Document Title: Risk Management

Document No.: Version No.: Page Number: 1 of 8

Issue Date: Effective Date: Review Date:
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Document Approval
Created by Job Title  Sign. / Date

Reviewed by Job Title Sign. / Date

Ismail Ibrahim Corporate HSE & Licenses Manager
Approved by Job Title Sign. / Date
Mohamed El-Toukhy Corporate QA Manager

Hanaa Abdel-Maguid CRQHSE Director

DISTRIBUTION
Document Type Document Type
Destination Destination
Hard Copy # Soft* Hard Copy # Soft*

N/A √ CRQHSE Director N/A √ PBIC

N/A √ Corporate QA Manager N/A √ EEPI
N/A √ PHARCO PHARMACEUTICALS N/A √ AMRIYA PHRMACEUTICALS
N/A √ PBI N/A √ SAFE PHARMA
N/A √ TECHNO PHARMA

* Record (√) if a soft copy is required to the related destination.

Contents
1. Abbreviations /Definitions
2. Forms/Attachments/Templates Objective
3. Related Documents
4. Objective
5. Scope
6. Responsibilities
7. HSE Consideration
8. Procedures
9. References
10. List of Tables and Figures
11. Appendices
12. Others
13. SOP History

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1. ABBREVIATIONS /DEFINITIONS

Term Definitions & Abbreviations

CRQHSE Corporate Research, Quality, Health, Safety, and Environment
SOP Standard Operation Procedure
The overall process of hazard identification, risk analysis, and risk
Risk assessment 
evaluation.
Hazard
The process of finding, listing, and characterizing hazards.
identification
A process for comprehending the nature of hazards and determining the level
Risk analysis
of risk.
The process of comparing an estimated risk against given risk criteria to
Risk evaluation
determine the significance of the risk.
the combination of the likelihood and consequence of the hazard being
Risk
realized
Is something that has the potential to cause injury, illness, harm, loss, or
Hazard
damage.
likelihood Probability of recurring accidents
The potential consequence (or severity) of the risk being realized (it is
Consequence
described in terms of levels of harm and/or loss)
PPE Personal Protective Equipment
2. FORMS/ATTACHMENTS/TEMPLATES
2.1. Risk Assessment Format
3. RELATED DOCUMENTS:
N/A
4. OBJECTIVE
4.1. To ensure that a consistent approach to the application of risk assessment techniques
is applied across all services.
4.2. To create and maintain a culture of risk awareness, which is reflected in both business
planning and operational management.
4.3. To promote a risk-aware organization through risk assessment and proactive risk
management across all services.
5. SCOPE

5.1. To ensure that there is a formal process for hazard identification, risk assessment, and
control to effectively manage workplace and safety hazards within Pharco corporate

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6. RESPONSIBILITIES
6.1. A risk assessment should be carried out by a committee made up of a worker, their
supervisor, and a health and safety advisor as well as the signature of a senior
manager.
6.2. Assessments should be done by a competent person or team of individuals who have a
good working knowledge of the situation being studied. Include either on the team or
as sources of information, the supervisors and workers who work with the process
under review as these individuals are the most familiar with the operation.
6.3. The responsibility of HSE members to collect and verify data.
6.4. The responsibility of the data operator is to obtain the maximum benefit from it.
6.5. The responsibility of the HSE manager in reviewing data and dealing with deviation
and compatibility cases.
7. HSE CONSIDERATION
7.1. Whole procedure related to HSE
8. PROCEDURES
8.1. Identify the hazards (what can go wrong?)
 To prevent harm, it is important to understand not only what is likely to go wrong but
also how and why it may go wrong. Consider the activity within the context of the
physical environment and the culture of the organization and the staff who perform
the activity.
 Decide who might be harmed or what the impact will be on the organization (assets,
environment, and reputation) and how. Take into account things that have gone wrong
in the past and near-miss incidents. Learn from the past:
 Walk around the workplace and talk to staff.
 Map or describe the activity to be assessed.
 The risk assessment may require a multi-disciplinary team to ensure that all areas of
the activity or task to be assessed are considered.
8.2. Decide who might be harmed or the effect on the organization and how (what
can go wrong? who is exposed to the hazard?)
 People will make mistakes. It is necessary to anticipate some degree of human error
and try to prevent the error from resulting in harm.
 Consider the number of staff members or patients that might be affected over a stated
period. When quoting the number of patients affected you should always state the
length of the assessment period.
8.3. Evaluate the risks (how bad? how often?) and decide on the precautions (is there
a need for further action?) Consider both the consequence (how bad?) and
likelihood (how often?).
 Is there a need for additional action? The law requires everyone providing a service to
do everything reasonably practical to protect people from harm.

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 Identify the current controls/precautions that are in place to prevent the risk from
causing harm or loss.
 Use the Matrix Tool (appendix 1) and guidance in the Risk Assessment.
 Decide whether further precautions need to be taken to reduce the risk and if action is
required, determine what changes need to be made.
 Re-evaluate the risks assuming the precautions (controls) have been taken (to check
the expected impact of the proposed changes).
8.4. Record your findings, proposed action and identify who will lead on what action.
Record the date of implementation.
8.4.1 Documentation
 It is a key part of this procedure that risk assessments must be recorded.
 The record serves as evidence that the risk has been identified and evaluated and
provides the information necessary to review progress accurately over time to see if
the risk has been reduced.
 Risk assessments and action planning should be reviewed and changed when
necessary. This is easy only if the assessment is well recorded and the logic behind
the decisions transparent. Your documentation should show the following:
 That a thorough check was made to identify all the hazards and treat all the significant
risks;
 The precautions that are in place are appropriate to the risk and remain effective;
 The solutions proposed or being actioned to reduce the risk are realistic, sustainable,
and effective.
8.4.2 Storing Completed Assessments
 Divisions and departments should make local arrangements for the storage of completed risk
assessments. A copy of the completed form can be sent to the Health and Safety Manager
who will store it on the risk server but it remains the responsibility of the local manager to
ensure that a copy is kept locally.
 If the electronic risk assessment form is used then it can be uploaded to the electronic
database operated by the Health and Safety Manager. This provides a storage facility and the
ability for other staff to review completed assessments which can facilitate local planning
for risk reduction.
 Copies of completed risk assessments can be sent to the Health and Safety manager for
filing; however, it is the responsibility of the local manager to maintain copies
8.5. Review and update the assessment as necessary
 Risk assessments should be reviewed in the following circumstances:
 When a change is planned that could have an impact on the risk. Conducting a Risk
Assessment Procedure.
 If the proposed action generates a new hazard.
 When there has been a significant change.
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 Following the completion of an action plan designed to reduce the risk (to confirm that risk
reduction has been achieved)
 Routinely at least on an annual basis; (more frequently for high risks)
 For all non-routine, unscheduled, and pre-arranged work.
8.6. Management of Risk Assessment
8.4.3 Department managers are responsible for ensuring risk assessments are
undertaken in their areas. The Health and Safety Manager will support the
Department’s managers.
8.4.4 The management of risks identified through the risk assessment process will
be determined by the risk rating, (appendix 1).
8.4.5 All risks assessments must be reviewed when a major change occurs that
could have an impact on risk.
8.7. Hierarchy of Risk Control
 The idea behind this hierarchy is that the control methods at the top of the graphic are
potentially more effective and protective than those at the bottom. Following this hierarchy
normally leads to the implementation of inherently safer systems, where the risk of illness or
injury has been substantially reduced

8.7.1 Elimination and Substitution

o Elimination and substitution, while most effective at reducing hazards, also tend to
be the most difficult to implement in an existing process. If the process is still at the
design or development stage, elimination and substitution of hazards may be
inexpensive and simple to implement. For an existing process, major changes in
equipment and procedures may be required to eliminate or substitute for a hazard.

8.7.2 Engineering Controls

o Engineering controls are favored over administrative and personal protective

equipment (PPE) for controlling existing worker exposures in the workplace because
they are designed to remove the hazard at the source before it comes in contact with
the worker. Well-designed engineering controls can be highly effective in protecting
workers and will typically be independent of worker interactions to provide this high
level of protection. The initial cost of engineering controls can be higher than the
cost of administrative controls or PPE, but over the longer term, operating costs are
frequently lower, and in some instances, can provide cost savings in other areas of
the process.

8.7.3 Administrative Controls and PPE

o Administrative controls and PPE are frequently used with existing processes where

hazards are not particularly well controlled. Administrative controls and PPE

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programs may be relatively inexpensive to establish but, over the long term, can be
very costly to sustain. These methods for protecting workers have also proven to be
less effective than other measures, requiring significant effort by the affected
workers.

9. REFERENCES
9.1. ISO 45001 / 2018 clause 6.1
9.2. OSHA Standard.
9.3. Egyptian labor law 2003
10. LIST OF TABLES AND FIGURES
N/A
11. APPENDICES
11.1. Appendix 1

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11.2. Appendix 2

12. OTHERS
N/A
13. SOP History

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Amendment Summary
Version
Issue Date Page No.
No.
Before After

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