Auditor wants to know where our calibration procedure came from - TS16949

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#11
The NA 17-20 series and the T.O. 33K series are military procedures.....if you don't have access to GIDEP, it is unlikely that you will have these. ASTM Standards exist for several fairly generic types of calibrations like force and oven surveys, but there are several so the equipment you listed may be covered by some of them, depending on the usage. There may also be ANSI procedures that cover the equipment.

Otherwise you plan to create a procedure seems reasonable. What you can pull directly from the manufacturer or the standard you mentioned can be considered validated. Specific lower level steps (e.g. turn knob to x position) likely do not require validation, unless they are sub-set in a section that is actually developed by the organization.

Hope this helps.

Hershal
 
Elsmar Forum Sponsor
K

Ken K

#12
We wrote our own calibration procedures back in 1994 to cover the equipment used in the lab. Our TS (was QS) manual has the following statement which has never been questioned by the auditor. The sources listed below helped us write those procedures.



The verification methods used by the lab have been written to ensure all applicable in-house instruments used for testing are within tolerance and traceable to NIST where applicable. These methods have been written with guidance from the following;

• MIL-STD 45662A - Military Standard Calibration Systems Requirements
• ISO 10012-1 - Quality Assurance Requirements for Measuring Equipment
• ANSI/NCSL Z540-1 - Calibration Laboratories and Measuring and Test Equipment
• Mitutoyo Recommended Practices
• Original equipment suppliers calibration methods / recommendations
 
R

RESET

#14
Update:
Our surveillance audit has come and gone. I asked our quality manager several times for more information. I never received any further explanation. Before the audit I went thru every one of our 21 calibration procedures. I did change a couple to correct some things that I thought were incorrect. The question of procedures never came up. This topic has not been discussed here since.

I want to thank you all for your input. I learned a couple things in the process and chasing this caused me to find other potential problems with our system.
 

Jim Wynne

Staff member
Admin
#15
RESET said:
I want to thank you all for your input. I learned a couple things in the process and chasing this caused me to find other potential problems with our system.
Ah, serendipity. The deeper you dig, the more likely you are to fortuitously find things you weren't looking for. It pays to pay attention.:)
 
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