Department | Environmental, Health and Safety | Document no | EHS-130 | ||
Title | EHS 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)
Likelihood | Value |
May well be expected | 10 |
Quite possible | 6 |
Unusual but possible | 3 |
Only remotely possible | 2 |
Virtually impossible | 1 |
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)
Consequences | Values |
Fatality and/or Major irreversible environmental impact; major media exposure | 50 |
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)
Exposure | Value |
Continuous | 10 |
1 period / day | 6 |
1 period / week | 3 |
1 period / month | 2 |
(less than) < 1 period / month | 1 |
(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 level | Risk score |
Very high | More than 500 |
High | 200 – 499 |
Medium | 50 – 199 |
Low | 21 – 49 |
Very low | Less 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 Hierarchy | Description |
Eliminate | Eliminate the substance, plant and / or risk |
Substitute | Substitute the substance, plant and / or task from personnel or personnel from the task |
isolate | Isolate the substance, plant and / or task from personnel or personnel from the task |
Engineering | Redesign or modify substance, plant and / or task E.g. Provide guarding, ventilation, extraction |
Administrative | Provide training, information, instruction, operator rotation, supervision on substance, plant and / or task |
PPE | Provide 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 Category | Risk score guideline | Risk level |
Acceptable standard | Less than 20 | Very low |
Risk exists but acceptable – could be better | 21 – 49 | Low |
Medium risk need action plan to address | 50 – 199 | Medium |
High risk need addressing in the short term | 200 – 499 | High |
Major risk needs immediate action or isolation of hazard | 300-499 | High |
Immediate major risk: Stop Work or isolate until addressed | Mora than 500 | Very 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
Hazard | A situation that has the potential to cause harm to people, plant / equipment and or the environment. |
Monitor & Review | The process by which implemented control measures are systematically reviewed to evaluate their effectiveness and to ensure that no new unforeseen hazards have been introduced |
MSDS | Material Safety Data Sheet |
OH&S | Occupational Health & Safety |
PPE | Personal Protective Equipment |
Risk Assessment | The process of using a mathematical tool to calculate a risk score based on the likelihood, consequences and exposure to a hazard |
Risk Control | The process by which the risks associated with a hazard can be systematically controlled by eliminating or reducing the risks associated with that hazard. |
Risk | The 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-130 | New |