laboratory quality management

HCT210: 2011Laboratory Quality Management Assignment one1. Define the following terms Quality Quality Control Quality assessment. Total quality management [5marks]2. Discuss the importance of chemical measurements in decision making [10marks]3. The six principles of Valid Analytical Measurement (VAM) provide a framework to enable organisations to deliver reliable results first time, every time, and achieve bottom line improvements through increased operational efficiency and reduction in risk. State the six principles Explain the importance of each principle How would you implement each of the stated principles in an analytical environment? [6, 6, 13]Assignment two1. Distinguish between simple random sampling and stratified random sampling. [2marks]2. Discuss how you would systematically control the quality of results for a measurement system that you are familiar with from sampling up to the issuing of results under the following sub-headings(i) Sampling plan [2marks](ii) Sample preparation and storage [3marks](iii) Sample analysis and quality control of analysis [10marks](iv) Technical records and reporting [10 marks]3. Explain how the following materials contribute towards traceability of chemical measurements.(i) Chemical standard(ii) Reference materials(iii) Certified reference material [6marks]4. Method validation is the process of determining the suitability of an analytical methodology for proving useful and reliable analytical data. The validation can be for a general or for a specific use. Describe briefly how you would systematically validate an analytical procedure before adopting it for routine use in your laboratory under the following sub-headings(i) Bias(ii) Recovery(iii) Selectivity(iv) Sensitivity(v) Limit of detection(vi) Precision [9marks]Assignment three(a) Distinguish internal quality assessment from external quality assessment. [5marks](b) State examples of internal quality assessment procedures [5marks](c) Explain the significance of the following external quality assessment schemes(i) Proficiency testing schemes. [5marks](ii) Collaborative studies [5marks](d) Outline the main benefits of correctly implemented ISO/IEC 17025:2005 and give the technical requirement of this standard. [5,10marks]Practical OneDesign a quality system of the following instruments, HPLC, GC, AAS under the following sub-headings.(i) Write down the standard operating procedures for each instrument [15marks](ii) The types of records kept for the instruments [15marks](iii) Preventive and corrective maintenance [10marks]Practical twoGive an outline of SAZ ISO 9001: 2008 certification scheme [25marks]All assignments and practicals are due on the 5th of September and are to be submitted before the start of the first lecture.; HCT210: 2011Laboratory Quality Management Assignment one1. Define the following terms Quality Quality Control Quality assessment. Total quality management [5marks]2. Discuss the importance of chemical measurements in decision making [10marks]3. The six principles of Valid Analytical Measurement (VAM) provide a framework to enable organisations to deliver reliable results first time, every time, and achieve bottom line improvements through increased operational efficiency and reduction in risk. State the six principles Explain the importance of each principle How would you implement each of the stated principles in an analytical environment? [6, 6, 13]Assignment two1. Distinguish between simple random sampling and stratified random sampling. [2marks]2. Discuss how you would systematically control the quality of results for a measurement system that you are familiar with from sampling up to the issuing of results under the following sub-headings(i) Sampling plan [2marks](ii) Sample preparation and storage [3marks](iii) Sample analysis and quality control of analysis [10marks](iv) Technical records and reporting [10 marks]3. Explain how the following materials contribute towards traceability of chemical measurements.(i) Chemical standard(ii) Reference materials(iii) Certified reference material [6marks]4. Method validation is the process of determining the suitability of an analytical methodology for proving useful and reliable analytical data. The validation can be for a general or for a specific use. Describe briefly how you would systematically validate an analytical procedure before adopting it for routine use in your laboratory under the following sub-headings(i) Bias(ii) Recovery(iii) Selectivity(iv) Sensitivity(v) Limit of detection(vi) Precision [9marks]Assignment three(a) Distinguish internal quality assessment from external quality assessment. [5marks](b) State examples of internal quality assessment procedures [5marks](c) Explain the significance of the following external quality assessment schemes(i) Proficiency testing schemes. [5marks](ii) Collaborative studies [5marks](d) Outline the main benefits of correctly implemented ISO/IEC 17025:2005 and give the technical requirement of this standard. [5,10marks]Practical OneDesign a quality system of the following instruments, HPLC, GC, AAS under the following sub-headings.(i) Write down the standard operating procedures for each instrument [15marks](ii) The types of records kept for the instruments [15marks](iii) Preventive and corrective maintenance [10marks]Practical twoGive an outline of SAZ ISO 9001: 2008 certification scheme [25marks]All assignments and practicals are due on the 5th of September and are to be submitted before the start of the first lecture.

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