ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence

Big Jim

Admin
One hypothetical situation. This is an external third party audit and you are the Quality Manager. The audit finishes with only one nonconformance (the one that was found in the previous post, against 7.5.1 b). The external auditor writes this nonconformance. Two questions:

1. If you are the owner of the document control process, and after the root cause analysis you find that only the people in maintenance are responsible for this kind of events, who would you include in your corrective action, the entire staff or only the people in maintenance?

2. Would you consider this a good finding made by the external auditor, one that really gives value to your company?

In your hypothetical, does the auditee have a documented procedure that requires him to keep maintenance records?
 

Big Jim

Admin
One hypothetical situation. This is an external third party audit and you are the Quality Manager. The audit finishes with only one nonconformance (the one that was found in the previous post, against 7.5.1 b). The external auditor writes this nonconformance. Two questions:

1. If you are the owner of the document control process, and after the root cause analysis you find that only the people in maintenance are responsible for this kind of events, who would you include in your corrective action, the entire staff or only the people in maintenance?

2. Would you consider this a good finding made by the external auditor, one that really gives value to your company?

OK, first I would take off my auditor's hat and my consultant's hat and put on my quality manager's hat.

Next, I would involve top management, then the entire staff, then the maintenance people. There needs to be buy in from the top and throughout the entire company. I would give the maintenance group a significant level of freedom in developing a resolution that meets the needs without being burdensome. If top management wants to micromanage the resolution and not honor the knowledge of those who need to live with it, I would try to get him to see how he is not taking full advantage of his resources. If top management feels that he needs to remain overbearing, I would probably freshen up my resume and prepare to leave. Managing up takes some real finesse and often doesn't end favorably. It is better to not stick around where you are not appreciated.
 
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