This is a lesson out of my ASQ CQA course with Andy Robertson, on how to write and classify audit findings.
Resources
I break down key terms like finding, nonconformity, observation, and noncompliance, and explains that everything must tie back to requirements and objective evidence. The episode covers when to write a nonconformity vs an observation, common severity levels (critical, major, minor), and how to structure clear findings. I also cover how to sequence audit results and where auditors often go wrong, especially when they insert opinion or recommend solutions.
Timestamps
- 00:00 Course preview
- 00:42 Key audit terms
- 01:56 What makes findings reportable
- 04:16 Severity classification
- 06:42 Writing findings
- 07:57 Structuring reports
- 10:38 Auditor boundaries
Subhi Saadeh is a certified ISO 13485 Lead Auditor, CQE, and CQA with experience leading audits and building quality systems across medical devices and combination products at companies like Baxter, Pfizer, and Gilead Sciences. Through Let’s ComBinate, he focuses on bridging the gap between pharma and devices through educational content, industry collaboration, and consulting.
