When conducting a root cause investigation, each piece of information discovered has the potential to reveal the Likely Root Cause. It could be one clue or a combination of several clues. This is where investigators use deductive reasoning to find their culprit.

Key Advice

Be specific and and make sure the cause statement consists of two clear and separate parts- Cause and Effect. Because of this condition - because “this” happened, we got this effect - or result. A good cause statement defines WHY something happened as well as WHAT happened.

Example: Imagine you are investigating that customer XYZ got the wrong parts. A typical cause statement we often see is “the operator selected the wrong label.” The likely answer here is to do retraining. However, consider this as a cause statement: “Orders are not kept separate. Parts and shipping labels were mixed together in the shipping area, causing the wrong parts to be shipped to customer XYZ. Looks more like a process issue doesn’t it?

It’s interesting to see how we arrived at a totally different conclusion with the better cause statement.

Do you have any additional advice to share? Please share in the comments below. If you have had other methods of success in conducting investigations, we’d love to hear about them.

Repeat CAPA investigations are arguably one of the largest areas of concern for Life Science organizations today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as up to 30% of all open investigations- or 1 in every 3.

What percentage of your quality system investigations are repeats?

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