Software monitors regulated manufacturing processes.
Share:
Press Release Summary:
SMART System Measurement Analysis Response Tool provides electronic Device History Record (eDHR). It verifies that training documentation is current, tools and equipment are in calibration, and that manufacturing materials are within expiration date parameters. It also makes sure ESD protection is verified, Appropriate Nonconformance Reports are generated and closed, and all manufacturing documentation is complete before releasing product.
Original Press Release:
eDHR - The Right Way
Manufacturing looks for ways to prevent mistakes!
A major medical device manufacturer recently embarked on a project to Poke Yoke or mistake proof their manufacturing process. Through a software application developed by Process Integrity called SMART (System Measurement Analysis Response Tool) they accomplished their goal. The final output of the software provides an electronic Device History Record (eDHR).
The client states, "As a regulated manufacturing facility, multiple requirements and detailed documentation are a part of our daily work lives. Many of these requirements rely on humans to perform all steps at or near perfection every day. In order to achieve expectations, our employees needed a tool to simplify many of their daily activities, specifically checking that
o Training documentation is current
o Tools and equipment are in current calibration
o Manufacturing materials are within expiration date parameters
o Electrostatic Discharge (ESD) protection is verified
o Appropriate Nonconformance Reports are generated and closed
o All manufacturing documentation is complete before releasing the product"
eDHR provides this tool by automatically verifying that these and other requirements have been met throughout the entire manufacturing process, thereby preventing mistakes and nonconformance from occurring.
A six-month effectiveness evaluation demonstrated that the system provided excellent operational control, improved the accuracy and quality of data, provided an electronic DHR, and was well accepted by users. Additional benefits were also revealed. Examples of these benefits included:
o Increased compliance to manufacturing instructions
o Ability to quickly sort through documentation to facilitate investigations and problem solving
o Creation of a single document that summarizes the manufacturing requirements and the steps to produce a complete product.
Based on the positive findings demonstrated during the pilot, agreement was reached to continue implementation of eDHR throughout all manufacturing operations. Additional functionality is being deployed, including verification of maintenance activities, e-mail notifications, control of reconfiguration processes, and additional integration with other systems. eDHR provides the foundation for application integration making the possibilities for Poke Yoking limitless."
About Process Integrity
Process Integrity is headquartered in Arlington, TX. Process Integrity has been improving businesses for two decades by centering our focus on monitoring processes throughout the enterprise. We save our clients money by forcing compliance in operations. It always costs less to do things right the first time. Intellisure, our business compliance engine prevents omissions and mistakes in processes. That can amount to 20 to 40% of COGS.
Our software products unique approach allows companies to force conformance to product requirements, business rules, best practices, regulatory requirements, work instructions, employee experience, and so forth. Then automatically monitor and preemptively adjust the work process to maintain compliance.
