Lecture-11:

Risk Assessments
(Ex. :BioRisk)

Scientific Ethics and

Safety
ENGR / SCI 304 Sherif H. El-Gohary , Phd
Assistant Professor,Biomedical Engineering
Partly compiled from internet sources shamdy@zewailcity.edu.eg
 Learner Outcomes
1. Understand that behind each fatality
or serious injury there are thousands
of at-risk behaviors and unidentified
hazards that contributed to the
incident.

2. State the definition of a hazard and

explain how to identify hazards in the
workplace.
Learner Outcomes
3. Determine methods for controlling
hazards in the workplace.

4. Complete a job RISK analysis .

3
 Safety
Laboratory
Safety
Chemical & Inspections Radiation
Laboratory
Safety
Safety
Laboratory &
Research Safety
Biological Laboratory
Safety Design Safety
Agricultural,
Field, Marine
Safety
Lab/Research
Community Safety
Involves & relies on

Teaching Laboratory Field

Laboratories Research Research

Chemical Hygiene Radiation & Bio

Officer Fire Prevention, Building Design & Safety Officers
Maintenance, Industrial Hygienists etc. 5
Departments Involved
• Air Pollution Research Center R
• Anthropology TRF
• Biochemistry TR
• Bioengineering TR
• Biology TRF
• Biomedical Sciences TR
• Botany & Plant Sciences TRF
• Cell Biology T
• Chemical Engineering T
• Chemistry TR
• CE-CERT RF
• Center for Conservation Biology RF
• Cell Biology & Neurosciences TR
• Earth & Planetary Sciences TRF
• Electrical Engineering TR
• Entomology TRF
• Environmental Engineering T
• Chemical & Environmental Engineering TRF
• Environmental Science TRF
• Environmental Toxicology T
• Inst Geophysics Planetary Physics R
• MS&E TR
• Mechanical Engineering TR
• Nematology TRF
• Neuroscience T
• Plant Pathology & Microbiology TRF
• Physics and Astronomy TRF
• Psychology RF
• Soil and Water Science TRF
• Education Abroad F
T = Teaching Labs
• Sociology F
R = Research Labs
F = Field Work
Brief :BioSafety Level 1
• Well characterized, non-pathogenic
organisms or agents

• Open bench- no containment

• Use good laboratory practices, waste

disposal, and aseptic techniques

• Example: E. coli K-12 strains

 Brief :BioSafety
Level 2
• Agents of moderate hazard to personnel or environment

• Basic lab, but restricted access, containment during

certain processes (i.e. aerosols, large volumes, etc.)

• Autoclave and Biological Safety Cabinet desired

• Use good laboratory practices, waste disposal, and aseptic

techniques

• Example: most non-respiratory, non lethal, agents

 Brief :BioSafety
Level 3
• Agents of high hazard to personnel or environment

• Respiratory exotic or indigenous agents which are easily

transmissible causing serious or lethal disease

• All work is contained, engineering controls and controlled

environments we currently do not have the facilities to
handle.

Example: Mycobacterium tuberculosis, SARS, etc.

 Brief :BioSafety
Level 4
• FORGET ABOUT IT!!!

• Hemorrhagic fever, deadly viruses, etc.

• Total containment, airtight labs, “submarine” doors,

air pumps, water treatment, HEPA filtration, etc.

• Positive pressure “moonsuits”

Safety, Health &
Environmental Goals
ZERO…
• workplace injuries
• workplace illnesses
• related injury/illness at home
• property loss
• unintended environmental damage
Why accidents happen?

Careless Inadequate Inadequate

Safety Training Instructions

Unsafe Over crowding

Experiments

Inadequate Facilities
Inadequate Equipment

Inadequate
Misbehavior Preparation
Ignorance

Poor Laboratory Teaching

Management Experiences
 Hazard

Anything that
may cause
harm
 Definition – HAZARD

“Source or situation or act with a potential for

harm in terms of human injury or ill health or a
combination of these”

e.g. - Toxic or flammable substances, electric energy, working at heights

etc.
Hazard is something that cause harm or injury
 Risk
The probability of harm
occurring

Chance of exposure to the hazard

X
Consequences (severity)
 Definition - RISK
•Combination of the likelihood of an occurrence of a hazardous event or
exposure(s) and the severity of injury or ill health that may be caused
by the event or exposure(s) (13 page 13)
•Likelihood that a hazard will cause a specific harm or injury to person
or damage property

Risk means the chance that someone will be

harmed by the hazard.
Risk = Hazard effect x Probability (likelihood of
Occurrence)
Types Risk Exposures
 Hazard risk
◦ risks related to accidental losses, such as workplace injuries, liability torts,
property damage, and natural disasters.
 Financial risk
◦ risks related to financial activities, such as pricing, asset valuation, currency
fluctuations, and liquidity.
 Operational risk
◦ risks related to operations, such as supply chain, customer satisfaction,
product failure, or loss of key personnel.
 Strategic risk
◦ risks related with an organization‟s long-term goals and management, such as
partnerships, mergers, and acquisitions.
 Compliance risk
◦ risks related to violations of or nonconformance with laws, rules, regulations,
prescribed practices, internal policies, and procedures, or ethical standards.
 Reputational risk
◦ risks related to the trustworthiness of business. Damage to a firm's reputation
can result in lost revenue or destruction of shareholder value.
Managing Risk:
Congruent Goals
• Targeted Risk Ethics & Compliance • Assess Key
Assessment Financial and Campus/Lab/OP
• Risk Financing Operational Management
• Assess Regulatory Risks
• Risk Control / Controls
• Develop Mitigation Plan
Mitigation • Advisory Services • Strategic Planning
• Monitor Key Mitigation
• Promote culture of • Key Management • Managing Identified
Activities
risk awareness Business Partner Risks from all
• Promote culture of Perspectives
ethics and compliance
Internal Audit
Risk Services

Assisting Campus/Lab/OP to Meet Operational Needs

Across All Risk Venues
 Risk Management
RISK MANAGEMENT

RISK REDUCTION
RISK ASSESSMENT
Activity Option Analysis Implementation
Characterisation


 Monitoring
Hazard Identification


Decision Making Audit or Review
Risk Estimation

RISK EVALUATION
RISK ANALYSIS
What is Risk Assessment?
Risk Assessment is a systematic approach to identify
hazards, evaluate risk and incorporate appropriate
measures to manage and mitigate risk for any work
process or activity.
Risk Concepts
What can go
Wrong
What are the
How likely is it?
Impacts

Risk Level

MANAGE
RISK
Risk management also includes control and monitoring of
risks, as well as communicating these risks
WHY we need to do RA?
Protect Ourselves
RA is key to prevention of accident
Everyone deserve to go home safely at the
end of the day
Elevate safety awareness & ownership
Aware of hazards, risks and controls and
practicing safe science
University/Entity Procedures
Compliance with Regulations
Controlling Risk
• Risk Avoidance – This strategy involves a conscious
decision on the part of the organisation to avoid
completely a particular risk by discontinuing the
operation producing the risk e.g. the replacing a
hazardous chemical by one with less or no risk potential.

• Risk Retention – The risk is retained in the

organisation where any consequent loss is financed by
the company. There are two aspects to consider here,
risk retention with knowledge and risk retention without
knowledge.
Controlling Risk
• Risk Transfer – This refers to the legal assignment of
the costs of certain potential losses from one party to
another. The most common way is by insurance.

• Risk Reduction – Here the risks are systematically

reduced through control measures, according to the
hierarchy of risk control described in earlier sections.
 Major Hazards
• Major hazards associated with complex chemical
or nuclear plants, may „warrant the need of such
techniques as Quantitative Risk Assessment‟.
• In Quantitative Risk Assessment (QRA) a
numerical estimate is made of the probability
that a defined harm will result from the
occurrence of a particular event.
Steps To Risk Assessment
Step One
Identify the
hazards
IDENTIFY POTENTIAL
HAZARDS
The most important step in any Risk Assessment -
hazards can only be controlled if they are identified

Equipment Procedures Agents

People Environment

Each step is analyzed for potential inherent hazards

Decision on the relevance of any particular hazard
come later in the risk assessment processes
 IDENTIFY POTENTIAL HARM
Identify what are the adverse conditions may arise due the hazard
present in your experiments, laboratory or environment

 Identify Source of Harm  Injury

 First Aid Treatment
 Hazardous event or process  Visit Clinic/ hospital
 Hazardous substance  Admitted in Hospital
 Permanent damage
 Equipment
 Acute Vs Chronic Effects
 Identify who could be harmed  Lab Acquired Infection
 Researcher  Property Damage
 Others students  Breakage of glassware
 Equipment
 Contractor/supplier  Furniture
 Visitor  Building

 Identify how harm could occur  Environmental Release

 Release to Air
 Accidental fall from height  Water
 Contact with corrosive chemicals  Waste materials - solid
 Methods Of Identifying
Hazards
• Health & safety audits
• Academic journals
• Research papers
• Consultation with other co-workers
• Accident reports
• Trade organisations
• HSE statistics
(Health and Safety Executive)
Methods Of Identifying
Hazards
• Similar Institutions
• Outside Advice (manufacturers of
equipment and materials)
• Internal Advice (University Safety
& Health Services)
Step Two

Identify who
might be
harmed
Who Might Be At Risk
•Employees
•Contractors
•Visitors
•General public
•Children
•People who share
the workplace
•Must be people specific
Don‟t forget vulnerable groups such as people with
disabilities, pregnant staff and those with little
experience or training.
 Step Three
Evaluate the risks
Risk Analysis

• Hazards and hazardous

situations are
systematically
identified.

• The level of risk

associated with each
hazard (situation) is
estimated
 Risk Evaluation
• A judgement is made as to
whether the level of risk is
acceptable or tolerable

• Will include a judgement on

corrective or preventative
measures
Completing the Risk
assessment
Organising actions and responsibilities to reduce
the hazards and risks to acceptable levels:
• Elimination of hazard (do I have to do this?)
• Substitution (materials, equipment etc)
• Physical safeguards (machinery guarding, extraction
etc)
• Personal Protective Equipment
• Safe working procedures
• Or any combination of above
 Evaluating The Risks
-some considerations

• Industry standards
• Legal requirements
• Precautions already taken
• Cost (so far as is reasonably practical)
• Different working conditions i.e. weather
• Numbers of people at risk
• Severity of injury
• Probability
• Length of exposure/frequency
Risk Evaluation
Severity Categories & Description
Level Human (Impact to Biological Impact Environmental Property
Physical Being) Damage Damage (S$)
(1) Minor No Injury or light May not cause human disease, if Reversible Up to $5,000
injury requiring does, the disease is unlikely to
only first aid spread to the community and there
treatment (MC < 4 is usually effective prophylaxis or
days MC) treatment available;
(2) Any injury/ill health Can cause severe human disease, Reversible but $5,001 to
Moderate leading to ≥ 4 days not ordinarily spread by casual takes years $50,000
MC or ≥ 1 day contact from one individual to
hospitalisation or another; it may spread to the
leads to temporary community, but there is usually
disability effective prophylaxis or treatment
available
(3) Major Fatality, permanent Can cause lethal human disease, Irreversible More than
Disability or life may be readily transmitted from one $50,000
threatening individual to another, or from animal
disease to human or vice-versa directly or
indirectly, or casual contact, it may
spread to the community; usually no
effective prophylaxis or treatment
available
Risk Evaluation
Likelihood Categories & Description

Level Events Frequency

(1) Remote Undesired event which may occur but
unlikely, once in 5 years
(2) Possible Undesired event which is probable, once
in a year
(3) Frequent Undesired event which probably occur in
most circumstances, once or more in a
month
Risk Evaluation
Risk matrix to determine Risk Level

Likelihood
Remote (1) Occasional (2) Frequent (3)
Severity
Minor (1) 1 2 3

Moderate (2) 2 4 6
Major (3) 3 6 9
Risk Evaluation
Acceptability of Risk

Risk Risk Acceptability

Recommended Actions
Score Level of Risk

Low No additional risk control measures required. To continue to monitor to

<3 Acceptable ensure risk do not escalate to higher level.
Risk
Acceptable to carry out the work activity; however, task need to be
reviewed to bring risk level to As Low As Reasonably Practicable.
Mediu Moderately Interim control measures such as administrative controls can be
3–4
m Risk Acceptable implemented. Supervisory oversight required.

Job must not be carried out until risk level is brought to at least medium
risk level.
Risk controls should not be overly dependant on personal protective
High Not equipment. Controls measures should focus on Elimination, substitution
>4 and engineering controls.
Risk Acceptable
Immediate Management intervention required to ensure risk being
brought down to at least medium level before work can be commenced.
 Step Four
Record your
findings
 Recording the Risk Assessment

The Elements

A description of the area or task

The hazards that personnel may be exposed

to

Details of the personnel who may be

exposed to the hazards
 Recording the Risk Assessment
Evaluate the risks

• Use the risk matrix on the form

• Estimate the risk before control measures
• Identify control measures to lower the risk
• Estimate the risk after control measures (residual
risk)
• Can you lower the risk further? Ideally all LOW
• Not all risks are injury – what about financial loss?
Risk Assessment Template
Activity or Experiment-Based Risk Assessment Form
Department: Name of Experiment/Activity:
Location: Name of Person in-charge: Name of PI:
Last Review Date: Next Review Date:

1. Hazard Identification 2. Risk Evaluation & Control

Existing Risk Additional

Possible Action
SN Task Hazards Control S L R / New Risk S L R Deadline
Consequences By
(if any) Control

Conducted by: (Name, Approved by: (Name,

designation) designation)
Signature: Signature:

Date: Date:
 Step Five
Review the assessment
Fault Tree Analysis

• A fault tree is a diagram that displays the logical

interrelationship between the basic causes of the
hazard.

• Fault tree analysis can be simple or complex

depending on the system in question. Complex
analysis involves the use of Boolean algebra to
represent various failure states.
 Fault Tree Analysis

The first stage is to select the hazard or top event

that is to be analysed.

The tree is structured so that the hazard appears at

the top. It is then necessary to work downwards,
firstly by identifying causes that directly contribute
to this hazard.

When all the causes and sub-causes have been

identified, the next stage is to construct the fault
tree.
Fault Tree Analysis

Symbol Designation Function

EVENT / CAUSE Causes or events that can be developed

further

BASIC Basic or Root Causes or events that cannot

EVENT/CAUSE be developed further

UNDEVELOPED Causes are not developed due to lack of

EVENT/CAUSE information or significance.

AND gate Output event occurs only if all input events

occur
OR gate Output event occurs if any one of the input
events occurs
Fault Tree Analysis
Example
• Consider the simple circuit diagram shown below:
LAMP

POWER
UNIT

+ BATTERY

-
FUSE SWITCH

Example from Harms Ringdahl L (1995), Safety Analysis: Principals and Practice in
Occupational Safety, Elsevier Applied Science.
 Fault Tree Analysis
• The corresponding fault tree for the above circuit, with the top
event (or hazard) being the lamp not working is as follows:
Lamp does not
light

No current
through the lamp

Faulty No power supply

Lamp to the lamp

No power feed Broken circuit

Broken Defective Defective

No Power No Power
Circuit switch fuse
from battery from unit

Example from Harms Ringdahl L (1995), Safety Analysis: Principals and Practice in
Occupational Safety, Elsevier Applied Science.
 Risk Assessment
Flowchart
Identify
2. Break Down into 4. Potential Harm (Ill health
1. Selecting Experiments 3. Potential Hazards
Successive Tasks condition)

Assess
5. Existing Control Measures 6. Evaluate Risk (Severity, Probability)

Manage Risk
8. Additional control
Review, Approval, Record Keeping and
7. Hazard Control measures (Responsible
Communicate Document Control
person, timeline)
Biorisk definition
(adapted from ISO/IEC Guide 51:1999)
• combination of the probability of occurrence of
harm and the severity of that harm where the
source of harm is a biological agent or toxin

• NOTE The source of harm may be an unintentional exposure,

accidental release or loss, theft, misuse, diversion, unauthorized access
or intentional unauthorized release
 Specific
guidelines

Available on www.cantacuzino.ro See Section “Biosiguranta – Biosecuritate”

Directives, guidelines, standards
EU DIRECTIVES
• EU Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on
the protection of workers from risks related to exposure to biological agents at work - HG 1092/2006
• EC Directive on the Contained Use of Genetically Modified Organisms – OU 77 and 78 / 2007

GUIDELINES
• Laboratory Safety Manual - WHO
• Biosafety in Microbiological and Biomedical Laboratories (BMBL) - CDC
• The Laboratory Biosafety Guidelines - Health Canada
• Guidelines for Research Involving Recombinant DNA Molecules EC - NIH
• Biorisk management. Laboratory biosecurity guidance - WHO
• Biosafety risk assessment methodologies – Sandia Report

STANDARDS
• OHSAS 18001
• ISO 15190:2003 - Medical laboratories - Requirements for safety
• CWA 15793:2008 - Laboratory biorisk management standard
 Biorisk definition

Biosafety risks are defined as a function of

the likelihood of infection by the agent
and the likelihood of exposure through an
infectious route based on the procedures
and work practices and the consequences
of disease assuming infection
Biosafety risks is a function of:
• likelihood of
• infection by the agent
• exposure through an infectious route
• consequences