Think Beyond "Human Error" in Corrective Action Requests in Quality Management Systems

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May 25, 2011

A key aspect of an effective and acceptable response to a Corrective Action Request (CAR) in a Quality Management System is the identification and statement of “Cause.”  A CAR is a procedure used in response to a nonconforming product, service or process.

The expectation from ISO guidelines is that the organization will investigate and resolve the process in their quality management system that:

  • did not exist,
  • failed, or 
  • was weak to the point of allowing the identified problem to occur.

Often organizations identify “Cause” by restating what happened, rather than a statement of cause.  For example, a CAR was issued for active gages exceeding their calibration due date. The company’s response for “Cause” was:  “Quality Technician missed these gages when he/she did last month’s calibrations.” 

While this certainly is what happened, it does not address the process within the quality management system failed or why it failed.  An acceptable response may be:  “The organization did not provide adequate resources such as an effective data-based gage recall system. Instead, the organization relied upon a manual data review each month. Thus, it was possible that gages could be overlooked.”

The next step is to define effective short- and long-term corrective action.  Related to the example above, here are some possible corrective actions:

  • Short-term:  Each month, the quality technician will meet with the quality manager and review next month’s gage calibration schedule as it now exists.  Once approved, the schedule will be broken down by production department.  Each sub-part of the schedule will be provided to the affected production supervisor.  Each production supervisor, in turn, will provide the list to the affected operators, the intent being to identify any gages that have not been listed or are missing.  Once the review is complete, the production supervisor will sign the list and return it to the quality technician.  The quality technician will update the list and execute the monthly calibrations.
  • Long-term:  The organization will investigate currently available gage calibration software.  A selection will be made within the next two months; the selected system will be implemented within the next four months following delivery of the new system.  Three months following implementation, a special internal audit will be executed to assess the effectiveness of the new gage calibration process.

Generally speaking, “human error” is not an acceptable response. While there are cases where the person did not do what was required, these events need be the exception, not the rule. Companies benefit from an in-depth Cause analysis and process changes that prevent these failures from happening in the future, as well as a process for measuring the ongoing success of the new procedures.

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