So far you have learned about a WID, now I want to briefly talk about a batch record form and how to fill it out. A batch record form is a form that is used to record the manufacture of a specific product. We enter all relevant information related to the process on the batch record form, then save it as a batch record.

For this next session please follow in the batch record form you downloaded previously called “Assembly of Cheek Cell DNA Extraction Kit - Batch Record Form”

This form is fairly basic and you just fill it out as you are completing the process. Because you have been taught about GDP, you will be responsible for applying GDP principles as listed in the GDP SOP anytime you fill something out. You should recognize this form as it is the same batch record form that you analyzed in the GDP exercise. I am not going to call out everything on this record because it is all very intuitive, however i do want to talk about lot numbers and batch numbers.

Just as identifying everything in the lab is identified and tracked through part numbers, the items produced by STUDENTfacturED are tracked and identified through lot and batch numbers. These numbers are generated as technicians do production work.

Manufacturing records are sorted by lot numbers and batch numbers in the document management system. By using a lot number and/or batch number, a product can be traced through the manufacturing process. Then we can identify all the details about the manufacture of a batch or lot of products. These records are an essential part of internal and external audits. We also use them to resolve customer complaints.

batch - a specific number of products or components (as identified on the work instruction document) that are manufactured together
For Cheek Cell DNA Extraction Kits a batch as listed on the WID is 30 kits

lot - up to 5 batches that are produced at the same time on the same date, by the same technician
Lot numbers consists of the date of manufacture (DDMMMYYYY), the technician’s initials, and the number of lots the technician made that day. Each lot number gives us two pieces of basic information: when the item was made and who made the item. The number is in the following format
DDMMMYYYY-Technicians Initials-Number of lots that a technician made that day.

On January 14, 2017, a technician named Tristan Johnson made a lot of media mixture in the morning, a lot of media plates at noon, and a lot of “Cheek Cell DNA Extraction Kits” in the afternoon.

How would the lots be numbered?

Click to see answer

media mixture lot: 14JAN2017-TJ-01

media plates lot number: 14JAN2017-TJ-02

cheek cell DNA extraction kits lot number: 14JAN2017-TJ-03

Batch numbers are just sequential numbers added to the end of the lot number, starting at 01.

Batch numbers are in the following format:

Lot number-sequential number of batches within that lot.

Continuing the example above, The lot of Cheek Cell DNA extraction kits Tristan Johnson made contained 5 batches (lot number:14JAN2017-TJ-03).

How would the batches be numbered?

Click to see answer

batch 1: 14JAN2017-TJ-03-01

batch 2: 14JAN2017-TJ-03-02

batch 3: 14JAN2017-TJ-03-03

batch 4: 14JAN2017-TJ-03-04

batch 5: 14JAN2017-TJ-03-05

For now the batch record for the product that you are making only allows for one batch at a time to be made. As you gain more experience in STUDENTfacturED you will be able to move on to making up to 5 batches at the same time and will be able to record all 5 batches on the same record.

Learning Objectives:

- 2.3 - Make a product using a WID