TE Variation.com

Dr. Wayne Taylor - Taylor Enterprises, Inc.
Applied Statistics
for Engineers and Quality in the FDA Regulated Industries

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  Contact Info

Dr. Wayne A. Taylor   linkedin
Ann Taylor
1 (847) 367-1032
1 (847) 367-1037
Postal address
5510 Fairmont Rd.
Libertyville, IL 60048
Electronic mail


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Please join me for the following two webinars:

Medical Devices - Complying With 820.250 Statistical Methods - Friday, October 12, 2018 | 10:00 AM PDT | 01:00 PM EDT| Duration: 90 Minutes      



Validation Sampling Plans for Process Validation, Design Verification and CAPA Effectiveness Checks - Monday, November 5, 2018|10:00 AM PDT|01:00 PM EDT| Duration: 90 Minutes



Products - Purchase at our store

Books - Purchase books at our store

Statistical Procedures for the Medical Device Industry  New book

This book provides statistical procedures designed to ensure that all statistical regulatory requirements for medical devices are met. These regulatory requirements can be found in:

Code of Federal Regulation 21CFR, Part 820 Quality System Regulations

ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes

This includes Statistical Policy Process Validation, Design Verification, Component/Material Qualifications, Design Validation, Audits and Effectiveness Checks, Test Method Validation, Manufacturing Acceptance Sampling Plans and Inspections, Trending Data, Setting Specifications Verification/Validation Sampling Plans, Equivalence Testing, Reliability Life Testing and Normality Testing and Transformations


Guide to Acceptance Sampling

This book focuses on manufacturing applications of acceptance sampling plans.  It also serves as a basic introduction to acceptance sampling intended for the practitioner. It avoids complex mathematical formulas. Instead it includes extensive tables.

Optimization & Variation Reduction in Quality

Covers how to optimize the average and reduce variation during product design, process design and process improvement.  Provides a unified approach to engineering product and product variation.

This landmark book integrates statistical process control, design of experiments, robust design methods, Shainan's methods and other lesser-known practices into a single system. Professionals engaged in product design, process development, and manufacturing activities will find this common framework has vast practical implications, not least of which is immensely improved communication between the various specializations in the product life cycle.


Pharmaceutical and Medical Device Validation by Experimental Design

Dr. Taylor wrote the chapter "The Role of Designed Experiments in Developing and Validating Control Plans" in this book.


Software - Purchase software at our store

Change-Point Analysis

Change-Point Analyzer               

State of the art tool for trending data to detect a change.   An important tool as part of problem investigations to determine the start of the problem.

Sampling Plan Analyzer

Sampling Plan Analyzer 2.0

Comprehensive tool for evaluating and selecting acceptance sampling plans for both manufacturing and validation/verifications applications.

Distribution Analyzer

Distribution Analyzer   

Tool for executing variables sampling plans.  State of the art procedures for testing for normality and transforming nonnormal data.  Makes confidence statements as to the percent conforming to specifications.

Sampling Plan Analyzer


Performs a state of the art approach to tolerance analysis called process tolerancing which is a unified approach to tolerance analysis combining both worst-case and statistical tolerances.  Also performs design optimization simultaneously optimizing the tolerance center and width to obtain high performance robust designs.



Training tool used to simulate manufacturing processes and generate data for DOE and Robust Tolerance Analysis courses.


Courses - offered at your site

Acceptance Sampling

Successful Acceptance Sampling (Manufacturing Focused)

Validation Sampling Plans

Validation Sampling Plans II   

Normality and Transformations 

Process Validation

Process Validation Principles

The above course plus the two previous courses Validation Sampling Plans and Normality and Transformations makes an excellent 2.5 day program covering the entire process validation process.

CAPAs and Trending of Quality Data  

Six Sigma Problem Solving Process

Trending of Quality Data

Failure Modes and Effects Analysis (FMEA)

Failure Modes and Effects Analysis (FMEA)

FMEA for Software Engineers

Measurement Systems Analysis

Measurement Systems Analysis

Spec Setting, Tolerance Analysis and Robust Design

Robust Tolerance Analysis

General Statistics

Statistics I

Statistics II

Variance Decomposition Methods

Statistical Process Control

Statistical Process Control I - Introduction

Statistical Process Control II - Trending Data

Design of Experiments

Design of Experiments I - Screening Experiments

Design of Experiments II - Response Surface Studies

Design of Experiments III - Advanced

Six Sigma for Engineers

Six Sigma Introduction (Includes Breakthrough Improvment process)

Design for Six Sigma (Includes DFSS process)

In addition, complete Six Sigma green belt and black belt curriculums are available.  These programs consist of different groupings of the other courses, combined with project work and coaching.  

Six Sigma Planning and Deployment

Six Sigma Executive Planning Workshop (top level planning)

Six Sigma Management Overview (role out to affected top level other management)

Six Sigma Technical Manager Workshop (role out to affected technical management)

Six Sigma Orientation (role out to any other affected employees)

Design for Six Sigma Executive Planning Workshop (top level planning)



Dr. Taylor  provides consulting, both on site and over the phone, in a number of the areas of expertise.  He specializes in compliance with FDA regulations including selection of statistically valid procedures and valid statistical justifications.  This includes samples sizes for validation and verification, manufacturing sampling plans, trending of quality data, test method validations, process validation, risk evaluations (FMEAs), CAPA investigations and CAPA effectiveness checks.

Dr. Taylor also teaches and consults on setting specifications and engineering variation during design through his Robust Tolerance Analysis course and VarTran software packages.  This process is a key part of the Design for Six Sigma (DFSS) approach.  He also provides general Statistics, Statistical Process Control, Design of Experiments and Six Sigma training and consulting.

Number Visits = since 28-Oct-2012

Copyright 1997-2017 Taylor Enterprises, Inc.
Last modified: September 08, 2017