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AS/APR 2006/CHWI561

UNIVERSITI TEKNOLOGI MARA FINAL EXAMINATION

COURSE COURSE CODE EXAMINATION TIME

QUALITY IN ANALYTICAL MEASUREMENT CHM561 APRIL 2006 3 HOURS

INSTRUCTIONS TO CANDIDATES 1. 2. 3. 4. This question paper consists of five (5) questions. Answer ALL questions in the Answer Booklet. Start each answer on a new page. Do not bring any material into the examination room unless permission is given by the invigilator. Please check to make sure that this examination pack consists of: i) ii) the Question Paper an Answer Booklet - provided by the Faculty

DO NOT TURN THIS PAGE UNTIL YOU ARE TOLD TO DO SO

This examination paper consists of 3 printed pages
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AS/APR 2006/CHM561

QUESTION 1 a) Distinguish between random, judgemental and systematic sampling plans, commenting on the relative advantages and disadvantages of the sampling plan in each case. (9 marks) Giving appropriate example, outline a flow procedure for these sampling terms: laboratory sample, analytical sample, primary sample, aliquot, analytical solution. (10 marks)

b)

QUESTION 2 a) State five factors to be considered in selecting: i) an 'analytical method' ii) a 'certified reference material (CRM)' (5 marks) b) i) ii) State two situations whereby methods need to be validated. Validation of an analytical method is primarily concerned with the quantification of the potential errors in the method. Explain how this problem is solved in method validation. (8 marks)

c)

In the validation of analytical methods for determining lindane in drinking water using gas chromatography, propose an outline of an analytical procedure (stepwise detailed manner) in establishing two of the following validation parameters. Environmental Protection agency (EPA) has set Maximum Contaminant Level (MCL) of 0.2 ppb for lindane in drinking water. i) Linearity and range ii) Limit of quantitation iii) Limit of detection (10 marks)

QUESTION 3 The production of B from A is as shown in Figure 1. Catalyst X > B 250 C Figure 1 Discuss the steps involved in optimizing the production of B using Experimental Design (DoE). Details on the justification for your choice of parameters and experimental values are required. (12 marks)
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AS/APR 2006/CHM561

QUESTION 4 a) Describe briefly the four steps involved in the uncertainty estimation process? (6 marks) Give the information required for a complete report of a measurement result. (6 marks) Describe briefly three typical sources of uncertainty. (6 marks) d) A student used a burette to measure a volume of distilled water and reported the measurement as 12.689 0.1543 ml_. Is the reported measurement acceptable? Justify your answer. (2 marks)

b)

c)

QUESTION 5 a) What is the difference between quality control and quality assurance based on definition from ISO 9000-2000? (2 marks) Total Quality Management (TQM) is an evolution of quality control. What does TQM emphasize and what are the benefits of TQM? Give four of each. (8 marks) What is the aim of ISO 9000 series? (1 mark) d) Good Manufacturing Practice (GMP) predates Good Laboratory Practice (GLP). i) ii) iii) iv) What are the significant differences between GMP and GLP? Who has to comply with GLP regulations? Give an example of a situation where GLP is required, Give an example of a situation where GLP is not required. (6 marks) e) You are in charge of the chemicals in laboratory of a manufacturing factory. These chemicals may be used in GLP-regulated studies. Give the required information in labeling these chemicals. (8 marks)

b)

c)

END OF QUESTION PAPER

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