MDSAP · Medium · 15 min lesson
Chapter 6 Production and service controls - twenty-nine tasks, process validation and sterile devices (Annex)
MDSAP AU P0002.009 Audit Approach, Chapter 6 (29 tasks) and Annex 2; ISO 13485:2016 clauses 6.3, 6.4, 7.5.1 to 7.5.11, 7.6, 8.3
What you will learn
- Audit the 29 tasks of Chapter 6 in a sensible order and say what evidence each group of tasks needs.
- Audit process validation and sterilization validation, including the sterile device annex.
- Trace traceability and device status from a finished device back to records, and write and grade a finding.
Key takeaways
- Chapter 6 has 29 tasks; tasks 7 to 9 are the validation block, and task 29 concludes the chapter.
- Clause 7.5.6 asks which outputs cannot be verified; the list and the rule behind it must be current.
- Sterilization and sterile barriers are validated before use and after changes (clause 7.5.7); Annex 2 guides sterile device audits.
- Traceability to materials and consignee applies to implantable and life-supporting devices; status applies to all product.
- Trace one lot both ways and compare each record with the device master file; write findings with clause, evidence and gap.
Free practice question
Halvern's special process list names sterilization and sealing only. The auditor finds that the cleaning of titanium screws is checked by a monthly residue sample and was never considered for validation.
What is the best finding basis?
Clause 7.5.6: the process output is not verified on every device, so the decision to validate was not made.
Correct. ISO 13485 clause 7.5.6 requires validation where output is not verified by later monitoring, and MDSAP task 7 tests the decision.
Clause 7.5.7: sterilization validation is missing.
Not quite. Clause 7.5.7 concerns sterilization and sterile barriers, whereas this gap is about a cleaning process under 7.5.6 and task 7.
Clause 8.3: nonconforming product was released.
Not quite. Nothing shows nonconforming product; the issue is that a process needing validation was never identified under clause 7.5.6.
No finding, because monthly samples are a sufficient control.
Not quite. A monthly sample does not verify every device, so clause 7.5.6 still requires a documented decision and likely validation.
Key terms
- process validation: Documented evidence that a process consistently achieves planned results when its output cannot be fully verified later (ISO 13485 clause 7.5.6).
- sterile barrier system: The minimum package that prevents ingress of microorganisms and allows aseptic presentation; validated under clause 7.5.7.
- device master file: The file of specifications, procedures and records for a device type or family (ISO 13485 clause 4.2.3; MDSAP Chapter 6 task 16).
- traceability: Ability to follow a device back to materials and forward to consignees; required in detail for implants (clause 7.5.9.2; task 18).
- product status: Identification of whether product is untested, held, released or rejected (clause 7.5.8; task 19).
- Annex 2: Part of the MDSAP audit approach that lists expectations for auditing sterile medical devices.
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.