RISK MANAGEMENT: WHAT HAVE WE LEARNED? AFDO 2009 CAPT JOSEPH L. SALYER, RS, MPH FDA, CDRH, OC
|
|
|
- Marlene French
- 5 years ago
- Views:
Transcription
1 RISK MANAGEMENT: WHAT HAVE WE LEARNED? AFDO 2009 CAPT JOSEPH L. SALYER, RS, MPH FDA, CDRH, OC
2 CDRH MISSION CDRH promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products.
3 FDA RESPONSIBILITIES Risk Management First human use (IDE) Safe experimental use (product development) Widespread use (market approval) Adverse Experience Evaluation (complaints)
4 Definitions Risk is a combination of the probability of occurrence of harm and the severity of that harm. Harm is physical injury or damage to the health of people, or damage to property, or the environment. Hazard is a potential source of harm.
5 Definitions Risk management is the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk.
6 Risk Management: Is a continuous and developing process which runs throughout an organization s strategic planning, decision making and implementation activities Provides a framework that enables future activity to take place in a consistent and controlled manner Contributes to move efficient use and allocation of resources Integrated into the culture of an organization with an effective policy and program led by senior management
7 RISK MANAGEMENT & THE QUALITY SYSTEM REGULATION Part 820.1(a)(1) The requirements in this part are intended to ensure that finished devices will be safe and effective Part (g) Design validation shall include software validation and risk analysis YOU CANNOT ENSURE THAT A DEVICE IS SAFE WITHOUT RISK MANAGEMENT IN PLACE
8 Premarket Approval Base degree of control on risk (Class of device) Weigh potential benefits vs. risk to determine safety and effectiveness Science based evidence Control risk prevent, eliminate, or reduce to an acceptable level Least burdensome approach
9 POSTMARKET SURVEILLANCE MDR, MEDWATCH, and MedSun Recalls Inspections (Complaints, CAPAs)
10 TOTAL PRODUCT LIFE CYCLE Risks should be managed throughout the entire product life cycle. Design through Disposal. Risk management activities change over time.
11 RISK MANAGEMENT SHOULD BEGIN EARLY IN THE RESEARCH AND DEVELOPMENT STAGE Is the device safe? Product Design Phase Process Additional hazards may be introduced Use Clinical, OTC, home health Distribution Disposal
12 TYPES OF RISK Business Risk Actual Risk Potential Risk Perceived Risk
13 Risk Management should be: Product Specific Probability of occurrence Consequence of loss (severity) Perception of the loss Process Specific Facility Specific
14 RISK MAMAGEMENT TOOLS QSR - DOES NOT REFERENCE TOOLS ISO APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES Preliminary Hazard Analysis (PHA) Fault Tree Analysis (FTA) Failure Mode and Effects Analysis (FMEA) Failure Mode, Effects and Criticality Analysis (FMECA)
15 RISK MAMAGEMENT TOOLS ISO APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES cont. Hazard and Operability Study (HAZOP) Hazard Analysis and Critical Control Point (HACCP)
16 Risk Based Inspections Class of Device (III, II, I) Critical Process Environments (Clean Rooms) Facility Type Manufacturer Re-packer Assembler Sterilization
17 INSPECTIONAL FINDINGS FOR Observations P & PC Risks CAPA Risks MGMT 563 DES Risks DOC - 323
18 IMPROVEMENT IS NEEDED Risk Management is often driven by failures: Recalls Complaints Field Reports MDRs, MEDWATCH, MedSun THESE DATA MUST BE EVALUATED FOR AN EFFECTIVE RISK MANAGEMENT SYSTEM!
19 DEVICE FAILURES: Not complete for many devices. (Preventive) Not understood by users. Begins after product development. Risks are not identified or known. Risk communication is not adequate. Risk analysis Residual risk
20 POTENTIAL OUTCOMES OF A RISK MANAGEMENT PROGRAM Safer Devices Improved Public Health Higher Profit Margin
21 THANK YOU QUESTIONS Contact info: Phone:
Risk Analysis and Management. May 2011 ISO 14971
Risk Analysis and Management Qsite May 2011 ISO 14971 1 Agenda Definitions Risk Management Development Phases Process Hazards Evaluation Residual Risk 2 Why Do We Need Risk Analysis 1. Quantify the risk
We will begin the web conference shortly. When you arrive, please type the phone number from which you are calling into the chat field.
Welcome We will begin the web conference shortly. When you arrive, please type the phone number from which you are calling into the chat field. To login to the audio portion of the web conference, dial
Risk Assessment for Drug Products with Device Components
Risk Assessment for Drug Products with Device Components Khaudeja Bano, M.D. Senior Medical Director, Medical Device Safety Head, Pharmacovigilance and Patient Safety AbbVie Inc. Process consisting of:
Basics of Quality Risk Management. CBE Pty Ltd
Basics of Quality Risk Management CBE Pty Ltd This training program is copyright to CBE Pty Ltd and may not be modified, reproduced, sold, loaned, hired or traded in any form without its express written
Master Class: Construction Health and Safety: ISO 31000, Risk and Hazard Management - Standards
Master Class: Construction Health and Safety: ISO 31000, Risk and Hazard Management - Standards A framework for the integration of risk management into the project and construction industry, following
RISK ASSESSMENT APPROACH AND ITS APPLICATION IN PHARMACEUTICAL INDUSTRY FOR PRODUCT QUALITY MANAGEMENT
Journal of Medical Pharmaceutical And Allied Sciences REVIEW ARTICLE RISK ASSESSMENT APPROACH AND ITS APPLICATION IN PHARMACEUTICAL INDUSTRY FOR PRODUCT QUALITY MANAGEMENT Singh U. K.* Pahwa Shilpa, Sethi
Streamlining Risk Management Evaluations for New Manufacturing Processes
May 1-3, 2012 Javits Center New York, NY Streamlining Risk Management Evaluations for New Manufacturing Processes Mike Porter Consultant Commissioning Agents, Inc. Title Date Javits Center New York, NY
AAMI Risk Management Summit Risk Terminology and Expectations: A Regulatory Perspective
AAMI Risk Management Summit Risk Terminology and Expectations: A Regulatory Perspective Melissa Torres PMA/HDE Program Director (Acting) Office of Device Evaluation Center for Devices and Radiological
Medical Device Recalls, Risk Management, and Safety Assurance Cases. Introduction
Medical Device Recalls, Risk Management, and Safety Assurance Cases Fubin Wu Co-founder of GessNet, a software and consulting company specializing in medical device risk management and safety assurance
RISK MANAGEMENT and ISO 17025:2017
RISK MANAGEMENT and ISO 17025:2017 Dr. Bill Hirt Global Technical Advisor ANAB / ANSI-ASQ National Accreditation Board January 31, 2018 Outline of Sections Introduction of ANAB Risk management consistency
Case for Quality Company D. Risk Management
Case for Quality Company D Introduction to procedure at Company X Establishes requirements for of Medical Devices with regards to Safety Combination of the probability of occurrence of harm and the severity
Quality Risk Management from Concept to Practical Strategies*
Quality Risk Management from Concept to Practical Strategies* H. Gregg Claycamp, Ph.D. Director Div. of Compliance Risk Management and Surveillance and Associate Director, CDER Office of Compliance gregg.claycamp@fda.hhs.gov
Risk and safety Part 2: Risk analysis and safety measures
Risk and safety Part 2: Risk analysis and safety measures EPA1132 Technology development and impact assessment Frank Guldenmund, Safety Science & Security Group, Faculty TPM Overview 1. Risk analysis (con?nued)
Planning the Risk Management File Audit
Planning the Risk Management File Audit This is a strategy to help prepare for a risk management file (RMF) audit. It incorporates requirements from the international standard ISO 14971:2007 as well as
ISO INTERNATIONAL STANDARD. Medical devices Application of risk management to medical devices
INTERNATIONAL STANDARD ISO 14971 Second edition 2007-03-01 Corrected version 2007-10-01 Medical devices Application of risk management to medical devices Dispositifs médicaux Application de la gestion
The Basics of Risk Management
The Basics of Risk Management Greg Sepeda, PE Sigma Consulting Group, Inc. Louisiana Transportation Conference March 1, 2016 The Basics of Risk Management What Why When Who and How? What is Risk? Risk
Tuesday Sept 11th, 2018 AGENDA: 1. Pre-Meeting Clinic: Q&A on Risk and a Company s Risk Culture. 2. Risk Management
Section 703 Tuesday Sept 11th, 2018 AGENDA: 1. Pre-Meeting Clinic: Q&A on Risk and a Company s Risk Culture 2. Risk Management Clinic 1) Risk management is designed to: a) Solve all risks b) Correct problems
The Definitive Guide to ISO Risk Management for Medical Devices
The Definitive Guide to ISO 14971 Risk Management for Medical Devices Jon Speer Founder & VP of QA/RA greenlight.guru Table of Contents 1 What is Risk? 2 Introduction 8 Design Controls & Risk Management
GAMP 5 Quality Risk Management. Sion Wyn Conformity +[44] (0)
![GAMP 5 Quality Risk Management. Sion Wyn Conformity +[44] (0)](/thumbs/84/90848680.jpg "GAMP 5 Quality Risk Management. Sion Wyn Conformity +[44] (0)")
GAMP 5 Quality Risk Management Sion Wyn Conformity +[44] (0) 1492 642622 sion.wyn@conform-it.com 1 GAMP5 Key Concepts Life Cycle Approach Within a QMS Scaleable Life Cycle Activities Process and Product
Risk Management Relevance to PAS 55 (ISO 55000) Deciding on processes to implement risk management
Risk Management Relevance to PAS 55 (ISO 55000) Deciding on processes to implement risk management Jeff Hollingdale DQS South Africa jeffh@dqs.co.za PAS 55 Risk Management The guideline states: (4.4.7);
ISO INTERNATIONAL STANDARD. Medical devices Application of risk management to medical devices
INTERNATIONAL STANDARD ISO 14971 Second edition 2007-03-01 Corrected version 2007-10-01 Medical devices Application of risk management to medical devices Dispositifs médicaux Application de la gestion
8 th Annual FDA Inspections Summit
8 th Annual FDA Inspections Summit Assuring Your EN ISO 14971:2012 Risk Management Strategy Adopts a holistic Approach Ibim Tariah Ph.D BSI Group Americas Inc Copyright 2013 BSI. All rights reserved. Risk
Risk and Compliance management in Technical Projects 2017 Global Risk Engineering Conference
Risk and Compliance management in Technical Projects 2017 Global Risk Engineering Conference Jos Hoedemakers Risk Engineering Zurich Benelux Technical Projects A project is a human endeavor which creates
RISKS. Diane Van Hoy and Jacob Kloos
RISKS Diane Van Hoy and Jacob Kloos Purpose of our Presentation Explain what risks are and the need for identifying them Explore 3 different techniques used to discover, assess, rank, and mitigate risk
MEDICAL DEVICE GUIDANCE
SEPTEMBER 2013 MEDICAL DEVICE GUIDANCE GN-10: Guidance on Medical Device Field Safety Corrective Action Revision 2 PREFACE This document is intended to provide general guidance. Although we have tried
7/25/2013. Presented by: Erike Young, MPPA, CSP, ARM. Chapter 2. Root Cause Analysis
Presented by: Erike Young, MPPA, CSP, ARM 1 Chapter 2 Root Cause Analysis 1 Introduction to Root Cause Analysis Root Cause The event or circumstance that directly leads to an occurrence Root Cause Analysis
An Update On Association Policies, Health Checks & Guidelines To A Safer Hockey Association. Lauren Woods Member Engagement & Operations
An Update On Association Policies, Health Checks & Guidelines To A Safer Hockey Association Lauren Woods Member Engagement & Operations Association Health Checks Issues arising from the health check: 3/27
YY/T / ISO 14971:2007 corrected version
Translated English of Chinese Standard: YY/T0316-2016 www.chinesestandard.net Buy True-PDF Auto-delivery. Sales@ChineseStandard.net YY ICS 11.040.01 C 30 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE
Medical Device Risk Management. And Safety Cases. Copyright AAMI Single user license only. Copying, networking, and distribution prohibited.
Medical Device Risk Management And Safety Cases Paul L. Jones and Al Taylor Safety assurance cases have been used in different industry sectors such as nuclear power, transportation, and military systems
RISK MANAGEMENT MANUAL
ABN 70 074 661 457 RISK MAGEMENT MANUAL QUALITY ASSURANCE - ISO 9001 ENVIRONMENTAL MAGEMENT - ISO 14001 OCCUPATIOL HEALTH AND SAFETY - AS 4801 This is a Controlled Document if stamped CONTROLLED in RED.
U.S. Consumer Product Safety Commission
U.S. Consumer Product Safety Commission Roberta Telles International Programs November 2011 Views expressed in this presentation are those of the staff and do not necessarily represent the views of the
Table of Contents Advantages Disadvantages/Limitations Sources of additional information. Standards, textbooks & web-sites.
Table of Contents Table of Contents 1. Consequence Analysis & Risk Reduction Option Selection 1.1. A description of the techniques, including its purpose 1.1.0.. Introduction 1.1.0.3. Consequence Analysis
Best Practices in Applying Medical Device Risk. Management Terminology
Best Practices in Applying Medical Device Risk Management Terminology Fubin Wu and Alan Kusinitz ANSI/AAMI/ISO 14971:2007 defines harm as physical injury or damage to the health of people, or damage to
Best Practices in Applying Medical Device Risk Management Terminology
Best Practices in Applying Medical Device Risk Management Terminology Fubin Wu and Alan Kusinitz About the Authors gessnet.com Fubin Wu is cofounder of GessNet risk management software in Sacramento, CA.
Presented by Mr. Rajesh Kandhai
Presented by Mr. Rajesh Kandhai OHSE Manager Senior Assessor STOW TT SBCS ALJGSB bptt EMA Inspector Trinmar EMA / UN 2 Introduction and Ground Rules Safety Leadership and Safety Culture Types of Risk and
A Cross-Functional Perspective of Key Issues Facing New Product Introductions
Joint Industry / FDA Symposium Managing Risks From Pipeline to Patient Track 4 Drug and Device Development and Clinical Trials A Cross-Functional Perspective of Key Issues Facing New Product Introductions
Medical Device Compliance Issues Update
Medical Device Compliance Issues Update Panel Discussion Fourteenth Pharmaceutical Compliance Congress and Best Practices Forum Washington, D.C. October 29, 2013 With you today Paul Kalb, M.D. Partner,
Concepts in Risk-based Assessment Risk in Medical Imaging Ehsan Samei, PhD. Outline. Outline 8/3/2016
Concepts in -based Assessment in Medical Imaging Ehsan Samei, PhD Outline Why of talk about risk? Science of risk and risk assessment in imaging Radiation risk in terms of patient welfare Outline Why of
Engineering as Social Experimentation
Engineering as Social Experimentation Engineering/Experimentation Comparison Engineering Objective is to solve problems which often involves: - unknowns - uncertain outcome - monitor, learn from past experiments
Post Market Surveillance & Vigilance - the way towards harmonisation-
Post Market Surveillance & Vigilance - the way towards harmonisation- Chadaporn (Miang) Tanakasemsub AHWP TC WG02 co-chair GHTF SG2 member Regional QA/RA director, Asia Pac Zimmer Asia Pacific 1 What is
Use of QRM to Quantify Particulate Contamination Risks
Use of QRM to Quantify Particulate Contamination Risks PDA Ireland Chapter Quality Risk Management Seminar NIBRT Mount Merrion, Blackrock, Co. Dublin Chris Roberts Agenda Background Objective / Scope Execution
ISO INTERNATIONAL STANDARD. Safety of machinery Risk assessment Part 1: Principles
INTERNATIONAL STANDARD ISO 14121-1 First edition 2007-09-01 Safety of machinery Risk assessment Part 1: Principles Sécurité des machines Appréciation du risque Partie 1: Principes Reference number ISO
To err is human. Pete Davis VP of Research & Development Neomend a subsidiary of Bard Davol
To err is human Pete Davis VP of Research & Development Neomend a subsidiary of Bard Davol 1 Really an R&D guy presenting risk analyses?? 2 Risks exist because perfection doesn t! 3 Communicating to Management
RISK EVALUATIONS FOR THE CLASSIFICATION OF MARINE-RELATED FACILITIES
GUIDE FOR RISK EVALUATIONS FOR THE CLASSIFICATION OF MARINE-RELATED FACILITIES JUNE 2003 American Bureau of Shipping Incorporated by Act of Legislature of the State of New York 1862 Copyright 2003 American
9. 1) Your Company has/will be engaged in: OPERATIONS LAST TWELVE (12) MONTHS NEXT TWELVE (12) MONTHS CANADA U.S. OTHER CANADA U.S. OTHER Manufacturin
THIS APPLICATION IS FOR A CLAIMS MADE POLICY PLEASE ENSURE THAT THE FOLLOWING ARE PROVIDED WITH THE APPLICATION Company brochures (if different than website product description) Product catalogue Curriculum
Challenges of implementation. a regulatory perspective
Challenges of implementation of ICH Q 9 a regulatory perspective Jacques Morénas Deputy Director Inspectorate and Companies Department The French Health Products Safety Agency (AFSSAPS) telephone : 33
Management Commitment. BEST Level 3 Guidance. Actions to Achieve Desired Outcomes
Management Leadership and Employee 1 Involvement Take proactive steps to build on earlier gains to improve the culture, systems, policies, and procedures that support a safe and healthy work environment.
Kidsafe NSW Risk Management Plan. August 2014
Kidsafe NSW Risk Management Plan August 2014 Document Control Document Approval Name & Position Signature Date Document Version Control Version Status Date Prepared By Comments Document Reviewers Name
FOOD SAFETY RISK ANALYSIS
Appendix D FOOD SAFETY RISK ANALYSIS 1.0 RISK IN FOOD PROCESSING 1.1 Risk Analysis 1.2 Risk Assessment 1.3 When to do a Risk Assessment 1.4 Risk Assessment and HACCP 1.5 The Health Risk Assessment Model
Risk Management Framework. Metallica Minerals Ltd
Risk Management Framework Metallica Minerals Ltd Risk Management Framework 23 March 2012 Table of Contents Contents 1. Introduction... 3 2. Risk Management Approach... 3 3. Roles and Responsibilities...
CONSULTANT EVALUATION SYSTEM GENERAL CRITERIA
CONSULTANT EVALUATION SYSTEM GENERAL CRITERIA INTRODUCTION The Consultant Evaluation System (CES) is an evaluation of a Consulting firm s past performance on NJDOT projects and an indication of a firm
RISK ASSESSMENT. A Practical Guide to Assessing. Operational Risks. Edited by GEORGI POPOV BRUCE K. LYON BRUCE HOLLCROFT. WlLEY
RISK ASSESSMENT A Practical Guide to Assessing Operational Risks Edited by GEORGI POPOV BRUCE K. LYON BRUCE HOLLCROFT WlLEY CONTENTS Preface Foreword List of Contributors About the Companion Websites xvii
ACTUAL METHODS ON TECHNOLOGICAL RISK ASSESSMENT
ACTUAL METHODS ON TECHNOLOGICAL RISK ASSESSMENT Marco Nicola Carcassi First European Summer School on Hydrogen Safety Belfast UK, 15th - 21st August 2006 Presentation Outline Technological Risk Categories
LOGISTICS ASSISTANCE REPRESENTATIVES
CECOM Directorate of Safety Risk Management Risk Management CECOM LOGISTICS ASSISTANCE REPRESENTATIVES Training Risk Management Why Safety? Battle and Non-battle Casualties Army W.W.II Korea Vietnam DS/S
PREP Course # 17 Compliance in Human Subject Research: Implementing Quality Systems. Office of Research Compliance. February 16 th, 2016
PREP Course # 17 Compliance in Human Subject Research: Implementing Quality Systems Office of Research Compliance February 16 th, 2016 1 CME Disclosure Statement The Northwell Health adheres to the ACCME
September 21, Panelists: Scott Soukup, Quality Specialist, RCA Inc. Joan M. Ward, Quality Subject Matter Expert, RCA Inc.
Conducting CAPA Investigations September 21, 2016 Panelists: Scott Soukup, Quality Specialist, RCA Inc. Joan M. Ward, Quality Subject Matter Expert, RCA Inc. Moderator and Panelist: Susan Schniepp, Distinguished
The Role of Quality Risk Management in the Manufacture of Biological Products CBER Perspective
The Role of Quality Risk Management in the Manufacture of Biological Products CBER Perspective CASSS CMC Strategy Forum: Practical Applications of Quality Risk Management 27-28 28 July 2009 Nancy Waites
RCA = root cause analysis SVA = security vulnerability analysis
Key acronyms Incident Investigation and Reporting RCA = root cause analysis SVA = security vulnerability analysis a s SAND No. 2011-1036C Sandia is a multiprogram laboratory operated by Sandia Corporation,
Crowe, Dana, et al "EvaluatingProduct Risks" Design For Reliability Edited by Crowe, Dana et al Boca Raton: CRC Press LLC,2001
Crowe, Dana, et al "EvaluatingProduct Risks" Design For Reliability Edited by Crowe, Dana et al Boca Raton: CRC Press LLC,2001 CHAPTER 13 Evaluating Product Risks 13.1 Introduction This chapter addresses
IEC : Annex F
IEC 61511-3:2016 - Annex F SAFETY REQUIREMENT SPECIFICATION Page: Page 2 of 6 CONTENTS 1. SIF SRS... 3 2. SIF SRS(S)... 4 Page: Page 3 of 6 1. SIF SRS Table 1. SRS for the SIS SIS Details Operator Interfaces
Common Safety Method (CSM) for risk assessment (Regulations 352/2009 & 402/2013)
Common Safety Method (CSM) for risk assessment (Regulations 352/2009 & 402/2013) inland transport of dangerous goods - Lille, 8-9 th October 2013 E-mail: CSM.risk_assessment@era.europa.eu Slide n 1 Introduction
ASSESSING THE ROBUSTNESS OF A QUALITY RISK MANAGEMENT PROGRAM
ASSESSING THE ROBUSTNESS OF A QUALITY RISK MANAGEMENT PROGRAM Amanda Bishop McFarland Senior Quality Risk Management and Microbiology Consultant ValSource, LLC. ABOUT AMANDA & HOME SWEET HOME Cary, North
RISK ASSESSMENT IN SHIP OPERATIONS
RISK ASSESSMENT IN SHIP OPERATIONS Background How we define Risk? Risk include any possible change of undesirable, adverse consequences to human life, health, property, or the environment. the threat or
ก ก Tools and Techniques for Enterprise Risk Management (ERM)
ก ก Tools and Techniques for Enterprise Risk Management (ERM) COSO ERM ISO ERM 31 2554 10:45 12:15.. 301, 302, 307 ก ก COSO Internal Control ERM Integrated Framework Application Technique ISO 31000 Guide
Due Diligence and Accident/Incident Investigations Bills 9 and 35
Due Diligence and Accident/Incident Investigations Bills 9 and 35 Presented by: Tom McKenna, National Representative, WCB Advocacy January 19, 2016 The information is not legal advice. This information
APPLICATION OF FORMAL SAFETY ASSESSMENT IN THE LEGAL ACTIVITY OF INTERNATIONAL MARITIME
Journal of KONES Powertrain and Transport, Vol. 21, No. 4 2014 ISSN: 1231-4005 e-issn: 2354-0133 ICID: 1130510 DOI: 10.5604/12314005.1130510 APPLICATION OF FORMAL SAFETY ASSESSMENT IN THE LEGAL ACTIVITY
Risk Assessment Policy
Risk Assessment Policy Introduction All independent schools are legally required to have risk assessments in place that cover a great many school activities, including all the many educational visits,
CONTROLLED DOCUMENT. Version Number: 4.1. On: January 2018 Review Date: June 2016 Distribution: Essential Reading for: Information for: 1 of 15
Risk Management Strategy and Policy CONTROLLED DOCUMENT CATEGORY: CLASSIFICATION: PURPOSE: Controlled Number: Document Strategy/Policy Governance To set out the principles and framework for the management
Risk-Based Thinking ISO 13485:2016. Risk Management / Analysis of Risk
Risk-Based Thinking in ISO 13485:2016 Risk Management / Analysis of Risk Risk-based thinking in ISO 13485:2016 1 Risk Management Every version of the ISO 13485 standard has advocated risk management and
Defining Risk and Risk Levels
Defining Risk and Risk Levels Implementing ICH Q9 Quality Risk Management Gamal Amer, Ph.D. Premier Compliance Services, Inc. All rights reserved. Do not copy without permission. 1 Why Risk Management
Pickering Whole-Site Risk
Pickering Whole-Site Risk Jack Vecchiarelli Manager, Pickering Relicensing Update to Commission Members December 14, 2017 CMD 17-M64.1 Outline Background Whole-site risk considerations Use of Probabilistic
Operational Date: Review Date: October 2018
Title: Author(s): Ownership: Corporate Risk Management Policy Katrina Keating, Risk Manager Dr David McManus, Medical Director Date of SEMT Approval: 28.07.16 Date of Trust Board Approval: 06.10.16 Operational
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
Page 1 of 13 1 GUIDANCE FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS Comments and suggestions regarding this document may be submitted any time. Submit comments to the Dockets Management Branch (HFA-305),
ISO INTERNATIONAL STANDARD. Lifts (elevators), escalators and moving walks Risk assessment and reduction methodology
INTERNATIONAL STANDARD ISO 14798 First edition 2009-03-01 Lifts (elevators), escalators and moving walks Risk assessment and reduction methodology Ascenseurs, escaliers mécaniques et trottoirs roulants
INMETRO MARK TESTING AND CERTIFICATION SERVICES SERVICE TERMS
INMETRO MARK TESTING AND CERTIFICATION SERVICES SERVICE TERMS These Service Terms shall govern INMETRO Mark Testing and Certification Services performed by UL (as identified in the Quotation or Project
Practical Water Utility Asset Management Plans
Kevin Campanella, Utility Planning Leader, Burgess & Niple September, 2016 Practical Water Utility Asset Management Plans Inconsistency Treatment plants One tracked pencils, another didn t track small
A SIMPLE METHOD OF RISK/HAZARD ASSESSMENT IN DREDGING
A SIMPLE METHOD OF RISK/HAZARD ASSESSMENT IN DREDGING T. M. Verna 1 and L. A. Prieto-Portar 2 ABSTRACT The assessment of the hazards and assignment of risk of each activity of a project is an important
SIL and Functional Safety some lessons we still have to learn.
SIL and Functional Safety some lessons we still have to learn. David Craig, Amec This paper reflects AMEC s recent experience in undertaking functional safety assessments (FSA) (audits against IEC 61511)
Classification Based on Performance Criteria Determined from Risk Assessment Methodology
OFFSHORE SERVICE SPECIFICATION DNV-OSS-121 Classification Based on Performance Criteria Determined from Risk Assessment Methodology OCTOBER 2008 This document has been amended since the main revision (October
OVERVIEW OF RISK ANALYSIS. APEC workshop: Hot Issues in Risk Analysis August 1, Singapore
OVERVIEW OF RISK ANALYSIS APEC workshop: Hot Issues in Risk Analysis August 1, 2009 - Singapore Risk Risk is everywhere Some risks more serious than others Zero risk is not an option Is unavoidable Is
http://www.sis.se http://www.sis.se http://www.sis.se http://www.sis.se http://www.sis.se Provläsningsexemplar / Preview Copyright SIS. Reproduction in any form without permission is prohibited. SVENSK
Engineering maintenance of safety instrumented functions
Engineering maintenance of safety instrumented functions Early involvement improves operations and maintenance through the safety life cycle Fast Forward The work required to design an adequate platform
BROCKWOOD PARK SCHOOL & INWOODS SMALL SCHOOL
BROCKWOOD PARK SCHOOL & INWOODS SMALL SCHOOL RISK ASSESSMENT POLICY Last Review Date August 2018 Policy endorsed by Policy is maintained by ISI reference The Trustees, Principal & Inwoods Head Teacher
Accident Investigation
Accident Investigation Purpose Accident prevention is the key to eliminating possibility of injury to employees and property loss. Learning from past accidents is one of the key elements in accident prevention.
1 P age. HIMSS System Risk Analysis Survey Report June, 2012
1 P age HIMSS System Risk Analysis Survey Report June, 2012 Executive Summary Overview and Analysis of Survey Medical technology has rapidly evolved in the past 20 years and little resembles what most
PRODUCT LIABILITY SUPPLEMENT
PRODUCT LIABILITY SUPPLEMENT This is a supplement to the ISO acord applications. Failure to provide answers to all questions will delay your quotation. Applicants Instructions: 1. Answer all questions.
Introduction to Risk Management
Introduction to Risk Management Risk Analysis Framework Risk Assessment * Science based Risk Management * Policy based Risk Communication * Interactive exchange of information and opinions concerning risks
(Ord ) Chapter RISK MANAGEMENT Background and findings Purpose and goals. Page 1.
Chapter 450-8 - RISK MANAGEMENT Sections: 450-8.002 - Background and findings. The board of supervisors of Contra Costa County finds as follows: (a) Recent incidents in Contra Costa County at industrial
Quality Risk Management for Quality system 辉瑞制药有限公司解馨
Quality Risk Management for Quality system 质量风险评估在质量保证体系中的应用 辉瑞制药有限公司解馨 Agenda Introduction to QRM The QRM Process The 10 step approach to QRM Case Studies Final Points Slide 2 QRM - What is it? Structured
Overview of Standards for Fire Risk Assessment
Fire Science and Technorogy Vol.25 No.2(2006) 55-62 55 Overview of Standards for Fire Risk Assessment 1. INTRODUCTION John R. Hall, Jr. National Fire Protection Association In the past decade, the world
CWMA Conference Workplace Responsibilities, Injury Statistics, OHS Program Requirements, And Recommended Practices
CWMA Conference Workplace Responsibilities, Injury Statistics, OHS Program Requirements, And Recommended Practices Kevin Bennett, CHSC, CRM Industry Specialist, Transportation and Occupational Road Safety
PANAMA MARITIME AUTHORITY
PANAMA MARITIME AUTHORITY MERCHANT MARINE CIRCULAR MMC-213 PanCanal Building Albrook, Panama City Republic of Panama Tel: (507) 501-5000 segumar@segumar.com To: Ship-owners/Operators, Company Security
Risk Management & FMEAs. By Jay P. Patel, ASQ Fellow CEO & President QPS Institute
Risk Management & FMEAs By Jay P. Patel, ASQ Fellow CEO & President QPS Institute Learning Objectives Understand Risk management process elements Learn the principles involved in the Risk process Know
Conducting Effective Risk Assessments. Occupational Health, Safety & Risk Unit
Conducting Effective Risk Assessments Occupational Health, Safety & Risk Unit 1 Objectives of this session: Explain the legislative responsibilities & requirements relating occupational risk management
Common Safety Methods CSM
Common Safety Methods CSM A common safety method on risk evaluation and assessment Directive 2004/49/EC, Article 6(3)(a) Presented by: matti.katajala@safetyadvisor.fi / www.safetyadvisor.fi Motivation
ORDINANCE NO N.S.
ORDINANCE NO. 1-13 N.S. AN ORDINANCE OF THE CITY COUNCIL OF THE CITY OF RICHMOND AMENDING CHAPTER 6.43 OF THE RICHMOND MUNICIPAL CODE RELATING TO INDUSTRIAL SAFETY WHEREAS, on December 18, 2001, the City
Risk Assessment Policy
Risk Assessment Policy Updated: April 2018 Date of next Review: April 2019 Policy Lead: Bursar Checked by: Middle Leadership Team 1. INTRODUCTION Beachborough School will have hazards which if not controlled
Manufacturers Errors & Omissions Application
Manufacturers Errors & Omissions Application NOTE: THIS IS A CLAIMS MADE COVERAGE OFFERING. Applicant Instructions: Please answer all questions. Attach additional sheets if necessary. If question is not
Reserve Event Notification Form
Reserve Event Notification Form Reserve Event Notifications must be received by Waikato District Council 2 onths prior to the event Applicant s details Club/Organisation/Group name: Postal address: Contact
Construction OS&H Processes and systems
Construction OS&H Processes and systems Summary Brief review of systems theory and practice: Systems theory at a glance ILO-OSH 2001: Guidelines on occupational safety & health management systems Hazards