ISO 9001 Surveillance Audit Nonconformance - Thermometers not Calibrated

C

Chance

#81
I don't understand. If the temperature in the freezer goes to... 60°F, what impact does that have on your materials? I would think at some point the temperature affects the materials.
It will take weeks before the materials get affected if the temperature is
60°F. If we have power outages, the room temp. is affected but at this very short period of time, the materials are still ok. Now if the problem takes weeks before fixing it, the consequence is that we have to double the amount of material that we normally use. Kinda complicated.

I can't imagine it being too expensive. There are lots of good calibration houses, and for the accuracy you would have on such a device, I wouldn't think it too much at all.:agree1:
I will just have to convince them....:agree:
 
Elsmar Forum Sponsor

BradM

Staff member
Admin
#82
Chance, I know you have probably been overloaded with posts and suggestions here. :) This has been a good, long-running thread with lots of good stuff in it. :agree1:

What I would like to ask you to do is back up a minute from this and not really think about the thermometer for a second.

You have a requirement in your internal procedure. Is that requirement needed?

Is the person who wrote the procedure available to ask?

It's really important for you to determine if you have a process requirement for monitoring the temperature at that requirement. If it is, then we can address what to do with the thermometer. But if you no longer have that requirement, it needs to be removed from the procedure; and the accuracy of the thermometer at that point no longer matters.:)
 
C

Chance

#83
You have a requirement in your internal procedure. Is that requirement needed?

Is the person who wrote the procedure available to ask?

It's really important for you to determine if you have a process requirement for monitoring the temperature at that requirement.
Brad, yes it is a requirement. That critical? Probably not. Why? Because none of these materials will go out to our customers. It won't affect the end product but it might affect us internally. We have to double the amount of material if temperature is not maintained for a long period of time.

:caution:So as a corrective action, I will buy one thermometer that comes with calibration record traceable to NIST. The cost is only 17 US dollars. I will do regular monitoring of our temperatures using my thermometer as a reference. How often? It is up to us, might be once a week.
Please comment. Thanks.
 
M

mguilbert

#84
Why not verify your non-certified thermometers with you calbrated one at specified intervals. But be sure to label each with the variance so the monitor can adjust temperature appropriately when monitoring.
 
C

Chance

#85
Why not verify your non-certified thermometers with you calbrated one at specified intervals. But be sure to label each with the variance so the monitor can adjust temperature appropriately when monitoring.
Yes that is exactly what I want to do - verify the uncalibrated one using the calibrated one once every week or month up to me.

But, I have one concern, when I bring my calibrated portable one to verify the uncalibrated one, how long does it take for the calibrated one to stabilize in order to get accurate temperature? Should I leave it there in the room for an hour and come back and use that data? You think this will work?:agree:
 

BradM

Staff member
Admin
#86
Brad, yes it is a requirement. That critical? Probably not. Why? Because none of these materials will go out to our customers. It won't affect the end product but it might affect us internally. We have to double the amount of material if temperature is not maintained for a long period of time.

:caution:So as a corrective action, I will buy one thermometer that comes with calibration record traceable to NIST. The cost is only 17 US dollars. I will do regular monitoring of our temperatures using my thermometer as a reference. How often? It is up to us, might be once a week.
Please comment. Thanks.
I don't know, Chance. I still think your best approach is to send that thing to a local, competent house and have them verify it. In the end it will save you the most time and money.

The device in your link, I would venture, is not any more accurate (or stable) than the device you are calibrating. Plus, verifying it in atmosphere, there are a lot of variances. Saying, even if both devices had 0 degrees error, they would probably end up being .3-.4°F off from each other.

Also, I know this is not that critical to you, but to be honest, I would highly suspect any readings (and the corresponding calibration) on a $17.00 dollar instrument. :D

I think you're better off getting something decent, having it calibrated by a good source, and extending the recall date on it.
 

Big Jim

Super Moderator
#87
I don't know, Chance. I still think your best approach is to send that thing to a local, competent house and have them verify it. In the end it will save you the most time and money.

The device in your link, I would venture, is not any more accurate (or stable) than the device you are calibrating. Plus, verifying it in atmosphere, there are a lot of variances. Saying, even if both devices had 0 degrees error, they would probably end up being .3-.4°F off from each other.

Also, I know this is not that critical to you, but to be honest, I would highly suspect any readings (and the corresponding calibration) on a $17.00 dollar instrument. :D

I think you're better off getting something decent, having it calibrated by a good source, and extending the recall date on it.
Actually, I see some humor in Chance's response.

I get the feeling that he feels that the accuracy of a $17.00 instrument is all the accuracy he needs. His choice of instruments could even be his own way of showing a small level of contempt for the auditor that insisted on making a mountain out of a mole hill.

Otherwise, I would agree with you.
 
C

Chance

#88
Actually, I see some humor in Chance's response.

I get the feeling that he feels that the accuracy of a $17.00 instrument is all the accuracy he needs. His choice of instruments could even be his own way of showing a small level of contempt for the auditor that insisted on making a mountain out of a mole hill.
I have 13 rooms x 250 per calibration = $ 3,250 calibration cost. My company don't want to spend that amount of money. They think that our material in the cold rooms can still be acceptable even if the temperature fluctuates +/- 3 degrees.
Trusting the display readings right now is the problem, we don't have any proof that it is accurate. So I am attempting to buy a calibrated one as our reference. The auditor also understand that our material is not that critical. Buying a 17 dollar equipment with calibration traceable to NIST might be an option. But according to Brad, the accuracy of that device is not acceptable.
I will submit my CA and will post here the update of it. If it is rejected, my plan B is to go ahead and calibrate all of them or buy new ones (17 dollard price plus certificate traceable to NIST) and replace all of them. :(
 

BradM

Staff member
Admin
#89
I have 13 rooms x 250 per calibration = $ 3,250 calibration cost. My company don't want to spend that amount of money. They think that our material in the cold rooms can still be acceptable even if the temperature fluctuates +/- 3 degrees.
Trusting the display readings right now is the problem, we don't have any proof that it is accurate. So I am attempting to buy a calibrated one as our reference. The auditor also understand that our material is not that critical. Buying a 17 dollar equipment with calibration traceable to NIST might be an option. But according to Brad, the accuracy of that device is not acceptable.
I will submit my CA and will post here the update of it. If it is rejected, my plan B is to go ahead and calibrate all of them or buy new ones (17 dollard price plus certificate traceable to NIST) and replace all of them. :(
Ah... didn't know you have 13 of these. That makes the economics different.

Whatever accuracy you feel you need the instruments in the freezer rooms, then you want a standard that is sufficiently more accurate than those. So in general, if you are going to have them at +/-°F, then your standard needs to be 1°F; and, it should be reliable and repeatable.

So I would invest a couple of hundred in a decent instrument. Set it for one year interval. Since these are freezers, I would get an extension long enough for the probe, where the meter sat outside the chamber. I would perform a once a month verification on the rooms/thermometers, and log on a sheet you keep by the rooms.
 

qusys

Trusted Information Resource
#90
I have 13 rooms x 250 per calibration = $ 3,250 calibration cost. My company don't want to spend that amount of money. They think that our material in the cold rooms can still be acceptable even if the temperature fluctuates +/- 3 degrees.
Trusting the display readings right now is the problem, we don't have any proof that it is accurate. So I am attempting to buy a calibrated one as our reference. The auditor also understand that our material is not that critical. Buying a 17 dollar equipment with calibration traceable to NIST might be an option. But according to Brad, the accuracy of that device is not acceptable.
I will submit my CA and will post here the update of it. If it is rejected, my plan B is to go ahead and calibrate all of them or buy new ones (17 dollard price plus certificate traceable to NIST) and replace all of them. :(
Hi Chance,
as a suggestion for you , it could be better to share also with other Covers which kind of material you control with that thermometer, so that they could have an additional detail.
Besides, as said in a post of mine, if you did a risk assessment or benchmarking to understand if the control of temperature was needed and you had data that your material is not affected by the parameter of the woking environment, you can also have the thermometer for reference only with no calibration, but yuo shall have data and demonstrate to have analysed them and take decision.
 
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