Risk Assessment Assignment
SHOJI NAKAYAMA, PH.D.
Risk Assessment
for
Engineering Technology
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Hazard vs. Risk
Hazard: It is a condition(s) that has a POTENTIAL to produce injury and/or property damage.
Risk: The PROBABLIITY that a hazard will be activated and produces injury or property damage.
Components: Frequency (Eg: occurrences per year)
Severity (Eg: magnitude of impact)
Types of impacts: Death, injury, environmental damage, direct/indirect financial losses, liability, penalties, loss of reputation, etc.
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What is Risk Assessment?
- A way to determine potential harm due to exposure to a hazard.
- To determine which hazard has what level of frequency (probability) and severity (impact ).
- Take necessary action(s) – eliminate/reduce risk level
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Why Risk Assessment?
- Reduction in injuries, illnesses, health
- Reduction in lost time
- Reduction in claims
- Reduction in insurance premiums
- Industry standards are requiring risk assessment
- Europe - CE mark requires risk assessment
- Customers are beginning to require risk assessment
- Lots of momentum in industry in risk assessment
- Risk assessment works
- Better, cheaper, faster, more productive
GOAL: To eliminate or reduce risks to an acceptable level(s).
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Barriers
- Barrier 1: Few design professionals possess sufficient expertise in safety.
- Potential solutions:
- Add safety to design professionals’ curricula.
- Develop and promote 10-hour and 30-hour OSHA courses for design professionals.
- Barrier 2: Such processes (risk assessment to design in safety) will increase both direct and overhead costs for designers.
- Potential solution:
- Educate owners that total project costs and total project life cycle costs will decrease.
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Risk Assessment Steps
- The process of logical steps to systematically examine the hazards associated with your work tasks/process.
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Risk Assessment –Step (1)
- These parameters can be limits of the machine or design, limits on uses, limits on the scope of the analysis, or other limits.
The nature of this step lends itself to a team approach such as brainstorming.
Risk Assessment –Step (2)
Hazard Identification
- Hazard: Anything which may cause harm, injury, illness health, death and/or property damage.
- Physical inspection of the workplace:
- Requires an inquiring mind
- Lateral thinking
- Ability to be and remain open minded
- Brainstorming:
- Conducting group meetings with people who are familiar with the operation of the area under review
- Recording all ideas and thoughts relating to possible hazards
- Sorting the results into some sort of priority order.
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Risk Analysis vs.
Failure Mode and Effects Analysis (FMEA)
The main difference between risk management according to ISO 14971 and FMEA is that FMEA tends to only find the risks associated with something broken. In addition, FMEA does not deal with acceptable and unacceptable risks, but only provides a priority order in which to work with risks. The RPN number (Risk Priority Number) is derived from the FMEA method.
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Standard FMEA Worksheet
FMEA focuses on the failure point of a concept, process, design, service or equipment, how to prioritize and fix the possible failure points. Risk Analysis focuses on the overall system/environment in which people function and harm that may come from that system/environment.
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Risk Assessment – Step (3)
Two risk factors are used:
- Probability/Frequency of occurrence
- Severity/Impact
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Risk Ranking
- Ranking Matrix combining risk elements of probability (frequency) and impact (severity)
The mapping is achieved by the two axis, the first being the likelihood of a risk broken into five discrete ranges. Similarly, the consequence scale is broken into five discrete ranges. These two criteria are merged and plotted (Probability x Impact = Risk) on the matrix to develop a total risk ranking.
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Probability (Frequency) and Impact (Severity)
| Impact Index | Impact /Severity Name | Impacts |
| 5 | Catastrophic | Enterprise wide impact to services and revenue. Branding, Reputation, and Public image severely compromised. Extreme loss of revenue, services, assets , buildings, equipment, and /or human resources |
| 4 | Major | Nationwide or regionalized impact to services and revenue. Branding, Reputation, and Public image compromised. Significant loss of revenue, services, assets , buildings, equipment, impact to human resources significant . |
| 3 | Serious | Multiple Market impact to services and revenue. Branding, Reputation, and Public image compromised in region/market. Concerning levels of impact to revenue, assets , buildings, equipment, and human resources |
| 2 | Moderate | Localized Single Markets loss of services and revenue. Branding, Reputation, and Public image repairable but tarnished. Moderate but limited loss of revenue, services, assets , buildings, equipment. Human resources impact held to minimum. |
| 1 | Low | Minimal loss of services and revenue. No impact to Branding, Reputation. Minimal impact to services and revenue, loss of assets , buildings, equipment,. No human resource impacts. |
| Seriousness Index | Probability / Frequency Name | Description | Estimated Relevant Probability |
| 5 | Highly Probable | Within the current environment, it is highly probable that the risk will occur | 81 - 100% |
| 4 | Likely | Within the current environment, it is Likely that the risk will occur | 61 – 80% |
| 3 | Possible | Within the current environment, it is possible that the risk could occur | 41 – 60% |
| 2 | Not Likely | Within the current environment, it is not likely that the risk will occur | 21 – 40% |
| 1 | Highly Unlikely | Within the current environment, it is highly unlikely that the risk will occur | 1 - 20% |
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Risk Assessment
- Risk Assessment Levels
- After the risks have been mapped the assessment of the level of risk has to be defined to identify what must be elevated for reporting.
- Those risks that are assessed as Catastrophic or Major may warrant further investigation to determine true loss exposure or enterprise value at risk (VaR).
- Further studies into loss exposures to determine VaR can be used to drive business case justification for investment in Risk Control strategies.
| Risk Assessment Value | Risk Category | Assessment Level |
| 25-20 | Catastrophic 81-100% | Event unavoidable. Probability and Impact are extreme with no mitigation possible. Highest levels of preparedness and event management strategies are mandatory |
| 20 -16 | Major 61-80% | Event is highly probable . Strategy and avoidance criteria must be identified and implemented. Corrective actions and highest levels of preparedness / actions mitigates exposure and impact. |
| 15 - 11 | Serious 41-60% | Event is preventable. Strategy and avoidance criteria is identified and implemented. Corrective actions and well defined levels of preparedness / actions mitigate exposure and impact. |
| 10 - 6 | Moderate 21-40% | Event is unlikely and avoided through mitigation strategies, moderate levels of preparedness actions/plans and due diligence will minimize impact. |
| 5- 1 | Low 0-20% | Event highly unlikely. Significance of event is of low impact, mitigation strategies and levels of preparedness reduce risk and exposure to minimal levels. |
Risk Assessment – Step (4)
Remedy actions are taken to reduce risks following the hazard hierarchy control:
Hierarchy of Control
(Most to lease effective)
- Eliminate through design
- Protect (Guarding, etc)
- Warn the user
- Train the user(s)
- Personal protective equipment
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Risk Assessment – Step (5)
Selected measure effectively reduce the risk.
Probability and severity are assessed to obtain residual risk level.
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Risk Assessment – Step (6)
This assessment verifies that the remedy actions have reduced the risks to an acceptable level.
A decision shall be made to accept or further reduce the residual risk.
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Acceptable level of risk
- As a safety/engineering professional – need to balance between “risk minimization ” and “budget”
- This is generally determined by what is prepared to be lost balanced against possible gains
When do we accept risk?
When it is insignificantly low.
When we are sure it is worth it.
When we do not know it is there.
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Reduce to An Acceptable Level
Caution:
- Any hazard, which is not identified, will not be addressed by safety measures and will not be detecting during testing.
- Hazard not identified during this analysis can create substantial risk to users of the design.
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Risk Assessment – Step (7)
The documentation can be added to a technical file for future use.
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Document, Monitor and Review
Procedures that has been followed
Hazards identification
Risk reduction methods employed (eliminate or reduced to an acceptable level)
Review what has been done to ensure that the controls put in place are effective
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Conclusion
- Hazard identification, risk assessment, control and review is not a task that is completed and then forgotten about. Hazard identification should be properly documented even in the simplest of situations
- Risk assessment should include a careful assessment of both likelihood and consequence. Control measures should conform to the recommendations of the hierarchy of control. The risk management process is an on going one.
- Eliminate by Design: Eliminate dangerous parts & conditions.
Design out hazard is important!!!
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Considering Safety During Design Offers the Most Payoff
Szymberski (1987)
Conceptual Design
Detailed Engineering
Procurement
Construction
Start-up
High
Low
Ability to Influence Safety
Project Schedule
Front side of the “Manual Data Entry”.
Back side of the “Manual Data Entry”
Use this RAW sheet (both sides) to capture & document all finding in Risk Assessment based on 2-Stage Approach.
Risk Assessment Worksheet (RAW)
Developed, used and shared by
Results and Documentation
When to stop / Residual Acceptable
Assess Residual Risks
Reduce Risk
Assess Initial Risk
Identify Hazards
Set limit of the assessment
Results and Documentation
When to stop / Residual Acceptable
Assess Residual Risks
Reduce Risk
Assess Initial Risk
Identify Hazards
Set limit of the assessment
Results and Documentation
When to stop / Residual Acceptable
Assess Residual Risks
Reduce Risk
Assess Initial Risk
Identify Hazards
Set limit of the assessment
FAILURE MODE AND EFFECTS ANALYSIS
Item:
Responsibility:
FMEA number:
123456
Model:
Prepared by:
Page :
1 of 1
Core Team: J. Doe (Engineering), J. Smith (Production), B. Jones (Quality)
FMEA Date (Orig):
Rev: 1
Process
Function
Potential
Failure
Mode
Potential
Effect(s) of
Failure
Sev
Class
Potential
Cause(s)/
Mechanism(s) of
Failure
Occur
Current
Process
Controls
Detec
RPN
Recommended
Action(s)
Responsibility and
Target Completion
Date
Action Results
Actions
Taken
Sev
Occ
Det
RPN
Results and Documentation
When to stop / Residual Acceptable
Assess Residual Risks
Reduce Risk
Assess Initial Risk
Identify Hazards
Set limit of the assessment
Results and Documentation
When to stop / Residual Acceptable
Assess Residual Risks
Reduce Risk
Assess Initial Risk
Identify Hazards
Set limit of the assessment
Results and Documentation
When to stop / Residual Acceptable
Assess Residual Risks
Reduce Risk
Assess Initial Risk
Identify Hazards
Set limit of the assessment
Results and Documentation
When to stop / Residual Acceptable
Assess Residual Risks
Reduce Risk
Assess Initial Risk
Identify Hazards
Set limit of the assessment
Results and Documentation
When to stop / Residual Acceptable
Assess Residual Risks
Reduce Risk
Assess Initial Risk
Identify Hazards
Set limit of the assessment