API Specification Q1 Tenth Edition 5.9 Control of Nonconforming Product

5.9.1 Procedure

5.9.1.1 General

The organization shall maintain a documented procedure addressing the controls and related responsibilities and authorities for nonconforming product during product realization and after delivery.

A nonconforming product is any product that does not meet specified requirements or standards. This can include deviations in dimensions, materials, performance, or any other criteria specified by the customer or industry standards. Controlling nonconforming products is crucial to ensure that products delivered to customers meet all specified requirements and to maintain the integrity of the quality management system. Effective control prevents the unintended use or delivery of defective products, thereby protecting the organization’s reputation, minimizing costs associated with rework or recalls, and ensuring customer satisfaction.

To meet the API Q1 requirements for controlling nonconforming products, the organization must establish and maintain a documented procedure. This procedure should include the following steps:

1. Identification: Clearly mark or tag nonconforming products to distinguish them from conforming products. Use appropriate documentation and records to log nonconforming items.
2. Segregation: Physically separate nonconforming products from conforming ones to prevent accidental use. Use designated areas for storing nonconforming products.
3. Evaluation: Assess the extent and impact of the nonconformance. Determine the root cause of the nonconformance through investigation and analysis.
4. Disposition: Decide the appropriate action for each nonconforming product. Possible dispositions include:
   • Rework: Modify the product to meet the requirements.
   • Repair: Restore the product to a usable condition that meets specified requirements.
   • Use As Is: Accept the product without modification (with customer approval, if necessary).
   • Scrap: Dispose of the product if it cannot be reworked or repaired.
5. Authorization: Ensure that decisions regarding the disposition of nonconforming products are authorized by designated personnel. Obtain customer approval for any deviations from specified requirements, if applicable.
6. Correction: Implement corrective actions to address and rectify the nonconformance. Prevent recurrence by updating processes, training personnel, or making design changes.
7. Communication: Notify relevant stakeholders, including customers, about nonconformances and the actions taken. Provide evidence of conformity for any reworked or repaired products.
8. Documentation and Records: Maintain detailed records of nonconformances, including identification, evaluation, disposition, and corrective actions. Use these records for analysis and improvement of the quality management system.

The organization shall maintain a documented procedure addressing the controls and related responsibilities and authorities for nonconforming product during product realization and after delivery.

Addressing controls and related responsibilities and authorities for nonconforming products both during product realization and after delivery is crucial for maintaining quality and customer satisfaction. Here is a detailed approach for implementing these controls and defining responsibilities and authorities:

Controls for Nonconforming Products During Product Realization

• Control: Implement rework or repair actions to correct the nonconformance.
• Responsibility: The production team carries out rework or repair based on instructions from the QA team.
• Authority: The production manager oversees and authorizes rework and repair activities.

1. Identification and Documentation
   • Control: Ensure all nonconforming products are clearly identified and documented.
   • Responsibility: Quality Control (QC) inspectors are responsible for identifying and documenting nonconformances.
   • Authority: QC inspectors have the authority to halt production if a nonconformance is detected.
2. Segregation
   • Control: Nonconforming products must be segregated to prevent unintended use.
   • Responsibility: Production staff are responsible for moving nonconforming products to a designated “Quarantine Area”.
   • Authority: Production supervisors authorize the movement of nonconforming products to the quarantine area.
3. Evaluation and Disposition
   • Control: Evaluate the nonconformance to determine the root cause and appropriate disposition.
   • Responsibility: The Quality Assurance (QA) team conducts evaluations and recommends dispositions such as rework, repair, use as-is, or scrap.
   • Authority: The QA manager approves all disposition decisions.
4. Rework and Repair
   • Control: Implement rework or repair actions to correct the nonconformance.
   • Responsibility: The production team carries out rework or repair based on instructions from the QA team.
   • Authority: The production manager oversees and authorizes rework and repair activities.
5. Verification of Corrective Actions
   • Control: Verify that reworked or repaired products meet specified requirements.
   • Responsibility: QC inspectors re-inspect reworked or repaired products.
   • Authority: The QC manager authorizes the release of products after successful re-inspection.
6. Communication
   • Control: Communicate nonconformance details and corrective actions to relevant stakeholders.
   • Responsibility: The QA team prepares and disseminates reports on nonconformance and corrective actions.
   • Authority: The QA manager approves and sends communication to stakeholders, including customers if necessary.

Controls for Nonconforming Products After Delivery

1. Customer Notification
   • Control: Notify customers immediately upon discovering nonconforming products that have been delivered.
   • Responsibility: The customer service team handles customer notifications.
   • Authority: The customer service manager authorizes customer notifications and any subsequent actions.
2. Return and Recall Management
   • Control: Manage the return or recall of nonconforming products.
   • Responsibility: The logistics team manages product returns or recalls.
   • Authority: The logistics manager authorizes return or recall actions.
3. Investigation and Root Cause Analysis
   • Control: Conduct thorough investigations and root cause analysis for nonconforming products identified after delivery.
   • Responsibility: The QA team performs investigations and root cause analysis.
   • Authority: The QA manager approves investigation reports and root cause findings.
4. Corrective and Preventive Actions
   • Control: Implement corrective and preventive actions to address the root cause of nonconformances.
   • Responsibility: The continuous improvement team develops and implements corrective and preventive actions.
   • Authority: The continuous improvement manager approves corrective and preventive action plans.
5. Documentation and Records Maintenance
   • Control: Maintain detailed records of nonconformances, investigations, and actions taken.
   • Responsibility: The document control team ensures all records are properly maintained and accessible.
   • Authority: The document control manager oversees record maintenance and ensures compliance with documentation standards.

Example Table of Responsibilities and Authorities

Control Activity	Responsibility	Authority
Identification and Documentation	QC Inspectors	QC Inspectors
Segregation	Production Staff	Production Supervisors
Evaluation and Disposition	QA Team	QA Manager
Rework and Repair	Production Team	Production Manager
Verification of Corrective Actions	QC Inspectors	QC Manager
Customer Notification	Customer Service Team	Customer Service Manager
Return and Recall Management	Logistics Team	Logistics Manager
Investigation and Root Cause Analysis	QA Team	QA Manager
Corrective and Preventive Actions	Continuous Improvement Team	Continuous Improvement Manager
Documentation and Records Maintenance	Document Control Team	Document Control Manager

By clearly defining controls, responsibilities, and authorities for nonconforming products during product realization and after delivery, the organization can effectively manage and mitigate the impact of nonconformances. This structured approach ensures accountability, facilitates prompt corrective actions, and maintains high-quality standards, ultimately leading to greater customer satisfaction and operational efficiency.

Example of Procedure for Control of Nonconforming Product

1. Purpose: The purpose of this procedure is to define the process for identifying, documenting, evaluating, and disposing of nonconforming products during product realization and after delivery to ensure product quality and customer satisfaction.

2. Scope: This procedure applies to all products produced by the organization, including those identified as nonconforming during manufacturing, testing, or after delivery to the customer.

3. Definitions

• Nonconforming Product: Any product that does not meet specified requirements.
• Disposition: The decision regarding the handling of a nonconforming product, such as rework, repair, use as-is, or scrap.

4. Responsibilities

• Quality Control (QC) Inspectors: Identify and document nonconforming products.
• Production Staff: Segregate nonconforming products and perform rework or repair as directed.
• Quality Assurance (QA) Team: Evaluate nonconformances, determine root causes, and recommend dispositions.
• Production Manager: Oversee and authorize rework and repair activities.
• Customer Service Team: Notify customers of nonconformances identified after delivery.
• Logistics Team: Manage the return or recall of nonconforming products.
• Continuous Improvement Team: Develop and implement corrective and preventive actions.
• Document Control Team: Maintain records of nonconformances and actions taken.

5. Procedure

5.1 Identification and Documentation

1. Detection: When a nonconformance is detected, the QC inspector immediately tags the product with a nonconformance label.
2. Documentation: The QC inspector fills out a Nonconformance Report (NCR) detailing the nature of the nonconformance, including:
   • Product details (e.g., part number, batch number)
   • Description of the nonconformance
   • Date of detection
   • Inspector’s name

5.2 Segregation

1. Quarantine: Nonconforming products are moved to a designated quarantine area to prevent their use in production.
2. Control: The quarantine area is monitored and access is restricted to authorized personnel only.

5.3 Evaluation and Disposition

1. Evaluation: The QA team reviews the NCR and conducts a root cause analysis.
2. Disposition Decision: The QA team recommends a disposition (rework, repair, use as-is, or scrap) and records the decision on the NCR.
3. Approval: The QA manager reviews and approves the disposition.

5.4 Rework and Repair

1. Instructions: The production team receives detailed instructions for rework or repair from the QA team.
2. Execution: The production team performs the rework or repair as instructed.
3. Verification: After rework or repair, the QC inspector re-inspects the product to ensure it meets specifications.

5.5 Verification of Corrective Actions

1. Inspection: QC inspectors verify that corrective actions have resolved the nonconformance.
2. Approval: The QC manager authorizes the release of the product after successful verification.

5.6 Customer Notification (if applicable)

1. Notification: The customer service team informs the customer of any nonconformances found after delivery.
2. Documentation: Details of the nonconformance and customer communication are recorded.

5.7 Return and Recall Management

1. Logistics: The logistics team arranges for the return or recall of nonconforming products.
2. Tracking: All returned or recalled products are tracked and documented.

5.8 Corrective and Preventive Actions

1. Action Plan: The continuous improvement team develops an action plan to prevent recurrence of the nonconformance.
2. Implementation: The action plan is implemented and monitored for effectiveness.

5.9 Documentation and Records Maintenance

1. Record Keeping: The document control team ensures all NCRs, evaluation reports, and corrective action plans are properly filed and maintained.
2. Access: Records are accessible to authorized personnel for review and audit purposes.

6. Records

The following records are maintained as part of this procedure:

• Nonconformance Reports (NCRs)
• Root Cause Analysis Reports
• Disposition Records
• Customer Notification Records
• Return and Recall Logs
• Corrective and Preventive Action Plans
• Verification and Re-inspection Reports

7. Review and Continuous Improvement

This procedure is reviewed periodically to ensure its effectiveness and updated as necessary to incorporate feedback and changes in process requirements.