Where do you draw the line on what fixtures/testing equipment require calibration

K

kat.k.

#1
The company I work for is an ISO/TS 16949 certified company. We had our first TS audit about 3 years ago and the auditors nailed our maintenance department for not having their gages that they use to check the machines for vibration, calibrated. Then environmental for their refractometers to check the fluid in the machines for not having their gages calibrated. Since then we want to throw everything into the calibration system.

Our heat treat department is now wanting us to calibrate paperless recorders for temperture control boxes. Do we now put the holders we use to hold the parts in place when the CMM is measuring, in the system? Do we put our Carbon & Sulfur Analyzer in the sytem? Do we put fixtures in the system that the only purpose is to where the final auditor will not forget to paint the time mark in the part? We do have a method that we can label a fixture "calibration not required" or "this is not a gage". But do you have to tag everything in the plant?

Our method in the past has been any fixture/gage/equipment that you use to validate a part, and devices that can produce test results should be calibrated. Any suggestions on keeping gage calibrations controlled??

Thanks
Kat.K
 
Elsmar Forum Sponsor
D

DrM2u

#2
Re: Where do you draw the line on what fixtures/testing equipment needs calibrated

The company I work for is an ISO/TS 16949 certified company. We had our first TS audit about 3 years ago and the auditors nailed our maintenance department for not having their gages that they use to check the machines for vibration, calibrated. Then environmental for their refractometers to check the fluid in the machines for not having their gages calibrated. Since then we want to throw everything into the calibration system.

Our heat treat department is now wanting us to calibrate paperless recorders for temperture control boxes. Do we now put the holders we use to hold the parts in place when the CMM is measuring, in the system? Do we put our Carbon & Sulfur Analyzer in the sytem? Do we put fixtures in the system that the only purpose is to where the final auditor will not forget to paint the time mark in the part? We do have a method that we can label a fixture "calibration not required" or "this is not a gage". But do you have to tag everything in the plant?

Our method in the past has been any fixture/gage/equipment that you use to validate a part, and devices that can produce test results should be calibrated. Any suggestions on keeping gage calibrations controlled??

Thanks
Kat.K
Well, the first step is to define what is 'inspection equipment' and what is 'work holding equipment'. The first is usually defined as any equipment or device used to inspect, monitor or verify the conformance of product or process to a requirement. The second falls in the category of tooling and equipment.

Since the temperature distribution in a heat treating oven or conveyor is critical to the product quality then the equipment used to monitor it (temperature recorders) should be calibrated. Think of what happens if you make a process adjustment based on readings from a faulty recorder. Now keep in mind that you might have 'reference' equipment used to monitor process parameters or product features that are not relevant or of significant improtance to the quality of the product (i.e. pressure gages sometimes). Following along these lines then you would have to calibrate the carbon & sulfur analyzer since the amount of both affect the heat treating process but not calibrate the fixtures that the parts sit on or remind people to paint something. Also i would not go to the extent of labeling all fixtures as not requiring calibration. It is a waste of time and serves no purpose. Just identify the equipment with a gage number or 'reference only'.

Another important thing to keep in mind is the differrence between 'calibration' and 'verification'. It would be a lot more affordable to verify the equipment mentioned instead of calibrating it at established intervals. For example you can verify the temperatire recorders against a 'master' recorder that gets calibrated at regular intervals based on frequency of use and previous calibration results. In such a case the other recorders would require calibration only if they are reading outside the OEM specified tolerance when compared to the master. I hope this makes sense and helps with your calibration system.
 
B

brahmaiah

#3
Re: Where do you draw the line on what fixtures/testing equipment needs calibrated

The company I work for is an ISO/TS 16949 certified company. We had our first TS audit about 3 years ago and the auditors nailed our maintenance department for not having their gages that they use to check the machines for vibration, calibrated. Then environmental for their refractometers to check the fluid in the machines for not having their gages calibrated. Since then we want to throw everything into the calibration system.

Our heat treat department is now wanting us to calibrate paperless recorders for temperture control boxes. Do we now put the holders we use to hold the parts in place when the CMM is measuring, in the system? Do we put our Carbon & Sulfur Analyzer in the sytem? Do we put fixtures in the system that the only purpose is to where the final auditor will not forget to paint the time mark in the part? We do have a method that we can label a fixture "calibration not required" or "this is not a gage". But do you have to tag everything in the plant?

Our method in the past has been any fixture/gage/equipment that you use to validate a part, and devices that can produce test results should be calibrated. Any suggestions on keeping gage calibrations controlled??

Thanks
Kat.K
In addition to all measuring and test equipment(MTE) which are mentioned in the Control Plan all MTE which are used by maintenance dept. require periodic calibration.In fact you have to mention those maintenance MTE in your Control Plan against Process characteristics.But Process characteristics colomn in CP is given less importance and often is left blank.Your maintenance MTE should be mentioned under measuring technic colomn against process characteristics.
Here one immportant thing to mention is the frequency and tolerable variation is left to the jugdement of the user.
V.J.Brahmaiah
 
#4
Re: Where do you draw the line on what fixtures/testing equipment needs calibrated

all MTE which are used by maintenance dept. require periodic calibration.

Here one immportant thing to mention is the frequency and tolerable variation is left to the jugdement of the user.
V.J.Brahmaiah
I don't believe this to be true! There are many items of equipment used in maintenance departments that do not require calibration! Furthermore, allowing personnel to determine calibration frequency on their judgment etc is totally inappropriate!
 

Helmut Jilling

Auditor / Consultant
#5
Re: Where do you draw the line on what fixtures/testing equipment needs calibrated

The company I work for is an ISO/TS 16949 certified company. We had our first TS audit about 3 years ago and the auditors nailed our maintenance department for not having their gages that they use to check the machines for vibration, calibrated. Then environmental for their refractometers to check the fluid in the machines for not having their gages calibrated. Since then we want to throw everything into the calibration system.

Our heat treat department is now wanting us to calibrate paperless recorders for temperture control boxes. Do we now put the holders we use to hold the parts in place when the CMM is measuring, in the system? Do we put our Carbon & Sulfur Analyzer in the sytem? Do we put fixtures in the system that the only purpose is to where the final auditor will not forget to paint the time mark in the part? We do have a method that we can label a fixture "calibration not required" or "this is not a gage". But do you have to tag everything in the plant?

Our method in the past has been any fixture/gage/equipment that you use to validate a part, and devices that can produce test results should be calibrated. Any suggestions on keeping gage calibrations controlled??

Thanks
Kat.K
The standard is simple and clear -

"Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified ..."

The judgement is not about departments or products. Simply, if the results must be valid... I often check or set my watch - because the results must be valid. The solution is not in excluding gages, but choosing approrpiate and simple methods to verify our gages.
 
D

DrM2u

#6
Re: Where do you draw the line on what fixtures/testing equipment needs calibrated

I don't believe this to be true! There are many items of equipment used in maintenance departments that do not require calibration! Furthermore, allowing personnel to determine calibration frequency on their judgment etc is totally inappropriate!
I second Andy's statement. There is no specifc requirement to calibrate maintenance inspection devices, like multimeters, etc. Also, the calibration frequency of equipment should be established based on OEM's reccomendations, frequency of use, criticality of features or parameters measured, and adjusted based on previous calibration data. Outside calibration labs will try to have an organization calibrate their equipment as often as they can get them to because that is how they make their money. Of course they will also use some industry guidelines but usually will not let you know that you can decrease the calibration frequency based on previous data.

To clarify Brahmaiah's statement, if a process parameter is listed in the control plan (or any other equivalent document) as something being monitored then the equipment used to monitor that process parameter needs to be calibrated. This is why the control plans should list only the process parameters that trully affect the product quality and can be monitored.
 

LUV-d-4UM

Quite Involved in Discussions
#7
Thank you. Your feedback is highly appreciated. In our case, the KF is not even in the Control Plan but it is in the list of lab equipment for calibration. And when we showed the ISO17025 certificate, we got the finding because the outsourced calibrator is not certified to calibrate titrators.
 
I

ISO 9001 Guy

#9
Another quip from the standard that might be of use here: ISO 9001:2008, 7.6: "The organization shall determine the monitoring and measurement to be undertaken and the monitoring an measuring equipment needed to provide evidence of conformity of product to determined requirements." (Italics mine.) Then it says that monitoring and measurement must be "carried out in a manner that is consistent with the monitoring and measurement requirements."
Measurements requiring calibrated devices are those applied to provide evidence of conformity of product to requirements. Any devices that are not used to provide evidence of conformity of product to requirements are not required to be calibrated.
If we defined a convention that "only devices bearing valid calibration labels are used to determine product conformity," then those devices without a label would be regarded as "for reference only,"--and not used to measure product. (Auditors like to poke at this one because of the possibility that a label will fall off. If it's your best solution due to having many devices, inform the auditor that you are aware of this possibility and you have decided to live with it.)
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#10
Outside of the standard, the real question may be what is the risk if any particular device is not calibrated (whether for product and process evaluation or not) and has excessive error? If there is practical reason to be assured that the device is reading correctly - especially based on economic risk of any sort, then it may be worth calibration.
 
Thread starter Similar threads Forum Replies Date
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
J Medical Device Failure Effects - Where to draw the line? FMEA and Control Plans 8
J Where to draw the line with Red Lining? US Food and Drug Administration (FDA) 7
C Quality Manager and employee issues, where to draw the line? Career and Occupation Discussions 17
E SOP or system Work Instruction? Controlled Document - Where does one draw the line? Document Control Systems, Procedures, Forms and Templates 5
J UDI - Where to document it? EU Medical Device Regulations 8
J Where to get a Black belt certification ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 13
D Any recommendations on where to find experienced quality hires in Chicago area? Job Openings, Consulting and Employment Opportunities 3
J Where is the definition of a critical supplier? ISO 13485:2016 - Medical Device Quality Management Systems 5
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
B When Travel is allowed - Where are you going? Travel - Hotels, Motels, Planes and Trains 16
G Where to buy Template / sample SCSMS Manual, checklist Supply Chain Security Management Systems 1
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
L Where to place the what/when/how/who/where procedures in a multi-regulation AS9110C organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Where to acquire EN 868-5 required dye (Amaranth red)? Other Medical Device Related Standards 2
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
H Where to get EK MED 1927/16 Other Medical Device Regulations World-Wide 3
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
O EN 301 489-1 and EN 301 489-17 - Where do we get the information of the Published versions? CE Marking (Conformité Européene) / CB Scheme 1
A AS9100 Training - Where do I start? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
qualprod Records where apply and stop recording everything? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Gage R&R - Where am I going wrong? Part of a FAIR submission (Aerospace) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
G New to ISO 9001 - Where to begin? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
K No IFU, where the requirements would go? EU Medical Device Regulations 5
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
GreatNate Where to get a KPI dashboard for QMS processes Quality Tools, Improvement and Analysis 5
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Implementing ISO 20000-1 - Where to start Other ISO and International Standards and European Regulations 2
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29
qualprod Statistics - Where to start in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Calibration of InfraRan Vapor Analyzer - where to get calibration for SF6 General Measurement Device and Calibration Topics 2
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Where can I find examples of PPAP? APQP and PPAP 6
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 9
D Where (in US) can I get the VDA Auditor Edition book? VDA Standards - Germany's Automotive Standards 3
S Where to get online AS standard audit certification classes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Where I can get a copy of either the 3rd or 4th edition of UL544? Other Medical Device Regulations World-Wide 7
G Where to find Proficiency Test provider for photometrics (spectral %R, %T, photo density) General Measurement Device and Calibration Topics 9
Marc Quiz - Where did the idea of an assembly line come from? Coffee Break and Water Cooler Discussions 4
F Quality Objectives - Where in the QMS Quality Objectives should be located ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Where to obtain a calibrated DICOM image? ISO 13485:2016 - Medical Device Quality Management Systems 1
R Where to get information - M6 per WA900 Manufacturing and Related Processes 1
S Where did FDA 510(K) form 3654 go? Other US Medical Device Regulations 4
W Where to begin with an ISO 9001:2015 internal audit Internal Auditing 13

Similar threads

Top Bottom