When Is An FMEA/RA Required For Laser Systems?...

12th DOE Laser Safety Officer Workshop May 8-10, 2018

University of Rochester Laboratory for Laser Energetics Dynamic Laser Solutions, Inc. of 42

When Is An FMEA/RA Required For Laser Systems?

Randolph Paura, P. Eng., CLSO Dynamic Laser Solutions, Inc.,

Fort Erie, Ontario, L2A 5M4, Canada

[email protected]

[email protected]




Abstract:

• Terms of “Risk Assessment” (RA) and “Failure Mode & Effects Analysis” (FMEA) are

increasingly used, abused and misunderstood.

• The purpose of a risk assessment is the demonstrable execution of due diligence in

fulfillment of the “General Duty” clause for safety in the workplace.

• For most “nominal” systems, laser user safety conformance via Tables 10 and 11

fulfillment, together with other standards (e.g. NFPA 79, etc.) will suffice.

• Suggested breakpoints when to conduct a more thorough valuation of hazard(s)

identification with control measure(s) review.

• FMEA/RA is an essential optimization tool for ensuring project success within constraints

of resources and time for the objectives of productivity, capability, efficiency and safety.




29CFR1910.132(d)(1)

• “The employer shall assess the workplace to determine if hazards are present,

or are likely to be present, which necessitate the use of personal protective

equipment (PPE). If such hazards are present, or likely to be present, the

employer shall:…”

Inherent Hazard(s) Residual Hazard(s)

Safety Control Measures




The P5 Rule: Proper Planning Provides Premium Performance

• Scale and scope of any plan is respective of its value, risk and reward

• For health and safety at the workplace, being responsible:

– What are the inherent hazard(s) and their risk(s) to personnel and property

– What are the control measure(s) for safeguarding

– What are the residual hazard(s) → are additional safeguards required

• The plan, via risk transfer and due diligence principles:

– Follow the user manual (e.g. for commodities)

– Employ consensus standards and regulations (e.g. integrated systems)

– Engage Risk Assessment protocols (e.g. high value/risk projects, unique systems)

• Attachment A has the list of various questions/tasks to be addressed that can

trigger appropriate efforts to plan for safety and success in a project




Purpose:

• Initiated at the start of a project (concept and/or design phase) for maximal

effectiveness

• Part of planning for conformance to established standards and regulations for

safety and efficiency

• You’ve got the process and equipment covered… what about the people?

– Training Needs Analysis;

– Ensure key people are aware of terms and objectives;

• A written plan provides structure for tracking, communication, continuous

improvement, risk transfer & demonstration of due diligence.




What it is:

• A core tool for project execution/management efficiency for success

• Methodical evaluation, avoid unintended consequences, or boxing the

process/equipment into a corner and “discovering” there’s a problem

• Ideally conducted whenever:

– changes are made, especially when new machinery or systems are introduced;

– new tasks are added or a new routine is devised;

– when adding new processes, evaluate what tasks may create the probability of a

hazardous event;




For responsible systems integrators, it is not up for debate:

• Regulatory build conformance:

– Per FLPPS (US 21CFR1040.10 and 1040.11)

– IEC 60825-1 per US FDA/CDRH Laser Notice 50 (LN56 W.I.P.)

• Safe build will enable safe use

• User safety conformance:

– ANSI Z136.9:2013, Z136.8:, Z136.1:2014

– IEC TR 60824-14:2004

– Note: User safety standards require addressing reasonably foreseeable failure

events, though not necessarily single fault failure protection principles




Complexity/uniqueness and capabilities can drive scope of RA efforts:

• Degree of hazards, evaluations, control measures and assessment tend to be

respective of their asset values, in manufacturing:

– Semiconductors (e.g. EUV laser, NBHs, new process frontiers)

– Ranging laser (well established boundaries for manufacturing)

– Marking (relatively mature, established boundaries)

– Welding/cutting and allied processes (increasing implementation and bounds)

• Drivers are increasing beam quality & power of the new generation lasers:

– Second order effects & NBHs are not necessarily linearly related to intensity/power

levels for laser-target-interactions → expect some surprises




Established breakpoints:

• Laser hazard classification with AELs have served the laser sector well

– High cost/risk projects will drive scrutiny for success

• What trends are emerging as acquisition costs for lasers decrease, enabling

greater adoption by smaller companies that potentially do not have the

experience base or resources to carefully plan and implement?

• Can other breakpoints or guidance markers for safety awareness be provided?

• Tables 10 and 11 of Z136 are sufficient foundations for user safety in principle,

though one mustn't forget second order effects, NBHs and single fault failure

protection when dealing with Class 4+ lasers/systems/processes




FMEA/RA by a Systems Integrator:

• Concept and design review for reliability,

robustness and redundancy (components and

system)

• Conservation of energy: an accounting for what

goes where – follow the energy

• General: ANSI B11.0, B111.TR3, ISA101, etc.

• Electrical: NFPA 79, ANSI B11.TR6, etc.

• Mechanical: ANSI/RIA 15.06, ANSI B11.19, etc.

• LGACs: OSHA, ACGIH, ASHRAE, etc.




FMEA/RA by a Systems Integrator:

Project execution:

• Timely coordination of resources to make it happen

• Accounting for contingencies in advance (constantly

adjusting the plan is not an option)

• Staying ahead of the curve

• Ensuring pro-active awareness of all elements in meeting their confluence

milestones to merge into the project for success

• Incorporates FMEA/RA on a macro-level, not just the debug and

commissioning level




Second order effects are the result of laser-target interactions and are driven

primarily by:

• Beam mode (CW vs Pulsed)

• Beam intensity (there are nominal threshold levels)

• Process (e.g. marking, cutting, welding, cladding)

• Materials being processed (e.g. ferrous, non-ferrous, non-metals)

• Primary (laser) wavelength (e.g. UV, VIS, NIR, FIR)

• Assist/shield gases employed (e.g. Air, O2, He, N2, Ar, CO2)

Products of which can be:

• Process re-radiation (UV, VIS, NIR)

• Plasma radiation (UV, VIS)

• Ionizing radiation




Frequently asked questions/requests:

• Class 4 starts at 0.5 W (CW), what’s next?

• What other thresholds or awareness markers are there?

• Is there a RA template for a basic laser system?

• What does a more rigorous RA document consist of?

• What should the user manual consist of? – Scope of risk transfer obligations

• --

• Premise from industry:

– We get that consensus standards are not prescriptive,

but give us a starting point or reference to work from (or against)




Class 4 starts at 0.5 W (CW), what’s next?

• It’s just a bigger elephant, with bigger safety control measures…

• Sweat the details, don’t lump it all together – break it down into elements

• The laser is a hazardous energy source (Lockout-Tagout principles apply)

• Specify the controls and safety architecture performance/integrity level

• Size the beam stops, barriers and containment system for durability and

reasonably foreseeable failure events

• Account for single fault failure protection in the sequence and process

• Beam on time monitoring becomes a requirement not an option

• Non-Beam Hazards (NBHs) to be investigated and addressed




What other thresholds or awareness markers are there?:

• It is difficult to achieve consensus on the next bio breakpoint with additional safety control

measures, nevertheless… depending upon the application sector, the following metrics

can be utilized to provide guidance:

• There are other NBHs being triggered below the 1012 W·cm-2 noted in Z136 (Table 7-1)

Laser Type UV VIS NIR FIR Note

CW Power (kW) Signal word: DANGER vs WARNING

Pulse Energy (J) Signal word: DANGER vs WARNING

tpulse (s) Greater attention on LPE, portals, etc

NHZ (m) Determines containment, LCA and human access considerations

OD Scaled with cutoff to restrict (filtered) direct viewing.

E (W/cm2) Scaled. LTIR protection tied to welding shade, material processed.

H (J/cm2) Scaled. LTIR protection tied to welding shade, material processed.




For materials processing, NIR laser welding aluminum:

• Second order effects are showing I < 107 W·cm-2

• Yb:fiber, 1070 nm, 200 µm fiber, 150 mm coll, 250 mm focus, ~333 µm spot size, Ar

Ref.: “Characteristics of Plasma Plume in Fiber Laser Welding of Aluminum Alloy”,

Huazhong University of Science and Technology, China (2014)

I (2kW) = 2.28 x 106 W·cm-2

I (3kW) = 3.42 x 106 W·cm-2

I (4kW) = 4.57 x 106 W·cm-2

I (5kW) = 5.71 x 106 W·cm-2

I (6kW) = 6.85 x 106 W·cm-2




What other thresholds or awareness markers are there, for industrial?

• For macro processes,

Ic0 ~ 106 W·cm-2 (between

conduction limited and keyhole

welding), +/- ~20%

• Broaching Ic1 ~ 107 W·cm-2 to

expect second order LTIR effects

and hazards

Source: Rofin Sinar




Is there a RA template for a basic laser system?: Yes – being drafted, SSC-9




What does a more rigorous RA document consist of?:

The product of a seamless and integrated success plan through the life-cycle of a

project (there is no set generic template, just the principles)

1. Initiate, define & plan

2. Specify (stds & regs)

3. Execute & monitor

4. Commission

5. Verify & transfer

Functional Safety

Life Cycle

Source: Rockwell Automation




What does a more rigorous RA document consist of?:

Also known as:

• Conformance Review

• Pre-Start Health and Safety Review

• --

• Know the type, scope and scale of the hazard(s)

• Safeguard personnel and property

• Respect & maintain the safety control measures

• See the reference list of equipment build standards and risk assessment

guidance documents in Attachments B & C

Source: HSE, UK




Summary:

• Laser technology continues to progress: its adoption is faster than society’s

ability to appreciate the hazard (c.f. electricity)

• The LSO is part of a multi-disciplinary team and needs to communicate

regarding risk assessment principles and terms, for project success

– Z136 can facilitate and should lead this effort: qualification, roles, responsibilities

• Appropriate markers/guidance is requested for thresholds in various sectors for

second-order effects and other hazards (e.g. nanoparticles)

– Create greater sense of awareness and respect of higher hazard(s)

– Eliminate confusion regarding control measures integrity/performance levels

– Address correct use of signage respective of application sector (Class 4+)




Summary: It’s required

The degree of documentation or record keeping will depend on:

• level of risk involved,

• legislated requirements, and/or

• facility or corporate requirements

Documentation should show that:

• conducted a sufficient hazard review,

• determined the risks of those hazards

(Z136 hazard classification scheme makes this easy)

• implemented control measures suitable for the risk,

• reviewed and monitored all hazards in the workplace




• Risk assessments are increasingly recognized to ensure safety, success and

capability of projects. It is an appropriate tool to ensure due diligence for:

– Light

– Applied

– Safely,

– Efficiently &

– Reliably

Randolph Paura, P. Eng., CLSO

[email protected]




Attachments:

• A, General Scope of Project Risk Management & Conformance

• B, Standards and Regulations

• C, Risk Assessment Guidance Standards



Attachment A: Project Safety by Design

• Project and equipment specifications to include safety objectives and

compliance plan,

• Broken down according to disciplines, ensure harmony across safety integrity

and performance levels (do not allow for weak links)

• Work through design objectives, tolerances and deviations, applicable

regulations, codes, consensus standards and guidance documents

• Schedule to have milestones for safety status reporting (pre-emptively address

shortcomings or excess)

• Training needs analysis for personnel (pre-requisites & continuing education)

• Start-up & commissioning plan, to include critical control measures

performance/integrity testing

• Customer hand-off (risk transfer) plan




General bullets/reminders:

• Beam (direct & indirect), secondary and non-beam hazards are in laser

equipment build standards/regulations. Safe build enables safe use.

• For high power Class 4 lasers, containment and control of the hazardous

powers/energies (primary and secondary) need to be accounted for and

addressed

• Engineering design reviews of the details (just like one follows the electrical

path, so to should the optical path of the beam to the target and beyond be

examined)

• Other standards apply when building a system and can contribute to the

overall safety without restricting usability or functionality, draw upon discipline

experts

• Mechanical, electrical, pneumatic/hydraulic, automation




Unique laser system components to be assessed

(additional to those identified in machine safety standards):

• Secondary, radiation and plasma effects of laser target material interaction

(incoherent, coherent, x-rays, temperature, oxygen depletion, LGACs, etc.)

• Identification of mission critical elements within laser system (power source,

delivery, process and beyond)

• Engineering design review of mission critical elements (to assist with FMEA,

FMMEA, FTA studies)

• FMEA of mission critical elements

• E/E/PE code reliability (fault tolerance & stress testing)

• Allow for automatic error recovery and condition monitoring (upgrades)

• Controlled emergency shut-down procedures (automatic and operator initiated)




Measures to mitigate risk on very high power Class 4 laser systems (power

source, equipment and process):

• Beam on-time monitoring (can determine time budget for shut-down response

prior to mission critical element failure)

• Control of hazardous energy (LOTO)

• Monitoring of mission critical elements (safe, out of tolerance, failure, drift &

deviations)

• Pre-commission radiometric audit

• Competency testing, on-the-job-training, re-certification program for personnel

• Maintenance and service re-commission checklist to validate safety

functionality before putting into operation




Consider all foreseeable hazard scenarios (which off-the-shelf components may

not have been designed to handle):

• Failure of power supplies and various control circuits

• Power surges and brown-outs, unanticipated E-stops

• Errors in software code (control logic and safety circuit)

• Effects (source or receiver) of EMC/EMI

• Environmental effects (temperature, humidity, dust, etc.)

• Operator “mode confusion”, will (how) the equipment resist incorrect operator

inputs of control system

• Emergency preparedness planning can identify weak links to be addressed



Attachment B: Equipment Standards & Regulations

• Understand the organization and

utility of standard levels




Standards Addressing General Requirements (“A” Level Standards)

U.S. International/European

OSHA 29CFR1910 (applicable provisions – see www.osha.gov for further information)

ISO 12100-1&2 (EN292) Safety of Machinery: Basic Concepts, General Principles for Design

OSHA 29CFR1910.212 General Requirements for (Guarding of) All Machines

ISO 14121 (EN1050) Safety of Machinery: Risk Assessment



Attachment B: Equipment Standards & Regulations Standards Addressing Safety, Safeguarding, and Methodologies (“B” Level Standards) – U.S.

ANSI/NFPA70 The National Electrical Code

OSHA 29CFR1910.147 The Control of Hazardous Energy (Lockout/Tagout)

ANSI/NFPA70E Electrical Safety Requirements for Employee Workplaces

ANSI Z244.1 Lockout/Tagout of Energy Sources

ANSI/NFPA79 Electrical Standard for Industrial Machinery (Aligned with IEC60204-1)

ANSI Z535 Safety Alerting Standards

OSHA 29CFR1910.333 Selection and Use of Work Practices (Electrical Safety)

ANSI Z136.9 Safe Use of Lasers in Manufacturing Environments

ANSI B11.21 Machine Tools Using Lasers – Safety

ANSI B11.0 Safety of Machinery; General Requirements and Risk Assessment

ANSI B11.19 Safeguarding (Machine Tools)

OSHA 3071 Job Hazard Analysis

U.S. 21CFR1040.10 & 1040.11 Performance Standards for Light Emitting Products



Attachment B: Equipment Standards & Regulations Standards Addressing Safety, Safeguarding, and Methodologies (“B” Level Standards) – International/European

IEC 60204-1 Electrical Equipment of Machines (Aligned with NFPA79)

ISO 14120 (EN953) Guards – General Requirements for the Design and Construction

ISO 14118 (EN1037) Prevention of Unexpected Start Up

ISO 14119 (EN1088) Interlocking Devices With and Without Guard Locking

ISO 13849 Safety Related Parts of Control Systems

IEC 61496 Electro Sensitive Protective Equipment

IEC 62061 Functional Safety of Electrical/Electronic/ Programmable Control Systems

ISO 13850 (EN418) Emergency Stop Devices, Functional Aspects – Principles for Design

IEC 61508 Functional Safety of E/E/PE Safety Related Systems (Software/Firmware)

IEC 1131 Programmable Controllers

ISO 11553 Safety of machinery — Laser processing machines

IEC 60825-1 Safety of laser products – Part 1: Equipment classification and requirements




Standards Addressing Specific Machine Applications (“C” Level Standards) – U.S., International/European

ANSI B11.20 Manufacturing Systems / Cells

ISO 11161 Industrial Automation / Safety of Integrated Manufacturing Systems

ANSI/RIA R15.06 Industrial Robots and Robot Systems

ISO 10218 Manipulating Industrial Robots – Safety

ANSI Z136.7 Testing and Labeling of Laser Protective Equipment

IEC 60825-4 Safety of laser products – Part 4: Laser guards

IEC 60825-5 Safety of laser products – Part 5: Manufacturer's checklist for IEC 60825-1



Attachment C: Risk Assessment Guidance Standards

General/OSHA:

• A3071 Job Hazard Analysis

ANSI:

• ANSI B11.0-2015, Safety of Machinery – General Requirements and Risk Assessment

• ANSI B11.19-2010, Performance Criteria for Safeguarding

• NSI B11.20-2004 (R2015), Safety Requirements for Integrated Manufacturing Systems

• ANSI B11.21-2006 (R2012), Safety Requirements for Machine Tools Using Lasers for Processing

Materials

• ANSI B11.TR 1-2016, Ergonomic Guidelines for the Design, Installation And Use of Machine Tools

• ANSI B11.TR 3-2000 (R2015), Risk Assessment and Risk Reduction- A Guideline to Estimate,

Evaluate and Reduce Risks Associated with Machine Tools

• ANSI B11.TR6-2010, Safety Control Systems for Machines




ANSI/ASSE:

• ANSI/ASSE Z10-2012 (R2017) Occupational Health and Safety Management Systems

• ANSI/ASSE Z244.1-2016, The Control of Hazardous Energy Lockout, Tagout and Alternative Methods

• ANSI ASSE/ISO Z690 Series, Risk Management: Vocabulary, Principles and Guidelines

ANSI RIA:

• ANSI/RIA R15.06-2012 American National Standard for Industrial Robots and Robot Systems- Safety

Requirements

• RIA TR R15.306-2016 Task-based Risk Assessment Methodology

• RIA TR R15.406-2014: Safeguarding

ASME:

• ASME-ITI Risk Analysis 2010




IEC:

• IEC 61882 Ed. 2.0 b:2016, Hazard and operability studies (HAZOP studies) - Application guide

• IEC 62502 Ed. 1.0 b:2010, Analysis techniques for dependability - Event tree analysis (ETA)

ISO:

• ISO Guide 73:2009, Risk management - Vocabulary

• ISO 31010:2009, Risk management - Risk assessment techniques

• ISO 14121-1:2007, Safety of machinery - Risk assessment - Part 1: Principles

• ISO/TR 14121-2:2012, Safety of machinery - Risk assessment - Part 2: Practical guidance and

examples of methods




MIL:

• MIL-STD-882E, DEPARTMENT OF DEFENSE STANDARD PRACTICE: SYSTEM SAFETY

(11-MAY-2012)

SEMI:

• SEMI S10-0815E - Safety Guideline for Risk Assessment and Risk Evaluation Process



Bibliography

Breakpoints regarding intensity thresholds:

• “Laser-Vapour Interaction in High-Power CW CO2 Laser Welding”, Paper P546

presented at ICALEO 2003 conference, Jacksonville, Florida, USA, 13-16 October 2003

https://www.twi-global.com/technical-knowledge/published-papers/laser-vapour-

interaction-in-high-power-cw-co2-laser-welding-october-2003/

• “Laser-Vapour Interaction in High-Power CW Nd:YAG Laser Welding”, Paper 1607

presented at ICALEO 2003 Conference, 13-16 October 2003, Jacksonville, Florida, USA,

https://www.twi-global.com/technical-knowledge/published-papers/laser-vapour-

interaction-in-high-power-cw-ndyag-laser-welding-october-2003/



Bibliography


• “Optical Radiation Hazards of Laser Welding Processes Part 1: Neodymium-YAG Laser”,

R. James Rockwell, C. Eugen Moss. (1983). American Industrial Hygiene Association

Journal. 44. 572-9. 10.1080/15298668391405346.

• “Optical Radiation Hazards of Laser Welding Processes Part II: CO 2 Laser “, R. James

Rockwell & C. Eugene Moss. (1989). American Industrial Hygiene Association Journal.

50. 419-27. 10.1080/15298668991374912.

• “Spectroscopic studies of plume/plasma in different gas environments”, Paper presented

at the International Congress on Application of Lasers and Electro-Optics (ICALEO) 15-

18 October 2001, Jacksonville, USA.

https://www.twi-global.com/technical-knowledge/published-papers/spectroscopic-studies-

of-plume-plasma-in-different-gas-environments-october-2001/



Bibliography


• “Laser-Vapour Interaction in High-Power CW CO2 Laser Welding”, Paper P546

presented at ICALEO 2003 conference, Jacksonville, Florida, USA, 13-16 October 2003

• “Characteristics of Plasma Plume in Fiber Laser Welding of Aluminum Alloy”, M. Gao, C.

Chen, M. Hu, L. Guo, Z. Wang, X. Zeng, Applied Surface Science (2014),

http://dx.doi.org/10.1016/j.apsusc.2014.11.136

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