Quality audits are an important element in implementing and maintaining an effective Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS.
In this workshop, participants examine the various types of audits to understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2nd party) play a role in an effective supplier management program; your company could be the subject of the audit. Independent audits (3rd party) can help provide assurance about the health of a QMS.
This workshop provides the tools to establish and maintain an effective quality audit program for medical device manufacturing. The program includes the two major elements. Develop a plan to schedule, conduct, report, and close audits. Assign qualified people based on training, skill, and conflict of interest considerations. The workshop explains how to implement these quality audit program elements using examples and exercises that help develop the necessary skills.
Another important part of an audit program is responding to audit nonconformances. This includes correction, investigation, and corrective action. An effective audit program determines and eliminates the causes of the nonconformity, corrective action, to prevent recurrence. The workshop provides methods and exercises to for these important activities.
Management needs to understand the results from each audit type as part of Management Review. The workshop presentation should use statistical methodology to analyze quality audit reports. The workshop discusses the role of management review and helps identify the appropriate statistical methodologies for effective communication to management.
Learn the difference among the audit types
Learn the difference among audit methods (system, product, process, etc.)
Understand audit scheduling and methods to establish and update the schedule
Recognize the role of auditor competency and how to determine it
Recognize which audits an auditor could conduct and which ones to avoid
Understand the role of correction and corrective action related to an audit nonconformance
Develop an effective approach for reporting at Management Review
Who Will Benefit:
Audit Managers, Lead Auditors, Audit Team Members, Management Representative, Quality Assurance Managers, Quality Engineers, Regulatory Affairs Managers, Supplier Management and Purchasing, Supplier Quality Engineers
Day 1 Schedule
Lecture 1: Audit requirements in QMS standards
Lecture 2: Setting Up the Audit Program
Lecture 3: Auditor Qualifications and Assignment
Lecture 4: Planning the Audit
Lecture 5: Conducting the Audit
Lecture 6: Audit Sampling Plans
Lecture 7: Reporting the Audit
Day 2 Schedule
Lecture 1: Conducting Second Party Audits
Lecture 2: Being Audited (2nd and 3rd party)
Lecture 3: Responding to audit nonconformances
Lecture 4: Reporting to Management Review
President, Ombu Enterprises
Dan O’Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.