Standard Operating Procedure for Laboratory Risk management
Revised by:
Job:
Date:
Approved by:
Checked by:
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Date:
1. Purpose:
The purpose of this procedure is to provide for a system and instructions to assign responsibilities for identifying
and evaluating risks and opportunities.
2. Scope:
NMQCRL activity include (risks to users, customers, environment, etc.); Health and Safety (risks to the health
and safety of workers); Environment (risks of uncontrolled emissions, spills, etc.); and any other types of risks
that need to be identified and controlled.
3. Definition and abbreviations:
4. Responsibility:
Task
Authorized
Code no: GQP 16 Version no: (02) Version date: /0/2018 Effective date:0/0/2021 Expire date: / / Page 1of 5
Responsible
lab director
Risk assessment team
HOD
HOU
HOU
NMPB staff
5. Procedure:
1. The lab director confirms the risk assessment team which who trained in risk management to establish the
risk assessment.
2. Establish the context
To define the external and internal context parameters must consider when they manage risk and it includes
2.1. The lab director and QAM identify the scope, goals, interested parties and etc by using form no ()
2.2. Classify and analysis of strengths and weaknesses by SWOT analysis using excel sheet for risk
Assessment - Internal & External Issue ().
2.3. Determine of the risk assessment criteria form ().
3. Risk assessment
3.1. Risk identification
3.1.1. Register the risk and identify the sources of a particular risk, areas of impacts, and potential events
including the causes and consequences
3.1.2. Classify the source as internal or external
Using form ()
3.2.Risk Analysis
Code no: GQP 16 Version no: (02) Version date: /0/2018 Effective date:0/0/2021 Expire date: / / Page 2of 5
3.2.1.
Identify a detailed consideration of uncertainties, risk sources, consequences, likelihood, events,
scenarios, controls and their effectiveness.
3.2.2. analysis the Risk
- Severity, Probability and detectability.
- Methods of scoring severity.
- Probability estimate – quantitative, qualitative.
- Assessment of detectability.
- Risk Levels, Risk Acceptability.
- Determining an acceptable level of risk.
- Determining the Risk Priority Number..
Using the FMAE model using form ()
3.2.3. Identification and evaluation of the controls currently in place
3.3.Risk Evaluation
3.3.1. Compare the results of the risk analysis with the established risk criteria to determine the significance
of risk.
3.3.2. make a decisions to treat or accept risks with consideration of internal, legal, regulatory and external
party requirements
3.4.Risk treatment
3.4.1. Select the most appropriate risk treatment option(s)
3.4.2. Design risk treatment plans specifying how the treatment options will be implemented, using form
()
1.1.1. Implement corrective action
1.1.2. Assess the effectiveness of that treatment and prepare status report using form ()
1.1.3. decide whether the remaining risk is acceptable; if not acceptable, taking further treatment
Using form no (),()
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2. Monitoring and review
The lab director and HODs and HOUs
2.1. Evaluate the effectiveness of the procedures performed by reviewing the changing activities and
matching them with the possible results of the variable activity with the risk management plan
2.2. Conduct an internal audit by internal audit team and preparation of the report
2.3. Implementation of supervisory visits and reporting
2.4. Management Review
3. Awareness of employees and beneficiaries the risk assessment team and HODs and HOUs
3.1. risk assessment team prepare awareness plan
3.2. Implement the awareness plan and its programs
4. Close the hazard status
The QA Manger takes a decision to accept risk and close it
5. Related documents:
6. References:
ISO 31000:2018
7. Attachments:
Code no: GQP 16 Version no: (02) Version date: /0/2018 Effective date:0/0/2021 Expire date: / / Page 4of 5
Risk management frame
Code no: GQP 16 Version no: (02) Version date: /0/2018 Effective date:0/0/2021 Expire date: / / Page 5of 5