Statistical Process Control Continued

With
Common & Special Cause Variations

1 OM
 Introduction
 The questions we need to answer are:
 Is the observed variation more or less than we would normally expect?
 Are there genuine outliers?
 Are there exceptionally good performers?
 What reasons might there be for excess variation?
 Alternative methods based on understanding variation may be more appropriate.
 Statistical process control is one such method and helps to answer these questions through the
use of control charts.

2 OM
 Introduction to Control Charts
Why use control charts?
Control charts are used to monitor, control, and improve
system or process performance over time by studying variation and it’s source.

What do control charts do?

• Focus attention on detecting and monitoring process variation over time
• Distinguishes special from common causes of variation, as a guide to local or management
action.
• Serves as a tool for ongoing control of a process
• Helps improve a process to perform consistently and predictably

3 OM
 Types of Variation
1. Common-cause or process variation is variation that is completely random; special-cause or extra-
process variation is non-random i.e. is the result of an event or action.
2. Special cause variation can be exhibited within or outwith control limits i.e trends, step functions,
drift etc.
3. In any system variation is to be expected. Using statistical techniques we define the limits of
variation (control limits and zones). Interpretation of the data relative to these limits or zones
identifies points that are worthy of investigation.

4 OM
 Definitions
 A process is said to be ‘in control’ if it exhibits
only “common cause” variation.
 This process is completely stable and predictable.

 A process is said to be ‘out of control’ if it exhibits

“special cause” variation.
 This process is unstable.

5 OM
 Basic control chart layout
Upper control
Warning zones limit
14.00%
Under Run Hours as a % of Allocated Hours

12.00%

Zone A
10.00%
Zone B
8.00%
Zone C

6.00% Zone C

4.00% Zone B

Zone A
2.00%

Centre line
0.00%
(usually mean Apr- May- Jun- Jul- Aug- Sep- Oct- Nov- Dec- Jan- Feb- Mar- Apr- May- Jun- Jul- Aug- Sep- Oct- Nov- Dec- Jan- Feb- Mar-

or median) 08 08 08 08 08 08 08 08 08 09 09 09 09 09 09 09 09 09 09 09 09 10 10 10

Date

Lower control limit

6 OM
 Types of control charts

 Control charts are plots of the data with lines indicating the target value (mean, median) and
control limits superimposed.
 The common types are based on statistical distributions:
 Poisson distribution for counts, rates and ratios; e.g number of violent crimes, number of
serious accidents
 Binomial distribution for proportions; e.g where the response is a category such as success,
failure, response, non-response
 Normal distribution for continuous data e.g measures such as height, weight, blood
pressure

7 OM
 Types of control charts

1. Conventional control charts (run charts)

 The indicator of interest is plotted on the y-axis, against time or the unit of analysis on
the x-axis.
 Control charts can be plotted with small numbers of data points although their power
is increased with more data.
2. Funnel plots
 A type of chart where the indicator of interest is plotted against the denominator or
sample size.
 This gives it the characteristic funnel shape

8 OM
Using control charts and SPC methods

 Control charts can help us to present and interpret our information more intelligently.
 They can be used
 To detect unusual or outlying patterns, e.g. poor performance, outbreaks or unusual
patterns of disease
 In health profiling and assessing levels of performance
 To decide whether or not targets are being met
 In assessing health inequalities

9 OM
 Examples – Run Charts & Control Charts
Run Charts:

 Display of data points plotted in chronological order

 Ideally 25 data points are required

 Centre line (mean or median) is included to identify types of variation

Control Charts:

 A Run chart plus control limits and warning limits (optional)

 Control limits are set at 3 standard deviations above and below the mean
Warning limits are set at 2 standard deviations above and below the mean

 These limits provide an additional tool for detecting special cause variation

10 OM
11
Time arrived at work

08:24
08:38
08:52
09:07
09:21
09:36
Mon
Tues
Wed
Thurs
Fri
Mon
Tues
Wed
Thurs
Fri
Mon
Run chart – Time to work

Tues
Wed
Thurs
Fri
Mon
Tues
Wed
Thurs
Fri
Mon
Tues
Wed
Thurs
Fri
OM
12
Time arrived at work

08:24
08:38
08:52
09:07
09:21
09:36
09:50
10:04
10:19
10:33
10:48
Mon
Tues
Wed
Thurs
Fri
Mon
Tues
Wed
Thurs
Fri
Mon
Run Chart – Out of control

Tues
Wed
Thurs
Fri
Mon
Tues
Wed
Thurs
Fri
Mon
Tues
Wed
Thurs
Fri
OM
Special Cause Rule Number 1: Shifts
For detecting shifts in the middle value, look for eight or more consecutive points
either above of below the center line. Values on the center line are ignored, they
do not break a run, and are not counted as points in the run.

SERUM GENTAMICIN LEVELS - TROUGH

2.2
Micrograms/ML

1.7

1.2

0.7

0.2
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

Blood Samples
13 OM
Special Cause Rule Number 2: Trends
For Detecting trends, look for six lines between seven consecutive points all going
up or all going down. If the value of two or more consecutive points is the same,
ignore the lines connecting those values when counting. Like values do not make or
break a trend.

ADVERSE DRUG REACTIONS

Number of Adverse Drug

5
4
Reactions

3
2
1
0
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
Week Number

14 OM
Special Cause Rule Number 3: Zig-Zag Patterns
Any non-random pattern may be an indication of a special cause variation. A
general rule is to investigate where 14 consecutive points go up and down
alternately.

120 DIASTOLIC BLOOD PRESSURE

115
MEASUREMENT

110
105
100
95
90
85
80
75
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

INDIVIDUAL PATIENT READINGS

15 OM
Special Cause Rule Number 4: Cyclical Patterns
A non-random cyclical pattern may be an indication of a special cause variation.
For example, a seasonal pattern occurring across months or quarters of the year.

5
Observations

0
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
Time
16 OM
Special Cause Rule Number 5: Points Outside Limits
A point or points outside control limits is/ are evidence of special cause. Control
limits are calculated based on data from the process.

ABNORMAL PAP TEST FOLLOW-UP PROCESS

70
Mean = 35
60
UCL
TIME IN DAYS

50

40

30

20

10

0
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

COLPOSCOPY PATIENTS
17 OM
 Determining if the process is out of
control – Control Rules

 One or more points fall outside of the control limits

 8 or more consecutive points on same side of centre line
 7 successive points all going up or down
 14 consecutive points going up and down alternately
 2 out of 3 consecutive points in zone A or beyond
 4 out of 5 consecutive points in zone B or beyond
 15 consecutive points in zone C (above and below)

18 OM
 8+ points on same side of centre line

19 OM
 16 points going up and down

20 OM
 Common cause

21 OM
 Common cause

22 OM
 7 points decreasing

23 OM
24
Under Run Hours as a % of Allocated Hours

10.00%
12.00%

0.00%
2.00%
4.00%
6.00%
8.00%
Ap
r-
M 08
ay
-0
Ju 8
n-
0
Ju 8
l-
Au 08
g-
Se 08
p-
0
O 8
ct
-0
N 8
ov
-
D 08
ec
-0
Ja 8
n-
0
Fe 9
b-
0
M 9
ar
-0
Ap 9
r-0
M 9

Date
ay
-0
Ju 9
n-
0
Ju 9
l-
Au 09
g-
Se 09
p-
0
O 9
ct
-0
N 9
ov
-
D 09
ec
-0
Ja 9
n-
1
Fe 0
b-
1
M 0
ar
-1
0
4 out of 5 points in zone B or beyond

OM
 Acting on Variation
Special or common cause variation?

Special Common

Is the process capable?

Search for and
eliminate Yes No
differences in causes
Search for and eliminate
between data points Do causes common to all
nothing data points
25 OM
 Management of Variation
Special Cause Variation
Appropriate Action
•Identify and study the special
cause.
•React to special cause
- If it is a negative impact,
prevent it or minimise impact.
-If it is a positive impact, build
into process.
Inappropriate Action
•Change the system to react to
special causes
26
Common Cause Variation
•Recognise that the capability will not
change unless the process is changed.
•Work to reduce variation due to
common causes
•Do not react to individual occurrences
or differences between high and low
numbers.
•Treat every occurrence as a special
cause
OM
 Summary
 Understanding the causes of variation has reformed industry

 Application to healthcare has provided important insight to

inform improvement

 Effectively highlights areas meriting further investigation

through simple data presentation

27 OM
 Example 1: rate of mortality at 120 days
following admission to a surgical specialty
 In this example each data point is a hospital (all hospitals in NHS Board X are shaded
blue).

 The number of people admitted to a surgical specialty is represented on the horizontal

axis, which essentially means that smaller hospitals appear towards the left hand side of
the graph and larger hospitals towards the right.

 The proportion of people who died within 120 days of admission to hospital is
represented on the vertical axis – the higher up the data point, the higher the rate of
mortality would appear to be.

 The funnel formed by the control limits (and from which the graph gets its name) is
wider towards the left hand side. This is simply so the level of activity (in this case, the
number of admissions) is taken into account when identifying ‘outliers’ (i.e. the larger
the denominator, the most stable the data points are).

28 OM
 Elective admissions to any surgical
specialty: overall mortality at 120 days
3.00

2.50
Mortality rate(%) at 120 days

2.00

1.50

1.00

.50

.00
0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 18,000

Number of Patients

OM
29
 12.00

10.00
Mortality (%) at 120 days

8.00

6.00

4.00

2.00

.00
0 50 100 150 200 250 300 350

Number of Patients

30 OM
31 OM
32 OM
33 OM
34 OM
35 OM
36 OM
37 OM
38 OM
39 OM
40 OM
41 OM
42 OM
43 OM
44 OM
45 OM
46 OM
47 OM
48 OM
49 OM
50 OM
51 OM
52 OM
53 OM
54 OM
55 OM
56 OM
57 OM
58 OM
59 OM
60 OM
61 OM
62 OM
63 OM
64 OM
65 OM
66 OM
67 OM
68 OM
69 OM
70 OM
71 OM
72 OM
73 OM
74 OM
75 OM
76 OM
77 OM
78 OM
79 OM
80 OM
81 OM
82 OM
83 OM
84 OM
85 OM