Cartas de Shewart Iso 8258

Applying Trend Analysis Techniques to
Quality Control Measurements in

Radionuclide Metrology
Simon Jerome, NPL
LSUF, NPL, 24
th
January 2006
Event and date 2
LSUF 24
th
January 2006
Quality Control ISO 17025:2005
5.9 Assuring the quality of test and calibration results
5.9.1 The laboratory shall have quality control procedures for monitoring the
validity of tests and calibrations undertaken. The resulting data shall be
recorded in such a way that trends are detectable and, where practicable,
statistical techniques shall be applied to the reviewing of the results. This
monitoring shall be planned and reviewed and may include, but not be
limited to, the following:
a) regular use of certified reference materials and/or internal quality
control using secondary reference materials
NOTE The selected methods should be appropriate for the type
and volume of the work undertaken.
Event and date 3
LSUF 24
th
January 2006
Two Techniques Commonly Used (More Are Available)
Shewhart more easily interpreted
CuSum (Cumulative Summation) more sensitive to change
Event and date 4
LSUF 24
th
January 2006
Use of Shewhart charts
Common usage is to set 2 and 3 limits, based on 11-31 replicate results
Action taken if 3 limit is exceeded expected 3 times in 1000
Warning is registered if 2 but not 3 limit is exceeded expected 5 times
in 100
Straightforward, but no warning signals before warning or action levels
breached
Event and date 5
LSUF 24
th
January 2006
3 exceeded action required
immediately, since the
procedure is out of control.
Measurement should stop
until the cause of the action
limit violation is identified
and corrected.
Shewhart Control Chart - RMG Ionisation Chambers Radium Check
Source Measurement
50.3150
50.3200
50.3250
50.3300
50.3350
50.3400
50.3450
50.3500
50.3550
50.3600
50.3650
1-Aug 3-Aug 5-Aug 7-Aug 9-Aug 11-Aug 13-Aug 15-Aug 17-Aug 19-Aug 21-Aug 23-Aug 25-Aug 27-Aug 29-Aug 31-Aug 2-Sep 4-Sep
Date
I
o
n

C
h
a
m
b
e
r

C
u
r
r
e
n
t
/
p
A

Event and date 6
LSUF 24
th
January 2006
2 exceeded situation needs
to be closely monitored
Shewhart Control Chart - RMG Ionisation Chambers Radium Check Source
Measurement
50.3150
50.3200
50.3250
50.3300
50.3350
50.3400
50.3450
50.3500
50.3550
50.3600
50.3650
1-Aug 3-Aug 5-Aug 7-Aug 9-Aug 11-Aug 13-Aug 15-Aug 17-Aug 19-Aug 21-Aug 23-
Aug
25-
Aug
27-
Aug
29-
Aug
31-Aug 2-S e p 4-S e p
Date
I
o
n

C
h
a
m
b
e
r

C
u
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r
e
n
t
/
p
A

Event and date 7
LSUF 24
th
January 2006
ISO 8258:1991 Shewhart Control Charts
Introduces the concept of Trend Analysis
Relies on the range observed in measurement:
r
j
= |x
(j+1)
x
j
|
X =
R =
'
'
N
x
j
j
'
'
) 1 (
N
r
j
j
Event and date 8
LSUF 24
th
January 2006
ISO 8258:1991 Shewhart Control Charts
Action limit set at: X R2.66
Warning limit set at: X R1.77
Information limit set at: X R0.89
Based on a series of single observations; limits vary depending on the batch
size and subgroup
Event and date 9
LSUF 24
th
January 2006
Warning Limit Exceeded
twice in under 42
measurements. Measurement
should stop until the cause of
the action limit violations are
identified and corrected. (ISO
8259:1991 suggests 2 out of 3
is an action point)
Measurement
50.3150
50.3200
50.3250
50.3300
50.3350
50.3400
50.3450
50.3500
50.3550
50.3600
50.3650
Aug
25-
Aug
27-
Aug
29-
Aug
Date
I
o
n

C
h
a
m
b
e
r

C
u
r
r
e
n
t
/
p
A

Event and date 10
LSUF 24
th
January 2006
Nine points in a row on one
side of the mean. This may
indicate that there has been a
shift in the mean; work can
continue, however the cause
of the shift needs to be
identified and the limits re-set
if justified
Measurement
50.3150
50.3200
50.3250
50.3300
50.3350
50.3400
50.3450
50.3500
50.3550
50.3600
50.3650
Aug
25-
Aug
27-
Aug
29-
Aug
Date
I
o
n

C
h
a
m
b
e
r

C
u
r
r
e
n
t
/
p
A

Event and date 11
LSUF 24
th
January 2006
Six points in a row steadily
increasing or decreasing.
Suggests that the
measurements are shifting
with time; needs investigation,
since the action and warning
limits will eventually be
exceeded
Measurement
50.3150
50.3200
50.3250
50.3300
50.3350
50.3400
50.3450
50.3500
50.3550
50.3600
50.3650
Aug
25-
Aug
27-
Aug
29-
Aug
Date
I
o
n

C
h
a
m
b
e
r

C
u
r
r
e
n
t
/
p
A

Event and date 12
LSUF 24
th
January 2006
Fourteen points in a row
alternating up and down.
Suggests a cyclical change in
conditions; may be due to two
different operators
Measurement
50.3150
50.3200
50.3250
50.3300
50.3350
50.3400
50.3450
50.3500
50.3550
50.3600
50.3650
Aug
25-
Aug
27-
Aug
29-
Aug
Date
I
o
n

C
h
a
m
b
e
r

C
u
r
r
e
n
t
/
p
A

Event and date 13
LSUF 24
th
January 2006
Four out of five points in a
row exceeding the information
level. This may indicate a
mean shift
Measurement
50.3150
50.3200
50.3250
50.3300
50.3350
50.3400
50.3450
50.3500
50.3550
50.3600
50.3650
Aug
25-
Aug
27-
Aug
29-
Aug
Date
I
o
n

C
h
a
m
b
e
r

C
u
r
r
e
n
t
/
p
A

Event and date 14
LSUF 24
th
January 2006
Fifteen points in a row
between the lower and upper
information levels. This may
arise after the procedure has
been operated for some time
and may require the limits to
be re-set
Measurement
50.3150
50.3200
50.3250
50.3300
50.3350
50.3400
50.3450
50.3500
50.3550
50.3600
50.3650
Aug
25-
Aug
27-
Aug
29-
Aug
Date
I
o
n

C
h
a
m
b
e
r

C
u
r
r
e
n
t
/
p
A

Event and date 15
LSUF 24
th
January 2006
Eight points in a row either
side of the mean with none
between the upper and lower
information levels. This may
indicate a mean shift.
Measurement
50.3150
50.3200
50.3250
50.3300
50.3350
50.3400
50.3450
50.3500
50.3550
50.3600
50.3650
Aug
25-
Aug
27-
Aug
29-
Aug
Date
I
o
n

C
h
a
m
b
e
r

C
u
r
r
e
n
t
/
p
A

Event and date 16
LSUF 24
th
January 2006
In practice.
Use software to record and present the data
Require operators to manually carry out a check (use a paper-based check
list) for the above conditions
Carry out investigations as necessary and institute improvement actions
However, it is incorrect simply to:
Repeat a measurement and find the chart to be in control
Reset the chart parameters without at least seeking a reason
Rely on the software to do it for you
Rely on manufacturers software
Event and date 17
LSUF 24
th
January 2006
In addition:
Use a CuSum Chart:
c
1
= x
1
X
c
2
= c
1
+ x
2
X
c
3
= c
2
+ x
3
X
.
.
.
c
i
= c
i-1
+ x
i
X
Deviation from control become clear very rapidly
Event and date 18
LSUF 24
th
January 2006
Shewhart Value Control Chart for TriCarb
64.3
64.5
64.7
64.9
65.1
65.3
65.5
65.7
65.9
66.1
3
0
-
J
u
n
-
0
3
1
9
-
A
u
g
-
0
3
0
8
-
O
c
t
-
0
3
2
7
-
N
o
v
-
0
3
1
6
-
J
a
n
-
0
4
0
6
-
M
a
r
-
0
4
2
5
-
A
p
r
-
0
4
1
4
-
J
u
n
-
0
4
0
3
-
A
u
g
-
0
4
2
2
-
S
e
p
-
0
4
1
1
-
N
o
v
-
0
4
3
1
-
D
e
c
-
0
4
1
9
-
F
e
b
-
0
5
1
0
-
A
p
r
-
0
5
3
0
-
M
a
y
-
0
5
1
9
-
J
u
l
-
0
5
Date
T
r
i
t
i
u
m

c
o
u
n
t
i
n
g

e
f
f
i
c
i
e
n
c
y

(
%
)
E
v
e
n
t

a
n
d

d
a
t
e
1
9
L
S
U
F

2
4
t
h
J
a
n
u
a
r
y

2
0
0
6
C
u
S
u
m

f
o
r

T
r
i
t
i
u
m

e
f
f
i
c
i
e
n
c
y
-
2
5
.
0
0
0
0
-
2
0
.
0
0
0
0
-
1
5
.
0
0
0
0
-
1
0
.
0
0
0
0
-
5
.
0
0
0
0
0
.
0
0
0
0
5
.
0
0
0
0
30-Jun-03
19-Aug-03
08-Oct-03
27-Nov-03
16-Jan-04
06-Mar-04
25-Apr-04
14-Jun-04
03-Aug-04
22-Sep-04
11-Nov-04
31-Dec-04
19-Feb-05
10-Apr-05
30-May-05
19-Jul-05
D
a
t
e
CuSum Tritium efficiency
Event and date 20
LSUF 24
th
January 2006
Tritium Check Source for LSC
Shewhart Chart gives first warning on 6
th
November 9 points in a row,
one side of the mean (and many thereafter)
CuSum Chart gives first warning around 1
st
November problem is clear
from this point on
On-board Q/C software gave first fault message on 30
th
January 3
limit violation
Event and date 21
LSUF 24
th
January 2006
Shewhart Value Control Chart for TriCarb
8.600
9.100
9.600
10.100
10.600
11.100
11.600
12.100
12.600
13.100
13.600
3
0
-
J
u
n
-
0
3
1
9
-
A
u
g
-
0
3
0
8
-
O
c
t
-
0
3
2
7
-
N
o
v
-
0
3
1
6
-
J
a
n
-
0
4
0
6
-
M
a
r
-
0
4
2
5
-
A
p
r
-
0
4
1
4
-
J
u
n
-
0
4
0
3
-
A
u
g
-
0
4
2
2
-
S
e
p
-
0
4
1
1
-
N
o
v
-
0
4
3
1
-
D
e
c
-
0
4
1
9
-
F
e
b
-
0
5
1
0
-
A
p
r
-
0
5
3
0
-
M
a
y
-
0
5
1
9
-
J
u
l
-
0
5
Date
T
r
i
t
i
u
m

b
a
c
k
g
r
o
u
n
d

(
c
o
u
n
t
s
/
s
e
c
o
n
d
)
E
v
e
n
t

a
n
d

d
a
t
e
2
2
L
S
U
F

2
4
t
h
J
a
n
u
a
r
y

2
0
0
6
C
u
S
u
m

f
o
r

T
r
i
t
i
u
m

B
a
c
k
g
r
o
u
n
d
-
1
0
.
0
0
0
0
0
.
0
0
0
0
1
0
.
0
0
0
0
2
0
.
0
0
0
0
3
0
.
0
0
0
0
4
0
.
0
0
0
0
5
0
.
0
0
0
0
6
0
.
0
0
0
0
30-Jun-03
19-Aug-03
08-Oct-03
27-Nov-03
16-Jan-04
06-Mar-04
25-Apr-04
14-Jun-04
03-Aug-04
22-Sep-04
11-Nov-04
31-Dec-04
19-Feb-05
10-Apr-05
30-May-05
19-Jul-05
D
a
t
e
CuSum Tritium Background
Event and date 23
LSUF 24
th
January 2006
Tritium Background for LSC
Shewhart Chart gives first warning on 15
th
December action limit
violation (event on 8
th
October assigned to
99
Mo/
99m
Tc source in
vicinity)
CuSum Chart gives first warning around 18
th
December problem is clear
from this point on (event on 8
th
October does not affect CuSum)
On-board Q/C software gave first fault message on 15
th
February 3
limit violation
Event and date 24
LSUF 24
th
January 2006
Analysis of data
Engineer called out in February
Deteriorating Photo-Multiplier tube identified
14
C check source did not return comparable data, apart from on action limit
violation that did not have an assignable cause
Subsequent measurements with other systems indicate general instability
of
3
H measurements observed at other establishments
Further investigations reveal hidden parameters that low energy -
emitters are very sensitive to (such as DBB)
Essential to know the system well before use
Event and date 25
LSUF 24
th
January 2006
Conclusions
Full implementation of ISO 8258:1991 allows operators to far better
understand measurement systems
Potential faults can be trapped by preventative actions rather than
corrective actions
Simple to use and interpret
Applicable to similar systems -spectrometers, Germanium -
spectrometers, NaI(Tl) -spectrometers, ionisation chambers &c
Customer calibrations and source generation can be carried out with
greater confidence
Questions and Feedback

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Cartas de Shewart Iso 8258

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Applying Trend Analysis Techniques to

Quality Control Measurements in

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