MDSAP Chapter 6 — Production and service controls

Chapter 6 is the making and servicing of the device: planned processes, the environment, validation, acceptance, traceability and the record that a specific unit was released.

The tasks loaded in HAVGATE start at 6.1, planning, and continue through process selection and control, cleanliness, infrastructure, work environment, processes that need validation, process validation, sterilization where it applies, monitoring of conformity, competence, calibration and out-of-tolerance impact, software used to run production, the device master file, production records, traceability for implantable or life-sustaining devices, product status, customer property, acceptance, and control and rework of nonconforming product. Use the checklist in the product for the exact last task number on your build. Do not quote a count from memory.

A startup that still builds at a contract manufacturer audits the agreement and the records the contractor returns, which also touches Chapter 7. Process validation and calibration are quality records. HAVGATE does not run the line. Calibration scheduling as its own module is marked coming soon on the platform page. Task 6.13 can still be audited against the records you have.

The device master file and the device history record are defined in the glossary. Bookkeeping invoices are not either of those files.

The working checklist is the full 6.1 onward 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.