FREE Statistical Techniques SOP
This 22-page Standard Operating Procedure (SOP) is based on my statistical consulting experience since 1999, during which time I also performed more than 500 quality-system audits at more than 200 bio-tech companies. This SOP helps meet regulatory requirements related to “procedures” for “valid” and “appropriate” statistical techniques, especially in regard to risk management.
All versions of this procedure are copyrighted by me, and all rights are reserved, except that anyone may use all or part of it in their own company's internal procedures.
Versions & feedback
VERSIONS — Date Effective: Change Description
1.20 — 2024-03-20:
Corrected all 3 plots in the Normality section; the Y-axes on each plot were labeled as "Z-table Values" but actually they had been mistakenly constructed using Median Rank values.
Added reference to a publication about the “Signed Coefficient of Determination”
1.12 — 2021-09-03:
Miscellaneous wording changes.
1.11 — 2020-08-19:
Miscellaneous wording and grammar 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
ISSUES Reported by Users:
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).
COMPLIMENTS provided by Users:
2020-09-17, from a 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.”
2020-04-08, from an 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!”
2020-01-28, from a Director of Operations: “I gave it a quick read and really liked it, especially all the Excel formulas you provide.”
2019-08-01, from a 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, from an 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, from a VP Quality/Regulatory: “Super paper -- will have to read it very carefully to gain even a few of the nuggets available.”
2017-08-16, from a Director of RA/QA: “Thanks for sending this, John. It's very helpful.”
2017-08-16, from a Senior Quality Engineer: “Wow. Thank you John for sharing your wealth.”
2017-08-16, from a Risk-Management Consultant: “Looks really comprehensive.”