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As part of its quality assurance commitment, a global medical device company partnered with UL to develop a comprehensive program with the multiple objectives of reducing "human errors," controlling quality assurance (QA) costs, expanding employee accountability for performance, and assuring compliance with regulatory requirements and corporate standards.
The centerpiece of the initial QA program was a new Operator Certification process to replace the existing costly, cumbersome and unreliable program. The new Operator Certification solution is operated on ComplianceWire®, UL's Part 11-validated technology platform, which enables the efficient management of qualification training, certification exams and status, and real-time credential checks on the shop floor. Documentation of all learning activities includes a three-part assessment of the certification process, audit tracking and ongoing assessments. Management and documentation of operator certification status is enabled through biometrics and an electronic signature that automatically confirms each employee's participation in required learning activities.
The Operator Certification program produced a 10-fold reduction in labor costs, improved employee accountability and efficiency and reduced human errors. Additionally, the company reduced its QA-to-Operator ratio from 1:5 to 1:50 while significantly expanding control over operator performance.
UL and the company are collaborating on an expansion of the Operator Certification Program. The expansion, now in the pilot stage at one of the company's global facilities, will integrate biometrics with the ComplianceWire® platform. The biometric function is designed to prevent uncertified employees from using equipment for which they lack adequate, documented knowledge. Under the pilot program, employees will identify themselves via electronic fingerprint technology before using specified equipment. The identification is automatically connected to the full certification documentation function to confirm employee proficiency or prevent access.
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