Dr W. Edwards Deming developed 14 Points for Quality Management. Amongst these were the following
principles:
Cease dependence on inspection to achieve quality
Improve constantly and forever every process for planning, production and service
Institute a vigorous program of education and training for everyone
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. Provide example of clauses from ISO/IEC 17025 to support your view.
Discuss whether, in your view, ISO/IEC 17025 is an improvement on the initial work of Dr Deming, using example of clauses from ISO/IEC 17025 to justify your opinion.
Microsoft Word - MOLS7253-MOLS8253_Assignment 4_2020.docx DEPARTMENT OF MOLECULAR SCIENCES Faculty of Science and Engineering Assignment 4 MOLS7253 / MOLS8253 LABORATORY QUALITY SYSTEMS Critical analysis and application of international standards Due: 5 pm, Friday 20 November 2020 Weighting: 40% Assignment 4 MOLS7253 / MOLS8253 LABOROATORY QUALITY SYSTEMS Due: 5 pm 20 Nov 2020 Version: 5/11/2020 Page | 2 Information and Instructions LEARNING OUTCOMES This assessment task relates to the following Learning Outcomes: Analyse the requirements of international standards ISO/IEC 17025, ISO 15189, ISO 9000 and the OECD Principles of Good Laboratory Practice. Prepare and maintain quality documentation. Critically analyse/evaluate an existing quality management system for the purpose of quality improvement. Develop a quality management system. 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. Enhance customer service and the experience of interested parties through the use of quality improvement techniques and processes. ASSIGNMENT GUIDE AND SUBMISSION Your assignment responses must be completed in a Word document as follows: Format - Wording spaced 1.5; Margins not less than 2.5cm on the right and left; Font/size 12 pt Times New Roman. Your name and student number must be included somewhere prominent in the document. You may include a title page. Part 1 – maximum one and a half (1.5) pages Part 2 – maximum 500 words for each task chosen (2 out of 4) The assignment is to be submitted via Turnitin link in the unit’s iLearn page. Turnitin is an online program that detects plagiarised pieces of work. It compares not only work between students in the current year but also across previous years, across institutions, with all published materials, and the internet. Do not under any circumstances lend your work to another student. If that student plagiarises your work you too will be liable. The penalties imposed by the University for plagiarism are serious and may include expulsion from the University. ANY evidence of plagiarism WILL be dealt with according to University policy. A full outline of the Universities policy on plagiarism is found at http://www.mq.edu.au/pol icy/docs/academic_honesty/policy.html. It is your responsibility to ensure all documents submitted or uploaded in ilearn are the correct file(s) and readable by the person marking your assignment. If files cannot be read, then late penalties will apply until re-submission of the work occurs. 10% will be deducted for each day (up to and including any time in the 24 hr period) if an assignment is late. This includes each day of a weekend. If you are unable to submit the assignment by the due date then an extension must be sought BEFORE the due date unless this is absolutely impossible. Notification after the event of an "anticipatable" absence will not be looked upon favourably. To support your extension, you must submit a "Special Consideration Request" request via www.ask.mq.edu.au. See https://students.mq.edu.au/study/my-study-program/special-consideration for instructions on how to do this. Please note that evidence must be given to support your request for an extension. Applications must also be made within five working days of the assessment task due date. Decisions to approve/not Assignment 4 MOLS7253 / MOLS8253 LABOROATORY QUALITY SYSTEMS Due: 5 pm 20 Nov 2020 Version: 5/11/2020 Page | 3 approve a special consideration request are made by the university (and NOT the unit convenor). MARKING GUIDE AND RUBRIC Weighting: 40% The assignment is marked out of 100. Marks for each task are allocated as follows: Part 1 – 30 marks Part 2 – 35 marks for each chosen task (2 out of 4) 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. Excellent HD-D Good Credit Satisfactory Pass Unsatisfactory Fail Content Meets the requirements and is expressed in a way that is engaging to the reader. 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 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. Well- structured and expressed in a way that is engaging to the reader. 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; difficult to understand; work on grammar needed; may have relied on jargon and made no meaningful attempt to use language that is 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 sources cited included according to APA style. Provides other useful sources of information for readers to follow-up if required. References to requirements and sources cited included according to APA style. Some referencing information provided, but this is not complete. No referencing of sources of information. Marks will be released on iLearn. It is your responsibility to check that marks released on iLearn are accurate. Note: Marks released on iLearn do not have late penalties applied. Late penalties are applied AFTER marking of the submitted work. See assignment guide and submission section of this document. Assignment 4 MOLS7253 / MOLS8253 LABOROATORY QUALITY SYSTEMS Due: 5 pm 20 Nov 2020 Version: 5/11/2020 Page | 4 Assignment Tasks Note: All references to ISO/IEC 17025 in this document is the current Australian Standard version, AS ISO/IEC 17025:2018. PART 1: Compulsory All students must attempt this task Word limit: maximum one and a half (1.5) pages Value: 30 marks Dr W. Edwards Deming developed 14 Points for Quality Management. Amongst these were the following principles: Cease dependence on inspection to achieve quality Improve constantly and forever every process for planning, production and service Institute a vigorous program of education and training for everyone 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. Provide example of clauses from ISO/IEC 17025 to support your view. Discuss whether, in your view, ISO/IEC 17025 is an improvement on the initial work of Dr Deming, using example of clauses from ISO/IEC 17025 to justify your opinion. PART 2: Choose two (2) from the following four (4) task options Please indicate which tasks you are answering in your submission. Word limit: Maximum 500 words for each task chosen Value: 35 marks for each chosen task (2 out of 4) PART 2: TASK 1 ISO/IEC 17025 contains requirements for handling samples (clauses under 7.4). 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. Guide: It is recommended that you include a process flow diagram and the contents page for the procedure(s) showing what the procedure(s) would cover. You may decide one procedure is sufficient or you may decide that you need more than one procedure for different parts of the process. This is your decision in how you implement the requirements of handling samples and document it. Assignment 4 MOLS7253 / MOLS8253 LABOROATORY QUALITY SYSTEMS Due: 5 pm 20 Nov 2020 Version: 5/11/2020 Page | 5 PART 2: TASK 2 Compare the requirements for equipment and facilities (only 3.1, 3.2 and 3.3 under facilities for GLP) 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 whether one standard is better than the other in dealing with these areas of a laboratory operation. Use examples to justify your answer. Note: It is preferred that your response is provided in a table format. 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 requirements 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 breach of the