Quality Control and Production: Teamwork Gets the Job Done

There are many steps to producing a product and the Quality Control department is there every step of the way to team up with the production personnel to ensure that the product is made correctly.

Raw Materials

The production departments start with raw materials that have been tested and released for use by QC. There is a master "recipe" for each product. This is called the Master Formula. The Master Formula lists all the ingredients and their amounts. It also lists the steps in making the product.

When a batch is needed a production ticket is issued which is just a duplicate of the Master Formula. This batch ticket is unique for a specific batch. The first step in making products is weighing the materials. The materials are weighed by a trained production operator. This weight is checked by a second production operator. All of the weights are documented and both production personnel sign the ticket. After the materials are weighed they are placed into the mixing vessel in the order specified on the ticket. The instructions also specify how long the batch is to be mixed. This process would be the same regardless of whether the mix is a liquid or powder mix.

Testing Each Batch

Once the mix is done, a sample is brought to the laboratory for testing. QC will conduct various tests depending on the product. These tests include physical testing such as density and moisture, and/or chemical testing such as assay or tests for rancidity. Once the testing is done, the QC inspector will review the results and the production ticket to make sure all the results are acceptable and the documentation is complete. QC will then release the mix for the next step in the process. The next step could be to bottle the mix as is or make it into a capsule or tablet.

Testing the Finished Product

If it is made into a capsule or tablet, the process starts over. A production ticket is issued for a specific batch. This time the ticket specifies what kind of machine to run the product on. It also gives some setup parameters for the machine operator. The production operator does routine checks throughout the run to make sure the product is being made uniformly. For instance, the weights will be checked and recorded throughout the run. The QC inspectors move from work station to work station checking to see if the routine checks are being done and recorded properly. The inspector will also do his or her own testing to verify the operator's results. Once the batch is done, a sample is brought to the lab for further testing. The testing may include weights, disintegration, assay/ID, tablet hardness, etc. The QC inspector reviews the test results and the documentation for acceptability and completeness. Assuming everything is acceptable according to specifications, the product is released by QC for the next step in the process.

Testing the Packaged Product

Eventually, most products are packaged into a bag or bottle. Once again, a production ticket is issued for a batch to be made. This ticket will specify what container, lid, label, type of insert, etc are needed. QC inspects the product during the run to verify everything is correct. The lab tests the product according to the specifications. Once the product is verified and the documentation is complete, the product is released to be placed into inventory making it available for customer orders.