(Process Capability)

...

1.
2.
3.

1.

(statistical quality control, SQC)

1

 1,2,3



(Quality Control Chart)4
(chance
cause)
(normal distribution) +3
(standard deviation, +3 ) 2
(average)
(variability)

(in-process manufacturing operation)
(finished product characteristics) (control chart)

2
(chance cause)
(assignable cause) chance cause
assignable cause



assignable causes
control limit
+3 lower control limit (LCL) upper control limit (UCL)
(product specifications)
(lower specification limit, LSL) (upper specification limit, USL)
+3 LSL USL
1

 1. +3 (a) (b) (c)

LSL USL5

2. X (capable process)6

3. X (incapable process)6
3


assignable cause

upper control limit
lower control limit
+3 USL LSL 1b
2 (compression process)
X (critical-to-quality, CTQ)
2
control limit 4.6
(UCL) 3.4 (LCL)
(standard specification limit) upper specification limit
(USL) lower specification limit (LSL) USL 6.0 LSL 4.0
specification limit


standard specification limit control limit

(process capability)
chance cause
capability index

(process mean)
control limit
1c 2
(control limit)
(UCL LCL) (USL
LSL) 3
(incapable process)
3
+3
control limit
4

2.

(process capability index) 2
(potential capability, Cp)
(actual capability, Cpk) Cp


Cpk

3.

(Process potential capability, Cp)

Cp

Cp = 1
(+3, normal distribution
99.73% +3 )

(process mean)

0.27 2700 (ppm)
+3 0.0027 1
Cp > 1

(process mean)

Cp < 1

 4. Cp 1 (
)7

5. 50 Cp 17
4.

(Process centering)

Cp > 1


4
5
Cp 1
0.27 (normal distribution)
(UCL-LCL)
(USL-LSL) Cp 1

(USL) control limit USL 50
6


Cp 1

5.

(Actual process capability index, Cpk)8

Cp
control limit

capability index

(actual process capacity index, Cpk)
Cpk
Cpu = (USL Average) / (3)
Cpl = (Average LSL) / (3)
Cpk = {Cpu Cpl}
Cpk < 1.0
Cpk = 1.0
Cpk 1.33
6 USL LSL
3
(+3) (specification limit)
Cpk Cpu Cpl Cpk

6
(target specification) Cpu Cpl Cpk
Cpu Cpl USL LSL
Cpk Cp

 6.

(Cpu = Cpl = Cpk = Cp)8

USL-mean

Mean-LSL
LSL

Target

-3

7.

USL

Mean

+3

7
Cpu Cpl Cpu Cpl Cpk Cpu Cpk
Cp Cp
6.

(Actual process capacity index, Ppk)8

Ppk Cpk

() Cpk (range)
(subgroup) Ppk
8



Ppk

Cpk

A2 = 3/ (d2 )
A2

-chart R-chart

R (R) d2
A2
Ppk
=
n m

7.

1
200 mg
+7.5%
+7.5% 200 mg 200+15.0 mg
USL LSL = 215 185 mg = 30 mg
upper control
limit lower control limit control limit UCL
LCL 36.42 mg
Cp
Cp

=
=

(USL LSL)/(UCL LCL)

30 / 36.42
9

=
0.82
Cp < 1.0 (incapable)
Cp 1.0
Cp
=
USL- LSL
UCL LCL
Cp
=
30 / (UCL LCL)
1
=
30 / (UCL LCL)
30
=
UCL LCL

UCL LCL =
30.0 mg
2
1 Cpk Ppk
25 4
m = 25 n = 4
1 (grand average, X ) 25
0.74 (range) 25 ( R ) 9.76

A2 = 3/ (d2 )
2 A2 4 (n = 4) 0.729

0.729 =
3 / (d2 )
0.729 =

3 / (2 d2)

d2

2.06

=
9.76 / 2.06
=
4.74
USL= 25 LSL = -25
Cpk =
min [ (25 - 0.74) , (0.74 - (-25)) ]
(3 x 4.74) (3 x 4.74)
=
min (1.71, 1.81)
=
1.71

10

 1.
8

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25

1
-10
-14
-2
-4
12
0
2
0
2
-8
4
-8
-10
-8
6
2
12
2
-6
-2
2
0
-2
-10
6

2
-6
-4
12
-6
6
0
-6
6
4
0
2
4
2
2
16
2
6
2
-4
4
4
4
4
4
8

3
0
-6
-2
-6
2
-6
8
4
6
-4
2
-14
-10
-4
10
0
0
0
2
0
2
2
-2
-12
-4

4
0
4
8
-2
2
-8
-6
8
8
2
6
6
4
4
18
2
2
-8
0
4
6
4
4
4
2

-4
-5
4
-4.5
5.5
-3.5
-0.5
4.5
5
-2.5
3.5
-3
-3.5
-1.5
12.5
1.5
5
-1
-2
1.5
3.5
2.5
1
-3.5
3

10
18
14
4
10
8
14
8
6
10
4
20
14
12
12
2
12
10
8
6
4
4
6
16
12

2. 3 1

(N)
2
3
4
5
6
7
8
9
10

R-chart
(D3)
(D4)
0.00
0.00
0.00
0.00
0.00
0.08
0.14
0.18
0.22

3.27
2.57
2.28
2.11
2.00
1.92
1.86
1.78
1.82

X -chart
(A2)
1.88
1.02
0.73
0.58
0.48
0.42
0.37
0.34
0.31

Ppk

=
grand average (0.74)
3701.04 m = 25, n = 4 nm = 100
11

3701.24 / (100 1)
6.11
ppk
min [ (25 - 0.74) , (0.74 - (-25)) }
(3 x 6.11) (3 x 6.11)
=
min (1.32, 1.40)
=
1.32
UCL LCL 4
=
Grand average =
0.74
X
=
Average range =
9.76
R
UCL X =
=
0.74 + (0.73) (9.76)
X + A2 R

= 7.86

LCL X =

UCLR =
LCLR =

=
=
=

- A2 R

0.74 - (0.73) (9.76)

= -6.38

D4 R

(2.28) (9.76)

= 22.25

D3 R

(0) (9.76)

=0

(N) 4 A2 0.73
D3 D4 0 2.28
8 X R control chart X R
control chart 15 X chart UCL
control chart UCL LCL
UCL (25) LCL(-25)
Cpk Ppk 1

8.

R control chart 18
12

 Cpk

Ppk

Ppk Cpk
Cpk Cpk

Cpk Ppk Ppk

control limit Cpk Ppk
Ppk

8.

Cp

Cpk Ppk

13

1. Khar RK, Vyas SP, Ahmad FJ, Jain GK. The theory and practice of industrial pharmacy.
4th ed. Philadelphia: Lea & Febiger, 2013: 1093-1094.
2. Farnum NR. Statistical quality control and improvement. Belmont: Wadsworth
Publishing Company, 1994: 181-187.
3. Montgomery DC, Runger GC. Applied statistics and probability for engineers. New
York: John Wiley & Sons, Inc., 1999: 757-762.
4. Dangprasirt P. Quality control chart. Pharmatime 2005; 3(29): 63-71.
5. Reid RD and Sanders NR. Operations management: an integrated approach, 4th ed. New
York: John Wiley & Sons, Inc., 2011: 202-206.
6. Cowdhury MR. Process capability analysis in pharmaceutical production. International
Journal of Pharmaceutial and Life Sciences 2013; 2(2): 85-89.
7. Gaafar LK. Introduction to six sigma (onlines). http://www.qualityamerica.com/
knowledgecente/articles/ANTONYdoe1.htm (2007).
8. Steiner S., Abraham B. and MacKay J. Understanding process capability indices
(onlines). http://www.stats.uwaterloo.ca/~shsteine/papers/cap.pdf (23 October 2014).
9. Ruffner DL. Understanding how Cp & Cpk are used to ensure quality (onlines). http://
www.isotemp.com/wp-content/uploads/2011/06/Understanding_how_CP_and_CPK_are
_used. pdf (1996).

14