1st Edition
Implementing Quality in Laboratory Policies and Processes Using Templates, Project Management, and Six Sigma
Section I: Establishing the Need
Introduction
What Manuals?
Application
A Manual by Any Other Name
Manual Categories
Manual Components
Overview of Quality Assurance
What Is Quality Assurance
Quality Assurance Program Components
Responsibilities
Quality Assurance Benefits
Quality Assurance Cost
Cost of NO Quality Assurance
Quality Control
Quality Assurance Documentation
Summary
Section II: Implementation Strategies
Project Management
Overview
What Is Project Management?
What Is a Project?
What Are the Phases of a Project?
Project Initiation
Project Planning
Project Execution
Project Monitoring and Control
Project Closure
Overview of Six Sigma
Overview
Six Sigma Foundation—DMAIC
Define
Measure
Analyze
Improve
Control
Conclusion
Outsourcing Quality Assurance Programs
Introduction
Services
Benefits
Conclusion
Section III: Policy Manual Development
Content and Format
Manual Types
Manual Categories
Manual Components
Content
Format
Operational Manuals
Definitions
Administrative Manual
Quality Manual
Health and Safety Manual
Sample Control Manual
Technical Methods Manuals
Training Manuals (TM)
Analytical Procedures
Quality Assurance Procedures
Documentation Requirements
Inventories
Criteria Files
Section IV: Appendices
Definitions
Administrative Policy Document Templates
Administrative Policy Manual Template
Quality Policy Document Templates
Quality Policy Manual Template
Safety Policy Document Templates
Safety Manual Template
Sample Control Document Templates
Sample Control Manual Template
Technical Manual Template
ISO 17025 Criteria File
ASCLD/LAB (Legacy) Criteria File
Policy/Procedure Association Templates
Project Management Templates
Index
Biography
Donnell R. Christian Jr., Stephanie Drilling
...The authors do deserve applause for preventing repetitions, which are the norm, rather than exceptions, in books of this kind ... it is an important book which describes how quality has to be managed in any laboratory...
—Puneet Setia and Avneesh Gupta, in Anil Aggrawal's Internet Journal of Forensic Medicine and Toxicology, Volume 11, Number 2, July - December 2010
