Understanding the Basics of Fishbone Analysis

Lean Biomanufacturing, Dr. Nigel J. Smart

Tackling the demands of the biopharmaceutical industry can prove to be quite trying in today’s competitive field. Yet with proper research and experimentation, companies can readily understand the kinks in their systematic methods early on, leading to great success in their research.

Tools like fishbone analysis can ultimately help yield accurate results and benefit researchers in the long term within their biopharmaceutical process.

For anyone who is familiar with lean biomanufacturing, one may already know that lean is most commonly identified in the biopharmaceutical industry as a “holistic and sustainable approach that uses less of everything to produce more.”

The financial burdens of today’s economy most certainly play a key role in this industry, which is why researchers utilize proactive methods of experimentation to best identify problems early on in their research.

A standard fishbone diagram follows a simple, yet systematic approach to understanding the potential downfalls of each of the mechanisms in a biopharmaceutical process (i.e. materials, methods, machines, measurements, environment, and people.)

Using fishbone analysis, a team of researchers creates a list of reasons to identify various problems in their findings. When utilizing this technique, one of the best practices involves creating a simple chart (template) for the responses of the research time, otherwise known as the ‘5 Whys’ Analysis.

Create a list of “Why 1, Why 2, Why 3, etc.” Then next to each item, identify the problem and then describe why that particular result occurred. Asking sequential questions, while filling out additional bones of the fish structure for each sub-reason, provide a fantastic “checks and balances” system for researchers.

For additional information, including case studies on fishbone analysis, refer to Lean Biomanufacturing by Dr. Nigel J. Smart.