Help - FDA Audit - Caliper Calibrated .750 Use - Calibrated @ 0 & 1"

[D_Wood]

FDA Auditers are questioning why we calibrated a dial caliper at 0", 1", 2", 3" and 4" when it is commonly used to measure .750" ?

I cannot believe the question, and sort of left wondering how to answer without offending them. If it's dead on at zero and dead on at 1", why in the world would it not be dead on at .750?

Help.
-Dan-

 

[Underdog - 2004]

It's not a why question!

Perhaps you run such a tight system that the auditors where desperate to dig something up. Pretty weak if you ask me. They say any cop worth his badge can issue at least a dozen citations against a car straight out of the show room.

You could certainly challenge that question very easily by just ignoring it.

If you wanted to through them a bone you could revise the calibration procedure to .750 intervals. I.E. .750, 1.50, 2.250 etc.,

PS I see how a question like that could through you, it's like adding insanity to madness.

 

[gpainter]

Just a thought, not much on calibration. Since you measure at 3/4th commonly maybe they thought that calibration at 3/8th increments would be more appropriate. I think this is called a rule of 10, not sure. If you only use it for 3/4 why calibrate to more than 2"?

 

[D_Wood]

I just received a little more information.
The calipers are used for measuring more than one dimension on the production line. (Two measurements actually).

This is what I told my quality guy:

"The dial caliper in question is capable of measuring over a full-scale of 0"-4". When calibrated it must be done such that an accuracy level is determined over the full range of the measuring device. Our calibration certificate states this item has an accuracy of +/- .001 over the full range, and shows it was calibrated at 1" intervals." And another reply to a question was: "There is nowhere in writing that states this measuring device must be calibrated to a specific dimension."

I have a feeling the auditor is trying to apply a rule for a go / no-go gage to a dial caliper. That just isn't going to work.
-Dan-

 

[Al Rosen]

FDA Auditers are questioning why we calibrated a dial caliper at 0", 1", 2", 3" and 4" when it is commonly used to measure .750" ?

I cannot believe the question, and sort of left wondering how to answer without offending them. If it's dead on at zero and dead on at 1", why in the world would it not be dead on at .750?

Help.
-Dan-

How about:

That it is the standard calibration procedure for a caliper. It is verified over the entire range at major increments. Add, that there has never been an issue where the measurement has come into question.

Do you have history(records) to further defend this? Validation of the process would also shut them up.

These guys love records. If you put some in front of them, they will be happy. They can use them for their report.

 

[Mike S.]

Nice seein' ya again, Indiana Dan!

I think Al is right. it's a common practice and you've never had a problem doing it that way. You must run a tight ship is this is what they look for to complain about! Good show.

 

[D_Wood]

Well, our 2-week audit by the FDA is over. We came out all right. 8 Minor write-ups, no majors. Four of the findings were related to customer complaint handling & procedures. Nothing developed that pointed to our test lab. The answer I provided for the caliper was accepted. It seems the individual who was questioned just did not have a good answer at first, and that provoked more questions. Anyway, I can breathe again now.
-Dan-

 

[Al Rosen]

Well, our 2-week audit by the FDA is over. We came out all right. 8 Minor write-ups, no majors. Four of the findings were related to customer complaint handling & procedures. Nothing developed that pointed to our test lab. The answer I provided for the caliper was accepted. It seems the individual who was questioned just did not have a good answer at first, and that provoked more questions. Anyway, I can breathe again now.
-Dan-

Congratulations!!!!

Don't forget that after the inspection the person with executive responsibility should send a letter, describing the CA plan, to the FDA office.