Sealed in Wax Thread Gages - ISO 9001 Clause 7.6 Calibration

Michael_M

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#1
I have thread gauges (mechanical device) that after 2 years are still sealed in wax for lack of use (and our database shows calibration data and a single extension for lack of use). I pull the thread gauges from 'active' to 'bond', note this in our calibration data base as "Date Pulled from service, reason: lack of use". All this is per our calibration procedure below:

3.8.1 Extensions
Extension of calibration intervals may be authorized under certain conditions (i.e., completion of test in progress or no usage of measuring equipment). These extensions must be authorized by Quality Assurance and must be based on in tolerance results of past calibrations or records of little or no use (mechanical equipment only). This decision will be documented in the calibration database.

The extension period may not exceed 1/3 of the calibration interval for electronic equipment. Mechanical equipment can be extended a full cycle at a time. All extensions will be entered in the calibration database. A calibration label will be attached to all device with the new calibration date and who authorized the extension.
When/if the thread gauge is needed again, I would re-calibrate it, but calibration seems to be taking about 3-6 weeks from the time I send out to the time I get it back and this usually would be too long by the time I know I will need the gauge.

Question:
1. If I change the procedure to reflect that "gauges still sealed in wax, or show no use, when pulled from the bond can be used, but must be calibrated immediately following usage" or some such language, would this pass an audit?


In the last year, I have pulled about 200 thread gauges from active duty, the company has been in business for 30+ years so we have a lot of extra gauges that were used at one time but may no longer be used or may be used once every 5 years.
 
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#2
Something I frequently see is simply that your procedure permits thread gauges still sealed in wax to be allowed to have their calibration extended. Sometimes I even see wording to the effect that the calibration interval does not start until the wax is removed if that event is recorded.

I'm sure there will be more comments.
 
#3
Sealed in wax gage = New gage
Has calibration report = Yes
In use = No
When in use bring into calibration plan = OK
Decide the frequency of calibration from time put in use in plan = OK
Is it valid to use = Yes, as it has a calibrated report from time of use
 
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