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Continuous improvement is a way of life at Oliver-Tolas Healthcare Packaging. By continuously improving our processes and products, we enable our customers to reduce costs while maintaining superior product quality.
Oliver-Tolas facility in Hamilton, OH ISO 9001:2008 certified
As part of our commitment to continuous improvement, Oliver-Tolas' facility in Hamilton, Ohio USA is now ISO 9001:2008 registered.
ISO 9001:2008 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
Oliver-Tolas strengthens its Feasterville facility Quality team
Oliver-Tolas Healthcare Packaging has reinforced its commitment to its quality policy, "Our highest priority is to exceed customer expectations through exemplary service and the supply of safe and effective products", with the addition of Steve DeSmedt as Quality Manager, Feasterville, Pa facility.
Steve brings to Oliver-Tolas over 23 years of Quality Assurance experience 10 of which were in medical device and regulated industries. Steve has led the efforts of previous employers to obtain ISO-9002, ISO-9001, ISO-17025 certifications, and FDA registrations. He has also hosted several successful FDA inspections as well as A2LA audits.
Oliver-Tolas facilities in Grand Rapids and Venray are ISO 13485:2003 certified
As part of our commitment to meeting the same stringent quality standards as those practiced by medical device and pharmaceutical manufacturers, Oliver-Tolas facilities in Grand Rapids, Michigan, USA and Venray, the Netherlands are now ISO 13485:2003 registered.
ISO 13485:2003 outlines a quality management system specifically designed for organizations that provide medical devices and related services that consistently meet applicable customer requirements. The standard also emphasizes risk management and effective processes.
Andy Post promoted to Quality Engineer Apprentice
Andy Post has been promoted to Quality Engineer Apprentice. Post joined Oliver-Tolas in January 2007 as Quality Technician III and has since passed the Certified Quality Technician (CQT) exam. As Quality Engineer Apprentice, Post has assumed responsibility for Oliver-Tolas' inspection program (including designing inspection plans and assisting with statistical sampling and release criteria); process charting; and cleanroom controls. In his new role, Post will continue to support the company's Six Sigma efforts.
Six Sigma certification coming mid-2009
Steve Morgan, QA team leader, Sr. CQE, CQA, CQT, has completed Six Sigma Green Belt Training. He is currently working toward formal certification for his project which examines opportunities for increased efficiency of internal processes. Morgan has received training on the Six Sigma Roadmap and essential elements of the statistical methodologies supporting Six Sigma projects. Morgan's certification is expected June 2009.
Medtronic approves Dock-to-Stock
Oliver-Tolas has increased the scope of products approved for the Dock-to-Stock program at Medtronic's Juncos, Puerto Rico facility. Five new parts have been approved for the program.
To qualify for the Medtronic program, Oliver-Tolas' quality team prepared a detailed FMEA, Process Flow Charts, and Inspection Plans, and passed a comprehensive process audit by Medtronic's Supplier Quality team. Qualification for Medtronic's dock-to-stock program requires successful completion of a rigorous approval process and attests to Oliver-Tolas' track record and commitment to meeting the stringent quality standards of medical device manufacturers (MDMs) worldwide.
Kelly Kane obtains ASQ certification
Kelly Kane has been named an American Society for Quality Certified Quality Auditor (ASQ CQA). Kane, who is a quality specialist, CQA, at Oliver-Tolas, has reached a significant level of professional recognition, indicating a proficiency in and a comprehension of quality auditing tools and techniques, according to the ASQ. Successful ASQ CQA candidates must possess eight years of related on-the-job experience, and be able to apply a variety of auditing techniques in examining, comparing, and evaluating products, processes and quality systems to specific standards. A Certified Quality Auditor can plan, develop, communicate, and execute an audit within a defined scope.
Having ASQ-certified auditors is part of Oliver-Tolas' ongoing commitment to providing the highest level of quality assurance for its customers.
Before joining Oliver-Tolas in early 2007, Kane worked as Quality Assurance Specialist for the American Red Cross/Great Lakes Region.
CATSWEB
Oliver-Tolas employs CATSWeb OnDemand for its global quality and compliance management system. The leading-edge software, designed specifically for the medical device and pharmaceutical industries, allows Oliver-Tolas to better document change control, complaint handling, audits, and order entry.
CATSWEB helps Oliver-Tolas' quality team collect, organize, analyze, and share information to better manage and improve quality and compliance performance. The all-in-one solution automates quality & regulatory compliance-related processes so issues—from detection to corrective action to trend analysis—can be globally managed.
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