If you’ve ever wondered how enterprise resource planning can establish predictable, repeatable, processes and reduce variability in medical device built-up, consider the following case. Before formally rejecting the lot, the lead inspector speaks with the director of quality to get to the bottom of the issue
Over the next few days, the director and the inspector begin their investigation to determine the key issues. They interview employees in production and resources and they look at the incoming inspection records from components delivered by suppliers. Together they compile a list of requirements that will deliver more consistent quality and that will make deliveries much more predictable. In reviewing the list, they considered how much easier it would be to perform these requirements with the control offered by an ERP solution:
1. Ensure all materials needed for an operation are available.
Jobs that stop and start because of shortages in components are one imperative cause of variations. An ERP solution enables users to query the amount of available material so that the in turn can be factored into production planning.
2. Make certain that all process steps are well documented.
Every production job from ERP must give the exact sequence of steps to be followed meant for proven best results. No production worker should need to wonder how two pieces fit together. Some operations, such as plastic extrusion, can yield good results at different pressures by adjusting the temperature and feed rate. Decide how your company will extrude and have need of all operators to use the same method defined in the ERP solution.
3. Reduce the length of paper trails.
Some prefer printed paper records and keep their own file of work instructions – don’t let this happen. To keep things organized, attach the most current work instructions within an ERP system to ensure that only the obligatory steps are on screen and happily visible from the workstation.
4. Verify that only fully qualified personnel are working.
ERP can track the familiarity, training, and certifications of all personnel. By setting experience standards in an ERP solution, you can separate the employees that can log onto a job or operation from those that should not.