A work instruction covering four separate submission components, the Table of Contents, the User Fee Submission, and the Acceptance Checklist among them, only holds together if every one of those components is merged to the same formatting standard.
Multiple components, one standard
Each component of a submission package can be individually correct in content and still fail as a package if its formatting doesn't match the others. The work instruction has to enforce one consistent standard across all of them.
- Comparing the existing checklist/instruction against the current regulation or process in practice
- Correcting discrepancies found across the Table of Contents, User Fee, and Acceptance Checklist components
- Confirming the update against the source document or QMS procedure
What an outdated instruction risks
An outdated checklist or work instruction being followed after the underlying regulation or process has changed applies just as much to a multi-component instruction as to a single-document one.
What the instruction delivered
Reformatting and merging the documents into the required standard made the package submission-ready across all four components.
The Real Takeaway
Formatting and merging documents seems purely cosmetic but is often a submission requirement in its own right.
Getting it wrong is a preventable reason for rejection, no matter how many components the instruction covers.