ISO 9001 3rd Party Audit Preparation - Open Issues Aspects

[ddchhaya]

Re: 3rd party audit prep

I really thank you for a very comprehensive and appropriate approach to clearing the mess. I read each line carefully and after a lapse of nearly five years also this approach is capable of enabling MRs to deal with such situations which are not so uncommon. Thank you again sir!

 

[foiley]

I share your pain as I am sure everyone else has a similar story.

DO I just keep quite and only react to what the auditor finds or should I try to get a plan and timing together for fixing the system?

Definately above and foremost – tell your audit exactly what is wrong. If you raise a corrective action in house, it is hard for the auditor to raise external non conformances.

My advice would be to prioritise the core of the QMS - the Corrective Actions. When you get your Non-conformance, Corrective and Preventative Actions right everything else should eventually fall in place.

I would close out every non-conformance report you have currently open. Review the corrective actions from this NCR. If it hasn't been implemented and the risk is still apparent create an entry on an actin plan. Note this on the original NCR. Open one NCR and link this to your action plan and priorities corrective actions base on a simple risk matrix.

You know the drill - create a table 5x5, likelihood that it will happen on the top and consequence, how much it will hurt down the bottom. The higher the subsequent risk, the sooner it should be done. Make an exceptable level of risk, everything higher than this must be done prior to the survillance audit. Your exceptable level of risk can be renegotiated at any point.

End of the day, it would be a heartless auditor who pinged you on a troubled QMS where you obviously have shown a high level of commitment trying to fix up the errors.

If you do pull a heartless auditor, I would keep on them to their audit scope. Make sure any NCRs which could be on the verge of beeing outside the scope are improvement suggestions not Non Conformances.