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Questions and Answers
What is the primary purpose of analyzing data from incident reports and audits in biorisk management?
What is the primary purpose of analyzing data from incident reports and audits in biorisk management?
Which of the following components should be included in an improvement plan for a biorisk management system?
Which of the following components should be included in an improvement plan for a biorisk management system?
How should data be utilized in the context of biorisk management decision-making?
How should data be utilized in the context of biorisk management decision-making?
What is the primary purpose of conducting a risk assessment in the PDCA cycle?
What is the primary purpose of conducting a risk assessment in the PDCA cycle?
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In the 'Do' phase of the PDCA cycle, what is the primary action taken?
In the 'Do' phase of the PDCA cycle, what is the primary action taken?
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What role does top management commitment play in establishing a proactive biorisk management culture?
What role does top management commitment play in establishing a proactive biorisk management culture?
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How can data-driven decision-making be supported in the PDCA cycle?
How can data-driven decision-making be supported in the PDCA cycle?
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What is the significance of monitoring progress after implementing improvement plans in biorisk management?
What is the significance of monitoring progress after implementing improvement plans in biorisk management?
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What role does top management commitment play in implementing improvement plans?
What role does top management commitment play in implementing improvement plans?
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Which of the following best describes a continuous improvement culture in biorisk management?
Which of the following best describes a continuous improvement culture in biorisk management?
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Which action should not be taken to support the creation of a proactive biorisk management culture?
Which action should not be taken to support the creation of a proactive biorisk management culture?
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Which of the following is a key characteristic of a continuous improvement culture?
Which of the following is a key characteristic of a continuous improvement culture?
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What is an essential element when developing training and awareness programs within biorisk management?
What is an essential element when developing training and awareness programs within biorisk management?
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What is the purpose of reviewing corrective actions in the PDCA cycle?
What is the purpose of reviewing corrective actions in the PDCA cycle?
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What should be the outcome of the 'Check' phase in the PDCA cycle?
What should be the outcome of the 'Check' phase in the PDCA cycle?
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What is a crucial step when assessing the need for prevention after an accident as per PDCA?
What is a crucial step when assessing the need for prevention after an accident as per PDCA?
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What is the first step to take in the PDCA cycle when addressing an increase in injury rates?
What is the first step to take in the PDCA cycle when addressing an increase in injury rates?
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In the context of increasing injury rates, which question is least relevant to evaluate?
In the context of increasing injury rates, which question is least relevant to evaluate?
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What is a critical element when planning for new research team members?
What is a critical element when planning for new research team members?
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Why is frequent monitoring important following the expansion of a laboratory program?
Why is frequent monitoring important following the expansion of a laboratory program?
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Which action reflects a commitment to continuous improvement within a laboratory setting?
Which action reflects a commitment to continuous improvement within a laboratory setting?
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How should the safety team respond if new labs have not communicated before initiating research activities?
How should the safety team respond if new labs have not communicated before initiating research activities?
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What role does management commitment play in biorisk management during program expansion?
What role does management commitment play in biorisk management during program expansion?
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When implementing improvements after the PDCA cycle, what should be checked first?
When implementing improvements after the PDCA cycle, what should be checked first?
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Study Notes
Biorisk Management System (II)
- Students will be able to apply risk management strategies, including administrative controls and proper PPE procedures, in laboratory settings.
- Students will be able to evaluate biorisk management systems using monitoring, auditing, and continual improvement processes (PDCA cycle).
- Students will be able to identify, evaluate, and manage incidents and non-conformities within the biorisk management system.
- Students will be able to analyze, evaluate, and use performance indicators and data generated from accident/incident investigations, inspections, and auditing to monitor and improve a biorisk management system.
Abbreviations
- SMART = Specific, Measurable, Achievable, Relevant, Timely
- CWA = CEN Workshop Agreement
- ISO = International Organization for Standardization
- GMPP = Good Microbiological Practices and Procedures
- BMBL = Biosafety in Microbiological and Biomedical Laboratories
- EPA = Environmental Protection Agency
- CEN = ? (unknown abbreviation)
Dealing with Incidents and Non-conformities
- Identifying, evaluating, and managing incidents and non-conformities requires a systematic approach, including regular monitoring, auditing, root cause analysis, risk assessment, and communication and documentation.
- Important steps to address incidents and non-conformities include: incident and non-conformity identification, evaluation, management, communication, and documentation.
- Incidents and non-conformities are crucial for continuous improvement in organizations, as they identify weaknesses in systems and procedures, enabling enhancements to prevent future problems and improve safety and quality.
Continual Improvement (PDCA Cycle)
- The PDCA cycle (Plan-Do-Check-Act) is a cyclical framework for conducting reviews of the management system.
- A risk assessment should be conducted to identify needs and opportunities, create a plan, and determine financial and personnel requirements. Adjustments and modifications to the plan are made based on the effectiveness of the plan and any needed changes.
- The plan should identify responsibilities for implementation, define standards of performance, and develop standard operating procedures (SOPs). Training should be provided.
- Performance should be monitored to check if expectations have been met. Performance should be evaluated to see if procedures are effective, and root causes of problems should be identified for corrective actions.
- If expectations aren't met, reassess the plan and consider corrective actions. Continuous improvement is crucial.
PDCA for Incident/Accident Investigation
- Review the potential for or actual non-conformity
- Determine the cause of non-conformities through an accident/incident investigation
- Evaluate the need for prevention or action to ensure no recurrence
- Determine and implement the action needed
- Record results of action taken
- Review corrective actions taken
Exercise (Needle-Stick Injuries)
- A suspected increase in needle-stick injuries among waste handlers requires application of the PDCA cycle for risk reduction.
PDCA Cycle (Biohazard Waste Bags)
- New lab staff are discarding syringes in biohazard waste bags.
- A biorisk officer begins a PDCA evaluation.
- Plan: set objective, conduct a risk assessment and develop risk mitigation training.
- Do: implement training; review training content; thoroughly investigate any accidents/injuries.
PDCA Cycle (Check/Act - Needle-Stick Injuries)
- Check: monitor injury report statistics to see if the injury rate is decreasing.
- Act: continue improvement efforts if yes. If not, ask specific questions about the increase in perceived risk of injury, if injury is recurring more frequently, and if staff turnover is contributing to more injuries.
Exercise -2
- A 30% increase in the size and scope of a BSL-2 laboratory project, with three new research team members.
- Apply the PDCA cycle to this situation.
Exercise -2/PDCA Cycle
- Contextual information regarding the biorisk management system, annual inspections, and existing resources.
- Key issues related to reassessment needed, insufficient resources, and need for more frequent monitoring.
- New research members hired without required biorisk review and exclusion of the biorisk officer from the hiring process.
Exercise -2/PDCA Cycle (Plan/Do/Check/Act)
- Plan: Develop a training plan for new team members and provide additional support for the safety team.
- Do: Implement the training and allocate additional staff as needed.
- Check: Ensure all new labs have communicated with the safety group before initiating research activities.
- Act: If communication occurred, maintain current system; if not, remind relevant parties about safety policy.
Objective 4
- Describe how to analyze, evaluate, and use performance indicators and data generated from accident/incident investigations, inspections, and auditing to monitor and improve a biorisk management system.
What is a Performance Indicator?
- Key performance indicators (KPIs) are quantifiable measurements used to gauge a company's long-term performance.
Use of KPIs and Monitoring Data for Improvement
- Use data to inform the decision-making process.
Analysis, Evaluation, Use of Performance Indicators
- Laboratory managers can continually improve the safety and effectiveness of biorisk management systems by analyzing, evaluating, and using performance indicators, data to monitor, and improve biorisk management systems.
Identify Relevant Performance Indicators
- The first step is to identify relevant performance indicators that monitor and evaluate the effectiveness of the biorisk management system (incident rates, near-miss reports, corrective actions, and compliance with regulations and standards).
Collect and Analyze Data
- The next step is to collect and analyze data related to the identified performance indicators. The data can be from investigations, inspections, auditing, training records, and incident reports.
Evaluate the Effectiveness of a BRM System
- The collected data should be used to evaluate the effectiveness of the biorisk management system, and to identify strengths and weaknesses and areas for improvement.
Develop Improvement Plans
- Based on the evaluation of the data, improvement plans should address identified weaknesses or areas for improvement.
- Specifically include actions, timelines, and responsible individuals or teams.
Implement and Monitor Improvement Plans
- Implement the improvement plans; progress should be monitored regularly to ensure that expected outcomes are achieved.
- Collecting additional data and performance indicators will help track progress and evaluate the effectiveness of the improvement plans.
Use Data to Inform Decision-Making
- The data collected and analyzed should be used to inform decisions related to the biorisk management system.
- Include making changes to policies, procedures, implementing new measures, and allocating resources to address areas of weakness.
Steps for Improvement
- Fostering effective internal communication, conducting meaningful performance reviews, increasing preventative actions, implementing beneficial follow-up activities, and establishing training programs that build biosafety and biosecurity skills.
- Documenting procedures is crucial for consistency and clarity in the organization.
Top Management Commitment
- Ensuring adequate resources, prioritizing and communicating biosafety and biosecurity policies, integrating biorisk management principles at all levels, regularly assessing and identifying improvement areas, and investigating root causes of system failures to prevent recurrence.
Continuous Improvement
- Encouraging employees to actively seek improvement opportunities, promoting ongoing process refinement, requiring staff participation in education and training focused on continual improvement, and including training on measuring progress and recognizing positive changes.
References
- Several references (World Health Organization, BMBL 5th Edition, Bioprism Manual, etc.) are listed.
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