The procedure for addressing nonconforming product identified during product realization shall include requirements for:
a) product identification and control to prevent unintended use or delivery
b) addressing the detected nonconformity
c) taking action to preclude its original intended use or delivery
d) authorizing its use, release, or acceptance under concession by relevant authority and, when required, by the customer.
Managing nonconforming products is a critical aspect of ensuring quality in the oil and gas industry. Nonconforming products are those that fail to meet specified requirements during any stage of the product realization process. The management of these products includes identifying, documenting, evaluating, and appropriately disposing of them to prevent their unintended use and ensure customer satisfaction.
Key Requirements
- Identification: Nonconforming products must be clearly identified to prevent unintended use. This includes marking or tagging the products and segregating them from conforming products.
- Documentation: All instances of nonconformance must be documented. This includes details about the nature of the nonconformance, its location, and the actions taken to address it. Records should be maintained as evidence of control and corrective actions.
- Evaluation and Disposition: Nonconforming products must be evaluated to determine the cause and the appropriate disposition. Disposition options typically include:
- Rework: Adjusting the product to meet specifications.
- Repair: Fixing the product to meet acceptable standards.
- Use As-Is: Accepting the product in its nonconforming state (with approval).
- Scrap: Disposing of the product if it cannot be corrected.
- Corrective Actions: Actions must be taken to correct the nonconformance and prevent recurrence. This includes analyzing the root cause, implementing corrective actions, and verifying their effectiveness.
- Communication with Customers: If nonconforming products are detected after delivery, the organization must communicate with the customer, document the issue, and agree on corrective actions or concessions.
Process for Managing Nonconforming Products
- Detection and Reporting
- Detection: Nonconforming products can be detected during various stages, such as incoming inspection, in-process inspection, or final inspection.
- Reporting: When a nonconformance is detected, it should be reported immediately to the quality control (QC) department.
- Identification and Segregation
- Tagging: Nonconforming products are tagged or marked to clearly indicate their status.
- Segregation: These products are moved to a designated nonconformance area to avoid accidental use.
- Documentation
- Nonconformance Report (NCR): An NCR is generated for each nonconformance, detailing the product, the nature of the defect, detection date, and the person reporting it.
- Evaluation and Disposition
- Root Cause Analysis: The quality assurance (QA) team performs a root cause analysis to determine why the nonconformance occurred.
- Disposition Decision: Based on the evaluation, the QA team decides whether to rework, repair, use as-is, or scrap the product. This decision is documented in the NCR.
- Corrective and Preventive Actions
- Corrective Action Plan: Develop and implement actions to correct the issue and prevent its recurrence. This may involve changes in processes, materials, or training.
- Verification: After corrective actions are implemented, the product is re-inspected to ensure compliance with specifications.
- Customer Communication (if applicable)
- Notification: Inform the customer if nonconforming products are discovered after delivery, and agree on corrective actions or concessions.
- Documentation: Maintain records of all communications and agreements with the customer regarding nonconformance.
- Records and Documentation
- NCRs: Maintain all NCRs and related documents for future reference and audit purposes.
- Corrective Action Records: Document all corrective actions taken and their effectiveness.
Responsibilities
- Quality Control (QC) Inspectors
- Detect and report nonconformances.
- Tag and segregate nonconforming products.
- Production Staff
- Perform rework or repair as directed.
- Ensure segregated products are not used in production.
- Quality Assurance (QA) Team
- Conduct root cause analysis.
- Recommend and approve dispositions.
- Develop and verify corrective actions.
- Customer Service Team
- Communicate with customers regarding nonconforming products found after delivery.
- Document Control Team
- Maintain all records related to nonconformance management.
By following these steps and maintaining detailed records, an organization can effectively control nonconforming products during product realization, ensuring quality and compliance with customer requirements. This process not only helps in managing defects but also contributes to continuous improvement and customer satisfaction.
Procedure for Addressing Nonconforming Product During Product Realization
1. Purpose
To establish a systematic approach for identifying, controlling, and addressing nonconforming products to prevent their unintended use or delivery.
2. Scope
This procedure applies to all stages of product realization, including incoming inspection, in-process inspection, final inspection, and after delivery.
3. Definitions
- Nonconforming Product: A product that does not meet specified requirements.
- Rework: Actions taken to make a nonconforming product conform to the requirements.
- Repair: Actions taken to make a nonconforming product acceptable for its intended use, though it may not meet the original specifications.
- Use-As-Is: Accepting a nonconforming product without corrective action.
- Scrap: Disposing of a nonconforming product because it cannot be corrected.
4. Responsibilities
- Quality Control (QC) Inspectors: Detect and report nonconformances, tag and segregate nonconforming products.
- Production Staff: Perform rework or repair as directed, ensure segregated products are not used in production.
- Quality Assurance (QA) Team: Conduct root cause analysis, recommend and approve dispositions, develop and verify corrective actions.
- Customer Service Team: Communicate with customers regarding nonconforming products found after delivery.
- Document Control Team: Maintain all records related to nonconformance management.
5. Identification and Segregation
- Upon detection, nonconforming products must be immediately identified with a red tag labeled “Nonconforming.”
- Nonconforming products must be moved to a designated nonconforming product area to ensure they are segregated from conforming products.
6. Documentation
- An NCR (Nonconformance Report) must be completed for each nonconformance, detailing:
- Product details (e.g., part number, batch number, quantity)
- Nature of nonconformance
- Date of detection
- Name of the person reporting the nonconformance
7. Evaluation and Disposition
- The QA Team conducts a root cause analysis to determine the cause of the nonconformance.
- Dispositions for nonconforming products include:
- Rework: Bringing the product into conformance with the requirements.
- Repair: Making the product usable but not necessarily meeting the original specifications.
- Use-As-Is: Accepting the product as is.
- Scrap: Disposing of the product.
- The disposition decision must be documented on the NCR and approved by the QA manager.
8. Corrective and Preventive Actions
- Corrective actions must be developed to address the root cause of the nonconformance.
- Implement corrective actions and verify their effectiveness through re-inspection or testing.
- Preventive actions must be identified and implemented to avoid recurrence of similar nonconformances.
9. Customer Communication
- If nonconforming products are found after delivery, the customer must be notified promptly.
- All communications and agreements regarding corrective actions or concessions must be documented.
10. Records Management
- Maintain NCRs, corrective action records, and customer communication records for a minimum of 5 years.
- Ensure records are easily retrievable and stored securely.
11. Training and Awareness
- Provide training to all personnel involved in the nonconformance process.
- Conduct regular refresher training sessions to ensure ongoing awareness and competence.
12. Review and Continuous Improvement
- Conduct periodic reviews of nonconformance data to identify trends and areas for improvement.
- Update the procedure as needed based on review findings and continuous improvement initiatives.
13. References
- API Specification Q1
- Quality Manual
Steps in Detail
Identification and Segregation
- Detection: Upon detecting a nonconforming product, the QC inspector immediately tags the product with a red “Nonconforming” label.
- Segregation: The nonconforming product is moved to a designated area marked “Nonconforming Products.”
Documentation
- NCR Creation: The QC inspector completes an NCR, including details such as product ID, description of the nonconformance, date, and inspector’s name.
- Recording: The NCR is logged into the quality management system (QMS) for tracking.
Evaluation and Disposition
- Root Cause Analysis: The QA Team conducts a root cause analysis to determine why the nonconformance occurred.
- Disposition Decision: The QA manager reviews the analysis and decides the appropriate disposition (rework, repair, use-as-is, or scrap).
- Approval and Documentation: The disposition decision is documented on the NCR and approved by the QA manager.
Corrective and Preventive Actions
- Corrective Action Plan: The QA Team develops a corrective action plan to address the root cause.
- Implementation: Corrective actions are implemented and the product is re-inspected or retested.
- Verification: The effectiveness of corrective actions is verified.
- Preventive Actions: Preventive actions are identified and implemented to prevent recurrence.
Customer Communication
- Notification: If nonconforming products are discovered after delivery, the customer is notified immediately.
- Documentation: All communications and resolutions with the customer are documented.
Records Management
- NCR Storage: NCRs and related records are stored securely and maintained for at least 5 years.
- Accessibility: Records are kept easily accessible for review and audits.
Training and Awareness
- Initial Training: Personnel involved in the nonconformance process receive initial training on the procedure.
- Refresher Training: Regular refresher training sessions are conducted to maintain awareness and competence.
Review and Continuous Improvement
- Periodic Review: Nonconformance data is reviewed quarterly to identify trends.
- Procedure Update: Based on the review, the procedure is updated to incorporate improvements.
By implementing this structured procedure, an organization can effectively manage nonconforming products, ensuring compliance with API Q1 and maintaining high-quality standards throughout the product realization process.
The procedure for addressing nonconforming product identified during product realization must include product identification and control to prevent unintended use or delivery
The process for addressing nonconforming products identified during product realization must include rigorous product identification and control to prevent unintended use or delivery. This is essential for maintaining quality, safety, regulatory compliance, customer satisfaction, and cost management. By implementing comprehensive detection, segregation, documentation, control, evaluation, corrective actions, training, communication, and continuous improvement measures, an organization can effectively ensure that nonconforming products are properly managed and do not compromise the integrity of the final product. Importance of Including Product Identification and Control in the Process for Addressing Nonconforming Product
Why It’s Necessary:
- Ensuring Quality and Safety:
- Quality Assurance: Nonconforming products can compromise the quality and safety of the final product. Proper identification and control ensure that these products do not reach customers or end users.
- Safety: In the oil and gas industry, nonconforming products can pose significant safety risks, potentially leading to accidents or environmental hazards.
- Compliance with Standards:
- Regulatory Compliance: Standards like API Q1 require strict control over nonconforming products to ensure compliance with industry regulations.
- Audit Readiness: Proper documentation and control are essential for passing audits and maintaining certifications.
- Customer Satisfaction:
- Customer Trust: Delivering nonconforming products can damage customer trust and lead to loss of business.
- Avoiding Disputes: Proper control helps avoid disputes and potential legal issues related to product quality.
- Cost Management:
- Reducing Rework and Scrap Costs: Early identification and control of nonconforming products can reduce the costs associated with rework, scrap, and warranty claims.
- Minimizing Liability: Preventing nonconforming products from reaching customers minimizes the risk of liability and associated costs.
How to Ensure Product Identification and Control:
- Detection and Immediate Action
- Initial Identification: When a product is identified as nonconforming during any stage of product realization, it must be immediately tagged or labeled. Use a visible marker such as a red tag that clearly states “Nonconforming”.
- Information on Tag: Include critical information on the tag, such as:
- Product details (part number, batch number, quantity)
- Nature of the nonconformance
- Date of detection
- Name of the person who identified the nonconformance
- Segregation
- Designated Areas: Establish specific areas or bins for nonconforming products. These areas should be clearly marked and separate from areas used for conforming products.
- Physical Barriers: Use physical barriers (e.g., cages, locked rooms) to ensure that nonconforming products do not mix with conforming products.
- Documentation
- Nonconformance Report (NCR): Create and maintain an NCR for each nonconforming product. This report should include all relevant details and be stored in a quality management system (QMS) for tracking and analysis.
- Traceability: Ensure all nonconforming products are traceable through the documentation system, from detection to final disposition.
- Control Measures
- Access Control: Limit access to nonconforming product storage areas to authorized personnel only to prevent accidental use.
- Periodic Audits: Conduct regular audits to ensure compliance with segregation and identification protocols. This helps catch any lapses in the control process.
- Evaluation and Disposition
- Root Cause Analysis: Perform a thorough analysis to determine the cause of the nonconformance. This helps in deciding the appropriate disposition (e.g., rework, use-as-is, scrap).
- Approval for Disposition: Ensure that any decision on the disposition of nonconforming products is approved by authorized personnel. This step is crucial to maintain control and accountability.
- Corrective Actions
- Implement Corrective Actions: Develop and implement corrective actions based on the root cause analysis. These actions should be documented and their effectiveness verified.
- Preventive Measures: Identify and implement preventive measures to avoid recurrence of similar nonconformances.
- Training and Awareness
- Employee Training: Provide comprehensive training to employees on the procedures for identifying and controlling nonconforming products. Ensure they understand the importance of these procedures.
- Regular Updates: Conduct regular refresher training sessions and updates to keep employees informed of any changes in the process.
- Customer Communication
- Notification: If nonconforming products are detected after delivery, promptly notify the affected customers. Document all communications and agreed actions to maintain transparency and trust.
- Continuous Improvement
- Data Analysis: Periodically analyze data on nonconforming products to identify trends and areas for improvement. Update procedures and practices based on these insights.
- Feedback Loops: Establish feedback loops to ensure that lessons learned from nonconformances are communicated and integrated into the organization’s quality management system.
The procedure for addressing nonconforming product identified during product realization must include addressing the detected nonconformity
Addressing detected nonconformities during product realization is crucial for maintaining product quality, compliance with standards, customer satisfaction, and cost management. By implementing a structured process for identification, evaluation, containment, disposition, corrective actions, verification, documentation, training, and customer communication, an organization can effectively manage nonconformities and prevent their recurrence. This approach ensures that only conforming products reach the customer, maintaining the integrity and reputation of the organization.
Why It’s Necessary:
- Ensuring Product Quality:
- Quality Control: Addressing nonconformity ensures that only products that meet the specified requirements are delivered to customers. This maintains the high quality of the product and prevents defective products from reaching the market.
- Preventing Recurrence: By addressing nonconformities, the root cause can be identified and corrected, preventing future occurrences of the same issue.
- Compliance with Standards:
- Regulatory Requirements: Standards such as API Q1 mandate the identification and correction of nonconformities to ensure compliance with industry regulations and maintain certification.
- Audit Readiness: Proper handling of nonconformities is essential for passing audits and demonstrating compliance with quality management standards.
- Customer Satisfaction:
- Meeting Customer Expectations: Addressing nonconformities ensures that the product meets customer specifications and expectations, which is crucial for customer satisfaction and retention.
- Building Trust: Prompt and effective resolution of nonconformities builds trust with customers, showing commitment to quality and reliability.
- Cost Management:
- Reducing Costs: Identifying and addressing nonconformities early in the process can reduce the costs associated with rework, scrap, returns, and warranty claims.
- Minimizing Liability: Addressing nonconformities minimizes the risk of liability and associated costs by ensuring that nonconforming products do not reach the market.
How an Organization Can Address Detected Nonconformity
- Identification and Documentation
- Immediate Identification: When a nonconformity is detected, it should be immediately identified and documented. This can involve tagging the product and recording details in a Nonconformance Report (NCR).
- Detailed Record: The NCR should include information such as the nature of the nonconformity, the date it was detected, the person who detected it, and any initial actions taken.
- Evaluation and Analysis
- Root Cause Analysis: Conduct a thorough analysis to determine the root cause of the nonconformity. Tools such as the 5 Whys, Fishbone Diagrams, or Failure Mode and Effects Analysis (FMEA) can be used.
- Impact Assessment: Assess the impact of the nonconformity on the product and the production process. Determine if it affects other batches or products.
- Containment Actions
- Immediate Containment: Implement immediate containment actions to prevent the nonconforming product from being used or delivered. This may involve segregating the product, stopping production, or halting shipments.
- Communication: Communicate the issue to relevant stakeholders, including production teams, quality control, and potentially the customer, if the nonconformity has broader implications.
- Disposition of Nonconforming Product
- Decision Making: Decide on the disposition of the nonconforming product. Possible actions include rework, repair, use-as-is (with or without concession), or scrapping the product.
- Approval Process: Ensure that any decision on disposition is reviewed and approved by authorized personnel, such as quality managers or engineering leads.
- Corrective Actions
- Develop Actions: Based on the root cause analysis, develop corrective actions to address the root cause and prevent recurrence. This may involve process changes, additional training, or equipment modifications.
- Implement Actions: Implement the corrective actions and document the changes made. Ensure that all affected personnel are aware of the new procedures or processes.
- Verification and Validation
- Effectiveness Check: Verify the effectiveness of the corrective actions by monitoring the production process and checking for the recurrence of the nonconformity.
- Validation: Validate that the corrective actions have successfully resolved the issue and that the product now meets the required specifications.
- Documentation and Records
- Maintain Records: Keep detailed records of the nonconformity, including the NCR, root cause analysis, containment and corrective actions, and any communications with stakeholders.
- Traceability: Ensure that records are traceable and easily accessible for audits and future reference.
- Training and Awareness
- Employee Training: Train employees on the new processes or procedures implemented as part of the corrective actions. Ensure they understand the importance of addressing nonconformities.
- Continuous Improvement: Encourage a culture of continuous improvement where employees are proactive in identifying and addressing potential nonconformities.
- Customer Communication
- Notification: If nonconforming products have already been delivered, promptly notify affected customers. Provide details of the nonconformity, the actions taken, and any steps they need to take.
- Resolution and Follow-Up: Work with the customer to resolve the issue and follow up to ensure their satisfaction. Document all communications and actions taken.
The procedure for addressing nonconforming product identified during product realization must include taking action to preclude its original intended use or delivery
The process for addressing nonconforming products during product realization must include measures to preclude their original intended use or delivery to ensure product quality, customer satisfaction, regulatory compliance, and cost management. By implementing robust identification, segregation, documentation, review, disposition, preventive measures, and continuous improvement practices, an organization can effectively manage nonconforming products and prevent their unintended use or delivery. This approach helps maintain high standards of quality, builds customer trust, and ensures compliance with industry regulations.
Why It’s Necessary:
- Quality Assurance:
- Maintain Standards: Ensuring nonconforming products do not proceed to their intended use or delivery helps maintain the organization’s quality standards and reputation.
- Prevent Defects: Preventing nonconforming products from being used or delivered minimizes the risk of defects and failures in the field, which could lead to safety issues or operational disruptions.
- Customer Satisfaction:
- Meet Expectations: Customers expect products to meet specified requirements. Delivering nonconforming products can lead to dissatisfaction, returns, and loss of trust.
- Brand Reputation: Consistently delivering conforming products enhances the organization’s brand and reliability in the market.
- Regulatory Compliance:
- Adherence to Standards: Compliance with industry standards like API Q1 requires strict control over nonconforming products. This ensures the organization meets all regulatory and contractual obligations.
- Avoid Penalties: Proper handling of nonconforming products helps avoid legal and financial penalties associated with non-compliance.
- Cost Management:
- Reduce Rework and Scrap: Identifying and segregating nonconforming products early can reduce the costs associated with rework, scrap, and warranty claims.
- Minimize Liability: Preventing the use or delivery of nonconforming products reduces the risk of liability and associated costs from product failures or recalls.
How to Take Action to Preclude Original Intended Use or Delivery
- Identification and Segregation
- Tagging and Labeling: Clearly tag and label nonconforming products to indicate their status. Use color-coded labels or tags that are easily recognizable.
- Segregated Storage: Store nonconforming products in designated areas separate from conforming products to prevent accidental use. Use physical barriers, separate bins, or marked shelves.
- Documentation and Tracking
- Nonconformance Reports (NCRs): Document each nonconforming product with a detailed Nonconformance Report. Include information such as the nature of the nonconformity, detection date, and responsible personnel.
- Tracking System: Implement a tracking system to monitor the status of nonconforming products. This can be a manual log or an electronic system integrated with the organization’s quality management software.
- Authorization and Disposition
- Review and Approval: Require review and approval by authorized personnel before any nonconforming product is reworked, repaired, or scrapped. This ensures that proper evaluation and decision-making processes are followed.
- Disposition Actions: Decide on the disposition of nonconforming products, which may include:
- Rework: Modify the product to meet specifications.
- Repair: Fix defects that do not affect overall functionality.
- Use-as-is: Accept the product with concessions (requires customer approval).
- Scrap: Discard the product if it cannot be brought to conformity.
- Preventive Measures
- Process Controls: Implement process controls to prevent nonconforming products from moving to the next production stage or being shipped. This can include checklists, quality gates, and automated systems.
- Employee Training: Train employees on the importance of identifying and handling nonconforming products. Ensure they understand the procedures and their role in maintaining quality.
- Customer Communication
- Notification: If nonconforming products have already been shipped, promptly notify the customer. Provide details of the nonconformity and actions being taken to address the issue.
- Resolution: Work with the customer to resolve the issue, which may include product replacement, repair, or concessions. Document all communications and agreed-upon actions.
- Continuous Improvement
- Root Cause Analysis: Conduct a root cause analysis for each nonconformance to identify underlying issues. Use tools like the 5 Whys or Fishbone Diagrams.
- Corrective Actions: Implement corrective actions to address the root causes and prevent recurrence. Monitor the effectiveness of these actions and make adjustments as needed.
The procedure for addressing nonconforming product identified during product realization must include authorizing its use, release, or acceptance under concession by relevant authority and, when required, by the customer.
The process for addressing nonconforming products identified during product realization must include authorizing their use, release, or acceptance under concession to ensure quality, customer satisfaction, regulatory compliance, and cost management. By establishing clear procedures, involving relevant authorities and customers, conducting thorough evaluations and risk assessments, maintaining detailed records, and monitoring the implementation, an organization can effectively manage nonconforming products and ensure they are used appropriately under controlled conditions. This approach helps maintain high standards of quality, builds customer trust, and ensures compliance with industry regulations.
Why It’s Necessary:
- Quality Assurance:
- Controlled Use: Authorizing the use, release, or acceptance of nonconforming products under concession ensures that the decision is made based on a thorough evaluation of the product’s fitness for purpose.
- Risk Mitigation: It allows the organization to manage risks associated with nonconforming products effectively by ensuring they are used only under controlled conditions.
- Customer Satisfaction:
- Transparency: Involving the customer in the decision-making process builds trust and ensures that they are aware of and agree to the use of nonconforming products under specific conditions.
- Meeting Expectations: Customers can provide input on whether the nonconforming product is acceptable for their needs, ensuring their requirements and expectations are met.
- Regulatory Compliance:
- Adherence to Standards: Complying with standards like API Q1 requires documented authorization for the use of nonconforming products. This ensures regulatory and contractual obligations are met.
- Avoid Penalties: Proper authorization processes help avoid legal and financial penalties associated with unauthorized use of nonconforming products.
- Cost Management:
- Resource Optimization: Authorizing the use of nonconforming products under concession can save costs by reducing the need for rework, scrap, or replacement, provided the product meets certain acceptable criteria.
- Warranty and Liability: Properly authorized use helps manage warranty claims and liability by ensuring that all parties are informed and agree to the product’s condition and use.
How to Include Authorization for Use, Release, or Acceptance Under Concession
- Establish Clear Procedures
- Documented Process: Develop a documented procedure that outlines the steps for authorizing the use, release, or acceptance of nonconforming products under concession. This should be part of the organization’s quality management system.
- Roles and Responsibilities: Define the roles and responsibilities of personnel involved in the authorization process. Ensure that relevant authorities within the organization and, when necessary, the customer, are clearly identified.
- Evaluation and Risk Assessment
- Detailed Evaluation: Conduct a thorough evaluation of the nonconforming product to understand the nature and extent of the nonconformity. Assess the impact on performance, safety, and reliability.
- Risk Assessment: Perform a risk assessment to determine the potential consequences of using, releasing, or accepting the nonconforming product. Consider factors such as safety, functionality, and customer requirements.
- Customer Involvement
- Notification and Agreement: Inform the customer of the nonconformity and provide details of the proposed concession. Obtain their agreement in writing before proceeding.
- Documentation: Record all communications with the customer regarding the nonconformity and their agreement to the concession. Ensure that this documentation is stored in the organization’s quality management system.
- Authorization by Relevant Authority
- Internal Review and Approval: Ensure that the use, release, or acceptance of the nonconforming product is reviewed and approved by relevant authorities within the organization. This could include quality managers, engineers, and senior management.
- Approval Documentation: Create a formal approval document that includes the details of the nonconformity, the evaluation results, risk assessment, and the conditions under which the product is authorized for use. This document should be signed by the relevant authorities.
- Traceability and Records
- Record Keeping: Maintain detailed records of the evaluation, risk assessment, customer communications, and authorization approvals. Ensure that these records are easily traceable and accessible for audits and reviews.
- Concession Records: Include concession records in the product’s quality documentation. This ensures that the history of the nonconforming product and its authorized use is transparent and available for future reference.
- Implementation and Monitoring
- Controlled Use: Implement controls to ensure that the nonconforming product is used only under the authorized conditions. This could involve special handling instructions, additional inspections, or usage limitations.
- Monitoring and Review: Monitor the performance of the nonconforming product in its authorized use. Review the outcomes to ensure that the concession did not negatively impact product performance or customer satisfaction.
To include authorizing the use, release, or acceptance of nonconforming products under concession by relevant authority and, when required, by the customer, the following records are necessary:
- Nonconformance Report (NCR)
- Description of Nonconformity: Detailed description of the nonconforming product, including the nature and extent of the nonconformity.
- Identification Information: Product identification details such as batch number, serial number, and relevant specifications.
- Evaluation Report
- Assessment of Impact: Evaluation of the nonconforming product’s impact on performance, safety, and reliability.
- Root Cause Analysis: Investigation and documentation of the root cause of the nonconformity, if applicable.
- Risk Assessment Document
- Risk Analysis: Detailed risk assessment considering the potential consequences of using, releasing, or accepting the nonconforming product.
- Mitigation Measures: Identified measures to mitigate any risks associated with the nonconforming product.
- Customer Communication Records
- Notification to Customer: Documentation of communications with the customer regarding the nonconformity and proposed concession.
- Customer Agreement: Written agreement or approval from the customer, if required, for the use, release, or acceptance of the nonconforming product under concession.
- Internal Approval Documents
- Authorization Form: Form or document showing internal authorization by relevant authorities within the organization.
- Signatures and Approvals: Signatures from quality managers, engineers, senior management, or other relevant authorities who have reviewed and approved the concession.
- Concession Records
- Concession Details: Specific conditions under which the nonconforming product is authorized for use, release, or acceptance.
- Documentation of Approval: Detailed record of the concession, including any special handling instructions, usage limitations, and additional inspections required.
- Traceability Records
- Identification Records: Records ensuring traceability of the nonconforming product, including serial numbers, batch numbers, and date of manufacture.
- Audit Trail: Comprehensive audit trail of all decisions, evaluations, approvals, and communications related to the nonconforming product.
- Implementation and Monitoring Records
- Controlled Use Instructions: Documentation of the specific controls and instructions implemented to ensure the nonconforming product is used only under authorized conditions.
- Performance Monitoring: Records of monitoring the performance of the nonconforming product in its authorized use, including any feedback or issues encountered.
- Corrective Action Records (if applicable)
- Corrective Action Plan: Documentation of any corrective actions taken to prevent recurrence of the nonconformity.
- Effectiveness Review: Records showing the review of the effectiveness of the corrective actions implemented.
Summary Table for Records
| Record Type | Details Included |
|---|---|
| Nonconformance Report (NCR) | Description of nonconformity, product identification details |
| Evaluation Report | Assessment of impact, root cause analysis |
| Risk Assessment Document | Risk analysis, mitigation measures |
| Customer Communication Records | Notification to customer, customer agreement |
| Internal Approval Documents | Authorization form, signatures, and approvals |
| Concession Records | Concession details, documentation of approval |
| Traceability Records | Identification records, audit trail |
| Implementation and Monitoring | Controlled use instructions, performance monitoring |
| Corrective Action Records | Corrective action plan, effectiveness review (if applicable) |
By maintaining these records, the organization ensures transparency, accountability, and compliance with API Q1 requirements for managing nonconforming products and authorizing their use, release, or acceptance under concession.
