Applied Sciences Homework

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.

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***