there is a way head for the excellence of Quality

1. Enabling Excellence to
Quality
Quality is the foundation of any business
relationship
Quality is a shared responsibility within an
organization
Quality is related to process and data
Ryan Chen

2. Cut Through the Clutter and Focus
There is never enough time for everything, but
there is plenty of time for focus …
1. Prevention
2. Consumer focus
3. Process capability
4. Process control
5. Variation reduction
6. The Pareto principle
7. (Breakthrough improvement)

3. Prevention - 1
It is about eliminating opportunities for error.
Prevention means
successfully applying
appropriate tools and
processes to prevent the
occurrence of defects,
errors, and waste …

4. Prevention - 2
It is about eliminating cost associated with poor
quality, and minimizing the total cost of quality …
Prevention cost – “The Good”
1. Strategic and business planning for quality
2. Developing quality requirements and specifications
3. Developing quality measurements and goals
4. Education and training
5. Design reviews
6. Product qualification
7. New supplier quality evaluations
8. Process capabilities studies
9. Process control
10 . Preventive maintenance

5. Prevention - 3
Appraisal cost – “The Bad”
1. Incoming, in-process, and final inspection and test
2. Product quality audits
3. Maintenance of inspection equipment
4. Materials and supplies for inspection
5. Processing and reporting on inspection data
6. Evaluation of stock for degradation
7. Status measurement and reporting

6. Prevention - 4
Internal failure cost – “The Ugly”
1. Scrap, including related labor, materials, and overhead
2. Rework to correct defectives
3. Re-inspection of reworked products
4. 100% sorting inspection for defectives
5. Engineering changes to correct a design error
6. Manufacturing process changes to correct deficiencies
7. Scrapping of obsolete product
8. Difference between normal price & reduced price due to quality
9. Unplanned downtime due to quality failures
10. Inventory shrinkage
11. Non-value-added activities

7. Prevention - 5
External failure cost – “The Very Ugly”
1. Defective returns
2. Complaint handling
3. Warranty charges
4. Product recalls
5. Product liability lawsuits
6. Allowance made to customer due to substandard product
7. Profit margin lost due to customer defection for quality
The strategy must be to continually reduce the
total cost of quality by investing resources in
prevention …

8. Prevention - 6
The root cause of most errors can be classified
as either lack of knowledge or lack of attention
checklist Pre-control

9. Prevention - 7
Anticipate and eliminate potential failures
FMEA – Failure modes and effects analysis
How component / process can fail;
Determine how that failure will affect the quality/function of product;
Develop strategic partnerships
The attitude and behavior of the supplier’s top management;
Measure supplier’s performance (quality/delivery), and maintain it
Quality plan – flow chart, FMEA, control plan, control chart, Cpk,
calibration, preventive maintenance, MSA, CAPA, housekeeping;
Share information, identify & control risk during design & production

10. Customer focus
It is all about building consumer loyalty
Earn and keep consumer loyalty
1. Spec. must be consumer focused.
2. Requirement shall be adequately
communicated and fully understood.
Build brands, not commodities
go beyond industry standards will result in
delighting the consumer and differentiating
your product from others.

11. Process Capability - 1
Maintain balance and control with precise, timely adjustments
The tightrope walker need to make body-
position adjustments to maintain balance.
A Type 2 error occurs when a “special cause” change occurs but no action
is taken.
When a gust of wind comes up ...
A Type 1 error occurs when there is not a special cause of variation
(change), but action is taken because a change is imagined.
To prevent neglecting the process
To prevent tampering with the process

12. Process Capability - 2
Define and document the process
People (operator)
Material (components)
Methods (SOP/SIP)
Equipment (parameter)
Measurement (GR&R)
Environment (ESD)
Inputs Process Output
* ESD: Electro-Static Discharge * GR&R: Gage Repeatability & Reproducibility

13. Process Capability - 3
Measure and Verify Process Capability
Cp (capability of process) = specification width / process width (6σ)
Cp is a good measure of process capability only when the process is centered. A process
is centered when the process mean is equal to the specification target.

14. Process Capability - 4
Measure and Verify Process Capability
Cpk = Min ((USL-Means), (Means-LSL)) / half of process width (3σ)

15. Process Capability - 5
Control Accuracy and Precision
Accuracy - how close an observed value is to the true value
Precision is the characteristic of consistency and repeatability.
Accuracy - Process mean
Precision - process
standard deviation
Calibration for Accuracy
Gage R&R for Precision
Gage R&R evaluates the
measurement variation (error)
in a measurement system

16. Process Control - 1
Maintain balance and control with precise, timely adjustments
A gust of wind body adjustments
Type 2 error
Type 1 error
A Type 2 error occurs when a
“special cause” change occurs
but no action is taken.
A Type 1 error occurs when
there is not a special cause of
variation (change), but action
is taken because a change is
imagined

17. Process Control - 2
Avoid Tampering and Neglect
A gust of wind body adjustments
Type 2 error
Type 1 error
Tampering - making an adjustment when without any special causes of
variation.
Neglecting - not making an adjustment when something has caused it to
change
Common causes are inherent in the process
Special causes are not inherent in the process
Special causes

18. Process Control - 3
Identify Critical Process Characteristics
20 percent (-) of the causes produce 80 percent (+) of the effect

19. Process Control - 4
Enforce Pre-control
Charting the process output and taking the action indicated by results.
Alert changes in process centering (mean) + process variation (σ)
Four steps of pre-control
Step 1: Set Up Pre-control Chart Zones
The specification width is divided
by 4 to create the pre-control zones
Step 2: Qualify the Process
Five consecutive units fall within the green zone; otherwise, the
cause of the variation must be determined and reduced or eliminated

20. Process Control - 5
Enforce Pre-control
Step 3: Begin Pre-control Charting
After production begins, take two consecutive units every half-hour,
record the results, and proceed according to the following rules:
1. If both units are in the green zone, continue production.
2. If one in green zone and the other in yellow zone, continue production.
3. If both in the same yellow zone, adjust the process + continue run.
4. If each unit falls into a different yellow zone, stop production, must
determine, reduce or eliminate the cause of variation, then step 2 again.
5. If one or both units are in the red zone, stop production. must
determine, reduce or eliminate the cause of variation, then step 2 again.

21. Variation Reduction - 1
Move from Zero Defects to Zero Variation
Zero defects - the process output is in the Spec. tolerance limit.

22. Variation Reduction - 2
Move from Zero Defects to Zero Variation
Zero variation - even though the process width is fully contained within the
specification width, we will continue to reduce the variation..

23. The Pareto Principle -1
Focus on the vital few, not on the trivial many.
Not All Problems Are Created Equal
There are always the most important few,
called the vital few, that account for the
vast majority of cost or loss. The vital few
problems are like the diamonds in the dirt,
and our attention and efforts must be
focused on them.

24. The Pareto Principle -2
From Causes to Vital Root Causes

25. The Pareto Principle -3
Place Importance Over Urgency – setting priorities