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.

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***

https://www.who.int/publications/m/item/laboratory-quality-manual