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7 Strategies for Building a Culture of Quality in Manufacturing - Paul A. Arrendell, Kinetic Concepts, Inc.

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Paul A. Arrendell, a speaker at the marcus evans Medical Device Manufacturing Summit Spring 2014 and the Medical Device R&D Summit Spring 2014, on building a Culture of Quality.
Interview with: Paul A. Arrendell, Vice President, Global Quality, Kinetic Concepts, Inc.

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Transcript of "7 Strategies for Building a Culture of Quality in Manufacturing - Paul A. Arrendell, Kinetic Concepts, Inc."

  1. 1. “The medical device industry is changing quickly as a result of increased competition, globalization, cost constraints, decreased customer spending, demands for efficiency, new and revised international regulations, supply chain complexity, and product and process changes as part of cost control and continuous improvement,” says Paul A. Arrendell, Vice President, Global Quality, Kinetic Concepts, Inc. “In this changing environment, it is incumbent upon companies to enhance current practices that adapt. Knowing the regulations and compliance requirements and following the standard operating procedures is not enough. To succeed, companies must understand and be able to interpret international regulations, implement (a.k.a. validate) processes and technologies, make sound decisions about quality, and drive business benefit. Quality is everyone’s job, from production floor workers to senior executives. Companies must promote a Culture of Quality that permeates the organization,” he advises. A speaker at the marcus evans Medical Device Manufacturing Summit Spring 2014 and the Medical Device R&D Summit Spring 2014, taking place in Las Vegas, Nevada, June 26-27, Arrendell discusses some areas where such a culture may begin, portions of which are from the FDA’s “Understanding Barriers to Medical Device Quality” (October 31, 2011). Design and reliability engineering. Conduct validation with production parts, utilize design-for-reliability and manufacturability, and ensure testing robustness for software. Use tools like Robust Parameter Design (Taguchi Method) to help with developing products and processes that perform as intended for a wide range of user’s conditions throughout the product life cycle. Robust post-production monitoring and feedback. Implement a strong Post Market Surveillance program that incorporates both proactive and reactive methods to understand how products perform on the market. A sophisticated program not only follows a company’s own products, but also reviews competitor products through international adverse event reporting and registries. Supplier management processes. With complex supply chains, knowing what suppliers and critical sub-contractors provide and having insight and approval to process changes are key to product quality and to continued regulatory compliance. Quality metrics and measurement systems. Move beyond compliance measures and drive to continuous improvement. While there are regulatory requirements to track product quality, it is important to include metrics that enable measurable process improvements. Quality organization. Integrate quality throughout the business. Get rid of the “gotcha” mentality; focus on both improvement and compliance. Performance management. Incorporate quality metrics for key roles associated with quality outcomes, like design engineers, as part of yearly objectives and provide incentives around the company’s quality performance. Quality culture. Be on the look-out for other companies’ challenges and learn from their mistakes. Trawl for information where companies have experienced severe quality, regulatory, and compliance issues to make your own improvements. 7 Strategies for Building a Culture of Quality in Manufacturing Paul A. Arrendell, a speaker at the marcus evans Medical Device Manufacturing Summit Spring 2014 and the Medical Device R&D Summit Spring 2014, on building a Culture of Quality. Interview with: Paul A. Arrendell, Vice President, Global Quality, Kinetic Concepts, Inc.
  2. 2. The marcus evans Summits group delivers peer-to-peer information on strategic matters, p r o f e s s i o n a l t r e n d s a n d breakthrough innovations. Please note that the Summit is a closed business event and the number of participants strictly limited. For more information please send an email to info@marcusevanscy.com or visit the event websites below: Medical Device Manufacturing Summit: www.medicalmanufacturingsummit.com Medical Device R&D Summit: www.medicalrdsummit.com Contact Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division Tel: + 357 22 849 313 Email: press@marcusevanscy.com For more information please send an email to info@marcusevanscy.com All rights reserved. The above content may be republished or reproduced. Kindly inform us by sending an email to press@marcusevanscy.com About marcus evans Summits marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, case studies, roundtables and one-on-one business meetings. For more information, please visit: www.marcusevans.com To view the web version of this interview, please click here: www.medical-summits.com/PaulAArrendell

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