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Long-Term Yield
Curbs
= required
process tolerances
CPK of 1 CPK of 2
(3 sigma) (6 sigma)
Understanding Variability
Variation exists in everything. Even the
best machine cannot make every unit
exactly the same.
Improved capability, becomes a necessity,
due to the need of :
• improved designs
• lower costs
• better performance
KPIV
Key
Controllable Inputs Process
X1 X2 X3
Quality Input
Characteristics: Variables
Inputs:
Outputs
Raw materials, The Process
components, etc. Y1, Y2, etc.
N1 N2 N3
Uncontrollable Inputs
On target,
minimum process variation
Improvement methodology
DMAIC
Define
Measure
Analyze
Improve
Control
Improvement methodology
Define
B1
B2 í factors which affect variation
C2
C1 í factors which shift the average and affect
variation
D1=D2
í factors which have no effect
DOE - (design of experiments)
Measure the Process
Controllable Inputs Establish the
performance
X1 X2 X3 baseline
Quality
Characteristics:
Outputs
LSL USL
Inputs: Y1, Y2, etc.
Raw
Materials,
The Process
components,
etc.
S O D R
Process Actions
Potential Failure Mode Potential Failure Effects E Potential Causes C Current Controls E P
Step/Input Recommended
V C T N
N1 N2 N3
DICY/Scale Scale > 0 Low DMF Charge 3 Water in Jacket 2 Visual Check of Jacket (SOP 5681) 4 24
Accuracy
Steam to
DICY/Scale Scale Inaccurate High DMF Charge 3 Tank Hanging Up 2 Visual Check (SOP 5681) 4 24
Accuracy
Uncontrollable Inputs
DOE - (design of experiments) Analyse the
Key Outputs:
1
2
Variable
Process
How Measured When Measured
1
2
3
4
5
Controllable Inputs
Controllable Inputs Variable How Measured When Measured
1
2
3
4
X1 X2 X3
5
Quality
Characteristics:
Outputs
LSL USL
Inputs:
Y1, Y2, etc.
Raw
Materials,
The Process
components,
etc.
Run Temperature Pressure
1 Hi Hi
2 Hi Hi
C a p a b ility u s in g P o o le d S ta n d a rd D e v ia tio n
X b a r a n d R Ch a rt Ca p a b ility Histo g ra m
3 Lo Hi
3 .0
4 Lo Hi
Means
2 .5 U C L =2 . 5 6 8
M U =2 .3 7 6
L C L =2 .18 3
2 .0
1. 5
1.5 2 .5 3 .5
S ubgr
0 .9
1 2 3 4
U C L =0 . 9 6 2 1
No rm a l P ro b P lo t 5 Hi Lo
N1 N2 N3
Ranges
0 .6
0 .3
R =0 . 5 16 2
6 Hi Lo
L C L =0 .0 7 0 2 7
0 .0
1.5 2 .5 3 .5
L a st 4 S u b g ro u p s Ca p a b ility P lo t
P ro c e ss To le ra n c e
7 Lo Lo
3 .0 1.8 3 17 5 2 .9 19 5 8
Uncontrollable Inputs
Values
2 .5 C p : 2 .7 6 I I I
2 .0
1. 5
C P U : 2 .9 9
C P L : 2 .5 3
C p k : 2 .5 3
1
I I
Sp e c if ic a t io n s
4
I
8 Lo Lo
1 2 3 4 St D e v : 0 .18 13 0 6
Su b g ro u p N u m b e r
DOE - (design of experiments) Improve the
Three Factor Design
Process
PrimWdth
Controllable Inputs
X1 X2 X3
Nip FPM
ScrewRPM
Quality
X Characteristics:
Outputs
LSL USL
Inputs:
X
Y1, Y2, etc.
Raw
Materials,
The Process
components,
etc.
X LSL USL
N1 N2 N3
Uncontrollable Inputs
DOE - (design of experiments) Control the
Process
Error Controllable Inputs
Proofing X1 X2 X3
Quality
Characteristics:
Outputs LSL USL
Inputs:
Raw Y1, Y2, etc.
Materials,
components, The Process
etc.
Work
Instructions Check
5 C’s Lists
N1 N2 N3
Uncontrollable Inputs
Analyze
• Investigate source of variation (Special cause / Common causes)
– Special cause variation are the one off, occasional and obvious
cause of a process / quality problems.
– Common cause variation are the day in day out causes of process
problems, because the process is not stable enough, they are hidden
(these form 80% of process problems)
Customer protection
Get control
Improve process
Improve
• Prioritise improvements
– Tool commonly in uses are, Impact Vs Effort,
Brainstorming, Affinity diagrams, Solution selection
matrix.
– These tools help define the best method to meet the
customer need (as defined in the QFD)
Control
Control
• Control the process