quality management

The constant need to deliver a near zero-defect production for every single lot produced is a challenge and requires the most modern tools possible to make quality management both precise and cost-effective.

In a digitized CAPA management system, actions and alarms are triggered automatically, and containment action may begin almost immediately once an event is detected.

Let’s examine a use case of MES implementation where there is a high level of vertical integration, multiple product variants, and production lines executing a mix of process and discrete manufacturing modes. There are also strict compliance requirements with paper-based capture of process data. Essentially, the MES is crucial to the manufacturing process and the value chain.

The challenge with a QMS is that it is often a standalone system with a reactive approach to quality issues, whereas the manufacturing process requires a proactive approach to quality. Our argument is that a Manufacturing Execution System MES or MOM solution is a necessity for your holistic approach to quality, and we offer you ten reasons why MES should be the backbone of your quality operations.

To bake a good cake, you must get the processes right. These include mixing to the right consistency and baking at the correct temperature for the appropriate length of time – but fundamental to your success is the recipe. To create your masterpiece, you must add the right ingredients in the proper quantities. The same is true for the MedTech manufacturers producing combination medical devices.