Context
The Australian Essential Requirement Checklists had fallen out of step with the current regulation and process in practice, and the submission package itself needed reformatting and merging into the required standard before it could go out.
Quality Assurance • Regulatory Affairs
Work Instruction Development
Duration: 3 months • Role: Quality Assurance Specialist
Updating the Australian Essential Requirement Checklists showed that formatting and merging documents (fonts, structure) seems purely cosmetic but is often a submission requirement in its own right. Getting it wrong is a preventable reason for rejection.
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- An outdated checklist or work instruction being followed after the underlying regulation or process has changed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.
Essential Requirements Checklist
QMS Procedures
Document Formatting
Outcome
Reformatted and merged the documents into the required standard, making the package submission-ready.
Key Lessons
Formatting and merging documents (fonts, structure) seems purely cosmetic but is often a submission requirement in its own right - getting it wrong is a preventable reason for rejection.
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