Optimizing Safety Through FMEA Based Risk Assessments

Good safety systems help spot problems early and keep workers safe.

• By Igor Chebotniagin , Robert N. Phalen
• Apr 09, 2025

Effective occupational health and safety management requires a structured approach to hazard identification and risk assessment, which is best achieved by a management system. The implementation of an effective Occupational Health and Safety Management System (OHSMS) requires robust methodologies for hazard identification and risk assessment. As emphasized in ISO 45001:2018, the primary objective is to "provide a framework for managing OH&S risks and opportunities" through systematic preventive measures (ISO, 2018). Among various risk assessment tools, Failure Mode, and Effects Analysis (FMEA) stands out as particularly valuable due to its structured, proactive approach to identifying potential failures and their consequences.

This article presents a refined FMEA methodology adapted specifically for occupational health and safety applications, maintaining alignment with ISO 45001 requirements while enhancing practical implementation. The approach builds upon traditional FMEA concepts but modifies them to better suit occupational health and safety contexts, particularly through the integration of a simplified 5×5 risk matrix for more efficient risk prioritization.

Stage 1: Preliminary Hazard Register

The foundation of effective risk management begins with a comprehensive hazard identification. As required by ISO 45001 (Subclause 6.1.2.1), this process must be proactive and ongoing, covering all phases of operations from design through daily activities. The preliminary hazard register serves as the cornerstone document for this process (see Table 1).

Table 1. Preliminary Hazard Register Form

The following key improvements to the hazard identification process will help ensure hazards are properly identified and effective control measures are implemented:

1. Specificity in Hazard Description: Rather than generic terms like "chemical exposure," precise identification of substances and circumstances (e.g., "isocyanate vapor exposure during paint mixing").
2. Comprehensive Affected Parties: Explicit inclusion of contractors, temporary workers, and visitors who may be exposed to hazards, as emphasized by ISO 45001's broad view of workplace health and safety.
3. Current Control Documentation: Accurate reporting of only those controls that are actively implemented.

Considering Statistical Data. Numerical data are often unavailable during the hazard identification process. However, workplace incident statistics can be invaluable in recognizing major sources of hazards. For example, according to the U.S. Bureau of Labor Statistics, transportation incidents are the leading cause of occupational fatalities, accounting for 36.8% of all fatal workplace events, followed by falls, slips, and trips at 16.8%. Additionally, special attention should be given to workplaces employing individuals aged 55 to 64, as this group represents 20.6% of all workplace fatalities despite comprising only 16.3% of the U.S. labor force. The primary causes of fatal incidents in this demographic include transportation accidents, falls, slips, and trips. Statistics also help uncover less obvious hazards. For instance, according to the U.S. Bureau of Labor Statistics, most fatal falls (64.4%) occur from moderate heights - between 6 and 30 feet - rather than from extreme elevations. Moreover, portable ladders and stairs are the most common sources of fatal falls.

Stage 2: On-Site Hazard Verification

The preliminary register requires validation through systematic on-site assessment, which should include:

1. Process Observation: Direct observation of work activities to identify unanticipated hazards and verify the accuracy of preliminary findings.
2. Employee Consultation: Engaging workers through interviews and focus groups to leverage their operational knowledge, as they often identify risks that may not be apparent through documentation review alone.
3. Documentation Review: Examination of maintenance records, incident reports, and near-miss data to identify recurring issues or emerging patterns.
4. Equipment Inspection: Physical inspection of machinery, tools, and work areas to verify conditions and identify potential failure points.

This stage frequently reveals previously unrecognized hazards or necessary adjustments to initial assessments. For example, while the preliminary register might identify "fall hazards" on-site inspection may reveal specific unguarded edges or unstable working surfaces that require targeted intervention.

Stage 3: Risk Assessment

For risk assessment, FMEA is extensively applied in occupational health and safety across multiple industries, either as a standalone method or in conjunction with other approaches (Shaymaa M. M. El-Awady, 2023; Tayyebeh Jaddi Madarsara, Saeed Yari, Hamzeh Saeidabadi, 2019; Yari S., 2017). Traditional FMEA evaluates risks through three factors: Occurrence (O), Severity (S), and Detection (D) (Akhyar Zuniawan, 2020). However, for occupational health and safety applications, we propose a streamlined version focusing on:

1. Probability (P): Likelihood of the hazardous event occurring
2. Severity (S): Potential consequences if the event occurs

This simplification aligns with ISO 45001's definition of OH&S risk while maintaining FMEA's analytical rigor. The detection aspect is incorporated into the evaluation of existing controls rather than as a separate scoring factor.

For risk assessment, it makes sense to use the common and effective 5×5 matrix to quantify and prioritize risks (Gul & Ak, 2018), while adapting it specifically for occupational health and safety applications (See Table 2).

Table 2. Risk Assessment Rating Scale: Probability and Severity

Risk scores are calculated by multiplying Probability × Severity, with results interpreted as follows (see Table 3):

1. Green (1-5): Acceptable risk (maintain controls).
2. Yellow (6-12): Moderate risk (plan improvements).
3. Red (15-25): Unacceptable risk (immediate action required).

Table 3. The 5x5 Risk Matrix

Practical Application Example

Consider the paint spray booth hazard from Table 1:

1. Probability Assessment:
• Frequency of painting operations: Daily
• Historical incidents: Two vapor exposure incidents in the past year
• Control effectiveness: Moderate (PPE compliance issues)
• Assigned Probability: 4 (Likely)
2. Severity Assessment:
• Isocyanates can cause asthma and other chronic conditions
• Potential for acute respiratory distress
• Assigned Severity: 4 (Major injury/illness)
3. Risk Calculation: P × S = 4 × 4 = 16 (Red zone - requires immediate action)

As we see this quantitative and structured approach enables objective comparison of risks across different operations and departments, facilitating better resource allocation for risk reduction efforts.

Stage 4: Corrective Action Development

Risk assessment results should be documented in a risk register. Corrective measures are required for yellow or red risks, while additional measures for green risks can be implemented if resources are available.

Through practical application, several common mistakes have been identified in this stage:

1. Over-reliance on Administrative Controls: Excessive dependence on training and procedures without adequate engineering controls often leads to compliance gaps.
2. PPE as a First Resort: While PPE is important, it should not be the primary control for significant hazards due to reliance on individual compliance.
3. Vague Action Plans: Corrective actions like "improve safety culture" or "increase awareness" lack measurable outcomes and accountability.
4. Inadequate Follow-up: Failure to verify control effectiveness after implementation through exposure monitoring or other metrics

The completed risk register (Table 4) serves as the central document for tracking hazards, assessments, and corrective actions:

Table 4. Hazard Identification and Risk Assessment Register

Stage 5: Monitoring and Review

Risk assessment is a continuous process, requiring regular updates to reflect new conditions. The risk register should be actively maintained, with quarterly reviews of high-risk items and an annual comprehensive review of all identified hazards.

The effectiveness of control measures must be evaluated (ISO 45001, subclause 6.1.4). After implementing corrective actions, risks should be reassessed using the same criteria. If they remain in the yellow or red zones, further controls must be developed, responsibilities assigned, deadlines set, and funding secured to ensure proper mitigation.

Summary

A well-structured risk assessment process is key to maintaining a safe workplace. By adapting FMEA for occupational health and safety and aligning it with ISO 45001, organizations can proactively identify and address hazards. The use of a simple 5×5 risk matrix helps prioritize risks and allocate resources where they are needed most. Regular reviews and reassessments ensure that health and safety measures stay effective, creating a healthier and safer, more resilient work environment for everyone.

The case study demonstrates the application of this refined FMEA framework, highlighting key challenges such as over-reliance on administrative controls and inadequate follow-up on corrective actions. The study emphasizes the importance of continuous monitoring and structured reviews to maintain an effective risk management system.