What Is a Nonconformity?
A nonconformity is any instance where a process, result, document, or practice fails to meet a defined requirement. Requirements may come from CLIA regulations, accreditation standards, internal policies, or customer expectations.
Common Sources of Nonconformities
- QC failures and unresolved instrument flags.
- Incomplete or missing documentation.
- Procedures not followed as written.
- Incorrect or delayed result reporting.
- Deficiencies cited during inspections or audits.
Steps for Handling Nonconformities
- Detection: Identify the issue through QC, audits, PT, complaints, or staff reports.
- Containment: Prevent further impact (e.g., hold results, re-run tests, notify clinicians).
- Investigation: Determine the root cause using structured methods (e.g., 5 Whys, fishbone diagrams).
- Corrective Action: Fix the immediate issue and prevent recurrence.
- Verification: Confirm that actions were effective.
- Documentation: Record all steps and decisions for QA and inspections.
Nonconformity Management in mylabcompliance.io
mylabcompliance.io helps laboratories manage nonconformities with:
- Centralized incident and nonconformity reporting forms.
- Built-in workflows for investigation, RCA, and corrective actions.
- Assignment of owners and due dates for each action.
- Dashboards to monitor open, overdue, and recurring nonconformities.