CBMS861 - Case Study of Laboratory Quality Systems - Principles of Good Laboratory Practice - Biotechnology Report Writing Assignment Help

Assignment Details -

Learning Outcomes - 

This assessment task relates to the following Learning Outcomes:

1. Analyse the requirements of international standards ISO/IEC 17025, ISO 15189, ISO 9000 and the OECD Principles of Good Laboratory Practice.
2. Prepare and maintain quality documentation.
3. Develop a quality management system.
4. Critically analyse/evaluate an existing quality management system for the purpose of quality improvement.
5. Understand, at an advanced level, technical management concepts including test methods, method selection, verification of methods, validation of methods, uncertainty of measurement, calibration and traceability.
6. Enhance customer service and the experience of interested parties through the use of quality improvement techniques and processes.

MARKING GUIDE AND RUBRIC

Weighting: 40% Following is the criteria used to assess this assignment. Although each factor will be taken into consideration, a holistic approach will be adopted to determine the final mark for this assignment.

PART 1: Compulsory

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/IEC 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: Choose two (2) from the following four (4) task options

PART 2: TASK 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. PART 2: TASK 2 Compare the requirements for testing and personnel of ISO/IEC 17025 with the similar OECD Principles of Good Laboratory Practice. Discuss the similarities and differences between the two standards and evaluate.

PART 2: TASK 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 non-compliances against the requirement of ISO/IEC 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 laboratory’s facilities or operations that have been shown by the assessment not to comply with the requirement of ISO/IEC 17025 (N/C), and

b) any aspects of the laboratory’s 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 functions 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 a public hospital and, before that, 6 years in academia.

PARA 3) Senior Genetics Scientist – Elizabeth Blackburn - has just commenced a part-time 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 laboratory’s 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 laboratory’s 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.”

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%.”

Description of discussions and events during the assessment 8:30am Lab Manager’s 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 Manager’s office.

PARA 11) James: “We’re really pleased to have you here today. We’ve 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 laboratory’s 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 manager’s 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 lab’s 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 laboratory’s quality system.

PARA 18) Betty: “That’s fine. Can we now look at the records of internal audits? How often are they conducted?”

PARA 19) James: “We haven’t conducted any internal audits. My interpretation of 17025 is that internal audits are only required when there is an independent auditor. That’s 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.

Your task is to prepare a 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.

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