Normalized OPSpecs Quality-Planning Tool

Westgard QC, Madison, WI 53717 USA Copyright 2000

Step-by-step directions
1. Define quality requirement %TEa 5. Plot normal operating point

Steps 5 ,6,and 7 show details for using a series of 4 normalized OPSpecs charts

2. Determine %CV, %Bias

6a. N=2,3 90% charts

Yes
7. Select QC, HI-Ped TQC Strategy

No
3. Calculate normalized operating point (%CV/%TEa)100 (%Bias/%TEa)100 6b. N=2,3 50% charts

Yes

7. Select QC, MOD-Ped TQC Strategy 7. Select QC, HI-Ped TQC Strategy 7. Select QC, MOD-Ped TQC Strategy 7. Select Max QC LO-Ped TQC Strategy

No
6c. N=4,6 90% charts

Yes

4. Utilize normalized OPSpecs charts for number of control materials of interest

No
6d. N=4,6 50% charts

Yes

No

See Basic Quality Planning, lesson 8, http://www.westgard.com for more detailed directions and example applications of this quality-planning tool.

Normalized OPSpecs Quality-Planning Tool, Copyright 2000, Westgard QC, Madison, WI 53717 USA - Page 2

Start with top chart (use bottom only if max N=2)

Normalized OPSecs Chart TEa 100.0% with 90% AQA(SE)

Allowable inaccuracy (bias as % of TEa)

100.0 90.0 80.0 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 0.0 10.0 20.0 30.0 40.0
Bia s+ 2s

N=2 and 90%AQA

P fr
cr ite r ion

12s
fo rs

0.09
tab le p

2 2 2 2 2

1 1 1 1 1

12.5s
erf o rm an

ce

0.03 13s /22s /R4s 0.01 13s 0.00 13.5s 0.00 50.0

Allowable imprecision (s as % of TEa) Normalized OPSecs Chart TEa 100.0% with 50% AQA(SE)

Allowable inaccuracy (bias as % of TEa)

100.0 90.0 80.0 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 0.0 10.0 20.0 30.0 40.0
Bia s+ 2s

N=2 and 50%AQA

P fr
cr ite r ion

12s
fo rs

0.09
tab le p

2 2 2 2 2

1 1 1 1 1

12.5s
erf o rm an

ce

0.03 13s /22s /R4s 0.01 13s 0.00 13.5s 0.00 50.0

Allowable imprecision (s as % of TEa)

Normalized OPSpecs Quality-Planning Tool, Copyright 2000, Westgard QC, Madison, WI 53717 USA - Page 3

Next, try these charts - top then bottom

Normalized OPSecs Chart TEa 100.0% with 90% AQA(SE)

Allowable inaccuracy (bias as % of TEa)

100.0 90.0 80.0 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 0.0 10.0 20.0 30.0 40.0
Bia s+ 2s

N=4 and 90%AQA

P fr
cr ite r ion

12s
fo rs tab le p

0.18 13s /22s /R4s /41s

erf o

4 4 4 4 4

1 1 1 1 1

0.03
rm an c

12.5s
e

0.04 13s 0.01 13.5s 0.00 50.0

Allowable imprecision (s as % of TEa) Normalized OPSecs Chart TEa 100.0% with 50% AQA(SE)

Allowable inaccuracy (bias as % of TEa)

100.0 90.0 80.0 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 0.0 10.0 20.0 30.0 40.0
Bia s+ 2s

N=4 and 50%AQA

P fr
cr ite r ion

12s
fo rs tab le p

0.18 13s /22s /R4s /41s

erf o

4 4 4 4 4

1 1 1 1 1

0.03
rm an c

12.5s
e

0.04 13s 0.01 13.5s 0.00 50.0

Allowable imprecision (s as % of TEa)

Normalized OPSpecs Quality-Planning Tool, Copyright 2000, Westgard QC, Madison, WI 53717 USA - Page 4

Start with top chart (use bottom only if max N=3)

Normalized OPSecs Chart TEa 100.0% with 90% AQA(SE)

Allowable inaccuracy (bias as % of TEa)

100.0 90.0 80.0 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 0.0 10.0 20.0 30.0 40.0
Bia s+ 2s

N=3 and 90%AQA

Pfr 12s
cr ite r ion

0.14 3 13s /2of3 2s /R4s /31s

fo rs

1 1 1 1 1 1

0.02
tab le p

3 3 3 3 3

12.5s
erf o rm an c

0.03 13s /2of3 2s /R4s

e

0.01 13s 0.01 13.5s 0.00 50.0

Allowable imprecision (s as % of TEa) Normalized OPSecs Chart TEa 100.0% with 50% AQA(SE)

Allowable inaccuracy (bias as % of TEa)

100.0 90.0 80.0 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 0.0 10.0 20.0 30.0 40.0
Bia s+ 2s

N=3 and 50%AQA

Pfr 12s
cr ite r ion

0.14 3 13s /2of3 2s /R4s /31s

fo rs

1 1 1 1 1 1

0.02
tab le p

3 3 3 3 3

12.5s
erf o rm an c

0.03 13s /2of3 2s /R4s

e

0.01 13s 0.01 13.5s 0.00 50.0

Allowable imprecision (s as % of TEa)

Normalized OPSpecs Quality-Planning Tool, Copyright 2000, Westgard QC, Madison, WI 53717 USA - Page 5

Next, try these charts - top then bottom

Normalized OPSecs Chart TEa 100.0% with 90% AQA(SE)

Allowable inaccuracy (bias as % of TEa)

100.0 90.0 80.0 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 0.0 10.0 20.0 30.0 40.0
Bia s+ 2s

N=6 and 90%AQA

P fr N R 13s /2of3 2s /R4s /31s /6x
cr ite r ion

0.07 6 13s /2of3 2s /R4s /31s

fo rs

1 1 1 1 1 1

0.05
tab le p

6 6 6 6 6

12.5s
erf o rm an c

0.06 13s /2of3 2s /R4s

e

0.02 13s 0.01 13.5s 0.00 50.0

Allowable imprecision (s as % of TEa) Normalized OPSecs Chart TEa 100.0% with 50% AQA(SE)

Allowable inaccuracy (bias as % of TEa)

100.0 90.0 80.0 70.0 60.0 50.0 40.0 30.0 20.0 10.0 0.0 0.0 10.0 20.0 30.0 40.0
Bia s+ 2s

N=6 and 50%AQA

P fr N R 13s /2of3 2s /R4s /31s /6x
cr ite r ion

0.07 6 13s /2of3 2s /R4s /31s

fo rs

1 1 1 1 1 1

0.05
tab le p

6 6 6 6 6

12.5s
erf o rm an c

0.06 13s /2of3 2s /R4s

e

0.02 13s 0.01 13.5s 0.00 50.0

Allowable imprecision (s as % of TEa)