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Spec Setting, Tolerance Analysis and Robust Design
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Contact Info
- Chairman
- Dr. Wayne A. Taylor
- President
- Ann B. 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.
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Book - Guide to Acceptance SamplingThis 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. |
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Software
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Software
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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
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
Normality and Transformations
Articles:
Methods and Tools for Process Validation (5/98 - 4 pages)
Other Sources of Information
DEVICES
- Code of Federal Regulation: Title 21, Subsection H, Part 820, Section 820.75.
- Federal Register - Preamble Vol. 61, No. 195, October 7, 1996.
- Global Harmonization Task Force (GHTF): “Quality Management Systems - Process Validation Guidance – Edition 2,” January 22, 2004.
- Food & Drug Administration (FDA): “Design Control Guidance for Medical Device Manufacturers,” March 1997.
DRUGS
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Food
& Drug Administration (FDA): “Process Validation: General
Principles and Practices ,” January 2011.
- Food & Drug Administration (FDA): “Guideline on General Principles of Process Validation,” May 1987.
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.
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Software
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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
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:
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Critical to Quality Outputs
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Requirements for Critical to Quality Outputs (spec limits based on customer need)
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Critical to Quality Inputs
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Effect of Critical to Quality Inputs on Critical to Quality Outputs: y=f(x)
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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.
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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
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.
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Software
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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: 
(84 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.
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SimulatorTraining 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
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.
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Optimization & Variation Reduction in QualityCovers 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. |
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)