RCA Posts

Don’t Guess on Variation and Corrective Action

Don’t Guess on Variation and Corrective Action

Mark Crawford

Jonathan D. Port, a quality management expert and owner of Beacon Quality Services LLC (www.beaconquality.com), wrote an article on understanding variation in the March 2012 issue of Quality Progress.

“Organizations with quality management systems compliant to ISO 9001:2008 are required to take action to eliminate the causes of nonconformities,” says Port. “Clause 8.5.2 defines steps required for corrective action (CA), including determination of the nonconformity cause, along with determination and implementation of necessary action to prevent recurrence. Similar wording is also present in clause 8.5.3 regarding preventive action (PA).” (more…)

Reviving Six Sigma

Mark Crawford

There’s been some industry discussion that Six Sigma, the longtime standard of quality implementation, isn’t what it used to be—that in fact, for a growing number of companies, it is actually more of a negative than a positive.

For example,a 2007 study by QualPro revealed that 53 of 58 large companies that use Six Sigma have trailed the S&P 500 since they implemented it.

Others maintain Six Sigma is outdated and being replaced by newer methods, such as the theory of constraints and systems thinking.

However, don’t be too quick to dump Six Sigma—it’s still the same; the difference is in the way companies use it today, especially when dealing with an increasingly fast-paced and competitive global marketplace. Companies simply aren’t taking enough time and attention to implement Six Sigma properly. (more…)

Root Cause Analysis and Human Factors

Mark Crawford

In its new white paper, “How to Reduce Human Error by Managing Human Factors,” the FDA indicates the “typical response to a human error is retraining. But studies have now shown that training —or lack thereof—is responsible for only about 10 percent of the human errors that occur. Despite [an increased] awareness of human errors, companies still frequently fail to substantively and correctly address errors.”

Companies often turn to training, or retraining, as a quick and easy solution for a human error, when the real cause may be a deeper, systemic issue that could be revealed through root cause analysis (RCA). (more…)