Writing Effective Nonconformity Reports

Introduction

A poorly written Nonconformity (NC) leads to confusion and ineffective corrective action. A good NC is irrefutable.

The Formula: P-L-O-R

• P (Problem): What is wrong?
• L (Location): Where was it found?
• O (Objective Evidence): What proof do you have?
• R (Requirement): What clause or procedure was violated?

Example

• Bad: “The records were a mess.” (Subjective, no evidence, no requirement).
• Good: “Contrary to Procedure QP-04 Rev 3 which requires daily temperature checks (Requirement), the temperature log for Fridge A (Location) had no entries for the dates Nov 1-5 (Objective Evidence). This indicates a failure to maintain required records (Problem).”

Tips

• Use the exact words of the standard or procedure.
• Be specific (cite document numbers, serial numbers).
• Avoid emotional language (“negligent,” “lazy”).