As-Found FAILED calibration

Vader22

Starting to get Involved
I agree Jim. Just flustered with the people that write these things not being able to say what they really want. It shouldn't be that difficult.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Because the standard does not explicitly call for this type of review like 9001 does, it would be easy to claim the NC is not valid.

However, there is a requirement to address nonconformities and adhere to the requirements of interested parties (previously called Legal and other obligations). When monitoring and measuring, there is an expectation that the process is effective and discovering instruments are providing incorrect results is causing the process to be less than effective.

What does your procedure say?
 

Mike S.

Happy to be Alive
Trusted Information Resource
Like I said before, I agree with the common sense of assessing the risk, I just don't see the requirement in the standard. If this is indeed a requirement of ISO 14001, then shouldn't it meet the requirements of being explicit? Stated clearly and in detail, leaving no room for confusion or doubt.

1. Do they operate under any other standard than 14001?

2. Technically speaking I see your point about 14001 not explicitly stating that requirement like 9001 does, but your overall QMS should have such a common-sense requirement in it, and if it doesn't I would look at this as a good opportunity to plug a hole in your system.
 

Mike S.

Happy to be Alive
Trusted Information Resource
We address it correctly in our QMS. I am just trying to help out our EMS engineer.

Then it should be done, always, period.

14001 is designed to work with other management systems:

"This International Standard does not include requirements specific to other management systems, such
as those for quality, occupational health and safety, energy or financial management. However, this
International Standard enables an organization to use a common approach and risk-based thinking to
integrate its environmental management system with the requirements of other management systems."
 

Sidney Vianna

Post Responsibly
Leader
Admin
I am just trying to help out our EMS engineer.
In that case, the assessment of the OUT-OF-TOLERANCE condition for the instrumentation makes a lot of sense. It seems that you are trying to obtain concurrence that this NC should be voided. But, what if the (potential) erroneous readings have any regulatory compliance implications? Does it? The implications could be severe. Or totally negligible. But having a record of the assessment and it's implications definitely fall under the 9.1.1 requirement that reads: "...The organization shall retain appropriate documented information as evidence of the monitoring, measurement, analysis and evaluation results. ..." as written up by the auditor.
 

Randy

Super Moderator
Calibration records indicated as found failures for several pH meters (MU1000 for 6/23/22 & 2/11/22 &4/18/22, MU1001 for 1/30/22 & 2/11/22 & 4/18/22 & 6/22/22) without evidence of investigation/assessment as to impact on environmental systems
Absolute regulatory requirement for monitoring pH such as in a waste water stream or just a feel good status of pH check on something?
 
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