Comprehensive Guide to Handling Non-Conforming Products in Medical Device Manufacturing
1) Purpose
The purpose of this SOP is to establish a standardized procedure for identifying, documenting, and handling non-conforming products in the manufacturing process. This ensures that all non-conforming products are managed in a way that maintains compliance with regulatory standards, prevents unintended use, and minimizes risks to product quality and patient safety.
2) Scope
This SOP applies to all manufacturing stages, including raw material inspection, in-process checks, and final product inspection. It is relevant to production staff, quality assurance personnel, and supervisors involved in detecting and resolving non-conformance issues.
3) Responsibilities
– Production Operators: Identify and report non-conforming products during manufacturing processes.
– Quality Assurance (QA): Investigate non-conformances, determine root causes, and approve corrective actions.
– Supervisors: Oversee the segregation and disposition of non-conforming products.
– Regulatory Affairs: Ensure non-conformance handling processes comply with regulatory requirements.
– Documentation Team: Maintain records related to non-conforming products, including root cause analysis and corrective actions.
4) Procedure
4.1 Identification of Non-Conforming Products
4.1.1 Inspection Stages
– Conduct inspections during raw material receipt, in-process manufacturing, and final product checks to identify non-conforming products.
– Use calibrated tools and testing equipment to detect deviations from specifications.
4.1.2
– Define non-conformance based on product specifications, regulatory standards, and quality management requirements.
– Examples include incorrect dimensions, contamination, missing components, or packaging defects.
4.1.3 Reporting Non-Conformance
– Record all detected non-conformances in a Non-Conformance Report (NCR).
– Include details such as product ID, batch number, nature of non-conformance, and date of detection.
4.2 Segregation of Non-Conforming Products
4.2.1 Immediate Isolation
– Segregate non-conforming products from conforming products to prevent unintentional use.
– Use designated areas or containers labeled as “Non-Conforming” for storage.
4.2.2 Tagging and Labeling
– Attach a non-conformance tag to each item or batch, including details such as batch number, date, and reason for segregation.
– Ensure tags are clearly visible and include the name of the person reporting the issue.
4.2.3 Inventory Adjustment
– Update inventory records to reflect the segregation of non-conforming products.
– Ensure traceability by documenting the location and status of segregated items.
4.3 Evaluation of Non-Conformance
4.3.1 Initial Assessment
– QA personnel must evaluate the severity of the non-conformance and its impact on product quality and safety.
– Classify non-conformance as minor, major, or critical based on its potential risks.
4.3.2 Root Cause Analysis
– Use structured methods such as Fishbone Diagrams or 5-Why Analysis to identify the root cause of the non-conformance.
– Involve cross-functional teams, including production and engineering, in the analysis.
4.3.3 Documentation
– Document findings in the NCR, including the root cause, contributing factors, and any immediate corrective actions taken.
4.4 Disposition of Non-Conforming Products
4.4.1 Disposition Options
– Rework: Modify the product to meet specifications, such as through additional processing or repairs.
– Return to Supplier: Return raw materials or components to suppliers if the non-conformance is supplier-related.
– Scrap: Dispose of products that cannot be reworked or repaired in compliance with waste management protocols.
– Use As-Is: Allow limited use of the product if it does not compromise safety, functionality, or regulatory compliance (requires QA approval).
4.4.2 Approval of Disposition
– Obtain approval for the disposition method from QA and relevant authorities before implementation.
– Record the approved disposition plan in the NCR.
4.4.3 Execution and Verification
– Execute the approved disposition plan and document actions taken.
– Verify that the reworked or repaired products meet specifications through additional testing or inspections.
4.5 Corrective and Preventive Actions (CAPA)
4.5.1 Corrective Actions
– Implement immediate corrective actions to address the identified non-conformance and prevent recurrence in the current batch.
– Examples include equipment adjustments, retraining operators, or modifying processes.
4.5.2 Preventive Actions
– Develop preventive measures to eliminate the root cause and reduce the likelihood of future non-conformances.
– Examples include revising SOPs, improving material inspection processes, or upgrading equipment.
4.5.3 Monitoring Effectiveness
– Monitor the effectiveness of corrective and preventive actions through regular audits and performance reviews.
– Update CAPA records to reflect progress and outcomes.
4.6 Documentation and Record Keeping
4.6.1 Non-Conformance Reports (NCR)
– Maintain detailed NCRs for all identified non-conformances, including root cause analysis, corrective actions, and final disposition.
– Ensure NCRs are signed by relevant personnel, including QA and supervisors.
4.6.2 CAPA Records
– Retain CAPA records related to non-conformances and link them to corresponding NCRs.
– Document actions, timelines, and effectiveness reviews.
4.6.3 Retention Period
– Store non-conformance records for at least five years or as required by regulatory standards.
– Ensure records are accessible during audits and inspections.
5) Abbreviations
– NCR: Non-Conformance Report
– QA: Quality Assurance
– CAPA: Corrective and Preventive Actions
– SOP: Standard Operating Procedure
6) Documents
– Non-Conformance Report (NCR) Template
– Root Cause Analysis Reports
– CAPA Records
– Inspection Logs
– Inventory Adjustment Records
7) Reference
– ISO 13485: Medical devices – Quality management systems
– FDA CFR Title 21, Part 820: Quality System Regulation
– ISO 14971: Application of Risk Management to Medical Devices
8) SOP Version
– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]
Annexure
Annexure 1: Non-Conformance Report (NCR) Template
| Date | Product/Batch ID | Description of Non-Conformance | Root Cause | Disposition | Approved By |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch ID | Description | Root Cause Details | Rework/Use As-Is/Return/Scrap | QA Name |
Annexure 2: CAPA Record Template
| Date | Action Type | Description | Responsible Person | Completion Date | Effectiveness |
|---|---|---|---|---|---|
| DD/MM/YYYY | Corrective/Preventive | Action Description | Responsible Name | DD/MM/YYYY | Effective/Needs Review |