Managing for Liability Avoidance. (c) Lewis Bass

Transcription

1 Managing for Liability Avoidance (c) Lewis Bass

2 Staying Safe in an Automated World Keys to Automation Safety and Liability Avoidance Presented by: Lewis Bass, P.E. Mechanical, Industrial and Safety Engineer and Product Safety Attorney Lewis Bass International, Inc. Campbell, California USA

3 (c) Lewis Bass

4 Equipment Risk Assessment and Product Liability Avoidance Why we are here? Why equipment safety and risk assessment is important? What must be done to manage equipment risk and avoid product liability? (c) Lewis Bass

5 (c) Lewis Bass Photo courtesy of DST Controls

6 How do we decide if a machine is safe enough? Product liability laws U.S. and international standards ANSI standards Customer requirements (c) Lewis Bass

7 Legal factors to be considered Likelihood of occurrence (LO)? Frequency of exposure (FE)? Degree of possible harm (DPH)? Number of people exposed to hazard (NP)? Are there safer alternative designs? What does it cost to make the machine safer? (c) Lewis Bass

8 Evaluating the total machine Product liability law applies risk analysis to the entire machine (c) Lewis Bass

9 What is a machine? Physical Product Catalog Data Owner s Manual Warranty Sales Brochure Service Machine Service Manual Advertising Warnings Maintenance Shipping Package Safety Spare Devic Partses Installation Software (c) Lewis Bass

10 Pipe Mill Control Large pieces of hot, sharp-edged moving mass. (c) Lewis Bass Photo courtesy of DST Controls

11 Human Factors A machine can be unsafe if it does not take into account the skills and abilities of the user. (c) Lewis Bass

12 Environmental Factors Hazardous location Interaction of machines Closeness of other machines or energy sources. (c) Lewis Bass

13 Machine Defects - What are they? Unsafe design Inadequate guarding Inadequate warnings Inadequate training (c) Lewis Bass

14 Warnings On-Product hazard warnings Operating manuals Installation, maintenance and service SOPs (standard operating procedures) (c) Lewis Bass

15 Why do we need to know about European Standards? CE Marking applies to machines entering the European Community Machines must meet the applicable directives Many U.S. ANSI standards are harmonizing with ENs There is a growing trend toward International Standards Organization (ISO) standards (c) Lewis Bass

16 (c) Lewis Bass Photo courtesy of DST Controls

17 Safety Related Control System (SRCS) EN Provides guidance on how to determine the type of safety related control system to use. (c) Lewis Bass

18 OSHA Requirements OSHA (b)(13) Control Reliability [for Mechanical Power Presses] When required by paragraph ( c )(5) of this section, the control system shall be constructed so that a failure within the system shall not prevent the normal stopping action from being applied to the press when required, but does prevent initiation of a successive stroke until the failure is corrected. The failure shall be detectable by a simple test, or indicated by the control system. (c) Lewis Bass

19 OSHA ( c) Safeguarding the Point of Operation (1) General Requirements. (I) It shall be the responsibility of the employer to provide and insure the usage of point of operation guards or properly applied and adjusted point of operation devices on every operation performed on a mechanical power press. (c) Lewis Bass

20 Approaches to machine safeguarding Fixed guards with special fasteners; Barrier guards or guard doors equipped with safety rated devices Safety rated light curtains and safety light beams Safety edges Safety mats Use of padlock with a controlled key on a guard Separating the operator by distance railing or barrier to prevent access to a dangerous point (c) Lewis Bass

21 Multi-national company machine safety standards policy Comply with company machine safety policy Install control reliable - Category 3 fail-to-safe electrical wiring on new high risk and selected existing equipment Upgrade lockout/tagout systems to ensure 100% compliance with applicable regulatory standards Eliminate operator bypassing of safety devices Install locking interlock switches and braking devices for high inertia components Implement and institutionalize safe behavior systems/programs. Establish and enforce a code of conduct (c) Lewis Bass

22 Risk Assessment ANSI B11.TR3:2000 Risk Assessment and Risk Reduction a Guide to Estimate, Evaluate and Reduce Risk Associated with Machine Tools EN 1050 Principles of Risk Assessment Risk Analysis Techniques (c) Lewis Bass

23 Risk Management Identify foreseeable hazards and the ways that a hazard can result in an injury Determine potential risk (Before) Evaluate design and warning countermeasures that reduce risk Establish method of verifying that requirements have been met Decide if the risk is acceptable (After) (c) Lewis Bass

24 Machine Risk Assessment MACHINE LIMITS Can Can you you foresee all all possible operation and and use use of of the the machine NO NO Work with with team to to expand foreseeability analysis YES YES HAZARD IDENTIFICATION Identify each hazard and and hazard scenario (way the the hazard can can cause an an accident) RISK REDUCTION RISK ESTIMATION Estimate the the risk risk level based on on Likelihood, Frequency, Degree of of harm and and Number of of people exposed RISK EVALUATION Is Is the the risk risk level acceptable? Are Are the the countermeasures adequate? NO NO END OF PROCESS (c) Lewis Bass

25 Machine Limits Analyze the machine limits and functions to identify potential hazards Foresee possible operations and uses of machine Foresee who will use or be in the vicinity of the machine (c) Lewis Bass

26 Equipment Life Cycle Installation Use Service Maintenance/Repair Disposal (c) Lewis Bass

27 Foreseeable Equipment Risks Foreseeable use Foreseeable misuse Foreseeable environment Foreseeable user Foreseeable malfunctions; emergencies (c) Lewis Bass

28 Hazard Identification Identify each type of hazard Identify each hazard scenario How can the hazard cause injury to a person (c) Lewis Bass

29 Risk Evaluation Techniques What if? Analysis Preliminary Hazard Analysis Failure Modes and Effects Analysis Fault Tree Analysis (c) Lewis Bass

30 Hazard Probability Level Description Individual Machine Product Line AA Frequent Likely to to occur frequently Continuously experienced BB Probable Will occur several times in in life of of a product Will occur frequently CC Occasional Likely to to occur sometime in in life of of a product W ill ill occur several times DD Remote Unlikely but possible to to occur in in life of of a product Unlikely but can reasonably be be expected to to occur EE Improbable So So unlikely, it it can be be assumed hazard will not occur Unlikely to to occur, but possible (c) Lewis Bass

31 Hazard Severity Category II II II III III IV IV Descriptive Word Catastrophic Critical Marginal Negligible Mishap Definition Death or or product loss Severe injury, severe illness or or major product damage Minor injury, minor illness, or or minor product damage Less than minor injury, illness, or or product damage (c) Lewis Bass

32 Acceptable Risk Level Matrix Hazard Cause Level A B C D E Hazard Cause Level A. A. Frequent B. B. Probable C. C. Occasional D. D. Remote E. E. Improbable Hazard Effect Category I. I. Catastrophic II. II. II. II. Critical Marginal IV. IV. Negligible IV III II I Hazard Effect Category Unacceptable Risk (c) Lewis Bass

33 Risk evaluation results Is the level of risk acceptable? What countermeasures should be used? Are the countermeasures consistent with machines with similar risks? What are the costs differences? Can we offer the safer system as an option? (c) Lewis Bass

34 The Hierarchy of Countermeasures Design For Minimum Risk Most Preferred Incorporate Safety Devices Provide Warning Devices Develop Procedures, Manuals Warnings, and Training Least Preferred (c) Lewis Bass

35 Criteria for Warnings and Instructions Present when needed Present where needed Attract attention; and Motivate change (c) Lewis Bass

36 (c) Lewis Bass Photo courtesy of DST Controls

37 Sufficiency Of Warnings Description of hazard Probability of hazard occurring Severity if occurs How to avoid hazard (c) Lewis Bass

38 Hazard Alerts: Signal Words Danger Used to indicate a situation which, if not avoided, will result in death or severe injury. This signal word is limited to the most extreme situations. Warning Used to indicate a situation which, if not avoided, could result in death or severe injury. Caution (with safety alert symbol) Used to indicate a situation which, if not avoided, could result in minor or moderate injury. Caution (without safety alert symbol) Used to indicate a situation which, if not avoided, could result in property damage. (c) Lewis Bass

39 Hazard Alerts Symbol: Hazard Description Safety Alert Symbol and Signal Word Text: Hazard ID, Consequence, Avoidance Symbol: Hazard Avoidance (c) Lewis Bass

40 Warnings in Manuals and Procedures Is there adequate safety information in the manuals and procedures? Is there a safety section? Are the warnings explained? (c) Lewis Bass

41 Summary: machine safety risk management Identify and assess the risk Decide what countermeasures to implement Evaluate potential product liability for different safeguarding measures for similar risks (c) Lewis Bass

42 We should have used Lewis Bass Int!! (c) Lewis Bass Photo courtesy of DST Controls

43 Thank You! Lewis Bass International, Inc. (408)

44 LEWIS BASS, P.E., J.D. Attorney and Safety Engineer LEW BASS applies his engineering experience to the analysis of the liability associated with products, facilities and the environment. He holds a B.S. in Mechanical Engineering, an M.S. in Industrial and Systems Engineering, and a J.D. in Law. Mr.. Bass has reviewed the safety of hundreds of products and factories. He has testified in court regarding risk assessment, warnings and safe design involving a wide variety of products. Mr. Bass has taught many courses in safety, risk analysis and liability prevention. Mr. Bass is the author of "Products Liability: Design and Manufacturing Defects 2nd Edition", published by The West Group and searchable on westlaw.com and the Editor of Managing for Products Liability Avoidance 3 rd Edition (2004), published by Commerce Clearing House (CCH). (c) Lewis Bass

45 Lewis Bass International For All of Your Safety Needs For over 26 years, we have provided Legal and Safety Engineering Consulting to large and small companies around the world. We work with companies in the construction, food processing, medical device, semiconductor equipment, consumer products and other industries. We evaluate machines for potential hazards and liability. Based on risk analyses, we provide recommendations for safety program improvement, safe product design, warnings and manuals. We provide clients with recommendations for warning content, placement and methods of communication to reduce liability and accidents and increase profits. (c) Lewis Bass

46 Total Safety Services Safety and Liability Avoidance Risk Analysis, Warnings and Manuals Regulatory Compliance Compliance and consultation Recall decision-making Safety Training Safe product design Warnings and instruction manuals Electrical and mechanical safety Guards and interlocks Ergonomics (c) Lewis Bass

47 LBI Clients Alcoa Aluminum Rockwell-Allen Bradley Motorola Emerson Electric Zurich Insurance Co. DST Controls Lee Industries Alza Ethicon Endo-Surgery Intel Scientific Technologies Inc. Applied Materials Metlsaw Hitachi (c) Lewis Bass

48 Safety Related Control System (SRCS) (c) Lewis Bass

49 Safety Related Control System (SRCS) The definitions for the different levels of severity and probability are as follows: S: Severity of potential injury S1: Slight injury (e.g. bruise) S2: Severe injury (e.g. amputation or death) F: Frequency of exposure to potential hazard F1: Infrequent exposure F2: Frequent to continuous exposure (c) Lewis Bass

50 Safety Related Control System (SRCS) P: Possibility of avoiding the hazard if it occurs P1: Possible P2 Less possible L: Likelihood of occurrence (e.g. if an interlock fails) L1: Very likely L2: Unlikely L3: Highly likely (c) Lewis Bass

51 Safety Related Control System (SRCS) Factors that influence the likelihood of occurrence are: policies related to high risk maintenance (e.g. performed only by trained personnel) How often personnel need to access the danger area. (c) Lewis Bass

52 Safety Related Control System (SRCS) Interlock Categories There are 5 Categories or Levels of interlocks defined in EN 954-1, Safety of Machinery Design of Safety Related Control Systems. Category B, 1,2,3, and 4 (c) Lewis Bass

53 Safety Related Control System (SRCS) Category B Safety Related parts of machine control systems and/or their protective equipment, as well as their components, are designed, constructed, selected, assembled and combined in accordance with relevant standards so that they can withstand the expected influence. When a fault occurs it can lead to loss of the safety function. (c) Lewis Bass

54 Safety Related Control System (SRCS) Category 1 The requirements of Category B apply together with the use of well tried safety components and safety principles. Category 1 requirements exceed Category B by utilizing higher reliability components. Both Category B and Category 1 utilize the principle of prevention of faults in selection of safety related components. (c) Lewis Bass

55 Safety Related Control System (SRCS) Category 2 Utilizes the requirements of well tried safety principles and introduces the requirement of checking the safety function at machine start up and periodically by the machine control system. If a fault is detected a safe state shall be initiated or a warning shall be given. The occurrence of a fault can lead to the loss of safety function between the checking intervals. (c) Lewis Bass

56 Safety Related Control System (SRCS) Category 3 Utilizes the same requirements as Category 2. A single fault in any of its parts does not lead to the loss of safety function. When a fault is detected the safety function is always performed. The loss of safety function can only occur by the accumulation of undetected faults. (c) Lewis Bass

57 Safety Related Control System (SRCS) Category 4 When a fault is detected the safety function is always performed and the faults will be detected in time to prevent the loss of safety functions by detecting a fault at or before the next demand on the safety function. Categories 2 4 utilize the principle of safety through fault detection in the design of the system. (c) Lewis Bass