Calibration of Setup Fixtures & Pin Gages

N

NWrubberQA

#1
Just had an AS9100/ISO9001 audit where a finding resulted from set up fixtures & pin gages not being calibrated. With the fixture it was a go / no-go used to set up the process and is not used to verify product conformity. I just don't feel that this requires calibration?? Anyone agree?

We have used pin gages to measure ID for years and or SOP is that they are verified prior to use with calibrated calipers. The auditor says that the pin gages still need to be calibrated or the verification documented. Any oppinions on this?
 
Elsmar Forum Sponsor

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#2
Re: Calibration of Set up Fixtures & Pin gages

Use of a caliper, even a digital, is insufficient to certify a pin gage, unless the pin can have a tolerance of 0.01 inch. The pin gages need to be calibrated and that should be by an accredited lab, and then you would have confidence in the pin.
 

Ron Rompen

Trusted Information Resource
#3
I agree completely with Hershal. Verification of a gauge pin needs to be done with an instrument with an accuracy of 1/10th (as a general guideline) of the tolerance being measured (i.e. if the hole diameter is ± 0.02mm, your verification instrument needs to be accurate to .004mm) (Another note, resolution/discrimination is not the same as accuracy).

In addition, if you are leaving the verification of the pin gauge to the user, you are (probably) setting yourself up for failure. Floor operators (in general) are unwilling to continually repeat the same measurement on the same piece of equipment, and the verification process becomes another 'tick the box' scenario.

IMO, it is easier to either send your pins out for calibration on a regular basis, purchase a bench micrometer with the correct accuracy and calibrate them yourse, or (if you are only using a few) simply replace them on a regular basis using (of course) a certified supplier.
 
D

Duke Okes

#4
I would agree that the setup device does not need calibration, assuming your are approving the setup by verifying product. However, there may be something in AS 9100 I'm not aware of.

I agree with others on pin gages. Unless they are to be used for very loose tolerances a micrometer does not have sufficient resolution/precision to calibrate. And if it did, the "calibration" would still need to be documented.
 
K

KwalityWonk

#5
Got the the same type of write up on last audit. Had all our Pin sets labled "verify prior to use". Tried to argue from acommon sense standpoint that calibration of Gage Pins was neither necessary or cost effective. The problem being that we accept product characteristics to gage pins and therefore they are required to be Calibrated / Verified. Had to bite the bullet and add them to the system to clear the finding. Cost of doing business just keeps going up!!!
 
J

Jeff Frost

#6
Just a few thoughts on the subject.

7.6 Calibration/Verification

You need to look at your process requirements. Are you maintaining a 4:1 or 10:1 accuracy ratio between the pin tolerance and the dimensional tolerance. Once you have identified what the required accuracy for the pins are then you must then apply 4:1 or 10:1 accuracy ratio to the Mic you will be using to verify the pins. 10:1 Example: Dimensional tolerance +/- .01, required pin accuracy +/- .001, required Mic accuracy +/- .0001, required calibration standard accuracy +/- .00001.

7.5.1.3 Control of production .... Tools

Set-up fixture could fall under this clause of the standard even if it is not used for the acceptance of product. You would need to verify the fixture prior to release for production and then assure that it is maintained for its intended purpose.

Jeff
 
Thread starter Similar threads Forum Replies Date
S Instrument Calibration Laboratory setup for API Pharmaceutical Company General Measurement Device and Calibration Topics 1
M Calibration of Custom 6061 T6 Aluminum or Delrin Plastic Setup Tools?? General Measurement Device and Calibration Topics 5
lanley liao Question regarding the calibration of monitoring and measure equipment. Oil and Gas Industry Standards and Regulations 0
N IATF Calibration Lean in Manufacturing and Service Industries 3
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
T Plug Gage Calibration Calibration and Metrology Software and Hardware 1
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
E Calibration Records needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Limited Range Calibration - 5000 lb Industrial floor scale General Measurement Device and Calibration Topics 3
D Calibration of Small Scales General Measurement Device and Calibration Topics 26
C How to Establish the Calibration & Measurement Capability (CMC)? ISO 17025 related Discussions 1
I IQOQ or just initial calibration required? General Measurement Device and Calibration Topics 3
B Calibration in real life ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
A Is calibration of test weight required General Measurement Device and Calibration Topics 4
S Calibration Frequency for Slip Gauge Kit used for CMM Calibration? General Measurement Device and Calibration Topics 0
S Calibration/Verification of customer fixtures IATF 16949 - Automotive Quality Systems Standard 6
Ron Rompen Calibration by manufacturer ISO 17025 related Discussions 4
Q Calibration verification records 7.1.5.2.1 IATF 16949 - Automotive Quality Systems Standard 2
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
W Next Calibration Due Date Calibration Frequency (Interval) 5
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
A OEM On-Site Calibration issues during Covid19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 1
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
G Calibration of "Master Parts" Used as Gauges Calibration Frequency (Interval) 5
R Calibration lab environmental monitoring General Measurement Device and Calibration Topics 4
G Calibration of Rotronic probe but not digital readout? General Measurement Device and Calibration Topics 3
F Standard Calibration Procedures: Recommended Practice ISO 17025 related Discussions 0
T Temperature Requirements For In House Calibration - AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
Crimpshrine13 Calibration of pH Meter Probe Calibration and Metrology Software and Hardware 3
F ESD workbench "calibration" Manufacturing and Related Processes 2
C Correct Calibration Method for Dial Depth Gage General Measurement Device and Calibration Topics 6
F Nist traceable calibration certificates General Measurement Device and Calibration Topics 1
G Tool tracebility and First calibration requirements for aerospace (AS9100) organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Calibration of Digital thermometer with surface probe General Measurement Device and Calibration Topics 1
T Calibration or Verification -> Cm and Cmk, etc. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
G Is repeatability required for equipment calibration? General Measurement Device and Calibration Topics 10
was named killer AS 9100D - Calibration Instructions - Controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
B Photovoltaic Tester Calibration General Measurement Device and Calibration Topics 0
B Temperature loop: partial calibration General Measurement Device and Calibration Topics 10
G Glass scale calibration at 74 degrees F? General Measurement Device and Calibration Topics 4
A Digital Timer Calibration Requirements General Measurement Device and Calibration Topics 3
Ron Rompen Barcode Verifier Calibration and Use Calibration and Metrology Software and Hardware 5
S Is Optical Parallel Set required calibration? ISO 17025 related Discussions 1
A Calibration of Power Supplies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Calibration Process Flow Map Example Wanted General Measurement Device and Calibration Topics 3
M Calibration or Verification? What terminology to use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1

Similar threads

Top Bottom