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The first step is to create the problem statement. You, and everyone on your team,
must understand exactly what the problem is. It is the focus of your investigation. A problem statement is a statement of fact clearly identifying what has a problem (object) and
what specifically is wrong (defect). It should be as clear and concise as possible. Beware
of vague words.
Note the object (product XYZ) and defect (scratched parts) in this problem statement:
Scratched parts for product XYZ increased by 70%.
The second step is to brainstorm possible causes. Be sure that your team follows
brainstorming rules (Figure 1). In the example, we ask the team to generate possible
responses to the question, Why are we seeing an increase in scratched parts?
At the end of this step you should have a good list of possible root causes. They
should then be clarified and grouped using some system of categories. The six M grouping (manpower, method, material, machinery, mother nature and management) is very
common, but any labels that make sense can be used. For example, PEMME (personnel,
equipment, method, material and environment) is popular also.
The third step is to draw the fish and labels and enter data appropriately (Figure 2).
These data are the summary and categories of possible root causes of the increase in
scratched parts. Most likely, the team will continue to present ideas, which can be incorporated until the diagram is completed. Continually asking Why? as you transfer the
data to the diagram helps you drill down through symptoms to causes. Its also important
throughout the process to challenge assumptions, support conclusions, etc. Remember
In God we trusteverybody else, bring data!
The fourth step is to determine the most likely cause. Organizing the data in a fishbone diagram gives you the ability to see linkages, relationships and patterns. At this
point, a number of things might happen (Figure 3). During your discussion, the most likely
cause may become clear to all. Some causes may drop out for obvious reasons. The
evidence gathered during the investigation may point to the cause. If there are several
possible root causes with no clear winner, you might ask each team member to select the
cause he or she considers most likely and to defend this choice. You could use a multivoting tool or ask team members to rank their top three causes. There are many ways to
conduct this step.
Finally, verify the most likely cause. This last step is simply to prove the root cause is
correct. What scientific tests might you conduct? How will you monitor the results? Set up
an experiment? Remember, if you can turn the defect on and off, youve identified the root
cause.
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Congratulations! You found the root cause using the fishbone diagram. However, the
job isnt finished. Apart from the upcoming corrective and/or preventive actions (CAPA),
you have an investigation report to complete and submit to your company and/or to the
proper regulatory authority.
Because you used this tool properly, your investigation went wide and deep. Not only
did you prove you found the right cause, you were also able to show and justify what you
did not select. The US Food and Drug Administration cares about all these things. Your
fishbone diagram (and other documentation) provides the evidence.
About the Author
Herb Miller has spent the past decade delivering quality systems training for life science and manufacturing professionals. He
has taught CAPA and documenting of investigations throughout the world. Miller has experience in change management, total
quality management and onsite investigations. He holds a masters degree in human resource management and a bachelors
degree in organizational management. Miller can be reached at http://www.pathwise.com/contact.php.
2013 by the Regulatory Affairs Professionals Society. All rights reserved.
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August 2013