2019

A Laboratory Quality Handbook Of Best Practices and Relevant Regulations

Donald C. Singer, ed., ASQ Quality Press, 600 N. Plankinton Ave., PO Box 3005, Milwaukee, WI 53203-3005, 2001, 404 pp., member $63, list $78.75 (book).

When you hear the terms "good manufacturing practices" and "good laboratory practices," you automatically think of well-established laboratories that perform tests on the raw materials, in-process batches and finished goods of pharmaceutical companies. This book provides an overview of ways to manage laboratories in all stages of development and all industries.

The book is valuable to new laboratory workers trying to set up a lab from scratch because it provides the actual guidelines that need to be followed in a clear step-by-step approach. For established firms, the book offers a reality check for comparing their current laboratory management systems with the best practices recommended by several leading practitioners.

After explaining the need for quality assurance in laboratories, the book discusses critical laboratory operations that should be established and improved. Regulatory compliance with the EPA's good automated laboratory practices and the FDA's guides to laboratory inspections and pharmaceutical and microbiological labs are also covered.

All in all, this handbook is a worthwhile read and useful when kept handy on the lab's reference bookshelf.

Jeff Stevens
CCL Custom Manufacturing
Cumberland, RI
 

The Passion Plan at Work

Richard Chang, Jossey-Bass, 605 Third Ave., New York, NY 10158-0012, 2001, 273 pp., $24.95 (book).

While my task is to review Richard Chang's book, it should be noted that this is not only a book but encompasses a whole process including multiple Web sites, presentations and step-by-step guides for interested readers. For those readers already familiar with The Passion Plan, this new book provides an overview similar to the original book but quickly moves to cases, applications and worksheets designed for business situations.

The book begins with a model for a passion driven organization and justification for this model in terms of both worker and customer satisfaction and profit for all involved. In the examples that follow in the step-by-step chapters, the relationship between a quality driven and passion driven organization are discussed but not clearly delineated.

Chapters three through seven cover the process of bringing passion into the company for the first time or of bringing it back. The recognition of a passion deficit is the first step in this process. Chang argues any level of the organization can call attention to the need to change, but, like quality improvement, this need must be universally recognized before change can take place. Each chapter is accompanied by worksheets. There is a Web site, www.thepassionplan.com, where readers can read and share case histories. The final chapter summarizes the benefits of rekindling passion in the workplace and treats it as a highly profitable endeavor for all involved (employees, management and customers).

For a future edition I would suggest creating stronger ties to the quality literature and a discussion in the early chapters of how passion and quality are related.

I. Elaine Allen
Babson College
Wellesley, MA
 

Process Problem Solving: Guide for Maintenance and Operations Teams

Bob Sproull, Productivity Press, PO Box 1339, Portland, OR 97213-0390, 2001, 192 pp., $29.95 (book).

Mainly written for a manufacturing audience, this is a hands-on book containing a systematic methodology for discovering and dissecting the root of problems. The methodology is structured using a problem analysis flowchart--an amalgam of various proven problem solving techniques and tools, such as cause-and-effect diagrams, tree diagrams, flowcharts and scatter diagrams. Learning aids and problem solving truths are sprinkled throughout the text to make the reader aware of important points. Appendices provide real-world case studies that illustrate the problem solving methodology.

Although the book was written to meet the needs of plant maintenance troubleshooters, it is versatile enough to be adapted to other disciplines. The book is simple, in that the techniques described are easy to learn and use, yet it is also comprehensive in its approach to problem solving.

The book is of limited value for the experienced person, but I strongly recommend it for those who want an introduction to systematic problem solving independent of the problem area.

Bengt Klefsjö
Luleå University
Luleå, Sweden
 

Corporate Culture and The Quality Organization

James W. Fairfield-Sonn, Quorum Books, 88 Post Road West, PO Box 5007, Westport, CT 06881-5007, 2001, 224 pp., $65 (book).

The author says this book was written with three audiences in mind: executives responsible for improving the quality of the products and services offered by their firms; external and internal consultants actively involved in helping others improve their work systems, processes and procedures; and academics and students interested in learning more about how others have been able to improve the quality of the goods and services they deliver. The books focus is on the corporate culture in which quality improvement actions must take place.

The book has three major sections and a selected bibliography. The first section provides an overview on how to start thinking about creating a quality organization. It begins with an interesting question that drives the entire process: "How much quality is enough?"

The next part explores how to drive a quality improvement effort into an organization. This process begins with making quality and quality improvement a corporate strategic priority and then turns to making the organization more customer focused.

The last section examines a number of the latest quality issues. Two of the newest issues addressed are the development of a learning organization and the pursuit of partnerships to continually improve the quality of products and services. The book concludes with a summary of the lessons learned.

This book achieves its goal and is well-suited for its designed audiences.

John D. Richards
SRA International
San Antonio
 

Project Management for Dummies

Stanley E. Portny, IDG Books Worldwide Inc., 919 E. Hillside Blvd., Suite 400, Foster City, CA 94494, 2001, 350 pp., $19.99 (book).

The yellow covers of the For Dummies books seem to be on bookshelves everywhere these days, although few are found in the business library that do not apply to software or the operation of electronics. This one focuses on project management from start to finish.

The three parts of any project--planning, organizing and controlling--are covered in depth along with all the issues associated with being the leader of a project in a business environment. The five phases of a project--conceive, define, start, perform and close--are well-documented, with examples to show how events may evolve during the project. All sections are thoroughly discussed from differing viewpoints. The author offers plenty of tips and the proper context in which to apply them.

If there are any weaknesses in this text, they are the depth and amount of detail given. The volume of information may frighten novices away from the opportunity to effectively complete their undertaking, even though not all the information is applicable to every situation. Clarification on what is appropriate for which projects could be a little more straightforward.

Because of a preconceived notion of the purpose of the book and the indicated audience (dummies), I had expected this book to be thorough, incomplete and lacking. What I found was a book that takes a complicated subject and much needed set of skills and distills them to their essence.

Usually, the books I review are placed in the company library for others to use. This one is not leaving my office! The information and checklists are too valuable to lose, even for a short period of time.

Marc A. Feldman
Solvay Interox Inc.
Houston
 

The TL 9000 Guide for Auditors

Mark Kempf, ASQ Quality Press, 600 N. Plankinton Ave., PO Box 3005, Milwaukee, WI 53203-3005, 2001, 131 pp., member $36, list $45 (book).

Among the family of ISO 9000 based industry standards is the TL 9000 standard for the telecommunications industry. Like its predecessors, TL 9000 incorporates the ISO 9000 standards and adds specific requirements. Unlike its predecessors, TL 9000 has divided these additional requirements, generally referred to as adders, into categories for different industry segments. In all, there are seven different categories of adders in this standard, requiring TL 9000 auditors to understand the specific applicability of each category. If that were not confusing enough, TL 9000 may be applied to an entire company, a business unit or even a department, yet the ISO 9000 requirements are applicable in each situation.

The primary purpose of The TL 9000 Guide for Auditors is to provide auditors with an understanding of these additional requirements and their application in an audit. In addition, the author has provided two or three key questions following each clause, as well as TL 9000's requirements definitions and measurement definitions for review and reference.

New auditors in the telecommunications industry will find this book very helpful, as will managers, quality managers and management representatives who are in the process of implementing the TL 9000 standard.

Terry Regel
Quality Management Resources
Mt. Juliet, TN
 

Quality and Power in the Supply Chain: What Industry Does
For the Sake of Quality

James Lamprecht, Butterworth-Heinemann, 225 Wildwood Ave., Woburn, MA 01801-2041, 2000, 219 pp., $29.95 (book).

James Lamprecht's book, Quality and Power in the Supply Chain, offers a critique of standardization efforts and what he describes as the ISO 9000 phenomenon. To foster better understanding of the present, Lamprecht provides a historical perspective on past attempts to regulate quality. It includes useful background information on the origins of current quality practices.

Throughout this book, Lamprecht speaks out against management and quality practices that he believes are misguided. Some areas are easy targets for criticism, and few would take issue with his comments. However, he also criticizes areas where readers will be less likely to agree.

Among his targets are bureaucracy, excessive documentation of process procedures, standardization efforts such as ISO 9000, registrars and quality awards such as the Baldrige Award.

Lamprecht also takes issue with the professionalization of quality, the establishment of a quality ideology and the conduct of the Annual Quality Congress of the American Society for Quality as a means for sustaining the quality ideology.

Rather than providing solutions, this book highlights areas that may require improvement. Lamprecht's voice of dissent is valuable because it questions conventional wisdom and may lead either to change or a re-evaluating of opinions and better understanding of our beliefs.

Richard Anderson
Raytheon
Oro Valley, AZ
 

RECENT RELEASES

Key Account Management and Planning, Noel Capon, The Free Press, 1230 Avenue of the Americas, New York, NY 10020, 2001, 384 pp., $45 (book).

Mastering Inner Leadership, Gilbert W. Fairholm, Quorum Books, 88 Post Road West, PO Box 5007, Westport, CT 06881-5007, 2001, 240 pp., $65 (book).

Modern Project Management, Norman R. Howes, Amacom, 1601 Broadway, New York, NY 10019, 2001, 262 pp., $59.95 (book).

Optimal Reliability Design: Fundamentals and Applications, Way Kou, V. Rajendra Prasad, Frank A. Tillman and Ching-Lai Hwang, Cambridge University Press, 40 W. 20th St., New York, NY 10011-4211, 2001, 389 pp., $59.95 (book).

Organizational Mastery With Integrated Management Systems: Controlling the Dragon, Michael T. Noble, John Wiley & Sons, 605 Third Ave., New York, NY 10158, 2000, 342 pp., $79.95 (book).

PMI Project Management Salary Survey 2000 Edition, Project Management Institute, Four Campus Blvd., Newton Square, PA 19073-3299, 2000, 248 pp., $199.95 (book).


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