20091203 mftg2 product safety and safety products

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

2

merely an introduction create awareness more elaborate later (?)(combine a safety product with product safety design engineering)


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1. INTRODUCTION: PRODUCT CHARACTERISTICS

FORM, FUNCTION, MEANING

3

..

FORM

FUNCTION MEANING

science


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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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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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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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SAFETY AS TYPICAL PRODUCT FUNCTION

7

safety

productfuncties

bedrijfseconomischefunctie

maatschappelijkefunctie

gebruiks-functies

instrumenteletechnische functies

emotionele

functies

technische

gebruiks-functies

safety safety

safetysafety


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SAFETY AS HIERARCHICAL PRODUCT FUNCTION

8

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.


3. PRODUCT SAFETY AND SAFETY PRODUCTS

APPLIES TO ALL PRODUCTS

9

...


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Assyrian helmets (ca. 900 BC)


4. CASE PRODUCT: HELMETS

HISTORY

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military and ceremonial origin


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Corinthian helmet (ca. 500 BC)



HISTORY

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new materials...
http://en.wikipedia.org/wiki/File:Corinthian_helmet_Denda_Staatliche_Antikensammlungen_4330.jpg


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1900 - 1950

Military applications (e.g. fighter pilots)

Motorcycle and car racing

American Football



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



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



HISTORY INNOVATIONS IN CONSTRUCTION AND MATERIALS

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the natural helmet


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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?)



APPLICATIONS

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types


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American Football



APPLICATIONS RECREATION AND SPORTS

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a revolution in head protection

Riddell Revolution


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APPLICATIONS ROAD TRANSPORTATION

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both road transportation...

BMW System 6


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APPLICATIONS PROFESSIONAL USE

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Canadian RiotPolice Helmet


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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=1


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Folding Helmets (1)



INNOVATIONS

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courtesy of Biokinetics and Associates Ltd. (Canada)


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Folding Helmets (2)



INNOVATIONS

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Folding Helmets (3)



INNOVATIONS

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HANS device (patented in 1985)



INNOVATIONS

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http://en.wikipedia.org/wiki/File:Ken_SchraderHANSdevice.jpghttp://en.wikipedia.org/wiki/File:Andy_Priaulx_2007_Curitiba_qualify.jpg


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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.jpg


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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.


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



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



HOW FMEA (CONDENSED DFMEA STEPS 1-5)?

33

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.



HOW FMEA (CONDENSED DFMEA STEPS 6-10)?

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simplified FMEA (6-10)


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FMEA SAMPLE SHEETS

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simplified FMEA sample sheets


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FMEA SAMPLE SHEETS

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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 [email protected]

further instructions on blackboard


6. ASSIGNMENT: FMEA ON HELMETS

38

assignment
mailto:[email protected]:[email protected]


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20091203Product Safety and Safety Products 39

Thanks, and good luck!

20091203 mftg2 product safety and safety products

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