1. Safety Through Design Bruce W. Main, PE CSP design safety engineering, inc. Ann Arbor, Michigan 10 Sept 2003

2. Presentation Overview Safety through design Safety through design Why you should care Why you should care Risk assessment basics Risk assessment basics designsafe demonstration and hints designsafe demonstration and hints Examples Examples

3. Safety Through Design... Design - optimizing against criteria Design - optimizing against criteria Late changes in criteria - safety Late changes in criteria - safety Getting it right the first time Getting it right the first time

4. Familiar Methods Government regulations (OSHA, FDA, etc.) Government regulations (OSHA, FDA, etc.) Industry standards Industry standards Checklists Checklists Safety factors Safety factors

5. “Recent” Advances FMEA FMEA Failure Modes & Effects Analysis Failure Modes & Effects Analysis Component failures Component failures Risk assessment Risk assessment People failures People failures

6. Safety Through Design… Getting it right the first time Getting it right the first time How? How? Risk assessment Risk assessment

7. Why you should care… Your professors think it’s a good idea Your professors think it’s a good idea Your grade depends on it Your grade depends on it

8. Other reasons to care Industry standards are requiring risk assessment Industry standards are requiring risk assessment Europe - CE mark requires risk assessment Europe - CE mark requires risk assessment Customers are beginning to require risk assessment Customers are beginning to require risk assessment Condition of sale Condition of sale Lots of momentum in industry in risk assessment Lots of momentum in industry in risk assessment Risk assessment works Risk assessment works Better, cheaper, faster, more productive Better, cheaper, faster, more productive

9. The Basics...

10. The Safety Hierarchy… Forms the theoretical basis for design safety The preferred approach to addressing hazards is: 1. Eliminate the hazard by design 2. Substitute less hazardous work methods or materials 3. Incorporate safety devices (guarding systems) 4. Provide warning systems 5. Apply administrative controls (work methods, training) 6. Provide personal protective equipment (PPE) (Manuele: Innovations in Safety Management 2001)

11. 1. Determine the limits of the Machine 2. Hazard Identification 3. Risk Estimation 4. Risk Evaluation 5. Risk Reduction (Countermeasures) 6. Verify Implementation 7. Document Results ANSI B11 TR3

12. Hazard Analysis... Identify hazards Identify hazards Task-based is a very useful approach Task-based is a very useful approach Focuses on what people do Focuses on what people do Users/tasks/hazards Users/tasks/hazards Brainstorming grounded in reality Brainstorming grounded in reality

13. Risk Assessment... Qualitative / semi-quantitative / quantitative Qualitative / semi-quantitative / quantitative Working to achieve acceptable risk Working to achieve acceptable risk risk which remains after protective measures have been taken risk which remains after protective measures have been taken risk which is accepted in a given context risk which is accepted in a given context Zero risk does not exist Zero risk does not exist

14. B11 TR3 Matrix NegligibleNegligibleLowLowRemote NegligibleLowMediumMediumUnlikely LowMediumHighHighLikely MediumHighHighHigh Very Likely MinorSeverityModerate Level of SeriousCatastrophic Probability of Occurrence of Harm

15. MIL-STD-882D Matrix (E) IMPROBABLE ( 10 -6 > X ) (D) REMOTE ( 10 -3 > X > 10 -6 ) (C) OCCASIONAL ( 10 -2 > X 10 -3 ) (B) PROBABLE ( 10 -1 > X > 10 -3 ) (A) FREQUENT ( X > 10 -1 ) (4)NEGLIGIBLE(3)MARGINAL(2)CRITICAL(1)CATASTROPHIC CATEGORY FREQUENCY UNACCEPTABLE UNDESIRABLE ACCEPTABLE WITH REVIEW ACCEPTABLE WITHOUT REVIEW

16. R15.06 Matrix Table 2 – Risk reduction decision matrix prior to safeguard selection R4 A1 Likely R3B A2 Not Likely E1 Infrequent exposure R3A A1 Likely R2C A2 Not Likely E2 Frequent exposure S1 Slight Injury First-aid R2B A1 Likely R2B A2 Not Likely E1 Infrequent exposure R2A A1 Likely R1 A2 Not Likely E2 Frequent exposure S2 Serious Injury More than First-aid RISK REDUCTION CATEGORYAVOIDANCEEXPOSURE SEVERITY OF INJURY

17. HFMEA Hazard Scoring Matrix Probability Severity CatastrophicMajorModerateMinor Frequent161284 Occasional12963 Uncommon8642 Remote4321

18. Risk Scoring Systems Bringing structure to a subjective analysis Bringing structure to a subjective analysis There is no one right approach There is no one right approach This is subjective This is subjective Become comfortable with subjectivity Become comfortable with subjectivity The goal is acceptable risk The goal is acceptable risk

19. Risk Assessment Results New design requirements/criteria !! New design requirements/criteria !! Assessment of risk: severity/probability ratings Assessment of risk: severity/probability ratings Road map for risk reduction activities Road map for risk reduction activities Framework for solutions (safety hierarchy) Framework for solutions (safety hierarchy) design changes, guarding systems design changes, guarding systems warnings, instructions, training, PPE requirements warnings, instructions, training, PPE requirements Risk reduced to acceptable risk Risk reduced to acceptable risk

20. A Demonstration designsafe…

21. Key Points about designsafe Guides you through the risk assessment process Guides you through the risk assessment process Conforms to current standards Conforms to current standards Helps you identify hazards Helps you identify hazards Prompts your risk reduction effort Prompts your risk reduction effort Creates the documentation Creates the documentation Free demo at www.designsafe.com Free demo at www.designsafe.comwww.designsafe.com

22. Too Much Residual Risk? What do you do? ReduceTransferAvoidAccept

23. When do we accept risk? When it’s insignificantly low. When it’s insignificantly low. When we are sure it is worth it. When we are sure it is worth it. When we do not know it is there. When we do not know it is there.

24. Tips on using designsafe… It is a guide. Use your head. It is a guide. Use your head. Keep your eye on the goal Keep your eye on the goal Identify hazards Identify hazards Reduce risks to an acceptable level Reduce risks to an acceptable level Risk scoring is not a scientific exercise. Risk scoring is not a scientific exercise. Look for effective shortcuts Look for effective shortcuts All users, all tasks All users, all tasks Cut, copy, paste Cut, copy, paste Make it work for you. Make it work for you.

25. Example – Large Oven System Oven system to bake finish on parts Oven system to bake finish on parts Elevated, overhead location Elevated, overhead location Access required from time to time Access required from time to time Service conveyor, oven Service conveyor, oven Retrieve fallen parts Retrieve fallen parts

26. View Inside of Oven Fallen Parts Tripping Hazards

27. Problems Lighting insufficient Lighting insufficient Access difficult Access difficult Introduced hazards to the workplace Introduced hazards to the workplace Task-based risk assessment finds these Task-based risk assessment finds these

28. Perishable Goods Processing Packaging system to extend food shelf life Packaging system to extend food shelf life Automated production system in operation Automated production system in operation Sales wants small, manual system Sales wants small, manual system customers can “try before they buy” customers can “try before they buy” Prototype hand-held design in development Prototype hand-held design in development Risk assessment performed Risk assessment performed

29. New hazards identified Electrical equipment in wet environmentElectrical equipment in wet environment - not hard wired- not hard wired Complex/confusing operationComplex/confusing operation unmarked/confusing controlsunmarked/confusing controls high probability for operator errorhigh probability for operator error equipment damage could occur if not properly doneequipment damage could occur if not properly done Hand puncture – needle stickHand puncture – needle stick

30. Changes Made GFI added GFI added Design changes to greatly simplify procedures Design changes to greatly simplify procedures Entirely eliminated need for operator to adjust controls Entirely eliminated need for operator to adjust controls Improved user information – manual, warnings, system ‘package ’ Improved user information – manual, warnings, system ‘package ’ Puncture resistant gloves added Puncture resistant gloves added

31. Common Themes Must identify hazards early Must identify hazards early Early is better, faster, cheaper and more effective Early is better, faster, cheaper and more effective Task based risk assessment helps identify more hazards Task based risk assessment helps identify more hazards Allows engineers to reduce risks Allows engineers to reduce risks Risk assessment helps to determine Risk assessment helps to determine What, why, how and how much What, why, how and how much

32. Review Safety through design Safety through design Why you should care Why you should care Risk assessment basics Risk assessment basics Demonstrated the process - designsafe Demonstrated the process - designsafe Example risk assessment applications Example risk assessment applications