Find The Errors In This Batch RecordBatch record Author: Michael Barazia Purpose:The purpose of this activity is to:
Brief Background Review:Documentation, that is, a system of written records, is essential in all laboratories and production environments. A batch record is a document used in production facilities and not in laboratories. The batch record accompanies a product as it is made. The batch record directs the operators in exactly how to make the product – and the operators must follow the batch record instructions just as it is written. Each time a product is to be made, the operators are issued a fresh copy of the current version of the batch record. The batch record also provides blanks that are filled in as the operator performs each task to document that they have done it. For critical steps, a witness watches the operator and signs off as well. By filling in the blanks properly, the operators demonstrate that they have done each task properly. Auditors are people whose job is to check that proper procedures are being followed and that products are being made as they should be. A major part of the job of an auditor is to review documentation to see that it has been filled out correctly. In this activity, you will review a batch record as if you were an auditor. Observe that when there are mistakes in a batch record, it indicates that the product may not have been made properly. Activities:An example of a batch record for making 6 molar hydrochloric acid is shown. The batch record is first shown as the operator would receive it, that is, with the blanks not filled in. Print out this batch record and look for these features: TITLE or SUBJECT. The title of the batch record is included on each page. ID NUMBER. Each batch record should be also contain a unique identification number. PAGE NUMBER. Each page of the batch record should be numbered. [For example the page number is shown on each page of the “Compounding Instructions: 6 Molar Hydrochloric Acid” in the format of p. 1 of 3 where 3 is the total number of pages in the Batch record.] HAZARD COMMUNICATION. This section warns the operator of any hazards associated with the procedure and any required safety precautions. [There are warnings in the “Compounding Instructions: 6 Molar Hydrochloric Acid” relating to using acids and high temperature water.] PROCEDURE. The core of the batch record details what the operator will do in LABEL INFORMATION. Every company will have specific instructions for labeling manufactured products. These instructions must be followed exactly to avoid any mix-ups. [The “Compounding Instructions: 6 Molar Hydrochloric Acid” batch record includes labeling information.] QA REVIEW. Every completed batch record is reviewed by a QA representative to ensure that it is properly filled out. The same batch record, “Compounding Instructions: 6 Molar Hydrochloric Acid, is also shown that has been filled in by an operator and a witness whose minds apparently were not on their work! The filled in batch record has many errors. Pretend that you are an FDA inspector who is reviewing this batch record. See how many errors you can find. When you are done, check your answers with the answer key. The printable version of this document.
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