-A process is sensitive to some environmental factor. The factor cannot be changed or controlled, but it is critical that the dimensions of the product is as specified - how can the required dimensions be ensured?
Epsilon analyzes measurable process data and product dimension. Thereby a correlation between process parameters and product dimensions can be determined. This one parameter can be used for process control. Any product from a cylce where this parameter is outside specifications will be automaticaly rejected. As a bonus the required inspection level is reduced 75%.
- A newly developed product does not meet the mechanical requirements. Should the problem be solved by altering process, design or material?
Epsilon will design an experiment and a testplan. Then do a measurement analysis and analyze test results form the experiment to make sure any effort in improvements are put in the area most gainfull. Thereby the project has the best probability of the fastest succes
- As a medical device manufacturer or being a subsupplier to one means facing a lot of demands and requirements or being business. Working with GMP equipment and proceses must be qualified and validated to comply with FDA and the customers requirements.
Epsilon can establish the needed documentation for validation. Procedures, protocol, report templates, methods and more. Perform process validation including the documentation using these procedures.
- Skilled personell has set up a process and supplemented with series of tests. The result indicates that further optimization may be possible, but how should the data be analyzed and what is the best way to proceed and make a well documented optimization?
Epsilon gives an introduction to process optimization and DoE. Writes a test plan (or protocol) and analyze the data to make a full report on the results.
- It has been observed that some projects and tasks are delayed. And it is found that it may be caused by communication failure and poor identifcation of roles and responsibilities.
Epsilon will help the department define and draw process diagrams describing the workflow. Thereby wastefull processes can be detected and eliminated and important interfaces between people and departments become clear and communication lines are clear.
-A manufacturing line produces many defects. Concerns about the measuring methods reliability are raised.
Epsilon performs a measurement system analysis of incomming goods inspection, QC inspection and critical to customer functionality. Determines the correlation between measurement methods and define measurement uncertainties to implement a new measuring system and quality data management. Rejection rate is reduce by 50% and product quality has a Cpk of more than 2.