Learn the difference among audit methods (system, product, process, etc.) Learn the difference among the audit types The workshop discusses the role of management review and helps identify the appropriate statistical methodologies for effective communication to management. The workshop presentation should use statistical methodology to analyze quality audit reports. Management needs to understand the results from each audit type as part of Management Review. The workshop provides methods and exercises to for these important activities. An effective audit program determines and eliminates the causes of the nonconformity, corrective action, to prevent recurrence. This includes correction, investigation, and corrective action. The workshop explains how to implement these quality audit program elements using examples and exercises that help develop the necessary skills.Īnother important part of an audit program is responding to audit nonconformances. Assign qualified people based on training, skill, and conflict of interest considerations. Develop a plan to schedule, conduct, report, and close audits. The program includes the two major elements. This workshop provides the tools to establish and maintain an effective quality audit program for medical device manufacturing. Independent audits (3rd party) can help provide assurance about the health of a QMS. Customer/supplier audits (2ndparty) play a role in an effective supplier management program your company could be the subject of the audit. Internal quality audits (1st party) help a company evaluate itself. In this workshop, participants examine the various types of audits to understand their role. Audits are one of the most powerful tools that management has to assure on effective QMS. Quality audits are an important element in implementing and maintaining an effective Quality Management System (QMS). Course "Quality Audits for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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