraid to ask the “stupid questions.” For example, a witness may say “The truck was late.” I can either write that down and move on or I can ask “How late” or “What do you mean by late?” or “Whose truck?” By challenging, I get more concrete information. Remember, challenging helps us to be thorough.
Also, make sure you’ve talked to all the witnesses. Gather all information using the necessary quality tools: checksheets, run charts, process maps, etc. I see too many investigations that are shallow because the investigator quits too early and in doing so, never identifies the root cause.

Fact gathering means all the facts- leaving no stone unturned.

Have you ever experienced this scenario while training a group? Please share your experience with us.

Analysis of root cause is a primary area of concern when addressing nonconformaties and deviations in life science organizations today.

In your opinion, what is the most common tool your investigators use when conducting a root cause analysis?

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After reviewing many CAPA SOP’s there appears to be two primary directions companies go in to decide if they are going to initiate a CAPA:

1. An issue (nonconformance ect.) is identified and a root cause investigation is conducted. Based on the the investigation a decision is made to address the issue as a CAPA or not.

2. CAPA is initiated (based on risk) and the first action is to conduct a root cause investigation.

Based on your companies current flow process, which comes first; initiation of a CAPA or a root cause investigation?