Corrective Action

SQA Advisory Number 10

Original date: October 21, 2004 Revision date: January 27, 2006 Download PDF (right-click; save target as)

Introduction:

In the normal course of business, things will inevitably go wrong. The degree of “wrongness” will vary from very minor to serious or catastrophic. Each organization must determine its own level of reaction to such occurrences. However, there is a truism that states: If the true cause of any problem is not identified and corrected, it is all but certain that the problem will recur.

Discussion:

Experience has shown that many people do not really understand the concept of root cause analysis and without it, true corrective action cannot be taken. It is not uncommon for a cause analysis to state “Operator error” or to simply be a restatement of the problem. Such responses or statements will fail to lead to a systemic corrective action.

SQA Position:

When problems are discovered as a result of process troubles, inspections, audits, returned material, customer complaints or other sources, it is incumbent upon the management of an organization to clearly define the problem, institute containment actions (as applicable and appropriate), determine the true root cause (see SQA Advisory #15), develop and implement corrective action, and take steps to assure that the actions taken are effective in preventing a recurrence of the original problem. Furthermore, they must prevent new problems that may result from the corrective actions taken. There are many sources of training and education on the topic of corrective action and root cause analysis, including books, schools and consultants. It is incumbent upon organizations to avail themselves of this knowledge and apply it in an effective manner.

It is our view, and SQA auditors are directed that corrective actions are actions that are taken to specifically address the root cause of a problem regardless of the magnitude of that problem. First, proper corrective action cannot be taken until the actual root cause of the problem has been identified.

Once the root cause and corrective action are identified, the original problem can be “controlled” by this action (i.e., turned on and turned off). When the right corrective action is taken, an existing system is “fixed” and the problem is expected to never return. Corrective actions taken to adjust human behavior (e.g., disciplinary actions, training, etc.) should be an exception and not a “rule”. People will always make mistakes therefore systems should be designed and adjusted to preclude this inevitability.

Other important aspects of the corrective action process include containment, consideration of defective products if applicable, temporary corrective measures and validation of effectiveness. Containment of the problem(s) is the first step. Before any other step is taken, the problem must be contained. If there is defective product at the customer, in transit or in storage, this must be considered for appropriate action including approved rework/repair. When the process is finished, follow-up activities must be scheduled to confirm that proposed actions are fully implemented.
 

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