QSR’s 820.20 — Management Responsibility
When Was the Last Time You Seriously Reviewed Your Quality System?
Under 21 CFR Part 820.20, device manufacturers must establish management controls, including active participation from executive management, to ensure that an effective quality system has been established and maintained. Sounds simple, right?
Unfortunately, device firms have been running afoul of 820.20. Here’s what the FDA has found in recent warning letters:
- “The last management review was conducted on Aug. 6, 2007. The meeting agenda for the Aug. 6, 2007, meeting has the next meeting scheduled for Feb. 25, 2008. There is no evidence that this Feb. meeting occurred or that any subsequent meeting occurred. According to the Chief Executive Officer, there is currently no schedule for management reviews.”
- “Complaint data and service-related issues are not trended and, in many cases, complaints and service issues related to devices under warranty are not reported to management by the complaint handling unit. No record of management review attendees is available to show that required personnel participated in management reviews.”
- “… requires management reviews be held at least twice a year, but no management reviews have been performed since June 16, 2010. In addition … requires management reviews include 13 specified topics, but the meeting held on June 16, 2010, only addressed quality audits.”
- “According to your firm’s … section 6.2 states that the management review process was to occur quarterly and be attended by the general manager. However, quarterly management review documentation did not confirm that the general manager, who is the firm’s top management official, was in attendance.”
This CD/Transcript of our Jan. 29, 2013 webinar will help you establish a quality policy and objectives. In addition, it will explain what data sets the FDA expects to support the quality objectives and demonstrate quality management system (QMS) effectiveness.
Noted QSR expert Dan O’Leary shares with you his proactive, proven plan for QSR 820.20 compliance. You will successfully understand:
- The best elements of a good quality policy — sure you have a policy, but is it a well written policy?
- How to correctly document quality objectives that explain to the FDA and your employees that you’re serious about quality
- How to develop the metrics to support a quality objective; some data sets are better than others
- Lessons from 20 years of experience; structuring management review agendas that really work
The FDA’s focus on management — and their commitment to quality — is increasing every month. Act now.
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.
This CD/Transcript of the QSR’s 820.20 — Management Responsibility webinar is a must for professionals in device and diagnostics companies, including:
- Compliance Officers
- Quality Assurance Managers
- Regulatory Affairs Managers
- Production Managers
- Design and Development Managers
- Process Owners
- Risk Management Specialists
- Executive Management
- General/Corporate Counsel
- Training Personnel
- Outside Attorneys
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600