Title: Manufacturing Following a WID
Course: BTEC-1300-301-302-303-F21 > Section: DNA Extraction Kits

Now that you know how to read a WID and fill out a batch record you will now be manufacturing a batch of Cheek Cell DNA Extraction Kits. Before you start as we discussed before read the WID thoroughly. Keep in mind a couple of things:

1. Determine where you will be manufacturing and set up your space accordingly
2. What materials are needed for this process
  1. Make sure you have enough of each item before you begin
3. What, if any, equipment is needed for this process
4. What components are needed for this process
5. Do you need to manufacture the components?
  1. What WIDS/batch records are needed to make these components?
  2. Locate these WIDs/Batch records in the document management system and follow them in order to make the components
6. Use GDP when filling out forms
7. Components have their own separate batch numbers and lot numbers so each thing that you make will have lot and batch numbers
8. Follow instructions as written
9. If there is something that is not detailed out specifically use your best judgement, and make sure to document it on the forms.

When you are done you should have the following:

1. 30 assembled Cheek Cell DNA Extraction Kits
2. Batch Records for the following
  1. Cheek Cell DNA Extraction Kits
    1. With associated pictures
  2. 50 mL Conical Tube with Salt
    1. With associated pictures
  3. Microfuge tube with soap
    1. With associated pictures

In order to make it into our Document management system, we need to file our records. Because the written copy is a source document, and anything else is a copy we need to keep the source document. We also want an electronic version for the document management. Quality system regulations require adequate backups, so we are going to scan our original and then upload a copy to the document management system for backup.

1. Scan and save your completed batch records and as PDF files
  1. Include the pictures you took at the end of each scanned record
  2. The lab computer has a scanner if you need one
  3. See instructor if you need help scanning and saving documents
2. Name the record in the following format then submit it to canvas
  1. Name of Form - Batch Record - Lot number of item created
  2. Example: Assembly of Cheek Cell DNA Extraction Kit - Batch Record-20JUN2018-TJ-03
  3. This ensures that we can find it later easily in the Document management system.
3. Email a copy to the document manager for storage in the Document management system. (in the future you will be responsible for uploading records as needed).
4. File the source in the filing cabinet located in STUDENTfacturED
  1. The cabinet has folders based on the item created.  And they are filed in reverse chronological order (meaning the newest documents are filed with the newest thing in the front)

Learning Objectives:

- 2.3 - Make a product using a WID

Whew! You made it! Now that you have made a batch of products, we can begin talking about improvement in the manufacturing environment, which is the subject of our next module.  The main take away from this module is following instructions. Sometimes it seems arbitrary, but they really matter. Every item in the QMS is there for a reason. The work instructions are derived from very real regulations that have real impacts of the safety and health of consumers. Once again compliance starts with you.