QFD-ID: QFD-Forum Ausgabe 23

The purpose of this paper is to describe how QFD can be used in a generic manner to assure that FDA regulatory requirements are considered throughout all relevant product development processes of medical equipment. The primary goal is to incorporate a set of pre-production design controls in order to prevent errors in medical devices which could be attributable to problems of product quality. This should increase the likelihood that the design output, when transferred to production will translate into devices which are appropriate for their intended use. The incorporation of design controls will greatly reduce the risks involved in the use of medical devices and will save lives by identifying in advance significant problems in these devices. Both the FDA and QFD have to meet identical requirements. These requirements are closely tied to customer satisfaction, which is well known as the primary concern of QFD methodology. It is the common goal of QFD and FDA to focus their efforts on improving productivity, product quality, customer satisfaction and company competitiveness through the use of a properly documented design control system. The application of QFD within the guidelines of FDA regulatory requirements for design control will combine customer orientation and regulatory concerns to achieve the common goal of developing safe and innovative medical devices for the medical profession and for the benefit of the patient. This complex process includes the design of the device through the entire development phase and through the subsequent manufacturing planning process of the product. The effective use of design control tools will play a decisive role. This is justified since it has been found that 44 % of the problems which affect the quality and performance of medical devices are caused by errors in the design which did not foresee either potential use-related hazards or the unpredictable effects of unknown interaction between users, devices and use environment.

Eberhard Mayer has a degree in Mechanical Engineering (Dipl. Ing. FH Esslingen Germany) He worked for HP for now more than 30 years and has 15 years experiences in designing medical equipment. His main focus was to hear and understand the voice of customers and translate those into technical solutions. With this engineering background he had the challenge joining HP´s procurement group as Material Engineer responsible for electromechanical components and OEM Assemblies. In this function he was the link between internal R&D groups and outside partners. It was needed to develop a vendor selection process to synchronize external and internal project requirements to take into account the increasing importance of outsourcing. Eberhard Mayer is convinced that a rigorous customer orientation is the key of success. QFD methodology is supporting this. To share "best practice" within HP´s organisation he had the opportunity presenting his idea on HP´s Corporate Procurement Panel (1997). The benefits of QFD along the complete Supply Chain Management Process have reached strategic importance. Gathering experiences by applying QFD, the generic 4 phase approach has been enhanced and enriched fitting better into the environment of Product Generation Process. Since November 2000 Eberhard Mayer is doing his own business (MECS GmbH). The focus is Quality Engineering Consulting, to help firms doing things better by means of QFD applications. Additional Eberhard Mayer is cooperating with a "Newcomer Company" developing Human Interface Technologies for medical applications (Allied Panels Austria). This expresses that teaching theories and applying them to own projects is not conflicting.

Using QFD to support FDA Requirements along the development process of medical equipment.

Abstract

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