API Specification Q1 Tenth Edition 5.9.2 Nonconforming Product

The organization shall address nonconforming product by performing one or more of the following:
a) repair or rework with subsequent inspection to meet specified requirements.
b) re-grade for alternative applications.
c) release under concession and/or
d) reject or scrap.

To address nonconforming product, the organization must consider and implement one or more of the following actions:

a) Repair or Rework with Subsequent Inspection to Meet Specified Requirements

Why: To restore the product to a state where it meets the specified requirements and can perform as intended.

How:

1. Identify Nonconformity: Clearly define and document the nature of the nonconformity.
2. Repair/Rework Plan: Develop a plan for the repair or rework of the nonconforming product. This plan should outline the steps needed to correct the nonconformity.
3. Implement Repair/Rework: Execute the repair or rework process as per the plan.
4. Inspection and Testing: Conduct thorough inspections and tests to ensure that the repaired or reworked product now meets the specified requirements.
5. Document Actions: Maintain records of the repair or rework activities, including details of the nonconformity, actions taken, and results of inspections.

b) Re-grade for Alternative Applications

Why: To utilize the nonconforming product in a different application where the nonconformity does not impact its usability or safety.

How:

1. Identify Alternative Applications: Determine potential alternative applications for the nonconforming product where the specific requirements are less stringent or different.
2. Re-grade Product: Re-classify the nonconforming product for the identified alternative application.
3. Update Documentation: Ensure all relevant documentation reflects the new grading and intended use.
4. Inform Stakeholders: Communicate the re-grading decision to all relevant stakeholders, including the customer if necessary.

c) Release Under Concession

Why: To formally accept the nonconforming product for use or delivery under specific conditions agreed upon by the relevant authority and, if required, the customer.

How:

1. Request Concession: Submit a formal request for a concession, detailing the nature of the nonconformity and the rationale for its acceptance.
2. Review and Approval: Obtain approval from the relevant authority within the organization and, if necessary, from the customer.
3. Document Concession: Maintain detailed records of the concession, including the conditions under which the nonconforming product is accepted.
4. Implement Conditions: Ensure that any conditions attached to the concession are fully implemented and communicated to all relevant parties.

d) Reject or Scrap

Why: To remove the nonconforming product from the production process to prevent its unintended use or delivery.

How:

1. Segregate Nonconforming Product: Immediately segregate the nonconforming product to prevent its unintended use or delivery.
2. Document Decision: Record the decision to reject or scrap the product, including the reasons for this decision.
3. Dispose of Product: Safely and responsibly dispose of the rejected or scrapped product according to the organization’s procedures and environmental regulations.
4. Review and Improve: Analyze the reasons for the nonconformity to prevent recurrence, and update processes and procedures as necessary.

Summary of Actions in a Table Format

Action	Steps	Records to Maintain
Repair or Rework	Identify nonconformity, develop and implement repair/rework plan, inspect and test, document actions	Repair/Rework plans, inspection reports, test results
Re-grade	Identify alternative applications, re-classify product, update documentation, inform stakeholders	Re-grading documentation, stakeholder communication records
Release Under Concession	Request concession, obtain approval, document concession, implement conditions	Concession requests, approval records, implementation records
Reject or Scrap	Segregate nonconforming product, document decision, dispose of product, review and improve	Rejection/scrapping records, disposal records, review reports

By systematically addressing nonconforming products through these methods, the organization ensures product quality and compliance with both internal standards and customer requirements. To determine which option to choose for addressing nonconforming products, an organization must follow a structured decision-making process. This process should involve a thorough analysis of the nonconformity, its impact, and the feasibility of corrective actions. Here’s a step-by-step approach the organization can take:

1. Identify and Document the Nonconformity
   • Detailed Description: Clearly document the nature of the nonconformity, including where it was found and its potential impact.
   • Root Cause Analysis: Conduct a root cause analysis to understand why the nonconformity occurred.
2. Assess the Impact
   • Severity: Evaluate the severity of the nonconformity in terms of safety, regulatory compliance, functionality, and customer satisfaction.
   • Extent: Determine the extent to which the nonconformity affects the product batch or production run.
3. Evaluate Options
   • Repair or Rework: Consider if the product can be brought back to conforming status through repair or rework.
   • Re-grade for Alternative Applications: Assess if the product can be used in a different application where the nonconformity is acceptable.
   • Release Under Concession: Determine if it’s feasible to seek a concession from the relevant authority and, if necessary, the customer.
   • Reject or Scrap: Consider if the product should be rejected or scrapped due to the severity or unfeasibility of other options.
4. Consult with Relevant Stakeholders
   • Internal Stakeholders: Involve quality assurance, production, engineering, and management teams in the decision-making process.
   • Customer: If customer requirements or satisfaction are impacted, involve them in the decision, especially for concessions or re-grading.
5. Make a Decision
   • Criteria for Decision: Base the decision on criteria such as cost, time, feasibility, regulatory compliance, and customer impact.
   • Document the Decision: Clearly document the chosen option and the rationale behind it.
6. Implement the Chosen Option
   • Action Plan: Develop and execute an action plan for the chosen option.
   • Verification: Ensure that the product meets the specified requirements after the chosen action is implemented (e.g., rework or concession conditions).
7. Monitor and Record
   • Records: Maintain detailed records of the nonconformity, decision-making process, actions taken, and verification results.
   • Review: Periodically review nonconformity cases to identify trends and opportunities for process improvements.

Example of Decision-Making Process in a Tabular Format

Step	Actions	Records
Identify and Document	Describe nonconformity, conduct root cause analysis	Nonconformity report, root cause analysis
Assess Impact	Evaluate severity and extent of nonconformity	Impact assessment report
Evaluate Options	Consider repair/rework, re-grade, concession, or rejection/scrapping	Evaluation report with pros and cons of each option
Consult with Stakeholders	Discuss with internal teams and customers if necessary	Meeting minutes, stakeholder feedback
Make a Decision	Choose the best option based on defined criteria	Decision documentation
Implement the Chosen Option	Develop and execute an action plan, ensure product meets requirements post-action	Action plan, verification results
Monitor and Record	Maintain records, periodically review nonconformity cases	Records of actions taken, periodic review reports

Detailed Example

Scenario: Nonconforming Valve Component

1. Identify and Document: The valve component is found to have a dimensional defect.
2. Assess Impact: The defect could affect the sealing performance, posing a risk to safety and functionality.
3. Evaluate Options:
   • Repair/Rework: Feasible by machining the component to correct dimensions.
   • Re-grade: Not feasible as the component has no alternative use in the current product line.
   • Concession: Possible if the customer accepts the minor deviation with a guarantee of no performance impact.
   • Reject/Scrap: Considered if repair or concession is not viable.
4. Consult with Stakeholders: Quality assurance, engineering, and the customer are consulted.
5. Make a Decision: Choose repair/rework based on feasibility and minimal impact on delivery schedule.
6. Implement the Chosen Option: Machining the component, followed by inspection to ensure conformity.
7. Monitor and Record: Document the repair process and results, review to prevent recurrence.

How the Organization Can Repair or Rework with Subsequent Inspection to Meet Specified Requirements

The organization can ensure that nonconforming products are effectively repaired or reworked to meet specified requirements. Subsequent inspections validate that the product meets quality standards, thereby maintaining product integrity and customer satisfaction. This process also ensures compliance with regulatory and industry standards, such as API Q1, by maintaining detailed documentation and traceability. To effectively repair or rework nonconforming products and ensure they meet specified requirements, an organization in the oil and gas industry can follow these detailed steps:

1. Identification and Documentation of Nonconforming Product

• Identify Nonconformance: Detect nonconforming products during inspections, tests, or any stage of product realization.
• Document Nonconformance: Record details in a Nonconformity Report, including:
  • Description of the nonconformity
  • Location and quantity of affected products
  • Date of identification
  • Person identifying the nonconformance
• Segregation and Marking: Clearly mark and segregate nonconforming products to prevent their unintended use or delivery.

2. Evaluation of Repair/Rework Feasibility

• Assess Feasibility: Determine if the product can be economically and technically repaired or reworked.
• Consultation: Involve relevant departments (e.g., QA, Engineering, Production) in the evaluation.
• Record Findings: Document the feasibility study and the proposed method for repair or rework.

3. Approval for Repair/Rework

• Internal Approval: Obtain internal approvals from the relevant authorities (e.g., QA Manager, Production Manager).
• Customer Approval: If the repair/rework significantly alters the product, seek customer approval.
• Authorization Documentation: Maintain records of all approvals for traceability.

4. Execution of Repair/Rework

• Develop Plan: Create a detailed repair/rework plan, specifying:
  • Steps and processes to be followed
  • Tools and materials required
  • Safety measures
• Perform Repair/Rework: The Production Team executes the plan, ensuring adherence to quality and safety standards.
• Record Activities: Document the repair/rework process, including:
  • Date of repair/rework
  • Personnel involved
  • Specific actions taken

5. Subsequent Inspection

• Inspect Reworked Product: Conduct thorough inspections post-repair/rework to verify conformity with specified requirements.
• Inspection Methods: Use appropriate inspection methods and tools to ensure reliable results.
• Document Results: Record the inspection findings, noting any deviations.

6. Verification of Conformity

• Compare Results: Ensure the repaired/reworked product meets all specified requirements.
• Release Product: If the product conforms, release it for further processing or delivery.
• Non-conformance Persistence: If the product still does not meet requirements, document the issue and escalate for further action.

7. Final Documentation and Record-Keeping

• Maintain Records: Keep detailed records of:
  • Nonconformity Reports
  • Repair/Rework Plans
  • Approval Documents
  • Activity Logs
  • Inspection Reports
  • Verification Records
• Traceability: Ensure these records are traceable and accessible for audits and reviews.

Review and Continuous Improvement

• Periodic Review: Regularly review the repair/rework process for effectiveness.
• Data Analysis: Analyze nonconformity and inspection data to identify trends.
• Process Improvement: Update procedures to improve efficiency and prevent recurrence of nonconformities.

Example Workflow:

Step	Description	Responsible Party	Records
1. Identification and Documentation	Identify and document nonconformance	QA Inspector	Nonconformity Report
2. Evaluation	Assess feasibility of repair/rework	QA & Engineering	Evaluation Report
3. Approval	Obtain necessary approvals	QA Manager	Approval Documentation
4. Execution	Perform repair/rework	Production Team	Repair/Rework Activity Log
5. Inspection	Inspect reworked product	Inspection Team	Inspection Report
6. Verification	Verify conformity	QA Inspector	Verification Records
7. Documentation	Maintain records	QA Department	All relevant records

How the Organization Can Re-grade for Alternative Applications

Re-grading nonconforming products for alternative applications involves determining if a product, which does not meet the initial specified requirements, can be used for a different purpose. This process allows the organization to minimize waste and maximize resource utilization. The organization can effectively re-grade nonconforming products for alternative applications. This process ensures that the product is still useful, meets the requirements of the alternative application, and adheres to customer and industry standards. Proper documentation and traceability throughout the process ensure compliance with regulatory and quality management system requirements, such as API Q1.Here’s how an oil and gas organization can effectively re-grade nonconforming products:

1. Identification and Documentation of Nonconforming Product

• Identify Nonconformance: Detect nonconforming products during inspections, tests, or any stage of product realization.
• Document Nonconformance: Record details in a Nonconformity Report, including:
  • Description of the nonconformity
  • Location and quantity of affected products
  • Date of identification
  • Person identifying the nonconformance
• Segregation and Marking: Clearly mark and segregate nonconforming products to prevent their unintended use or delivery.

2. Evaluation of Alternative Applications

• Assess Feasibility: Evaluate if the nonconforming product can meet the requirements for an alternative application.
• Consultation: Engage relevant departments (e.g., Engineering, Production, Sales) to assess alternative uses.
• Customer Requirements: Ensure that the alternative application meets any customer or industry requirements.
• Record Findings: Document the evaluation process, including potential alternative applications and any necessary modifications.

3. Approval for Re-grading

• Internal Approval: Obtain internal approvals from relevant authorities (e.g., QA Manager, Engineering Manager).
• Customer Approval: If required, seek approval from the customer for using the product in an alternative application.
• Authorization Documentation: Maintain records of all approvals for traceability.

4. Modification (If Required)

• Develop Modification Plan: Create a plan for any modifications needed to make the product suitable for the alternative application.
• Execute Modifications: Carry out the modifications, ensuring adherence to quality and safety standards.
• Record Activities: Document the modification process, including the date, personnel involved, and specific actions taken.

5. Subsequent Inspection

• Inspect Modified Product: Conduct inspections on the modified product to ensure it meets the requirements for the alternative application.
• Inspection Methods: Use appropriate inspection methods and tools to ensure reliable results.
• Document Results: Record the inspection findings, noting any deviations.

6. Verification and Validation

• Verify Suitability: Confirm that the re-graded product is suitable for the alternative application.
• Validation Testing: Perform any necessary validation testing to ensure the product performs as required in its new application.
• Record Results: Document the verification and validation results.

7. Final Documentation and Record-Keeping

• Maintain Records: Keep detailed records of:
  • Nonconformity Reports
  • Evaluation and Feasibility Studies
  • Approval Documents
  • Modification Plans
  • Inspection Reports
  • Verification and Validation Records
• Traceability: Ensure these records are traceable and accessible for audits and reviews.

Example Workflow:

Step	Description	Responsible Party	Records
1. Identification and Documentation	Identify and document nonconformance	QA Inspector	Nonconformity Report
2. Evaluation	Assess feasibility of re-grading	QA & Engineering	Evaluation Report
3. Approval	Obtain necessary approvals	QA Manager	Approval Documentation
4. Modification	Perform any required modifications	Production Team	Modification Activity Log
5. Inspection	Inspect modified product	Inspection Team	Inspection Report
6. Verification	Verify suitability for alternative application	QA Inspector	Verification Records
7. Documentation	Maintain records	QA Department	All relevant records

How an Organization Can Release Nonconforming Product Under Concession

Releasing nonconforming products under concession involves formally authorizing the use, release, or acceptance of a product that does not meet specified requirements, under agreed-upon conditions. This process must be carefully controlled to ensure that the product is still safe and fit for use, and that all relevant parties are informed and agree to the concession. Releasing nonconforming products under concession allows an organization to utilize products that do not fully meet initial specifications while ensuring safety and compliance. This process requires thorough documentation, careful evaluation, and formal authorization, involving both internal and customer approvals when necessary. By following this structured approach, the organization can effectively manage nonconformities, minimize waste, and maintain customer satisfaction while adhering to quality management standards like API Q1.Here’s a detailed approach for how an oil and gas organization can release nonconforming products under concession:

1. Identification and Documentation of Nonconformance

• Identify Nonconformance: Detect and identify nonconforming products during inspections, tests, or at any stage of product realization.
• Document Nonconformance: Record details in a Nonconformity Report, including:
  • Description of the nonconformity
  • Location and quantity of affected products
  • Date of identification
  • Person identifying the nonconformance
• Segregation and Marking: Clearly mark and segregate nonconforming products to prevent unintended use or delivery.

2. Evaluation of Nonconforming Product

• Assess Impact: Evaluate the impact of the nonconformity on the product’s performance, safety, and compliance with regulatory and customer requirements.
• Consultation: Involve relevant departments (e.g., Engineering, QA, Production) to assess the feasibility of releasing the product under concession.
• Customer Requirements: Review customer specifications and requirements to understand the implications of the nonconformity.

3. Proposal for Concession

• Develop Concession Proposal: Prepare a detailed concession proposal outlining:
  • Nature of the nonconformity
  • Proposed use or application of the nonconforming product
  • Justification for why the product is still acceptable for use
  • Any compensatory measures or modifications
  • Impact on performance, safety, and compliance
• Internal Review: Obtain internal reviews and approvals from relevant authorities (e.g., QA Manager, Engineering Manager).

4. Customer Approval

• Submit Proposal to Customer: Submit the concession proposal to the customer for review and approval, if required.
• Customer Feedback: Address any customer concerns or requirements and revise the proposal as necessary.
• Document Approval: Maintain records of the customer’s approval or any agreed-upon conditions.

5. Authorization and Release

• Internal Authorization: Obtain final internal authorization for the concession release from relevant authorities.
• Document Authorization: Record the authorization, including the names and signatures of approving authorities.
• Release Product: Release the nonconforming product under the agreed-upon conditions.

6. Monitoring and Verification

• Track Concession Use: Monitor the use of the product released under concession to ensure compliance with agreed conditions.
• Feedback Loop: Gather feedback from the customer and end-users to verify that the product meets their needs and identify any issues.
• Document Findings: Record any findings and actions taken in response to feedback.

Example Workflow:

Step	Description	Responsible Party	Records
1. Identification and Documentation	Identify and document nonconformance	QA Inspector	Nonconformity Report
2. Evaluation	Assess impact and consult relevant departments	QA & Engineering	Evaluation Report
3. Proposal for Concession	Develop and internally review concession proposal	QA Manager	Concession Proposal
4. Customer Approval	Submit proposal to customer and address feedback	Sales/Customer Service	Customer Approval Documentation
5. Authorization and Release	Obtain final internal authorization and release product	QA Manager	Authorization Record
6. Monitoring and Verification	Track use and gather feedback	QA Department	Monitoring Reports

How an Organization Can Reject or Scrap Nonconforming Product

Rejecting or scrapping nonconforming products involves formally identifying and disposing of products that do not meet specified requirements and cannot be used, reworked, or released under concession. This process ensures that nonconforming products are removed from the production cycle and prevents their unintended use. Rejecting or scrapping nonconforming products is a critical step in maintaining quality and compliance in an oil and gas organization. This process involves thorough documentation, evaluation, and control measures to ensure nonconforming products are properly identified, segregated, and disposed of, preventing their unintended use. By following a structured approach, the organization can effectively manage nonconformities, uphold quality standards, and comply with regulatory requirements like API Q1.Here’s a detailed approach for how an oil and gas organization can reject or scrap nonconforming products:

1. Identification of Nonconforming Product

• Detection: Identify nonconforming products during various stages of production, including in-process inspections, final inspections, or customer returns.
• Initial Documentation: Record the details of the nonconformity, including the nature of the defect, quantity of affected products, and the point in the process where the nonconformity was detected.

2. Evaluation and Decision

• Assess Nonconformity: Evaluate the severity of the nonconformity and determine whether the product can be reworked or needs to be scrapped.
• Consult Relevant Departments: Involve relevant departments such as Quality Assurance (QA), Engineering, and Production to assess the product and determine the appropriate course of action.
• Decision Making: Based on the evaluation, decide whether the product will be rejected or scrapped. This decision should be documented and approved by authorized personnel.

3. Segregation and Control

• Segregation: Clearly mark and segregate nonconforming products in a designated area to prevent accidental use. Use tags or labels to indicate that the product is nonconforming and awaiting disposal.
• Control: Maintain strict control over the nonconforming products to ensure they are not inadvertently reintroduced into the production process.

4. Documentation and Approval

• Nonconformance Report: Complete a Nonconformance Report (NCR) that details the nonconformity, including:
  • Description of the nonconformity
  • Quantity of affected products
  • Decision to reject or scrap
  • Reasons for the decision
  • Names and signatures of authorized personnel
• Approval: Obtain necessary approvals from designated authorities, such as the QA Manager or Production Manager.

5. Disposal of Nonconforming Product

• Rejecting: If the product is to be rejected, document the rejection process and notify relevant stakeholders, such as suppliers or customers, if necessary.
• Scrapping: If the product is to be scrapped, ensure proper disposal according to company policies and environmental regulations. This may involve physical destruction, recycling, or other disposal methods.

6. Record Keeping

• Maintain Records: Keep detailed records of all nonconforming products that are rejected or scrapped, including the Nonconformance Report and any related documentation.
• Traceability: Ensure that records are traceable and can be retrieved for future reference, audits, or regulatory compliance.

Example Workflow:

Step	Description	Responsible Party	Records
1. Identification	Detect and document nonconformity	QA Inspector	Initial Nonconformance Report
2. Evaluation and Decision	Assess and decide on rejection or scrapping	QA, Engineering, Production	Evaluation Report
3. Segregation and Control	Segregate and mark nonconforming products	Production Supervisor	Segregation Log
4. Documentation and Approval	Complete NCR and obtain approvals	QA Manager	Nonconformance Report (NCR)
5. Disposal	Reject or scrap nonconforming product	Production Supervisor	Disposal Records
6. Record Keeping	Maintain records of rejected or scrapped products	QA Department	Nonconformance Records