This diagram comes from the STUDENTfacturED quality manual. It shows the different types of documents that make up the quality management system. This is called a documentation structure

Diagram of the STUDENTfacturED Documentation Structure

## Level 1

This level includes only a single item: the quality manual. The quality manual provides the details of the quality management system by defining policies related to the quality management system. These policies are created by management and are derived from regulatory standards.

## Level 2

This level includes documents that cover procedures and process maps. Procedures and process maps describes WHAT and WHY a procedure or process is performed. The documents in this category you’ll use most are standard operating procedures (SOP). An SOP describes what a company does to meet a particular policy defined in the quality manual. An example of an SOP in STUDENTfacturED is a document called “Good Documentation Practices for Handwritten Forms - Standard Operating Procedure.” This is a document that describes rules that an employee follows when filling in handwritten forms.

## Level 3

This level includes documents such as work instructions, job aids, and protocols. These documents provide details on HOW to carry out a process, often containing step-by-step instructions for completing specific tasks. The two documents in this category you’ll be using most are work instruction documents (WID) and standard work documents (SWD).

A WID describe HOW to actually carry out a process or procedure. WIDs are detailed enough to explain how to carry out the procedure, yet not overly detailed as to make the process inefficient and cumbersome. WIDs will be one of the most important documents that a technician will be using in the lab, so we will go over the sections of a WID in much more detail in a future lesson.

A standard work document or SWD, is a document that describes a standard way of completing the process listed in a WID. A WID is detailed but not overly detailed; in contrast, a SWD is very detailed and list out how exactly how to carry out a process. These documents are often much more detailed than WIDs on the specifics of how to complete a particular task. We will learn more about these documents in a later module.

## Level 4

This level includes documents such as forms and record. These are the base of the pyramid because the whole system rests on the records that demonstrate compliance to quality system regulations. In STUDENTfacturED a technician will encounter two types of documents at this level: Forms and records.

Forms are documents that are filled out by personnel in the STUDENTfacturED lab. There are many forms that you will fill out as you complete processes and tasks in the lab. Forms are one of the types of documents that a technician in STUDENTfacturED will be interacting with the most.

Records come into existence once a technician fills out a form and signs it. Once the form is complete, the form becomes a record. Another way to say it is a record is a completed form. There are many types of records. They are essential for making improvements to our process, as well as demonstrating compliance.

If we made a batch of Cheek Cell DNA Extraction Kits, we would fill out a form called “Assembly of Cheek Cell DNA Extraction Kit - Batch Record Form”. Once we complete the form and sign it, it becomes a record that records the process of making those kits

Learning Objectives:

- 1.2 - Identify different types of documents used in the manufacturing process