Unit convenor and teaching staff |
Unit convenor and teaching staff
Maree Stuart
Danny Wong
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Credit points |
Credit points
4
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Prerequisites |
Prerequisites
Admission to MLabQAMgt or PGCertLabQAMgt or GradDipLabQAMgt or GradCertLabQAMgt or MRadiopharmSc or MSc or MBiotech or MBioBus
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Corequisites |
Corequisites
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Co-badged status |
Co-badged status
CBMS761
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Unit description |
Unit description
This unit covers topics and concepts central to the successful implementation of quality within analytical testing laboratories. Topics include coverage of various quality management system standards such as ISO 17025, ISO 15189, ISO 9000 and GLP, the reasons for implementing such standards and their requirements with respect to laboratory practices, as well as the accreditation process through agencies such as the National Association of Testing Authorities.
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Information about important academic dates including deadlines for withdrawing from units are available at https://www.mq.edu.au/study/calendar-of-dates
On successful completion of this unit, you will be able to:
Name | Weighting | Hurdle | Due |
---|---|---|---|
Assignment 1 | 10% | No | 6 pm, Tuesday 14 August |
Assignment 2 | 10% | No | 6 pm, Tuesday 21 August |
Assignment 3 | 10% | No | 6 pm, Sunday 17 September |
Mid Session Test | 10% | No | 11:59 pm Sunday 17 September |
Assignment 4 | 20% | No | 6 pm, Tuesday 20 November |
Assignment 5 | 40% | No | 6 pm, Friday 30 November |
Due: 6 pm, Tuesday 14 August
Weighting: 10%
Quality principles, policy and objectives
Due: 6 pm, Tuesday 21 August
Weighting: 10%
This assessment task will consist of a series of hypothetical problem questions on the topics of impartiality, risk management and structural requirements for a laboratory organisation.
Due: 6 pm, Sunday 17 September
Weighting: 10%
Laboratory Processes
Due: 11:59 pm Sunday 17 September
Weighting: 10%
The exam will consist of 15 multiple choice questions. Each question of the exam consists of a laboratory scenario, based on real life situations. For each scenario/question you will be required to identify the relevant clause(s) or sub-clause(s) in ISO/IEC17025 which you believe most specifically address the scenario.
The exam will be completed on-line on the iLearn site and will be released on Monday 10 September and access will close at 11:59 pm on Sunday 16 September. You may only make one attempt at the exam.
Due: 6 pm, Tuesday 20 November
Weighting: 20%
Management System Problem questions
Due: 6 pm, Friday 30 November
Weighting: 40%
For assignment 5 you have the option of selecting 2 plus 1 compulsory assessment task from a total of 5 possible assessment tasks. Topics covered include:
Quality Control Charts, Laboratory Records, OECD Principles of Good Laboratory Practice, Preparing for Accreditation, Laboratory Assessment - A Case Study.
This unit is taught concurrently with CBMS761.
Attendance of all lectures and tutorials is strongly recommended.
Use will be made of literature search tools, such as the library’s catalogue and Journal Finder resources, Word (all assignments will need to be word-processed) and Excel. Items of interest and links to other on-line material will be placed on the unit website.
All assessment tasks are to be submitted in Turnitin on iLearn.
General use computers are provided by the University, but it would be extremely advantageous to have your own computer and internet access.
AS ISO/IEC 17025-2018: General requirements for the competence of testing and calibration laboratories (ISBN: 0-7337-7018-5). Available via the library’s “Journal Finder”, search for “Standards Australia [electronic resource] : on-line premium”.
Use will be made of this text on a regular basis. You must bring your copy to every lecture/tutorial.
All are available via the library’s “Journal Finder”, search for “Standards Australia [electronic resource] : on-line premium”. Note: The license for the downloaded PDF requires you to print out the standard within 3 days or else the PDF will become unusable. Note also that the university has only one license to Standards Australia. Thus, if someone else is using it, you will not be able to access the documents until they log off.
All are available in University Library, Call numbers provided at the end of each reference.
Asia Pacific Laboratory Accreditation Cooperation (APLAC) |
http://www.aplac.org |
Eurachem |
http://www.eurachem.org/ |
National Association of Testing Authorities (NATA) |
http://www.nata.com.au/ |
The web page for this unit can be found at: http://ilearn.mq.edu.au
You are expected to access the web pages frequently, where you may find announcements, links to interesting internet facilities and sites of interest to the course, view your marks in relation to unit averages, and lots of other interesting stuff.
Week 1 | Quality Management Principles |
Week 2 | Acting Ethically and Laboratory Structures |
Week 3 | Resource requirements: People |
Week 4 | Resource requirements: Facilities and equipment |
Week 5 | Process requirements: Client interactions and testing |
Week 6 | Process requirements: Method development, validation and QC |
Mid-semester break | |
Week 7 | Reporting results, Customer complaints |
Week 8 | When things go wrong: nonconformances, corrective action and problem solving |
Week 9 | Controlling information and data |
Week 10 | Internal audits and management reviews |
Week 11 | OECD GLP |
Week 12 | Technical Infrastructure and Conformity Assessment |
Week 13 | Q&A session including preparation of final assignment |
Macquarie University policies and procedures are accessible from Policy Central (https://staff.mq.edu.au/work/strategy-planning-and-governance/university-policies-and-procedures/policy-central). Students should be aware of the following policies in particular with regard to Learning and Teaching:
Undergraduate students seeking more policy resources can visit the Student Policy Gateway (https://students.mq.edu.au/support/study/student-policy-gateway). It is your one-stop-shop for the key policies you need to know about throughout your undergraduate student journey.
If you would like to see all the policies relevant to Learning and Teaching visit Policy Central (https://staff.mq.edu.au/work/strategy-planning-and-governance/university-policies-and-procedures/policy-central).
Macquarie University students have a responsibility to be familiar with the Student Code of Conduct: https://students.mq.edu.au/study/getting-started/student-conduct
Results shown in iLearn, or released directly by your Unit Convenor, are not confirmed as they are subject to final approval by the University. Once approved, final results will be sent to your student email address and will be made available in eStudent. For more information visit ask.mq.edu.au.
Macquarie University provides a range of support services for students. For details, visit http://students.mq.edu.au/support/
Learning Skills (mq.edu.au/learningskills) provides academic writing resources and study strategies to improve your marks and take control of your study.
Students with a disability are encouraged to contact the Disability Service who can provide appropriate help with any issues that arise during their studies.
For all student enquiries, visit Student Connect at ask.mq.edu.au
For help with University computer systems and technology, visit http://www.mq.edu.au/about_us/offices_and_units/information_technology/help/.
When using the University's IT, you must adhere to the Acceptable Use of IT Resources Policy. The policy applies to all who connect to the MQ network including students.
Our postgraduates will demonstrate a high standard of discernment and common sense in their professional and personal judgment. They will have the ability to make informed choices and decisions that reflect both the nature of their professional work and their personal perspectives.
This graduate capability is supported by:
Our postgraduates will be able to demonstrate a significantly enhanced depth and breadth of knowledge, scholarly understanding, and specific subject content knowledge in their chosen fields.
This graduate capability is supported by:
Our postgraduates will be capable of utilising and reflecting on prior knowledge and experience, of applying higher level critical thinking skills, and of integrating and synthesising learning and knowledge from a range of sources and environments. A characteristic of this form of thinking is the generation of new, professionally oriented knowledge through personal or group-based critique of practice and theory.
This graduate capability is supported by:
Our postgraduates will be capable of systematic enquiry; able to use research skills to create new knowledge that can be applied to real world issues, or contribute to a field of study or practice to enhance society. They will be capable of creative questioning, problem finding and problem solving.
This graduate capability is supported by:
Our postgraduates will be able to communicate effectively and convey their views to different social, cultural, and professional audiences. They will be able to use a variety of technologically supported media to communicate with empathy using a range of written, spoken or visual formats.
This graduate capability is supported by:
Our postgraduates will be ethically aware and capable of confident transformative action in relation to their professional responsibilities and the wider community. They will have a sense of connectedness with others and country and have a sense of mutual obligation. They will be able to appreciate the impact of their professional roles for social justice and inclusion related to national and global issues
This graduate capability is supported by:
Information in the lecture and associated materials have been updated to reflect changes in laboratory quality systems standards and regulations. The structure of the unit has been substantially revised to reflect the change in structure and content of the main laboratory standard, AS ISO/IEC 17025.
The assessment structure and dates have been modified to allow for early assessment prior to the census date and to more evenly spread assessment tasks throughout the unit.