What to Investigate?

The answer to the question of “what to investigate” is clearly defined in the regulations. A manufacturer is required to “investigate the cause of nonconformities relating to product, process, and the quality system.”

For most companies, the ability to identify non-conforming product is relatively simple—that is, they have established pre-defined specifications (i.e. limits) and they test according to those specifications. When a result is obtained that falls outside of a set limit (i.e., release, alert, or action), an investigation usually ensues based upon that company’s operating procedures. Most companies will investigate that failure to determine the root cause for the failure and implement corrective actions to fix the problem.

One of the more prevalent issues that I find in the companies that I have worked with, in particular, those with significant compliance violations, is that they often do not delve deep enough into the investigation to identify the root cause of this event; or they fail to identify the much larger process related non-conformance which failed to prevent the issue from occurring in the first place. I call this the “reactive vs. pro-active” approach to quality systems investigations. Let me explain further…

Many companies take a “reactive” position when they have a product-related non-conformance. That is, they rush to conduct an investigation and in an effort to meet unrealistic, self-imposed time constraints, they hurriedly close the investigation once they have identified what preliminary indications show to be a “root” cause. Oftentimes, this initial cause is rarely the “root” cause but more likely, a symptom of an underlying systemic cause (I will discuss the difference between a root cause and a symptom of the root cause in subsequent blogs).

The “pro-active” approach to investigations dictates that in any product/process/quality system-related non-conformance, the investigative team delves deep enough into the investigation to not only identify the true “root cause” (as opposed to a symptom of a much larger issue) but also ask the tougher systemic-related questions that will enable the team to effectively implement corrective and preventive actions in order to prevent future recurrence.

Therefore, as a product manufacturer, what should you investigate? Here are a few examples:
*Any product / process / quality system non-conformance
*Any trend that may indicate that your product / process / quality system is or may potentially trend towards non-compliance
*Any complaints (verbal, written, or electronic)