NonConformances come from many sources including:

1
Quality Management Tool Box

• Non-Conformances come from many sources
  including
• Variation
• Culture
• Complexity
• Mistakes

Each must be managed to improve quality and
reliability.
2
Cultural Aspects

• What comes first? Whats rewarded?
• Deming
• ISO 9000
• Six Sigma (DMAIC)
• Define the customer, the project and what success
  is
• Measure performance
• Analyze the process and causes of defects
• Improve the process by removing causes
• Control the process to maintain improvements

3
Cost of Quality COQ

• Costs of Conformance prevention appraisal
• Costs of Non-Conformance Internal Failure
  External

4
Everyday Examples
3.5 inch diskettes cannot be inserted unless
diskette is oriented correctly. This is as far
as a disk can be inserted upside-down. The
beveled corner of the diskette along with the
fact that the diskette is not square, prohibit
incorrect orientation.
Fueling area of car has three error-proofing
devices 1. insert keeps leaded-fuel nozzle
from being inserted 2. tether does not allow
loss of gas cap 3. gas cap has ratchet to
signal proper tightness and prevent
overtightening.
New lawn mowers are required to have a safety bar
on the handle that must be pulled back in order
to start the engine. If you let go of the safety
bar, the mower blade stops in 3 seconds or less.
5
Evidence of the Effectiveness Source
Productivity Inc. and Shingo prize profiles

• Cooper Automotive
• 95 less defects than nearest competitor
• 75 less injuries
• 99.6 less customer defects (13 ppm)
• 88 in-plant defect reduction
• 70 less warranty cost
• 89 scrap reduction (0.7)
• 60 productivity increase

6
Devices Tend to be Inexpensive...
Evidence of the Effectiveness
Cost of Poka-Yoke Devices
1
0.9
0.8
0.7
0.6
Frequency of Occurrence
0.5
Probability
Cumulative Probability
0.4
0.3
0.2
0.1
0
25 to 100
25 or less
100 to250
250 to 1000
1000 or more
Cost
7
and Very Effective

• The 101, 1001, even 10001 rates of return
  referred to by Bhote above are not unreasonable
  in practice.
• Dana corporation has reported a 500,000 savings
  resulting from a 6 device. (83,0001)
• ATT Power Systems (Lucent Technologies) reported
  net saving of 2545 per device (3300 devices)
  Marchwinsky, 1997. (251)
• Weber Aircraft reports saving 350,000 during
  their first year of implementation of
  approximately 300 devices. (111)

Assumes and average devise cost 100
8
Examples

• Wire harness board (sockets, labels clips)
• Hog trough (modular harness handling)
• DE-STA-CO Molded test fixture

9
ExampleBlood-Loc

• Transfusion error administering wrong unit of
  blood to patient
• Code for lock found on patients wristband

10
ExamplesOff the Shelf
Pick-to-light bin system with sensors Metal
sensing drill
11
ExamplesOff the Shelf
Miniature barcode readers Vision
systems Laser part locators
12
ExamplesOff the Shelf
Huck Fasteners proper tightening without threads
or torque
13
ExamplesOff the Shelf
Wireless barcode reading palm-pilot scans the
patient, the medication and the care giver, to
confirm the patient, medication, dose, time and
route are correct. Point of care automation
provides correct medication and dose Central
pharmacy is small AS/RS