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  Contact Info

Chairman
Dr. Wayne A. Taylor
President
Ann Taylor
Telephone
1 (847) 367-1032
FAX
1 (847) 367-1037
Postal address
5510 Fairmont Rd.
Libertyville, IL 60048
USA
Electronic mail
info@variation.com
Web
www.variation.com

 

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 Areas of Expertise

Acceptance Sampling

Dr. Taylor is a leading expert on acceptance sampling in the FDA regulated industries.  His books, software and courses cover both manufacturing and validation applications.

Book - 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 in inclues extensive tables.

Sampling Plan Analyzer

Software
Sampling Plan Analyzer 2.0

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

Distribution Analyzer

Software
Distribution Analyzer
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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.

 

Courses:

Successful Acceptance Sampling (Manufacturing Focused)

Validation Sampling Plans  

Normality and Transformations

 

Articles:

Confidence Statements Associated With Sampling Plans (12/97 - 1 page)

Selecting Statistically Valid Sampling Plans (10/97 - 6 pages)

Alternative Sample Sizes for Verification Dose Experiments and Dose Audits (5/97 - 12 pages) 

Acceptance Sampling Update (10/95 - 8 pages)

Selecting Representative Samples (2/95 - 2 pages)

The Importance of Trending Attribute Data (11/94 - 1 page)

The Effect of Lot Size (9/94 - 1 page)

Statistically Valid Sampling Plans (3/94 - 1 page)

Classifying Defects and Selecting AQLs (11/93 - 1 page)

 

Other Sources of Information

List of Standards

Frequently Asked Questions

 

Process Validation

Dr. Taylor is the author of ANNEX A of the GHTF guidance document on Process Validation.  His expertise in process validation is widely recognized including delivery of his process validation training to the FDA and is a frequent presenter at MDM conferences.

Books:

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

Pharmaceutical and Medical Device Validation by Experimental Design

 

Courses:

The following three courses make an excellent 2.5 day program for teaching validation engineers the entire process validation process.

Process Validation Principles     

Validation Sampling Plans

Validation Sampling Plans II   new.gif (2069 bytes)

Normality and Transformations 

 

Articles:

Methods and Tools for Process Validation  (5/98 - 4 pages)

 

Other Sources of Information

DEVICES

 DRUGS

 

CAPAs and Trending of Quality Data

Dr. Taylor was helped dozens of companies bring their CAPA systems into compliance following Form 483s, warning letters and consent decrees from the FDA.  He has also facilitated over 100 CAPA teams addressing CAPAs.  CAPA systems can be overwhelmed, rendering them ineffective, if either too many CAPAs are generated or if CAPAs cannot be effectively resolved.  Dr. Taylor's problem solving course teaches how to effectively resolve CAPAs and document their resolution.  His trending course covers statistically valid methods of trending quality data and addresses the common problem of false detections.

Also learn about Dr. Taylor's powerful new tool, change-point analysis, for isolating the start of the problem.

Change-Point Analysis

Software
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.

 

Courses  

Six Sigma Problem Solving Process

Trending of Quality Data

 

Failure Mode and Effects Analysis (FMEA)

Teaches how FMEAs should be linked to the overall risk management system including their use to identify high risks items, track corrective actions, determine when the design can be frozen, determine the sample sizes for validation/verifications, scope revalidations and as part of CAPA investigations.

Courses  

Failure Modes and Effects Analysis (FMEA)

FMEA for Software Engineers

 

Measurement Systems Analysis

Learn the basics including a Gage R&R Study along with the practical aspects of implementing an overall system including: selecting acceptance criteria and their justifications, how to handle destructive tests and how to handle attribute inspections.

Courses  

Measurement Systems Analysis

 

Articles:

Measurement Error Due To Rounding (10/97 - 1 page)

Describing Compounder Accuracy (12/04 - 1 page)

  

Spec Setting, Tolerance Analysis and Robust Design (DFSS)

Dr. Taylor's Robust Tolerance Analysis course has become a key part of the DFSS programs at companies like Honeywell, Boston Scientific and others.  Learn how to set specification limits based on customer needs rather then the trial and error approach of setting them based on process capability and using customer feedback to determine if they work, an approach that frequently results in specification limits tighter than they need be.

At the heart of this process is the ability to identify the 5 critical pieces of information:

  1. Critical to Quality Outputs

  2. Requirements for Critical to Quality Outputs (spec limits based on customer need)

  3. Critical to Quality Inputs

  4. Effect of Critical to Quality Inputs on Critical to Quality Outputs:  y=f(x)

  5. Behavior/Capability of Critical to Quality Inputs

From this tolerance analysis can be used to evaluate a design.  Rather than evaluating a single design, thousands of alternate designs can be evaluated and the optimal design determined using robust design criteria.  Learn state of the art methods for both tolerance design and robust design and how to use these to achieve the ultimate objective - setting of specifications.

Sampling Plan Analyzer

VarTran

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.

 

Courses

Robust Tolerance Analysis

 

Articles:

Process Tolerancing: A Solution to the Dilemma of Worst-Case Versus Statistical Tolerancing (9/97 - 15 pages)

Reducing Variation During Design (2/96 - 6 pages)

Comparing Three Approaches to Robust Design: Taguchi Versus Dual Response versus Tolerance Analysis (10/96 - 10 pages - pdf)

  

General Statistics

Dr. Taylor has a practical way of introducing statistics including a set questions one should always ask and the classification scheme that makes it easy to identify which statistical procedure should be used.  He also addresses the FDA regulatory requirement for the use of statistically valid methods.  

Courses  

Statistics I

Statistics II

Variance Decomposition Methods

 

Statistical Process Control

SPC I covers capability studies and capability indices while introducing control charts.  SPC II covers trending of manufacturing data.  The Trending of Quality Data course focuses on trending of nonmanufacturing data include complaints and services events, a key element of your CAPA program.  Also learn about Dr. Taylor's powerful new tool, change-point analysis, for determining the start of a problem and detecting multiple changes.  

Change-Point Analysis

Software
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.

 

Courses  

Statistical Process Control I - Introduction

Statistical Process Control II - Trending Data

Trending of Quality Data

 

Articles:

Change-Point Analysis: A Powerful New Tool For Detecting Changes - Detailed explanation of how a change-point analysis works.  19 pages.  To download in pdf format, click here:  (85 KB).

A Pattern Test for Distinguishing Between Autoregressive and Mean-Shift Data - Very technical.  14 pages.  To download in pdf format, click here:  (80 KB).

ASA 2002 Presentation - Change-Point Analysis - To download slides in pdf format, click here:  (59 KB).  To download paper in pdf format, click here:  (84 KB).

 

Design of Experiments

Design of experiments are a powerful tool for identifying critical to quality inputs and for understanding their effect on the critical to quality outputs (items 3 and 5 of the 5 critical pieces of information for specification setting).  However, the ultimate objective is to set specifications.  The courses below teach this entire process.

Simulator

Simulator

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

 

Courses

Design of Experiments I - Screening Experiments

Design of Experiments II - Response Surface Studies

Design of Experiments III - Advanced

Robust Tolerance Analysis

Six Sigma

Dr. Taylor was the driving force behind Baxter's Six Sigma program and has helped dozens of other companies implement Six Sigma programs including Boston Scientific, Abbott Laboratories and Honeywell.  He offers Six Sigma green belt and black belt curriculums as well as workshops to aid in the implementation of Six Sigma.

 

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.

 

Courses

Six Sigma Introduction (Includes Breakthrough Improvment process)

Design for Six Sigma Introduction (Includes DFSS process)

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)

Green Belt Program

Black Belt Program

 


Copyright 1997-2012 Taylor Enterprises, Inc.
Last modified: August 04, 2012