API Specification Q1 Tenth Edition 5.9.1.3 Nonconforming Product After Delivery

QMS for Oil and gas 11 Minutes

The procedure for addressing nonconforming product delivered to the customer shall include requirements for:
a) identifying, documenting, and reporting nonconforming product
b) the analysis of nonconforming product, provided the product or documented evidence supporting the nonconformity is available to facilitate the determination of the cause
c) taking action appropriate to the effects, or potential effects, of the nonconformity
d) authorizing its use or acceptance under concession by relevant authority and, when required, by the customer.

Addressing nonconforming products after delivery is essential for maintaining customer satisfaction, upholding quality standards, and complying with industry requirements such as API Q1. Here’s how an organization can systematically address nonconforming products after delivery to the customer:

Steps to Address Nonconforming Products After Delivery

1. Customer Notification and Initial Response

  • Customer Complaint Handling: Establish a process for receiving and documenting customer complaints or notifications about nonconforming products.
  • Acknowledgment: Promptly acknowledge receipt of the complaint to the customer and provide an initial response indicating that the issue is being investigated.

2. Identification and Documentation

  • Nonconformance Report (NCR): Create a detailed NCR that includes:
    • Description of the nonconformity
    • Customer details and contact information
    • Product identification (e.g., serial number, batch number)
    • Date and context of discovery
  • Documentation: Record all relevant information about the nonconformity, including any supporting evidence provided by the customer (e.g., photos, test results).

3. Containment Actions

  • Segregation: Identify and segregate any remaining inventory of the affected product to prevent further use or shipment.
  • Customer Instructions: Provide the customer with instructions on how to handle the nonconforming product, such as quarantine procedures or return instructions.

4. Root Cause Analysis

  • Investigation Team: Assemble a team to investigate the nonconformity, including personnel from relevant departments such as quality control, production, and engineering.
  • Data Collection: Collect data from the production process, inspection records, and customer feedback.
  • Analysis Tools: Use tools such as the 5 Whys, Fishbone Diagram, or Failure Mode and Effects Analysis (FMEA) to determine the root cause of the nonconformity.

5. Corrective Actions

  • Action Plan: Develop a corrective action plan to address the root cause and prevent recurrence. This plan should include:
    • Specific actions to be taken
    • Responsible personnel
    • Timelines for implementation
  • Implementation: Implement the corrective actions as per the plan.
  • Verification: Verify the effectiveness of the corrective actions by re-inspecting the product, conducting additional tests, or auditing the process.

6. Communication with the Customer

  • Investigation Findings: Communicate the findings of the root cause analysis and the corrective actions taken to the customer.
  • Resolution Agreement: Agree on the resolution with the customer, which may include product replacement, repair, refund, or another form of compensation.

7. Disposition of Nonconforming Product

  • Return or Rework: Arrange for the return or rework of the nonconforming product if feasible.
  • Scrap: If the product cannot be reworked or returned, decide on scrapping the product with proper documentation.
  • Authorization: Obtain necessary approvals for the disposition method chosen from relevant authorities and, if applicable, the customer.

8. Updating Records

  • NCR Update: Update the NCR with details of the investigation, corrective actions, and final disposition.
  • Records Maintenance: Maintain comprehensive records of all activities related to the nonconforming product, including customer communications, investigation reports, corrective action plans, and disposition documentation.

9. Review and Continuous Improvement

  • Management Review: Include discussions of nonconformities and their resolutions in management review meetings to identify trends and opportunities for improvement.
  • Feedback Loop: Use the insights gained from addressing nonconformities to enhance the quality management system, update procedures, and train personnel to prevent future occurrences.

Procedure for addressing nonconforming product delivered to the customer

1. Customer Notification and Initial Response

  • Step 1.1: Receive Complaint
    • Responsible: Customer Service/Quality Department
    • Action: Log the complaint received from the customer regarding a nonconforming product.
    • Records: Customer Complaint Form
  • Step 1.2: Acknowledge Complaint
    • Responsible: Customer Service
    • Action: Acknowledge receipt of the complaint within 24 hours and inform the customer that the issue is under investigation.
    • Records: Complaint Acknowledgment Email

2. Identification and Documentation

  • Step 2.1: Create Nonconformance Report (NCR)
    • Responsible: Quality Control
    • Action: Document details of the nonconformance, including product identification, description of the issue, customer information, and date of discovery.
    • Records: Nonconformance Report (NCR) Form

3. Containment Actions

  • Step 3.1: Segregate Remaining Products
    • Responsible: Inventory/Quality Control
    • Action: Identify and segregate any remaining stock of the affected product to prevent further use or shipment.
    • Records: Inventory Segregation Log
  • Step 3.2: Customer Instructions
    • Responsible: Customer Service/Quality Control
    • Action: Provide the customer with instructions on handling the nonconforming product, such as quarantine or return procedures.
    • Records: Customer Communication Log

4. Root Cause Analysis

  • Step 4.1: Assemble Investigation Team
    • Responsible: Quality Control Manager
    • Action: Form a team comprising members from relevant departments.
    • Records: Team Assembly Record
  • Step 4.2: Conduct Investigation
    • Responsible: Investigation Team
    • Action: Collect data, analyze the issue, and determine the root cause using appropriate tools (e.g., 5 Whys, Fishbone Diagram).
    • Records: Root Cause Analysis Report

5. Corrective Actions

  • Step 5.1: Develop Corrective Action Plan
    • Responsible: Quality Control
    • Action: Create a plan detailing specific corrective actions, responsible personnel, and timelines.
    • Records: Corrective Action Plan
  • Step 5.2: Implement Corrective Actions
    • Responsible: Assigned Personnel
    • Action: Carry out the corrective actions as per the plan.
    • Records: Corrective Action Implementation Record
  • Step 5.3: Verify Effectiveness
    • Responsible: Quality Control
    • Action: Verify the effectiveness of corrective actions through re-inspection or additional tests.
    • Records: Verification Report

6. Communication with the Customer

  • Step 6.1: Report Findings to Customer
    • Responsible: Quality Control/Customer Service
    • Action: Communicate the investigation findings and corrective actions to the customer.
    • Records: Customer Communication Log
  • Step 6.2: Agree on Resolution
    • Responsible: Customer Service
    • Action: Agree on the resolution with the customer (e.g., product replacement, repair, refund).
    • Records: Resolution Agreement Document

7. Disposition of Nonconforming Product

  • Step 7.1: Return or Rework Product
    • Responsible: Quality Control/Production
    • Action: Arrange for the return or rework of the nonconforming product.
    • Records: Return Authorization Form, Rework Order
  • Step 7.2: Scrap Product
    • Responsible: Quality Control
    • Action: Scrap the product if it cannot be reworked or returned, with appropriate documentation.
    • Records: Scrap Report

8. Updating Records

  • Step 8.1: Update NCR
    • Responsible: Quality Control
    • Action: Update the NCR with details of the investigation, corrective actions, and final disposition.
    • Records: Updated Nonconformance Report

9. Review and Continuous Improvement

  • Step 9.1: Management Review
    • Responsible: Management Team
    • Action: Review nonconformities and their resolutions in management meetings to identify trends and improvement opportunities.
    • Records: Management Review Minutes
  • Step 9.2: Implement Improvements
    • Responsible: Quality Control
    • Action: Use lessons learned to update procedures, train personnel, and enhance the quality management system.
    • Records: Improvement Implementation Record

The procedure for addressing nonconforming product delivered to the customer must include identifying, documenting, and reporting nonconforming product

To effectively address nonconforming product after delivery, an organization must establish a robust process for identifying, documenting, and reporting nonconforming products. Here’s how this process can be structured:

Identifying Nonconforming Product

  1. Customer Complaint/Feedback Mechanism:
    • Action: Establish channels for customers to report nonconforming products. This can include hotlines, email, online forms, or customer service representatives.
    • Tools: Customer feedback forms, complaint tracking software.
  2. Internal Audit and Review:
    • Action: Conduct regular internal audits and reviews of product performance in the field to identify potential nonconformities.
    • Tools: Audit checklists, review meetings, performance data analysis.
  3. Warranty and Service Reports:
    • Action: Monitor warranty claims and service reports for indications of nonconforming products.
    • Tools: Warranty claims database, service report logs.

Documenting Nonconforming Product

  1. Nonconformance Report (NCR):
    • Action: When a nonconforming product is identified, create a detailed Nonconformance Report.
    • Contents:
      • Product identification (e.g., model, serial number).
      • Description of the nonconformity.
      • Date and method of discovery.
      • Customer information and contact details.
      • Initial assessment of the impact.
    • Tools: NCR forms (physical or electronic).
  2. Containment Action Log:
    • Action: Document immediate containment actions taken to isolate the nonconforming product and prevent further use or delivery.
    • Contents:
      • Steps taken to segregate affected products.
      • Instructions provided to customers.
      • Any temporary measures to address the issue.
    • Tools: Containment action forms, segregation logs.

Reporting Nonconforming Product

  1. Internal Reporting:
    • Action: Report the nonconforming product to relevant internal stakeholders such as quality control, production, and management.
    • Tools: Internal communication channels, NCR system.
  2. Customer Notification:
    • Action: Notify the customer about the nonconformance, the steps being taken to address it, and any immediate actions they need to take.
    • Contents:
      • Description of the nonconformity.
      • Impact assessment.
      • Instructions for handling the nonconforming product.
      • Contact details for further assistance.
    • Tools: Customer communication templates, emails, phone calls.
  3. Regulatory Reporting (if applicable):
    • Action: If required by regulatory bodies, report the nonconformance to appropriate authorities.
    • Contents:
      • Detailed description of the nonconformance.
      • Actions taken to address the issue.
      • Preventive measures implemented.
    • Tools: Regulatory reporting forms, compliance management software.

Example Workflow

StepActionTools/RecordsResponsible
1. Customer Complaint ReceivedLog the complaint in the system.Customer Complaint FormCustomer Service
2. Initial AssessmentEvaluate the complaint and determine if it is a nonconformance.Initial Assessment ChecklistQuality Control
3. Create NCRDocument the nonconformance details.NCR FormQuality Control
4. Containment ActionsImplement immediate actions to contain the issue.Containment Action LogQuality Control
5. Internal ReportingNotify relevant departments about the issue.Internal Communication SystemQuality Control
6. Customer NotificationInform the customer about the nonconformance and next steps.Customer Notification Email/LetterCustomer Service/Quality
7. Root Cause AnalysisInvestigate the cause of the nonconformance.Root Cause Analysis ReportQuality Control Team
8. Corrective ActionsDevelop and implement corrective actions.Corrective Action PlanAssigned Personnel
9. VerificationVerify the effectiveness of the corrective actions.Verification ReportQuality Control
10. Final CommunicationCommunicate the resolution and preventive measures to the customer.Final Resolution CommunicationCustomer Service/Quality
11. Regulatory Reporting (if needed)Report to regulatory bodies as required.Regulatory Reporting FormsCompliance Manager
12. Record KeepingMaintain all records related to the nonconformance.NCR Database, Containment Logs, Corrective Action RecordsDocument Control

By implementing these steps, the organization can ensure that nonconforming products are promptly identified, accurately documented, and effectively reported, thereby maintaining product quality and customer satisfaction.

The procedure for addressing nonconforming product delivered to the customer must include the analysis of nonconforming product, provided the product or documented evidence supporting the nonconformity is available to facilitate the determination of the cause

To analyze nonconforming product after delivery, the organization must conduct a thorough investigation to determine the cause of the nonconformity. Here’s how this analysis can be conducted:

  1. Gather Information: Collect all available information related to the nonconforming product, including product specifications, inspection records, customer complaints, service reports, and any other relevant documentation.
  2. Review Documentation: Examine the product documentation and evidence supporting the nonconformity to understand the nature and extent of the issue.
  3. Root Cause Analysis (RCA): Conduct a root cause analysis to identify the underlying factors that led to the nonconformance. This may involve using techniques such as:
    • 5 Whys: Asking “why” repeatedly to trace the root cause of the problem.
    • Fishbone Diagram (Ishikawa Diagram): Identifying potential causes categorized into factors like people, process, equipment, materials, etc.
    • Fault Tree Analysis: Mapping out all possible causes and their interrelationships to identify the root cause.
  4. Investigate Process Steps: Review the entire production and delivery process to identify any points where the nonconformity may have originated or been introduced.
  5. Consult Experts: Engage relevant stakeholders, subject matter experts, or quality assurance professionals to provide insights and expertise in analyzing the nonconformance.
  6. Document Findings: Record the findings of the analysis, including the identified root cause(s) and any contributing factors. Ensure that all documentation is clear, accurate, and comprehensive.
  7. Verify Findings: Validate the identified root cause(s) through testing, analysis, or additional verification methods to confirm their accuracy.
  8. Corrective Actions: Develop corrective actions based on the root cause analysis findings to address the underlying issues and prevent recurrence of similar nonconformities in the future.
  9. Implement Preventive Measures: Implement preventive measures to proactively address potential causes of nonconformities and improve the overall effectiveness of the quality management system.
  10. Monitor and Review: Establish mechanisms for ongoing monitoring and review of the corrective and preventive actions to ensure their effectiveness and sustainability over time.

By following these steps, the organization can systematically analyze nonconforming product after delivery, identify the root cause(s) of the nonconformity, and implement appropriate corrective and preventive actions to prevent recurrence and continually improve product quality and customer satisfaction.

The procedure for addressing nonconforming product delivered to the customer must include taking action appropriate to the effects, or potential effects, of the nonconformity

To address nonconforming product after delivery, the organization must take action appropriate to the effects or potential effects of the nonconformity. Here’s how the organization can approach this:

  1. Assess Impact: Evaluate the severity and potential consequences of the nonconformity on product performance, safety, regulatory compliance, customer satisfaction, and other relevant factors.
  2. Immediate Containment: Implement immediate containment measures to prevent further distribution or use of the nonconforming product, especially if it poses safety risks or significant quality issues.
  3. Determine Corrective Actions: Based on the severity and nature of the nonconformity, determine appropriate corrective actions to address the root cause(s) and mitigate any adverse effects.
  4. Prioritize Actions: Prioritize corrective actions based on the level of risk associated with the nonconformity and its potential impact on stakeholders, regulatory compliance, and the organization’s reputation.
  5. Communicate with Stakeholders: Communicate transparently with internal and external stakeholders, including customers, regulatory agencies, suppliers, and employees, about the nonconformity and the actions being taken to address it.
  6. Implement Corrective Measures: Execute the identified corrective actions promptly and effectively to rectify the nonconformity and prevent its recurrence.
  7. Monitor Effectiveness: Monitor the effectiveness of the corrective actions through ongoing evaluation, testing, and verification to ensure that the nonconformity is adequately addressed and prevented from recurring.
  8. Document Actions Taken: Maintain comprehensive records documenting all actions taken to address the nonconformity, including containment measures, corrective actions, communication logs, and verification activities.
  9. Review and Improve Processes: Conduct a review of the incident to identify opportunities for process improvement and preventive measures to minimize the likelihood of similar nonconformities in the future.
  10. Continuous Improvement: Continuously monitor and review the organization’s processes, procedures, and controls to identify and address potential sources of nonconformities and drive continual improvement in product quality and customer satisfaction.

By taking action appropriate to the effects or potential effects of the nonconformity, the organization can effectively address nonconforming product after delivery, minimize risks, and maintain customer confidence and satisfaction.

The procedure for addressing nonconforming product delivered to the customer must include authorizing its use or acceptance under concession by relevant authority and, when required, by the customer.

To address nonconforming product after delivery, authorizing its use or acceptance under concession by relevant authority, and when required, by the customer can be addressed through the following steps:

  1. Identify Nonconforming Product: Upon identifying nonconforming product after delivery, assess the severity and impact of the nonconformity to determine if it can be addressed through concession.
  2. Concession Authorization Process:
    • Establish a formal process for reviewing and authorizing concessions for nonconforming products.
    • Define criteria for determining when concessions are appropriate, including factors such as the nature of the nonconformity, its impact on product performance or safety, and regulatory requirements.
  3. Evaluation by Relevant Authority:
    • If the nonconforming product can be authorized for use under concession, involve the relevant authority or department responsible for approving concessions.
    • Ensure that the relevant authority has the necessary expertise and authority to assess the nonconformity and make informed decisions regarding its disposition.
  4. Documenting Concession Requests:
    • Document all concession requests, including details of the nonconformity, its impact, proposed corrective actions, and any supporting documentation.
    • Maintain records of concession requests and approvals for traceability and accountability purposes.
  5. Customer Communication:
    • If required by contractual agreements or customer expectations, communicate with the customer regarding the nonconformity and the proposed concession.
    • Provide clear and transparent information about the nature of the nonconformity, the proposed corrective actions, and any implications for product performance or safety.
  6. Obtain Customer Approval (if required):
    • If the customer’s approval is required for accepting nonconforming product under concession, seek their authorization through formal channels.
    • Provide the customer with the necessary information and documentation to make an informed decision regarding the concession.
  7. Implement Corrective Actions:
    • Once authorization for concession is obtained, implement the agreed-upon corrective actions to address the nonconformity and mitigate its impact.
    • Ensure that all corrective actions are completed promptly and effectively to restore product quality and safety.
  8. Verification and Validation:
    • Verify and validate the effectiveness of the corrective actions to ensure that the nonconformity has been adequately addressed and that the product meets the required specifications and standards.
  9. Continuous Improvement:
    • Review the concession authorization process periodically to identify opportunities for improvement and enhance the effectiveness of concession management.
    • Incorporate lessons learned from concession experiences into the organization’s quality management system to prevent similar nonconformities in the future.

By following these steps, the organization can effectively address nonconforming product after delivery by authorizing its use or acceptance under concession when appropriate, ensuring compliance with relevant requirements and customer expectations.

Example of Records to be Maintained

Record TypeDetails Included
Nonconformance Report (NCR)Description of nonconformity, customer details, product identification, initial assessment
Customer Communication RecordsNotifications from and to the customer, instructions provided, resolution agreement
Root Cause Analysis ReportInvestigation team details, data collected, analysis tools used, root cause identified
Corrective Action PlanActions to address root cause, implementation timeline, responsible personnel
Verification RecordsEvidence of corrective action implementation, verification results
Disposition RecordsChosen disposition method, authorizations, and approvals
Management Review MinutesDiscussion on nonconformities, trends identified, decisions made for continuous improvement
Feedback and Improvement RecordsLessons learned, changes made to processes or procedures, training records

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