Writing Effective Nonconformity Statements During a Medical Device QMS Audit

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About This Course

This one-day course will introduce you to the importance of writing effective nonconformity statements during medical device manufacturer quality management systems audits.

Learners will identify the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements. Learners will recognize when to communicate nonconformities during an audit and identify tools and tips for writing effective nonconformity statements. Learners will also demonstrate how to assess nonconformity statements to confirm they are free from opinion and bias.

In addition, learners will apply the knowledge gained during the course through the practical application of the concepts presented. 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.

Key Learning Objectives

  • Identify valuable 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
  • Demonstrate through practical application the knowledge gained

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.

Course Tutors

Course tutors include:

Robert Ruff - Robert Ruff has over 35 years of experience in the medical device and public health sectors, including working in orthopedic implant manufacturing and completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes leading the development of the Medical Device Single Audit Program as well as co-authoring the MDSAP Audit Approach and the Quality System Inspection Technique (QSIT). Since 2017, Rob has conducted audits relative to a variety of criteria for NSF. He is also responsible for NSF training on medical device manufacturing topics. In this role, Rob has developed courses on a range of subjects, including auditing against the EU MDR and EU IVDR, risk management, FDA inspection readiness, design controls, and more.