When you think of the output from Manufacturing operations, you quickly identify the Product that you need built. Depending on the type of product being manufactured, however, there may be many more things required by your manufacturing department or contract manufacturer.
In this section, we discuss:
Product – what is the full scope of the product being built, tested, calibrated, packed, and shipped? This is seldom addressed completely in the initial Bill of Materials, but as the product approaches milestones for Regulatory Approval, Process Validation, and First Commercial Shipment, the requirements become apparent and can slow the process if you are not prepared.
Product Packaging and Shipping – the product must get from the manufacturer to your customer, cost effectively and undamaged. How will that happen and what are the considerations? This section will cover the product’s exterior box, interior product support features, over-packaging for individual shipment and palletizing the product for bulk shipment.
Manufacturing Process Documentation – identifying the information to be maintained and designing a system to efficiently and accurately collect and store that information is a significant part of the manufacturing process. Using this information to continuously improve the product and manufacturing is key. This section will cover Serial Number and Lot Number Traceability, Batch Records and Device History Records.