Conducting and Enforcing Internal Quality Audits for Devicemakers

Conducting and Enforcing Internal Quality Audits for Devicemakers - Webinar CD/Transcript

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Internal quality audits. Section 820.22. You’re supposed to have a process – and be using it.

But the FDA is citing 820.22 violations frequently in Form 483s and warning letters.

The problems tend to break down this way:

  • Companies have no process and have never conducted an internal audit.
  • Or a company has a process, but doesn’t audit to the regulations. Companies regularly allow staff to audit their own work, don’t re-audit deficiencies they find or fail to create a written report and submit it to management.

If you need an 820.22 game plan or just to tweak what you have, read on…

What would happen if an FDA inspector showed up at your company tomorrow?  Think your audit program is ready for prime time? Maybe, or maybe not.

Here are just a few of the comments found in recent warning letters detailing internal quality auditing failures:

  • “Your Internal Quality System Audit procedures … require audits of your quality system to be conducted at least annually. You did not conduct an audit of your quality system in 2011 or 2012.”
  • “… when your firm’s President was asked if it has conducted quality audits, he stated that he conducts quality assessments. Your firm’s President did not provide documentation of completed quality assessments to confirm that they had taken place and he said that there was no documentation of these assessments.”
  • “For example, the 2010 audit plan was not performed for nine of [redacted] departments to be audited and the plan does not include auditing all areas of the quality system. Complaint handling is not covered by any of the defined areas.”
  • “For example: [redacted] requires ‘each activity is audited at least once a year,’ but your firm did not perform any quality audits between 2010 and 2012.”
  • “… the Chief Executive Officer has the responsibility of conducting quality audits. The Chief Executive Officer also has direct responsibility over the matters being audited such as design and development, control of non-conforming product, corrective and preventive action, infrastructure management, and work environment control.”
  • “You do not have procedures addressing quality audits, nor do you have records documenting quality audits of your facility and suppliers.”

FDAnews, in conjunction with medical device expert Dan OLeary, brings you a quality audit compliance plan to improve systems like yours. Mr. O'Leary's proven blueprint draws from the regulation, the preamble, and recent warning letters to provide a total compliance program

In 90 minutes, you’ll discover how to set up systems and procedures for conducting quality audits that pass FDA muster — plus tips and strategies to assure that audit plans get good, and stay good.

Companies with a quality audit in place will discover secrets of improving their plan and learn what the FDA is focusing on now.

Mr. O'Leary is no 20,000 ft. theorist. He gets into the nitty gritty:

  • Purpose of internal quality audits: What the FDA expects from you
  • Developing quality audit procedures that pass FDA inspection
  • Why it’s better to audit processes and procedures, not FDA QSR or ISO 13485
  • Understanding auditor competency: Tips for identifying the right staffer to perform internal audits
  • The “fox/henhouse dilemma:” Making sure you meet the no-direct-responsibility requirement for matters under audit
  • How to develop an audit schedule — and stick to it
  • Understanding elements of a well-written audit nonconformity report
  • The role of corrective action in an effective audit program
  • Management responsibility for matters being audited
  • How to report internal audits at management review
  • Scoring audits using the GHTF model
  • And much more

Instructor Mr. O’Leary has more than 30 years of experience in quality, operations and program management in regulated industries, including medical devices and clinical labs. A frequent presenter at FDAnews seminars and conferences, Mr. O’Leary consistently gains high marks from attendees.

An effective audit program is your best defense against Form 483s and warning letters because it will help you uncover and fix problems before FDA investigators spot them. Discover audit strategies that consistently pass FDA scrutiny.

  • Medical device manufacturing and executives
  • QA/QC managers and directors
  • Internal quality auditors
  • Production managers and supervisors
  • Training managers
  • Regulatory affairs and compliance professionals
  • Corporate counsel

Dan O’Leary has more than 30 years of experience in quality, operations and program management in regulated industries, including aviation, defense, medical devices and clinical labs. Mr. O’Leary is now president of Ombu Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a master’s degree in mathematics, is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt and is certified by APICS in resource management.