Considerations Related to an EASA - Compliant Risk-Based Approach in Safety and Quality Assurance
Presented by Sofema Online (SOL)
Integrating a risk-based approach into safety and quality assurance processes involves a structured and systematic procedure.
This approach focuses on identifying, assessing, and mitigating risks to ensure regulatory conformity and operational safety. Here’s how it can be effectively implemented:
Identifying Hazards -The process starts with the identification of potential hazards that could impact safety and quality. This involves collecting and analysing data from various sources such as incident reports, safety audits, operational processes, and employee feedback.
Establish a Risk Identification Framework
Develop a risk management policy to set the foundation for risk identification, including the objectives, scope, and responsibilities within the organization.
>> Conduct operational analysis: Examine all aspects of operations to understand where risks might arise. This includes reviewing operational procedures, maintenance records, and previous safety incidents.
>> Encourage a culture of safety where employees can freely report safety concerns, hazards, or near misses.
>> Employee insights can be invaluable in identifying potential risks.
>> External data sources: Consider regulatory advisories, safety bulletins from EASA, incident reports from other organizations, and industry trends to identify external risks that could impact operations.
Use Risk Identification Tools and Techniques
>> Develop and utilize checklists tailored to different areas of operations to systematically identify known risks and potential hazards.
>> SWOT analysis (Strengths, Weaknesses, Opportunities, Threats): This strategic planning tool can help identify internal and external risks affecting the organization.
>> For more complex systems, a HAZOP study can identify risks related to the malfunctioning of operational processes.
>> Consider Bow-tie analysis to help visualize the path from potential causes (threats) to consequences (impacts), identifying risks along the way.
Conduct Safety Audits, Analysis and Inspections
>> Conduct thorough audits of all operational areas to identify non-compliance, hazards, and potential risk areas.
>> Perform regular safety inspections of equipment, facilities, and operational practices to identify risks associated with wear and tear, misuse, or procedural deviations.
>> Thoroughly analyze all incidents and near-misses to identify the underlying risks and contributory factors.
>> Look for patterns in incidents, accidents, and safety reports over time to identify emerging risks or overlooked areas.
Risk Mitigation
Based on the assessment, risks are prioritized, and mitigation strategies are developed. These strategies could include engineering controls, administrative controls, training, or procedural changes. The goal is to reduce the risk to an acceptable level as defined by the organization and EASA’s standards.
Prioritize Risks
>> Use a risk matrix to prioritize risks based on their likelihood and impact. This helps focus efforts on the most significant risks first.
>> Conduct cost-benefit analyses for each mitigation strategy to ensure resources are allocated efficiently and effectively.
Develop and Implement Mitigation Strategies
>> Engineering Controls
>> Modify equipment or operational environments to eliminate hazards or reduce exposure to risks.
>> Develop or update SOPs to include risk mitigation measures.
>> Ensure they are accessible and understood by all relevant personnel.
>> Implement or revise safety policies to include risk mitigation strategies and communicate them across the organization.
>> Modify operational practices to minimize risk exposure.
>> Monitor the effectiveness of mitigation strategies through the SMS, and adjust as necessary based on performance data.
Sofema Aviation Services and Sofema Online provide EASA - Compliant Webinar, Classroom & Online training in over 50 Quality Assurance and Compliance Related Subjects – Please see the websites or email team@sassofia.com
