Greenberg, Harold P. (1990, ASQC) Wakefield, MA
This paper will discuss the steps necessary to assure that a project is reliable. We begin with the definition of reliability and review the sequence of events that leads to a successful conclusion.
The FDA recommended Guideline for Medical Device Preproduction Quality Assurance Planning is used as a baseline for establishing a Credible reliability program. The significant points of such a program as described in the Guideline, e.g., organization, specifications, design review, reliability assessment, parts and materials, quality assurance, software quality assurance, labeling, and release to production will be discussed in some detail and recommendations offered. While written for the medical device community, the Guideline recommendations are equally applicable to other types of products. Sound application of Quality Assurance principles results in a thoroughly evaluated design and a manufacturing operation capable of producing product that complies in every respect with design requirements.
This paper should provide the reader with a clear understanding of what constitutes an effective reliability program and what the FDA expects for medical devices.