BERKSHIRE ENSURES delivery of consistent, high-quality products through constant focus and improvement in process control.
Corrective & Preventive Action (CAPA) System
Berkshire is committed to the constant adherence to and improvement of the following methods and principles of process control:
- Vertical Integration of the Raw Material Supply with Berkshire Processes
- Dedicated Processing Equipment
- Process Management Plans
- Raw Material Specifications
- Supplier Testing Coupled with Incoming Inspection
- Change Control Management
- Change Validation
- Closed-Loop Corrective Action in Excursion Management
Process capability refers to the repeatability and consistency of a manufacturing process relative to the customer requirements, especially in terms of specification limits of a product parameter. This measure is used to objectively quantify the degree to which a process is or is not meeting its requirements.
Berkshire ensures delivery of the highest quality and most consistent products through constant focus and improvement in the following method and principle of process control:
Process capability measurements and analysis with goals of Cpk>1.33 for all critical parameters
Statistical Process Control (SPC)
To determine whether a process is operating within appropriate limits, Berkshire International employs Statistical Process Control (SPC). Using statistical techniques, we monitor the quality of our processes and products to ensure the delivery of the highest-quality and most consistent products possible.
Our statistically developed control limits provide critical parameters for real-time analysis, monitoring, and alarm with regard to critical process inputs. An in-house metrology enables the measurement and testing of our critical process parameters and product characteristics. Statistical analysis then enables trend review and continuous improvement validation.