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Article #211

QS9000, Chapter 4.11 Dilemma

#211
From: Daniel J O'Leary
Date: Thu, 20 Aug 1998 00:00
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John W. Beemster asked, "Under chapter 4.11 of QS-9000, it states all tools
  that are used to   determine conformance of a product to stated
tolerances
must be calibrated.    This means one must calibrate each steel ruler on
our manufacturing floor. This also means tracking, controlling, and
dispositioning over three  hundred rulers!"

This is easy, if you think about it the right way. The problem is that you
need a way   to know if the steel rule is telling you the truth. It must
be easy to use   and effective.  Don't confusing calibration with recall,
adjustment, etc.

In the electronics industry we what a similar problem with wrist straps to
control electro-static discharge. They must be check frequently to
ensure they work, this  is analogous to calibration. The common
method is to install wrist strap test stations around the plant and
have each employee check his/her wrist strap every day.
The employee writes the results in a log posted at the station. If the
wrist strap is defective, it is replaced and discarded.

The wrist strap test stations are in the calibration recall program, not
the wrist straps.

At audit time, we ask the employee which station they commonly
use and check the  records for the day they worked.

In the steel rule case, do the same thing. I assume these are six
inch  rules. Set up a a, say, four inch measure station and ask
each employee to check the rule daily.   If they get the right
measurement, they are done. If not, discard the rule and issue
a new one.

Put the measurement stations in the recall program.

Be smart about how you check the rule, so you really find problems.
If your employees are allowed to measure from the end, then
you should check the end, not start the measurement at 1 inch.
You can also use this as a check to make sure that employees
know the proper technique. People will think it is a silly quality
rule, so try to get some value from it.

  Dan O'Leary
  doleary@qbe.picker.com
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From: "Daniel J O'Leary" <doleary@ntssmtp.picker.com>
Subject: QS9000, Chapter 4.11 Dilemma
Date: 1998/08/20
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