Writing Effective Nonconformity Statements During Medical Device QMS Audits
This instructor-led course will introduce you to the importance of writing effective nonconformity statements during medical device manufacturer quality management systems audits.
This course covers the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements; and how to recognize when to communicate nonconformities during an audit; and identify tools and tips for writing effective nonconformity statements.
In addition, learners will apply the concepts covered during the course through practical application. Working in groups, learners will review multiple nonconformity scenarios, develop nonconformity statements relative to the scenarios and participate in instructor-led analysis of the nonconformity statements.
Learning Outcomes
At the end of this training, learners will be able to:
- Identify useful techniques to apply when writing effective nonconformity statements
- Review fundamental terminology important to writing effective nonconformity statements including audit, objective evidence, audit criteria, and nonconformity
- Evaluate the use of the acronym FOCAL as a tool for developing an effective nonconformity statement.
- Apply the three key principles when writing a nonconformity statement
Who Should Attend
This course is vital for anyone who conducts or manages internal, supplier or third-party audits within the medical device manufacturing space. The tools and tips shared in this training will help ensure that the auditee organization clearly understands the nonconformities, so that they can identify and implement effective investigations and subsequent containment, correction, corrective action, and systemic corrective actions, as appropriate.
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