Nonconformance

Nonconformance (also spelled non-conformance or nonconformity) refers to the failure of a product, process, or quality management system element to meet specified requirements, standards, or regulatory expectations. In medical device manufacturing, effective nonconformance management is critical for ensuring product quality, patient safety, and regulatory compliance.

Definition and scope:
A nonconformance can occur at any point in the medical device lifecycle including:
- Design specifications not meeting user needs or regulatory requirements
- Raw materials or components failing acceptance criteria
- Manufacturing processes deviating from documented procedures
- Finished products not meeting product specifications
- Quality management system procedures not followed
- Regulatory requirements not adequately addressed
- Supplier deliverables not meeting purchase order specifications

Types of nonconformances:

Product Nonconformances:
- Dimensional or functional failures
- Cosmetic defects outside acceptance criteria
- Labeling errors or omissions
- Packaging defects
- Sterilization or biocompatibility failures
- Performance testing failures

Process Nonconformances:
- Deviation from standard operating procedures
- Manufacturing process parameters out of specification
- Calibration or maintenance overdue
- Environmental conditions outside limits
- Documentation errors or omissions

System Nonconformances:
- QMS procedure violations
- Missing or inadequate documentation
- Training requirements not met
- Audit findings and observations
- Regulatory inspection citations (FDA 483s)

Regulatory requirements:

FDA 21 CFR 820.90 - Nonconforming Product:
The FDA Quality System Regulation requires manufacturers to:
- Establish and maintain procedures to control nonconforming product
- Identify, document, evaluate, segregate, and disposition nonconforming product
- Review and evaluate nonconformances to determine need for investigation
- Document the nonconformance including description and disposition
- Ensure nonconforming product is not distributed unless properly dispositioned

ISO 13485:2016 Clause 8.3 - Control of Nonconforming Product:
ISO 13485 requires organizations to:
- Ensure nonconforming product is identified and controlled to prevent unintended use or delivery
- Define responsibilities and authorities for handling nonconforming product
- Document the nature of nonconformities and subsequent actions taken
- Re-verify product after rework or correction
- Maintain records of nonconformities and actions taken
- Communicate relevant information to regulatory authorities when required

Nonconformance handling process:

1. Identification and Documentation
- Detect nonconformance through inspection, testing, audit, or complaint
- Document with unique identifier (Nonconformance Report - NCR)
- Record detailed description, location, quantity, and date discovered
- Photograph or retain samples when appropriate

2. Segregation and Containment
- Physically separate or clearly identify nonconforming material
- Prevent inadvertent use, mixing with conforming product, or shipment
- Use quarantine areas, hold tags, or electronic system controls
- Assess inventory to identify potentially affected lots

3. Evaluation and Investigation
- Determine root cause of nonconformance
- Assess severity and impact on product safety/performance
- Review previous occurrences and trending data
- Determine if investigation under CAPA system required
- Evaluate potential impact on distributed product

4. Disposition Decision
- Use-as-is - Accept without correction (requires justification and authorization)
- Rework - Correct to meet original requirements (verify after rework)
- Regrade - Modify intended use or application (with approval)
- Scrap - Destroy or dispose (document destruction)
- Return to supplier - For supplier-caused nonconformances
- Concession decisions must be approved by authorized personnel

5. Corrective Action Determination
- Evaluate if nonconformance requires CAPA initiation
- Consider severity, frequency, and potential for recurrence
- Significant or recurring nonconformances typically trigger CAPA
- Link NCR to CAPA system for tracking

6. Verification and Closure
- Verify disposition implemented correctly
- Re-inspect or re-test reworked product
- Document completion and obtain final approvals
- Close NCR with all required signatures and dates

Triggers for CAPA from nonconformances:
Nonconformances that should trigger CAPA investigation include:
- Recurring similar nonconformances (trend)
- Nonconformances affecting product safety or performance
- Process capability issues indicated by multiple failures
- Systemic issues identified through root cause analysis
- Customer complaints related to nonconformance
- Regulatory compliance failures
- Supplier quality issues impacting multiple lots

Documentation and record-keeping:
Complete nonconformance records must include:
- NCR number and date opened
- Detailed description of the nonconformance
- Product/process identification and traceability information
- Quantity affected and location
- Root cause analysis when performed
- Disposition decision with justification
- Rework instructions if applicable
- Verification results after correction
- CAPA linkage if initiated
- Approval signatures and closure date

Metrics and trending:
Effective nonconformance management tracks:
- Total NCRs per period by type and source
- Nonconformance rate per units produced
- Cost of poor quality (COPQ) from nonconformances
- NCRs by product line, process area, or supplier
- Disposition types (scrap rate, rework rate, use-as-is)
- Average time to close NCRs
- Repeat nonconformances indicating ineffective CAPA
- Top nonconformance categories for prioritization

Relationship to other QMS processes:
- CAPA - Nonconformances frequently trigger corrective and preventive actions
- Risk Management - Nonconformances may reveal previously unidentified hazards
- Complaint Handling - Customer complaints often result in NCRs
- Internal Audit - Audits identify system nonconformances
- Supplier Management - Supplier nonconformances tracked for performance evaluation
- Management Review - Nonconformance trends reported to senior management
- Process Validation - Repeated nonconformances may indicate need for revalidation

Best practices:
- Establish clear nonconformance acceptance criteria and thresholds
- Implement barcode or electronic systems to prevent use of nonconforming product
- Conduct timely root cause analysis to prevent recurrence
- Train personnel on identifying and reporting nonconformances
- Segregate nonconforming material in designated quarantine areas
- Review disposition decisions by qualified personnel
- Analyze trends to identify systemic issues early
- Communicate nonconformances to relevant stakeholders
- Use Pareto analysis to focus improvement efforts
- Verify effectiveness of corrective actions through follow-up

Effective nonconformance control protects patients, reduces waste and rework costs, improves process capability, demonstrates regulatory compliance, and drives continuous quality improvement in medical device organizations.