Humidity not recorded weekly - How would you Correct it?

[Pudge]

Hello again,
We just recently went through our registrar audit. All in all, we did ok. Except we received a minor nonconformity stating that, "Organization's procedures to record Humidity weekly are not being followed." His objective evidence was the Humidity X Chart in QA Lab. Ok, so a CAR was issued, but during the investigation process, I found no procedure in the companies CMS or Procedures Booklet saying that the Humidity would be recorded weekly or at anytime. My question is, How would you close out a CAR in this situation?

Thanks in advance,
Jeremy Hill

 

[CarolX]

Hi Jeremy and congrats on one minor…great job.



One question..why is humidity recorded?



Was it something someone started years ago and folks just kept it up? Or is a requirement that the humidity needs to verified on a regular basis. Answer those questions and you can answer your CAR.

 

[Al Rosen]

Hello again,
We just recently went through our registrar audit. All in all, we did ok. Except we received a minor nonconformity stating that, "Organization's procedures to record Humidity weekly are not being followed." His objective evidence was the Humidity X Chart in QA Lab. Ok, so a CAR was issued, but during the investigation process, I found no procedure in the companies CMS or Procedures Booklet saying that the Humidity would be recorded weekly or at anytime. My question is, How would you close out a CAR in this situation?

Thanks in advance,
Jeremy Hill

Do you state that the environmental conditions will be controlled? If so, where do you state this and where is the objective evidence?

 

[Jonell]

I think that I would try to dig a bit deeper, there are a couple of things that come to mind here. The first one would be to talk to whoever escorted him during this portion of the audit. Maybe there is a procedure floating around out in your shop that is not under document control. Another possiblity is that there are actual instructions on the chart itself and the auditor read those instructions and found that your company wasn't following them. If that doesn't yield any results, then you may want to consider contacting the registrar to see if he/she can tell you what procedure he/she is referring to.

If all that fails, you might have to answer that no documented procedure exists for the problem stated.

Hope this helps!
Jonell

 

[Pudge]

The Humidity is supposed to be recorded in the lab for our CMM, while it is known verbally that it is to be done it isn't stated in any procedures that it will be done

 

[Al Rosen]

The Humidity is supposed to be recorded in the lab for our CMM, while it is known verbally that it is to be done it isn't stated in any procedures that it will be done

If it is known verbally then it is part of an undocumented procedure. If someone was interviewed during your audit and stated that the humidity is supposed to be recorded and it is not being done, you are not following procedures. You didn't mention which standard, but ISO 9001:2000 does not require a documented procedure except for 6 areas, so a verbal procedure is all that is required. I would start recording the humidity and state that in your answer to the car. A documented procedure would be a good idea in this situation.

 

[Hershal]

The previous answers are all good. I belive that documenting appropriate environmental conditions is essential to calibration.

A CMM may not necessarily require RH to be recorded however. Temp certainly, vibration of course (e.g. the lab is by a railroad track).....but RH perhaps not. Depends a lot on what you are checking with the CMM and the ambient environment.

Then you also need to procedurize the recording of appropriate enviornmental conditions and train the personnel on that recording. That is the answer the auditor is likely looking for.

Just my thoughts.

Hershal

 

[Sidney Vianna]

Hello again,
We just recently went through our registrar audit. All in all, we did ok. Except we received a minor nonconformity stating that, "Organization's procedures to record Humidity weekly are not being followed." His objective evidence was the Humidity X Chart in QA Lab. Ok, so a CAR was issued, but during the investigation process, I found no procedure in the companies CMS or Procedures Booklet saying that the Humidity would be recorded weekly or at anytime. My question is, How would you close out a CAR in this situation?

Thanks in advance,
Jeremy Hill

Jeremy, before you proceed, I believe that you need to know where the requirement is coming from. Your external auditor HAS to identify the source for the requirement. If the requirement comes from one of your own internal documents, he should be able to identify the document back to you. Did you not have a de-briefing or exit meeting? Apparently he did not follow ISO 19011:
"...Nonconformities and their supporting audit evidence should be recorded. Nonconformities may be graded. They should be reviewed with the auditee to obtain acknowledgement that the audit evidence is accurate, and that the nonconformities are understood. Every attempt should be made to resolve any diverging opinions concerning the audit evidence and/or findings, and unresolved points should be recorded...."

 

[Greg B]

Pudge,

Good points are made by several of the reply posts especially (IMHO) Al and Sidney.

I would definitely have been asking, at the close out (exit) meeting, what did the auditor base his/her NC on (As Sidney stated). Do not be intimidated by the auditor, you are ALLOWED to discuss ALL facets of their findings and argue your case, if necessary.

How you close the CAR out is entirely up to you. Do you want a procedure? The procedure could be the actual ‘Humidity Form’. Just add some text at the top with instructions on how it is to be completed or filed etc. Identify it in your system and Bob's your Uncle. A procedure does not need to be a tomb.

 

[Ken K]

We use to measure and record temp/humidity of the lab twice a day until we had our ISO17025 audit. The auditor wanted to know the levels at a certain time of day and we couldn't provide the information.

He didn't write us up, just suggested we improve our procedure, so we bought a chart recorder, revised the procedure and let the recorder do the work.