MDSAP · Medium · 14 min lesson
Chapter 3 Measurement, analysis and improvement - sixteen tasks: data, CAPA, complaints, internal audit, nonconforming product
MDSAP Audit Approach Chapter 3 (16 tasks); ISO 13485:2016 clauses 8.2.1, 8.2.2, 8.2.4, 8.3, 8.4 and 8.5
What you will learn
- Audit the 16 tasks of Chapter 3 in a sensible order.
- Trace a CAPA thread and a complaint thread from source to closure.
- Grade CAPA findings using the base grade and the escalation rules.
Key takeaways
- Chapter 3 has 16 tasks in four groups: system and data, CAPA, nonconforming product, and internal audit, review, complaints and reporting links.
- Audit Chapter 3 early because the task 2 data analysis steers the complaint sample and the design, production and purchasing sampling.
- Trace a CAPA from complaint trend to cause, action, change record and effectiveness evidence; each hand-off needs a record.
- Concession for nonconforming product needs justification and approval; release without it adds a grading escalation.
- Clauses 8.5.2 and 8.3 start at base grade 3 and clause 8.2.4 at base grade 1; add one per escalation rule, capped at 5.
Free practice question
Marlowe Infusion closed corrective action CAPA-114 in nine days with the cause recorded as operator error. Twelve similar complaints arrived afterwards. The record has no effectiveness check.
What does the auditor primarily question?
Whether the cause was found and whether the effectiveness of the action was reviewed
Correct. Clause 8.5.2 requires cause determination and review of effectiveness, and MDSAP Chapter 3 task 5 tests both.
Whether the training email was well written
Not quite. The wording of the email is secondary; MDSAP task 5 looks at cause and effectiveness under clause 8.5.2.
Whether the complaint form has a signature box
Not quite. A signature box is a format matter, whereas clause 8.5.2 concerns analysis and effectiveness evidence.
Whether CAPA numbers run in sequence
Not quite. Numbering helps traceability but does not address the substantive review of effectiveness in clause 8.5.2.
Key terms
- CAPA: Corrective and preventive action to remove the cause of an actual or potential nonconformity (clauses 8.5.2 and 8.5.3).
- effectiveness check: Evidence, against a criterion set in advance, that an action removed the cause without harming the device (clause 8.5.2).
- concession: Authorized release of nonconforming product with technical and scientific justification (clause 8.3.2).
- internal audit: Planned, impartial audit of the quality system by the organization itself (clause 8.2.4).
- escalation rule: A grading rule that adds one point to the base grade, such as repeat finding or release of nonconforming device (MDSAP AU P0037).
Official sources
- MDSAP AU P0002.009 MDSAP Audit Approach (FDA)
- MDSAP AU P0037.001 Guidelines on the use of the nonconformity grading system for MDSAP purposes (FDA)
- Medical Device Single Audit Program (MDSAP) Frequently Asked Questions (FDA)
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
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.