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Quality Processes

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

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

Process FMEA

Failure Mode Effect Analysis (FMEA) provides a structured approach to the analysis of root causation in failure as well as the estimation of severity or impact or the effectiveness of strategies for prevention. The ultimate result of the process is the generation of action plans to prevent, detect, or reduce the impact of potential modes of failure.

Berkshire ensures delivery of the highest-quality and most consistent products through constant focus on and improvement of Process FMEA in design and manufacturing.

Statistical Process Control (SPC)

To determine whether a process is operating within appropriate limits, Berkshire Corporation 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.