Quality Control Tools Journal Guidelines
The Alzemoxi project team has completed its quality planning and quality assurance work. Customers and stakeholders have been identified and prioritized. Project requirements have been identified and prioritized. Standards and metrics have been developed. The company's quality system has been assessed and revised to ensure it can support the project.
The project is well underway. The Alzemoxi drug has successfully passed animal testing and phase 1 study in humans. The drug is currently in phase 2 of human testing. The data from some of the quality metrics for this phase is provided below.
Prepare and analyze the data using the following quality control tools:
1) Pareto Chart (Data Set 1)
2) Cause-and-Effect Diagram (Data Set 2)
3) Scatter Diagram (Data Set 3)
4) Control Chart (Data Set 4)
Data Set 1- Pareto Chart
Patients who received Alzemoxi reported a number of side effects:
|
Side Effect
|
Number of Patients Reported
|
|
Nausea & Vomiting
|
107
|
|
Diarrhea
|
23
|
|
Vertigo (Dizziness)
|
5
|
|
Dry Mouth
|
127
|
|
Difficulty Urinating
|
83
|
|
Blurred Vision
|
19
|
|
Shortness of Breath
|
7
|
|
Tingling in Extremities
|
173
|
|
Euphoria
|
3
|
Data Set 2 - Cause-and-Effect Diagram
The team is having difficulty recruiting a sufficient number of patients for the testing. Patients or health care providers have given several reasons for declining to participate:
Study will take too much time
Clinic is difficult to reach:
- Patients not able to drive
- Cannot transport
Want to make sure the patient gets actual drug rather than a placebo
Concerned about several side effects:
- Death
- Nausea
- Vertigo
- Blurred Vision
Don't want to be "poked or prodded"
Fear of unknown secondary impacts:
- Advancing symptoms
- Development of other health issues
No impact - Waste of time.
Data Set 3 - Scatter Diagram
Project researches are using the combined assessment instrument to measure the change in the severity of symptoms in each patient 6 months after treatment starts and just before treatment starts. Researchers are also giving different amounts of the drug to patients to determine the optimal dosage. Below are both data points for 20 randomly selected patients who received Alzemoxi.
|
Patient ID
|
Change in Symptoms -
Combined Assessment
Instrument Score as a Result
of Treatment (percent)
|
Dosage (milligrams)
|
|
1
|
43
|
20
|
|
3
|
71
|
35
|
|
6
|
46
|
20
|
|
34
|
60
|
35
|
|
45
|
49
|
25
|
|
59
|
-3
|
15
|
|
64
|
-18
|
30
|
|
68
|
24
|
15
|
|
73
|
-7
|
15
|
|
86
|
10
|
15
|
|
104
|
6
|
10
|
|
114
|
55
|
30
|
|
115
|
57
|
30
|
|
122
|
18
|
15
|
|
127
|
-15
|
10
|
|
143
|
7
|
10
|
|
152
|
-8
|
15
|
|
153
|
-17
|
25
|
|
164
|
50
|
25
|
|
177
|
-15
|
30
|
Data Set 4 - Control Chart
Patient attrition is a concern in clinical studies. Patients move, die (from the disease, the treatment, or unrelated factors), or stop participating for unknown reasons. If too many patients drop out, the data is not reliable. Below is the attrition data for the first year of the phase 2 testing. Assume the standard deviation is 2.9:
|
Month
|
Number of Patients Who
Dropped Out
|
|
January
|
1
|
|
February
|
5
|
|
March
|
19
|
|
April
|
9
|
|
May
|
11
|
|
June
|
1
|
|
July
|
10
|
|
August
|
10
|
|
September
|
6
|
|
October
|
12
|
|
November
|
7
|
|
December
|
9
|
1. Calculate the mean.
2. Calculate the UCL and LCL.
3. Construct a control chart on the data set, mean, and standard deviation.
4. Decide whether the clinical study is producing reliable data based on the patient dropout data.