Implementing Quality in Laboratory Policies and Processes
Using Templates, Project Management, and Six Sigma
CRC Press – 2009 – 1,432 pages
In order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in setting up laboratories, Implementing Quality in Laboratory Policies and Processes: Using Templates, Project Management, and Six Sigma provides templates for the various policies, procedures, and forms that should be contained in the quality assurance, operational, and technical manuals of a laboratory seeking accreditation.
Templates for the entire project life cycle
The book begins with a general introduction and overview of quality assurance and then moves on to cover implementation strategies. It contains best practices and templates for the project management of the design and implementation of the laboratory operational and technical manuals required to establish a quality assurance program. The templates span the entire project life cycle, from initiation, to planning, to execution, to monitoring, and finally, to closure. The book also examines how Six Sigma concepts can be used to optimize laboratories, and contains templates that cover administrative issues, quality assurance, sample control, and health and safety issues. In addition, there is a section of criteria files that relate the individual document templates to specific accreditation criterion.
Addresses the standards of ISO 17025
The results of any laboratory examination have the potential to be presented in court and can ultimately affect the life and liberty of the parties involved. Therefore, a stringent quality assurance program, including well-documented policies and a procedure manual, is essential. Ensuring that laboratories meet the standards of ISO 17025, this volume is a critical component of any laboratory’s accreditation process.
…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
Section I: Establishing the Need
A Manual by Any Other Name
Overview of Quality Assurance
What Is Quality Assurance
Quality Assurance Program Components
Quality Assurance Benefits
Quality Assurance Cost
Cost of NO Quality Assurance
Quality Assurance Documentation
Section II: Implementation Strategies
What Is Project Management?
What Is a Project?
What Are the Phases of a Project?
Project Monitoring and Control
Overview of Six Sigma
Six Sigma Foundation—DMAIC
Outsourcing Quality Assurance Programs
Section III: Policy Manual Development
Content and Format
Health and Safety Manual
Sample Control Manual
Technical Methods Manuals
Training Manuals (TM)
Quality Assurance Procedures
Section IV: Appendices
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