LPA Implementation Can Drive Improvement
by Thomas A. Gray Layered process audits (LPAs) have become very popular lately. Their popularity…
Distribution Analysis in Auditing
by Duke Okes Financial auditors often apply Benford’s Law to look for potential signals of…
QbD for Pharmaceuticals: Assessing Quality Through Risk
by Stéphanie Peika (Editor’s note: This is the first half of a two-part article series that…
Auditing Software Development Life Cycles
by John Helgeson Timing is everything. In your personal and business life, it can mean…
How’s Your Objectivity?
by Denise Robitaille Did you get your summer reading done? I certainly did. I’ve been…
Preventive Action Is Not Corrective Action
by Dave Bennett An examination of ISO 9001:2008 clauses 8.5.2 (corrective action) and 8.5.3 (preventive…
Auditing Corrective Action
by Duke Okes Implementation of a quality management system (QMS) provides standardized processes that reduce…
Annual Product Reviews Facilitate Process Auditing
by Stéphanie Peika The U.S. Food and Drug Administration’s (FDA) Good Manufacturing Practices (GMP) regulations…
Improvement, OFIs, and Auditor Independence
by John R. Broomfield An organization’s systems are the responsibility of its top management, so…
Economy Trends, Services, and Quality Auditing
by Bill Combs Recessions such as the United States has been enduring for the past…