NCR Procedure

This procedure defines the process for identifying, documenting, evaluating, segregating, and dispositioning nonconforming product, materials, and components. It ensures that nonconforming items are controlled to prevent unintended use or delivery, and that appropriate corrective actions are initiated when warranted.

This procedure applies to all nonconformances identified at any stage of the product lifecycle, including: - Incoming inspection of raw materials, components, and supplier-provided goods - In-process manufacturing and assembly - Final inspection and testing - Post-market (field failures, customer returns) - Environmental monitoring excursions (where applicable)

Any Employee: Report suspected nonconformances immediately to their supervisor or Quality. Quality Inspector / QC Technician: Document the nonconformance on the NCR Form (FRM-NC-001), physically segregate and tag nonconforming material. Quality Engineer / CAPA Owner: Investigate root cause, determine disposition, assess whether CAPA is warranted. Quality Manager: Review and approve dispositions. Approve any concession or use-as-is disposition (requires documented risk assessment). Material Review Board (MRB): For complex or high-risk nonconformances, the MRB (Quality, Engineering, Regulatory, Operations) convenes to determine disposition.

4.1 Detection & Reporting - Nonconformances may be detected during incoming inspection, in-process checks, final inspection, complaint investigation, or audit findings - Upon detection, immediately complete the NCR Form (FRM-NC-001) with: date, description of nonconformance, product/lot/batch number, quantity affected, discovery point - Notify the Quality department immediately for Critical nonconformances 4.2 Segregation & Identification - Nonconforming items shall be physically segregated in the designated NCR Hold Area - Attach an NCR tag (red tag) with the NCR number - If physical segregation is impractical, clearly label the item "NONCONFORMING — DO NOT USE" and document location - Electronic systems shall be updated to reflect hold status 4.3 Investigation - Conduct investigation proportional to risk severity - Determine root cause using appropriate methodology (5 Whys, Fishbone, etc.) - Assess impact on other lots, products, or processes - Determine if the nonconformance is isolated or systemic 4.4 Disposition Disposition options: - Accept / Use-As-Is: Product meets intended use despite nonconformance. Requires documented risk assessment, regulatory review, and Quality Manager approval. May require customer notification. - Rework: Product can be corrected to meet specifications. Rework instructions must be documented and reworked product re-inspected. - Return to Supplier: Nonconforming incoming material returned to supplier per Supplier Management SOP. Supplier CCAR issued if warranted. - Scrap/Destroy: Product cannot be made conforming. Document destruction method and witness. - Regrade: Product is acceptable for alternative, less-critical use (if applicable). 4.5 CAPA Evaluation - Evaluate whether the nonconformance warrants a CAPA per the CAPA Procedure (SOP-CA-001) - CAPA initiation is required for: repeat nonconformances (3 or more of same type in 12 months), patient safety risk, regulatory non-compliance, systemic root cause 4.6 NCR Closure - Verify disposition is complete with objective evidence - Update the NCR Log (FRM-NC-002) - Quality Manager reviews and closes the NCR

- NCR Form (FRM-NC-001) - NCR Log (FRM-NC-002) - MRB meeting minutes (when applicable) - Risk assessments for use-as-is dispositions - Rework records and re-inspection results - Scrap/destruction records

- ISO 13485:2016 Clause 8.3 Control of Nonconforming Product - FDA 21 CFR 820.90 Nonconforming Product - SOP-CA-001 CAPA Procedure - SOP-SM-001 Supplier Management