Valid Statistical Techniques SOP
on which to base your company's procedure
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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.
Version
Date
Changes
1.10
2019-08-07
--Removed some unnecessary
parentheses from formulas in section "8.a".
--Copied the formula for a "lower 1-sided
confidence limit on a proportion" (in section
"8.a"), rearranged it, and then put it into
section "12.a".
--Miscellaneous minor wording changes.
1.04
2018-07-19
--Corrected the formula for the signed
version of the Coefficient of Determination
(in the denominator, replaced "r" with
"absolute value of r")
1.03
2017-08-31
--Added note about Word_2011 issue
1.02
2017-08-17
--Added instructions for copy/paste
--Added note about WORD_2010 issue
1.01
2017-08-16
--First version released for distribution
Feedback from Users
Send feedback to     JOHNZORICH@YAHOO.COM
Compliments
Issues
2019-08-01
  • Director, Regulatory/Quality: "Our internal procedures
    have been updated based upon his Statistics SOP, which
    helps to assure that we meet regulatory requirements for
    valid and justified plans. A perfect fit for our needs!"


2019-02-21
  • R&D Engineer: "I found it extremely helpful. It helped me
    remember the stats class I took 8 years ago. I will probably
    still need to do some practice problems, but I will refer to
    this SOP a lot when determining what test to do. I found
    the SOP very well organized. All the questions I wrote
    down [while reading it] were answered in the following
    [subsequent] paragraphs so I don't have any questions.
    Thank you so much for putting this resource together."

2017-08-31
  • VP Quality/Regulatory: "Super paper -- will have to read it
    very carefully to gain even a few of the nuggets available."

2017-08-16
  • Director of RA/QA : "Thanks for sending this, John. It's
    very helpful."
  • Senior Quality Engineer: "Wow. Thank you John for
    sharing your wealth."
  • Risk-Management Consultant: "Looks really
    comprehensive, John."
2019-02-21
  • One user reports that when viewed with the Mac 2011 version of
    Word, some of the text in boxes overlapped with some of the
    section titles (e.g., the box at the top of page 8 overlapped with
    the section title just below it (i.e. "b. Confidence....).  

2017-08-17
  • 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).