A Fishbone diagram is a risk management tool used to visualize cause and effect to analyze the root cause of a product or quality problem in the pharmaceutical and medical device industry. The fishbone diagram is additionally known as the Ishikawa diagram, created by Kaoru Ishikawa in the 1940s.

Fishbone diagrams are commonly used in brainstorming sessions to immediately identify and categorize potential causes of a problem. The first step in utilizing a fishbone diagram is to understand the problem statement at hand. Then identify the major categories of the causes that led to the problem such as people, equipment, methods, materials, measurement, and environment1. After identifications then it is best to ask, “Why does this happen” and narrow down the causes based on the categories until there are a few options for each.

During the brainstorming process, it is important to consider all ideas for potential causes of the incident. The most common causes of problems in the industry tend to lean toward the assumptions of human error which can be backed up by improper training or not following Good Manufacturing Practices2. Human error might be the easy option but choosing the human error route may overlook other causes that lead to the problem.

It is important to focus on the problem and not the associated discrepancies to the problem. Fishbone diagrams are used in association with various other tools for root cause analysis. When using an RCA tool, it can be best to use multiple tools in conjunction to identify the root cause of the problem. If your company needs assistance with producing a fishbone diagram or with root cause analysis, EMMA International can assist. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.

1American Society of Quality (2022), Fishbone Diagram, retrieved on June 5, 2022, from https://asq.org/quality-resources/fishbone

2Pharmaceutical Guidelines (February 2022), Fishbone Tool of Investigation in Pharmaceutical, retrieved on June 5, 2022, from https://www.pharmaguideline.com/2017/06/fishbone-tool-of-investigation.html

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

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