The document discusses hazard and risk management, outlining the processes of identifying, assessing, and controlling risks to protect life, health, property, and the environment. It emphasizes the importance of risk assessment for decision-making, compliance, and resource allocation while detailing methods such as failure mode effects analysis and hazard analysis. Additionally, it introduces a systematic risk management process that includes risk identification, analysis, evaluation, control, communication, and review.

1. 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

2. 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.

3. 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

4. Risk Management Process
systematic process for assessing,
controlling, communicating, and
reviewing risks
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5. 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

6. 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

7. 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.

8. 8
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

9. 9
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.

10. 10
PHA
Prerequisites
Hazard
Identification
Risk ranking
and follow-up
actions
Steps involved in preliminary
hazard analysis