|Valid Statistical Techniques SOP
on which to base your company's procedure
All versions of this procedure are
copyrighted by John Zorich.
All rights are reserved, except that
anyone may use all or part
of it in their own company's
This Standard Operating Procedure (SOP) is based upon the author's statistical consulting experience since 1999, during which time he also performed more than 500 quality-system audits at more than 200
bio-tech companies. He believes that something like this helps meet FDA and ISO requirements related to "procedures" for "valid" and "appropriate" statistical techniques, especially in regards to risk management.
||--Corrected the formula for the signed
version of the Coefficient of Determination
(in the denominator, replaced "r" with
"absolute value of r")
||--Added note about Word_2011 issue
||--Added instructions for copy/paste
--Added note about WORD_2010 issue
||--First version released for distribution
|Feedback from Users|
Send feedback to JOHNZORICH@YAHOO.COM
- VP Quality/Regulatory: "Super paper -- will have to read it
very carefully to gain even a few of the nuggets available."
- Director of RA/QA : "Thanks for sending this, John. It's
- Senior Quality Engineer: "Wow. Thank you John for
sharing your wealth."
- Risk-Management Consultant: "Looks really
- One user reports that when viewed with MSWord_2010, a few
text-boxes look out-of-place, but that after copying the entire
document to a blank copy of Word, the text-boxes can be easily
moved out of the way of each other. (Same issue reported on
Aug 31, regarding MSWord_2011).