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Presented By:
Miss. Mohini Tawade,
First Year M. Pharmacy,
Department of Quality Assurance,
Guided By:
Dr. (Mrs.) Shubhangi Pharande,
Dr. D.Y. Patil College of Pharmacy, Akurdi,
Pune.
Hazard And Risk
Management

8/03/20XX PITCH DECK 2
INTRODUCTION
Hazard:
Situation that posses a level of threat to life, health, property, or environment
Hazard Management involves identifying hazard, assessing the hazard, and controlling the
risk.
Risk:
Risk = Probability + Severity
Risk management involves risk identification, assessment, mitigation, elimination and
communication.

Importance of Risk Assessment and Risk Management:
 Identifying and understanding potential risk
 Prioritizing Risks/ Risk Ranking
 Preventing or minimizing the negative impact on the organization
 Enhancing decision-making
 Ensuring compliance with regulations and standards
 Supporting continues improvement
 Cost-effective resource allocation
 Corrective and Preventive Action

Risk Management Process
systematic process for assessing,
controlling, communicating, and
reviewing risks
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1) Initiating a Quality Risk Management Process
Defining and identifying risk
Gathering background information
2)Risk Assessment
Risk
identification
Systematic use of
information to
identify hazards
Risk Analysis
Estimation of
the risk
associated with
the identified
hazards
Risk Evaluation
Compares the
identified and
analysed risk
against given risk
criteria

3) Risk Control
Risk Reduction: Reduce the risk to an acceptable level.
Risk acceptance
4) Risk Communication
Sharing the information of risk and risk management documents between the decision-
makers and others
5) Risk Review
The output/results of the risk management process should be reviewed

Risk Management Methods and Tools:
Basic Risk Management Facilitation Methods
For example
Flowcharts; Check Sheets; Process Mapping; Cause and Effect Diagrams (also called an
Ishikawa diagram or fishbone diagram)
Failure Mode Effects Analysis (FMEA)
Used to evaluate failure mode for processes and its effect on results or product performance.
Failure Mode, Effects, and Criticality Analysis (FMECA)
Investigation of the degree of severity of the outcomes, their respective probabilities of
occurrence, and their detectability.
Fault Tree Analysis (FTA)
Determines the possible causes and probability of occurrence of an unexpected event.

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Hazard Analysis and Critical Control Points (HACCP)
It is a systematic, proactive, and preventive tool for assuring product quality, reliability,
and safety
Preliminary Hazard Analysis (PHA)
Analysis based on applying prior experience or knowledge of a hazard or failure to
identify future hazards
Risk Ranking and Filtering
Supporting Statistical Tools
Enable effective data assessment and facilitate more reliable decision making

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Preliminary Hazard Analysis:
Preliminary hazard analysis (PHA) is a semi-quantitative analysis that is performed to:
Identify all potential hazards and accidental events that may lead to an accident
Rank the identified accidental events according to their severity
Identify required hazard controls measures and follow-up actions
As an initial step of a detailed risk analysis of a system concept or an existing system.

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PHA
Prerequisites
Hazard
Identification
Risk ranking
and follow-up
actions
Steps involved in preliminary
hazard analysis

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Hazard And Risk Management.pdf

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Hazard And Risk Management.pdf