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| Ferreting out root cause can explain the reasons behind a "no fault found" condition. |
by Harish Jose
Senior Quality Assurance Engineer
As a quality engineer working in the medical device field, I find there is nothing more frustrating than a “no-fault-found” condition on a product complaint. The product is returned by the customer due to a problem while in use, and the manufacturer cannot replicate the problem. This is commonly referred to as no-fault-found (NFF). I could not find a definite rate on NFF for medical devices. However, I did find that for the avionics industry it is 40 percent to 60 percent of all the complaints.
The NFF can be also described as “cannot duplicate,” “trouble not identified,” “met all specifications,” “no trouble found,” or “retest ok.” This menacing condition can be quite bothersome for the customer as well as the manufacturer. In this post, I will define some red flags that one should watch out for and provide a list of root causes that might explain the reasons behind the NFF condition. I will finish off with a great story from the field.
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