Risk Assessment: basics and benchmarks
By Bruce W. Main, PE, CSP Published by design safety engineering, inc., Ann Arbor, MI phone (888) 628-8788 www.designsafe.com 2004, hardcover, 478 pp (8.5x11”), cost $95.00 + shipping & handling.
By: Wayne C. Christensen, CSP, PE
In the design and development of facilities, equipment, processes, products in the USA and the world, there is a growing emphasis toward application of risk assessment principles. Numerous Standards and practices have been adopted offering varying approaches to assurance that acceptable risk is attained. Written for safety practitioners, engineers and managers, this book is an excellent effort to accumulate in one volume a large portion of this information to assist readers in their personal efforts toward achieving acceptable risk in designs.
The author indicates, and rightly so, “This is a very exciting time to be involved in the risk assessment process because risk assessment is in such a state of flux...Today entities are beginning to discover, demand, and deploy improved risk assessments in their organizations.” Industries such as auto, machine tool, aerospace, robotics, packaging machinery and others, specify hazard analysis and risk assessment in their Standards or purchase specifications. Requirements for risk assessment are in the new ANSI Lockout/Tagout Standard and OSHA has used them in a fatality case Citation.
A major portion of the book is allocated to sharing a comprehensive, but not exhaustive, gathering of what is occurring in a wide range of business and government activity, and internationally. After a brief introduction, four sections in the book share basic concepts, practical guidance, benchmarks, and future process improvements, where the author concludes among other things that risk assessment will become a condition of sale and a productivity issue.
Risk Assessment: basics and benchmarks is a dual use book for the identified audience to gain knowledge and apply the principles in their operations, and as a reference. Bruce Main concludes “Similar to the quality movement, integrating risk assessment into industry will not just happen in a matter of months…Existing processes will require time to evolve and adapt.” A thumbs-up book for your use and library.
Wayne C. Christensen, CSP, PE
Christensen Consulting For Safety Excellence, Ltd.
Wayne C. Christensen is an Accident Prevention Consultant, and is Project Manager for the Institute for Safety Through Design and a Training Consultant for the National Safety Council. His career has focused on safety, fire prevention and protection, and disaster control and he has long advocated the safety through design concepts. He has also served as Managing Director, American Society of Safety Engineers (ASSE), Corporate Director of Safety, Owens Corning, and is a devoted husband to Betty. Mr. Christensen has a Fire Protection and Safety Engineering degree from IIT, is a Certified Safety Professional (CSP), a Fellow of ASSE, and a Registered Professional in Safety Engineering (CA). He is a Member, Society of Fire Protection Engineers, and a member of the American Society for Engineering Education and the American Society for Training and Development.
Back to top.By: Paul King, Vanderbilt University
Risk Assessment: Basics and Benchmarks, by Bruce Main
To be published in the IEEE Engineering in Medicine and Biology Magazine
I have used the software (designsafe) written and sold by Bruce Main through his company for a number of years in my biomedical engineering senior design lectures and homework exercises. I require the use of the software in student projects to ensure that students have considered safety in their design process. I was pleased to see that he has written a text covering his and others practices in risk assessment and volunteered to review it.
This text is a well written comprehensive coverage of the field of risk assessment, consisting of 44 chapters and 5 appendixes. The preface suggests that the text was written for engineers, safety practitioners, and managers (page xi) who face responsibility for assessing the risks of equipment, product, facility, or system designs. I would add to this list design instructors, in any engineering area, as the book covers a large number of applications. I will pay special attention, in the review below, to its use in Biomedical Engineering.
The text begins with an executive summary of the contents, followed by an introductory chapter on the field of risk assessment. The remainder of the book is broken into four major sections with multiple chapters covering different aspects of the material. Section one covers, in four chapters, the basic concepts involved in the field of risk assessment. It gives a nice overview of the basic terminology used, discusses cost savings realized when safety is considered throughout the design process, considers acceptable risks, and the process necessary for design reviews. Section two is titled practical guidance, it covers (primarily) task-based team reviews, and justifies the use of true teams of designers, management, maintenance, and users in design reviews (and the occasional use of lawyers too!) A chapter details seven examples of design reviews (from bagel slicer to medical device), another discusses implementation processes, and a final chapter details several scoring systems used. Section three is titled Risk Assessment Benchmarks; it has twenty-eight chapters covering industry specific guidelines and benchmarks. Specific to Biomedical Engineering design are chapters on the environment, ergonomics, maintenance, consumer product safety, food safety, medical device safety, process safety, education, robotics, and liability. Each of these chapters could easily be a lecture in a design sequence. The final section is titled Improving the Risk Analysis Process, and covers other techniques used in risk analysis, harmonization possibilities, and a brief discussion of the future of risk analysis.'
Each chapter begins with a bullet list of key points included in the chapter. Each chapter is well referenced. The appendixes assist in reconciling the different terminologies and methods used in risk analysis. Also appended is a CD with a demonstration version of the designsafe software. The text is comprehensive in coverage, examples and references are international in nature. For medical device manufacturers, risk analysis is mandated for sales involving the CE mark. This text is highly recommended for use by designers and design instructors in biomedical engineering.
Paul King
Vanderbilt University
By: Rodney J. Simmons, Ph.D., CSP
Journal of System Safety, May-June 2004
What are the differences in risk assessment as practiced in the machine tool industry versus the medical device or aerospace industry? Within a given industry, are there differences between the approaches taken by the U.S. practitioners and those in Europe or Australia? What are the regulatory drivers and consensus standards that drive practice around the world? How have some major corporations constructed or calibrated their risk assessment matrices?
These issues are addressed in a new book, Risk Assessment: Basics and Benchmarks. The author, Bruce W. Main, is a Professional Engineer and Certified Safety Professional, and is the principal of a safety engineering and analysis consulting firm.
For the system safety practitioner seeking a compendium of the approaches taken toward risk assessment as it is practiced in over 25 sectors and settings, along with the related regulations and standards in the U.S., Canada, Europe, Australia and New Zealand, this nearly 500-page text provides brief introductions to each, along with extensive references. In addition to risk assessment as applied to occupational exposures, chapters are also devoted to environmental and product liability concerns. The book includes a CD-ROM with several useful resources: a compiled bibliography covering the entire text, Web site links for the organizations discussed in the book, along with an executive summary for the book Risk Assessment for Maintenance Work and a demonstration version of the designsafe® risk assessment software program, both of which are published by design safety engineering, inc. The book is organized into four major sections: (I) Basic Concepts, (II) Practical Guidance on Risk Assessment, (III) Benchmarks, and (IV) Improving the Risk Assessment Process.
The Basic Concepts section describes the definitions of risk that are used in various settings, along with the concept of the risk assessment matrix. The Practical Guidance section expands upon the basics of risk assessment. It includes examples drawn from several industries, and offers guidance on implementing risk assessment along with an overview of risk scoring systems. In this text, the author adopts the risk scoring system concept to describe the approach by which the components of risk (probability and severity, for example) are combined to provide an overall assessment of risk. The author also takes the view that risk assessment, as a technique, is roughly synonymous with what the classically trained system safety practitioner would call task-based preliminary hazard analysis.
The Benchmarks section has 27 chapters, each devoted to risk assessment activities in a particular industry or setting. Within each chapter/setting, the general approach is to devote separate subsections of the chapter to industry-specific risk assessment practice in several countries. Within each country or regulatory framework section, the reader with then find the background of the method (the regulatory drivers), a description of the method used in the context, a flow chart of the process (where applicable), a description of the risk scoring system (where applicable), and the status of the consensus standard or regulatory driver. This section also includes a very good discussion of the risk assessment as it relates to product liability issues.
The final section of the book, Improving the Risk Assessment Process, includes a comparison or the terminology used in the benchmark methods, a comparison of risk assessment to other system safety analysis techniques, and a discussion of the documentation and harmonization issues. It concludes with three chapters that offer guidance toward improving risk assessment, as well as a look to the future. The book includes three useful appendices: an extensive compilation of risk assessment terms, with a summary of the various definitions for each term as presented in regulations, standards and standards guidance documents; a comparison of benchmark risk terms drawn from various industries, standards, agencies and reference texts; a comparison of risk scoring methods used in various industries and settings; and a list of acronyms.
Experienced system safety practitioners may take issue with some of the views expressed in the book. For example, on page 112,
“There is no particular reason why a risk assessment process could not use two different risk scoring systems for the before and after rating. For example, the before rating could use a common two or three factor system and the after [sic] could use a single factor system or vice versa.”
If the analyst is attempting to demonstrate the amount of risk reduction that will be achieved via implementation of a particular countermeasure, it seems that the argument must be based on apples to apples rather than apples to oranges comparison, pre- and post-countermeasure. To change – midway through the analysis – the standard by with beauty, effectiveness or any other attribute is judged, is folly.
The mechanics of developing and calibrating a risk assessment matrix, in terms of either the roles of the stakeholder representatives or the impact of the exposure interval, receive inadequate attention. The author also posits that the analyst should begin the risk assessment process by finding hazards, and only later develop and calibrate a risk assessment matrix for use in gauging the risks posed by the identified hazards. Since most of the analysis techniques described in the book are the “spreadsheet type,” including task-based analyses (which many practitioners would term as variants of preliminary hazard analysis) and FMEA, it is critical to develop and calibrate a risk assessment matrix prior to beginning the hazard identification process. A properly calibrated matrix can save time in the analysis. If, at the sub-assembly level, failure doesn’t produce unacceptable risk, then why (in an FMEA) analyze down to the cotter-pin level?
On page 414, the author’s assertion that the lack of repeatability (in a risk assessment process) “may be less of a problem than first though” assumes that the proprietor has only one system whose risk must be controlled to an acceptable level. Without a repeatable risk assessment process, how will h proprietor (who owns more than one system) prioritize the control efforts when it comes to budgeting and schedule?
The author states on page 422, “As long as each independent risk is acceptable, then the total system risk will be acceptable.” This is incorrect, as a simple thought experiment quickly proves. Contrast the likelihood of your passing unscathed through a neighborhood that has a single sniper (whose accuracy is nominal 10%) vs. passing through the same neighborhood when it is populated with 10 (or 100) snipers, each with an accuracy and homicidal motivation equal to that of the original long gunman.
In the balance, this book is an excellent window into risk assessment as it is practiced in its many forms. The experienced system safety analyst will find the book particularly valuable for its extensive survey of the approaches, guidance documents and regulatory drivers for risk assessment as it is practiced in a wide variety of industries and settings in the U.S., Canada, Europe and elsewhere. The included CD-ROM is an important productivity aid for the reader. While the experienced system safety professional may take issue with some of the author’s views on risk assessment, the book remains a valuable addition to the professional library.
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