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 | 8% | No | 6 pm, Tuesday 15 August |
Assignment 2 | 10% | No | 6 pm, Tuesday 12 September |
Mid Session Test | 10% | No | 11:59 pm Sunday 17 September |
Assignment 3 | 12% | No | 6 pm, Tuesday 3 October |
Assignments 4-6 | 60% | No | Weeks 10-13 |
Due: 6 pm, Tuesday 15 August
Weighting: 8%
Quality policy and objectives
Due: 6 pm, Tuesday 12 September
Weighting: 10%
Sampling and Sample Management
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 11 September and access will close at 11:59 pm on Sunday 17 September. You may only make one attempt at the exam.
Due: 6 pm, Tuesday 3 October
Weighting: 12%
Laboratory Test Methods
Due: Weeks 10-13
Weighting: 60%
For assignments 4-6 (20% ea) you have the option of selecting 2 plus 1 compulsory assessment task from a total of 5 possible assessment tasks. Topics covered in assignments 4-6 (20% ea) 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 17025-2005: 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 | Lecture Topic |
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1 | Concepts of Quality Management |
2 | Documentation Part 1 |
3 | Documentation Part 2 |
4 | People Management Part 1 |
5 | People Management Part 2 |
6 | Technical Management Part 1 |
7 | Technical Management Part 2 |
8 | Technical Management Part 3 |
9 | Quality Control |
10 | Laboratory Records and Reports |
11 | System Improvement |
12 | Good Laboratory Practice (GLP) |
13 | Conformity Assessment and Technical Infrastructure |
Macquarie University policies and procedures are accessible from Policy Central. Students should be aware of the following policies in particular with regard to Learning and Teaching:
Academic Honesty Policy http://mq.edu.au/policy/docs/academic_honesty/policy.html
Assessment Policy http://mq.edu.au/policy/docs/assessment/policy_2016.html
Grade Appeal Policy http://mq.edu.au/policy/docs/gradeappeal/policy.html
Complaint Management Procedure for Students and Members of the Public http://www.mq.edu.au/policy/docs/complaint_management/procedure.html
Disruption to Studies Policy (in effect until Dec 4th, 2017): http://www.mq.edu.au/policy/docs/disruption_studies/policy.html
Special Consideration Policy (in effect from Dec 4th, 2017): https://staff.mq.edu.au/work/strategy-planning-and-governance/university-policies-and-procedures/policies/special-consideration
In addition, a number of other policies can be found in the Learning and Teaching Category of Policy Central.
Macquarie University students have a responsibility to be familiar with the Student Code of Conduct: https://students.mq.edu.au/support/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 assessment dates have been modified to allow for early assessment prior to the census date.
The module on System Improvement has been moved to earlier in the schedule.