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SOP Nonconformance

Use this SOP template to systematically identify, document, evaluate, and manage nonconformances in hardware and software medical devices during manufacturing, testing, or inspection. Completing this document is essential whenever a product or process deviates from specified requirements, ensuring regulatory compliance, product safety, and traceability of corrective actions. This template helps you fulfill ISO 13485, FDA 21 CFR 820, and EU MDR requirements for controlling nonconforming products and processes.
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SOP Nonconformance of Product and Process

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1. Purpose

This SOP outlines the procedures for identifying, documenting, evaluating, and disposing of nonconforming products and processes for both hardware and software medical devices.

2. Scope

This procedure applies to all nonconforming products and processes identified during the manufacturing, testing, and inspection of hardware and software medical devices.

3. Definitions

  • Nonconformance: Any deviation from specified requirements for product or deviation from defined process.
  • Disposition: The decision made regarding the nonconforming product or process.

4. Procedure

4.1 Identification

  • Nonconformances can be identified during inspections, testing, or customer feedback.
  • Document the nonconformance using the Nonconformance Report (NCR) form.
  • For hardware:
    • Inspect physical attributes and functionality.
    • Use testing equipment to verify performance against specifications.
  • For software:
    • Review code for deviations from requirements.
    • Conduct functional testing and user acceptance testing (UAT), if appropriate.
    • Analyze logs and error reports.

4.2 Evaluation

  • Assess the impact of the nonconformance on the product's safety, performance, and regulatory compliance.
  • Determine the root cause of the nonconformance.
  • Evaluate the nonconformance based on the following criteria:
    - Severity of the deviation from specified requirements.
    - Potential impact on patient safety and product performance.
    - Frequency of occurrence.
    - Regulatory implications.
  • For hardware:
    • Check for physical defects, component failures, and assembly issues.
    • Evaluate the impact on device performance and patient safety.
  • For software:
    • Identify coding errors, logic flaws, and integration issues.
    • Assess the impact on software functionality, data integrity, and user experience.
  • Assess if a Corrective and Preventive Action (CAPA) is needed based on the evaluation criteria.

4.3 Disposition Mechanisms

  • Rework: Modify the nonconforming product to meet the specified requirements.
    • For hardware: Adjust or replace components, recalibrate devices.
    • For software: Correct code errors, update software versions.
  • Repair: Fix the nonconforming product to make it acceptable for use.
    • For hardware: Perform physical repairs, replace faulty parts.
    • For software: Apply patches, fix bugs.
  • Use As-Is: Accept the nonconforming product without modification if it meets the essential requirements.
    • For hardware: Ensure it does not compromise safety or performance.
    • For software: Validate that it does not affect critical functionality.
  • Scrap: Dispose of the nonconforming product if it cannot be reworked or repaired.
    • For hardware: Follow proper disposal procedures for electronic waste.
    • For software: Remove and securely delete nonconforming code or versions.
  • Return to Supplier: Send the nonconforming product back to the supplier for correction or replacement.
    • For hardware: Coordinate with the supplier for returns and replacements.
    • For software: Work with the vendor for updates or fixes.

4.4 Documentation

  • Record the disposition decision and actions taken in the NCR form.
  • Update relevant records and databases to reflect the nonconformance and its resolution.
  • Maintain detailed logs for software changes, including version control and change history.

4.5 Review and Approval

  • The Quality Assurance (QA) team reviews and approves the disposition decision.
  • Ensure all corrective actions are implemented and verified.
  • For software: Conduct regression testing to ensure fixes do not introduce new issues.

5. Responsibilities

  • Quality Assurance (QA): Oversee the nonconformance process and ensure compliance with this SOP.
  • Production Team: Identify and report nonconformances.
  • Engineering Team: Assist in the evaluation and disposition of nonconforming products.
  • Software Development Team: Address software nonconformances, implement fixes, and conduct testing.

6. References

  • ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes.
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  • IEC 62304: Medical device software – Software life cycle processes.

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