Auditing a Subsystem: Auditing Performance Feedback
by Russell T. Westcott Performance feedback includes: Communicating expectations and requirements to workers Correcting improper…
The Myth of the Clean Audit
by Denise Robitaille We’ve all heard the expression from managers and supervisors about their desire…
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…