MDSAP · Expert · 14 min lesson
The audit report package - AU F0019.1 report, F0019.2 grading form, guidelines G0019.3 and G0019.4, policy P0019 and P0027
MDSAP AU F0019.1 sections 1 to 18, AU F0019.2, AU G0019.3, AU G0019.4, AU P0019 and MDSAP AU P0027 section 5, ISO 13485:2016 clause 5.6
What you will learn
- Read the report forms section by section.
- Check completeness before submission.
- Use the report for management review.
Key takeaways
- The package holds the audit report, grading form, nonconformity reports with plan and review, evidence for grade 4 or 5, and report attachments (MDSAP AU P0027 5.2).
- The report has 18 sections; section 12 nonconformities must match the grading form, and section 14 may be not applicable only when nothing needs follow-up.
- The grade comes from four parameters: QMS impact, repeat, absent procedure and released nonconforming device (AU G0019.4).
- Timing: 5-day notice for grade 5 or more than two grade 4; package at D0+45 with notice, otherwise D0+90; updated NC reports in 10 calendar days on request.
- Audit results are a management review input (ISO 13485 clause 5.6); give each open finding an owner, a date and an effectiveness check.
Free practice question
Marlowe's report describes in section 11.6 a missing batch record check, but section 12 lists no matching nonconformity and the grading form shows two nonconformities while section 12 lists three.
What is the correct reading?
The report and the grading form are inconsistent; the manufacturer should ask the auditing organization to reconcile them.
Correct. Guideline G0019.3 requires every NC in section 12 to appear on the grading form, so a mismatch is a package defect to raise.
Both are correct because the grading form lists only major findings.
Not quite. The grading and exchange form under guideline G0019.4 lists all nonconformities of any grade, not only major ones.
The manufacturer should edit the grading form to match.
Not quite. The grading form belongs to the auditing organization under MDSAP policy, so manufacturer edits would break the approved record.
Regulators will reconcile it themselves, so no action is needed.
Not quite. Regulators receive the package as submitted under MDSAP AU P0027, and an unreconciled record weakens its value to them.
Key terms
- audit report package: The report, grading form, nonconformity reports, evidence and attachments that the auditing organization sends to regulators (MDSAP AU P0027 section 5.2).
- D0: The audit end date, from which post-audit timelines are counted.
- grading and exchange form: Form AU F0019.2 recording each nonconformity with clause, evidence, grade and status for regulators.
- 5-day notice: Early notice to regulators within 5 working days of D0 for a grade 5 or more than two grade 4 findings.
- left open: Section 14 status where actions were implemented but effectiveness could not yet be verified, with no recurrence.
- amending memorandum: The way a report is changed after approval; amendments to a shared report also go to the regulators.
Official sources
- MDSAP AU G0019.3 Medical Device Regulatory Audit Report Form Guidelines (FDA)
- MDSAP AU G0019.4 Guidelines, NC Grading and Exchange Form (FDA)
- MDSAP AU P0019 Medical Device Regulatory Audit Reports Policy (FDA)
- MDSAP AU P0027 Post Audit Activities and Timeline Policy
- MDSAP Audit Procedures and Forms (FDA)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.