1 Risk Assessment and Management Allen L. Burgenson Manager, Regulatory Affairs Lonza Walkersville Inc.
2 Standard Disclaimer Standard Disclaimer: This presentation is the opinion of the presenter, and does not necessarily represent the opinions or practices of Lonza Inc. or its subsidiaries.
3 Overview Concepts Definitions Specific Applications
4 What is Risk
5 Risk and Consequences
6 Definitions Hazard: The potential source of harm (ISO/IEC Guide 51) Risk: The combination of the probability of occurrence of harm, and the severity of that harm (ISO/IEC Guide 51) Quality: The degree to which a set of inherent properties of a product, system, or process fulfills requirements. (ICH Q9)
7 Definitions Risk Acceptence: The decision to accept risk (ISO Guide 73) Risk Analysis: The estimation of the risk associated with the identified hazards (ICH Q9) Risk Assessment: A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of the hazards, and the analysis and evaluation of risks associated with the exposure to these hazards (ICH O9)
8 Definitions Risk Communication: The sharing of information about risk and risk management between the decision maker and the stakeholder Risk evaluation: The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk Risk identification: The systematic use of informaton to identify potential sources of harm (hazards) referring to the risk question or problem description.
9 Definitions Risk management: The systematic application of quality management policies, procedures and practices to the tasks of assessing, controlling, communicating, and reviewing risk. Risk reduction: Actions taken to lessen the probability of occurrence of harm and the severity of that harm. Risk review: Review or monitoring of output/results of the risk management process considering (if appropriate) new knowledge and experience about the risk.
10 Definitions Severity: A measure of the possible consequences of a hazard Stakeholder: Any individual, group, or organization that can affect, be affected by, or perceive itself to be affected by a risk. Decision makers might also be stakeholders.
11 Hazard A real or potential condition, situation, or agent that could cause immediate or long-term harm to people or an organization; damage or loss of a system, equipment, property, or the environment, or other things of value James L. Vesper Risk Assessment and Risk Management in the Pharmaceutical Industry (2006) PDA/DHI
12 Risk Risk is the possibility that human activities or natural events will lead to consequences that affect what people value. It is a measure of the potential ability to achieve overall program objectives within defined costs, schedule, and performance criteria. Risk has three components: What could go wrong? What is the probability of failing to achieve a particular outcome? What is the impact of failing to achieve a particular outcome?
13 The Risk Management Process System Definition Hazard Identification Risk Estimation Risk Evaluation Risk Control Risk Monitoring and Re-evaluation evaluation Risk Communication
14 The Risk Management Process System, Product, or Process Definition Risk Assessment Risk Analysis System Description Hazard Identification Risk Estimation Risk Management Risk Analysis Tools: - PRA - FMEA - FTA - HAZOPS - HACCP - ETC. Risk Acceptable? YES NO Monitoring and Re-evaluation Control and Mitigation Communication Vesper, 2006
15 Risk Management Process Establish overall structure, goals Establish team Define the scope for the process/product Identify the potential hazards Identify how risk can be expressed and criticality Determine if the risk is acceptable If risk is to be controlled, identify appropriate methods
16 Risk Management Process Re-evaluate evaluate the controlled risk to determine if risk is now acceptable Implement risk control methods Compile records to document activities Monitor the process for effectiveness Actively communicate with stakeholders throughout the process!
17 System Definition What is to be evaluated? What stage of production is being evaluated? Why is this being evaluated? Assemble cross-functional team for assessment
18 Hazard Identification Is there an intrinsic hazard? Are there multiple hazards? Are the hazards immediately detectable, or are they long-term? Does the hazard trigger a chain reaction of events? Who or what do the hazards effect?
19 Risk Estimation What is the probability that the risk is expressed? Qualitative Semi-quantitative Quantitative What is the impact of the resulting effects? Local effects End effects
20 Risk Evaluation Is the risk acceptable? Do the risks need to be mitigated or controlled? ALARA As Low As Reasonably Achievable ALARP As low As Reasonably Practicable
21 Risk Control How can the risk be controlled? Substitution Uncoupling Process simplification Isolation Elimination Changing conditions Providing more information
22 Risk Control How can the risk be controlled? Decreasing the frequency of an event happening Decreasing the consequences Duplicating assets Changing the source Implementing standard procedures Engineering controls Training and preparedness
23 Risk Monitoring and Re-evaluation evaluation Collect data on the process Have any unpredicted risks appeared? Risk environment changes Company expectations Regulatory environment Societal expectations
24 Risk Communication Effective communication should take place throughout the entire risk management process. Include ALL stakeholders!
25 Risk Assessment Tools FMEA and FMECA Fault Tree Analysis Event Tree Analysis Hazard Operability Studies HACCP Preliminary Risk Analysis etc.
26 FMEA and FMECA Failure Mode Effects Analysis Failure Mode Effects & Criticality Analysis Adds criticality analysis to FMEA Structured inductive tools to identify known or potential failure modes
27 FMEA and FMECA Benefits: Used to examine high-level systems or small components Scalable Quantitative or semi-quantitative Limitations Each event is a separate occurrence Does not show interactions
28 FMEA and FMECA 1. Define what is being analyzed 2. Identify the potential failure modes 3. Identify the effects of each failure mode 4. Rate each effect for: Probability of occurrence Severity Detectability Calculate Risk Priority Number RPN = probability x severity x detectability*
29 FMEA and FMECA 5. Prioritize the effects based on RPN and determine risk acceptability 6. If risk acceptable, continue monitoring 7. If risk must be modified or eliminated, consider appropriate control or mitigation strategies 8. Prepare report and retain documentation
30 The PROBABILITY of Occurrence Probability Rating Amount of Data significant data on the same activity significant data on similar activities limited data on similar activities significant data on similar activities limited data on similar activities significant data on dissimilar activities limited data on dissimilar activities no prior data on similar activities limited prior data on similar activities significant data on similar activities Probability of Occurrence of Adverse Event virtually no likelihood very low likelihood low likelihood fair likelihood fair likelihood fair likelihood good likelihood good likelihood significant likelihood near certain
31 IMPACT OF RISK ON THE PERFORMANCE OF THE PRODUCT OR SERVICE Impact Rating Product or Service Quality Impact Process Changes no measurable impact some negative impact some negative impact impact negatively impact negatively significant, negative impact significant, negative impact significant, negative impact critically negative impact critically negative impact none remains well within acceptable tolerances remains within acceptable tolerances requires very minor changes in production requires modest changes in production requires work-arounds to meet acceptable tolerances extensive work-arounds may be necessary extensive work-arounds are necessary even the work-arounds present significant risk there is no alternative or solution
32 Impact and Probability The Severity Index Severity P r o b a b I l I t y Highest Impact of the Risk Event
33 Risk Level Definition High 60 & above Because concerted and continual emphasis and coordination may not be sufficient to overcome major difficulties, these events must be placed in the program and fully funded. They are likely to cause significant disruption in the schedule, increase in cost (relative to the total production cost of the product), and/or degradation of technical performance. Medium Special emphasis and close coordination will be required to mitigate this risk. Should this risk occur significant disruption of schedule, increase in cost (relative to the production cost of the product) and/or degradation of technical performance is likely. Low Below 20 Normal emphasis and close coordination should be sufficient to mitigate major difficulties. However, should this risk occur, there is potential for disruption of schedule, increase in cost (relative to the production cost of the product), and/or degradation of technical performance. Fund at the risk-adjusted value.
34 Risk in Project Management When everything is a priority, nothing is a priority!
35 The PROBABILITY of Occurrence Probability Rating Amount of Data significant data on the same activity significant data on similar activities limited data on similar activities significant data on similar activities limited data on similar activities significant data on dissimilar activities limited data on dissimilar activities no prior data on similar activities limited prior data on similar activities significant data on similar activities Probability of Occurrence of Adverse Event virtually no likelihood very low likelihood low likelihood fair likelihood fair likelihood fair likelihood good likelihood good likelihood significant likelihood near certain
36 IMPACT ON THE ACTIVITY SCHEDULE SHOULD A RISK EVENT OCCUR 1. A risk event occurs, and has a small, immeasurable impact on the activity under assessment. 2. A risk event occurs, and the time to complete the activity under assessment has been extended by 1 month. 3. A risk event occurs, extending the activity schedule by 2 to 3 months. 4. A risk event occurs, extending the activity schedule by 3 to 6 months. 5. A risk event occurs and extends the activity schedule by 6 to 9 months. 6. A risk event occurs and extends the activity schedule by 9 to 12 months. 7. A risk event occurs and extends the activity schedule by 12 to 18 months. 8. A risk event occurs and extends the activity schedule by 18 to 24 months. 9. A risk event occurs and delays the activity schedule by more than two years. 10. A risk event occurs and it stops the program!
37 Risk Effects on Timelines Project "A" Timelines Optomistic 1 Realistic Pessimistic
38 HACCP Hazard Analysis and Critical Control Points Originally established for use in the food industry A system of hazard control pioneered by the Pillsbury Co. Now accepted internationally as a system of food risk assessment. Can easily be adapted to other industries
39 HACCP Preliminary Activities 1. Assemble the HACCP team 2. Describe the product and its distribution 3. Describe the intended use and consumers of the product 4. Develop a process flow diagram 5. Verify the flow diagram
40 HACCP Principles 1. Conduct a Hazard Analysis 2. Identify the Critical Control Points in the Process 3. Establish critical limits associated with each identified control point 4. Establish CCP monitoring requirements
41 HACCP Principles 5. Establish corrective action when deviation occurs 6. Establish effective recordkeeping to document HACCP system 7. Establish procedures to verify HACCP system is working 8. Establish procedures to verify HACCP system is working
42 Conduct a Hazard Analysis Team uses the process flow diagram to identify any risks that may occur at a given process step. Assess the risks for probability of occurrence and impact Assess potential preventative measures
43 Identify the Critical Control Points in the Process A critical Control Point is a step or procedure that can be applied, and a food hazard prevented, eliminated, or reduced to an acceptable level. Example: a specified heat process, at a given time and temperature to destroy a specified microbial pathogen, is a CCP.
44 Establish Critical Limits Associated With Each Identified Control Point A critical limit is defined as a criterion that must be met for each preventative measure associated with a CCP. Each CCP may have one or more preventative measures for the CCP
45 Establish CCP Monitoring Requirements Monitoring is a planned sequence of observations to assess if a CCP is under control, and produce an accurate record. If monitoring shows the process to begin to lose control, the process can be modified to bring it into control.
46 Establish Corrective Action When Develop a plan to: Deviation Occurs Dispose of non-compliant product fix or correct the cause of the deviation maintain records documenting the corrective actions The data must demonstrate that the CCP can be brought into control
47 Establish Effective Recordkeeping To Document HACCP System The HACCP records should: List the HACCP team and responsibilities Describe the product and intended use Contain a flow diagram indicating the CCPs Identify hazards associated with each CCP and preventative measures Critical limits Describe the monitoring system Describe corrective action plans Describe recordkeeping procedures Describe procedures for verification of HACCP system
48 HACCP Flowchart
49 Risk and Consequences
50 Risk and Consequences "Red on yellow, kill a fellow. Red on black, won't hurt Jack."
51 For Additional Information Vesper, James Risk Assessment and Risk Management in the Pharmaceutical Industry Clear and Simple PDA/DHI ICH Q9 Quality Risk Management (2006) U.S. Food & Drug Administration. HACCP: Establishing Hazard Analysis Critical Control Point Programs (1993) Food Processors Institute ISO/IEC Guide 73:2002 Risk Management Vocabulary- Guidelines for use in standards Stamatis, D.H. Failure Mode and Effect Analysis (1995) ASQ Quality Press
Lotlikar et al Journal of Drug Delivery & Therapeutics; 2013, 3(2), 149-154 149 Available online at http://jddtonline.info REVIEW ARTICLE QUALITY RISK MANAGEMENT (QRM): A REVIEW Lotlikar MV Head Corporate
Quality & Compliance Associates, LLC Best Practice In A Change Management System President Quality & Compliance Associates, LLC Change Control and Its Role in a Continuous Improvement Environment 3 Benefits
Risk Assessment for Medical Devices Linda Braddon, Ph.D. Bring your medical device to market faster 1 My Perspective Work with start up medical device companies Goal: Making great ideas into profitable
International Journal of PharmTech Research CODEN (USA): IJPRIF ISSN : 0974-4304 Vol.6, No.3, pp 908-914, July-Aug 2014 Quality Risk Management in Pharmaceutical Industry: A Review V Vijayakumar Reddy*,
Improved Utilization of Self-Inspection Programs within the GMP Environment A Quality Risk Management Approach Barbara Jeroncic Self-inspection is a well-established and vital part of the pharmaceutical
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE QUALITY RISK MANAGEMENT Q9 Current Step 4 version
Guidance for Industry Q9 Quality Risk Management U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation
Controlling Risks Risk Assessment Hazard/Risk Assessment Having identified the hazards, one must assess the risks by considering the severity and likelihood of bad outcomes. If the risks are not sufficiently
Risk Assessment Tools for Identifying Hazards and Evaluating Risks Associated with IVD Assays Robert C. Menson, PhD AACC Annual Meeting Philadelphia, PA 22 July 2003 What Risks Must Be Managed? Risk to
Manufacturing Technology Committee Risk Management Working Group Risk Management Training Guides Hazard Analysis and Critical Control Points (HACCP) 1 Overview Hazard Analysis and Critical Control Point
Leila Kakko Tampere University of Applied science TRADITIONAL FOOD IN COMBATING FOODBORNE PATHOGENS 2011 World Food Programme Food quality control is necessary to ensure that food aid supplies are safe,
Introduction to HACCP Principles in Meat Plants1 Jeff W. Savell Professor and E.M. Rosenthal Chairholder Department of Animal Science Institute of Food Science and Engineering Texas A&M University College
PS/INF 1/2010 * * Quality Risk Management Quality Risk Management Implementation of ICH Q9 in the pharmaceutical field an example of methodology from PIC/S Document > Authors: L. Viornery (AFSSAPS) Ph.
A Risk Management Standard Introduction This Risk Management Standard is the result of work by a team drawn from the major risk management organisations in the UK, including the Institute of Risk management
Final Draft Rev. December 28, 2008 Quality Risk Management Principles and Industry Case Studies T. Frank 1, S. Brooks 2, R. Creekmore 3, B. Hasselbalch 4, K. Murray 5, K. Obeng 6, S. Reich 5, E. Sanchez
Hazard Analysis & Critical Control Point (HACCP) Objective: Understand the objectives, structure and possible project uses for HACCP Who Cares and Why Saves your business money in the long run Avoids you
CONCEPTS OF FOOD SAFETY AND QUALITY MANAGEMENT SYSTEMS Mrs. Malini Rajendran Brief background 1963 - The Codex Alimentarius Commission was created by FAO and WHO to develop food standards, guidelines and
Choosing the Best Device Sample Size for Verification and Validation Steven Walfish Staff Statistician, Corporate Quality Agenda Validation scope Statistical tools MSA Design Verification and Validation
Medical Device Risk Management ISO 14971 Dan O Leary President Ombu Enterprises, LLC Dan@OmbuEnterprises.com www.ombuenterprises.com OMBU ENTERPRISES, LLC 1 Speaker Biography Dan O Leary Dan O Leary is
Impact Assessment in a Science & Risk Based Environment R. Legland 11/04/11 Background US GMP s EU GMP s Japan GMP s ICH Q8, Q9, Q10 Guidance ASTM Standard E2500-07 Science and Risk Based Approach to Determine
The use of risk assessment tools for microbiological assessment of cleanroom environments by Tim Sandle Email: firstname.lastname@example.org / email@example.com Web: www.pharmig.blogspot.com Environmental
Using Risk Assessment to Put the Design into QbD GMPs for the 21 st Century... The FDA introduced their Pharmaceutical cgmps for the 21 st Century A Risk-Based Approach (Aug 2002) to reassess their approach
HACCP: Hazard Analysis Critical Control Points Dr. Angela Shaw Department of Food Science and Human Nutrition Extension and Outreach Information Adapted from: Hazard Analysis and Critical Control Point
FMEA and FTA Analysis Why it is Coming to Your Hospital and Your Laboratory Tina A. Krenc Director, R&D Phase Systems Abbott Laboratories 1 Agenda Background on requirements for risk management Tools to
MANUFACTURING STRATEGY LIUC - Università Cattaneo RISK ANALYSIS Carlo Noè Scuola di Ingegneria e-mail: firstname.lastname@example.org 1 RISK ANALYSIS Risk Analysis: technique that considers the "risk" as a key element to
3.0 Risk Assessment and Analysis Techniques and Tools Risks are determined in terms of the likelihood that an uncontrolled event will occur and the consequences of that event occurring. Risk = Likelihood
Quality Risk Management in the FDA-Regulated Industry Jose Rodriguez-Perez ASQ Quality Press Milwaukee, Wisconsin List of Figures and Tables Acronyms Preface Acknowledgments xi xiii xv xix Chapter 1: Introduction
Managing Clinical Trial Risk: It's a Tough Job, But One Person Has To Do It Michael Macri, Director, Strategic Services, inventiv Health Clinical Sherry Merrifield, Director, Clinical Monitoring, inventiv
Guidance for Industry: Quality Risk Management Version 1.0 Drug Office Department of Health Contents 1. Introduction... 3 2. Purpose of this document... 3 3. Scope... 3 4. What is risk?... 4 5. Integrating
Appendix 3 (normative) High level structure, identical core text, common terms and core definitions NOTE In the Identical text proposals, XXX = an MSS discipline specific qualifier (e.g. energy, road traffic
World Health Organization WHO Technical Report Series, No. 908, 2003 Annex 7 Application of Hazard Analysis and Critical Control Point (HACCP) methodology to pharmaceuticals 1. Introduction Traditionally,
Media fills Periodic performance qualification (Re-Validation) Minimum number of Simulations Number of units Contaminated Units Action a Two per Year (Retrospective & Prospective Validation) < 5000 5000
Risk Management Primer Purpose: To obtain strong project outcomes by implementing an appropriate risk management process Audience: Project managers, project sponsors, team members and other key stakeholders
An Introduction to Risk/Hazard Analysis for Medical Devices By Daniel Kamm, P.E., C.Q.A. Rev May 6, 2005 Risk analysis, or hazard analysis, is a structured tool for the evaluation of potential problems
Compliance Risk Assessment in Capital Expansion Projects Julie Lea Lipszyc, Quality Lead/Engineering Services, Therapure Biopharma Inc. September 2015 Share an applied and practical approach to perform
HACCP Manager Certification Training Version 3.0 Center for Public Health Education Developed by the NSF Center for Public Health Education HACCP Training Manual Table of Contents CHAPTER 1 1.0 What is
ANSWERS TO THE QUESTIONS IN THE COURSE GUIDE Risk Assessment and Treatment ARM 55 1 st Edition 2015-2016 CONTENTS Assignment Title Page 1 Introduction to Risk Assessment and Treatment 7 2 Root Cause Analysis
An Integrated Operational Risk Management Framework for Power Generation Ir Stephen W.K. Pang Acting Plant Risk Manager Generation Business Group CLP Power Hong Kong Limited Introduction Excellent risk
U.S. Dept. of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research ICH Q9 Quality Risk Office of Compliance Management - Regulatory Perspective Joseph C. Famulare
Edwin Lindsay Principal Consultant, Tel: + 44 (0) 7917134922 E-Mail: email@example.com There were no guidelines/ regulations There was no training No Procedures No Inspectors Inform All staff of
PREREQUISITE PROGRAMS The World Health Organization defines prerequisite program as practices and conditions needed prior to and during the implementation of HACCP and which are essential for food safety.
Training Modules on General Food Safety Plans for the Food Industry Hazard Analysis and Critical Control Points This module is part of a training program on General Food Safety Requirements for the Food
Overview: The FDA requires medical device companies to verify that all the design outputs meet the design inputs. The FDA also requires that the final medical device must be validated to the user needs.
SCADA Business Continuity and Disaster Recovery Presented By: William Biehl, P.E. 913-601-0104 (mobile) Bill.Biehl@we-inc.com Business Continuity Planning, a Sound Process A Business Continuity Plan: "A
FMEA and HACCP: A comparison Steve Murphy Marc Schaeffers FMEA and HACCP: A comparison Introduction FMEA and Control planning is being used more and more in industry. In the food industry companies use
Research Article Planning of Hazard Analysis Critical Control Point (HACCP) in Pharmaceuticals Rasika Patil, *Gangadharappa H.V, Kiran H.C, Sandhya K Department of Pharmaceutics, JSS College of Pharmacy,
PROJECT RISK MANAGEMENT http://www.tutorialspoint.com/pmp-exams/project_risk_management.htm Copyright tutorialspoint.com Here is a list of sample questions which would help you to understand the pattern
II.2 Life Cycle and Safety Safety Life Cycle: The necessary activities involving safety-related systems, occurring during a period of time that starts at the concept phase of a project and finishes when
FOCUS ON... COMPLIANCE Author Insights Online Exclusive www.bioprocessintl.com/bpiextra Quality Risk Management for Drug Products and Drug Substances by Thomas A. Little Risk assessment is used as a vetting
Risk Management Series - Part 6: Estimating Probability of Occurrence Foreword MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in
The Utility of Root Cause Analysis and Failure Mode and Effects Analysis in the Hospital Setting Learning objectives: Upon completion of this activity, the participant should be able to: 1. Discuss the
TRAINING TITLE: Johnson & Johnson CAPA Owners Certification (CERT-009) OVERVIEW: Medical devices, biopharmaceutical, and traditional drug manufacturing companies devote an important part of their resources
ISO/TMB WG on Risk management N 066 Date: 2008-04-01 ISO/IEC CD 2 Guide 73 ISO/TMB WG on Risk management Risk management Vocabulary Warning This document is not an ISO International Standard. It is distributed
Nova Scotia EMO Hazard Risk Vulnerability Assessment (HRVA) Model Guidelines for Use October, 2010 EMO NS Hazard Risk Vulnerability Assessment Model Page 1 of 10 Table of Contents 1. Background 2. Definitions
1. The purpose of a is to provide a clear, simple outline of the steps involved in a food process A. hazard analysis. B. monitoring procedure. C. verification exercise. D. flow diagram. 2. The MOST important
Audit of HACCP systems Module 1 HACCP Systems ABC Food Safety Online Aim The aim of this module is to provide delegates with an overview of food safety management systems based on the principles of HACCP.
A Study on Development of Railway Accident Scenarios for Railway Workers Chanwoo Park, Jongbae Wang, Yunok Cho, Sanglog Kwak, Joonam Park Safety Technology Research Team, Korea Railroad Research Institute,
A Recipe for Safe Food: ISO 22000 and HACCP by John G. Surak Food safety experts insist that the U.S. food supply is one of the safest in the world. However, the Centers for Disease Control and Prevention
Introduction The company is committed to supplying safe products for consumption. As part of this commitment, all products and processes used in the manufacture of food products are subject to hazard analysis
Advanced Fault Tree Analysis for Improved Quality and Risk Assessment Jussi-Pekka Penttinen 1, Timo Lehtinen 2 Abstract Traditional fault tree analysis (FTA) has formed a common language for the modelling
Principle #4 - Monitoring Principle #4 - Monitoring Monitoring Conduct a planned sequence of observations or measurements to assess whether a CCP is under control & to produce an accurate record for future
Hazard Analysis Critical Control Point Program Overview Hazard Analysis Critical Control Point (HACCP) is the final stage of an integrated, proactive food safety program targeting the handler and designed
Summary of Learning Outcomes Level 3 Award in HACCP for Food Manufacturing 1 Qualification Number: 500/7612/7 Contents Contents... 2 SUMMARY OF LEARNING OUTCOMES FOR LEVEL 3 AWARD IN HACCP FOR FOOD MANUFACTURING...
Training Modules on General Food Safety Plans for the Food Industry Section 3-9: Principle 7: Record- Keeping Procedures Section Overview The seventh and final principle of HACCP is to establish effective
NCA Best Practice: Hazard Analysis Critical Control Point (HACCP) Introduction Hazard Analysis Critical Control Point (HACCP) is a systematic approach to food safety management throughout the supply chain.
IN-DEPTH REVIEW Occupational Medicine 2004;54:311 315 doi:10.1093/occmed/kqh074 Occupational safety risk management in Australian mining J. Joy Abstract Key words In the past 15 years, there has been a
APPLICATION OF HACCP PRINCIPLES IN SHELLFISH DEPURATION Iddya Karunasagar Products, Trade and Marketing Service Fisheries and Aquaculture Department Food and Agriculture Organization of The United Nations.
Controlling Risks Safety Lifecycle Objective Introduce the concept of a safety lifecycle and the applicability and context in safety systems. Lifecycle Management A risk based management plan for a system
Certified HACCP Auditor Quality excellence to enhance your career and boost your organization s bottom line www.asq.org/certification Certification from ASQ is considered a mark of quality excellence in
Risk Management Motivations When we looked at project selection we just took into account financial data In the scope management document we emphasized the importance of making our goals achievable, i.e.
Standard Rio Tinto management system December 2014 Group Title: Rio Tinto management system Document No: HSEC-B-01 Standard Function: Health, Safety, Environment and Communities (HSEC) No. of pages: 23
HACCP What is HACCP? Hazard Analysis and Critical Control Point system Sometimes referred to as Hazard Analysis and Critical Control Points Hazard Analysis of Critical Control Points (incorrect) What is
Operational Prerequisite Programme Training Guide Operational Prerequisite Programmes Operational prerequisite programmes are put in place for significant hazards that are not controlled in the HACCP plan
Deviation Handling and Quality Risk Management A note for guidance for the manufacture of prequalified vaccines for supply to United Nations agencies July, 2013 Vaccine Quality and Regulations (VQR), Essential
DRAFT ISO 45001 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards
FOOD SAFETY MANAGEMENT SYSTEMS (FSMS): REQUIREMENTS FOR ANY ORGANISATION IN THE FOOD CHAIN (ISO 22000:2005) Dr.R.MANAVALAN, M.Pharm., Ph.D. Professor and Research Director, Department of Pharmaceutics,
Bow-tie Risk Analysis Paulo Rheinboldt Process and Industrial Safety Consultant Det Norske Veritas Objectives Presentation the Bow-tie methodology basic concepts Risk Management Risk Management is growing
Appendix V Risk Management Plan Template Version 2 March 7, 2005 This page is intentionally left blank. Version 2 March 7, 2005 Title Page Document Control Panel Table of Contents List of Acronyms Definitions
Title: Basic Principles of Risk Management for Medical Device Design WHITE PAPER Author: Ganeshkumar Palanichamy Abstract Medical devices developed for human application are used for diagnostic or treatment
MHRA GDP Symposium 2013 Novotel London West, London. 4th December 2013 Quality Risk Management An introduction. Steve Todd, Senior GDP Inspector Contents Risk quotations QRM definitions ICH Q9 QRM in the
PROJECT RISK MANAGEMENT DEFINITION OF A RISK OR RISK EVENT: A discrete occurrence that may affect the project for good or bad. DEFINITION OF A PROBLEM OR UNCERTAINTY: An uncommon state of nature, characterized
Patient safety in external beam radiotherapy - Guidelines on risk assessment and analysis of adverse events and near misses. Risk management for external beam radiotherapy Recommendations (draft) Jean-Luc
Critical Control Points and Operational Prerequisite Programs ISO 4 HACCP Principle 2 Identify the Critical Control Points (CCPs) in the process. The Stop Sign of the process. In ISO 22000, you also must