B11 LMSS™ Module 1 Rev 04 Secure PDF

DO NOT COPY – DO NOT SHARE B11 LMSS™  Welcome to B11 LMSSTM DO NOT COPY – DO NOT SHARE Safety Services UK and EU Lead– Matt Chandy 3 years’ experience supporting Safety Interlocks...

DO NOT COPY – DO NOT SHARE B11 LMSS™  Welcome to B11 LMSSTM DO NOT COPY – DO NOT SHARE Safety Services UK and EU Lead– Matt Chandy 3 years’ experience supporting Safety Interlocks Customer Application Support Manager B11 LMSSTM Certification #AA311265150 VP of Technical Safety – Jenny Tuertscher Expert member of ISO TC199 WG3, WG5, WG6, WG7, WG8 and ISO TC313 WG1 Member of ANSI B11 committees, B11 SDC, B155.1, and Z244.1 FS Engineer (TÜV Rheinland) #14247 / 17 – Machinery B11 LMSSTM Certification #AA311265118 B11 LMSS™  Welcome to B11 LMSS Module 1 DO NOT COPY – DO NOT SHARE Join in! Time Session Ask questions at any time 30 Mins Intro to presenters, attendees Breaks and the B11 LMSS We will aim for a break every hour or 40 Mins Intro to standards and so with one longer break in the regulations middle 40 Mins Risk Assessment Responsibilities Mute 90 Mins Risk Assessment Process and When you’re not talking please use examples the mute button 40 Mins Risk Reduction Measures Reactions 30 Mins Training and other examples Please make use of the “reaction” buttons Lower your hand by pressing it again B11 LMSS™  Overview B11 LMSS DO NOT COPY – DO NOT SHARE Module 1 Module 2 Module 3 Module 4 Module 5 Examination Introduction to B11.19 Risk B11.26 Integrating LOTO and 50 Multiple Standards and Reduction Functional Machines and electrical safety choice questions Regulations Measures Safety Robotics ANSI Z244.1 and 90 Mins B11.0 Safety of Inherently Safe Performance B11.20 and RIA NFPA 79 Machinery By Design Levels R15.06 Risk Engineering Categories Assessment Controls Control General Administrative Reliability Requirements Controls Fault considerations B11 LMSS™  B11 LMSSTM Scope DO NOT COPY – DO NOT SHARE This course will instruct you on: Standards and Regulations What are machinery safety standards Why are they useful How do you use them Overview of the key standards This course does not: Cover specific machinery/industry details Cover every single requirement laid out in the standards and regulations (But it will show you how to find them!) B11 LMSS™ DO NOT COPY – DO NOT SHARE Introduction to Fortress B11 LMSS™  Fortress Introduction DO NOT COPY – DO NOT SHARE Fortress Designs & Manufactures Customized Safety Equipment, Protecting Lives in Hazardous Workplaces. We believe every employee working in a potentially dangerous environment around the world deserves the best possible protection. Fast & Effective Our custom solutions can be delivered quickly, integrate with your existing systems, are easy to install and simple to use Global Support Our global network of employees and trusted safety partners ensure your individual safety needs are always fully supported. Engineered Products Protect your team with high quality, robust solutions which are built to last for years, even in the harshest environments Innovation & Expertise Our automation safety engineers utilize emerging technologies to offer a friendly innovative approach to co-developments B11 LMSS™  Introduction to B11 Standards DO NOT COPY – DO NOT SHARE B11 Standards, Inc. is ANSI-accredited Standards Developing (ASD) organization that administers the process through which the ANSI B11 series of American National Standards and Technical Report on machine/machine tool/machinery safety are developed and approved. ANSI B11 SCOPE Standardization of concepts, general principles and requirements for safety of machinery incorporating terminology, methodology, and risk reduction measures for new, existing, modified or rebuilt power driven industrial and commercial machinery, not portable by hand while working. This includes associated equipment that may be used in the production system. Buy B11 Standards: https://www.b11standards.org/ Buy other ANSI or ISO standards: https://webstore.ansi.org/ B11 LMSS™  Introduction to B11 DO NOT COPY – DO NOT SHARE Standards B11 LMSS™  B11 SDC Members DO NOT COPY – DO NOT SHARE Alan Metelsky, FS Eng., Chair / Anne Matthias, PE,Vice-Chair / David Felinski, Secretary Organizations Represented Names of Representatives Organizations Represented Names of Representatives (Delegates and Alternates) (Delegates and Alternates) A3 – Association for Advancing Automation Carole Franklin Jeff Fryman LM - Liberty Mutual Craig Karasack, CSP Julie Thompson, CSP AEC - Aluminum Extruders Council Mel Mitchell, CSP Bradley Wyatt, CSP, CMSE MAG - MAG Automotive LLC Erik Carrier Doug Watts Amazon Robotics Jeread Sines, FS Eng, B11 LMSS Pat Barry MPIF - Metal Powder Industries Federation Bill Edwards James P. Adams ASSP - American Society of Safety Professionals Ted Sberna, Sr. Anne Matthias, PE NIOSH - National Institute for Occupational Safety & Health Richard Current, PE AMT - Association for Manufacturing Technology Russ Bensman Alan Metelsky, FS Eng. Omron Tina Hull, FS Exp. Frank Webster BOEING - The Boeing Company Rhiannon McPherson Mark Ellington & Stephen Thomas OSHA - Occupational Safety and Health Administration Ken Stevanus Mary Bauer, CSP, CIH, B11 LMSS Bridgestone Kenji Furukawa, FS Eng. Joey Hinson, FS Eng. PILZ - Pilz Automation Safety, LP Mike Beerman Dino Mariuz CSA - Canadian Standards Association Andrea Holbeche, P. Eng. Walter Veugen PLASTICS - Plastics Industry Association Jeff Linder Dale Bartholomew Deere & Co. Tony Beeth Scott Winter PMA - Precision Metalforming Association James G. Barrett, Jr. PhD David Klotz Euchner Ron Yemmens Jilani Bouchane PMMI, Assoc. of Packaging and Processing Technology Bruce Main, PE, CSP Tom Egan Exponent, Inc. Stephen Andrew, PE, CSM Alex Zelhofer, PhD, PE PSDMA - Presence Sensing Device Manufacturers Association Jim Kirton Mike Carlson FDR – FDR Safety, LLC Mike Taubitz Joe Wolfsberger, CIH & Luke Contos Rockford Systems Brian Boes Matt Brenner Fortress Safety Jenny Tuertscher, FS Eng., B11 LMSS Joshua Hill Rockwell Automation Darin Magnuson, FS Eng Jonathan Barrett, FS Eng GM - General Motors Corporation Mike Douglas Tony Ross Safe-T-Sense Mike Poynter, FS Eng Federico Badillo Honda Development & Manufacturing of America Todd Dickey Doug Titus SMACHA - Sheet Metal & Air Conditioning Justin Crandol, CSP Rick Di Ioli Contractors National Association IDEM Safety Mark Witherspoon Amir Mohtasham SICK, Inc. Chris Soranno, FS Exp. Nate Gose, FS Exp. Komatsu America Industries, LLC George Schreck James Landowski TMMNA - Toyota Motor Manufacturing North America Earl Boertlein Michael Collier, B11 LMSS B11 LMSS™  Why Participate in B11 Standards? DO NOT COPY – DO NOT SHARE Help your organization or clients achieve acceptable risk with feasible risk mitigation Reflect your company’s voice into future standards Gain a deeper understanding of future standards Great networking opportunity with leading safety specialists in a variety of sectors Exceptional cross educational opportunities B11 LMSS™ DO NOT COPY – DO NOT SHARE Introduction to Standards and Regulations B11 LMSS™  Learning Objectives DO NOT COPY – DO NOT SHARE What are Standards and Regulations What is and isn’t law Why are consensus standards important US specific Standards and Regulations, how they differ from ISO/European Different types of standards and how to use them B11 LMSS™  DO NOT COPY – DO NOT SHARE What is Safety? B11 LMSS™  Accident or Incident DO NOT COPY – DO NOT SHARE Any unexpected outcome of Accident an event, usually undesirable that might result in injury Incident An event in which an injury or illness or fatality occurred, or could have occurred Near An incident could have caused serious injury or Miss illness but did not B11 LMSS™  Safety Statistics Facts DO NOT COPY – DO NOT SHARE How often is a worker injured on the In 2021, job every 14 seconds a in the USA 99,000,000 production days worker a) was Every 14 injured on the job, seconds lost in 2020 due to work- 13Every b) per day were fatal injuries 14 minutes related injuries c) Every 14 hours Total cost of workplace injuries in 2020 was $163.9 billion Data for 2020 and 2021 from National Safety Council B11 LMSS™  OSHA Citations DO NOT COPY – DO NOT SHARE Penalty Minimum Penalty Maximum Type of Violation (per violation) (per violation) Top 10 Fall protection Serious $1,116 $15,625 OSHA Other-than-serious $0 $15,625 citations Hazard communication FY 2022 Willful or Repeated $11,162 $156, 259 Ladders Posting $0 $15,625 Respiratory protection Requirements Failure to Abate N/A $15,625 per day Scaffolding Control of Hazardous Energy (LOTO) Powered Industrial Trucks Fall Protection Training Eye and Face Protection Machinery and Machine Guarding B11 LMSS™  What is OSHA? DO NOT COPY – DO NOT SHARE OSH Act – Occupational Safety and Health Act Occupational Safety and Health Act of 1970 was passed to prevent workers from being killed or seriously harmed at work OSHA – Occupational Safety and Health Administration Created by the OSH Act to set and enforce protective workplace safety and health standards Part of the US Department of Labor Promulgate regulatory standards, Enforcement (inspections and citations), Advice and Education 29 CFR 1910 – OSHA Regulations for General Industry Codifies OSHA standards directly written into law Either adopted (or adapted) from consensus standards or federal standards developed by the agency B11 LMSS™  Machinery Safety and US Law DO NOT COPY – DO NOT SHARE OSH Act of 1970 – General Duty Clause (5a 1) https://www.osha.gov/laws- regs/regulations/standardnumber/1910 Each employer shall furnish each of his employees, employment and a place of employment, which is free from recognized hazards that are causing or are likely to cause death or serious physical harm The following elements are necessary to prove a violation of the General Duty Clause: 1.The employer failed to keep the workplace free of a hazard to which employees of that employer were exposed; 2.The hazard was recognized; 3.The hazard was causing or was likely to cause death or serious physical harm; and 4.There was a feasible and useful method to correct the hazard. B11 LMSS™  OSHA 29 CFR 1910 DO NOT COPY – DO NOT SHARE 1910.147 The Control of Hazardous Energy This standard covers the servicing and maintenance of machines and equipment in which the unexpected energization or start up of the machines or equipment, or release of stored energy, could harm employees. This standard establishes minimum performance requirements for the control of such hazardous energy 1910 Subpart O Machinery and Machine Guarding One or more methods of machine guarding shall be provided to protect the operator and other employees in the machine area from hazards such as those created by point of operation, ingoing nip points, rotating parts, flying chips and sparks. 1910.06 Incorporation by Reference ecfr.gov List of relevant standards, mostly ANSI, which are incorporated by OSHA as regulatory standards - Electronic Code of Federal Regulations - Changes to CFR B11 LMSS™  Who Is Responsible Under OSHA? DO NOT COPY – DO NOT SHARE Employer Sole responsibility for the safety of his employees Employer must either acquire machinery which meet the OSHA safety requirements or must upgrade deficient machinery/installations until they do Employee Each employee shall comply with occupational safety and health standards and all rules, regulations and orders issued pursuant to this Act which are applicable to his own actions and conduct OSH Act of 1970 Public Law 91-596 Clause 5(b) Manufacturers and Integrators Machinery manufacturers and integrators may not be subject to OSHA citation if they build an unsafe machine or installations Machine manufacturers and integrators are subject to wrongful injury or death (Tort) laws in Civil Court due to unsafe machines or installations B11 LMSS™  What about European Law? DO NOT COPY – DO NOT SHARE Employer Responsibility for Health and Safety The employer shall have the duty to ensure the safety and health of the workers in every aspect related to the work Article 5 paragraph 1, Dir 1989/391/EEC Machinery Directive (Law in all EU member states) Applies to all machines supplied into European member states, conformance is signaled by CE marking. Applies to manufacturers and integrators. B11 LMSS™  What is the Machinery Directive? DO NOT COPY – DO NOT SHARE Freedom of movement of machinery between member Aims: states Common (high) safety level of machinery Machinery, partly completed machinery, interchangeable Scope: equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices 1st party (i.e. self) declaration CE Indicates the product complies with all relevant directives Must be affixed or approved by the manufacturer or Marking: authorized representative established within the European Community B11 LMSS™  What are Safety Standards? DO NOT COPY – DO NOT SHARE Documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. B11 LMSS™  Are Standards Law? DO NOT COPY – DO NOT SHARE Sometimes… Yes - Directly Regulatory Standards - Legal requirements and enforceable by law No – not directly Some standards are voluntary. Consensus standards – Developed through a rigorous and inclusive procedural process Industry Standards – Sector specific developed in an exclusive and rarely a consensus process B11 LMSS™  Types of Standards DO NOT COPY – DO NOT SHARE Type C (Machinery Safety Standards) deal with the detailed safety requirements for a particular machine or group of machines Type B (Generic Safety Standards) deal with one or more safety aspects or one or more types of safeguards that can be used across a wide range of machinery Type A (Basis Standards) give basic concepts, principles for design, and general aspects that can be applied to machinery B11 LMSS™  Types of Technical Documents DO NOT COPY – DO NOT SHARE Technical Report (EU, ISO and ANSI) Generally a further explanation of the intent and application of a published standard – no mandatory requirements Should rather than shall e.g., ANSI/RIA TR R15/606 is a national adoption of ISO/TS15066 on Collaborative Robots Technical Specification (EU and ISO only) Preliminary publication of data which is intended to be included in a published standard after further refinement and testing Represents industry best practice at the time of publication Carries more weight than a Technical Report Uses shall to indicate a normative, mandatory requirement B11 LMSS™  Who Publishes International Standards? DO NOT COPY – DO NOT SHARE Cooperation to ensure standards are seamless International Organization for Standardization International Electrotechnical Commission An independent, non-governmental international Prepares and publishes International organization with a membership of 164 national Standards for all electrical, electronic and standards bodies related technologies Etc. Etc. B11 LMSS™  Who Publishes Consensus Standards in the USA? DO NOT COPY – DO NOT SHARE A. Individual ANSI-Accredited Standards Developing organizations ANSI ANSI establishes procedures and accredits Standards Developing Organizations Used in proving violations of General Duty Clause Hazards recognized by the industry Feasible and useful method to correct the hazard B11 Standards Inc. B11 Standards, Inc. is an ANSI-accredited Standards Developing (ASD) organization which develops standards according to ANSI principles and procedures B11 Standards Inc. is also accredited by ANSI as the United States Technical Advisory Group Administrator to ISO Technical Committee 199 (machinery safety standards) and ISO Technical Committee 39 Subcommittee 10 (machine tool safety standards). B11 LMSS™  Harmonization/ Harmonisation DO NOT COPY – DO NOT SHARE Generally Standards from different committees/countries etc. use the same language/definitions and actively avoid contradictions European Standards Developed by CEN, CENELEC or ETSI following the standard gives a “Presumption of Conformance” to the Machinery Directive B11 LMSS™  Consensus Standards How are they written? ISO DO NOT COPY – DO NOT SHARE Technical Committee (TC) approves the work 1 Assigned to a Subcommittee or Work Group 2 TC Member bodies participate as national delegations (called TAGs 3 in the US, “mirror committees” in the EU) to develop the document Voted and commented upon by TC Member bodies; submitted to 4 ISO Central Secretariat Approved by ISO as an international standard 5 B11 LMSS™  Consensus Standards How are they written? ISO DO NOT COPY – DO NOT SHARE Stage 1 New Working Item Proposal Stage 2 Working Draft Stage 3 Committee Draft Stage 4 Draft International Standard Stage 5 Final Draft International Standard Stage 6 International Standard B11 LMSS™  Consensus Standards How are they written, B11? DO NOT COPY – DO NOT SHARE B11 Standards B11 Standing Writing National Committee Committee Subcommittee Authorized by standing Balanced group of Approve final draft and committee to develop a stakeholders publish standard standard on subject Review final draft and Provide procedures by matter within given vote on authorization which the standards are limits developed and reviewed B11 LMSS™  Understanding Standards DO NOT COPY – DO NOT SHARE Foreword Background to the standard and other relevant information Scope Useful to read to understand what is/isn’t covered by the standard Definitions Definitions of specific terminology that can differ from common usage or dictionary definitions Normative requirements must be followed to meet requirements of the standard – use the term shall Recommendations Denoted by the word should – a recommendation but not a normative requirement B11 LMSS™  Understanding Standards DO NOT COPY – DO NOT SHARE Informative text Indented italics or right-hand column. Explanatory information Annexes Additional information and examples at the end of the standard. Annexes can be either normative or informative B11 LMSS™  How to Use ANSI/B11 Standards DO NOT COPY – DO NOT SHARE Type A General guidance for risk assessments and the implementation of machine design and risk reduction measures Type B Provide functional description of multiple risk reduction measures and methodologies No hierarchy or relative value of these alternatives Selection of measures is driven by the Risk Assessment and application Type C For specific machines covered in the standard If a Type C standard requirement conflicts with a Type A or Type B standard, the Type C requirement generally takes precedence B11 LMSS™  ANSI/B11 Standards DO NOT COPY – DO NOT SHARE # SHORT TITLE / TOPIC YEAR TYPE B11.0 Safety of Machinery 2023 A B11.1 Mechanical Power Presses 2009 (R20) C B11.2 Hydraulic & Pneumatic Power Presses 2013 (R20) C B11.3 Power Press Brakes 2022 C B11.20 Integration of Machinery into a System 2017 B B11.4 Shears 2003 (R20) C B11.21 Machine Tools Using Lasers for Processing Materials 2006 (R20) B B11.5 Ironworkers 1988 (R20) C B11.22 Turning Centers and Automatic Numerically Controlled Turning 2002 (R20) C B11.6 Manual Turning Machines w/ or without Auto Control 2022 C Machines B11.7 Cold Headers and Cold Formers 2020 C B11.23 Machining Centers & CNC Milling, Drilling & Boring Machines 2002 (R20) C B11.8 Manual Milling, Drilling, & Boring Machines 2021 C B11.24 Transfer Machines 2002 (R20) C B11.9 Grinding Machines 2010 (R20) C B11.25 Large Machines 2022 B B11.10 Sawing Machines 2003 (R20) C B11.26 Functional Safety for Equipment / Machine Control Systems 2018 B B11.11 Withdrawn (Gear Cutting Machines) Combined into B11.23 2001 (R12) C B11.27 Electro-Discharge Machines 2020 C B11.12 Roll Forming and Roll Bending Machines 2005 (R20) C B15.1 Withdrawn (Mech Power Trans App) Combined into B11.19 2000 (R08) B B11.13 Single & Multiple-Spindle Automatic Bar and Chucking Machines 2020 C B11.TR1 Ergonomics 2016 B B11.14 Withdrawn (Coil Slitting Machines; combined into B11.18) (1996) C B11.TR2 Metal Working Fluids 1997 (R16) B B11.15 Pipe, Tube and Shape Bending Machines 2022 C B11.TR3 Risk Assessment / Risk Reduction Guide Combined into B11.0 2000 (R15) B B11.16 Powder / Metal Compacting Presses 2014 (R20) C B11.TR4 Selection of Programmable Electronic Systems (PES/PLC) 2004 (R15) B B11.17 Horizontal Hydraulic Extrusion Presses 2023 C B11.TR5 Noise Measurement 2006 (R17) B B11.18 Machines Processing or Slitting Coiled or Non-Coiled Metal 2006 (R20) C B11.TR6 Withdrawn (Safety Control Systems) Combined into B11.26 (2010) B B11.19 Performance Requirements for Risk Reduction Measures 2019 B B11.TR7 Integration of Lean and Safety 2007 (R17) B (Safeguarding) B11.TR8 Sustainable Safety Systems Through Inspection of Risk Reduction 2022 B Measures B11.TR9 Cybersecurity 2019 B B11.TR10 Guidance on Artificial Intelligence into Machinery Functional 2020 B Safety Applications ANSI/ISO Safety of machinery (national adoption of ISO 12100-2010) 2012 A 12100 B11 LMSS™  How to Access ANSI/B11 Standards DO NOT COPY – DO NOT SHARE B11standards.org Webstore.ANSI.org B11 LMSS™  Standards Pop Quiz DO NOT COPY – DO NOT SHARE Type A standards always take False 1 precedence If there is a contradiction, Type C takes precedence A hazard must be recognized to lead True 2 to a General Duty Clause citation Standards are only relevant for False 3 machine users There are requirements for and benefits to all parties B11 LMSS™  What did you Learn DO NOT COPY – DO NOT SHARE What are Standards and Regulations Regulations, consensus standards, industry standards What is and isn’t law Regulations are enforceable by law Why are consensus standards important Compliance with the general duty clause Help you to know what to do, especially Type C standards for specific machinery US specific Standards and Regulations, how it differs from ISO/European Machinery directive and CE marking for Machinery Suppliers Different types of standards and how to use them Type A, B, C, Technical Specifications and Technical Reports B11 LMSS™ DO NOT COPY – DO NOT SHARE ANSI B11.0 – 2023 Safety of Machinery B11 LMSS™  B11.0 Safety of Machinery Subcommittee DO NOT COPY – DO NOT SHARE B11 LMSS™  Learning Objectives DO NOT COPY – DO NOT SHARE Why and when to do a risk assessment Who is responsible for what in a risk assessment B11 LMSS™  Introduction to B11.0 DO NOT COPY – DO NOT SHARE ANSI B11.0 – 2023 Type A standard Approved 27th June 2023 Applies to machine manufacturers, suppliers, and users Applies to new, existing, modified, or rebuilt power- driven machines Compliance with ANSI B11.0 will automatically result in compliance with the requirements of ISO 12100 ISO 12100:2010 // ANSI/ISO 12100-2012 IDT US identical text adoption in 2012 Technical requirements from 1990s Applies to machine manufacturers/suppliers ONLY B11 LMSS™  Introduction to B11.0 DO NOT COPY – DO NOT SHARE 1 Scope (1) 2 Normative References (1) 3 Definitions (13) 4 Responsibilities (6) 5 Lifecycle Requirements and Responsibilities (4) 6 Risk Assessment Process (13) 7 General Risk Reduction Requirements (17) 8 Information for Operation and Maintenance of Machinery (1) 9 Supervision (1) 10 Training (3) B11 LMSS™  Risk Assessment Key Definitions DO NOT COPY – DO NOT SHARE Clause 3 The process by which the intended use of the machine, the tasks and Risk Assessment hazards, and the level of risk are determined The combination of the probability of occurrence of harm and the severity of Risk that harm Harm Physical injury or damage to the health of people Risk Reduction Any action or means used to eliminate hazards and/or reduce risks (Protective) Measure A risk level achieved after risk reduction measures have been applied. It is a Acceptable Risk risk level that is accepted for a given task (hazardous situation) or hazard Any specific activity that is done with, on or around the machine during its Task lifecycle Hazard A potential source of harm B11 LMSS™  Every Day Risk Assessment? DO NOT COPY – DO NOT SHARE B11 LMSS™  Why carry out a Risk Assessment? DO NOT COPY – DO NOT SHARE Reduce rate and severity of injuries Also reducing the frequency and severity of associated costs of injuries Improve Employee Morale Show that the company cares about their safety Increase understanding of the hazards of Plant Operations Increase or maintain operational efficiency by correctly specified and designed risk reduction measures Stay Legal No Federal requirement for risk assessment except in selection of PPE (OSHA 3151-12R 2003) BUT OSHA requires that risks be “assessed and reduced” and inspectors will ask for documentation to prove this has been accomplished All consensus standards require a risk assessment B11 LMSS™  Risk Assessment Who’s Who DO NOT COPY – DO NOT SHARE Annex P B11 LMSS™  Risk Assessment Who’s Who DO NOT COPY – DO NOT SHARE Supplier An individual, corporation, partnership or other legal entity or form of business that provides equipment or services. User An individual, corporation, partnership other legal entity or form of business that utilizes a machine, machine production system or related equipment. Component Supplier Machine supplier Integrator, Modifier, Rebuilder Machine User Personnel B11 LMSS™  Risk Assessment Collaboration DO NOT COPY – DO NOT SHARE Clause 4 “The supplier and the user either separately or jointly shall identify hazards, assess risks and reduce risks to an acceptable level within the scope of their respective work activities as described in this standard” Both suppliers and users should: Involve qualified personnel in meeting their responsibilities Use related regulations and standards applicable to their work activity Collaborate and communicate! At a minimum communicate and document any risks passed from supplier to user For custom machinery – develop a set of specifications suited to the location and application specifics B11 LMSS™  Responsibilities Machine Supplier (Component user) DO NOT COPY – DO NOT SHARE Clause 4 Integration Determine risk reduction measures needed to achieve acceptable risk with any components it integrates into the machine Documentation Obtain and collate documentation regarding installation, operation and maintenance from the component supplier Design for and develop the information for operation and maintenance and cleaning of the machinery, considering the lifecycle of the machine Engineering controls If engineering controls are provided, the machine supplier is responsible for ensuring they are integrated and installed in line with B11.0 If no engineering controls are bought with the components, then the supplier must provide engineering controls in line with B11.0 or other relevant standards B11 LMSS™  Responsibilities Machine User DO NOT COPY – DO NOT SHARE Clause 4 Space Provide and maintain sufficient access and working space to permit safe operation and maintenance Training All personnel working on or around the machine (e.g., Supervisors, operators, maintenance and service personnel) trained in accordance with risk assessment and relevant type C standards, including what to do if there is a malfunction or improper operation Training should be documented and kept up to date Use Changes If deviating from supplier information, then consult with the supplier and use the risk assessment proves to maintain risk at an acceptable level After any changes to tooling, process or procedure ensure the machine and affected components continue to meet requirements of B11.0 (and any machine-specific type C standards) Ongoing assessment The user must ensure policies, procedures, training and instructions are consistently in place to reduce risk to an acceptable level B11 LMSS™  Responsibilities Co-Manufacturer DO NOT COPY – DO NOT SHARE Clause 4.7 Reduce risks to acceptable level Within scope of work Defined responsibilities Between machine owner, machine supplier, and machine user B11 LMSS™  Responsibilities Other DO NOT COPY – DO NOT SHARE Clause 4 Machinery as a service Responsibilities shall be defined between the machine supplier, the service supplier, and the machine user. Purchasers of Used Machinery Ensure original machinery supplier’s risk reduction measures are installed and functional or that other measures are provided to achieve acceptable risk Contact original machinery supplier to obtain manual(s), warning labels, and other information for use. B11 LMSS™  Responsibilities Personnel DO NOT COPY – DO NOT SHARE Clause 4.10 Defeat of risk reduction measures Personnel shall not circumvent, remove or otherwise disable any risk reduction measures (unless as a task identified in the risk assessment) Follow instructions! Personnel must follow all policies, procedures, training and instructions given by the machine user Jewelry should not be worn if it could be hazardous, appropriate clothing should be worn for the situation and not present additional hazard(s), likewise for hair B11 LMSS™  Risk Assessment New and Changed Machinery DO NOT COPY – DO NOT SHARE Clause 5 1) Perform a risk assessment 2) Comply with all current applicable standards New Machinery (New or used components) Repair / Rebuild / Refurbish Machinery (Components that change the function or safety performance) Modify / Reconfigure / Remanufacture Existing Machinery (Hazards created by the change) B11 LMSS™  Risk Assessment Moved and unchanged Machinery DO NOT COPY – DO NOT SHARE Clause 5 Repair/ Rebuild/ Refurbish (Comparable components) No risk assessment required Comply with applicable standards existing at time of manufacture or initial installation Reconfigure/ Relocate Machinery (Existing machinery moved) Risk assessment on any hazards created and to confirm risks are at an acceptable level Comply with current applicable standards on any new hazards Comply with applicable standards from time of manufacture/installation for existing hazards B11 LMSS™  Responsibilities Lifecycle of the Machine DO NOT COPY – DO NOT SHARE Clause 5 Design Construction Reconstruction Modification Set-up Installation Operation Maintenance Dismantling Disposal B11 LMSS™  Responsibilities Installation, commissioning, start-up DO NOT COPY – DO NOT SHARE Within the scope of their respective work activities, the user and supplier shall reduce the risks Clause 5.3 associated with the installation, commissioning and start-up of the machinery to an acceptable level Installation, commissioning and start-up Before placing into production, risk reduction measures must be tested/checked by the user Accomplish in accordance with: Standards (e.g., building regulations, ANSI Standards, etc.) Recommendations for use of machine features to aid installation (e.g., lifting bolts) Supplier and user installation instructions Recommendations for interim risk reduction measures, energy control procedures and signage B11 LMSS™  Responsibilities Operation, Maintenance DO NOT COPY – DO NOT SHARE User responsibilities during operational portion of the machine lifecycle Clause 5.4 Maintain risk at an acceptable level Within established limits Operate consistent with supplier information Establish and follow periodic and regular inspection and maintenance in accordance with supplier information Control hazardous energy in accordance with ANSI/ASSP Z244.1 Deviations from supplier information Consult with the supplier and use risk assessment to maintain risk at an acceptable level including any additional training B11 LMSS™  Responsibilities Modify / Rebuild Existing DO NOT COPY – DO NOT SHARE Clause 5.5 Maintain risk at an acceptable level Solicit original supplier’s recommendations Risk assessment for modified or affected portions Include in the risk assessment process Experience in the field History of past incidents and near misses Number of machines in the field Internal safety audits or regulatory visits B11 LMSS™  Risk Assessment Decommissioning DO NOT COPY – DO NOT SHARE Clause 5.6 Decommissioning Supplier shall consider decommissioning during design and provide information on known hazardous components or processes User shall ensure acceptable risk is maintained during decommissioning Consideration of environmental damage is important – safe disposal and recycling The means to disconnect, isolate and dissipate all sources of hazardous energy of the machine shall be identified and the hazardous energy controlled B11 LMSS™  Risk Assessment Pop Quiz DO NOT COPY – DO NOT SHARE Following B11.0 will ensure True 1 compliance with ISO 12100:2010 Qualified personnel require a False certificate The requirements 2 depend on the situation Machine suppliers are responsible False for training personnel Training is the 3 responsibility of the User B11 LMSS™  What did you Learn? DO NOT COPY – DO NOT SHARE Why and when to do a risk assessment Keep people safe… All new machinery and any significant changes to machinery Who is responsible for what in a risk assessment Supplier, User and Personnel all have responsibilities for their own parts B11 LMSS™ DO NOT COPY – DO NOT SHARE Risk Assessment Process – B11.0 2023 B11 LMSS™  Learning Objectives DO NOT COPY – DO NOT SHARE How to carry out a risk assessment B11 LMSS™  Risk Assessment Aims DO NOT COPY – DO NOT SHARE Clause 6 Goal The goal of risk assessment is to reduce risks to an acceptable level. The risk assessment process shall continue until acceptable risk is achieved Method Exact method doesn’t matter as long as it follows the “fundamental steps” It’s the results that are the important aim Qualified Personnel Technically competent and skilled personnel Risk Assessment in design stage Identify issues and opportunities to optimize systems and processes Reduce costs by designing in risk reduction and avoid costly retrofitting and modifications B11 LMSS™  Risk Assessment Process DO NOT COPY – DO NOT SHARE Clause 6 1. Prepare for and Set Limits of the Assessment 2. Identify Tasks and Hazards 3. Assess Initial Risk 4. Reduce Risk 5. Assess Residual Risk 6. Residual No Risk Acceptable? New/Next Hazard Yes 7. Validate Solutions 8. Results/Documentation Assessment Complete B11 LMSS™  Step 1 Prepare and Set Limits DO NOT COPY – DO NOT SHARE Clause 6.2 Suppliers and users either jointly or separately shall adequately prepare for, set limits on, Annex C document the parameters of the assessment, and establish the level(s) of acceptable risk Set the Scope Machine(s) covered including interfaces Operational states covered Specific machine/process Specific portions of the life cycle Who can be harmed What can be damaged Limits of the machine Lifecycle limits – Design, Build, Install, Use, Maintenance, Decommission Use limits (intended use of the machine) Space limits Time limits e.g., production rates, cycle times, maintenance Environmental limits Interface limits e.g., other machines or energy sources Human factors e.g., ergonomics, cognitive capabilities, time requirements B11 LMSS™  Step 1 Prepare and Set Limits DO NOT COPY – DO NOT SHARE Example Milling machine and area immediately around, marked by shelves/walls Limits – Normal operational part of lifecycle, all tasks/modes and basic maintenance B11 LMSS™  Step 1.1 DO NOT COPY – DO NOT SHARE Choose a Team Annex C Personnel with the technical competence and relevant skill set shall be involved in the risk assessment process in order to ensure that the fundamentals listed in 6.1.3 are adequately addressed and documented Upper Management Buy in is important to show that safety is taken seriously Resource allocation/budgeting Users of the machine (operators, maintenance, etc.) Buy in is key to reducing incentive to defeat Know realities of using equipment and have ideas Experts External expert in hazard identification and risk reduction Good knowledge of standards and risk assessment processes May bring new ideas Facilitator No vested interest in the outcome, impartial B11 LMSS™  Step 1.1 Choose a Team DO NOT COPY – DO NOT SHARE Risk Assessment Leader Manufacturing Engineer Safety expert Operator (Machine shop team leader) B11 LMSS™  Step 1.2 Gather Information DO NOT COPY – DO NOT SHARE Annex C To conduct the risk assessment, the team should obtain necessary resource information. Examples of relevant information and documentation Limits of machinery and lifecycle requirements Previous risk assessments, accident history, near misses – or from similar machinery Function and purpose of the machinery List of affected persons and interactions with machinery Design drawings, system descriptions of the machinery Design layout and proposed systems System layout and proposed building/existing system integration Integration of subsystems and other equipment Information about energy sources Applicable local regulations for machinery or process B11 LMSS™  Step 1.2 Gather Information DO NOT COPY – DO NOT SHARE Information gathered for Risk Assessment ANSI B11.0 ANSI B11.19 ANSI B11.23 ISO 16090-1 Machine documentation/manual Previous risk assessment for similar machine Operator knowledge Accident and near miss data B11 LMSS™  Step 2 Identify Tasks and Hazards DO NOT COPY – DO NOT SHARE Clause 6.3 The reasonably foreseeable tasks and associated hazards shall be Annex D identified for the applicable phases of the lifecycle of the machine Both tasks and hazards must be understood to identify and properly apply risk reduction measures which will be effective Tasks Any specific activity that is done with, on or around the machine during its lifecycle Hazards A potential source of harm B11 LMSS™  Step 2 Identify Tasks and Hazards DO NOT COPY – DO NOT SHARE Clause 6.3 Identifying tasks and hazards is a critically important part of the risk assessment proves because hazards not identified can create substantial unknown risks Methods for identifying tasks and hazards: using intuitive operational and engineering judgment examining system specifications and expectations reviewing codes, regulations, and consensus standards e.g., Type C interviewing current or intended system users and/or operators gaining input from experienced operators and service personnel consulting checklists reviewing studies from similar systems evaluating the potential for unwanted energy releases/exposures to hazardous environments reviewing historical data/industry experience, incident investigation reports (including accident or near-miss events), OSHA Bureau of Labor Statistics and National Safety Council data, manufacturer’s literature considering potential mishaps with surrounding equipment and operations brainstorming B11 LMSS™  Step 2.1 Identify Affected Persons DO NOT COPY – DO NOT SHARE Clause 6.3.1 Identify persons who interact either directly with the machine or who might otherwise be affected Examples: cleaning personnel contract / service personnel engineer installation and removal personnel leader / supervisor maintenance personnel manager / administrative personnel materials handler operator / helper public / passer-by / non-user set-up personnel temporary / stand-in operator trainee B11 LMSS™  Step 2.2 Identify Tasks and Hazards DO NOT COPY – DO NOT SHARE Clause 6.3.2 Auto Operations Manual Maintenance Start up Processes Changeover Loading supplies Lubrication Major maintenance will Minor Cleaning usually require its own Maintenance Replacing worn items risk assessment Adjustment Tooling jams Generally most dangerous Bad material Interventions QC check – unpredictable and often Incorrect set up unplanned Reasonably Foreseeable misuse Other External influences (nearby machines etc.) B11 LMSS™  Step 2.2 Identify Tasks and Hazards DO NOT COPY – DO NOT SHARE Clause 6.3.2 The use of a machine in a way not intended by the supplier or user, but which may result from readily predictable human behavior. Reasonably Foreseeable Misuse Errors and poor judgment Reflexive/reactive behavior Path of least resistance Risk reduction measure impedes the task Foreseeable behavior of unauthorized or untrained persons B11 LMSS™  Step 2.3 Identify Tasks and Hazards DO NOT COPY – DO NOT SHARE Clause 6.3.3 Hazard identification should be conducted with all risk reduction measures conceptually removed Annex D Electric Shear Pneumatic Cut Generally most dangerous Hydraulic Crush– unpredictable and often Energy Gravity Injuries Pinchunplanned Sources Radiation Trap Thermal Strike Trapped Puncture Wastewater Slip Environ Hazardous gases Falls Trip mental Weld slag Fall B11 LMSS™  Step 2 Identify Tasks and Hazards DO NOT COPY – DO NOT SHARE B11 LMSS™  Risk Assessment 2. Identify Tasks and Hazards DO NOT COPY – DO NOT SHARE B11 LMSS™  Step 3 Assess Initial Risk DO NOT COPY – DO NOT SHARE Clause 6.4 The risks associated with each hazard shall be assessed using the following steps: 1) Select a risk scoring system 2) Assess risk using the risk factors of the risk scoring system 3) Derive a risk level Severity of Probability of Risk Is a function of harm and occurrence The highest credible level of severity shall be Assess selected Severity The highest credible level of probability shall be Assess selected Probability For each hazard or task/hazard pair, an initial risk Derive Risk level shall be derived using a risk scoring system B11 LMSS™  Step 3 Assess Initial Risk DO NOT COPY – DO NOT SHARE Clause 6.4 An example of a two-factor risk scoring system. Other risk scoring system examples given in Annex F of B11.0 Severity of Harm Probability of Occurrence Catastrophic Serious Moderate Minor Very Likely High High High Medium Likely High High Medium Low Unlikely Medium Medium Low Negligible Remote Low Low Negligible Negligible B11 LMSS™  Step 3 Assess Initial Risk DO NOT COPY – DO NOT SHARE B11 LMSS™  Step 3 Assess Initial Risk DO NOT COPY – DO NOT SHARE B11 LMSS™  Step 3 Assess Initial Risk – ANSI/ASSP Z10 DO NOT COPY – DO NOT SHARE B11 LMSS™  Step 3 Assess Initial Risk – ANSI/RIA TR R15.306 DO NOT COPY – DO NOT SHARE B11 LMSS™  Step 3 Assess Initial Risk DO NOT COPY – DO NOT SHARE This figure from ISO 13849-1 2015 is not a method of assessing risk. It is a tool for determining the required reliability (Performance Level) of a safety function and is only relevant for a Safety Related Part of a Control System if that is the chosen risk reduction measure. It will be covered in more detail in Module 3 B11 LMSS™ DO NOT COPY – DO NOT SHARE Risk Assessment Hazard Rating Number HRN LO X FE X DPH X NP = HRN 5 X 4 X 4 X 1 = 80 0.033 X 4 X 2 X 1 = 0.264 B11 LMSS™  Step 3 Assess Initial Risk DO NOT COPY – DO NOT SHARE B11 LMSS™ DO NOT COPY – DO NOT SHARE Severity of Harm Probability of Occurrence Catastrophic Serious Moderate Minor Very High High High Medium Likely Likely High High Medium Low Unlikely Medium Medium Low Negligible Remote Low Low Negligible Negligible B11 LMSS™  Step 4 Reduce Risk DO NOT COPY – DO NOT SHARE Clause 6.5 If the level of risk is not acceptable, feasible risk reduction measures shall be implemented to reduce that risk. Risks shall be reduced using the hazard control hierarchy. Severity of Probability of Risk Is a function of harm and occurrence Therefore, risks can be reduced by: Reducing the potential severity of harm presented by the hazard Improving the possibility of avoiding the harm Reducing the need for access to the hazard zone B11 LMSS™  Step 4 Reduce Risk DO NOT COPY – DO NOT SHARE Clause 6.5.1 B11 LMSS™  Step 4.1 Inherently Safe by Design DO NOT COPY – DO NOT SHARE Clause 6.5.1 Where feasible, hazards shall be eliminated by design Hazard Elimination Reduce blind spots from control positions Remove crushing/shearing hazards by increasing minimum gap Avoid sharp edges or protrusions Consider ergonomics Limit the force/mass/velocity to reduce or eliminate hazard Reduce noise/vibration Task Design Consider maintainability to reduce exposure Move location of where work is carried out Eliminate exposure through use of a no-touch tool Substitution Use less toxic or hazardous materials/substances Use processes that produce less toxic or hazardous emissions Use automated material handling as a substitute for manual B11 LMSS™  Step 4.2 Engineering Controls DO NOT COPY – DO NOT SHARE Clause 6.5.1 Guards or devices and associated safety-related parts of the control system used to reduce risk Types of Engineering Fixed Guards Access requirements Controls Frequency? Whole body? movable Guards Delayed access for run down? What is the environment? Interlocks Hygienic Explosive Dust, dirt, etc. Presence Sensing Devices Connectivity Mechanical Other engineering controls Wired Connected B11 LMSS™  Step 4.3 Administrative Controls DO NOT COPY – DO NOT SHARE Clause 6.5.1 Information for use shall contain all directions required to ensure safe and correct use of the machine Awareness Means Warnings of residual risk Barriers, warnings, signals Training required PPE required Risks from misuse Training and Procedures Explain potential hazards Purpose and function of risk reduction measures Safe work procedures to avoid hazards Personal Protective Equipment In conjunction with other risk reduction measures When no other control method is available or feasible B11 LMSS™  Step 4 Reduce Risk DO NOT COPY – DO NOT SHARE Initial Risk Engineering and Administrative Controls Design out risk Guards, control system, PPE Be mindful of new risks created B11 LMSS™  Step 4 Reduce Risk DO NOT COPY – DO NOT SHARE Clause 6.5.2 Regulatory obligations Effectiveness Durability and maintainability Ergonomic impact Introduction of new hazards Productivity / machinery performance Usability Technological feasibility Economic feasibility B11 LMSS™  Step 4 Motivation/Incentive to Defeat DO NOT COPY – DO NOT SHARE Clause 6.5.2 For the continued safe operation of a machine it is important that the protective measures allow its easy use and do not hinder its intended use Is using this safeguarding device worth it? Perception Habit Obstacles Barriers B11 LMSS™  Step 4 Motivation/Incentive to Defeat DO NOT COPY – DO NOT SHARE Clause 6.5.2 Risk estimation shall take account of the possibility of defeating or circumventing protective measures. It shall also take account of the incentive to defeat or circumvent protective measures Incentives to consider include: Easier/more convenient/less physical effort Faster/greater productivity Greater visibility/audibility Greater freedom of movement Avoidance of interruptions Perceived “necessity” of defeating protective devices according to operating modes. B11 LMSS™  Step 4 Motivation/Incentive to Defeat DO NOT COPY – DO NOT SHARE Preventing access to the interlock by mounting out of 1 reach or shielding. Preventing the substitution of actuators by introducing 2 the use of unique coding for actuators Using non-detachable fixings to prevent interlocks and 3 actuators being removed Using the control system to monitor interlocks to ensure 4 their correct function Flow Chart from ISO 14119 B11 LMSS™  Step 4 Reduce Risk DO NOT COPY – DO NOT SHARE B11 LMSS™  Step 4 Reduce Risk DO NOT COPY – DO NOT SHARE B11 LMSS™  Step 4 Reduce Risk DO NOT COPY – DO NOT SHARE Requirements on Interlocking devices in Enclosures of security level III Tips for introducing an extended security concept B11 LMSS™  Step 4 Reduce Risk DO NOT COPY – DO NOT SHARE B11 LMSS™  DO NOT COPY – DO NOT SHARE B11 LMSS™  DO NOT COPY – DO NOT SHARE B11 LMSS™  Step 5 Assess Residual Risk DO NOT COPY – DO NOT SHARE Clause 6.6 1. Prepare for and Set Limits of Once feasible risk reduction measures have been selected, the residual risk the Assessment shall be assessed in order to verify that the selected risk reduction measures, including training and PPE, are appropriate for the application and that they 2. Identify Tasks and Hazards effectively reduce the risk. 3. Assess Initial Risk Is a Severity of Probability of 4. Reduce Risk Risk function of harm and occurrence 5. Assess Residual Risk The highest credible level of severity shall be Assess selected 6. Residual Severity No Risk Acceptable? The highest credible level of probability shall be Assess selected New/Next Hazard Yes Probability 7. Validate Solutions For each hazard or task/hazard pair, an initial risk Derive Risk level shall be derived using a risk scoring system 8. Results/Documentation Assessment Complete B11 LMSS™  Step 5 Assess Residual Risk DO NOT COPY – DO NOT SHARE Influence of different Risk Reduction Measures on the Risk Factors Inherently Safe By Design Automate the loading process Affects the severity of harm Greatly reduces probability of harm and probability of occurrence Use a different process Removes hazard entirely Example – Metal Bending Machine hazard of crushing fingers Engineering Controls Two-handed control operation Greatest impact on Reduces probability of harm, does not reduce severity of harm probability of harm Interlocked Guard Minimal, if any, impact on Reduces probability of harm, does not reduce severity of harm severity of harm Administrative Controls Potential impact on Safe work procedures probability of harm Potential impact on probability of harm No impact on severity of Wearing of heavy-duty gloves harm except the use of Tools Potential impact on severity of harm, no impact on probability or PPE B11 LMSS™  Step 5 Assess Residual Risk DO NOT COPY – DO NOT SHARE B11 LMSS™  St