Assignment 5 Due: 2 pm, Friday 30 November 2018 Weighting: 40% Assignment Questions and General Information Students must answer both Part 1 and Part 2. There is one compulsory question in Part 1. Students must also select two questions from the optional question bank 1-4 in Part 2. Please indicate which questions you are answering in your submission for Part 2. Submit your responses to all THREE questions by 2 pm, Friday 30 November 2018. The assignments are to be submitted in Turnitin on iLearn and a hard copy of each is to be provided via the assignment drop box, Ground floor, 14 Sir Christopher Ondaatje Avenue (E7B). Failure to submit by the due date will result in 0 marks being awarded for this assignment, unless an extension is granted according to the disruption to studies policy. All disruption applications are to be made through Ask- MQ Your assignment must be double spaced with margins not less than 2.5cm on the right and left. It must be typed in 12 pt Times New Roman. References are expected for all answers. Referencing must be done in accordance with the requirements of the APA style. PART 1: Compulsory question All students must attempt this question. Word limit: 1000 words (20 marks) Dr W. Edwards Deming developed 14 Points for Quality Management. Amongst these, were the following principles. 1. Create constancy of purpose for improving products and services. 2. Cease dependence on inspection to achieve quality. 3. Improve constantly and forever every process for planning, production and service. In this unit, we have studied the ISO/IEC 17025 approach to quality management. Critically evaluate the requirements of ISO 17025 against the three principles above. You must carefully explain the meaning of each of the principles and analyse whether ISO/IEC 17025 approach to quality management has adopted these principles. Discuss whether, in your view, ISO/IEC 17025 is an improvement on the initial work of Dr Deming, using examples to justify your opinion. PART 2: Students must choose 2 of the following 4 questions. Each question has a word limit of 500 words and a weighting of 10%. Please indicate which question you are answering in your submission. Question 1 ISO/IEC 17025 contains requirements for handling samples. Examine these requirements and discuss how you would implement all these requirements in a laboratory. Give specific details of processes and procedures you would expect a laboratory to have in place to meet the requirements. Question 2 Compare the requirements for testing and personnel of ISO 17025 with the similar OECD Principles of Good Laboratory Practice. Discuss the similarities and differences between the two standards and evaluate whether one standard is better than the other in dealing with these areas of a laboratory operation. Use examples to justify your answer. Question 3 Case Study: The Assessment of a Biotechnology Laboratory The basis of this scenario is given in a case study involving an external assessment of a testing laboratory by a team of assessors from an accreditation body. Consider the information and evidence presented in the case study and identify any noncompliances against the requirement of ISO 17025 revealed by the assessment. Your task is to consider the information and evidence presented in the case study, and identify: a) aspects of the laboratorys facilities or operations that have been shown by the assessment not to comply with the requirement of ISO 17025 (N/C), and b) any aspects of the laboratorys facilities or operations on which more investigation would be needed in order to confirm compliance or noncompliance (MIN) Present your findings in the form of a table showing for each incident you choose to report: the paragraph number(s) in the case study in which the incident occurs a brief statement of the incident and, if rated as a non-compliance, the manner in which it is breech of the ISO 17025 requirement a reference to the specific clause in ISO 17025 to which the incident relates. The subject of this case study is a commercial biotechnology laboratory providing analytical services in testing for cancers in humans. The case study gives an account of what happens during several portions of an assessment of the laboratory by a team of external assessors. Background The principal function of the laboratory are the testing of blood and tissue samples from humans to assist clinicians in the diagnosis of cancer. The laboratory normally has a staff of six people, with the senior staff comprising: PARA 1) Laboratory Manager James Alison who is a long-experienced and professionally qualified medical laboratory scientist; he has a MSc in organic analytical chemistry, and a PhD. in Determination of chemical markers for liver cell lymphomas. Dr Alison has worked in this laboratory for the last 20 years. PARA 2) Senior Clinical Scientist Tasuku Honju has a MSc majoring in organic chemistry and a PhD. in molecular identification of cytokines. Dr Honju joined this laboratory 5 months ago, having previously spent 4 years in the research and development laboratory of a medical research institute associated with e public hospital and, before that, 6 years in academia. PARA 3) Senior Genetics Scientist Elizabeth Blackburn has just commenced a parttime PhD. course at University of Tasmania. Ms Blackburn has had a long career in molecular biology and has a MSc. in molecular techniques for identification of telomeres in chromosomes. PARA 4) Complete details of the education, training and work experience of all employees (including these three laboratory people) are held in confidential personnel files by the Administration Manager. PARA 5) During her preparation for this assessment, the assessment team leader (Betty Boop) reviewed the laboratorys quality manual and was satisfied that it addressed all of the requirements of 17025, except that it contained nothing relating to the externally provided products and services used by the laboratory. Joining the assessment team leader is the technical assessor, Fearless Fred. Additional Information The following extracts from the laboratorys quality manual are relevant to the incidents described in this case study: PARA 6) All 26 thermometers used in the laboratory for testing purposes shall be calibrated by an external accredited calibration laboratory at least once every 10 years, and be subjected to an ice-point zero check every 6 months. Laboratory Quality Manual Section 9 PARA 7) All test results involving any calculations must be checked by a second person. Laboratory Quality Manual Section 16, paragraph 6(a) PARA 8) The person responsible for the testing shall bring to the immediate attention of the Laboratory Manager any test results which show any unusually high variation or are outside acceptable limits. Laboratory Quality Manual Section 16, paragraph 6(g) PARA 9) The method used in this laboratory for the identification of tumour marker CA-125 requires duplicate results to agree to within 0.5%. Laboratory Quality Manual Section 18 Description of discussions and events during the assessment 8:30am Lab Managers Office PARA 10) On arrival at the laboratory, the assessment team is met by the Laboratory Manager, the Senior Clinical Scientist and the Senior Genetics Scientist in the Laboratory Managers office. PARA 11) James: Were really pleased to have you here today. Weve All been a bit nervous! Unfortunately, our Trainee Molecular Biologist, Maxine Singer, is absent today, with a sudden illness. But this should not interfere with the assessment as All of her workbooks are available. Both Elizabeth and I constantly supervise and check her work and are fully aware of her activities. PARA 12) Betty confirms with the Laboratory Manager that the scope of the assessment is consistent with the range of tests for which accreditation is being sought. She Also confirms that the assessment will be conducted against 17025:2017 and the laboratorys documented quality system. PARA 13) Betty: Would it be possible to have a brief familiarisation tour of the laboratory? PARA 14) During the tour, the assessment team see a prominent sign on the main entrance door to the laboratory stating Laboratory Personnel Only Strictly no admittance without approval of the Laboratory Manager. The team returns to the Lab managers office. PARA 15) Betty: Can you explain to me your management review process? PARA 16) James: We hold regular staff meetings once a week, but matters affecting the status and operation of the labs management system are discussed at the monthly Senior Management meetings. PARA 17) James shows the assessment team two files containing minutes of these meetings conducted over the past 12 months. The minutes of each meeting record discussions and, in some cases, decisions about the laboratorys quality system. PARA 18) Betty: Thats fine. Can we now look at the records of internal audits? How often are they conducted? PARA 19) James: We havent conducted any internal audits. My interpretation of 17025 is that internal audits are only required when there is an independent auditor. Thats what we rely on your assessors to do. PARA 20) The assessment team enter a discussion about the requirements of internal audits and how they might apply to this laboratory. PARA 21) Betty: I was interested to know why there is no documented procedure in the quality manual for externally provided products and services, like equipment servicing and reagents. PARA 22) James: I have a copy of the organisations Administration Manual here. The purchasing procedure is in here. This procedure applies to All purchasing within the organisation, so a separate procedure is not required. In fact, I dont think management would allow it. PARA 23) Betty: Can we have a look at the training records for the five laboratory personnel? PARA 24) James: All personnel records are kept under strictly confidential conditions by the Administration Manager, who is unfortunately at a conference in France. Nobody else in the organisation has a key to open the locked filing cabinet. PARA 25) At that point, the Team Leader asks the assessor to examine the way in which molecular testing is undertaken while she continues discussions regarding the quality system with the Lab Manager. Tasuku Honju takes Fearless Fred to the laboratory. 9:00am Laboratory PARA 26) Tasuku: The Laboratory has no direct control over how the samples are taken because this is done by our referring doctors. PARA 27) Fearless Fred: How do you know if they are taking the samples correctly? PARA 28) Tasuku: Many years ago, James gave some written instructions to the Department on how samples should be collected. I dont know if these procedures still exist or are being followed. PARA 29) Fearless Fred: How do the samples get from the doctors to the laboratory? PARA 30) Tasuku: A courier collects them and delivers them to us in sample vials. The samples have the name and date of birth of the patient. PARA 31) From there, it is placed into the refrigerator until one of our laboratory people pick it up for testing. PARA 32) A label on the refrigerator indicates that it is intended to be maintained at 2 2C and the refrigerator contains a glass thermometer in water for this purpose. The assessor notes that the current temperature of the refrigerator is 5 oC and asks the Senior Clinical Scientist why this is so. PARA 33) Tasuku: Ah, yes. The refrigerator developed a problem about two months ago. We have to keep turning the temperature up because it was freezing the samples. PARA 34) We have done some studies and it seems it doesnt matter if the samples are frozen, but we want to make sure we keep the indicated temperature within our limits of 2 2C so we dont have to change our label and confuse our staff. PARA 35) Fearless Fred: What do you do with the samples once they are in the refrigerator? PARA 36) Tasuku: Each day, a laboratory scientist will check the refrigerator to see if there are any new samples. The laboratory test cards for samples awaiting testing are in the in-tray adjacent to the refrigerator. The sample is usually then moved into the molecular prep room. PARA 37) But if the sample is only for chemical analysis, it is removed from the refrigerator and taken to our chemical analyser straight away, we record this on the laboratory test card. PARA 38) While this assessment is being conducted, the courier delivers twelve samples into the laboratory. The assessor observes that these samples are processed as described. The assessor watches as the Senior Clinical Scientist performs moves these samples into the correct locations. Two of the samples are just for chemical analysis and the assessor watches as the Laboratory Technician loads in the samples into the chemical analyser and starts the test. He is satisfied that these tests are being done correctly and in accordance with the laboratorys documented methods. PARA 39) Fearless Fred: Can you show me the calibration records for the equipment used in this test? PARA 40) The assessor is shown valid calibration records for the chemical analyser used by the laboratory technician for these tests. He is also shown valid certificates for the certified reference standards used to calibrate the chemical analyser. 11.30 am Molecular Diagnostics testing PARA 41) The assessor moves on to discussion about the other tests within the scope of accreditation being sought the identification of tumour marker CA-123. The assessor asks the Senior Genetics Scientist to demonstrate the performance of this test. PARA 42) Fearless Fred: I noticed there is a typed list of instructions for the test pinned to the wall behind the apparatus there. What are they used for? PARA 43) Elizabeth: I have an official copy of method in my office, but I prepared these simplified set of instructions to help the Trainee Chemist. PARA 44) I do not need to refer to these instructions or the test method because I remember this test very well from the time I worked in the petroleum laboratory. PARA 45) As the Senior Genetics Scientist continues preparing the apparatus, the assessor notes that she is intending to use a Max-Min thermometer (#590-03) instead of the general purpose thermometer (#765) specified in the method. PARA 46) Fearless Fred: Why have you chosen to use the Max-Min thermometer? PARA 47) Elizabeth: I always used to use the Max-Min thermometers when conducting this test in the university laboratory. I want to make sure that the temperature does not go out of range in the room as our air conditioner in here is a bit temperamental. I was not aware that the method specified any particular thermometer. PARA 48) Fearless Fred: Do you have the official copy of Cancer Council method on which your method is based? PARA 49) Elizabeth looks through her collection of methods and pulls out the 2004 edition of the Cancer Council Monograph of methods. PARA 50) Fearless Fred: This volume is 14 years out-of-date and that method has been revised several times since 2004! PARA 51) The assessor observes the performance of the test by the Senior Genetics Scientist and is satisfied that the test was conducted as described by the official Cancer Council method. At the end of the test, the assessor is shown a valid calibration certificate for the thermometer used, but no records are available to show that icepoint zero checks have been conducted on this thermometer at 6-monthly intervals as required by the laboratorys equipment checking program. PARA 52) Towards the end of the assessment, the assessor asks to see the workbook containing the records of the tests performed by the Trainee Molecular Scientist. One of the tests he selects for examination is the determination of CA-125 in blood samples. PARA 53) In this workbook, the assessor finds the following results obtained on the last four quality control replicates PARA 54) Date Duplicate results Average PARA 55) 23/08/2018 104.8%,98.2% 101.5% PARA 56) 24/08/2018 96.4%, 99.8% 99.1% PARA 57) 25/08/2018 100.2%,94.6% 97.4% PARA 58) 26/08/2018 101.1%, 104.9% 103.0% PARA 59) Continuing his investigation of these tests, the assessor finds the corresponding entries on the relevant test reports as follows: PARA 60) 23/08/2018 101.5% 24/08/2018 99.1% 25/08/2018 94.7% 26/08/2018 103.0% PARA 61) Fearless Fred: I notice here there are no signatures or other markings to indicate these results have been checked by James or yourself. PARA 62) Elizabeth: Hmmm youre right there. Im not sure why that has happened. PARA 63) During their examination of other tests in Molecular Diagnostics testing, the assessor finds another thermometer (#496-09) for which a valid calibration certificate is available but for which there are no records of ice-point zero checks. End of case study Question 4 In this scenario, you will be given basic information about a laboratory and asked to develop an action plan to enable it to gain accreditation. You are the newly appointed quality manager of a well-established multi-section independent testing laboratory. You have been directed by the senior management to develop an action plan to enable the laboratory to gain NATA accreditation against ISO 17025 within six months and to present your proposal in the form of a report to the Board of Directors. The basic facts about the laboratory are these: a) It has been in operation for about 10 years and currently employs 22 people. b) It consists of four sections General Chemistry, Environmental Chemistry, Sample Preparation, and Administration. c) Management Meetings involving the General Manager, the Laboratory Manager, and the four Section Heads are held monthly; you expect to participate in these meetings in future. From a preliminary appraisal of the laboratorys facilities and operations, you are reasonably confident about the correctness of the results being generated, but you have found that a lot needs to be done to raise the laboratory to accreditation status; for example: the laboratory does not have a quality manual the test methods are well documented, but only a few of the management procedures have been documented, and most of the work tasks are based on word of mouth instruction there is no central or coordinated calibration program, Although the Laboratory Manager has started working on this no internal audits have been conducted, and management and staff generally have little understanding of document control, corrective and preventive action, and quality improvement. Your task is to prepare report to the Board which includes an action plan outlining the steps you have identified to ensure that the laboratory is ready for an accreditation assessment in six months time. In your report, list the key issues that will need to be examined and addressed, and indicate other personnel whom you may need to involve in your project. You may present your report in the form of a table if you wish. Below are the criteria against which your assignment will be assessed. Even though each factor will be taken into account, a holistic approach will be adopted in settling the final mark for this assessment. ExcelTasukut = HD-D Good = Credit Satisfactory = Pass Unsatisfactory = Fail Assignments 5 will be assessed according to the following criteria: Content Meets the requirements and is expressed in a way that is engaging to the reader. The assignment submission clearly sets out the various procedures required in the scenario. Meets the requirements and clearly sets out the various procedures required in the scenario. Meets the requirements Fails to meet the requirements Clarity of submission The submission uses a variety of techniques to ensure that the information is clearly presented and that the needs of the audience are met in terms of presentation of the information. The submission is very clear and logical. The submission information in a a logical manner to some degree. The submission is not logical and is difficult to follow. Written Expression Excellent written expression; excellent grammar and sophisticated writing style. Written in a way that was easy to understand. Wellstructured. Good written expression; good grammar and writing style. Good structure adopted that is generally easy to follow. The submission may have relied too much on jargon instead of using language that is easy to understand. Clear written expression not always used making it difficult to understand; work on grammar needed; may have relied on jargon and made no meaningful attempt to use language that it easy to understand. Attempt to structure the submission has been made, but not very easy to follow. Poor expression and grammar making it impossible to read. No attempt made to use language that is easy to understand or to structure the submission coherently. Referencing References to requirements and other sources cited included in accordance with APA style. Provides other useful sources of information for readers to followup if required References to requirements and other sources cited included in accordance with APA style. Some referencing information provided, but this is not complete. No referencing of sources of information
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