With the publication of the Final CLIA Rule, new method validation responsibilities came to the laboratory. Previously, moderately complex methods did not need to be validated. But the Final Rule combined moderately and highly complex methods into a category of non-waived methods. Now Laboratories must validate all non-waived methods introduced after April 24, 2003. To help laboratory professionals comply with these new regulatory changes, a second edition of this manual was prepared. Book jacket.

A practical introduction to the management and planning of quality control. With the aid of cartoons and more than 60 illustrations, Dr. Westgard dispels the confusion over how to select quality control procedures for laboratory methods. Using a detailed step-by-step planning process, the author shows you how to define the quality needed for a laboratory test, how you can select control rules for tests, and how you can set specifications for allowable bias and CV. CLIA requirements, JCAHO guidelines, CLSI methodologies and QC practice guidelines are discussed, and more than 20 quality-planning examples are graphically demonstrated covering applications for automated chemistry, blood gas, immunoassay, and coagulation tests. Appendices include tables of CLIA quality requirements, European goals for total biologic error, as well as a complete glossary, reference list, online reference list, and a set of self-assessment questions and detailed answers. Basic Planning for Quality is a much-needed primer on the management of quality control in the laboratory. For lab managers and directors, quality specialists, and clinical laboratory scientists who are looking for a saner way to manage quality in their labs, this manual will provide the missing ingredient - an objective way to manage your testing processes to achieve the quality needed for patient care while accounting for the actual performance of the methods in your laboratory. * Establish a practical process for managing quality in your laboratory! * Plan your quality logically, efficiently, and quickly! * Move beyond compliance with JCAHO, CLIA, NCCLS, and other rules! * Optimize your QC to minimize waste and maximize performance! * Select the best control rules for your tests! Basic Planning for Quality makes use of over 65 illustrations, graphs and tables, explains more than two dozen applications in detail, covers CLIA, JCAHO, NCCLS and other requirements, includes appendices on C

"Once solely the domain of engineers, quality control has become a vital business operation used to increase productivity and secure competitive advantage. Introduction to Statistical Quality Control offers a detailed presentation of the modern statistical methods for quality control and improvement. Thorough coverage of statistical process control (SPC) demonstrates the efficacy of statistically-oriented experiments in the context of process characterization, optimization, and acceptance sampling, while examination of the implementation process provides context to real-world applications. Emphasis on Six Sigma DMAIC (Define, Measure, Analyze, Improve and Control) provides a strategic problem-solving framework that can be applied across a variety of disciplines.Adopting a balanced approach to traditional and modern methods, this text includes coverage of SQC techniques in both industrial and non-manufacturing settings, providing fundamental knowledge to students of engineering, statistics, business, and management sciences.A strong pedagogical toolset, including multiple practice problems, real-world data sets and examples, provides students with a solid base of conceptual and practical knowledge."--

This comprehensive reference on software development quality assurance addresses all four dimensions of quality: specifications, design, construction and conformance. It focuses on quality from both the micro and macro view. From a micro view, it details the aspect of building-in quality at the component level to help ensure that the overall deliverable has ingrained quality. From a macro view, it addresses the organizational level activities that provide an environment conducive to fostering quality in the deliverables as well as developing a culture focused on quality in the organization. Mastering Software Quality Assurance also explores a process driven approach to quality, and provides the information and guidance needed for implementing a process quality model in your organization. It includes best practices and valuable tools and techniques for software developers.Key Features • Provides a comprehensive, inclusive view of software quality • Tackles the four dimensions of quality as applicable to software development organizations • Offers unique insights into achieving quality at the component level • Deals comprehensively with all aspects of measuring software quality • Explores process quality from the standpoint of implementation rather than from the appraiser/assessor point of view • Delivers a bird's eye view of the ISO and CMMI models, and describes necessary steps for attaining conformance to those models