Because you are going to be following these documents a lot, you need to understand how to read them. Just keep in mind at this point we have stepped away from the regulations and into the world of a company's Quality management system. (Which is informed by the regulations). As was discussed previously the regulations are purposely open, leaving companies free to create a unique approach to the quality system regulations that works for them.

Everything from here on out is STUDENTfacturED’s approach to those regulations. The goal moving forwards is not to drill you on regulations but teach you how to work in a similar regulated environment. With that said let's discuss following a WID.

Follow along in the WID you downloaded before “Assembly of Cheek Cell DNA Extraction Kit - Work Instruction Document” and we will discuss each section.

The first section is the document history here we show what date this document was effective, what revision the document is. You can use this section to make sure you are using the current version.

PURPOSE

This section describes the purpose of the document. This puts clear boundaries on what this WID covers and what it does not, and it further informs how the rest of the document is created.

REFERENCE DOCUMENTS

This section is a list of documents that were consulted in the creation of this WID. Usually these are documents are things like a material safety data sheets, instructions for use, or an equipment manual. These documents are there to provide a resource for further information if needed. All reference documents will be available in the Document Management System.

CORRESPONDING DOCUMENTS

These are documents that are used as part of the process you are working on. The kind of documents in this list generally fall into the three categories.

1. Related WID’s such as WIDs for component that are needed to make this product, or WIDS that lead to or from the current WID
2. Documents used at the at the same time as you are following this WID such as a batch record form.
3. Documents that detail standardized instructions such as a standard work instruction document (more on these in a future module)

MATERIALS

Materials are items that do not require any alteration or preparation prior to being incorporated into a product. Materials are things like conical tubes, petri dishes, or agar powder. This section lists all required materials by name, part number, and storage location. The technician just needs to collect them.

COMPONENTS.

Components are items that need alteration or preparation prior to being incorporated into a product. Components are thing like, a 50 ml conical tube with salt or a molten media mixture. This section lists all of the components needed by name and part number. Components will have a have a location listed if relevant (some components can be made in batches and stored and some need to be made at the time of manufacture.) The WID’s required to manufacture each component will be listed here. Components have their own WIDS, and forms, etc.

NOTE: For this exercise you will be making all of these components yourself, not pulling them from stock!

EQUIPMENT

This section lists all equipment needed by name and part number. The Personal Protective Equipment is listed in this section as well.

DEFINITIONS

This section is a reference section. It contains useful definitions and acronyms that are used in this WID. It will also detail how many products are in a batch.

SAFETY

This section lists important safety information that is has been collected from the reference documents.

PROCESS

This section is the heart of the document it lists the steps needed to complete the process. This is the section that you will be the most involved with

FLOWCHART

This section shows the flow chart. The flowchart is a type of diagram that represents a process. It shows the steps as boxes of various kinds, and their order by connecting them with arrows. This diagrammatic representation illustrates how a process should occur.

See the link for more information on flowcharts

http://asq.org/learn-about-quality/process-analysis-tools/overview/flowchart.html

The final section is the revision history. Here we detail the history of what revisions have occurred, when they were approved and who has approved them.

Learning Objectives:

- 2.3 - Make a product using a WID