MDSAP · Expert · 14 min lesson
Responding to findings - remediation plans, root cause, effectiveness, 15 and 30 day rules and appeals
MDSAP AU F0019.2 exchange form, AU P0027 sections 5.1 to 5.6, AU P0037 section 5.3, ISO 13485:2016 clause 8.5.2, ISO/IEC 17021-1 clause 9.7
What you will learn
- Write a remediation plan with cause, extent, correction, corrective action, evidence and criteria.
- Define measurable, dated and independently checked effectiveness criteria.
- Use the appeals process correctly and know the 15 and 30 day timelines and the 5-day notice.
Key takeaways
- Timelines run from D0: remediation plan within 15 calendar days; for grade 4 or 5, evidence within 30 calendar days counts in the first package (AU F0019.2).
- The package is due by D0+90, or D0+45 when the 5-day notice criteria are met (AU P0027 5.5, 5.6); updated reports are due 10 calendar days after a regulator request.
- A plan holds investigation and cause, extent, correction, corrective action, evidence of implementation and effectiveness criteria (clause 8.5.2).
- Effectiveness criteria are measured, dated, sourced and independently checked, and they test the cause, not the activity.
- Corrections never change a grade; only the auditing organization's documented appeals process can (AU P0037 5.3), and it does not pause the clock.
Free practice question
Brightwater's audit ended on 10 July. The quality manager plans to send the remediation plan at the end of August after the summer break.
What is the problem?
There is no problem; any date before the next audit is fine.
Not quite. The MDSAP form sets a default response time that starts at the audit end date.
The plan should be provided within 15 calendar days of D0, so the end of August is too late.
Correct. The MDSAP nonconformity grading and exchange form AU F0019.2 states 15 calendar days for the remediation plan.
The plan is due on the date the certificate expires.
Not quite. Certificate expiry is not the reference date for MDSAP responses, so it does not fit the requirement set out in the MDSAP documents.
The plan is not needed for findings that are corrected on site.
Not quite. MDSAP still expects a response with cause and evidence for each finding.
Key terms
- remediation plan: The manufacturer's response to a finding: investigation, cause analysis, correction, corrective action and evidence.
- correction: Action that eliminates the detected nonconformity itself.
- corrective action: Action that eliminates the cause of a nonconformity to prevent recurrence.
- effectiveness criterion: A measurable, dated check, with a source record and an independent checker, that the action worked.
- D0: The audit end date, from which response and report timelines in the post-audit policy are counted.
- appeal: The auditing organization's documented process that is the only route to amend a grade (ISO/IEC 17021-1 clause 9.7).
Official sources
- MDSAP AU F0019.2 Nonconformity Grading and Exchange Form (FDA)
- MDSAP AU P0027.007 Post-Audit Activities and Timeline Policy (FDA)
- MDSAP AU P0037.001 Guidelines on the use of the nonconformity grading system for MDSAP purposes (FDA)
- MDSAP AU P0002.009 MDSAP Audit Approach (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.