Methods - Areas of Expertise
Books
- Statistical Procedures for the Medical Device Industry
- STAT-07, Statistical Techniques for Audits and Effectiveness Checks
Software
- Sampling Plan Analyzer
- Can be used to select sampling plans for effectiveness checks.
Courses
- Validation Sampling Plans (1 day)
- Effectiveness checks use one-time sampling plans to make confidence statements, the same as used in other validation/verification studies.
Blog Articles
Forum Questions and Answers
Related Methods
- Validation Sampling Plans
Books
- Optimization and Variation Reduction in Quality
- The heat sealer case study and Chapter 12 focus on DOE.
- Statistical Procedures for the Medical Device Industry
- STAT-11, Statistical Techniques for Setting Specifications, describes DOE and its role in specification setting.
Software
- VarTran
- Uses equations generated by DOEs to set specifications. Interfaces with several DOE packages.
- Simulator
- Used in DOE training courses to generate data for DOEs. Provides simulations of both products and processes.
Courses
- Design of Experiments I – Screening Experiments (1 day)
- Design of Experiments II – Response Surface Studies (1 day)
- Designed of Experiments III – Advanced (1 day)
- Robust Tolerance Analysis (2 day)
- Uses results of DOE to set specification limits
Blog Articles
Forum Questions and Answers
Related Methods
- Spec Setting, Tolerance Analysis and Robust Design
Books
- Statistical Procedures for the Medical Device Industry
- STAT-06 Statistical Techniques for Design Validation
Software
- Sampling Plan Analyzer
- Can be used to select sampling plans for validations/verifications
Courses
- Validation Sampling Plans (1 day)
Blog Articles
Forum Questions and Answers
Related Methods
- Validation Sampling Plans
Books
- Statistical Procedures for the Medical Device Industry
- STAT-04 Statistical Techniques for Design Verification
Software
- Sampling Plan Analyzer
- Can be used to select sampling plans for validations/verifications
Courses
- Validation Sampling Plans (1 day)
Blog Articles
Forum Questions and Answers
Related Methods
- Validation Sampling Plans
Books
- Guide to Acceptance Sampling
- Statistical Procedures for the Medical Device Industry
- STAT-09 Manufacturing Acceptance Sampling Plans and Inspections
- STAT-18 Statistical Techniques for Normality Testing and Transformations
- List of Standards
Software
Courses
- Successful Acceptance Sampling (1 day)
- Normality Testing and Transformations (1/2-day)
- Variables sampling plans reduce sample sizes but require dealing with the assumption of normality
Blog Articles
Forum Questions and Answers
Related Methods
- Normality Testing and Transformations
Books
- Statistical Procedures for the Medical Device Industry
- STAT-18 Statistical Techniques for Normality Testing and Transformations
Software
- Distribution Analyzer
- Used to test for normality and handle nonnormal data
- STAT-18 – Skewness Kurtosis Normality Tests.xlsx
Courses
- Normality Testing and Transformations (1/2-day)
Blog Articles
Forum Questions and Answers
Related Methods
- Validation Sampling Plans
- Manufacturing Sampling Plans
Books
- Statistical Procedures for the Medical Device Industry
- STAT-03 Statistical Techniques for Process Validation
- STAT-05 Statistical Techniques for Component/Material Qualifications
- Pharmaceutical and Medical Device Validation by Experimental Design
- Dr. Taylor wrote the chapter “The Role of Designed Experiments in Developing and Validating Control Plans”
- References for 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.
- See Methods and Tools for Process Validation appearing as Annex A of the guidance.
- Global Harmonization Task Force (GHTF): “Quality Management Systems – Process Validation Guidance – Edition 1,” June 29, 1999. (OBSOLETE)
- Food & Drug Administration (FDA): “Design Control Guidance for Medical Device Manufacturers,” March 1997.
- References for Drugs
Software
- Sampling Plan Analyzer
- Can be used to select sampling plans for validations/verifications
- Distribution Analyzer
- Used to execute variables sampling plans
- STAT-12 to 16 – Confidence Intervals and Equivalence Tests.xlsx
Courses
- Process Validation Principles (1-day)
- Validation Sampling Plans (1 day)
- Validation Sampling Plans II (1 day)
- Normality Testing and Transformations (1/2-day)
Blog Articles
Forum Questions and Answers
- Sampling Plan Analyzer Software Package
- Distribution Analyzer Software Package
- Process Validation (Process and Supplier Testing)
Related Methods
- Validation Sampling Plans
- Normality Testing and Transformations
Books
- Statistical Procedures for the Medical Device Industry
- STAT-17 Statistical Techniques for Reliability Life Testing
Software
- Requires Minitab
Courses
- None
Blog Articles
Forum Questions and Answers
Related Methods
- Validation Sampling Plans
Books
- Optimization and Variation Reduction in Quality
- This book served as the basis for Baxter’s Six Sigma program
Further Information
Storyboards
- Six Sigma Improvement Process (MAIC)
- Six Sigma Design Process (IDOV)
- Six Sigma Problem Solving Process (MAIC)
- Six Sigma Validation Process (IQ-OQ-PQ)
Courses
- Six Sigma for Engineers
- Six Sigma Planning and Deployment Management Workshops
- Six Sigma Executive Planning Workshop (top level planning)
- Design for 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)
Blog Articles
Forum Questions and Answers
Related Methods
- All
Important Advances
- Process Tolerance Analysis is a unified approach to tolerancing that encompasses both worst-case and statistical tolerances. Using process tolerancing, worst-case tolerances and statistical tolerances can be combined into the same analysis. The flexibility provided by process tolerancing results in solutions to such common problems as multiple components from the same lot and off-center processes.
- Robust Tolerance Analysis is a combination of tolerance analysis and robust design which is the best-demonstrated process for achieving robust design. The result is a systematic approach to setting targets and tolerances to achieve a specified level of quality at the lowest possible cost.
Books
- Optimization and Variation Reduction in Quality
- The hinge and heat sealer case studies and Chapter 13
- Statistical Procedures for the Medical Device Industry
- STAT-11, Statistical Techniques for Setting Specifications
Software
Courses
- Robust Tolerance Analysis (2 day)
Blog Articles
Forum Questions and Answers
Related Methods
- Design of Experiments
Books
- Statistical Procedures for the Medical Device Industry
- STAT-01 Statistical Policy
- STAT-02 Glossary of Statistical Terms
- One Sample Confidence Intervals
- STAT-12 Verification/Validation Sampling Plans for Proportion Nonconforming
- STAT-13 Verification/Validation Sampling Plans for Rate of Nonconformities
- STAT-14 Verification/Validation Sampling Plans for Average
- STAT-15 Verification/Validation Sampling Plans for Standard Deviation and RSD
- Two Sample Comparisons
- STAT-16 Statistical Techniques for Equivalence Testing
- STAT-19 Rounding of Data
- Optimization and Variation Reduction in Quality
Software
Courses
- Statistics I (1-day)
- Statistics II (1-day)
- Variance Decomposition Methods (1-day)
- Validation Sampling Plans (1 day)
- Validation Sampling Plans II (1 day)
- Design of Experiments I – Screening Experiments (1 day)
- Design of Experiments II – Response Surface Studies (1 day)
- Designed of Experiments III – Advanced (1 day)
- Normality Testing and Transformations (1/2-day)
Blog Articles
Forum Questions and Answers
Related Methods
- Design of Experiments
- Validation Sampling Plans
- Normality Testing and transformations
Books
- Statistical Procedures for the Medical Device Industry
- STAT-08 Statistical Techniques for Test Method Validation
- Optimization and Variation Reduction in Quality
- Chapter 7: Evaluating Measurement Systems
Software
- Requires Minitab
Courses
- Measurement Systems Analysis (1 day)
Blog Articles
Forum Questions and Answers
Related Methods
- Areas of Application Requiring Validated Test Methods
- Design Validation (Clinical and User Testing)
- Design Verification (Product Testing)
- Process Validation (Process and Supplier Testing)
- Manufacturing Sampling Plans
Important Advances
- Change-Point Analysis is a powerful trending tool for detecting change, including multiple changes. It is a great CAPA investigation tool, outperforming traditional control charts at detecting sustained shifts, and better describing the changes.
- Normalized IN control charts allows I charts to be normalized based on volumes. This makes it the preferred chart for complaint and other count data. Average and IN charts may be the only 2 types of control charts you ever need.
Books
- Statistical Procedures for the Medical Device Industry
- STAT-10 Statistical Techniques for Trending Data
- Optimization & Variation Reduction in Quality
- Chapter 9: Control Charts
Software
Courses
- Trending of Quality Data (1 day)
- Statistical Process Control I – Introduction (1 day)
- Statistical Process Control II – Trending Data (1 day)
Blog Articles
Forum Questions and Answers
Related Methods
- Test Method Validation
- Normality Testing and Transformations
Books
- Statistical Procedures for the Medical Device Industry
- STAT-12 Verification/Validation Sampling Plans for Proportion Nonconforming
- STAT-13 Verification/Validation Sampling Plans for Rate of Nonconformities
- STAT-14 Verification/Validation Sampling Plans for Average
- STAT-15 Verification/Validation Sampling Plans for Standard Deviation and RSD
- STAT-16 Statistical Techniques for Equivalence Testing
- STAT-17 Statistical Techniques for Reliability Life Testing
- STAT-18 Statistical Techniques for Normality Testing and Transformations
Software
- Sampling Plan Analyzer
- Can be used to select sampling plans for validations/verifications
- Distribution Analyzer
- Used to execute variables sampling plans
- STAT-12 to 16 – Confidence Intervals and Equivalence Tests.xlsx
Courses
- Validation Sampling Plans (1 day)
- Validation Sampling Plans II (1 day)
- Normality Testing and Transformations (1/2-day)
- Variables sampling plans reduce sample sizes but require dealing with the assumption of normality
Blog Articles
Forum Questions and Answers
- Sampling Plan Analyzer Software Package
- Distribution Analyzer Software Package
- Validation Sampling Plans
Related Methods
- Reliability Testing
- Normality Testing and Transformations
- Areas of Application
- Audits and Effectiveness Checks
- Design Validation (Clinical and User Testing)
- Design Verification (Product Testing)
- Process Validation (Process and Supplier Testing)
- Test Method Validation