Applied Sciences Homework
hala alqasab
2 years ago
15
files (3)QUAL54219-SimulationAssignmentRubric.pdf
stimulationassignment2.pdf
- stimulationassignmentQuality.pdf
QUAL54219-SimulationAssignmentRubric.pdf
QUAL54219 Simulation Assignment Grading Rubric
Criteria Mastery: Level 4 (A+) Developing: Level 3 (B) Emerging: Level 2 (C) Beginning: Level 1 (D)
Overall Organization
Document is well organized and presented in a manner that
allows the reader to envision the major transitions in the
writing.
5 marks
Document is somewhat organized however 1 instance exists where the reader cannot envision the major transitions in the writing.
4 marks
Document is not very organized and 2 or more instances where
reader cannot see the major transitions in the writing (disconnected portions).
3 marks
Document is not organized at all and several portions are
disconnected from the rest of the assignment.
2 marks
Factual Information
Document is based on appropriate technical facts as
per the requirements in a quality manual to describe QMS
and the procedures are explained properly and
applicably.
8 marks
Technical facts for the quality manual are provided in the assignment with a simple
explanation on their applicability to the company’s QMS.
6 marks
Technical facts are provided in the assignment with minimal
explanation to the applicability of these facts to quality manual.
5 marks
Technical facts provided with no explanation to
their applicability to the quality manual.
3 mark
Guidance Documents
All relevant documents have been used to create the quality
manual. Links are shown between the quality manual
and QMS requirements.
4 marks
Relevant documents have been cited however the quality manual
is not complete. Links to the assignment are not very clear.
3 marks
Selected documents not all applicable to the assignment and no linkages are provided to the
submitted work.
2 marks
No documents are provided and/or selected
documents not applicable.
0 marks
Referencing
Proper APA or MLA style utilized both in-text and on reference page. No errors. 3 marks
Proper APA or MLA style utilized both in-text and on reference page. Some errors in text. 2 marks
Incorrect use of APA or MLA style and missing either the in-text citations or reference page 1 marks
Major issues with referencing 0 mark
Final Total (out of 20):
Total Marks out of 20 for the Quality Manual part of the simulation assignment.
stimulationassignment2.pdf
QUAL54219 Simulation Assignment: Quality Manual and Quality Assurance Report Form
The quality manual is an important document that provides a general description of an organization's
Quality Management System (QMS). It enables personnel to understand their roles within the
organization to ensure that procedures, forms, reports, process and activities are followed to meet the
requirements for regulated industry standards. For this assignment, you will have the opportunity to
select an industry that you are interested in and write a quality manual for a company you have recently
joined (20 % of final mark). You will then complete a Quality Assurance Report Form to attest that your
organization complies with GMP requirements (15% of final mark).
Due Friday February 25, 2024 before 11:59PM
Select an industry that you are interested within the life sciences sector and consider the following
scenario. You have been recently hired by a new company to help them develop their QMS. The first
task is to help them develop a quality manual. Read the document “Writing the Quality Manual” and
follow the steps to draft the quality manual document for your organization. Then, review the Quality
Assurance Form to observe the type of items Health Canada evaluates to provide site licenses and
ensure that you have thought about all aspects of GMP to ensure your quality manual provides the
necessary information to help you company drive processes within compliance. As mentioned in the
“Writing the Quality Manual” guidance document, the quality manual can be anywhere between 5
pages to 30 pages. What is important is that you provide a good strategy to meet all the QMS
requirements for your organization whether you are manufacturing biologics, cosmetic products, food
products, pharmaceuticals, medical devices, natural health products or veterinary products. In your
document, please include the following:
1) Title page and table of contents
2) A brief description of the company and the type of products that are manufactured at this
company
3) The quality manual for your company which you will create using the provided document. You
may also refer to WHO’s guidance on this subject:
https://www.who.int/publications/m/item/laboratory-quality-manual
4) In the appendix section, include any forms you may have created for your company
5) For this simulation, fill out the Quality Assurance Report Form (QAR) on behalf of you company
in preparation for submission to Health Canada to obtain site licenses to manufacture your
product. Although this QAR for is for natural health products, you can use this form for your
company’s products unless your selected industry has a specific form. This form is worth 15% of
your mark and it will be marked based on completeness. Please make sure that you provide
titles for potential SOPs and a numbering system for the SOPs in your QAR form. You are not
required to include drafts of SOPs for this simulation. Please attach the signed completed QAR
form at the end of you document.
***Please refer to the rubric which will be used to evaluate the quality manual submissions***
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