Oral Exam on Quality Measures (PDF)

Botany Department Faculty of Science Suez Canal University Oral Exam on Quality Measures fo...

Botany Department Faculty of Science Suez Canal University Oral Exam on Quality Measures for the Fourth Level Microbiology Students First term 2013/ 2014 Answer one or more of the following questions: 1. Define quality, quality control, quality assurance or quality assessment? Quality according to ISO, quality is defined as totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs. Quality Control refers to a series of analytical measurements used to assess the quality of the analytical data (The “tools”) Quality Assurance defined as an overall management plan to guarantee the integrity of data (The “system”) Quality Assessment - quality assessment is a means to determine the quality of the results generated by the laboratory. Quality assessment is a challenge to the effectiveness of the quality assurance and quality control programs. 2. What are the aims of quality control and/ or quality assurance? “The aim of quality control is simply to ensure that the results generated by the test are correct. However, quality assurance is concerned with much more, including that the right test is carried out on the right specimen, and that the right result and right interpretation is delivered to the right person at the right time” 3. Do you know the meaning of ISO certificates? International Standards Organization (ISO) is one of the leading international bodies that have brought together international community in developing uniform standards for quality in manufacturing and service sectors.  4. Give examples of some ISO certificates? ISO 9000 series: (9000,9001,9002,9003,9004,etc.) refer to design development, production, installation, servicing and final inspection and testing as applied to manufacturing processes. ISO Guide 25: refer to performance of objective measurements, use of reference material and calibration as well as test methodology. ISO Guide 43: design and operation of external quality assessment scheme ISO Guidelines 15189: indicates quality management of medical laboratories 5. What are the variables that affect the quality of microbiological tests? Variables that affect the quality of microbiological results are as follows: The educational background and training of the laboratory personnel The condition of the specimens The controls used in the test runs Reagents Equipment The interpretation of the results The transcription of results The reporting of results 6. Can you generalize briefly the aim of QC programs in Microbiological tests? Quality control programs in Microbiological aims to:  Check:  Sterility  Ability to support growth  Selective or inhibitory characteristics of the medium  Biochemical response  Check frequently  Test organisms with each new batch or lot number  Check  Growth of fastidious organisms on media of choice – incubate at time and temperature recommended   Record results on QC form 7. What are the differences between accuracy and precision? Which of them are needed to ensure the quality of tests? Accuracy: How well a measurement agrees with an accepted value Precision: How well a series of measurements agree with each other The degree of fluctuation in the measurements is indicative of the “precision” of the assay. The closeness of measurements to the true value is indicative of the “accuracy” of the assay. Quality Control is used to monitor both the precision and the accuracy of the assay in order to provide reliable results. 8. What are the characteristics of a good sample? Good sampling design should take into account both of the two main components of sampling strategies: 1. Selecting the sample, 2. Processing the data. The sampling protocol should be established before any investigation proceeds. Good Sample should: Relate to the objective(s) of the investigations, Taken at random, Large enough to give sufficient precision, Be practical and achievable, Be cost-effective in terms of equipment and labor, Provide estimates of population parameters that are truly representative and independent. 9. Can you classify biological variables? Give some examples Quantitative variables: they are two basic types, 1. Continuous variables: such as length: these are usually measured against a numerical scale. 2. Discontinuous variables: such as the number of eggs in a nest, these are always obtained by counting Ranked variables: These provide data which can be listed in order of magnitude (i.e. ranked). A familiar example is the abundance of an organism in a sample, which is often expressed as a series of ranks: Rare = 1 Occasional = 2 Frequent = 3 Common = 4 And abundant = 5 When such data are given numerical ranks, rather than descriptive terms, they are sometimes called “semi-quantitative data”. Qualitative variable: These are non- numerical and descriptive, they are described in terms of categories: dead or alive, shape (round, flat, elongated,…). These qualitative data can be used to derive ratios, percentages, indices and rate. 10. What are the types of measurement scales? The measurement scale is important in determining the mathematical and statistical methods used to analyze data. Variables may be measured on different types of scale: Nominal scale: this classifies objects into categories based on descriptive characteristics. It is the only scale suitable for qualitative data. Ordinal scale: this classifies by rank. There is a logical order in any number scale used. ( Measure ranked variables) Interval scale: this is used for quantitative variables: Numbers on an equal unit scale are related to an arbitrary zero point. (measures quantitative data) Ratio scale: this is similar to the interval scale, except that the zero point now represents an absence of that character (i.e. it is an absolute zero). 11. What are the importance SI units? List the seven base SI units? SI units (The Systeme International d’Unites (SI): it is an internationally ratified form of the meter – kilogram – second system of measurement and represents the accepted scientific convention for measurements of physical quantities.  12. List the seven base SI units of measurements? Base SI units: 1. Length 2. Mass 3. Amount of substance 4. Time 5. Electric current 6. Temperature 7. Luminous intensity This oral exam will account for 10% of the final mark = 15 Questions Bank of the Course: Quality Measures, For Level Year Microbiology Students, First term, 2013/ 2014. Prof./ Ishrak Khafagi, December 2013