|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.
||--Miscellaneous wording & grammar
||--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
--Miscellaneous minor wording changes.
||--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
- Director of Operations at a small orthopedics company:
"This is a great reference that is small enough to keep on
my iPad. The SOP is easy to read and understand, and
covers the most commonly used topics."
- Engineering Manager: "I found the SOP to be extremely
helpful. Each statistical technique is outlined well and gives
a great introduction that is clear and understandable. This
will definitely be my go-to for now on!"
- Director of Operations: "I gave it a quick read and really
liked it, especially all the Excel formulas you provide."
- 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!"
- 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."
- 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 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....).
- 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).