Risk Assessment: A Practical Guide to Assessing Operational Risk Chapter 11: Risk Assessment and the Prevention through Design (PtD) Model 12/5/2018

Risk Assessment and the Prevention through Design (PtD) Model Objectives Introduce relationships between Risk Assessment Methodologies and PtD Model Review Risk Assessment Techniques and Demonstrate use in PtD Model Demonstrate PtD principles/tools that can be used as a part of management practices and business process of the organization 12/5/2018

PtD Model Introduction As discussed in Chapter 10 Design Safety Reviews, the use of risk assessment techniques in the design and redesign phase is one of the most effective ways to avoid and eliminate risk from being introduced into a system or product. While its use has increased during the past decade, design-phase risk assessments remain one of the most under-utilized aspects of operational risk management. This represents an important opportunity for SH&E professionals that desire to enhance their organization’s risk management process as well as their own value within the company. 12/5/2018

Risk Assessment and Prevention through Design (PtD) Standards A significant number of standards, guidelines and initiatives for the practice of operational risk assessments are available worldwide. Since 2005, there have been more than 35 such standards, and initiatives that require or promote the use of risk assessments as outlined by Fred Manuele in Chapter 1, Addendum A. As noted in other chapters of this text, the requirement for employers to perform operational risk assessments has primarily occurred outside of the United States. In 2011, two important consensus standards were released by the American National Standards Institute (ANSI) providing requirements for the practice of risk management and risk assessment in the workplace: ISO 31000/ANSI Z690 series and ANSI/ASSE Z590.3-2011 12/5/2018

Risk Assessment and Prevention through Design (PtD) Standards The purpose of the ISO 31000/ANSI Z690 series is to establish principles and guidelines for the practice of risk management and risk assessment. These risk management standards are designed to be applied to an entire organization, as well as specific processes, activities or projects. The process of managing risk involves applying an internationally recognized process depicted in the figure to the right. Risk Management Process reprinted with permission ANSI/ASSE Z690.2-2011 (Courtesy of the American Society of Safety Engineers) 12/5/2018

The Concept of Prevention through Design (PtD) As the highest rung on the Hierarchy of Controls ladder, avoidance of hazards and risk should be the absolute first choice. This is echoed in the Prevention through Design principles and initiatives discussed in this text. Fundamentally, and practically, it makes the most sense to avoid a problem rather than allow it to exist and try to manage it. This is the concept of PtD. 12/5/2018

The Concept of Prevention through Design (PtD) Although there were earlier efforts to establish prevention through design, in 1994 the American Society of Safety Engineers (ASSE) released a Position Paper approved by the Board of Directors to promote gathering of knowledge and application of “Designing For Safety” concepts. Followed by the National Safety Council in 1995 with the establishment of the Institute for Safety through Design. The Institute was formed to fulfill a need to integrate hazard analysis and risk assessment into the early stages of design so that hazards and risks could be avoided and minimized to an acceptable level. In 1999, the Institute published “Safety through Design”, a significant work with 20 contributing authors edited by Fred Manuele and Wayne Christensen. 12/5/2018

The Concept of Prevention through Design (PtD) In 2007, the National Institute for Occupational Safety and Health (NIOSH) launched the Prevention through Design (PtD) initiative. Like Safety through Design, the purpose of PtD is to "design out" or minimize hazards and risks. Experienced safety professionals are well aware that eliminating or avoiding hazards is the most effective way to reduce risk and control occupational injuries, illnesses, and fatalities. In 2011, an important standard for the safety profession was released. The ANSI/ASSE Z590.3-2011 Prevention through Design – Guidelines for Addressing Occupational Hazards and Risks in Design and Redesign Processes standard is the first standard to address such needs in the design and redesign phase. Its purpose is to provide a framework for effectively preventing or minimizing work-related hazards and risks associated with the construction, manufacture, use, maintenance, and disposal of facilities, materials, equipment, and the service sector. 12/5/2018

Risk Assessment Process and the PtD Model The ISO 31000/ANSI/ASSE Z690.2-2011 Risk Management Principles and Guidelines standard includes three main sections: Risk Management Principles (Clause 3); Framework (Clause 4), and Process (Clause 5). Within the ANSI/ASSE Z590.3-2011 Prevention through Design standard there are six primary sections: Roles and Responsibility (Section 4); Relationships with Suppliers (Section 5); Design Safety Reviews (Section 6); The Hazard Analysis and Risk Assessment Process (Section 7); Hazard Analysis and Risk Assessment Techniques (Section 8); and Hierarchy of Controls (Section 9). A review of the two standards and their structures reveals similarities and differences. 12/5/2018

Risk Assessment Process and the PtD Model ISO 31000 (later adopted nationally as ANSI/ASSE Z690.2-2011) was not one of the standards referenced in the ANSI/ASSE Z590.3 -2011 Prevention through Design standard; however, the principles align with the risk management process. PtD is a critical concept to the management of risk and should be integrated into an organization’s risk management process. SH&E professionals should lead this effort and help to facilitate its integration. Within the ISO 31000/ANSI Z690.2, Clause 5 defines the risk management process. Central to this process is Risk Assessment (Section 5.4). Similarly, Section 7 of the ANSI/ASSE Z590.3 PtD standard defines process slightly different as the Hazard Analysis and Risk Assessment Process. 12/5/2018

Risk Assessment Process and the PtD Model Although there are subtle differences, the authors of this text see a direct link between the ISO 31000/ANSI Z690 series and the ANSI Z590.3 PtD standard. Both standards provide sound guidance on risk assessment and fundamental techniques. ISO 31010/ANSI Z690.3-2011, Risk Assessment Techniques covers more than 30 different risk assessment methods, while ANSI Z590.3 addresses eight common techniques. 12/5/2018

Risk Assessment Process and the PtD Model Figure 11.3 ISO 31000/ANSI Z690.2 and ANSI Z590.3 -2011 Integration 12/5/2018

Risk Assessment Process and the PtD Model As illustrated in Figure 11.3 (previous slide) and Figure 11.4, the two standards are similar in the process steps with a few differences. Figure 11.4 Comparisons of Risk Assessment in ISO 31000/ANSI Z690.2 and ANSI Z590.3 12/5/2018

Risk Assessment Process and the PtD Model SH&E professionals are facing increased pressure to diversify and develop their skills in new risk assessment techniques. It is vital that professionals know how to develop tools and models to incorporate appropriate hazard identification and risk assessment techniques into the risk management process. Some of the newly developed tools are based on the recommended risk assessment techniques referenced in both standards. The PtD model follows the well-established Six Sigma practice of DMAIC (Define, Measure, Analyze, Improve, and Control) logic. The PtD model presents a logical step by step approach to conduct hazard analysis and risk assessment in all life-cycles of a product or system. To demonstrate a practical application of the PtD model, the following case study is presented. 12/5/2018

Risk Assessment Process and the PtD Model Case Study To demonstrate a practical application of the PtD model, the following case study is presented. A small size manufacturing company requested that a hazard analysis and risk assessment be performed on a new product. The company’s products are intended for export to the European Union, which requires all products meet ISO standard requirements. However, the product is manufactured in the USA. For a number of beneficial reasons, senior management wanted to implement PtD principles. The purpose of this project was to determine the noise levels, hand and arm vibration risk, and potential particulate matter exposure from a normal production unit. The risk assessment evaluation included sound level meter, hand and arm vibration instruments and particulate matter measurement system. The evaluation was conducted during simulated work activities. 12/5/2018

Risk Assessment Process and the PtD Model Case Study Methods A new decision making model was developed to evaluate a new product intended for export. This case study identified potential areas of SH&E professional involvement in the decision making process. PtD model that incorporates: Risk assessment Hierarchy of controls, and Future state risk reduction. Applicability of FMEA tools to prioritize the hazards and modify the procedures was utilized to demonstrate and quantify the risk reduction after the proposed SH&E improvements. Hand and arm vibration, noise levels and air pollutants emissions were evaluated. 12/5/2018

Risk Assessment Process and the PtD Model Case Study Results Utilization of hazard analysis and risk assessment tools described in both ISO 31010/ANSI Z690.3 and ANSI Z590.3 PtD, including FMEA and a modified model were estimated to significantly reduce the risks of ergonomics injuries, noise levels and air pollutants of the product evaluated in this case study. Similar benefits are possible for products manufactured in the U.S. and intended for the European Union market. 12/5/2018

Risk Assessment Process and the PtD Model Case Study Results – Hand and Arm Vibration Hand-Arm Vibration Sampling Data – Left Hand Hand-arm Vibration Sampling Data – Right Hand 12/5/2018

Risk Assessment Process and the PtD Model Case Study Results Noise - None of the tested units exceeded 85 the dBA noise level. PM exposure measurements - The company’s engineering unit designed a special filtering dust containment system to reduce the PM pollution and operators’ exposure. The results are presented in the figure to the right. Figure 11.6 Dust Exposure Measurements in µg/m3 12/5/2018

Risk Assessment Process and the PtD Model Case Study After a careful evaluation of the results, the authors developed a new PtD model. The model follows Define, Measure, Analyze, Improve, and Control (DMAIC) logic. 12/5/2018

Risk Assessment Process and the PtD Model Case Study During the Define phase, Preliminary Hazard Analysis (PHA) was performed for Hand-arm vibration, Noise and PM exposures. The current state PHA example is presented in Figure 11.9 (right) 12/5/2018

Risk Assessment Process and the PtD Model Case Study Risk Priority Number (RPN) can be calculated using standard FMEA and RPN worksheet as shown in Figure 11.10. (below). Figure 11.10 FMEA & RPN Worksheet 12/5/2018

Risk Assessment Process and the PtD Model Case Study Based on the initial limited hazard analysis, a Bow-Tie analysis diagram was prepared. Figure 11.11 (below) presents the current state risk assessment. Figure 11.11 Current State Risk Assessment 12/5/2018

Risk Assessment Process and the PtD Model Case Study The PtD Hierarchy of Controls (see Figure 11.12 below) was utilized to develop suggestions for engineering controls. A better handle design was suggested. Polyurethane dampers could reduce vibrations and a new muffler and lower RPMs could further reduce noise. Figure 11.12 The PtD Hierarchy of Controls 12/5/2018

Risk Assessment Process and the PtD Model Case Study Based on PtD improvements, future state FMEA RPN were calculated (see Figure 11.13 below) Figure11.13 Future State FMEA 12/5/2018

Risk Assessment Process and the PtD Model Case Study Future state Bow-Tie risk analysis was prepared based on the future state RPNs (see Figure 11.14 below) Figure11.14 Future State Bow-Tie Analysis 12/5/2018

Risk Assessment Process and the PtD Model Case Study Residual Risk and Risk Reduction were calculated. SH&E improvements resulted in a 55% (S x P) and 85% (RPN) risk reduction (see Figure 11.15). Figure 11.15: Risk Reduction and Residual Risk Calculations 12/5/2018

PtD and the Business Process As stated in NIOSH PtD initiative “PtD's purpose is to promote this concept and highlight its importance in all business decisions.” PtD integration into the business decision will be discussed in greater detail in Chapter 19 Business Aspects of Operational Risk Assessment. The authors strongly believe that SH&E professionals can play a significant role in new products development and business decision making through active participation in the process. PtD principles can be successfully integrated into the ISO 31000/ANSI Z690.2 risk management process. The case study described in this chapter illustrates how the process can lead to a decision by management to approve the new product design, which will result in reduced ergonomics injuries, reduced emissions and improved operator productivity. The case study effectively demonstrates that risk reduction is a vital business benefit for the company. 12/5/2018

Summary This chapter has provided an example of effectively integrating the Prevention through Design concept into the ISO 31000/ANSI Z690.2 Risk Management standard. There are many other specific risk assessment techniques assessment methods used in numerous companies and industries, non-profit organizations, and governmental agencies. PtD methodologies remain critical part of the risk management process. The case study and the PtD tool provided an example of hazard identification, initial risk assessment, hierarchy of controls, consequent risk analysis and evaluation to manage risk to a tolerable level. The case study also demonstrated that the PtD tools could be successfully incorporated in the risk management and business decision making process. 12/5/2018