Context
Updating complaint handling procedures against ISO 13485 and revising the Essential Requirement Checklists meant writing each update from how the process was actually followed, not from an assumed baseline.
Quality Assurance • Regulatory Affairs
Quality & Regulatory Documentation Cleanup
Duration: 1 months • Role: Quality Assurance Specialist
A work instruction only prevents rework if it's written from how the task is actually done, not from how it's assumed to be done, that gap is usually where the next person doing the task gets stuck.
Primary Risks Identified
- An outdated checklist or work instruction being followed after the underlying regulation or process has changed
Testing Approach
Compared the existing checklist/instruction against the current regulation or process in practice, corrected discrepancies, and confirmed the update against the source document or QMS procedure.
Checklist Comparison
Work Instruction Verification
Outcome
Delivered a new work instruction, giving the team a repeatable, documented method for the task.
Key Lessons
A work instruction only prevents rework if it's written from how the task is actually done, not from how it's assumed to be done, that gap is usually where the next person doing the task gets stuck.
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