ISO 9001 Surveillance Audit Nonconformance - Thermometers not Calibrated

Big Jim

Super Moderator
#61
Re: ISO 9001 Surveillance - Thermometers not calibrated

I am still waiting for the CAR from him..
This is very alarming. You should check with your CB. Some CBs do not permit this. If they don't permit this, he may already be on their radar as an auditor that is sloppy with his paperwork.

All too often, auditees don't appeal when they have a legitimate problem. This is so rampant that the CBs actually don't believe that it is happening. This is certainly a case of you get what you tolerate. You, and others, will continue to be bullied.

And by the way, if you loose the appeal with the CB, you can appeal to the accreditation body.
 
Elsmar Forum Sponsor

Golfman25

Trusted Information Resource
#62
Every new auditor that comes in has looked at the 100 foot measuring tape that is sealed to our production floor. Before they can finish asking, "Where is the calibration data?" I reply, "There is none, it is not necessary, move on." If they persist, I say, "If you write this up, I will appeal, I will win, and you will not be invited back. I have the data to back that up." No one has been unwise enough to continue. We make electronics, not wire by the foot. If you found several voltage meters out of calibration, you would have some grounds for a calibration finding.
Could you explain this further? We had a very similar issue and it was the most frustraiting experience ever. Thanks.
 

BradM

Staff member
Admin
#63
Could you explain this further? We had a very similar issue and it was the most frustraiting experience ever. Thanks.
I'm certainly not Icy. :tg: But if I may comment on this....

To me, there were two areas of interest in this thread.

1) I have always found it very useful to identify, in writing, the status of process equipment. By writing down it's purpose, intended use, accuracy, etc., then at any point, after "people" have left the company, identification of equipment can be determined. You will always know what the equipment was purchased for, and thus, know when the equipment is no longer needed.

So as Icy explains in his example, he had equipment that he had clearly identified had no bearing on the quality results, process impact, etc. And thus, no calibration was required. It's your process. You should determine what is important, what needs routine calibration, what needs one-time verification, etc.

2) By the evidence presented in this thread, the auditor has moved from assuring an adequate process, to mandating what is required in the customer's process. Until the original poster receives the audit write-up with the citation, non-conformance, etc., it appears the auditor is bullying the customer into doing calibrations that are most probably not required.

Do these thermometers really need to be calibrated?
Or does the auditor feel they need to be calibrated? There's a difference.

So in Icy's explanation, he is not going to let the auditor come in and tell them they need to calibrate his tape measure, when he knows better, and there is nothing in his quality requirements to mandate that it be calibrated. So if the auditor mandates that he calibrate a piece of equipment that doesn't need to be (the tape measure in question), then he is going to fight that observation.

And that.... is always a better solution (IMHO) than 'rolling over' and doing some innane task that serves no value to the process; simply because and auditor "said so". :)
 
#64
All too often, auditees don't appeal when they have a legitimate problem. This is so rampant that the CBs actually don't believe that it is happening. This is certainly a case of you get what you tolerate. You, and others, will continue to be bullied.
This is why it is so important to appeal questionable findings. We are not perfect, that is why auditors generate findings. Auditors are not perfect, that is why there is an appeals process. Do you feel like you need revenge on an auditor when he writes a legitimate finding? Why should an auditor need revenge on you when you win a legitimate appeal?
Could you explain this further? We had a very similar issue and it was the most frustraiting experience ever. Thanks.
Brad, has done an excellent job above.
I'm certainly not Icy. :tg:
There can be only one.
So in Icy's explanation, he is not going to let the auditor come in and tell them they need to calibrate his tape measure, when he knows better, and there is nothing in his quality requirements to mandate that it be calibrated. So if the auditor mandates that he calibrate a piece of equipment that doesn't need to be (the tape measure in question), then he is going to fight that observation.

And that.... is always a better solution (IMHO) than 'rolling over' and doing some innane task that serves no value to the process; simply because and auditor "said so". :)
Exactly. When I am "measuring" several 50 foot lengths of 1 AWG wire for a harness, the overall length can grow if I pull really hard, or shrink if the ambient temperature drops, plus or minus 6 inches easily. My gauge precision and accuracy is so far inside this that it is pointless to "calibrate" or even verify the tape. What is the probability that my 100 foot tape is going to change by more than an inch (0.08%)? Nearly zero unless there is an earthquake and I can see a huge crack in my concrete floor. What is the probability that the customer is going to be dissatisfied with the length of my 50 foot harness? Nearly zero, since we have designed this cable for a 40 foot installation to allow a little extra on each end (ever heard of a service loop?). My customer is not buying a "50 foot harness"; they are buying a harness that fits their application. Calibration not required.

We also have a number of metal yardsticks that are bolted to our benches. There are a thousand different point to point wires that go into our products. They cannot be "tight" and pulling on the connections and they cannot be so "loose" that they are draped all over the place. However, there is not a 12 inch wire in the place that couldn't be 11-13 inches without an issue. We don't even bother putting tolerances on the drawings for these wires. If the designer did not find it necessary to put a tolerance on the length then the average, non-calibrated ruler, operated with the mark two eyeballs and the mark 5 fingers is sufficient for accuracy. The lack of a tolerance on a drawing, when there are a million other measurements that have tolerances, makes for an easy defense that "we meant to do that" and "I don't need to calibrate devices used to measure items without tolerances."
 
Last edited:
C

Chance

#65
Okay here is the exact citation:
Requirement Audited:
Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards
Citation:
The thermometers used are not calibrated.
 
Last edited by a moderator:
C

Chance

#66
Exactly. You must know which section they cite before you can fight/appeal.That is grounds for having an auditor removed from your case. I've done it, with cause, with DNV. Registrars are especially eager to remove auditors if you win the appeal. .
Filing an appeal is not an easy thing to do. I don't think my company would go in this direction. Unless I have a strong reason to convince them.
 
C

Chance

#67
Based on this OP? Yes, indeed, it's one worth taking back to them for clarification. I see nothing here that would indicate (sorry for the partial pun) that the thing is a non-conformity.
I tried it during the closing meeting, the auditor got mad and told me that it was too late for me to update him the finding. He suggested for me to file an appeal instead.
I thought closing meeting is intended to discuss findings but he said I have no word to say....He was mad...
 
C

Chance

#68
Is it acceptable if I will validate it instead of calibrating it? How about I take some ice, measure it with mercury thermometer, if it reads 0 degree F, that is pretty darn accurate. Then I take that same thermometer and measure the temperature inside the room - that has a finding. You think that is acceptable?
 
Last edited by a moderator:

Jim Wynne

Staff member
Admin
#69
Okay here is the exact citation:
Requirement Audited:
Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards
Citation:
The temperature probes used are not calibrated.
The point here has to do with whether or not calibration is needed in order to ensure valid results. You say it's not needed. The auditor seems to be one of those misguided souls who believes everything that's used to measure anything should be calibrated. You have the basis for an appeal. Your options at this point:
  1. Appeal
  2. Don't appeal
 
C

Chance

#70
The point here has to do with whether or not calibration is needed in order to ensure valid results. You say it's not needed. The auditor seems to be one of those misguided souls who believes everything that's used to measure anything should be calibrated. You have the basis for an appeal. Your options at this point:
  1. Appeal
  2. Don't appeal
I am a young QM that does not have enough bravery/skills to do an appeal. I think it is easier said than done deal...
 
Thread starter Similar threads Forum Replies Date
Q ISO 9001:2015 man days for surveillance audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Surveillance Audit of 2008 before Transition Audit to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
C ISO 9001:2008 Surveillance Audit - No Internal Audits Internal Auditing 9
K Bi-Annual ISO 9001 Surveillance Audit Help ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
R Frequency of ISO 9001 Surveillance Audit after Recertfication Audit General Auditing Discussions 2
H ISO 9001:2008 Surveillance Audit Frequency Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
J ISO/AS Surveillance Audit - Minor for not updating my QA Manual to ISO 9001:2008 Quality Management System (QMS) Manuals 95
M When is the ISO 9001 Surveillance Audit? Certification process for ISO9001:2000 General Auditing Discussions 4
P Is it necessary to undergo the ISO 9001 surveillance audit before going for TPM ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
L Surveillance Audits for ISO 9001:2000 - defined intervals ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Need Advise on upcoming ISO 9001:2000 Surveillance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Need suggestions for Top Management Preparedness for ISO 9001 surveillance audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
Claes Gefvenberg An interesting audit coming up - First combined ISO 9001 / 14001 surveillance audit General Auditing Discussions 6
CarolX Surveillance Audits under the ISO 9001:2000 version Registrars and Notified Bodies 8
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 2
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 31
T Relationship between ISO 9001 and ISO – IEC BS EN 870079- 34 2020 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Sequence of ISO 9001:2015 Implementation Steps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
qualprod Business Continuity Planning in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S ISO 9001:2015 Internal Auditing Internal Auditing 8
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 4
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S ISO 9001 implementation in a Gold exporting business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
A Tips and Tricks to understand ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
B ISO 9001 - "Remote Audit Fee" Registrars and Notified Bodies 13
John C. Abnet ISO 9001 4.4.1 "...shall determine the processes needed..." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 72
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34

Similar threads

Top Bottom