Why are Deviations Important for Nye?
In today’s world, variables are all around us. Even the most robust of processes need to be flexible enough to handle environmental variables, raw material variables, and variations in equipment performance. As part of our process, Nye incorporates the flexibility of documenting subtle process changes when external variables that are beyond our control come into play. We create and record the changes we make to any process to ensure all organizational and stringent ISO standards are met. These changes are called deviations and can include everything from change in material color, hardware or software changes, methods of manufacturing (i.e. the number of passes through equipment) and testing parameters. The possibilities are endless.
It is important that approval and management of the deviation must always be well documented. This documentation is fully traceable and auditable. After the creation of a deviation, Operations, Quality, and R&D sign offs are required before being approved for use. In some cases, manufacturing or packaging drawings, quality clauses and specifications must be approved by the customer. Though rare, requested deviations that are customer driven must be reviewed before the official deviation can be implemented.
Recently, Nye received a customer concern regarding air bubbles in a cartridge. Quality and Process Engineering added a versation step to deaerate the grease before packaging into the cartridges. The procedure and outcome of the versation step were captured in the deviation. The addition of the versation step before packaging helped to improve the dearation of the grease. The customer was made aware of the improvement and our packaging procedure was updated to include the new versation step. Capturing the details of the deviation now offers traceability and allows Nye a better understanding of our procedures.
Deviations are an important part of Nye to maintain conformity within our organization. As we continue to grow our business, the amount of deviations will increase. We hope to get better at streamlining our deviation process and ensure our customers continue to get the best quality and service Nye has to offer. In an imperfect world, deviations allow us to keep our products perfect for our customer’s applications.
