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EHS-130 Environmental Health and Safety Risk Assessment Methodology

DepartmentEnvironmental, Health and SafetyDocument noEHS-130
TitleEHS Risk Assessment Methodology
Prepared by: Date: Supersedes: 
Checked by: Date: Date Issued: 
Approved by: Date: Review Date: 

1. AFFECTED PARTIES

All Environment, Health and Safety personnel

2. PURPOSE

This SOP details the steps and procedure involved in carrying out an EHS Risk Assessment in the GMP site.

3. SCOPE

In a GMP environment a risk-based approach has to be used to evaluate the hazards and controls used to mitigate them. Hence it is essential for Risk assessments to be performed to ensure that all hazards in a plant are identified and are controlled if the risk associated with them is unacceptable.  To evaluate and control all risks, Risk Assessment Process has been developed and widely accepted by the industry.

4. RESPONSIBILITY \ BUSINESS RULES

It is the responsibility of all Colleagues to perform risk assessments whenever a risk based decision making is required. It is the responsibility of EHS team to advise and assist in the risk assessments and its associated controls if required. EHS will also file and keep all Risk Assessments in safe and secured manner.

The risk assessment process and the development of a risk control plan to eliminate or minimize those risks shall be undertaken and developed in consultation with the following personnel:

– Environment Health & Safety Committee Colleague;

– Area / Department Manager or delegate; i.e. supervisor or Team Leader;

– Colleagues directly responsible for the day-to-day use and/or operation and maintenance of the plant / equipment, substance, task being assessed.

– All plant and equipment are required to be risk assessed and these risk assessments will be reviewed under the following conditions:

– When there is new plant / equipment to be installed;

– When there are changes / additions to plant, equipment;

– When new tasks or processes are to be performed;

– When the method or process of performing a task or process changes

– When a change request is raised.

Depending on the complexity of the workplace operations and the risks to be controlled, subject matter experts may be required from time to time to assist in the undertaking of the risk assessment process and the development and or implementation of a risk control plan. Subject matter experts may include but are not limited to:

– Production Colleagues

– Engineering Colleagues

– EHS Colleagues

– Technical Services Colleagues

– Quality Colleagues

– Supply Chain Colleagues

– Senior Management Team

5. PROCEDURE

The risk assessment process consists of four (4) main steps parts:

Figure 1: Risk Assessment Process

5.1 Hazard Identification

Workplace hazards may be identified through, but not limited to the following processes:

– Accident / injury reports

– Accident / incident investigation

– Hazard notification

– Hazard identification

– EHS Monthly Walk Around audits

– EHS Yearly Audits

– Introduction of new plant, equipment, substance and or process

– Modification of plant, equipment, substance and or process

– Manufacturer’s Directives or Recommendations.

– When new information becomes available that affects health and safety (i.e. Material Safety Data Sheet (MSDS)

– Assessments as required by legislation

– Reports from external persons / bodies

– Environmental / biological monitoring.

5.2 Risk Assessment

The risk assessment shall consider the following:

– The likelihood of the hazard causing harm (L)

– The severity of the consequences in the event of the hazardous event or situation occurring (C)

– The exposure of personnel to that hazard (E).

5.2.1 Likelihood (L)

5.2.1.1 Determine the numerical value for the likelihood of the identified hazard to cause harm.  (See Table 1 – Likelihood below).

5.2.1.2 Record the determined value for consequences on the EHS Risk Assessment Tool form (Form 0435) and EHS Risk Control & Assessment Form (Form 0436).

Table 1: Likelihood (L)

LikelihoodValue
May well be expected10
Quite possible6
Unusual but possible3
Only remotely possible2
Virtually impossible1

 

5.2.2 Consequences (C)

5.2.2.1 Determine the numerical value for the most likely consequences if the identified hazard were to cause harm.  (As per Table 2 – Consequences below).

5.2.2.2 Record the determined value for consequences on the EHS Risk Assessment Tool form (Form 0435) and EHS Risk Control & Assessment Form (Form 0436).

5.2.3 Exposure (E)

Table 2: Likelihood (C)

ConsequencesValues
Fatality and/or Major irreversible environmental impact; major media exposure50

Permanent disability or multiple serious injuries / illness and/or

Moderate environmental damage; on and off site effect – can reverse within one month; media exposure

40

Serious injury / illness – lost time and/or

Moderate environment impact – on site containment; can reverse within a week; no media exposure

25

Medical treatment injury / illness and/or

Minimal environment impact – minimum remediation required; no media exposure

5

First aid injury / illness and/or

Negligible, local environment impact – no remediation required; no media exposure

1

 

5.2.3.1 Determine the numerical value for the level of the exposure of personnel to the identified hazard.  (See Table 3 – Exposure).

5.2.3.2 Record the determined value for consequences on the EHS Risk Assessment Tool form (Form 0435) and EHS Risk Control & Assessment Form (Form 0436).

Table 3: Exposure (E)

ExposureValue
Continuous10
1 period / day6
1 period / week3
1 period / month2
(less than) < 1 period / month1
(1 period < 1hr) Greater than 1 hr use next highest level up 

 

5.2.4 Risk Score

5.2.4.1 Calculate the Risk Score by multiplying the numerical value determined for Likelihood (L), Consequences (C) and Exposure (E) together.

5.2.4.2 Record the calculated value for Risk Score on the EHS Risk Control & Assessment Form (Form 0436).

Risk score = L X C X E

5.2.5 Risk Level

5.2.5.1 The Risk Level may be interpreted qualitatively using the terms in the Risk Score table (Table 4).

5.2.5.2 Record the determined value for consequences on the EHS Risk Assessment Tool form (Form 0435) and EHS Risk Control & Assessment Form (Form 0436).

Table 4: Risk score

Risk levelRisk score
Very highMore than 500
High200 – 499
Medium50 – 199
Low21 – 49
Very lowLess than 20

 

5.3 Risk Control

The primary aim of risk control is to eliminate the risk and the best way of eliminating risk is to eliminate the hazard.

If this is not possible, the risk must be minimized as far as is practicable using one or more of the other control options from the Hierarchy of Controls.

Risk control must be achieved using a Hierarchy of Controls as described below in Table 5.

In many cases, it will be necessary to use more than one control method from the Hierarchy of Controls.  Back-up controls (such as PPE and administrative controls) should only be used as a last resort or as a support to other control measures.

Table 5: Hierarchy of controls

Control HierarchyDescription
EliminateEliminate the substance, plant and / or risk
SubstituteSubstitute the substance, plant and / or task from personnel or personnel from the task
isolateIsolate the substance, plant and / or task from personnel or personnel from the task
EngineeringRedesign or modify substance, plant and / or task E.g. Provide guarding, ventilation, extraction
AdministrativeProvide training, information, instruction, operator rotation, supervision on substance, plant and / or task
PPEProvide suitable PPE as to reduce risk of exposure of personnel to that hazard. Note PPE does not reduce the likelihood or exposure, however it may reduce the consequences.

 

5.4 Monitor and Review

After risks associated with a hazard have been assessed and control measures introduced those controls must be monitored and reviewed to evaluate their effectiveness.

This is to ensure that no hazards were overlooked in the original assessment process, and that no new unforeseen hazards have been introduced as a result of the implemented controls.

Monitoring and review shall involve the systematic re-implementation of the original risk management program steps of:

– Hazard identification

– Risk assessment

– Risk control

This shall be done as soon as is practicable after the implementation of control measures.

Note: If Manual Handling or Hazardous Substances are listed as a risk the following SOPs must also be consulted:

SOP EHS-145 Hazard assessment of New and Existing Materials with appropriate Risk Form attached.

SOP EHS-150 Manual Handling ergonomics policy with appropriate Risk Form attached.

5.5 Rating Category

Table 6: Rating Category

Rating CategoryRisk score guidelineRisk level
Acceptable standardLess than 20Very low
Risk exists but acceptable – could be better21 – 49Low
Medium risk need action plan to address50 – 199Medium
High risk need addressing in the short term200 – 499High
Major risk needs immediate action or isolation of hazard300-499High
Immediate major risk: Stop Work or isolate until addressedMora than 500Very High

 

The Rating Category as seen in Table 6 will provide the magnitude of the nature and level of risk that was assessed to be inherent in the process/system or equipment.

The appropriate risk control measure can then be undertaken accordingly.

The ratings provided will also linked to the Monthly EHS walk around and yearly EHS audits and will provide an indication of the risk that is involved in a process, system or equipment.

6. DEFINITIONS / ACRONYMS

HazardA situation that has the potential to cause harm to people, plant / equipment and or the environment.
Monitor & ReviewThe process by which implemented control measures are systematically reviewed to evaluate their effectiveness and to ensure that no new unforeseen hazards have been introduced
MSDSMaterial Safety Data Sheet
OH&SOccupational Health & Safety
PPEPersonal Protective Equipment
Risk AssessmentThe process of using a mathematical tool to calculate a risk score based on  the likelihood, consequences and exposure to a hazard
Risk ControlThe process by which the risks associated with a hazard can be systematically controlled by eliminating or reducing the risks associated with that hazard.
RiskThe likelihood of harm associated with a hazard actually occurring. Expressed as a function of the consequences of the hazard causing harm and  the degree of exposure to that hazard.

7. SUMMARY OF CHANGES

Version #Revision History
EHS-130New