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) 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 30Data 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: 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. 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. 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 9Instructor 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 Exemplary (100%) Proficient (90%) Needs Improvement (70%) Not Evident (0%) Value Quality Control Tools Entry clearly describes the quality control tools with specific relevant examples Entry describes quality control tools with examples Entry describes most elements of quality control tools of the project Entry does not show evidence of understanding quality control tools of the project 25 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 Synthesis 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 Writing 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 Total 100%