MDSAP Chapter 3 — Measurement, analysis and improvement

Chapter 3 is the long loop: you collect quality data, you investigate, you correct, you audit yourselves, and you feed management review.

HAVGATE loads tasks 3.1 through 3.16. The set includes procedures for measuring the system, sources of quality data, investigation of actual and potential nonconformity, correction and CAPA, the effect of a CAPA on design and on process, control of nonconforming product including after delivery, internal audit, management-review inputs, post-production information and complaints, communications with external parties, reportability, advisory notices, and management commitment to the loop.

This is the chapter that connects the modules. Task 3.5 is CAPA. Task 3.10 is the internal audit programme. Tasks 3.12 to 3.15 are complaints, vigilance and field action. A startup that only writes SOPs and never runs this chapter will feel ready and will not be.

The CRM does not create these records. A complaint that arrives as a sales email still has to be logged in the quality process. Bookkeeping does not close a CAPA. See the CRM and bookkeeping pages for that boundary.

The working checklist is the full 3.1 to 3.16 set inside /mdsap-audit-checklist and in the product, not a PDF. Grades, when you assign them, are explained on the grading page. Confirm the current audit approach document before you treat a task title as the only criterion.