Dr. Wayne Taylor - Taylor Enterprises, Inc.
for Engineers and Quality in the FDA Regulated Industries
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Areas of Expertise
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.
Confidence Statements Associated With Sampling Plans (12/97 - 1 page)
Selecting Statistically Valid Sampling Plans (10/97 - 6 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
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.
Dr. Taylor wrote the chapter "The Role of Designed Experiments in Developing and Validating Control Plans" in the following book:
The following three courses make an excellent 2.5 day program for teaching validation engineers the entire process validation process.
Methods and Tools for Process Validation (5/98 - 4 pages)
Other Sources of Information
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.
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.
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.
Measurement Error Due To Rounding (10/97 - 1 page)
Describing Compounder Accuracy (12/04 - 1 page)
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:
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.
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)
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.
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: 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 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.
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.
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)
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Last modified: September 08, 2017