Jay Jacobus Consulting
                  .... in a nutshell
Corrective and Preventive Action

The ISO 9001 standard confuses the topics of nonconformance, corrective action and preventive action.  For non-conforming products (section 8.3)  the standard says that these products will be controlled and prevented from unintended use or delivery.  This seems clear.

What needs to be done is to specify how nonconforming products will be identified and, once identified, treated.  That seems simple enough, but the standard goes on to specify two actions which are designed to eliminate or release the nonconforming products.

Eliminate sounds like preventive action and release sounds like one possible corrective action.   This is confusing.

Moving to Corrective Action (section 8.5.2), the standard includes an objective to prevent recurrence of non-conformances.  The word prevent refers to preventive action so the standard is again confusing.  The actions required seem to confirm that this element is referring to preventive action.  Words used include
"determining the causes of non-conformities" and "ensuring that non-conformities do not recur".  Both these sub clauses refer to preventive action and not to corrective action.

The section (8.5.3) refers correctly to preventive action and gives actions which, if followed properly, will lead to preventive action.

To remove confusion it will be helpful to think of controlling non-conformances as inspection and test (reject) and quarantine (action).  Think of corrective action as rework, replace, return to source or get a concession.  Think of preventive action as removing weaknesses in the operation such that errors will not recur.  Documentation needs to be done for each section.

In most companies, non-conformances rarely slip through but a documented procedure will ensure that they are handled properly.  This usually means tagging rejects, placing them in quarantine, writing a record and then going to corrective actions.

Again, most companies handle corrective action properly.  They resolve the immediate problem through rework, replace, return to vendor or get a concession.

Preventive action is not handle well at most companies.  When a mistake is found, it is often resolved by speaking harshly to the person that made the mistake.  This is not always the best solution.  Non-conformances often arise from a weakness in the tools, machines, instructions, labels, training, resources, skills and / or the procedures.  The manager in charge of preventive action should identify the weakness and change the system appropriately.

If the weakness is a training issue, then the untrained person should be given training and the company's training procedures should be evaluated for weaknesses.  To just train one person does not address the larger problem.

The preventive action should always be applied to the specific weakness but a systemic weakness should always be considered.  


Beyond Compliance

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Form vs. Function

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