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safety reviews are most effective when performed early in the design process while objectives are being discussed and should be considered in any major planned changed. Design reviews typically include a compliance/codes review aspect. ANSI Z590.3 states that the design safety review process is an effective means for achieving “inherently safer designs” and includes an informative addendum (Addendum E) on Design Safety Reviews. An example showing the trigger points for design safety review risk assessments in the life‐cycle of a system is presented in Figure 6.
Operational risk management within life cycle phases (4, 12). SH&E, E, C stands for Safety, Health and Environment, Ergonomics and Compliance.
Source: From Popov et al. (12). © 2016 John Wiley & Sons.
FIGURE 7 Design safety review process.
The process should be systematically applied to all designs, changes in existing designs, procurement and construction of new systems, and used to anticipate, identify, or avoid eliminated or controlled hazards. A commitment from management is required to fully integrate PtD concepts into the organization. The model depicted in Figure 7 provides steps for a design safety review process (1):
1 Policy. A written policy providing direction on when, where, and how hazard analyses and risk assessments are performed, including the design phase, should be implemented and communicated. The policy should define roles, responsibilities, and accountabilities for engineers, designers, production, maintenance, quality, legal, SH&E, human resources, procurement, and other involved parties in the design safety process.
2 Team. A leader and cross‐functional team to perform the design safety review should be selected. Design safety review team members should have expertise in areas such as safety and health, ergonomics and human factors engineering, environmental safety, fire prevention and protection, and product liability prevention as appropriate for the project. Production, maintenance, and/or operator experience is important so that lessons learned from a similar situation (work‐as‐done) can be brought into the design (work‐as‐imagined). It may be necessary to include outside consultants or specialists to assist in the review.
1 Method selection. Specific methods should be selected for conducting the design safety review based on the complexity of the project, and the established context.
2 Safety review. In the conceptual stages, a hazard analysis and risk assessment should be initiated to identify hazards. Design safety reviews should be performed as the design objectives are being discussed. Reviews may include analysis of similar designs, plan drawings, specifications and limitations, hazard checklists, applicable standards, discussions with manufacturers of components and materials, safety data sheets (SDSs), loss experience related to similar designs, existing controls and technology on similar designs, etc. The review should assess hazards/risks in the operational phase as well as any nonroutine activities such as maintenance, emergency upsets and repairs, testing, adjusting, lubricating, and other related activities.
3 Deviations approval. Established safety standards and specifications should be strictly followed. An example of design safety specifications is provided in Table 4. For any deviation from a stated standards or specifications, appropriate management personnel including OSH, legal, or other parties must review the request and determine if it is approved or denied.
4 Completion signoff. Upon completion, the project leader should sign‐off on the project that the design safety review has been completed and that there is a consensus among the safety team and engineering group. Communication between the design safety review team and engineering/design group throughout the process is critical.
5 Action plan. Findings and recommendations from the completed design safety review may include modifications or mark‐ups of drawings; changes in specifications; a prioritized list of specific hazards and means for avoidance or control; a list of design modifications necessary prior to approval; action item list with assigned responsibilities; follow up questions, concerns or requests for additional information necessary to satisfy or complete the review and approve the design.
Table 4 Design safety specifications example (1).
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Source: From Lyon et al. (1). © 2019.
9 PD CASE STUDY
9.1 Case Study: Large Winery Operation
A large winery with an annual production capacity of over 1 million gallons of wine had concerns regarding the use of liquified sulfur dioxide (SO2). Management was alarmed when a minor release of pure liquified SO2 outside the facility sent an employee to the urgent care facility. Fortunately, the release was small and occurred outdoors reducing the severity of exposure.
Inhalation is the major route of exposure to sulfur dioxide. The odor threshold is five times lower than the OSHA permissible exposure limit (PEL) (5 ppm). Sulfur dioxide exposures can have both short‐term and chronic health consequences for people with lung disease. Inhaled sulfur dioxide readily reacts with the moisture of mucous membranes to form sulfurous acid (H2SO3), which is a severe irritant (13). The reaction of SO2 and moisture is presented below.
A second concern was discovered when a chemical dosing machine in the bottling line had a minor release during a change out of the chemical dimethyl dicarbonate (DMDC). The employees were evacuated without injury.
These two incidents led the winery to determine the level of risk and potential solutions. A risk assessment team was formed, and an assessment was performed. The team determined that the SO2 and DMDC exposure risks both presented multiple fatality – level risk and required immediate risk treatment.
Management sets the expectations, context, and objectives of the assessment. The risk assessment team was established that included the consultant as facilitator, the winemaker, assistant winemaker, cellar manager, operations manager, bottling department manager, maintenance manager, and Health and Safety Executive (HSE) manager.
Data were collected regarding the SO2 and DMDC operations, equipment and instruments used, instructions, chemicals, and their SDSs, operator training, procedures, and available incident information. A search for similar events involving SO2 and DMDC were also conducted. Employees were interviewed to learn from their experiences, concerns, and suggestions.
The two procedures were observed to document and understand the sequence of tasks and potential risks associated with tasks. Photographs, tank quantities, room dimensions and configurations, distances to exits, means of egress, and other physical attributes were collected.
After reviewing the information, the potential concerns of fatalities or serious incidents were discussed. Workplace exposures such as pure SO2 releases and DMDC releases which present a potential for fatalities or serious incidents must be given the highest priority and controlled to an acceptable level. As a side note, the consultant explained that unlike like less‐serious workplace incident rates, fatality, and