2012/SCSC/WKSP/014 ASSET Safety Management Process

Transcription

1 2012/SCSC/WKSP/014 ASSET Safety Management Process Submitted by: Underwriters Laboratories Workshop on Developing a Harmonised Electrical Equipment Regulatory Risk Assessment Tool Singapore May 2012

2 ASSET Safety Management Process 2012 APEC JRAC Harmonized Risk Assessment Tool Workshop Thomas Lanzisero 16 May 2012 Singapore All rights reserved. This document may not be reproduced or distributed without authorization. Risk Assessment Potential Benefits Safer living and working environments for people Many stakeholders: government, industry, regulators, consumers, others Enhance free trade, economic cooperation, trust, consumer confidence Reduce compliance time, cost & resources Relevant to Safety Standards, Codes and Regulations Development / Implementation / Enforcement Design / Evaluation Information Sharing: planning, communication, reporting Slide 2 1

3 Harmonized Risk Assessment Tool - Objectives Standardized & Consistent Suitable / Correct Repeatable & Reproducible Relevant & Robust Independently Supported & Verified Assessments, evaluations, certifications Global reach & local presence: coverage, capacity, competence, integrity Slide 3 Risk Assessment and Safety Management Part of bigger picture of Safety Management Subsystem within overall safety system Proactive: Anticipate emerging issues Preventive as well as corrective Broad: Comprehensive, system approach Address entire product lifecycle & conditions Consider supply chains & distribution chains Deep: Detailed, hazard-based Suitable protective measures based on conditions, mechanisms and objects of harm Safety attributes suitably evaluated & controlled Slide 4 2

4 Safety Management Cycle Slide 5 Two Aspects of Safety 1. Identification and analysis of risks Objective activity based upon facts, data, research, evaluation, testing, etc. 2. Deciding on what s an acceptable level of safety Subjective activity based on consensus and other factors Slide 6 3

5 Establishing an Level of Safety By means of the requirements of previously identified, broadly recognized consensus standards, codes, regulations and their intent By means of additional or alternative requirements to address gaps that may need to be filled Slide 7 Safety into the Future: Innovation Challenges Safety standards / codes / regulations: keep pace with innovative technology, functions, products & applications Hazards and potential harm not anticipated or covered Additional requirements meet safety objective? Alternative / innovative protective measures not anticipated Achieve equivalent level of safety meet safety objective? Appropriate, consistent manner Level playing field Balancing multiple stakeholders and needs Slide 8 4

6 Meeting Basic Safety Objectives Should we follow a systematic process to: Formulate questions to identify the scope of the product, system or service to be evaluated for potential harm? Identify and analyze hazards (potential sources of harm)? Identify, analyze and evaluate protective measures to reduce the risk of harm? Determine whether or not an acceptable level of safety is achieved? Understand and apply methods to maintain and continuously improve safety? Slide 9 Goals Determine the scope of the product, process or service to be assessed and the context for the assessment System approach Subject of the assessment Intended use Reasonably foreseeable misuse Other conditions or factors throughout lifecycle Applicable standards, codes and/or regulations (initial) Slide 10 5

7 Goals Identify potential types and sources of harm, and entities subject to harm Determine how harm can occur and the severity of the harm (tools, techniques) Sort consequences initially by the level of severity Determine if the applicable standards, codes and/or regulations address the identified hazards Slide 11 Goals Establish the safety objective(s) Determine the need for protective measures Identify the potential protective measure strategies, categories and mechanisms Analyze and prioritize protective measures Specify, identify, design and then implement the protective measures Slide 12 6

8 Evaluate Goals Determine whether protective measures are adequate and effective by Assessing whether and how protective measures meet specific safety objectives Identifying safety attributes that are being relied upon and need to be controlled Evaluating those safety attributes Evaluate Slide 13 () Safety Decision Outcomes If acceptable level of safety has not been achieved, assess and decide on action Evaluate Slide 14 7

9 () Safety Decision Outcomes If acceptable level of safety has been achieved, control, monitor, and review to maintain safety Evaluate Slide 15 to Maintain Safety Goals Ensure that safety is maintained by Establishing controls throughout the life cycle to ensure that safety is maintained Evaluate Monitoring field performance and factors that may impact safety by means of surveillance and follow up Periodically reviewing and assessing results and deciding on appropriate actions Slide 16 8

10 Present Level of Safety Maintained? () Safety Decision Outcomes If present level of safety is not being maintained, assess and decide on action Evaluate Present Level of Safety Maintained? Slide 17 Present Level of Safety Maintained? () Safety Decision Outcomes If present level of safety is being maintained, continue to control, monitor, and review Evaluate Present Level of Safety Maintained? Slide 18 9

11 Monitor / Assess Opportunities for Improvement Goals Identify opportunities for improvement. Assess / decide based on need and/or ability, wrt: Safety & safety standards Increase level of safety and/or confidence Evolving demand (drivers) and/or capabilities Techniques to determine whether and how safety is achieved and maintained Evaluate Present Level of Safety Maintained? Reduce variations / defects Increase consistency Identify Opportunities For Improvement Slide 19 ASSET Safety Management Process Evaluate Present Level of Safety Maintained? Identify Opportunities For Improvement ASSET (Applied Safety Science and Engineering Techniques) is a trademark of UL LLC Slide 20 10

12 Managing the Process & Interactions Plan Prepare Consult Communicate Document Record Evaluate Present Level of Safety Maintained? Identify Opportunities For Improvement Address relevant stakeholder interests, views, values, perceptions, criteria Including appropriate expertise, endorsement, support Regarding the existence, nature, form, likelihood, significance, evaluation and treatment of risk, and the acceptability of the level of safety and its management Slide 21 Focus Resources as eeded Deeper dives, e.g., HBSE FTA FMEA Functional Safety (E/E/P/S) Essential Performance (medical) Evaluate Present Level of Safety Maintained? Identify Opportunities For Improvement Slide 22 11

13 Application Examples Safety Designers Regulatory Compliance Product Safety Certifiers Standards/Codes Developers Product and Program Safety Managers Evaluate Hazard-Based Safety Engineering Safety Research Safety Design Conformity Assessment ew standards development Present Level of Safety Maintained? Conformance, Compliance Certification Market and Conformity Surveillance Follow-up for Certification Mark Integrity Updates in regulations, codes, standards ew / emerging technologies that may benefit / threaten safety Identify Opportunities For Improvement Improvements in regulations, standards, codes Improvements in safety assessment processes, methods and tools Slide 23 ASSET Objective To utilize Applied Safety Science and Engineering Techniques* and the ASSET Safety Management Process: As the evolution of hazard-based safety engineering principles and safety science disciplines, into an overall framework of a safety management process, based on principles of management of risk, quality, design, etc. For informed decisions to achieve, maintain and continuously improve the safety of products, processes and services By assessment of best available data / information With greatest degree of confidence Together with existing standards, codes and regulations Slide 24 12

14 Working Together to Close the Loop Slide 25 Thank ou! Questions / Comments? Thomas Lanzisero, P.E. Sr. Research Engineer I UL University, UL LLC 1285 Walt Whitman Rd Melville, USA (W) thomas.p.lanzisero@us.ul.com Slide 26 13