Engaged. Knowledge. Application
Conducting an Effective Failure Investigation: Going Deep Enough to Hit Root Cause
current concern related to the adequacy of failure investigations in identifying root cause. Effective failure investigation to true root cause is the heart of the CAPA (Corrective Action/Preventive Action) system.
In an effort to simplify the analysis of data, failures are often grouped into generic categories (human error, inadequate training, procedure not followed, etc.) Unfortunately, investigations often stop at this point because the actual cause gets lost in this attempt at simplification. Too often, a “band aid” fix is put in place (re-train, change the procedure, etc.)
Most textbooks on failure investigation identify key steps in the process:
· Identify the general problem –the problem statement should be as clear and concise as possible.
· Gather data or samples as necessary
· Investigate the failure through experiment and/or examination as necessary – can you re-create the failure? Is it repeatable?
· Brainstorm the causal factors – this is a great place to use tools (fishbone, affinity diagram, 5 whys, etc)
· Define the root cause based on the data and analysis.
· Develop the hypothesis – based on the data and analysis what do you think is the real problem? What do you need to do to prevent it from happening?
· Test the hypothesis – design the experiment to demonstrate you have eliminated the source of failure.
While the steps listed above are important to a true failure investigation, here are a few points to keep in mind:
· Use common sense –
· Don’t overlook the obvious – look for the most likely causes first
· The problem should dictate the tool, not the other way around.
· Avoid analysis paralysis – don’t make a problem more complicated than it is.
· Most problems can have more than one root cause – remember this is an integrated system. There are many touch points within processes. If you have identified those Critical to Quality (CTQ), you can be proactive in preventing failures.
· Tools are generic – you may need to modify the tool to fit the situation
· Don’t generalize the investigation – ask more “why”questions. Be as specific as possible.
About the Author
· B. Christine Park is a quality systems consultant with expertise in the implementation and remediation of sustainable and regulatory compliant quality systems. She has led the successful implementation of quality systems in large corporations, as well as small start up companies. Her
industry experience and background supports compliant yet practical, pragmatic quality systems. She can be contacted at 678-480-5411 and cpark928@mindspring.com
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