SELF AUDIT PROCEDURES FOR REGULATORY COMPLIANCE ISSUES

Abstract

In the past decade we have seen phenomenal improvements in the New Product and Service Introduction processes (NPSI). Applications of tools and methods, and use of process and quality management approaches have enabled companies to reduce continuously their cycle time, introduce products faster, cheaper, with higher quality, and better satisfy market needs. Among the enabling technologies, audits and assessments have played a critical role in driving these improvements. In major companies, these have become a permanent fixture of the NPSI processes. This paper discusses evolution of audits and assessments, and application of these tools from products to processes. The author presents recent developments in process audits for software and hardware development, some results achieved, and future trends.