STATISTICAL  APPLICATIONS and Quality Systems Consulting Services David L. Kuhns Circle Pines, MN e-mail: e4e5@e4e5.net

 

Expert consulting services provided in the following areas:

Quality Assurance  Statistics Quality Systems 

Quality Engineering and Management:

Statistical Process Control, application, implementation and instruction:

· Attribute control charts - p, np, c and u charts, demeritis charts,

· Variables control charts - x-bar, R, s, median, individual, moving range, Cusum, EWMA charts,

· Interaction charts,

· Pareto Analysis,

· Short run charting techniques,

· Pre-control charting techniques,

· Non-normal control charting,

· moving x-bar,

· charts of non-normal distributed data.

Data collection:

· Sampling;

· Simple random sample,

· Completely randomized,

· Blocked,

· Stratified,

· Selective,

· continuous,

· Skip lot sampling,

· Beyesian sampling.

· Single, Double and Multiple sampling plans,

· Sampling for conformance, verification, qualification, and validation ,

· MIL-STD-105 (ANSI/ASQC Z1.4),

· MIL-Std-414 (ANSI/ASQC Z1.9),

· C=0 and other AQL techniques.

· Non-destructive testing,

· Manual and automated data collection systems,

· Guage analysis, gauge repeatability and reproducibility,

· Complete metrology

· traditional equipment,

· non-contact including laser, infrared and sonic,

· CMM, and various visual systems, Paired sampling,

· Tests for randomization and for population representation,.

Design of Experiments:

· Full and fractional factorial,

· Multiple level factorial designs,

· Taguchi and Plackett Berman,

· Orthoganal arrays,

· Latin and Graeco-Latin Squares,

· Central composite designs,

· Randomized block designs,

· Split-Plot designs,

· Mixture designs,

· Nested designs of homogeneous and mixed designs,

· Replications,

· Fractional replication,

· Analysis of residuals,

· Incidence base Cox analysis,

· Prevalence base case studies,

· Analysis of Variance and covariance,

· Model building,

· Surface plots,

· Confounding, blocking and covariance,

· Analysis of bias and effects of blocks,

· Missing and messy data,

· Analysis and identification of outliers.

Statistical analysis:

· Histograms and stem-and-leaf diagrams,

· Variables and attributes hypothesis testing,

· Paired and random population comparisons,

· Confidence limits,

· Normal and non-normal probability plots,

· Operating characteristic curves,

· Conditional probability analysis,

· Queueing theory,

· Time series analysis and statistical forecasting,

· Control charts,

· Interpolation and extrapolation predictive models,

· Normal, Chi-Square, F, Poisson, t distributions,

· Non-normal, binomial, geometric, hypergeometric, order distributions,

· Non-parametric, Wilcoxon rank sum, Mann-Whitney, Beyesian,

· Probability theory and permutations and combinations,

· Linear and non-linear regression,

· Single and multiple regression.

Quality concepts and tools:

· Quality Function Deployment (QFD),

· Total Quality Management (TQM),

· Customer Focused Quality (CFG),

· Deming's quality philosophy and 14 points.

· Team Oriented Problem Solving (8 Discipline),

· Fishbone diagrams, flow diagrams,

· Pert charts,

· Gantt charts,

· Cause and effect analysis,

· Hazard, Failure Mode and Effect Analysis,

· Material Review Board,

· Benchmarking,

· Concepts of continuous improvement, Plan - Do - Check - Act cycle,

· Taguchi Loss Function,

· Cost of Quality analysis and reporting,

Quality Systems Implementation:

· Ford Q1, Q-101

· GM Targets for Excellence,

· ISO-9001,2,3, 14001, QS-9000,

· CE registration,

· FDA Good Manufacturing and Good Lab Practices (GMP and GLP),

· Medical Device Directives (EC-MDD),

· Supplier certification programs,

· Complete documentation systems,

· Engineering change order systems,

· Standard Operating Procedures,

· Work center procedures and instructions,

· Develop and writing of quality manuals for ISO and GMP compliance.

Conformance to requirements:

· Control charting and concepts,

· Design reviews,

· Developing customer requirements and specifications,

· Design verification, design validation,

· Pilot build and production simulations,

· Tool build and verification, Tool qualification,

· Process development,

· Process stressing experiments,

· Conformance analysis,

· Design for 6-sigma compliance,

· Zero defects,

· Cp, Cpk, Cpr, Cpm,

· Loss Function and other indicators of conformance,

· Benchmarking and verification of improvements,

· Validation and qualification protocols and reporting,

· Internal auditing,

· Supplier and system audits for GMP and ISO requirements.

Regulatory Compliance:

· Auditing for compliance,

· 510(k) and PMA submissions,

· Patent searches,

· Literature searches,

· IDE and clinical trial submissions.

Industries:

· Class 1, 2, and 3 medical devices,

· Electronics and electro-mechanical assembly,

· Electronic service and repair,

· Plastic molding and extrusion,

· Pharmaceutical manufacturing.

Clients:

· Magnetic Peripherals, Inc.

· Control Data Corporation

· UFE, Inc.

· Statistical Applications Consulting

· Product Design and Engineering Company

· Minntech Renal Systems

· CIMA Labs, Inc.

· B. Braun Medical

· SIMS Deltec, Inc.

· Pharmatarget, Inc.

· Medtronic, Inc.

· Endocardial Solutions, Inc. 

Other Activities

· Member, American Society for Quality (ASQ)

· Certified Quality Engineer (ASQ)

· Member, American Statistical Association (ASA)

· President, Minnesota State Chess Association

· Delegate and Regional Vice President, United States Chess Federation (USCF)

· Certified National Tournament Director, USCF

· Member, ratings committee, USCF

· Chief organizer, and Assistant Director, 1982 and 2000 U. S. Open Chess tournaments

· Assistant Director, 1992 and 1993 National Open Chess Tournaments

· "Royal Chess Master", Minnesota Renaissance Festival

· Certified Soccer Referee, United States Soccer Federation

· Certified Instructor, Minnesota Technical College System