MDSAP · Expert · 15 min lesson
Capstone B - mock MDSAP audit: Design, Production, Purchasing, grading, closing meeting and report package
MDSAP AU P0002 chapters 5 to 7, AU P0037 sections 5.2 and 5.3, AU P0027 post-audit timelines, ISO 13485:2016 clauses 7.3.9, 7.4.1, 7.5.1, 7.5.6 and 8.3
What you will learn
- Grade all findings from the Design, Production and Purchasing chapters using the AU P0037 steps.
- Run the closing meeting without surprises and without negotiating grades.
- Complete the exchange form, apply the report package timelines and write a response the auditing organization can accept.
Key takeaways
- Trace one design, one lot and one supplier; the broken links are the findings.
- AU P0037: base 1 or 3 by clause impact, plus 1 per escalation rule, maximum 5.
- Corrections never change a grade; only the appeals process can.
- Grade 5 or more than two grade 4 findings trigger the 5-day notice to regulators.
- Response plan within 15 calendar days; grade 4 or 5 implementation evidence within 30.
Free practice question
Halden's file for its contract sterilizer shows one entry: approved supplier, 2019. There is no quality agreement, no performance monitoring and no re evaluation date. The sterilizer treats every Corvin kit.
How should the auditor treat this under clause 7.4.1 and AU P0037?
As a direct impact nonconformity, graded at least 3, with an uplift if no documented process exists.
Correct. Clause 7.4.1 is within the direct range of AU P0037 section 5.2.1, so the base grade is 3 with escalation under section 5.2.2.
As an observation, because the supplier is certified.
Not quite. A supplier certificate does not replace the evaluation and monitoring required by clause 7.4.1 of ISO 13485.
As an indirect impact finding graded 1, because suppliers are management matters.
Not quite. Clause 7.4 sits in the direct range 6.4 to 8.5 of AU P0037 section 5.2.1, so grade 1 is wrong.
As no finding, because the relationship is long.
Not quite. Clause 7.4.1 requires criteria, monitoring and re evaluation records, which duration of the relationship cannot substitute.
Key terms
- nonconformity grade: A number from 1 to 5 calculated under AU P0037 from the clause impact plus escalation rules.
- direct impact clause: ISO 13485 clauses 4.2.3 and 6.4 to 8.5 except 8.2.4, which start at grade 3 (AU P0037 section 5.2.1).
- escalation rule: A rule that adds one grade: repeat within three years, no process plus no implementation, or release of a nonconforming device.
- exchange form: The MDSAP nonconformity grading and exchange form that carries each finding, its grade and the status of the response.
- 5-day notice: Notice to regulators within 5 working days for a grade 5, more than two grade 4, a public health threat or fraud (AU P0027).
- closing meeting: The formal meeting at audit end where findings, grades, timelines and the appeals route are presented.
- remediation plan: The company response for each finding: investigation, cause, correction and corrective action, due in 15 calendar days.
- D0: The audit end date from which post-audit timelines are counted.
Official sources
- MDSAP AU P0037.001 Guidelines on the use of the nonconformity grading system for MDSAP purposes (FDA)
- MDSAP AU P0027.007 Post Audit Activities and Timeline Policy (FDA)
- MDSAP Frequently Asked Questions (FDA)
- MDSAP AU P0002.009 MDSAP Audit Approach (FDA)
- MDSAP Guidelines NC Grading Exchange Form (MDSAP.global)
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.