Q: Under the standard ISO/TS 16949:2009 Quality management systems – Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations — is it acceptable to allow an instrument user to request a calibration extension under certain circumstances?
Here are just a couple of examples:
The user is in the middle of a test that they don’t want to disrupt until completed.
Equipment is installed on a test vehicle that is at a remote location and is not readily available.
I should note we are an automotive supplier engineering facility doing advanced product development.
A: Here is my usual advice about calibrations:
1. The calibration frequency is both a matter of use and criticality of measures. Instrument companies err on the side of frequent recalibrations.
2. As with most standards based on ISO 9001:2008, the calibration frequency is an internal company decision as the requirement is:
• Process for calibration management
— Records need to show (7.6.2):
> Equipment identification, including the measurement standard against which the equipment is calibrated
> Revisions following engineering changes
> Any out-of-specification readings as received for calibration/verification
> An assessment of the impact of out-of-specification condition
> Statements of conformance to specification after calibration/verification
> Notification to the customer if suspect product or material has been shipped
Therefore, it is the supplier who determines the frequency of the calibration, as well as the standard to which they are using. If the supplier sets a frequency schedule they should follow it unless they get a concession from their customer.
I have done a large calibration study where an engine plant did the statistical analysis, which saved them millions of dollars to set optimal gauging schedules for an engine plant. I recommend that such a study be conducted by this company as soon as possible.
Voting member of the U.S. TAG to ISO/TC 176