Quality Manual Problem Root Cause Analysis

[Khumo]

good day

we have a bit of a problem with root cause and preventive actions. we had a non conformity of having implementation of system but not actually documenting them in our quality manual. now i am a bit stumped as what to write as a root cause for this, please assist.

thnak you Khumo

 

[Miner]

Which standard was the nonconformance written against? If ISO 9001, was it one of the mandatory procedures?

 

[Khumo]

ISO 17025

 

[Jim Wynne]

good day

we have a bit of a problem with root cause and preventive actions. we had a non conformity of having implementation of system but not actually documenting them in our quality manual. now i am a bit stumped as what to write as a root cause for this, please assist.

thnak you Khumo

Could you post the full nonconformity statement from the auditor? It will help us to give better advice.

 

[Khumo]

There are a couple of them, and they are all basically in this format: A title (e.g TEST REPORT or CALIBRATION CERTIFICATE) addressed in the calibration certificate but not addressed/documented in the Policy Manual.

 

[Jim Wynne]

The nonconformity statement should include reference to the requirement (from the standard or the organization's own documentation), and the evidence of nonconformity at a minimum.

What kind of audit was it? Can you please post one full nonconformity statement just as it was written by the auditor?

 

[RoxaneB]

There are a couple of them, and they are all basically in this format: A title (e.g TEST REPORT or CALIBRATION CERTIFICATE) addressed in the calibration certificate but not addressed/documented in the Policy Manual.

Hello, Khumo.

I think we are a bit confused here. Your subject line implies that your organization has systems in place for root cause analysis and preventive action, but has not sufficiently outlined them in the quality manual OR that there is a problem with your quality manual and your organization is uncertain how to identify a root cause for this problem.

Additional confusion is because you mention a test report or calibration certificate.

This confusion is why you are being asked for the full and complete wording of one nonconformance from the auditor.

If you are asking us for assistance in identifying your root cause, we can hopefully provide some possibilities once we see the full wording, but only your organization will be able to determine what is the true root cause.

 

[normzone]

I'm reading this as they're doing something they need to be doing, but it didn't get mentioned in the Quality Manual that they do this.

A repetition of the nonconformance statement would not meet the best practices for defining the root cause, but it would be close.

My guess is that the requirement for this practice to be documented at this level in the Quality Manual was not identified at the time of the manual's inception.

 

[Jim Wynne]

I'm reading this as they're doing something they need to be doing, but it didn't get mentioned in the Quality Manual that they do this.

A repetition of the nonconformance statement would not meet the best practices for defining the root cause, but it would be close.

My guess is that the requirement for this practice to be documented at this level in the Quality Manual was not identified at the time of the manual's inception.

We're not even sure at this point what the problem was, or if there was anything that actually needed to be in the QM. The NC statement will tell us (I hope) what the actual finding was, and what the requirement was that was allegedly not fulfilled. Without that, we're all guessing.