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QSO 645 Quality Control Tools Journal Guidelines and Rubric The
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Please refer to the attached rubric. I need someone well versed in Quality Control Tools.


QSO 645 Quality Control Tools Journal Guidelines and Rubric

 

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)

 

2)

 

3)

 

4)

 


 

Pareto Chart (Data Set 1)

 

Cause-and-Effect Diagram (Data Set 2)

 

Scatter Diagram (Data Set 3)

 

Control Chart (Data Set 4)

 


 

Data Set 1 ? Pareto Chart

 

Patients who received Alzemoxi reported a number of side effects:

 

Side Effect

 

Nausea & Vomiting

 

Diarrhea

 

Vertigo (Dizziness)

 

Dry Mouth

 

Difficulty Urinating

 

Blurred Vision

 

Shortness of Breath

 

Tingling in Extremities

 

Euphoria

 


 

Number of Patients Reported

 

107

 

23

 

5

 

127

 

83

 

19

 

7

 

173

 

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

 

1

 

3

 

6

 

34

 

45

 

59

 

64

 

68

 

73

 

86

 

104

 

114

 

115

 

122

 

127

 

143

 

152

 

153

 

164

 

177

 


 

Change in Symptoms ?

 

Combined Assessment

 

Instrument Score as a Result

 

of Treatment (percent)

 

43

 

71

 

46

 

60

 

49

 

-3

 

-18

 

24

 

-7

 

10

 

6

 

55

 

57

 

18

 

-15

 

7

 

-8

 

-17

 

50

 

-15

 


 

Dosage (milligrams)

 

20

 

35

 

20

 

35

 

25

 

15

 

30

 

15

 

15

 

15

 

10

 

30

 

30

 

15

 

10

 

10

 

15

 

25

 

25

 

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

 

January

 

February

 

March

 

April

 

May

 

June

 

July

 

August

 

September

 

October

 

November

 

December

 


 

1.

 

2.

 

3.

 

4.

 


 

Number of Patients Who

 

Dropped Out

 

1

 

5

 

19

 

9

 

11

 

1

 

10

 

10

 

6

 

12

 

7

 

9

 


 

Calculate the mean.

 

Calculate the UCL and LCL.

 

Construct a control chart on the data set, mean, and standard deviation.

 

Decide whether the clinical study is producing reliable data based on the patient dropout data.

 


 

Journals are private between the student and the instructor. Approach these activities as (a) an opportunity to reflect upon and apply what you learn each week

 

based on the assigned readings, discussions, and activities, and (b) an opportunity to share your knowledge and expertise based on your educational and

 

professional experiences in the past. As a successful professional, you will need good reflective and writing skills. Journal activities offer you the opportunity to

 

further develop these skills. For more information about Blackboard blogs and journals, review these tutorials.

 


 

Instructor Feedback: This activity uses an integrated rubric in Blackboard. Students can view instructor feedback in the Grade Center. For more information,

 

review these instructions.

 

Rubric

 

Critical Elements

 

Quality Control

 

Tools

 


 

Exemplary (100%)

 

Entry clearly describes the

 

quality control tools

 

with specific relevant

 

examples

 


 

Proficient (90%)

 

Entry describes quality control tools

 

with examples

 


 

Needs Improvement (70%)

 

Entry describes most elements

 

of quality control tools of the

 

project

 


 

Not Evident (0%)

 

Entry does not show

 

evidence of understanding

 

quality control tools of the

 

project

 


 

Calculations

 


 

Effectively works with

 

numerical data and solves

 

quantitative problems with

 

accurate calculations

 


 

Works with numerical data and

 

solves most quantitative problems

 

accurately

 


 

Works with numerical data and

 

solves quantitative problems

 

with minimal effectiveness

 


 

Is not able to work with

 

numerical data and solve

 

quantitative problems

 


 

25

 


 

Entry shows excellent

 

evidence of synthesis of the

 

module content and exhibits

 

careful consideration of the

 

topic

 


 

Entry shows good application of the

 

module content and demonstrates

 

that the student has read the

 

module content

 


 

Entry shows limited application,

 

indicating the student may have

 

reviewed the module content

 

but needs to explore further

 


 

Entry does not address the

 

journal prompts and reflects

 

that the student has not

 

read the module content

 


 

25

 


 

Entry is free of errors in

 

organization and grammar

 


 

Errors of organization and grammar

 

are marginal and rarely interrupt the

 

flow

 


 

Errors of organization and

 

grammar are limited enough so

 

that entries can be understood

 


 

Errors of organization and

 

grammar make the entry

 

difficult to understand

 


 

25

 


 

Synthesis

 


 

Writing

 


 

Total

 


 

Value

 

25

 


 

100%

 


 

 







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