Examples of Process Change are as follows:
1.) Raw Material Supplier or Process used to make the raw material.
2.) Location of manufacturing equipment even if being moved within the facility.
3.) Type of machine, tool or process used to manufacture, assemble or package the product.
4.) Change of Supplier or change in the process at your Supplier impacting HYG product.
5.) Any changes, additions or rotations involving more than 20% of the current production staff working on HYG product.
6.) Additional tooling, complete replacement or complete / major refurbishment of existing tooling.
7.) Product packaging changes.
8.) Serial # / Bar code format changes.