Bill McLain is an American Society on Quality (www.asq.org) expert on auditing. He is a member of Regulatory Affairs Professional Society (RAPS) and ASQ’s Biomedical Division. McLain has earned the Regulatory Affairs Certification and holds a Bachelor of Science degree in mechanical engineering from Grove City College.
Q: What is the purpose of doing internal audits? Keeping the FDA from knocking on the door? Keeping clients and end users safe? Saving on operational costs? Being competitive?
There are two main reasons for conducting internal audits. A mature organization will conduct audits because it truly believes in the “plan-do-check-act” cycle. Those organizations realize that internal auditing is one of the best tools available to check what has been implemented. These organizations may be further along in their auditing experience to entrust the auditors with auditing for business improvement, efficiency, and overall effectiveness. (more…)