MDSAP · Expert · 15 min lesson
Writing nonconformities in MDSAP style - requirement, evidence, finding, the 5W2H and the so-what
MDSAP AU P0037 (grading guidelines, sections 5.1 to 5.3), GHTF SG3 N19:2012, MDSAP AU F0019.2 exchange form, AU P0027 section 5.4, ISO 13485:2016 clauses 4.1 to 8.5
What you will learn
- Write a defensible finding with one requirement, traceable evidence and a factual statement.
- Choose the clause and the country requirement that give the most specific and relevant basis.
- Grade a finding with the two-step method and explain the so-what, including the 5-day notice.
Key takeaways
- A finding cites one specific requirement with its source; if several fit, choose the one yielding the highest grade (AU P0037 5.1).
- Evidence states source, job titles, when and where, and extent; the statement says how the requirement is unmet and gives no advice.
- Step 1: indirect impact scores 1 (clauses 4.1 to 6.3 and 8.2.4); direct impact scores 3 (4.2.3 and 6.4 to 8.5).
- Step 2 adds 1 each for repeat, missing process with non-implementation, and release of nonconforming device; the cap is 5 and corrections do not change it.
- One grade 5 or more than two grade 4 findings start the 5-day notice (AU P0027 5.4); the 5W2H aid is practical, not an MDSAP term.
Free practice question
An auditor's draft reads: some supplier evaluations were not done. The lead auditor returns it.
What is the best improvement?
Add advice that the manufacturer should evaluate its suppliers.
Not quite. Findings state how a requirement is unmet and do not contain advice under MDSAP practice.
State the supplier count, the records sampled, the job titles and dates, and the clause, e.g. 5 of 12 critical suppliers lacked evaluation, ISO 13485:2016 clause 7.4.1.
Correct. The MDSAP grading guidelines section 5.1 ask for traceable evidence including extent and source.
Replace the clause with the general phrase quality system.
Not quite. MDSAP findings need the most specific requirement and a general phrase fails that rule.
Delete the finding because evidence is missing.
Not quite. The evidence can be completed from records, so the finding can be strengthened rather than deleted in MDSAP.
Key terms
- nonconformity: A failure to fulfil a requirement, written with a cited requirement, traceable evidence, a statement and a grade.
- objective evidence: Traceable facts from procedures, records, interviews or observation, with source, time, place and extent.
- direct impact: A requirement with direct effect on device safety or performance, scoring 3 at step 1 of the grading method.
- escalation rule: A step 2 rule that adds one point: repeat, missing process with non-implementation, or release of a nonconforming device.
- 5-day notice: Early notice to regulators within 5 working days of the audit end for a grade 5 or more than two grade 4 findings.
- 5W2H: A drafting checklist: who, what, where, when, why, how and how many; practical aid, not an MDSAP term.
Official sources
- MDSAP AU P0037.001 Guidelines on the use of the nonconformity grading system for MDSAP purposes (FDA)
- GHTF SG3 N19:2012 Nonconformity Grading System for Regulatory Purposes and Information Exchange (IMDRF)
- MDSAP AU P0027.007 Post-Audit Activities and Timeline Policy (FDA)
- MDSAP AU F0019.2 Nonconformity Grading and Exchange Form (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.