Handling of Out of Calibration (OOC) Instruments and Equipment

Definition

Out of Calibration (OOC) refers to an instrument or equipment that, during calibration verification, fails to meet the specified acceptance criteria or shows results outside its defined tolerance limits.

Procedure for Handling OOC Instruments & Equipment

1. Immediate Actions

• Stop usage of the instrument/equipment immediately.

• Tag as “Out of Calibration” to prevent accidental use.

• Inform Quality Assurance (QA) and relevant department heads.

2. Investigation

• Review calibration results to determine the extent and nature of the deviation.

• Check last known calibration date and calibration certificate.

• Assess impact on previously analyzed data since the last calibration.

• Review maintenance, usage logs, and any recent repairs.

3. Impact Assessment

• Determine if previous results generated using the OOC equipment are valid.

• If impact is found:

  • Initiate product quality impact assessment.

  • Recall or re-test affected batches if necessary.

4. Corrective Actions

• Re-calibrate the instrument and verify performance.

• If unable to re-calibrate, send for repair or replace the equipment.

• Update SOPs and training to prevent recurrence.

5. Documentation

• Record details in Calibration Logbook and Deviation Report.

• Document investigation findings, impact assessment, and corrective/preventive actions (CAPA).

• Maintain traceability for regulatory compliance (GMP, GLP).

6. Preventive Measures

• Follow calibration schedules strictly.

• Use qualified service providers for calibration.

• Perform periodic verification checks between calibrations.

• Ensure proper environmental conditions to avoid drift in calibration.

✅ Regulatory Note:
As per 21 CFR Part 211 and WHO GMP, OOC instruments must be immediately removed from use, investigated, and all impacted results assessed before batch release decisions.