Internal Audit Program & Checklist
Risk-based self-inspection program with an annual schedule, area-by-area checklists, and finding-to-CAPA tracking. Maps to ICH Q10 self-inspection and 21 CFR 820.22.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
A risk-based self-inspection programme and the checklists that structure each audit — the schedule that decides what is audited and when, the evidence captured during each audit, and the route from finding to closure. An audit programme that always audits the same areas at the same depth is a calendar, not a risk-based programme, and the schedule is where that distinction is made visible.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
EU GMP Chapter 9 requires self-inspections to be conducted to monitor compliance and propose corrective measures, with records of the inspections and subsequent actions. For devices, 21 CFR 820.22 requires quality audits by individuals without direct responsibility for the matters audited, and 21 CFR 820.20 requires management to be made aware of the results. ICH Q10 places internal audit among the monitoring activities feeding management review. The risk-based scheduling model here is SPEQ synthesis; the classification criteria you adopt are your determination.