This document provides an overview of risk analysis as it relates to food safety. It defines risk as a function of hazard probability and severity. Risk analysis includes risk assessment, management, and communication. Risk assessment involves hazard identification, characterization, exposure assessment, and risk characterization. The document outlines the steps of a risk assessment and notes that risk management involves weighing policy alternatives based on risk assessment results. It also provides details on Hazard Analysis and Critical Control Points (HACCP), a food safety system that identifies, evaluates, and controls hazards through establishment of critical control points and limits.
Presentation: Quality risk management issuesTGA Australia
Quality Risk Management (QRM) is a fundamental element of the regulation of medicinal products. Manufacturers and sponsors widely incorporate the elements of ICH Q9 into their QMS systems. Although Annex 20 (Quality Risk Management) is a voluntary Annex, version 13 of the PIC/S guide to GMP for medicinal products has seen a significant increase in the mandated QRM requirements through the general chapters and Annexes. What do organisations need to do to ensure that they understand their obligations to risk.
Critical Hazard Management System (CHMS)AnkitVasoya5
TOPIC ~ Critical Hazard Management System
What Is Hazards ?
Why Management ?
The most common hazards
How to prevent workplace from Hazards
Identification of Hazards
Risk Assessment
Controlling risk and Hazards
Risk / Hazard monitoring
References.
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
Presentation: Quality risk management issuesTGA Australia
Quality Risk Management (QRM) is a fundamental element of the regulation of medicinal products. Manufacturers and sponsors widely incorporate the elements of ICH Q9 into their QMS systems. Although Annex 20 (Quality Risk Management) is a voluntary Annex, version 13 of the PIC/S guide to GMP for medicinal products has seen a significant increase in the mandated QRM requirements through the general chapters and Annexes. What do organisations need to do to ensure that they understand their obligations to risk.
Critical Hazard Management System (CHMS)AnkitVasoya5
TOPIC ~ Critical Hazard Management System
What Is Hazards ?
Why Management ?
The most common hazards
How to prevent workplace from Hazards
Identification of Hazards
Risk Assessment
Controlling risk and Hazards
Risk / Hazard monitoring
References.
Quality Risk management in pharmaceutical Industry. A general Review on Risk analysis and Risk assessment in pharmaceutical Industry as it is prescribed by GMP regulations of WHO, ICH, FDA.
ICH Guideline Q9 - Quality Risk Managementmuna_ali
A presentation of the ICH guideline Q9 (Quality Risk Management). It discusses the basic risk management procedure, list of recognized risk management tools and its role in pharmaceutical industry.
HAZARD ANALYSIS RISK-BASED PREVENTIVE CONTROL [HARPC] & TRADITIONAL HACCPEng. A.karam Al Malkawi
A new module to analyse food safety hazards using risk-based thinking to preventive hazards from being occur in food safety chain. if you find this article useful Share it and let more people know what is the new topic means.
What are the process of a well-defined Risk Assessment. When taken in sequence, support better Decision Making by contributing to a greater insight into risks and their impacts.
ICH Guideline Q9 - Quality Risk Managementmuna_ali
A presentation of the ICH guideline Q9 (Quality Risk Management). It discusses the basic risk management procedure, list of recognized risk management tools and its role in pharmaceutical industry.
HAZARD ANALYSIS RISK-BASED PREVENTIVE CONTROL [HARPC] & TRADITIONAL HACCPEng. A.karam Al Malkawi
A new module to analyse food safety hazards using risk-based thinking to preventive hazards from being occur in food safety chain. if you find this article useful Share it and let more people know what is the new topic means.
What are the process of a well-defined Risk Assessment. When taken in sequence, support better Decision Making by contributing to a greater insight into risks and their impacts.
Effective Risk Management,
Measurement, Monitoring & Control is
the process of:
proactively planning for risks
identifying risks
diligently conducting sound risk
management,
fully analyzing risk
customizing risk response being
sensitive to the 1st impact and the
earliest timing
Monitoring risks until they no longer
exist &/or the project objectives are
achieved or cancelled
Effectively and Efficiently
controlling risk outcomes
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Risk management tools and techniques for environmental monitoring:
Application of HACCP for selecting environmental monitoring locations; Use of risk filtering to determine frequencies of monitoring ; Applying FMEA to assess risks from process equipment – a sterility testing isolator.
this presentation contains information about HACCP implementation in food industry. with example, easy to understand comment below how is this presentation
hello there , During M pharm , I have presented this for seminar purpose named as '' QUALITY RISK MANAGEMENT " Hope it will reach your expectations. thank you.
HACCP stands for Hazard Analysis Critical Control Point which is important and preliminary step used for ensuring safety of food before it reaches to consumers
In an era where food safety is of paramount importance, HACCP has emerged as a systematic and preventive approach to identifying and managing potential hazards in food production processes. This presentation aims to shed light on the fundamental principles of HACCP, its benefits, and its significance in ensuring the safety of our food supply.
Definition and Background:
We begin by defining HACCP as an internationally recognized food safety management system designed to identify, evaluate, and control hazards that may pose risks to the safety of food products. It originated in the 1960s, developed by the Pillsbury Company in collaboration with NASA, with the primary objective of ensuring safe food for astronauts. Since then, HACCP has been widely adopted and applied across various sectors of the food industry.
Principles of HACCP:
Next, we delve into the seven core principles of HACCP, providing a comprehensive understanding of its systematic approach:
a. Conducting Hazard Analysis: Identifying potential biological, chemical, and physical hazards associated with each step of the food production process.
b. Determining Critical Control Points (CCPs): Identifying critical points in the process where control measures can be applied to prevent, eliminate, or reduce hazards to an acceptable level.
c. Establishing Critical Limits: Setting measurable criteria that define the maximum or minimum values to which control measures must be maintained at CCPs to ensure food safety.
d. Monitoring CCPs: Implementing procedures to regularly observe and record the control measures applied at CCPs to ensure they remain within established critical limits.
e. Implementing Corrective Actions: Establishing protocols to take immediate action when monitoring indicates that a CCP is not within its critical limits, aiming to prevent unsafe food from reaching consumers.
f. Verifying the System: Periodically evaluating the effectiveness of the HACCP system to ensure it is functioning correctly and providing the desired level of protection.
g. Establishing Documentation and Record-Keeping: Maintaining comprehensive records of all procedures, actions, and results to demonstrate the application and effectiveness of the HACCP system.
Benefits of HACCP:
This section focuses on the numerous advantages offered by implementing HACCP within the food industry:
a. Enhanced Consumer Protection: By systematically identifying and managing hazards, HACCP significantly reduces the risk of foodborne illnesses, protecting consumer health and well-being.
b. Regulatory Compliance: HACCP is a widely recognized and mandated approach in many countries, ensuring compliance with regulatory requirements and fostering a culture of food safety.
c. Improved Product Quality: Implementing HACCP promotes consistent adherence to quality standards, leading to improved product quality and customer satisfaction.
d. Cost Reduction:
Risk assessment and management during food preparationaleeban_irasna
About the challenges reagarding food safety,risk analysis, risk assessment and principles of food safety management in food industry. Also contains the case study of Listeria monocytogenes in Deli meats
5. Hazard identification Biological Chemical Physical agents Hazard characterization Qualitative and/or Quantitative Evaluation Nature of adverse effects by agents Chemical agents-a dose response Physical and Biological-dose response if data present or obtainable
9. RISK MANAGEMENT Weighing policy alternatives in the light of the results of risk assessment. Selecting and implementing appropriate control options,including regulatory measures. Note:Major concern human health cosideration.
19. Control hazards , significant for food safety.
20. Evolution of HACCP System Developed for micro biological food safety of ASTRONAUTS Original system Drawn up by Pillsbury Company working with NASA and the US military
21. HACCP Terminology CCP-CCP is an operation(practice,process,procedure or location) at which a preventive or control measure can be exercised that will eliminate,prevent or minimize a hazard or several hazard. CRITICAL LIMIT- The value of a monitored action which separates the acceptable from unacceptable. CONTROL POINT-It is an operation at which preventive and/or control actions are taken because of good manufacturing practices,regulations,product reputation, corporate/company policies or aesthetics. Such distinction between CCP and CP are one of the unique features of HACCP System. This allows setting priorities on risk and emphasizes operations that offer the greatest potential for control.
22. CORRECTIVE ACTION-It is a specified prompt action to be taken when the criteria are not met or when the results of monitoring the CCP indicates a trend towards loss of control. VERIFICATION-Review of monitoring records to determine whether the HACCP system is in place and functioning as planned and to ensure that monitoring is carried out effectively and efficiently. DECISION TREE-A sequence of Questions applied to each process step with a potential hazard to identify which process steps are critical to food safety.
23. 7-HACCP Principles 1. Conduct Hazard Analysis- Process flow diagram. Identify hazards and Preventive measure 2. Determine CCP’s in process Establish the points where control is critical to mange the safety of the product. 3. Establish critical limits for preventive measures associated with each identified CCP The critical limits describe the difference between safe and unsafe product at the CCPs These must involve a measureable parameter and may also known as the absolute tolerance for the CCP
24. 4. Establish a system to monitor control of the CCP. Specify monitoring requirements for management of the CCP within its critical limit. It involves specifying monitoring actions along with frequency and responsibility. 5. Establish the corrective action to be taken when monitoring Act to bring the process back under control. Act to deal with product manufactured while the process was out of control.
25. 6. Establish procedures for verification to confirm that the HACCP system is working effectively 7. Establish documentation concerning all procedures and records appropriate to these principles and their application.
26. Application Stages of HACCP Determine the terms of reference Assemble and Train the HACCP team Describe the processes/products Identify intended use Construct flow diagram On-ste verification of flow diagram List all potential hazards Conduct a Hazard analysis Determine control measures Determine CCPs Establish critical limit for each CCP Establish a monitoring system for each CCP Establish Corrective Action for Deviations that may occur Establish Verification Procedures Establish record keeping and Documentation Review the HACCP plan
27. Need For HAccp Ensuring Food Safety Preventing food borne deseases outbreak International obligations-SPS,TBT