North America

West Henrietta’s Quality and Compliance Journey

Left: Members of the Quality Assurance team in West Henrietta
Right: CooperVision West Henrietta, New York facility

CooperVision’s West Henrietta logistics facility began a multi-year path of evaluating and bolstering the site’s quality and compliance processes and performance. Ultimately, their goal was to increase customer satisfaction while holding true to a spirit of continuous improvement.

“West Henrietta had always been a well-run operation, yet we knew that as CooperVision grew, the demands on the facility and our people would only become more significant,” said Michele Bosa, Vice President, Americas Distribution. “Making sure that we had the infrastructure and mindset needed to underpin future success became a priority.”

First, organizational updates were needed. In 2012 and 2013, the Quality Assurance (QA) team started to take shape as an independent group in West Henrietta dedicated to the unique aspects of secondary packaging and distribution.  This group was built with the right people and the right knowledge and skills to carry out the QA mission – including Quality Engineering, document control, and quality systems expertise.

Next, the whole organization focused on strong fundamentals: good standard operating procedures, clear product specifications and inspection requirements, and sound auditing and sampling practices.  These standards were developed in conjunction with the packaging and distribution team as the entire packaging department was re-organized, with multiple pieces of equipment retired and the rest re-located.  Changes were accompanied by a new focus on strong equipment design and robust validation practices.

Quality systems such as management review and internal audits were performed for West Henrietta as an independent site, and practices of Corrective and Preventive Action (CAPA) and supplier management became more rigorous and organized.  As the Global Quality Management System took shape, new practices were adopted and advanced in the areas of change management and risk management.

In 2017 and 2018, major changes occurred as the JDA warehouse management system replaced Red Prairie and the Mercury program commenced.  Throughout these adjustments, the quality system grew and changed with the achievements and challenges of the business.

This past April, the U.S. Food & Drug Administration announced it would conduct a routine audit of the facility. After an intense three-day inspection, with hundreds of documents and records reviewed by an experienced and diligent investigator, the inspection concluded successfully. CooperVision had once again demonstrated its commitment to compliance and continuous improvement.

“This journey has only been possible through the hard work, dedication, and teamwork of the entire West Henrietta team in all areas of the operation.  The changes and improvements over the past seven years have been remarkable and transformative, and yet the drive for improvement in our efficiency, effectiveness, and culture of quality will continue into the future,” noted Michele.


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Lynne Tran
Internal Communications Director
or (925) 460-3643

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