› External Controlled Documents

At present, we consider the following as external controlled documents: Part/mold drawings, QS-9000 manuals (7), IASG QS-9000 Sanctioned Interpretations since all of them affects our quality system. How about handbooks that we used as reference for performing some functions, are they considered external controlled documents since it affects the computation of our mold fabrication? Also, are machine/equipment manuals included? These questions were raised during our Management Review.

Thank you very much in advance.

Comments

forrestbreyfogle 5/8/2005

INITIAL POSTING: How do you measure Gage R&R for data involving downtime or set up times?

RESPONSE: Let's consider that the overall variance measured for either downtime or set-up time consists of two variance components (the actual time plus the variance of the difference between the recorded time and the true actual time).

You could determine an estimate of the above difference by video recording the operation, where there is a clock on the recorded video.

You would later watch the video to determine the ACTUAL time for the activity.

You could then match the ACTUAL with the RECORDED time for a set of random occurrences of activities. A variance calculation of the difference between the actual and recorded times could then be divided by the total variance of the operation as it is typically recorded. This calculation could be used as an estimate for variability component that is contributed by measurement inaccuracies.

Hope this helps.

Contact me off-line if you would like to discuss further.

Forrest Breyfogle
Six Sigma Moderator
forrest@smartersolutions.com
512-918-0280
www.smartersolutions.com

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