Risk and Apportunity and Action Plan For Internal and External Issue - 2023
Risk and Apportunity and Action Plan For Internal and External Issue - 2023
Risk and Apportunity and Action Plan For Internal and External Issue - 2023
RISK AND APPORTUNITY AND ACTION PLAN FOR INTERNAL AND EXTERNAL
ISSUE
Contents
Should You Document your Risks & Opportunities Procedure?
How Do You Address Risk and Opportunities?
Why is Risk Management Important?
Risk Management Methodology
Risk Management Information
Communication of Risks
Outsourced Processes
Design & Development
Risk Registers
Auditing Risk Management
Clauses that Promote Risk-based Thinking
Risk Evaluation Process
Clauses that Promote Risk-based Thinking
Risks & Opportunities Procedure - What Might You Document?
Risks & Opportunities Procedure [ISO 9001, ISO 14001 & ISO 45001]
The risk and opportunity management framework define the current risk
management process, which includes; methodology, risk appetite, methods for
training and reporting.
External and internal issues, and relevant needs and expectations of relevant
interested parties may be sources of risks. Objective evidence may be in the
form of a dedicated risk matrix, risks added to other forms such as an aspect
register, corrective/preventive action log and forms, etc.
Each of the processes of a QMS do not represent the same level of risk in terms
of your organization’s ability to meet its objectives. Due to this reason, the
consequences of failures or non-conformities in relation to processes, systems,
products and/or services will not be the same for all organizations.
When deciding how to plan and control the QMS, including its component
processes and activities, your organization needs to consider both the type and
level of risk associated with them. Ensure that your organization is taking a
planned approach to addressing risks and realizing opportunities, and that any
actions taken have been recorded. Options to address risks and opportunities
can include:
Avoiding risk
Taking risk in order to pursue an opportunity
Eliminating the risk source
Changing the likelihood or consequences
Sharing the risk
Retaining risk by informed decision
SWOT analysis by the organization as part of its business strategy to identify
the external risk and opportunities and action plan to address them
Formal business risk assessment performed by the organization talking into
consideration its context, associated risk and opportunities and mitigation
plan
Use of process approach by organization to identify sources of input,
activities, output, receiver of output, performance indicators to control and
monitor processes, the risks and opportunities associated with them and
action plan to address them
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Your organization should begin to view the management of risks to its people,
assets and all aspects of its operations as an important responsibility. Implement
and maintain a risk management process to protect and support your
organization’s responsibilities. An effective risk management approach is not
only good business practice but provides organizational resilience, confidence
and benefits, including:
Communication of Risks
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Outsourced Processes
Your organization might outsource the provision of some processes or the
manufacture of components, sub-assemblies or entire units. In order to maintain
control over the processes, your organization should incorporate appropriate risk
management activities for these processes and products by planning and by
ensuring risk control measures are appropriately applied. Before the approval
and implementation of a change to any outsourced process or product, your
organization should:
For each identified hazard, the risk in both normal and fault conditions is
estimated. In risk evaluation, you should decide whether risk reduction is
needed. The results from this risk evaluation such as the need for risk control
measures then become part of the design input.
Risk Registers
While not mandated by ISO 9001:2015 or ISO 14001:2015, risk registers can
help identify and record the risks and opportunities facing different areas of the
business and identifying risk is a critical step in managing it.
Risk registers will allow your organization to assess the risk in context with the
overall context of your organization and will help to record the controls and
treatments of those risks. Risk registers can be developed in tiers:
Strategic level
Operational level
Process level
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A table presents a great deal of information in just a few pages. As the register
is a living document, it is important to record the date that risks are identified or
modified.
This should include reviews of processes and controls over high risks as
determined through the risk planning process. The internal audit function
provides independent appraisal of the adequacy and effectiveness of internal
controls. Recommendations should be provided, where applicable, for
improvements to controls, efficiency and effectiveness of processes.
There are six clauses in ISO 9001:2015 that require your organization to
consider risk:
1. Clause 4.4.1 requires your organization to determine the risks which can
affect its ability to meet the system objectives. Risk-based thinking means
considering risk quantitatively as well as qualitatively, depending on the
business context.
2. Clauses 5.1.1 and 5.1.2 require Top Management to demonstrate
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The overall aim of risk evaluation is to ensure that organizational capabilities and
resources are employed in an efficient and effective manner to manage
opportunities and threats.
Your organization should develop and document a plan that briefly describes
how and when risk, in the form of strengths, weaknesses, opportunities and
threats, will be assessed, and who will be involved. This should reflect
the scope (including its complexity, interfaces, etc.), policies and objectives.
Step 2: Identification
Risk identification should be carried out with the full involvement of the relevant
parties to ensure the relevant perspectives and expertise should be represented
(e.g. appropriately qualified representatives from various functions, contractors,
stakeholders, suppliers and specialists as appropriate.
Risk identification involves the relationship between your organization and the
broader, external environment or community.
Opportunities and threats associated with the local, regional, state and
global economic, social, political, cultural, environmental, regulatory and
competitive environments
Key thrusts of stakeholder strategies
Strengths and weaknesses of in attaining objectives
Operational risk identification involves gaining an understanding of the
organization’s capabilities, goals, objectives, strengths and weaknesses by
considering:
Step 3: Assessment
Having identified all hazards and associated risks which could impact on
occupational health and safety, the process of rating the risks for significance
can be carried out.
This crucial process, together with a thorough knowledge of legal and other
similar requirements, provide the foundations of the management system.
This assessment process is vital in determining the need for controls aimed at
either reducing risk to levels deemed to be tolerable or meeting the
requirements of legislation.
The significance level (or risk rating) should then be used to prioritize actions.
The assessment of the severity of a risk should drive management attention and
supports the planning for risk mitigation. Quantitative risk assessments (QRA)
can be undertaken to provide an improved understanding of the risk profile and
derive a more detailed understanding of certain cost and time risks. The output
of QRA can also support decision making and monitoring of risk management
activities.
Step 4: Response
For each risk, the risk owner must establish an appropriate level of mitigation.
Control measures in addition to those already existing may be needed to achieve
this level of mitigation.
When a response action is completed, the risk should be reassessed (i.e. repeat
Step 3) to reflect any newly introduced existing control measure.
Step 5: Review
Regular review and challenge is essential to ensure that risks are being
appropriately managed, and that the risk data remains accurate and reliable,
reflecting any changes in circumstances or management activities.
Step 6: Reporting
Step 7: Monitoring