Best Practices for Non-Compliance Reporting in ISO 9001

Question:
I have just assumed the role of Quality Assurance Manager for a worldwide manufacturer and installer of transportation systems.  As part of learning my new responsibilities and getting familiar the existing Quality Management System (we are currently ISO 9001:2008 certified), I have  encountered some things that I think may need to be changed.  Any opinions and/or advice would be greatly appreciated.

Here’s the issue; our current system for generating and tracking Non-Compliance Reports (NCRs) seems flawed.  The way it is set up, all NCRs that are generated include a check box to show any Corrective Actions or Preventative Actions.  If these boxes should be checked, the report is now called a NCR/CAR/PAR, all on the same form. The creator can then enter any actions taken.  There is also a section to enter the “solution” for the non-compliance.  The way this system works, it is not possible to create just a Corrective Action or Preventative Action Report (CAPA); they are shown as results, or solutions, to the NCR. Is this a good practice?

Are there better ways to utilize this process?  In going through the report from last year’s third party ISO audit, it was mentioned that we needed to improve on this process, and that the NCR/CAR/PAR should be tracked separately.  Any suggestions?

Response:
Generally, it is a good idea to use the same process for internal corrective action , a supplier corrective action, or a preventative action activity.  This will ensure that all required steps will be followed. As a Senior Quality Director for a company, we had our computer system log each type  separately as we set different deadlines for our corrective actions and preventatives.

The issue may be resolved by having the reporting system separate each type with aging timeless. I believe  each type needs to be tracked and reported monthly as well as Management Review meetings.

Ron Berglund
ASQ Fellow

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