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8/8/2019 20091203 Mftg2 Product Safety and Safety Products
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PRODUCT SAFETY AND SAFETY PRODUCTS
ANINTRODUCTIONTO DESIGN FORSAFETY
2009-12-03
M. BEUSENBERG
LECTURE: MANUFACTURING2 / KW2 / 2009-2010
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1. Introduction: Product Characteristics
2. Product Functions
Functions and Values
Function Classification by Type or Hierarchy Safety as Product Function
3. Product Safety and Safety Products
4. Case Product: Helmets
5. Case Method: FMEA
6. Exercise : FMEA on Helmets
20091203Product Safety and Safety Products
CONTENTS
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merely an introduction create awareness more elaborate later (?)(combine a safety product with product safety design engineering)
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20091203Product Safety and Safety Products
1. INTRODUCTION: PRODUCT CHARACTERISTICS
FORM, FUNCTION, MEANING
3
..
FORM
FUNCTION MEANING
science
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20091203Product Safety and Safety Products
2. PRODUCT FUNCTIONS
FUNCTIONS AND VALUES
4
value creation
FUNCTION(S)
NEED(S)
VALUE(S)
socio-economic(user)
business(manufacturer)
user technology
society business
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20091203Product Safety and Safety Products
2. PRODUCT FUNCTIONS
FUNCTION CLASSIFICATION BY TYPE
5
Eekels, J. W.A. Poelman: Industriele productontwikkeling; ISBN 90-5189-435 X; 1995
productfuncties
bedrijfseconomischefunctie
maatschappelijkefunctie
gebruiks-functies
instrumenteletechnische functies
emotionele
functies
technische
gebruiks-functies
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20091203Product Safety and Safety Products
2. PRODUCT FUNCTIONS
FUNCTION CLASSIFICATION BY HIERARCHY
6
Eekels, J. W.A. Poelman: Industriele productontwikkeling; ISBN 90-5189-435 X; 1995
productfuncties
primaire functies secundaire functies
hoofdfuncties nevenfuncties
subfuncties(ondersteunende
functies)
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20091203Product Safety and Safety Products
2. PRODUCT FUNCTIONS
SAFETY AS TYPICAL PRODUCT FUNCTION
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safety
productfuncties
bedrijfseconomischefunctie
maatschappelijkefunctie
gebruiks-functies
instrumenteletechnische functies
emotionele
functies
technische
gebruiks-functies
safety safety
safetysafety
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20091203Product Safety and Safety Products
2. PRODUCT FUNCTIONS
SAFETY AS HIERARCHICAL PRODUCT FUNCTION
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safety
productfuncties
primaire functies secundaire functies
hoofdfuncties nevenfuncties
subfuncties(ondersteunende
functies)
safety
safety safety
safety
safety
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Laws, regulations, directives, standards
CE-marking (Europe)
Safety is a form of quality
Subjective and objective assessment: risk analysis, safety testing
PPE
Machinerichtlijn
MDD
...etc. etc.
20091203Product Safety and Safety Products
3. PRODUCT SAFETY AND SAFETY PRODUCTS
APPLIES TO ALL PRODUCTS
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...
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Assyrian helmets (ca. 900 BC)
20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
HISTORY
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military and ceremonial origin
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Corinthian helmet (ca. 500 BC)
20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
HISTORY
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new materials...
http://en.wikipedia.org/wiki/File:Corinthian_helmet_Denda_Staatliche_Antikensammlungen_4330.jpg8/8/2019 20091203 Mftg2 Product Safety and Safety Products
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1900 - 1950
Military applications (e.g. fighter pilots)
Motorcycle and car racing
American Football
20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
HISTORY
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main developments in only a few applications
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1900 - 1950
Military applications (e.g. fighter pilots)
Motorcycle and car racing
American Football
20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
HISTORY
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American Football helmet history
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1950s: origin of helmet test standards
1960s 2000: from art to science through biomechanics
1990s now: numerous applications, designs, and innovations
20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
HISTORY INNOVATIONS IN CONSTRUCTION AND MATERIALS
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the natural helmet
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20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
GENERAL CONSTRUCTION OF CRASH HELMETS
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construction
Arai Quantum 2
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Recreation and Sports: American Football, Speed Skating, Short Track,Whitewater Kayaking / Canoeing, Lacrosse, Ice Hockey, Boxing, Football,Skiing / Snowboarding, Equestrian Sports, Cricket, Baseball, Climbing,Martial Arts, Rodeo, Racing (auto, motorcycle)
Road Transportation: Motorcycle, Bicycle
Professional Use: Construction (hard hat), Mining, Riot Police, CoastGuard, Fire Fighting, Welding, Space, Diving, Fighter Pilot, Ceremonial[e.g. custodial helmet worn by English and police bobby])
Military
Miscellaneous (no helmets?)
20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
APPLICATIONS
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types
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American Football
20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
APPLICATIONS RECREATION AND SPORTS
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a revolution in head protection
Riddell Revolution
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20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
APPLICATIONS ROAD TRANSPORTATION
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both road transportation...
BMW System 6
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20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
APPLICATIONS PROFESSIONAL USE
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Canadian RiotPolice Helmet
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20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
APPLICATIONS - MILITARY
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PASGT helmet
http://images.google.com/imgres?imgurl=http://www.matshelmets.se/helm_pics/ee/ee-pasgt-int.jpg&imgrefurl=http://www.matshelmets.se/ee_helm.html&usg=__3_RPbZieulOip7rhWCkYecJbm-c=&h=351&w=435&sz=57&hl=nl&start=59&um=1&tbnid=oSz0b0KKtg6gxM:&tbnh=102&tbnw=126&prev=/images?q=pasgt&ndsp=21&hl=nl&lr=&rlz=1G1GGLQ_NLUS355&sa=N&start=42&um=18/8/2019 20091203 Mftg2 Product Safety and Safety Products
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Folding Helmets (1)
20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
INNOVATIONS
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courtesy of Biokinetics and Associates Ltd. (Canada)
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Folding Helmets (2)
20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
INNOVATIONS
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Folding Helmets (3)
20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
INNOVATIONS
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HANS device (patented in 1985)
20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
INNOVATIONS
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http://en.wikipedia.org/wiki/File:Ken_SchraderHANSdevice.jpghttp://en.wikipedia.org/wiki/File:Andy_Priaulx_2007_Curitiba_qualify.jpg8/8/2019 20091203 Mftg2 Product Safety and Safety Products
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20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
APPLICATIONS: HELMET OR NO HELMET?
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20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
APPLICATIONS: HELMET OR NO HELMET?
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http://www.shareasale.com/m-pr.cfm?merchantID=12990&userID=225926&productID=466638287http://kotaku.com/assets/resources/2007/09/helmet-crop.jpg8/8/2019 20091203 Mftg2 Product Safety and Safety Products
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20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
APPLICATIONS: HELMET OR NO HELMET?
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20091203Product Safety and Safety Products
4. CASE PRODUCT: HELMETS
APPLICATIONS: HELMET OR NO HELMET?
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Wat is FMEA? Failure Mode and Effect Analysis (FMEA) of Failure ModeEffect and Criticality Analysis (FMECA) is een methode die gebruikt wordtvoor systematische risicoanalyse en kwaliteitsverbetering van processen,producten en diensten in verschillende stadia van ontwikkeling.
Waarom FMEA? De FMEA methode kan potentile kwaliteitsproblemenvroegtijdig onderkennen en voorkomt zo hoge kosten (of erger) achteraf.De tijdsinvestering in het uitvoeren van de methode wordt altijd ruimterugverdiend ten opzichte van reparatie, garantiekosten en/ofreputatieschade. De methode heeft als voordelen dat het gebruik maaktvan een systematische en multidisciplinaire aanpak, duidelijke prioriteiten
voor kwaliteitsverbetering oplevert en de gemaakte ontwerpkeuzendocumenteert.
20091203Product Safety and Safety Products
5. CASE METHOD: FMEA
BACKGROUND: WHY FMEA?
31
errare humanum est
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FMEA is part of several quality standards; hence is required for RegulatoryCompliance; including
enhanced compliance with 21 CFR, Part 11 (regulating the use ofelectronic records and signatures)
FDA 21 CFR Part 820 QSR (cGMP)
Medical Devices Directive (MDD)
ISO 13485:2003
ISO 14971:2000
ISO 9001:2000
SAE J1739, ARP 5580
IEC 60812
20091203Product Safety and Safety Products
5. CASE METHOD: FMEA
BACKGROUND: WHY FMEA?
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regulatory compliance
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1. Define the product / system / service and the extent of the FMEA. Alsoestablish the proper team (...).
2. Functional analysis: break down the product in functional subassemblies.Ensure to distinguish intentional use and unintentional use. Document
each function or part (subassembly).
3. Generate failure modes: what can go wrong?. Brainstorm, write, draw.
4. Determine consequences of failure: also score severity (seriousness).Note: 10 (= most severe) implies also the lower defined problems apply.
5. Investigate the causes: why did it go wrong?. Score the probability
(chance of happening). 10 = failure is unavoidable
20091203Product Safety and Safety Products
5. CASE METHOD: FMEA
HOW FMEA (CONDENSED DFMEA STEPS 1-5)?
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simplified FMEA (1-5)
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6. Determine how failures can be detected and the chance of failures to bedetected. Score detection. 10 = almost impossible to detect failure.
7. For each failure mode: calculate Risk Priority NumberRPN = severity probability detection
Rank the failure modes: highest RPN on top.
8. Establish an RPN tolerance limit all modes above this limit need to beaddressed.
9. Determine actions to eliminate failure modes or other actions to bring RPNdown under tolerance limit.
10. Implement improvements and recalculate RPN.
20091203Product Safety and Safety Products
5. CASE METHOD: FMEA
HOW FMEA (CONDENSED DFMEA STEPS 6-10)?
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simplified FMEA (6-10)
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20091203Product Safety and Safety Products
5. CASE METHOD: FMEA
FMEA SAMPLE SHEETS
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simplified FMEA sample sheets
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20091203Product Safety and Safety Products
5. CASE METHOD: FMEA
FMEA SAMPLE SHEETS
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simplified FMEA sample sheets
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20091203Product Safety and Safety Products
5. CASE METHOD: FMEA
FMEA SAMPLE SHEETS
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simplified FMEA sample sheets
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18 groups
min. 5, max. 10 students per group
chose 1 helmet type, model, make (real helmets)
execute FMEA (all 10 steps)
submit sheets to c.m.beusenberg@utwente.nl
further instructions on blackboard
20091203Product Safety and Safety Products
6. ASSIGNMENT: FMEA ON HELMETS
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assignment
mailto:c.m.beusenberg@utwente.nlmailto:c.m.beusenberg@utwente.nl8/8/2019 20091203 Mftg2 Product Safety and Safety Products
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20091203Product Safety and Safety Products 39
Thanks, and good luck!
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