Additional Exam Laboratory Quality Control Management System 2023-24 PDF

Additional Exam Subject: Laboratory Quality Control Management System (Autumn Semester, 2023-24) Group: MEDF 21-7 Student Name: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Surname: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ **This Examination paper is in three sections. Please, attempt all secti...

Additional Exam Subject: Laboratory Quality Control Management System (Autumn Semester, 2023-24) Group: MEDF 21-7 Student Name: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Surname: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ **This Examination paper is in three sections. Please, attempt all section.** **First section consists of 15 MCQs Questions (15 Points)** **Second section consists of 10 SAQs Questions (10 Points)** **Third Section consists of 5 Study Cases Questions (15 Points)** **Time: 2 Hour** **First section** 1\. When selecting laboratory equipment, important factors to consider are (check all that apply)-1 point **a. Ease of operation** **b. Performance specifications** **c. Repair cost** **d. Environmental requirements** 2\. Safety glasses, face shields or other eye and face protectors must be worn when: 1 point **a. Working with caustic and toxic materials** b\. Present in technical work area c\. Viewing microbiology culture plates d\. Processing specimens using a splash barrier 3\. The main sources of contamination within diagnostic laboratories are:(1Point) a. Air conditioning vents b. **Aerosols** c. Animal cages d. Sick employees 4\. Gloves worn in the laboratory for specimen processing must be removed and hands washed when: 1point a\. Answering the telephone in the technical work area b\. Carrying a specimen outside the technical work area through \"clean\" areas **c. Answering the telephone in a designated \"clean· area** d\. After handling specimens from known isolation precaution patients 5\. **Which strategies can contribute to the prevention of laboratory errors?** **(Select all that apply) 1point** **a. Implementing regular staff training programs** **b. Establishing clear Standard Operating Procedures (SOPs)** **c. Increasing the complexity of testing procedures** **d. Reducing reliance on automated systems** 6\. **What does the term \"standard deviation\" measure in the context of laboratory statistics? 1point** **a. Central tendency\ b. Spread or variability of data\ c. Accuracy of test results\ d. Standard error of the mean** **7. If the variance in internal quality control increases, what impact does it have on precision? 1point** **a. Precision decreases\ b. Precision increases\ c. No impact on precision\ d. Variance and precision are unrelated** **8. All of the following are key aspects Except: 1point** **a. Considers customer's needs** **b. Depends upon customer perceptions** **c. Does not change with time** **d. High levels of precision** **9. Which document provides a laboratory's policies, procedures, and objectives for quality and includes a description of its quality management system? 1point** **a. Standard Operating Procedure (SOP)\ b. Quality Control Plan\ c. Quality Manual\ d. Calibration Certificate** **10. What is the significance of implementing document control in a Laboratory Quality Management System? 1point** **a. To reduce paperwork in the laboratory\ b. To expedite the release of test results\ c. To maintain the integrity and traceability of documents\ d. To minimize staff involvement in quality control** **11. The most effective investigational technique for occurrence management is: 1point** **a. Analysis of all QC data** **b. Survey of all the laboratory's customers** **c. Evaluation of employee performance** **d. Root cause analysis** **12.** Consider an assay with a Sigma level of 4.5. If the laboratory aims to move the assay to the \"world-class\" category, what specific actions should be taken based on the grading system? 1point **a. Increase Bias and decrease SD** **b. Decrease Bias and increase SD** **c. Increase Bias and SD proportionally** **d. Maintain Bias and SD** **13. If the standard deviation index (SDI) consistently shows a negative value for control results over time, what potential issue might be indicated by this trend? 1point** **a. Increased precision in the assay.** **b. A systematic positive bias in the results.** **c. Improved accuracy of the control material.** **d. Instrument drift leading to lower results.** **14. Laboratory information management is majorly concerned with: (1Point)** **a. Complaints documentation** **b. Sample logs and records** **c. Route cause analysis** **d. Critical services inventory** **15. Consider an assay with a Sigma level of 4.5. If the laboratory aims to move the assay to the \"world-class\" category, what specific actions should be taken based on the grading system? 1point** **a) Increase Bias and decrease SD** **b) Decrease Bias and increase SD** **c) Increase Bias and SD proportionally** **d) Maintain Bias and SD** **Second section** **16. Identify and discuss two external factors, not related to laboratory processes, that may impact the results of internal quality control? 1point** **Environmental conditions: Changes in temperature and humidity and level workspace can affect reagent stability and instrument performance.** **Supply chain issues: Delays or inconsistencies in the supply of control materials or reagents can impact the laboratory\'s ability to perform effective internal quality.** **17.** Describe two key activities performed during the Analytical phase that contribute to the accuracy of laboratory test results? 1point **Two key activities during the Analytical phase include instrument calibration, which ensures the accuracy of measurement instruments, and data analysis, which involves processing and interpreting test results to generate accurate and reliable information.** 18\. Witch are effective and useful tools for detecting occurrence in occurrence management system? 1point **Occurrences are detected through a variety of investigative techniques. Monitoring of complaints and satisfaction surveys will yield much information. Once the laboratory establishes and monitors quality indicators, deficits will be noted. The tools of external assessment, such as proficiency testing, external quality assessment, accreditation and certification processes, will be very useful in occurrence management. A very valuable tool is the internal audit, which can be performed at any time in the laboratory. The laboratory's process improvement efforts will identify opportunities for improvement.** 19\. **List some main benefits of a good equipment management policy in the laboratory (1Point)** 1. **Enhanced Accuracy and Reliability: Properly maintained and calibrated equipment ensures accurate and reliable test results, crucial for accurate diagnoses and patient care.** 2. **Improved Workflow Efficiency: Regular maintenance and calibration schedules prevent unexpected equipment breakdowns, reducing downtime and maintaining a smooth workflow.** 3. **Cost Savings: Proactive equipment management reduces the likelihood of costly repairs or replacements due to neglect or unexpected failures. It also maximizes the lifespan of equipment, optimizing investments.** 4. **Adherence to Regulatory Standards: Ensuring equipment meets regulatory and accreditation standards through proper management helps maintain compliance, avoiding penalties or loss of accreditation.** 5. **Quality Control and Assurance: Well-managed equipment contributes to consistent quality control processes, enabling the lab to meet high-quality standards and ensure reliable testing.** 6. **Safety Assurance: Regular maintenance and safety checks prevent accidents or mishaps, ensuring a safe working environment for laboratory staff.** 7. **Data Integrity: Calibrated and well-maintained equipment reduces the risk of errors, preserving the integrity of test results and associated data.** 8. **Improved Staff Morale and Efficiency: Functioning equipment reduces frustration among staff due to equipment failures or errors, leading to increased productivity and job satisfaction.** 9. **Risk Mitigation: A good equipment management policy includes risk assessment and mitigation strategies, reducing the potential for equipment-related risks or failures.** 10. **Facilitates Long-term Planning: By monitoring equipment performance and lifespan, labs can plan and budget for equipment upgrades or replacements in advance, preventing sudden disruptions.** **In summary, a robust equipment management policy not only ensures the accuracy and reliability of test results but also contributes significantly to overall operational efficiency, regulatory compliance, and staff satisfaction within the laboratory setting.** **20. What are the differences in systematic error and random error? (1Point)** **Random error is error for which the cause cannot definitely be identified, such as temporary variations in voltage, air bubbles in a reagent line, or differences in technique among workers. Systematic error is a variation that makes results consistently higher or lower than the actual value as a result of factors such as out of date reagents or mechanical problems in an instrument.** **21.** On which parameters depend Quality Goal Index (QGI) and when is mandatory to calculate? 1point **QGI depends on Bias and CV%** **It is mandatory to calculate, when Sigma level is less than 5** 22\. Shortly **Explain the Deming PDCA cycle. 1point** **The Deming PDCA cycle, also known as the Deming Wheel or Shewhart Cycle, is a continuous improvement framework, shows how to achieve continual improvement in any process. consisting of four stages: Plan, Do, Check, and Act. It is a systematic approach to problem-solving and process improvement.** 23\. What is the interpretation if the SDI is **± 2.0 or greater?** 1point **Your result falls among the laboratories with the poorest performance Troubleshoot bias problem and perform corrective action. Troubleshoot BIAS problem and perform corrective action.** 24\. To describe a Gaussian distribution, we need only 2 statistics, what are they? (1Point) **SD** ---------- **Mean** 25\. **You need to centrifuge three tubes of blood. Two of the tubes are adult-size and the other is pediatric-size. Explain how you will balance the centrifuge? 1point** **If you do not have an even number of blood tubes to spin, you can balance the centrifuge with a similar tube filled with water or saline. An unbalanced centrifuge is similar to a washing machine that is heavier on one side than the other.** **Third Section** **Study and analyze Case. Answer the following questions clearly: (2point)** **While checking the control values of your hemoglobin A1C monitor, you discover that the results are outside acceptable limits.** **First double checks the expirations of the control materials. If they are past the expiration date, replace them and repeat the control check. If the control material has not passed its expiration date, you may repeat the control test. However, failure warrants immediate calibration, repair, or replacement of the system and should be reported immediately.** **Study and analyze Levey-Jennings Chart. Answer by choose from A to G list: (3Point)** **The current population demonstrates \_\_\_**   **Study and analyze Case. Answer the following questions clearly: (3point)** **The laboratory handles a high volume of patient samples for blood analysis, covering a wide range of tests for diagnostics, monitoring, and research purposes. The current workflow faces challenges such as sample processing delays, resource utilization inefficiencies, and occasional errors in reporting results. As a Laboratory quality manager specialist, after inspection, you noticed accuracy, and overall productivity problems in the hematology and biochemistry laboratory part.** - **The laboratory receives a large number of patient samples throughout the day for various hematological and biochemical tests.** - **Laboratory instruments and staff resources are not always optimally utilized, leading to occasional bottlenecks.** - **Ensuring the accuracy and reliability of test results is critical in a clinical laboratory.** - **Patients and clinicians often require prompt test results for timely diagnosis and treatment decisions.** Answer the questions: 1. How can the sample reception and processing phase be optimized to reduce turnaround times, minimize errors, and ensure proper sample tracking? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 2. How can resource utilization be improved to accommodate high sample volumes, prevent instrument downtime, and ensure a balanced workload for laboratory staff? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 3. What measures can be implemented to strengthen quality control and assurance processes, especially in the context of both hematology and biochemistry tests? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 4. How can the laboratory improve turnaround times for test results without compromising accuracy, and what strategies can be employed for effective result reporting? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 1. **Question 1:** - **How can the sample reception and processing phase be optimized to reduce turnaround times, minimize errors, and ensure proper sample tracking?** **Answer 1:** - **Implementing a barcode system for sample tracking, optimizing sample transportation logistics, and introducing automated sample processing systems can reduce manual errors and speed up the overall sample processing time. A dedicated team for sample reception, with clear protocols, can ensure efficient handling and recording.** 2. **Resource Utilization:** - **Laboratory instruments and staff resources are not always optimally utilized, leading to occasional bottlenecks.** **Question 2:** - **How can resource utilization be improved to accommodate high sample volumes, prevent instrument downtime, and ensure a balanced workload for laboratory staff?** **Answer 2:** - **Introducing a laboratory information management system (LIMS) can help in better instrument scheduling and workload balancing. Predictive maintenance schedules for instruments, cross-training of staff, and implementing flexible work shifts can ensure continuous operation and reduce downtime.** 3. **Quality Control and Assurance:** - **Ensuring the accuracy and reliability of test results is critical in a clinical laboratory.** **Question 3:** - **What measures can be implemented to strengthen quality control and assurance processes, especially in the context of both hematology and biochemistry tests?** **Answer 3:** - **Regular calibration and maintenance of instruments, participation in external quality assurance programs, and implementing comprehensive training programs for laboratory staff can strengthen quality control. Establishing a robust documentation system for each testing step and introducing real-time result validation checks can further enhance result accuracy.** 4. **Turnaround Time and Reporting:** - **Patients and clinicians often require prompt test results for timely diagnosis and treatment decisions.** **Question 4:** - **How can the laboratory improve turnaround times for test results without compromising accuracy, and what strategies can be employed for effective result reporting?** **Answer 4:** - **Streamlining result validation processes, optimizing reporting protocols, and employing electronic reporting systems can significantly reduce turnaround times. Implementing a priority system for urgent samples and providing continuous communication channels for clinicians can enhance the overall efficiency of result reporting.** **Study and analyze Case. Answer the following questions clearly: (3point)** **Innumerate Laboratory sample rejection criteria, Sample safety and packaging requirements during the sample transportation:** **Sample Rejection Criteria** -- -- Sample Safety Requirements during transportation -- -- Sample packaging Requirements during transportation -- -- **Study and analyze Case. Answer the following questions clearly: (4point)** **"A new laboratory quality manager was hired by Laboratory X. The laboratory has not had a quality manual in the past, but the new manager wants to develop one."** Why do you think a quality manual is important? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Who should the laboratory manager involve in the process? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ How can the laboratory manager ensure that all of the details are included? Would this result in increased costs for patient management, and what would increase the cost? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_  List some of the content required for a quality manual and what that they think should be included in a quality manual. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_  Who should be responsible for writing the quality manual? \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Dr. Malkhaz Babuashvili Point: \_\_\_\_ Comment: