This book provides guidelines for obtaining research and development (RD) results of a consistent and known quality. The approaches discussed here have been developed for an industrial research center engaged in RD to support operating divisions of the parent corporation.

Chapter 7: PROJECT CONSTRUCTION -- I. MATERIAL IDENTIFICATION AND CONTROL -- II. CONTROL OF SPECIAL PROCESSES -- III. INSPECTION -- IV. HANDLING, STORAGE, AND SHIPPING -- V. NONCONFORMING MATERIALS, PARTS, OR COMPONENTS -- APPENDIX: AN ANALYSIS OF CORRECTIVE ACTION REPORTS GENERATED DURING A 3-YEAR PERIOD -- REFERENCES -- Chapter 8: CONTROL OFMEASURING AND TEST EQUIPMENT -- I. THE NEED FOR FORMAL CONTROL -- II. TRACEABILITY -- A. Definition of Traceability -- B. Purposes and Uses of Traceability -- C. Measurement Traceability and Standards Traceability -- D. The Question Posed to NBS -- E. NBS Advice on Traceability -- III. PROGRAM DESCRIPTION -- IV. SCOPE -- V. QUALITY LEVELS -- VI. CENTRALIZED CONTROL -- VII. CALIBRATION PROCEDURES -- IX. EVALUATION OF CALIBRATION SUPPLIERS -- REFERENCES -- Chapter 9: TEST CONTROL -- I. TEST PLAN -- II. TEST PROCEDURES -- III . DOCUMENTATION AND REVIEW OF RESULTS -- REFERENCES -- Chapter 10: SOFTWARE -- I. BACKGROUND -- II. THE SOFTWARE QUALITY ASSURANCE PROGRAM -- A. Planning -- B. Software Quality Levels and QA Plans -- C. Software Development Process -- D. Evaluation -- REFERENCES -- Chapter 11: RECORDS AND REPORTING -- I. PROJECT RECORDS -- II. REPORTS -- III. TRACEABILITY -- IV. RETENTION -- REFERENCES -- Chapter 12: AUDITING THE PROGRAM -- I. GENERAL AUDITING CONSIDERATIONS -- II. PROJECTS -- A. Specified QA -- B. Standard Laboratory Practice -- III. SYSTEM AUDITS -- IV. SUPPLIER AUDITS -- REFERENCES -- INDEX

Helping human research protection program professionals create, implement, and evaluate quality assurance/quality improvement programs. Quality Assurance and Quality Improvement Handbook for Human Research is the first comprehensively designed instructional manual aimed at teaching human research protection program (HRPP) professionals how to create, implement, evaluate, and improve QA/QI programs. Geared toward institutions and individuals responsible for establishing new QA/QI programs or functions, the book offers several organizational models for consideration. It also provides practical information for improving and strengthening established programs, both big and small. Written in a conversational style, the book's step-by-step instructions make it easily accessible to those who may not be well versed in QA/QI concepts and fundamentals. Developed by the QA/QI Subcommittee of the Harvard Catalyst Regulatory Foundations, Ethics, and Law Program, which is committed to designing and strengthening QA/QI programs and functions, this volume • includes contributions by fifteen experts with diverse professional experiences from varied organizations • is enhanced with flow charts, examples, sample forms, and templates • incorporates model slide presentations and instructional materials • discusses the respective benefits and challenges of different organizational models • is applicable across many organizational types with a variety of reporting structures and available resources, including academic and medical institutions Perfect for both seasoned personnel and newcomers to the field, Quality Assurance and Quality Improvement Handbook for Human Research is a needed resource for ensuring investigative accountability. Contributors: Hila Bernstein, MS, MPH, Barbara E. Bierer, MD, Elizabeth Bowie, JD, MPH, MSc, Susan Corl, MSW, MPH, CIP, CCRP, Jacquelyn-My Do, MPH, Lisa Gabel, CIP, Alyssa Gateman, MPH, CCRP, Jennifer A. Graf, Nareg D. Grigorian, Leslie M. Howes, MPH, CIP, Jennifer Hutchinson, CIP, CPIA, Cynthia Monahan, MBA, CIP, Eunice Newbert, MPH, Sarah A. White, MPH, CIP, Elizabeth Witte, MFA

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Covers important concepts, issues, trends, methodologies, and technologies in quality assurance for model-driven software development.

This book examines how and why collaborative quality assurance techniques, particularly pair programming and peer code review, affect group cognition and software quality in agile software development teams. Prior research on these extremely popular but also costly techniques has focused on isolated pairs of developers and ignored the fact that they are typically applied in larger, enduring teams. This book is one of the first studies to investigate how these techniques depend on and influence the joint cognitive accomplishments of entire development teams rather than individuals. It employs theories on transactive memory systems and functional affordances to provide answers based on empirical research. The mixed-methods research presented includes several in-depth case studies and survey results from more than 500 software developers, team leaders, and product managers in 81 software development teams. The book’s findings will advance IS research and have explicit implications for developers of code review tools, information systems development teams, and software development managers.