Audit

Sterile Processing & Decontamination Audit Checklist

An interactive, actionable audit designed to validate sterile processing workflows, instrument lifecycle controls, documentation, staff competency, sterilization monitoring, and storage. Collects structured observations, records corrective actions, and recommends audit frequency.

Interactive Tool

Sterile Processing & Decontamination Audit Checklist

Use this audit to assess core sterile processing practices that protect patients and ensure predictable instrument availability. Complete each item, add observations where needed, and record corrective actions. Recommended frequency: daily/weekly/monthly depending on local risk and volume.

Location where the audit is performed (hospital, clinic, central sterile department).
E.g., Central Sterile, Endoscopy SPD, Satellite SPD, OR storage.
YYYY-MM-DD or local date format.
Unique identifier, UDI, or case/pack reference.
Check for leakproof containers, intact packaging, correct labels and separation of soiled vs clean pathways.
Describe issues such as contamination, damaged packaging, or incorrect labeling.
Evidence that irrigations, gross soil removal, or enzymatic wipedown occurred immediately after use when required.
Check washer-disinfector cycle logs, chemical indicators, and manual cleaning SOP adherence.
Look for instrument lumens clean, tips intact, ratchets working, and checklist/pack list used.
Verify appropriate tray wrappers, pouch seals, and use of protective materials to prevent damage or contamination.
Confirm sterilizer cycle printouts/logs and adherence to validated cycle parameters for the device and load type.
Look for BI results, CI placement practices, and mechanical parameter trend logs.
Check shelving, date rotation, humidity control, and use-by labeling.
Verify instrument history for a sample of sets and that records meet retention policy.
Look for PM logs, calibration certificates, and recent service records.
Review training files, competency checklists, and observation of technique when possible.
Note any breaches that might impact sterility or cross-contamination.
Check SOP versioning and whether staff can access and cite the procedures used.
Record the sample instrument or set you followed through the process and any discrepancies.
Auditor judgment based on the audit findings.
1.0 10.0
Enter count of items marked Non-compliant in this audit.
Describe the issue, immediate containment, root cause hypothesis, and corrective / preventive actions.
YYYY-MM-DD or local date format.
Document evidence that the corrective action was completed and effective.
High-priority risks, suggested process improvements, or recommended audit cadence changes.
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