Product Safety Management. Protecting People + Profits.

Post on 23-Dec-2015

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Product Safety Management

Protecting People + Profits

Don’t Reinvent the Wheel,Make it Rounder—

Safety by Design

Risk Assessments

Hazards --> Risks --> Dangers

Design FMEA

(Failure Mode Effects Analysis)

• Failure > Cause > Effects

• Occurrence X Severity X Detection = RPN

Risk Priority Number

• Extremely High (12 and over) – Design out the hazard.

• High (9 - 11) – Guard the hazard.

• Medium (5 - 8) – Labeling and Manual

• Low (1 - 4) – Manual

LS400 FMEA

• Failure Mode– Brake handle too close to frame

• Effects of Failure– Creates Pinch Point

• Causes of Failure– Designed w/o adequate clearance

LS400 FMEA (cont’d)

• Occurrence - 4

• Severity - 3

• Detection - 1

• RPN - 12– Design out the hazard.

Recommended Corrective Action

• Complete Redesign of Brake Handle– Eliminates pinch point.

Current Testing Practices

• Static

• Dynamic

• Curb Drop

• Two Drum

• EMC

Additional Testing Applications

• Splash/Salt

• Extreme Heat

• Extreme Cold

• Test Track

• Real World

Proper Label Format

• Signal Word– Danger, Warning, Caution

• Describe the hazard.

• Describe how to avoid the hazard.

• Consequences of not following instructions.

Current Labeling System(max. weight capacity)

Safety SignsAccording to US Department of Education and Census

Bureau statistics (1990)• App. 23% of American adults are functionally illiterate.• About 12% of Americans speak a language other than

English at home.• More than 14 million Americans speak English poorly or

not at all.• Up to 86% of non-English speaking people who can’t

read English are also illiterate in their native tongue.

ANSI Z535 Labeling

+ +

+

+

=

ISO 3864

Harmonization

Consolidate Labels

+ - =

Cost for Product Labeling

• Maintain Inventory

• Translation

• Mislabeling in Production

• Fewer BOM Configurations

• Lower BOM Maintenance and Cost

• Liability

Eliminate by Engineering Design

Global Information

PREFACE (in owner’s manual)

Safety

WELCOME to Pride Mobility Products Corporation (Pride). The wheel chair you have purchased combines the state of art components with safety, comfort and styling in mind. We are confident that the design features will provide you with the conveniences you expect during your daily activities. Understanding how to safely operate and care for your wheelchair should bring you years of trouble free operations and service.

Read and follow all instructions, warnings, cautions and notes in this manual before attempting to operate your wheelchair for the first time. In addition, your safety depends upon you, as well as your provider, caretaker, or healthcare professional in using good judgement.

If there is any information in this manual in which you do not understand, or if you require additional assistance for setup or operation, please contact your authorized Pride provider. Failure to follow the instructions, warnings, cautions and notes in this manual and those located on your wheelchair, can lead to personal injury and /or damage to the wheelchair, including voiding the warranty.

To Err is Human

To Forgive is Design...