The release under concession of nonconforming product that does not satisfy manufacturing acceptance criteria (MAC) shall be permitted when the organization’s relevant authority has conducted an evaluation, and authorized release provided that: a) products continue to satisfy the applicable DAC and customer criteria; or b) the violated MAC is determined as unnecessary to satisfy the applicable DAC and/or customer criteria; or c) the DAC is changed and the affected products satisfy the revised DAC and associated MAC requirements. When the DAC was previously agreed with customer, the DAC change shall be authorized by the customer. The organization shall not release product not conforming to DAC or contract requirements without customer authorization.
Release of Nonconforming Product Under Concession is a controlled process in which nonconforming products are released for use or delivery under specific conditions agreed upon by relevant authorities and, when necessary, the customer. This ensures that any deviations from standard requirements are documented, evaluated, and approved before the product is used or shipped.Releasing nonconforming products under concession is a structured process that ensures deviations from standard requirements are properly evaluated, documented, and approved before use. This helps maintain product integrity, compliance with standards, and customer satisfaction while allowing flexibility in handling minor nonconformances. By following these steps, an oil and gas organization can effectively manage and control nonconforming products.
Key Aspects of the Process:
Identification and Documentation of Nonconformance
Identify Nonconforming Product: Detect nonconformities during inspections, testing, or customer feedback.
Document Details: Record the nature of the nonconformity, affected quantities, and where in the process it was identified.
Evaluation and Decision Making
Assess Impact: Evaluate the severity and impact of the nonconformity on the product’s performance, safety, and compliance.
Determine Feasibility: Assess if the product can still meet essential requirements with the nonconformance.
Authorization for Concession
Internal Authorization: Obtain approval from relevant internal authorities, such as the QA Manager, Engineering Manager, or Production Manager.
Customer Approval: When required, seek approval from the customer to release the nonconforming product.
Record of Concession
Concession Documentation: Maintain a detailed record of the concession, including:
Description of the nonconformance
Assessment and justification for release
Conditions for release or use
Approvals from internal authorities and customer (if applicable)
Release and Control
Controlled Release: Ensure the product is released under controlled conditions specified in the concession documentation.
Traceability: Maintain traceability of the nonconforming product released under concession.
Monitoring and Review
Monitor Performance: Monitor the performance and feedback of the nonconforming product in use to ensure it meets the agreed-upon conditions.
Review Concession Process: Periodically review the concession process to identify improvements and ensure compliance with standards.
Steps for Releasing Nonconforming Product Under Concession
Identification and Documentation of Nonconformance
Detection: Nonconforming product is identified during routine inspection.
Recording: An NCR (Non-Conformance Report) is initiated with details of the nonconformance.
Evaluation and Decision Making
Impact Assessment: The QA team assesses the impact of the nonconformance on product performance and safety.
Feasibility Determination: Engineering determines if the product can still meet critical requirements.
Authorization for Concession
Internal Review: The NCR is reviewed by QA, Engineering, and Production managers.
Customer Approval: If required, the customer is notified and approval is sought for the release of the nonconforming product.
Record of Concession
Concession Documentation: A concession form is completed, detailing:
Nature of the nonconformance
Justification for release
Conditions for use
Approvals from internal authorities and customer
Release and Control
Controlled Release: The nonconforming product is released for use or delivery under the specified conditions.
Labeling and Traceability: The product is labeled to indicate it is released under concession, ensuring traceability.
Monitoring and Review
Performance Monitoring: The product’s performance is monitored to ensure it meets the agreed conditions.
Process Review: The concession process is reviewed periodically to ensure effectiveness and compliance.
Example of Concession Documentation
Field
Description
Nonconformance Report ID
NCR-2024-001
Date
June 10, 2024
Product Details
Product XYZ, Batch No. 12345
Description of Nonconformance
Minor dimensional deviation
Impact Assessment
Deviation does not affect product performance
Justification
Product still meets critical performance criteria
Conditions for Use
Only for non-critical applications
Internal Approvals
QA Manager Engineering Manager
Customer Approval
Customer Representative
Date of Approval
June 12, 2024
Release Date
June 15, 2024
Monitoring Plan
Periodic inspection during use
Review Date
December 15, 2024
The release under concession of nonconforming product that does not satisfy manufacturing acceptance criteria (MAC) shall be permitted when the organization’s relevant authority has conducted an evaluation, and authorized release
The organization’s relevant authority, typically comprising individuals with appropriate expertise and decision-making authority, conducts evaluation and authorizes release of nonconforming products under concession through a structured process. Here’s how they can do it:
1. Nonconformance Assessment:
Review Nonconformance Report (NCR): The relevant authority begins by reviewing the NCR detailing the identified nonconformance. This report provides information on the nature, location, and potential impact of the nonconformance.
2. Impact Assessment:
Assess Severity and Impact: Evaluate the severity and potential impact of the nonconformance on product functionality, safety, compliance, and customer requirements.
Consider Risk Factors: Take into account any associated risks or consequences of releasing the nonconforming product under concession.
3. Feasibility Determination:
Evaluate Feasibility: Assess whether the nonconforming product can still meet critical requirements and whether its use is feasible despite the nonconformance.
Consider Mitigation Measures: Explore possible mitigation measures to address the nonconformance and minimize associated risks.
4. Decision Making:
Authorize Release: If it is determined that the nonconforming product can be released under concession without compromising safety or quality, the relevant authority authorizes its release.
Document Decision: Document the decision to release the product under concession, including the rationale behind the decision and any conditions or restrictions imposed.
5. Communication and Approval:
Internal Communication: Communicate the decision to relevant stakeholders, including production personnel, quality assurance team, and any other parties involved in the release process.
Customer Approval (if required): If customer approval is required per contract or agreement, seek consent from the customer before proceeding with the release.
6. Record Keeping:
Document Authorization: Maintain records of the authorization decision, including the NCR, evaluation findings, approval documentation, and any conditions or restrictions imposed.
Traceability: Ensure that all documentation provides a clear audit trail, allowing for traceability and accountability.
7. Monitoring and Review:
Monitor Performance: Regularly monitor the performance of released products to ensure they meet specified conditions and do not pose risks to safety or quality.
Periodic Review: Conduct periodic reviews of the concession process to identify areas for improvement and ensure compliance with organizational policies and standards.
Example Scenario:
Suppose a Quality Assurance Manager (QA Manager) identifies a nonconformance in a valve assembly during routine inspection. After assessing the nonconformance’s impact and feasibility of release, the QA Manager presents their findings to the Engineering Manager for evaluation. Upon reviewing the assessment and determining that the nonconformance poses no safety risks and can be released under restricted use, the Engineering Manager authorizes its release under concession. This decision is documented and communicated to relevant stakeholders, and the released products are monitored during installation to ensure compliance with specified conditions.
The non conforming product can be released under concession when products continue to satisfy the applicable Design Acceptable Criteria and customer criteria
Allowing the release of nonconforming products under concession, provided they still meet applicable Design Acceptable Criteria and customer criteria, is often a pragmatic decision made to balance various factors, including operational efficiency, customer satisfaction, and risk management. Here’s why organizations may choose to take this approach:
Operational Continuity: Releasing nonconforming products under concession allows organizations to maintain production schedules and meet customer demand without significant disruptions.
Minimized Waste: Rather than scrapping or reworking nonconforming products, releasing them under concession can minimize waste and reduce associated costs.
Customer Flexibility: In some cases, customers may be willing to accept nonconforming products under certain conditions, especially if they still meet their functional requirements.
Risk Assessment: Organizations conduct thorough assessments to ensure that the nonconforming products pose minimal risk to safety, performance, or regulatory compliance.
Regulatory Compliance: If the nonconforming products still comply with applicable regulations and standards, releasing them under concession may be permissible.
Customer Relationships: Preserving customer relationships by fulfilling orders or commitments, even with nonconforming products, can be crucial for long-term partnerships.
Cost Considerations: The cost of rework, scrap, or customer dissatisfaction may outweigh the risks associated with releasing nonconforming products under concession.
Continuous Improvement: Organizations may use incidents of nonconforming product release as opportunities for learning and process improvement to prevent similar occurrences in the future.
However, it’s important to note that releasing nonconforming products under concession should be a controlled and well-documented process, with appropriate risk mitigation measures in place to ensure that safety, quality, and customer satisfaction are not compromised. The decision to release nonconforming products under concession should always be made transparently and with full consideration of potential consequences. Releasing nonconforming products under concession involves a thorough evaluation to ensure they still meet applicable criteria, including Design Acceptable Criteria and customer requirements. This evaluation typically involves the following steps:
Review of Design Acceptable Criteria:
Assessment of Design Requirements: Evaluate whether the nonconforming product still meets the original design specifications and requirements.
Review of Tolerances and Specifications: Assess if the nonconformance falls within acceptable tolerances and specifications outlined in the design criteria.
Verification Against Customer Criteria:
Customer Requirements: Verify that the nonconforming product continues to meet the specific requirements outlined by the customer.
Contractual Obligations: Ensure compliance with any contractual agreements or specifications provided by the customer.
Impact Assessment:
Functional Assessment: Determine if the nonconformance affects the product’s intended function or performance.
Risk Evaluation: Assess any potential risks associated with releasing the nonconforming product, considering factors such as safety, reliability, and regulatory compliance.
Mitigation Measures:
Implementation of Controls: Implement appropriate controls or mitigation measures to address the nonconformance and minimize associated risks.
Compensatory Actions: Identify any compensatory actions or additional measures required to ensure product integrity and customer satisfaction.
Documentation and Authorization:
Documented Evaluation: Document the evaluation process, including findings related to the nonconformance’s impact on design and customer criteria.
Authorization for Release: Obtain authorization from the relevant authority, such as quality assurance or engineering management, to release the product under concession.
Customer Communication:
Transparent Communication: Communicate with the customer regarding the identified nonconformance, proposed concession, and any associated risks or limitations.
Obtain Consent: Seek customer consent or approval before proceeding with the release under concession, particularly if contractual obligations require customer involvement.
Continuous Monitoring:
Ongoing Monitoring: Continuously monitor the released products to ensure they continue to satisfy applicable criteria and perform as intended.
Feedback Mechanisms: Establish feedback mechanisms to promptly address any issues or concerns identified during product use.
By following these steps and ensuring that nonconforming products released under concession still meet applicable design and customer criteria, organizations can mitigate risks and uphold quality standards while addressing nonconformities in their products.
The non conforming product can be released under concession when the violated Manufacturing Acceptable Criteria is determined as unnecessary to satisfy the applicable Design Acceptable Criteria and/or customer criteria
Organizations may be allowed to release nonconforming products when the violated Manufacturing Acceptable Criteria (MAC) is deemed unnecessary to satisfy the applicable Design Acceptable Criteria and/or customer criteria for several reasons:
Risk Assessment: The organization conducts a thorough risk assessment to determine the impact of the violated MAC on product functionality, safety, and compliance with customer requirements. If the risk is deemed acceptable and does not compromise the overall integrity of the product, releasing the nonconforming product may be considered.
Engineering Judgment: Engineering or technical experts assess the relationship between the violated MAC and the product’s design and functionality. If they determine that the nonconformance does not affect the product’s ability to meet its intended purpose or performance requirements, releasing it may be justified.
Customer Agreement: In some cases, customers may explicitly agree to accept products with certain nonconformities, especially if they do not significantly impact the product’s usability or performance.
Cost-Benefit Analysis: Releasing nonconforming products may be a more cost-effective option compared to scrapping or reworking them, especially if the cost of addressing the nonconformity outweighs the potential benefits.
Regulatory Compliance: If the violated MAC does not affect the product’s compliance with relevant regulations and standards, releasing the nonconforming product may be permissible.
To ensure that the release of nonconforming products under these circumstances is appropriate and controlled, organizations typically follow a structured process, which may include:
Risk Assessment: Evaluate the impact of the violated MAC on product performance, safety, and compliance.
Technical Evaluation: Engage technical experts to assess the relationship between the nonconformance and product requirements.
Customer Communication: Communicate transparently with customers regarding the identified nonconformities and obtain their agreement if necessary.
Documentation: Document the decision-making process, including the rationale behind releasing the nonconforming product and any associated risks or mitigations.
Quality Controls: Implement additional quality controls or monitoring mechanisms to ensure that released products continue to meet customer requirements and regulatory standards.
By following such a process, organizations can make informed decisions about releasing nonconforming products when the violated MAC is determined to be unnecessary to satisfy design and customer criteria, while also managing associated risks effectively.
The non conforming product can be released under concession when the Design Acceptable Criteria is changed and the affected products satisfy the revised Design Acceptable Criteria and associated Manufacturing Acceptable Criteria requirements.
Organizations may be allowed to release nonconforming products when the Design Acceptable Criteria (DAC) is changed, and the affected products satisfy the revised DAC and associated Manufacturing Acceptable Criteria (MAC) requirements for several reasons:
Continuous Improvement: Changes to the DAC often reflect efforts to improve product design, functionality, or performance based on updated engineering practices, technological advancements, or lessons learned from previous iterations. Releasing nonconforming products that meet the revised DAC allows organizations to implement these improvements and enhance product quality.
Compliance with Updated Standards: DAC changes may be driven by updates to industry standards, regulations, or customer requirements. Releasing nonconforming products that comply with the revised DAC ensures alignment with current standards and regulatory obligations.
Risk Assessment: Organizations conduct thorough risk assessments to evaluate the impact of nonconforming products against the revised DAC. If the nonconformance poses minimal risk to product safety, functionality, or customer satisfaction, releasing the products under concession may be deemed acceptable.
Customer Authorization (if applicable): If the original DAC was established in agreement with the customer, any changes to the DAC require customer authorization. Releasing nonconforming products under concession ensures that the revised DAC meets customer expectations and aligns with their evolving needs.
Cost Considerations: Scraping or reworking nonconforming products can be costly and resource-intensive. Releasing them under concession, provided they meet the revised DAC, may be a more cost-effective solution while still maintaining product quality and compliance.
Operational Efficiency: Releasing nonconforming products that meet the revised DAC allows organizations to maintain production schedules, fulfill customer orders, and minimize disruptions to supply chains or project timelines.
To ensure that the release of nonconforming products under these circumstances is appropriate and controlled, organizations typically follow a structured process that includes:
Thorough evaluation of nonconforming products against the revised DAC and associated MAC requirements.
Technical review by subject matter experts to assess product compliance and evaluate any associated risks.
Documentation of the decision-making process, including rationale for releasing the products under concession and any customer authorizations obtained.
Implementation of additional quality controls or monitoring mechanisms to ensure ongoing compliance with the revised DAC.
By following these steps and ensuring alignment with the revised DAC and associated requirements, organizations can responsibly release nonconforming products when DAC changes occur, while still upholding product quality, regulatory compliance, and customer satisfaction.
When the Design Acceptable Criteria was previously agreed with customer, the Design Acceptable Criteria change shall be authorized by the customer. when the Design Acceptable Criteria (DAC) was previously agreed upon with the customer, any changes to the DAC must be authorized by the customer. This ensures that the product design aligns with the customer’s expectations and requirements. Here’s why this authorization is necessary and how it can be obtained:
Customer Agreement: When the DAC is established in agreement with the customer, it reflects the specific design characteristics, features, and performance requirements that the customer expects from the product. Any changes to these criteria can potentially impact the product’s functionality, usability, or suitability for its intended purpose.
Maintaining Customer Satisfaction: Obtaining authorization from the customer ensures that they are aware of and agree to the proposed changes in the DAC. This helps maintain transparency and trust between the organization and the customer, enhancing overall customer satisfaction and loyalty.
Compliance with Contractual Obligations: Many customer agreements or contracts include provisions regarding changes to product specifications, including the DAC. Adhering to these contractual obligations is essential for maintaining a positive relationship with the customer and avoiding disputes or legal issues.
Risk Management: Customer authorization provides an opportunity for the customer to assess the potential impact of the DAC changes on their needs, requirements, and intended use of the product. This allows them to identify any risks or concerns associated with the proposed changes and provide input or feedback as necessary.
To obtain customer authorization for DAC changes, organizations typically follow these steps:
Notification: The organization notifies the customer of the proposed changes to the DAC, including details of the revisions and the rationale behind the proposed modifications. This notification may be communicated through written correspondence, meetings, or other forms of communication as per the contractual agreement.
Review and Approval: The customer reviews the proposed DAC changes and assesses their impact on product performance, functionality, and suitability for their intended use. If the customer agrees to the proposed changes, they provide formal approval or authorization for the revisions.
Documentation: The organization documents the customer’s authorization for the DAC changes, including any correspondence, agreements, or approvals obtained from the customer. This documentation serves as evidence of the customer’s consent to the proposed modifications.
By obtaining customer authorization for DAC changes, organizations can ensure that any modifications to the product design align with the customer’s expectations and requirements, ultimately contributing to enhanced customer satisfaction and positive business relationships.
The organization shall not release product not conforming to DAC or contract requirements without customer authorization.
The organization must not release any product that does not conform to the Design Acceptable Criteria (DAC) or contract requirements without obtaining explicit authorization from the customer. This requirement is crucial for maintaining product quality, meeting customer expectations, and upholding contractual agreements. Here’s why this restriction is essential and how it can be enforced:
Customer Confidence: Releasing nonconforming products without customer authorization can erode customer confidence and trust in the organization’s ability to deliver products that meet their requirements. Customers rely on organizations to adhere to agreed-upon specifications and standards, and any deviation from these expectations can result in dissatisfaction and potential loss of business.
Risk Mitigation: Nonconforming products pose risks to both the customer and the organization. They may fail to perform as intended, leading to safety concerns, operational issues, or product failures. By obtaining customer authorization, organizations can ensure that customers are aware of any deviations from the agreed-upon specifications and can assess the associated risks before accepting the products.
Contractual Obligations: Contractual agreements often stipulate specific requirements regarding product quality, specifications, and conformity to standards. Releasing nonconforming products without customer authorization may constitute a breach of contract, leading to legal ramifications, financial penalties, or damage to the organization’s reputation.
Transparency and Accountability: Obtaining customer authorization for nonconforming products promotes transparency and accountability in the organization’s processes. It demonstrates a commitment to open communication and collaboration with customers, allowing them to participate in decision-making regarding product quality and compliance.
To enforce this requirement effectively, organizations typically implement the following measures:
Strict Controls: Establish robust controls and procedures to prevent the release of nonconforming products without customer authorization. This may include thorough inspection, testing, and verification processes to ensure that all products meet the specified requirements before being released to the customer.
Authorization Process: Implement a formal authorization process that involves obtaining explicit approval from the customer before releasing any nonconforming products. This process may include documenting the customer’s consent, rationale for the release, and any associated risks or mitigating actions.
Communication Channels: Maintain open communication channels with customers to facilitate the authorization process. Clearly communicate any deviations from the DAC or contract requirements, along with the proposed corrective actions or concessions, to ensure that customers are fully informed and can make informed decisions.
Documentation and Record-Keeping: Document all instances of nonconforming products, including details of the deviation, actions taken, and customer authorization obtained. Maintain comprehensive records to demonstrate compliance with contractual requirements and regulatory standards.
By adhering to these measures and ensuring that nonconforming products are not released without customer authorization, organizations can uphold product quality, mitigate risks, and maintain positive relationships with customers.
an example of a record documenting the release of nonconforming product under concession:
Record ID
Date Released
Product ID
Description of Nonconformity
Reason for Release
Customer Authorization
Comments
NC-001
2024-06-30
PRD-123
Dimensional deviation
Minor deviation from specifications. Concession granted due to minimal impact on functionality.
Customer approval obtained via email on 2024-06-28.
Product reinspection conducted post-concession. No further nonconformities identified.
In this example:
Record ID: Unique identifier for the record.
Date Released: Date when the nonconforming product was released under concession.
Product ID: Identification code or number for the nonconforming product.
Description of Nonconformity: Brief description of the identified nonconformity or deviation from specifications.
Reason for Release: Explanation of why the nonconforming product was released under concession, including the rationale for granting the concession.
Customer Authorization: Details of the authorization obtained from the customer, including the method of authorization (e.g., email, written approval) and the date of authorization.
Comments: Additional comments or notes related to the release of the nonconforming product, such as post-concession actions taken or follow-up inspections conducted.
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:
Identify Nonconformity: Clearly define and document the nature of the nonconformity.
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.
Implement Repair/Rework: Execute the repair or rework process as per the plan.
Inspection and Testing: Conduct thorough inspections and tests to ensure that the repaired or reworked product now meets the specified requirements.
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:
Identify Alternative Applications: Determine potential alternative applications for the nonconforming product where the specific requirements are less stringent or different.
Re-grade Product: Re-classify the nonconforming product for the identified alternative application.
Update Documentation: Ensure all relevant documentation reflects the new grading and intended use.
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:
Request Concession: Submit a formal request for a concession, detailing the nature of the nonconformity and the rationale for its acceptance.
Review and Approval: Obtain approval from the relevant authority within the organization and, if necessary, from the customer.
Document Concession: Maintain detailed records of the concession, including the conditions under which the nonconforming product is accepted.
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:
Segregate Nonconforming Product: Immediately segregate the nonconforming product to prevent its unintended use or delivery.
Document Decision: Record the decision to reject or scrap the product, including the reasons for this decision.
Dispose of Product: Safely and responsibly dispose of the rejected or scrapped product according to the organization’s procedures and environmental regulations.
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
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:
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.
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.
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.
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.
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.
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).
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
Identify and Document: The valve component is found to have a dimensional defect.
Assess Impact: The defect could affect the sealing performance, posing a risk to safety and functionality.
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.
Consult with Stakeholders: Quality assurance, engineering, and the customer are consulted.
Make a Decision: Choose repair/rework based on feasibility and minimal impact on delivery schedule.
Implement the Chosen Option: Machining the component, followed by inspection to ensure conformity.
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.
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.
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
Customer Complaint/Feedback Mechanism:
Action: Establish channels for customers to report nonconforming products. This can include hotlines, email, online forms, or customer service representatives.
Evaluate the complaint and determine if it is a nonconformance.
Initial Assessment Checklist
Quality Control
3. Create NCR
Document the nonconformance details.
NCR Form
Quality Control
4. Containment Actions
Implement immediate actions to contain the issue.
Containment Action Log
Quality Control
5. Internal Reporting
Notify relevant departments about the issue.
Internal Communication System
Quality Control
6. Customer Notification
Inform the customer about the nonconformance and next steps.
Customer Notification Email/Letter
Customer Service/Quality
7. Root Cause Analysis
Investigate the cause of the nonconformance.
Root Cause Analysis Report
Quality Control Team
8. Corrective Actions
Develop and implement corrective actions.
Corrective Action Plan
Assigned Personnel
9. Verification
Verify the effectiveness of the corrective actions.
Verification Report
Quality Control
10. Final Communication
Communicate the resolution and preventive measures to the customer.
Final Resolution Communication
Customer Service/Quality
11. Regulatory Reporting (if needed)
Report to regulatory bodies as required.
Regulatory Reporting Forms
Compliance Manager
12. Record Keeping
Maintain all records related to the nonconformance.
NCR Database, Containment Logs, Corrective Action Records
Document 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:
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.
Review Documentation: Examine the product documentation and evidence supporting the nonconformity to understand the nature and extent of the issue.
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.
Investigate Process Steps: Review the entire production and delivery process to identify any points where the nonconformity may have originated or been introduced.
Consult Experts: Engage relevant stakeholders, subject matter experts, or quality assurance professionals to provide insights and expertise in analyzing the nonconformance.
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.
Verify Findings: Validate the identified root cause(s) through testing, analysis, or additional verification methods to confirm their accuracy.
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.
Implement Preventive Measures: Implement preventive measures to proactively address potential causes of nonconformities and improve the overall effectiveness of the quality management system.
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:
Assess Impact: Evaluate the severity and potential consequences of the nonconformity on product performance, safety, regulatory compliance, customer satisfaction, and other relevant factors.
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.
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.
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.
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.
Implement Corrective Measures: Execute the identified corrective actions promptly and effectively to rectify the nonconformity and prevent its recurrence.
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.
Document Actions Taken: Maintain comprehensive records documenting all actions taken to address the nonconformity, including containment measures, corrective actions, communication logs, and verification activities.
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.
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:
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.
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.
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.
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.
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.
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.
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.
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.
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 Type
Details Included
Nonconformance Report (NCR)
Description of nonconformity, customer details, product identification, initial assessment
Customer Communication Records
Notifications from and to the customer, instructions provided, resolution agreement
Root Cause Analysis Report
Investigation team details, data collected, analysis tools used, root cause identified
Corrective Action Plan
Actions to address root cause, implementation timeline, responsible personnel
Verification Records
Evidence of corrective action implementation, verification results
Disposition Records
Chosen disposition method, authorizations, and approvals
Management Review Minutes
Discussion on nonconformities, trends identified, decisions made for continuous improvement
Feedback and Improvement Records
Lessons learned, changes made to processes or procedures, training records
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:
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
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.
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:
Identification: Clearly mark or tag nonconforming products to distinguish them from conforming products. Use appropriate documentation and records to log nonconforming items.
Segregation: Physically separate nonconforming products from conforming ones to prevent accidental use. Use designated areas for storing nonconforming products.
Evaluation: Assess the extent and impact of the nonconformance. Determine the root cause of the nonconformance through investigation and analysis.
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.
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.
Correction: Implement corrective actions to address and rectify the nonconformance. Prevent recurrence by updating processes, training personnel, or making design changes.
Communication: Notify relevant stakeholders, including customers, about nonconformances and the actions taken. Provide evidence of conformity for any reworked or repaired products.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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
Detection: When a nonconformance is detected, the QC inspector immediately tags the product with a nonconformance label.
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
Quarantine: Nonconforming products are moved to a designated quarantine area to prevent their use in production.
Control: The quarantine area is monitored and access is restricted to authorized personnel only.
5.3 Evaluation and Disposition
Evaluation: The QA team reviews the NCR and conducts a root cause analysis.
Disposition Decision: The QA team recommends a disposition (rework, repair, use as-is, or scrap) and records the decision on the NCR.
Approval: The QA manager reviews and approves the disposition.
5.4 Rework and Repair
Instructions: The production team receives detailed instructions for rework or repair from the QA team.
Execution: The production team performs the rework or repair as instructed.
Verification: After rework or repair, the QC inspector re-inspects the product to ensure it meets specifications.
5.5 Verification of Corrective Actions
Inspection: QC inspectors verify that corrective actions have resolved the nonconformance.
Approval: The QC manager authorizes the release of the product after successful verification.
5.6 Customer Notification (if applicable)
Notification: The customer service team informs the customer of any nonconformances found after delivery.
Documentation: Details of the nonconformance and customer communication are recorded.
5.7 Return and Recall Management
Logistics: The logistics team arranges for the return or recall of nonconforming products.
Tracking: All returned or recalled products are tracked and documented.
5.8 Corrective and Preventive Actions
Action Plan: The continuous improvement team develops an action plan to prevent recurrence of the nonconformance.
Implementation: The action plan is implemented and monitored for effectiveness.
5.9 Documentation and Records Maintenance
Record Keeping: The document control team ensures all NCRs, evaluation reports, and corrective action plans are properly filed and maintained.
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.
The organization shall maintain a registry of the TMMDE identified in 5.8.1-General that includes a unique identification, specific to each piece of equipment. Results of calibration per 5.8.2-Procedure shall be recorded and maintained. When calibration of the third-party, proprietary, and customer TMMDE to the requirements of 5.8- Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) is limited by customer, contract, or licensing agreement, the organization shall maintain records of the limitations imposed.
The organization shall maintain a registry of the TMMDE identified in 5.8.1-General that includes a unique identification, specific to each piece of equipment.
Maintaining a registry of Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) that includes unique identification for each piece of equipment is crucial for several reasons:
Traceability:
Ensures each piece of equipment can be traced back to its calibration history, maintenance records, and usage.
Facilitates accountability and tracking of equipment performance over time.
Accuracy and Reliability:
Helps in ensuring the equipment used for testing and measurement is accurate and reliable.
Ensures that only calibrated and properly maintained equipment is used for critical measurements.
Compliance:
Necessary for compliance with industry standards (e.g., API Q1) and regulatory requirements.
Ensures adherence to quality management systems and internal policies.
Maintenance and Calibration Scheduling:
Helps in planning and scheduling regular maintenance and calibration.
Prevents the use of equipment that is out of calibration or due for maintenance.
Operational Efficiency:
Streamlines equipment management and minimizes downtime.
Ensures quick identification and location of equipment for operational needs.
Customer Confidence:
Provides customers with confidence that measurements and tests are performed with reliable equipment.
Supports claims of quality and precision in product realization.
Steps to Maintain the Registry:
Integrate the registry with the organization’s quality management system for seamless management and reporting.
Unique Identification: Assign a unique identification number to each piece of equipment. This could be a serial number, barcode, or alphanumeric code.
Detailed Records: Maintain detailed records for each piece of equipment, including type, model, manufacturer, calibration status, last calibration date, next calibration due date, maintenance history, and current location.
Regular Updates: Ensure the registry is regularly updated to reflect any changes, such as calibration status, maintenance activities, or changes in equipment location.
Access Control: Ensure that only authorized personnel can update the registry to maintain data integrity.
Integration with Quality Management System: Integrate the registry with the organization’s quality management system for seamless management and reporting.
Why Maintain a Registry?
Traceability:
Identification: Unique identifiers help trace each piece of equipment throughout its lifecycle.
Historical Records: Allows for tracking of calibration, maintenance, and usage history.
Accountability:
Responsibility Assignment: Ensures specific personnel are responsible for each piece of equipment.
Compliance: Helps meet regulatory and industry standards by keeping accurate records.
Quality Assurance:
Calibration and Maintenance: Ensures equipment is calibrated and maintained as per schedule.
Operational Efficiency: Prevents the use of out-of-calibration or malfunctioning equipment.
Preventive Actions:
Damage Control: Identifies and addresses issues before they affect product quality or safety.
Planning: Aids in planning for replacements and upgrades.
How to Maintain the Registry?
Unique Identification:
Assign Unique IDs: Each piece of equipment should have a distinct identifier.
Labeling: Physically label the equipment with its unique ID for easy identification.
Database Management:
Digital Registry: Use a digital database or software to maintain the registry.
Regular Updates: Ensure the registry is regularly updated with new data and changes.
Information to Include:
Equipment Details: Type, model, manufacturer, and serial number.
Calibration Details: Dates of last and next calibration, status.
Maintenance Records: Dates of last and next maintenance, any issues found.
Ownership: Whether the equipment is owned by the organization, a third party, or a customer.
Location: Current location of the equipment.
Responsible Personnel: Person or department responsible for the equipment.
Example of TMMDE Registry Record
Below is a sample format of a TMMDE registry record, demonstrating the essential information that should be included.
Equipment ID
Type
Model
Manufacturer
Serial Number
Owner
Calibration Due Date
Last Calibration Date
Calibration Status
Next Maintenance Date
Location
Assigned To
Comments
12345
Pressure Gauge
PG-200
Acme Corp
PG200-12345
Third-Party
2024-06-15
2023-06-15
Calibrated
2024-12-15
Lab 1
aa
Calibration confirmed
67890
Temperature Sensor
TS-100
TempTech
TS100-67890
Proprietary
2024-08-01
2023-08-01
Calibrated
2024-11-01
Field Site A
ss
Manufacturer ensures suitability
54321
Flow Meter
FM-50
FlowCorp
FM50-54321
Customer
2024-09-05
2023-09-05
Calibrated
2024-11-05
Field Site B
wn
No suitability requirement by customer
98765
Torque Wrench
TW-300
TorqueMasters
TW300-98765
Third-Party
2024-10-10
2023-10-10
Calibrated
2024-12-10
Maintenance Room
ee
Calibration confirmed
Maintaining a registry of TMMDE with unique identification ensures effective management and control of equipment, supporting quality assurance, regulatory compliance, and operational efficiency. This registry acts as a central record, facilitating easy access to vital information about each piece of equipment, ensuring it is used correctly and maintained properly.
Results of calibration per 5.8.2-Procedure shall be recorded and maintained.
To ensure the accuracy and reliability of Testing, Measuring, Monitoring, and Detection Equipment (TMMDE), it is essential to record and maintain the results of calibration. This practice is crucial for demonstrating compliance with standards such as API Q1 and ensuring the integrity of the equipment used in the oil and gas industry.
Why Record and Maintain Calibration Results?
Compliance:
Standards Adherence: Ensures compliance with industry standards and regulatory requirements.
Audit Trail: Provides a documented history for audits and inspections.
Quality Assurance:
Accuracy Verification: Confirms that equipment is providing accurate measurements.
Defect Identification: Helps identify equipment that is out of tolerance or malfunctioning.
Traceability:
Historical Records: Maintains a historical record of calibration activities and results.
Issue Investigation: Facilitates root cause analysis in case of product quality issues.
Operational Efficiency:
Maintenance Scheduling: Informs maintenance schedules and intervals.
Resource Allocation: Helps in planning for replacements or repairs.
How to Record and Maintain Calibration Results?
Recording Calibration Results:
As-Found and As-Left Conditions: Document the condition of the equipment before (as-found) and after (as-left) calibration adjustments.
Calibration Data: Record specific calibration data, such as measured values, deviations, and adjustments made.
Calibration Certificate: Generate a calibration certificate that includes all relevant information and results.
Maintaining Calibration Records:
Digital Records: Use digital systems or databases to store calibration records for easy access and retrieval.
Physical Records: Maintain physical copies of calibration certificates and logs if required.
Retention Policy: Establish a retention policy to ensure records are kept for the necessary period as per regulatory and organizational requirements.
Content of Calibration Records:
Equipment Identification: Include the unique identifier, model, and serial number.
Calibration Date: The date when the calibration was performed.
Calibration Interval: The next due date for calibration.
Calibration Results: Detailed results including as-found and as-left conditions, measurement data, and any adjustments made.
Calibrated By: The name and details of the person or third party who performed the calibration.
Calibration Status: Indicate whether the equipment passed or failed the calibration.
Example of Calibration Record
Here is an example of a calibration record in tabular form:
Equipment ID
Type
Model
Serial Number
Calibration Date
As-Found Condition
As-Left Condition
Calibration Results
Calibrated By
Next Calibration Due
Status
12345
Pressure Gauge
PG-200
PG200-12345
2023-06-15
2% deviation
Within tolerance
Adjustment made
aa
2024-06-15
Calibrated
67890
Temperature Sensor
TS-100
TS100-67890
2023-08-01
Within tolerance
Within tolerance
No adjustment needed
ff
2024-08-01
Calibrated
54321
Flow Meter
FM-50
FM50-54321
2023-09-05
1.5% deviation
Within tolerance
Minor adjustment made
qq
2024-09-05
Calibrated
98765
Torque Wrench
TW-300
TW300-98765
2023-10-10
Out of tolerance
Within tolerance
Significant adjustment made
ee
2024-10-10
Calibrated
Recording and maintaining calibration results is a critical practice for ensuring the accuracy and reliability of TMMDE in the oil and gas industry. By systematically documenting calibration activities and results, organizations can ensure compliance, maintain quality, and support operational efficiency. This practice provides a clear and traceable record of the equipment’s performance, facilitating effective management and continuous improvement.
When calibration of the third-party, proprietary, and customer TMMDE to the requirements of 5.8- Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) is limited by customer, contract, or licensing agreement, the organization shall maintain records of the limitations imposed.
When calibration of third-party, proprietary, and customer-owned Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) is limited by customer, contract, or licensing agreement, it is crucial for the organization to maintain records of these limitations. This ensures transparency, compliance with contractual obligations, and traceability in the management of such equipment.
Why Maintain Records of Limitations Imposed on TMMDE Calibration?
Compliance:
Contractual Obligations: Ensures that the organization adheres to specific requirements or limitations outlined by customers or contracts.
Regulatory Requirements: Facilitates compliance with industry standards and regulatory requirements, even when exceptions are made.
Transparency:
Clear Documentation: Provides clear documentation of any deviations from standard calibration procedures due to contractual limitations.
Audit Trail: Maintains an audit trail that can be reviewed during internal or external audits.
Risk Management:
Risk Assessment: Helps in assessing risks associated with using equipment that may not fully comply with standard calibration practices.
Decision Making: Informs decision-making processes regarding the use and reliability of TMMDE.
Customer Communication:
Notification: Ensures that customers are informed about any limitations and the potential impact on measurement accuracy and product quality.
How to Maintain Records of Limitations Imposed on TMMDE Calibration?
Record Keeping:
Create a Dedicated Log: Maintain a dedicated log or database for recording limitations imposed on the calibration of TMMDE.
Detailed Entries: Ensure each entry includes detailed information about the specific limitations, including the type of equipment, nature of the limitation, and the party imposing the limitation.
Information to Include:
Equipment Identification: Unique ID, type, model, and serial number of the TMMDE.
Limitation Details: Specific details about the limitation imposed by the customer, contract, or licensing agreement.
Imposing Party: The name and details of the customer or contractual party imposing the limitation.
Date of Imposition: The date when the limitation was communicated or agreed upon.
Impact Assessment: Assessment of how the limitation affects the calibration and usage of the equipment.
Approval and Authorization: Documentation of approval or acceptance of the limitation by relevant organizational authorities.
Documentation Formats:
Digital Records: Use digital systems or software to store and manage records for ease of access, retrieval, and updates.
Physical Records: Keep physical copies if required, ensuring they are organized and stored securely.
Review and Update:
Periodic Review: Regularly review and update records to ensure they remain accurate and current.
Customer Communication: Maintain communication with customers regarding any changes or updates to the limitations.
Example of Records of Limitations Imposed on TMMDE Calibration
Here is an example of how to document limitations imposed on TMMDE calibration in a tabular format:
Equipment ID
Type
Model
Serial Number
Limitation Details
Imposing Party
Date of Imposition
Impact Assessment
Approved By
12345
Pressure Gauge
PG-200
PG200-12345
Calibration to national standards not required
Customer XYZ
2023-06-01
May affect accuracy, acceptable per contract
QA Manager
67890
Temperature Sensor
TS-100
TS100-67890
Calibration interval set by customer at 24 months
Contract ABC
2023-08-15
Longer interval than standard, risk accepted
QA Manager
54321
Flow Meter
FM-50
FM50-54321
Proprietary equipment, no external calibration
Licensing Agreement 456
2023-09-10
Rely on internal checks, agreed by contract
QA Manager
98765
Torque Wrench
TW-300
TW300-98765
Limited to OEM guidelines only
Customer DEF
2023-10-05
Compliance with OEM, deviation documented
QA Manager
Maintaining records of limitations imposed on the calibration of third-party, proprietary, and customer-owned TMMDE is essential for compliance, transparency, and risk management. By systematically documenting these limitations, the organization ensures that it can effectively manage and mitigate any risks associated with deviations from standard calibration practices. This practice supports clear communication with customers and facilitates compliance with contractual and regulatory requirements.
When TMMDE is third-party, proprietary, or customer-owned, the organization shall confirm the equipment is in calibration prior to use. When limited by customer, contract, or licensing agreement, the Following requirements shall not apply
5.8.2, Item c) traceability to international or national measurement standards; where no such standards exist, the basis used for calibration shall be recorded;
5.8.2, Item d)calibration method and acceptance criteria;
5.8.2, Item e) frequency of calibration, and when the calibration interval begins;
5.8.2, Item f) documentation of the calibration measurements prior to adjustment and measurements after any adjustments during calibration;
5.8.2, Item j)maintenance;
5.8.2, Item k) suitability for the planned monitoring and measurement activities.
When using third-party, proprietary, or customer-owned Testing, Measuring, Monitoring, and Detection Equipment (TMMDE), it is essential to ensure that these tools meet the necessary standards and requirements for accuracy, reliability, and compliance. This involves establishing processes for verification, calibration, maintenance, and documentation.
Importance of Managing External TMMDE
Accuracy and Reliability: Ensures the equipment provides accurate and reliable measurements.
Compliance: Meets industry standards and regulatory requirements.
Quality Assurance: Maintains the integrity of the quality management system.
Risk Management: Minimizes risks associated with equipment failures or inaccuracies.
Steps for Managing External TMMDE
Verification Prior to Use
Initial Verification: Confirm that the third-party, proprietary, or customer-owned equipment meets the required specifications and is suitable for the intended application before use.
Calibration Records: Review the calibration records to ensure the equipment has been calibrated according to the required standards.
Performance Testing: Conduct performance tests to verify the accuracy and reliability of the equipment.
Calibration and Maintenance
Calibration Schedule: Establish a calibration schedule based on the equipment’s usage and manufacturer’s recommendations.
Documentation: Maintain detailed records of calibration, including dates, results, and any adjustments made.
Maintenance Procedures: Ensure regular maintenance is performed to keep the equipment in optimal condition. This includes routine checks and servicing as per the manufacturer’s guidelines.
Identification and Traceability
Unique Identification: Assign unique identification numbers to all external TMMDE to track their usage and maintenance history.
Calibration Status: Clearly label the equipment with its calibration status, including the next calibration due date.
Traceability: Ensure traceability to national or international standards. If such standards do not exist, document the basis used for calibration.
Environmental Conditions
Suitable Conditions: Ensure that the equipment is used under suitable environmental conditions as specified by the manufacturer.
Protection: Safeguard the equipment from damage and deterioration during handling, maintenance, and storage.
Control of Equipment Use
Authorization: Restrict the use of external TMMDE to authorized personnel who are trained and knowledgeable about the equipment.
Documentation: Maintain records of who uses the equipment, for what purpose, and under what conditions.
Compliance Checks: Regularly check that the equipment is being used in compliance with established procedures and standards.
Non-Conformance Management
Out-of-Calibration Equipment: Identify and segregate any equipment found to be out-of-calibration or malfunctioning to prevent unintended use.
Validity Assessment: Assess the validity of previous measurements taken with out-of-calibration equipment and take corrective actions as necessary.
Customer Notification: Notify the customer if suspect product has been shipped due to the use of out-of-calibration or faulty equipment.
Documentation and Record Keeping
Equipment Logs: Maintain logs for each piece of external TMMDE, including calibration dates, maintenance activities, and performance checks.
Audit Trails: Keep comprehensive audit trails to track the history of each piece of equipment.
Customer Requirements: Ensure that the management of customer-owned equipment complies with any specific requirements or standards provided by the customer.
When TMMDE is third-party, proprietary, or customer-owned, the organization shall confirm the equipment is in calibration prior to use.
When using third-party, proprietary, or customer-owned Testing, Measuring, Monitoring, and Detection Equipment (TMMDE), it is crucial to confirm that the equipment is properly calibrated before its use. This ensures the accuracy and reliability of measurements and helps maintain compliance with industry standards and regulations.Confirming that third-party, proprietary, or customer-owned TMMDE is in calibration prior to use involves reviewing calibration certificates, assessing calibration records, performing inspections and functional tests, maintaining thorough documentation, and ensuring user awareness of the calibration status. These steps help ensure the accuracy and reliability of the equipment, supporting the overall quality management system and compliance with industry standards.
Steps to Confirm Calibration Prior to Use
Verification of Calibration Certificates
Review Calibration Certificates: Obtain and review the calibration certificates for the TMMDE. Ensure that the certificates are up-to-date and provided by a recognized and accredited calibration service.
Check Calibration Dates: Confirm that the calibration was performed within the specified interval and that the next calibration due date has not passed.
Assessment of Calibration Records
Traceability: Ensure that the calibration records are traceable to national or international standards. If such standards do not exist, verify that the basis for calibration is documented and acceptable.
Calibration Status: Check the equipment for any calibration status labels or tags that indicate the last calibration date and the due date for the next calibration.
Inspection and Testing
Initial Inspection: Conduct an initial inspection of the equipment to check for any visible signs of damage or wear that could affect its performance.
Functional Testing: Perform functional tests to verify that the equipment operates correctly and produces reliable results. This might include comparing the equipment’s output against known standards or benchmarks.
Documentation and Record Keeping
Maintain Records: Keep detailed records of the verification process, including the review of calibration certificates, inspection results, and functional tests.
Calibration Log: Update the calibration log to include information about the verification of third-party, proprietary, or customer-owned TMMDE.
User Awareness
Inform Users: Ensure that all users are aware of the calibration status of the TMMDE before using it. This includes providing access to calibration records and certificates.
Labeling: Clearly label the equipment with its calibration status and the next calibration due date.
Example of a Calibration Verification Log
Date
Equipment ID
Type
Owner
Calibration Due Date
Verification Date
Verified By
Status
Comments
2024-01-15
12345
Pressure Gauge
Third-Party
2024-06-15
2024-01-15
John Doe
In Calibration
Calibration certificate verified
2024-02-01
67890
Temperature Sensor
Proprietary
2024-08-01
2024-02-01
Jane Smith
In Calibration
Functional test passed
2024-03-05
54321
Flow Meter
Customer
2024-09-05
2024-03-05
Mike Brown
Out of Calibration
Recalibration required
2024-04-10
98765
Torque Wrench
Third-Party
2024-10-10
2024-04-10
Sarah Lee
In Calibration
Inspection and test verified
When limited by customer, contract, or licensing agreement, the requirements of 5.8.2, Item c) “traceability to international or national measurement standards; where no such standards exist, the basis used for calibration shall be recorded” – shall not apply.
In specific situations where the organization is limited by customer agreements, contracts, or licensing terms, it may not be required to meet the stringent traceability requirements to international or national measurement standards. Here is an explanation of how and why this exception is applied, and what the organization should do in such cases.
Understanding the Exception
Customer Requirements: Sometimes, a customer might specify certain conditions that do not necessitate full traceability to national or international standards.
Contractual Agreements: Contracts may outline specific requirements for TMMDE that differ from standard industry practices, including exemptions from traceability standards.
Licensing Agreements: Licensing terms might restrict certain procedures or set unique calibration requirements that do not align with traceability to recognized measurement standards.
How to Handle the Exception
Documentation of Exceptions
Record Exceptions: Clearly document any exceptions to the traceability requirements, citing the relevant customer agreement, contract, or licensing term that mandates this exception.
Approval: Ensure that these exceptions are approved by relevant authorities within the organization and are well-communicated to all stakeholders.
Alternative Calibration Basis
Define Basis for Calibration: In the absence of traceability to recognized standards, specify the basis used for calibration. This might include internal standards, manufacturer specifications, or other relevant criteria.
Documentation: Maintain detailed records of the alternative calibration methods used, including any internal standards or benchmarks applied.
Customer Communication
Notification: Inform the customer of the calibration and traceability methods being used, especially if they differ from typical industry standards.
Approval: Obtain customer approval for the alternative calibration approach to ensure alignment and avoid any potential disputes.
When limited by customer, contract, or licensing agreement, the requirements of 5.8.2, Item d) “calibration method and acceptance criteria”- shall not apply.
In certain situations, an organization may be exempt from addressing the standard requirements for calibration methods and acceptance criteria, particularly when constrained by customer specifications, contractual agreements, or licensing terms. Here is an explanation of how this exception can be managed, and what steps the organization should take in such cases.
1. Customer, Contract, or Licensing Limitations
Customer Specifications: Sometimes, a customer might outline specific calibration methods and acceptance criteria that the organization must follow, which may not align with standard practices.
Contractual Agreements: Contracts may specify particular calibration requirements, possibly diverging from the organization’s typical methods and criteria.
Licensing Terms: Licensing agreements may impose unique calibration procedures that must be adhered to, potentially differing from established industry norms.
How to Handle the Exception
Documentation of Exceptions
Record Exceptions: Clearly document any deviations from the standard calibration methods and acceptance criteria, citing the specific customer, contract, or licensing terms that mandate this exception.
Approval: Ensure that these exceptions are approved by relevant authorities within the organization and are communicated to all necessary personnel.
Alternative Calibration Methods and Criteria
Define Alternative Methods: Specify the alternative calibration methods and acceptance criteria that will be used in place of the standard requirements. This might include methods prescribed by the customer, detailed in the contract, or specified in the licensing agreement.
Documentation: Maintain thorough records of the alternative calibration methods and acceptance criteria used, ensuring they are well-documented and accessible for review.
Customer Communication
Approval: Obtain customer approval for the alternative methods and criteria to ensure alignment and avoid potential disputes.
Notification: Inform the customer of the calibration methods and acceptance criteria being used, particularly if they differ from typical practices.
When limited by customer, contract, or licensing agreement, the requirements of 5.8.2, Item e) “frequency of calibration, and when the calibration interval begins”- shall not apply.
In certain cases, an organization may be exempt from standard requirements regarding the frequency of calibration and the starting point for the calibration interval, particularly when directed by customer specifications, contractual agreements, or licensing terms. Here is an explanation of how this exception is managed and what steps the organization should take in such cases.
Customer, Contract, or Licensing Limitations
Customer Specifications: Customers may dictate specific calibration frequencies and intervals that must be followed, which may not align with the organization’s standard practices.
Contractual Agreements: Contracts might outline particular requirements for calibration frequency and intervals.
Licensing Terms: Licensing agreements may impose unique calibration schedules that must be adhered to, differing from standard industry norms.
How to Handle the Exception
Documentation of Exceptions
Record Exceptions: Clearly document any deviations from the standard requirements for calibration frequency and intervals, citing the specific customer, contract, or licensing terms that mandate this exception.
Approval: Ensure that these exceptions are approved by relevant authorities within the organization and are communicated to all necessary personnel.
Alternative Calibration Schedules
Define Alternative Schedules: Specify the alternative calibration schedules that will be used. This might include frequencies and intervals prescribed by the customer or detailed in the contract or licensing agreement.
Documentation: Maintain thorough records of the alternative calibration schedules, ensuring they are well-documented and accessible for review.
Customer Communication
Approval: Obtain customer approval for the alternative schedules to ensure alignment and avoid potential disputes.
Notification: Inform the customer of the calibration schedules being used, particularly if they differ from typical practices.
When limited by customer, contract, or licensing agreement, the requirements of 5.8.2, Item f) “documentation of the calibration measurements prior to adjustment and measurements after any adjustments during calibration”- shall not apply.
In some instances, an organization may be exempt from the standard requirement to document calibration measurements prior to adjustment (“as-found”) and after any adjustments (“as-left”), especially when constrained by customer specifications, contractual agreements, or licensing terms. Below is an explanation of how this exception can be managed and the steps the organization should take in such cases.
Customer, Contract, or Licensing Limitations
Customer Specifications: Customers may dictate specific requirements that do not necessitate documentation of “as-found” and “as-left” calibration measurements.
Contractual Agreements: Contracts might outline particular calibration documentation requirements, possibly excluding the need for detailed before-and-after adjustment records.
Licensing Terms: Licensing agreements may impose unique calibration documentation procedures that must be adhered to, potentially differing from standard industry practices.
How to Handle the Exception
Documentation of Exceptions
Record Exceptions: Clearly document any deviations from the standard requirement to document “as-found” and “as-left” calibration measurements, citing the specific customer, contract, or licensing terms that mandate this exception.
Approval: Ensure that these exceptions are approved by relevant authorities within the organization and communicated to all necessary personnel.
Alternative Documentation Practices
Define Alternative Practices: Specify the alternative documentation practices that will be used. This might include summary reports, periodic audits, or other forms of documentation as prescribed by the customer or detailed in the contract or licensing agreement.
Documentation: Maintain thorough records of the alternative documentation practices used, ensuring they are well-documented and accessible for review.
Customer Communication
Notification: Inform the customer of the documentation practices being used, particularly if they differ from typical practices.
Approval: Obtain customer approval for the alternative documentation practices to ensure alignment and avoid potential disputes.
When limited by customer, contract, or licensing agreement, the requirements of 5.8.2, Item j) “maintenance” – shall not apply.
When an organization is limited by customer specifications, contractual agreements, or licensing terms, it may be exempt from performing maintenance on Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) for several reasons:
Customer Specifications
Customer Control: The customer might prefer to take responsibility for the maintenance of the TMMDE, especially if the equipment is specialized or critical to their operations.
Consistency: Customers might have specific maintenance protocols that ensure consistency across different suppliers or locations.
Contractual Agreements
Specified Conditions: Contracts can explicitly outline that maintenance is not required or will be performed by a third party or the customer. This can be due to various reasons, such as the nature of the equipment, usage frequency, or specific project requirements.
Liability and Responsibility: Contracts might assign maintenance responsibility to the customer or another party to delineate liability and ensure that the equipment meets specific standards as defined by the customer.
Licensing Agreements
License Terms: Licensing agreements may include terms that specify the maintenance procedures or state that no maintenance is required under certain conditions.
Proprietary Technology: If the equipment involves proprietary technology, the licensor might retain responsibility for maintenance to protect intellectual property or ensure proper functioning.
How to Manage This Exception
Document the Exceptions
Record Details: Maintain clear documentation outlining the exceptions, including references to customer specifications, contractual clauses, or licensing terms that mandate the deviation.
Approval and Communication: Ensure the exceptions are approved by relevant internal authorities and communicated to all necessary personnel to avoid confusion and ensure compliance.
Alternative Maintenance Practices
Customer-Driven Maintenance: In cases where the customer handles maintenance, ensure that their procedures are documented and that the organization is aware of the schedule and requirements.
Record-Keeping: Even if maintenance is not performed by the organization, keeping records of any maintenance performed by the customer or third parties is crucial for traceability and quality assurance.
Customer Communication
Approval: Obtain and document customer approval for these practices to ensure alignment and prevent any misunderstandings or disputes.
Notification: Clearly inform the customer of the maintenance practices, or lack thereof, being implemented.
When limited by customer, contract, or licensing agreement, the requirements of 5.8.2, Item k) “suitability for the planned monitoring and measurement activities”- shall not apply.
When limited by customer, contract, or licensing agreement, the organization may be exempt from addressing the suitability for the planned monitoring and measurement activities due to several reasons. Below is an explanation of why this might be the case and how the organization can manage such exemptions.
Reasons for the Exemption
Customer Specifications:
Customer Assurance: The customer might already have assurance mechanisms in place to verify that the equipment is suitable for the intended monitoring and measurement activities.
Pre-determined Standards: The customer may provide specific standards or criteria that guarantee the equipment’s suitability.
Contractual Agreements:
Defined Responsibilities: Contracts might outline that the customer or a third party is responsible for determining the suitability of the equipment.
Explicit Exemptions: Contracts could explicitly state that the organization does not need to address equipment suitability under certain conditions.
Licensing Terms:
Proprietary Constraints: Licensing agreements for proprietary technology may include provisions that the licensor ensures suitability.
Specific Use Cases: Licensing terms may cover specific use cases that inherently guarantee the suitability of the equipment.
Managing the Exemption
Documenting the Exemption
Record Details: Clearly document the reasons for the exemption, referencing specific customer specifications, contractual clauses, or licensing terms.
Approval and Communication: Ensure these exemptions are approved by relevant internal authorities and communicated to all necessary personnel.
Alternative Assurance Practices
Customer-Driven Assurance: If the customer is responsible for ensuring suitability, document their assurance processes and ensure the organization is aware of these standards.
Record-Keeping: Maintain records of any customer or third-party assurances regarding equipment suitability.
Customer Communication
Approval: Obtain and document customer approval to ensure alignment and prevent misunderstandings or disputes.
Notification: Clearly inform the customer about the exemption and how the suitability is being managed.
TMMDE Record for Third-Party, Proprietary, or Customer-Owned Equipment
TMMDE Inventory Record
Equipment ID
Type
Owner
Calibration Due Date
Calibration Status
Basis for Exemption
Document Reference
Approved By
Comments
12345
Pressure Gauge
Third-Party
2024-06-15
Calibrated
Contract #5678
Contract #5678
aa
Calibration confirmed by third-party
67890
Temperature Sensor
Proprietary
2024-08-01
Calibrated
Licensing Agreement #4321
Licensing Agreement #4321
qq
Manufacturer ensures suitability
54321
Flow Meter
Customer
2024-09-05
Calibrated
Customer Agreement #9087
Customer Agreement #9087
dd
No suitability requirement by customer
98765
Torque Wrench
Third-Party
2024-10-10
Calibrated
Contract #7854
Contract #7854
ww
Calibration confirmed by third-party
Calibration Confirmation Record
Equipment ID
Type
Owner
Calibration Status
Calibration Date
Calibration Certificate ID
Performed By
Approved By
Comments
12345
Pressure Gauge
Third-Party
Calibrated
2024-06-15
CERT-12345
Third-Party Calibrator
yy
Calibration confirmed by third-party
67890
Temperature Sensor
Proprietary
Calibrated
2024-08-01
CERT-67890
Manufacturer
ff
Manufacturer ensures suitability
54321
Flow Meter
Customer
Calibrated
2024-09-05
CERT-54321
Customer
ww
No suitability requirement by customer
98765
Torque Wrench
Third-Party
Calibrated
2024-10-10
CERT-98765
Third-Party Calibrator
ee
Calibration confirmed by third-party
Suitability and Usage Record
Equipment ID
Type
Owner
Suitable for Use
Assurance Provided By
Assurance Date
Approved By
Comments
12345
Pressure Gauge
Third-Party
Yes
Third-Party Calibrator
2024-06-15
aa
Calibration and suitability confirmed
67890
Temperature Sensor
Proprietary
Yes
Manufacturer
2024-08-01
qq
Manufacturer ensures suitability
54321
Flow Meter
Customer
Yes
Customer
2024-09-05
ss
No suitability requirement by customer
98765
Torque Wrench
Third-Party
Yes
Third-Party Calibrator
2024-10-10
ee
Calibration and suitability confirmed
This tabular format for records of TMMDE owned by third-parties, proprietary, or customer-owned helps ensure that:
Calibration Status: All equipment is calibrated and the status is documented.
Suitability: The equipment is suitable for its intended use, confirmed by the responsible party (third-party, manufacturer, or customer).
Documentation: Exemptions and basis for not addressing certain requirements are clearly recorded.
Approval and Oversight: Appropriate personnel have reviewed and approved the records to ensure compliance and traceability.
By maintaining these records, the organization can demonstrate that it meets the requirements for managing third-party, proprietary, and customer-owned equipment effectively.
TMMDE identified in 5.8.1 shall: a) be calibrated. b) have the calibration status identifiable by the user prior to and during use. c) be safeguarded from adjustments or modification that would invalidate the measurement result or the calibration status. d) be protected from damage and deterioration during handling, maintenance, and storage; e) be used under environmental conditions that are suitable for the calibrations, inspections, measurements, and tests being performed.
When used in the testing, monitoring, measurement, or detection of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed prior to initial use and reconfirmed, as necessary.
Oil and gas organizations require a variety of equipment to ensure the safety, quality, and efficiency of their operations. The equipment can be broadly categorized into four types: testing, measuring, monitoring, and detection. Here’s an overview of each category and the specific equipment typically required:
Testing Equipment
Pressure Testers: To test the integrity of pipelines, tanks, and other pressurized systems.
Hydrostatic Testers: Used to test the strength and leak resistance of pipes and vessels.
Viscometers: To measure the viscosity of drilling fluids.
Chemical Test Kits: For testing water quality, gas composition, and other chemical properties.
Measuring Equipment
Flow Meters: To measure the flow rate of liquids and gases.
Thermometers and Temperature Sensors: To measure temperatures in various parts of the operation.
Manometers and Pressure Gauges: To measure pressure in pipelines and equipment.
Level Gauges: To measure the level of liquids in tanks and containers.
Monitoring Equipment
Vibration Monitors: To detect and analyze vibration levels in machinery, indicating potential issues.
Condition Monitoring Systems: For continuous monitoring of equipment health and performance.
SCADA Systems (Supervisory Control and Data Acquisition): For real-time monitoring and control of industrial processes.
Corrosion Monitoring Devices: To monitor the rate of corrosion in pipelines and equipment.
Detection Equipment
Gas Detectors: To detect the presence of hazardous gases such as methane, hydrogen sulfide, and carbon monoxide.
Leak Detectors: To identify leaks in pipelines and vessels.
Fire and Flame Detectors: To detect fires and ensure safety.
Ultrasonic Detectors: For non-destructive testing and detecting flaws in materials.
To ensure that the equipment used is reliable, accurate, and compliant with standards, oil and gas organizations must manage it effectively. Here’s how an organization can manage such equipment:
Identification and Documentation
Inventory Management: Maintain an up-to-date inventory of all equipment, including details such as type, model, serial number, and location.
Unique Identification: Assign a unique identification code to each piece of equipment for easy tracking and reference.
Calibration and Validation
Calibration Schedule: Establish and follow a regular calibration schedule based on manufacturer recommendations, industry standards, and usage patterns.
Traceability: Ensure all calibrations are traceable to national or international standards. Where no such standards exist, document the basis used for calibration.
Validation Procedures: Validate equipment performance under actual operating conditions to ensure it meets the required specifications.
Maintenance and Monitoring
Preventive Maintenance: Implement a preventive maintenance program to minimize equipment failures and extend equipment life. This includes regular inspections, cleaning, lubrication, and part replacements.
Condition Monitoring: Continuously monitor the condition and performance of equipment using appropriate technologies.
Maintenance Records: Keep detailed records of all maintenance activities, including the date, description of work performed, parts replaced, and the name of the technician.
Training and Competence
Personnel Training: Provide training programs for personnel to ensure they have the necessary skills and knowledge to operate, calibrate, and maintain the equipment.
Competence Assessment: Regularly assess the competence of personnel handling the equipment to ensure they can accurately perform the required tasks.
Handling Non-Conformities
Out-of-Calibration Equipment: Clearly label and remove any equipment found to be out of calibration, beyond its calibration interval, or not in service to prevent unintended use.
Assessment and Action: Assess the validity of previous measurements taken with out-of-calibration equipment and take appropriate actions on the equipment and product, including notifying the customer if suspect product has been shipped.
Documentation and Record Keeping
Calibration Records: Maintain detailed records of all calibration activities, including calibration certificates, as-found and as-left data, and next calibration due dates.
Maintenance Logs: Keep logs of all maintenance activities, including preventive and corrective maintenance.
Validation Reports: Document the results of validation activities.
By identifying the required equipment and implementing a comprehensive management system, oil and gas organizations can ensure that their testing, measuring, monitoring, and detection equipment is accurate, reliable, and compliant with industry standards. This involves systematic identification, regular calibration, preventive maintenance, continuous monitoring, and thorough documentation, all supported by trained and competent personnel. This approach helps maintain the integrity of the measurement processes, ensures consistent product quality, and supports overall operational efficiency.
TMMDE must be calibrated.
In the oil and gas industry, it is essential that all Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) are calibrated to ensure accurate and reliable measurements. Calibration is the process of comparing the measurements of an instrument against a standard reference to identify and correct any deviations.
Calibration is Essential for the following reasons:
Accuracy and Reliability: Ensures that all measurements are accurate, providing reliable data for decision-making.
Compliance: Meets regulatory and industry standards, such as API Q1, ISO 9001, and other relevant standards.
Safety: Helps in maintaining operational safety by ensuring equipment functions correctly.
Quality Assurance: Supports quality control processes by providing precise measurements.
How the Organization Can Ensure Calibration of TMMDE
Establish a Calibration Program
Identify Calibration Needs: Determine which equipment needs calibration based on its impact on the quality of the product, safety, and compliance requirements.
Create a Schedule: Develop a calibration schedule that specifies the frequency of calibration for each piece of equipment. This schedule should be based on:
Manufacturer’s recommendations
Industry standards
Usage frequency
Historical calibration data
Risk assessments
Traceability to Standards
National/International Standards: Ensure all calibrations are traceable to recognized national or international standards.
Documentation: Where no standards exist, document the basis used for calibration.
Use of Accredited Calibration Services
Third-Party Services: Utilize accredited third-party calibration services to ensure unbiased and precise calibrations.
Internal Calibration: If calibration is performed in-house, ensure that the personnel are trained and that the calibration process is regularly audited.
Record Keeping and Documentation
Calibration Certificates: Maintain calibration certificates for all TMMDE, including the results of the calibration, the date, and the next due date.
Calibration Logs: Keep detailed logs that track the calibration status of each piece of equipment.
Handling Out-of-Calibration Equipment
Labeling: Clearly label any equipment that is out of calibration or beyond its calibration interval to prevent its use.
Assessment and Notification: Assess the validity of previous measurements taken with out-of-calibration equipment. If suspect product has been shipped, notify the customer and take appropriate actions.
Calibration Procedure
As-Found and As-Left Data: Document the measurements before adjustment (as-found) and after any adjustments (as-left). If no adjustments are made, the as-found and as-left data should be the same.
Calibration Method: Define and document the calibration methods and acceptance criteria.
Regular Maintenance: Integrate calibration into the preventive maintenance program to ensure equipment is functioning correctly and remains within calibration limits.
Competence and Training
Personnel Training: Train personnel involved in calibration activities on proper calibration techniques, use of calibration equipment, and documentation requirements.
Competence Evaluation: Regularly evaluate the competence of calibration personnel to ensure they maintain the necessary skills and knowledge.
Example of a Calibration Record (Tabular Form)
Equipment ID
Equipment Type
Calibration Date
As-Found Data
As-Left Data
Next Calibration Date
Calibrated By
Traceability to Standard
EQ-101
Digital Caliper
2024-01-15
±0.02 mm
±0.01 mm
2024-07-15
dd
NIST SRM 1234
EQ-102
Pressure Gauge
2024-02-10
±0.2 bar
±0.1 bar
2024-08-10
qq
ISO 9001
EQ-103
Temperature Sensor
2024-03-20
±1.0°C
±0.5°C
2024-09-20
qq
ASTM E2877
EQ-104
Flow Meter
2024-04-05
±0.05 L/min
±0.01 L/min
2024-10-05
ee
NIST SRM 6789
Ensuring the calibration of TMMDE is crucial for maintaining the accuracy, reliability, and compliance of measurements in the oil and gas industry. By establishing a robust calibration program, utilizing accredited calibration services, maintaining detailed records, and training personnel, an organization can effectively manage the calibration process, thus ensuring the quality and safety of its operations.
TMMDE must have the calibration status identifiable by the user prior to and during use.
To maintain accuracy and reliability, it is essential that the calibration status of all Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) is easily identifiable by users before and during use. This helps prevent the use of out-of-calibration equipment, which could lead to incorrect measurements and potentially unsafe conditions.
Why Identifiable Calibration Status is Important
Accuracy and Reliability: Ensures measurements are based on calibrated equipment, thereby maintaining data integrity.
Compliance: Meets regulatory and industry standards, such as API Q1 , which require calibration status to be clearly identified.
Safety: Prevents the use of equipment that may give inaccurate readings, thus enhancing operational safety.
Quality Assurance: Supports consistent quality control by ensuring that only properly calibrated equipment is used.
How to Ensure Calibration Status is Identifiable
1. Calibration Labels and Tags
Visible Labels: Attach a clearly visible label or tag to each piece of equipment indicating its calibration status.
Information on Labels: The label should include:
Calibration date
Next calibration due date
Calibration status (e.g., “Calibrated,” “Due for Calibration,” “Out of Calibration”)
Unique identification number of the equipment
2. Digital Tracking Systems
Barcode or RFID Tags: Use barcodes or RFID tags on equipment to store calibration information digitally. Users can scan these tags to access calibration data instantly.
Calibration Management Software: Implement software systems that track calibration status and provide alerts when calibration is due. These systems can be integrated with equipment management databases for real-time status updates.
3. Calibration Certificates
On-Site Documentation: Keep a copy of the calibration certificate with the equipment, either in a physical logbook or a digital format accessible via scanning a QR code on the equipment.
Centralized Records: Maintain centralized digital records of all calibration certificates, accessible to all relevant personnel.
4. Regular Audits and Inspections
Periodic Checks: Conduct regular audits and inspections to ensure that calibration labels and records are up to date and correctly displayed.
Compliance Verification: Verify that all equipment in use has current and visible calibration status labels during routine checks.
5. Training and Awareness
User Training: Train all users on the importance of checking calibration status before and during equipment use.
Awareness Programs: Implement awareness programs to emphasize the role of calibration in maintaining quality and safety standards.
Example of a Calibration Label
Calibration Label
Equipment ID: EQ-101
Calibration Date: 2024-01-15
Next Calibration Due: 2024-07-15
Status: Calibrated
Calibrated By: ww
Traceability: NIST SRM 1234
Example of a Digital Calibration Record (Accessible via QR Code)
Equipment ID
Calibration Date
Next Calibration Due
Status
Calibrated By
Traceability
EQ-101
2024-01-15
2024-07-15
Calibrated
qq
NIST SRM 1234
As-Found:
±0.02 mm
As-Left:
±0.01 mm
By ensuring that the calibration status of TMMDE is identifiable, organizations can maintain the accuracy and reliability of their measurements. This can be achieved through visible calibration labels, digital tracking systems, maintaining calibration certificates, conducting regular audits, and providing user training. Such measures help comply with industry standards, ensure safety, and support overall quality assurance.
TMMDE must be safeguarded from adjustments or modification that would invalidate the measurement result or the calibration status.
Safeguarding TMMDE from unauthorized adjustments is critical for maintaining the integrity of measurement results and ensuring compliance with industry standards. This can be achieved through a combination of physical security measures, access controls, administrative controls, regular audits, technical safeguards, and comprehensive training programs. By implementing these measures, organizations can ensure that their TMMDE remains accurate, reliable, and compliant with regulatory requirements. Ensuring the integrity of Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) is crucial for maintaining accurate and reliable measurements. Unauthorized adjustments or modifications can invalidate measurement results and calibration status, leading to potential safety hazards and non-compliance with industry standards such as API Q1.
Importance of Safeguarding TMMDE
Accuracy: Prevents inaccurate measurements caused by unauthorized adjustments.
Reliability: Maintains the reliability of measurement data for decision-making.
Compliance: Ensures adherence to regulatory and industry standards.
Safety: Reduces the risk of safety incidents due to incorrect measurements.
Quality Assurance: Supports consistent quality control processes.
How to Safeguard TMMDE from Unauthorized Adjustments
Physical Security Measures
Lockable Cabinets: Store sensitive equipment in lockable cabinets or secure areas accessible only to authorized personnel.
Tamper-Evident Seals: Use tamper-evident seals on equipment to indicate if unauthorized adjustments have been made.
Access Control
Restricted Access: Limit access to TMMDE to authorized personnel only. Implement access control systems to monitor and restrict entry to areas where equipment is stored or used.
Authorization Levels: Define different levels of authorization for operating, adjusting, and calibrating equipment. Ensure that only qualified personnel have the authority to make adjustments.
Administrative Controls
Standard Operating Procedures (SOPs): Develop and enforce SOPs for the use, adjustment, and calibration of TMMDE. Ensure all personnel are trained and aware of these procedures.
Calibration Logs: Maintain detailed calibration logs that record who performed the calibration, when, and any adjustments made. This ensures accountability and traceability.
Regular Audits and Inspections
Routine Inspections: Conduct regular inspections to ensure that equipment is being used according to the established procedures and that no unauthorized adjustments have been made.
Audit Trails: Implement audit trails in digital systems to track any changes or adjustments made to the equipment settings.
Technical Safeguards
Password Protection: Use password protection or digital locks on equipment settings to prevent unauthorized adjustments.
Firmware Locks: Enable firmware or software locks that restrict the ability to change calibration settings or other critical parameters.
6. Training and Awareness
Personnel Training: Provide regular training to all personnel on the importance of safeguarding TMMDE and the correct procedures for use and adjustment.
Awareness Programs: Implement awareness programs to highlight the consequences of unauthorized adjustments and the importance of equipment integrity.
Example of a Calibration and Access Log
Date
Equipment ID
Action
Performed By
Authorization Level
Comments
2024-01-15
EQ-101
Calibration
dd
Calibrator
Calibration completed, no issues
2024-03-20
EQ-101
Adjustment
ww
Operator
Unauthorized adjustment detected
2024-03-21
EQ-101
Re-calibration
ff
Calibrator
Re-calibrated after unauthorized adjustment detected
2024-06-01
EQ-101
Inspection
qq
Inspector
Tamper-evident seal intact
TMMDE must be protected from damage and deterioration during handling, maintenance, and storage
To maintain the accuracy, reliability, and longevity of Testing, Measuring, Monitoring, and Detection Equipment (TMMDE), it is essential to protect this equipment from damage and deterioration during handling, maintenance, and storage. This protection is critical for ensuring the equipment remains in optimal working condition and continues to produce valid results.
Importance of Protecting TMMDE
Accuracy and Reliability: Prevents measurement errors caused by damaged or deteriorated equipment.
Longevity: Extends the usable life of the equipment.
Compliance: Ensures adherence to industry standards such as API Q1.
Safety: Reduces the risk of safety incidents due to faulty equipment.
Cost Efficiency: Minimizes repair and replacement costs by maintaining equipment in good condition.
Methods to Protect TMMDE from Damage and Deterioration
1. Handling
Training: Train personnel on proper handling techniques to prevent accidental damage. This includes lifting procedures, transport protocols, and usage guidelines.
Protective Gear: Use protective gear such as gloves and anti-static wristbands when handling sensitive equipment.
Handling Equipment: Utilize appropriate handling equipment such as carts, trolleys, or lifting devices to move heavy or delicate TMMDE safely.
2. Maintenance
Scheduled Maintenance: Develop and adhere to a regular maintenance schedule to keep equipment in optimal condition. Include checks for wear and tear, calibration, and functionality tests.
Authorized Personnel: Ensure that only trained and authorized personnel perform maintenance tasks.
Maintenance Records: Keep detailed records of all maintenance activities, including dates, actions taken, and personnel involved. This helps in tracking the equipment’s condition and maintenance history.
3. Storage
Designated Storage Areas: Store TMMDE in designated areas that are clean, dry, and free from extreme temperatures, humidity, and contaminants.
Protective Packaging: Use protective packaging such as foam inserts, anti-static bags, and sturdy cases to prevent physical damage during storage.
Environmental Controls: Implement environmental controls to maintain optimal storage conditions. This may include climate control systems to regulate temperature and humidity.
4. Protection During Use
Protective Covers: Use protective covers or shields on equipment during use to guard against accidental impacts or exposure to harmful substances.
Stable Work Surfaces: Ensure that equipment is placed on stable, level surfaces to prevent tipping or falls.
Usage Guidelines: Follow manufacturer’s usage guidelines and industry best practices to avoid misuse or overloading the equipment.
5. Monitoring and Inspections
Regular Inspections: Conduct regular inspections to detect any signs of damage or deterioration. This includes visual checks and functional tests.
Monitoring Systems: Implement monitoring systems to track the condition of equipment and alert personnel to potential issues before they become serious problems.
Example of a TMMDE Maintenance and Storage Log
Date
Equipment ID
Action
Performed By
Comments
2024-01-15
EQ-101
Calibration
aaa
Calibration completed, no issues
2024-02-01
EQ-101
Inspection
qqq
No damage detected
2024-03-01
EQ-101
Maintenance
ddd
Replaced worn-out parts
2024-03-15
EQ-101
Storage
fff
Stored in climate-controlled area
2024-04-01
EQ-101
Inspection
eee
Protective cover intact
To protect TMMDE from damage and deterioration, organizations must implement comprehensive handling, maintenance, and storage practices. These practices include training personnel, using protective gear, adhering to maintenance schedules, designating proper storage areas, using protective packaging, and conducting regular inspections. By maintaining rigorous standards for the protection of TMMDE, organizations can ensure the accuracy, reliability, and longevity of their equipment, thereby supporting overall operational efficiency and compliance with industry standards.
TMMDE must be used under environmental conditions that are suitable for the calibrations, inspections, measurements, and tests being performed.
Maintaining suitable environmental conditions for Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) is essential to ensure the accuracy and reliability of calibrations, inspections, measurements, and tests. Environmental factors such as temperature, humidity, vibration, and cleanliness can significantly impact the performance of TMMDE.
Importance of Suitable Environmental Conditions
Accuracy: Ensures that measurements and calibrations are precise and reliable.
Consistency: Maintains consistency in test results across different conditions and time periods.
Compliance: Meets regulatory and industry standards for environmental control.
Equipment Longevity: Prevents damage and wear due to unsuitable environmental conditions.
Safety: Reduces risks associated with inaccurate measurements in critical applications.
Key Environmental Factors and Control Methods
1. Temperature
Control Methods:
Use climate control systems to maintain a stable temperature in areas where TMMDE is used or stored.
Monitor temperature continuously using thermometers or digital sensors.
Suitable Ranges:
Follow manufacturer specifications for optimal temperature ranges for each piece of equipment.
2. Humidity
Control Methods:
Use dehumidifiers or humidifiers to maintain appropriate humidity levels.
Implement hygrometers to monitor humidity continuously.
Suitable Ranges:
Maintain humidity levels as specified by the equipment manufacturer, typically within 30-50% relative humidity.
3. Vibration
Control Methods:
Place equipment on stable, vibration-free surfaces.
Use anti-vibration pads or mounts to absorb shocks and vibrations.
Suitable Ranges:
Ensure that vibration levels are within the limits specified by the equipment manufacturer.
4. Cleanliness
Control Methods:
Implement cleanroom standards if necessary, with controlled air quality and regular cleaning schedules.
Use protective covers or enclosures to shield equipment from dust and contaminants.
Suitable Ranges:
Follow industry-specific cleanliness standards, such as ISO 14644 for cleanrooms.
5. Lighting
Control Methods:
Ensure adequate and appropriate lighting for accurate visual inspections and measurements.
Use adjustable lighting systems to reduce glare and shadows.
Suitable Ranges:
Provide illumination levels that meet the requirements of the inspection or measurement tasks.
Steps to Ensure Suitable Environmental Conditions
Environmental Monitoring
Install sensors and monitoring systems to continuously track environmental conditions such as temperature, humidity, and vibration.
Use data loggers to record environmental conditions over time and identify any fluctuations.
Controlled Environment Rooms
Designate specific rooms or areas with controlled environments for critical calibrations and measurements.
Equip these rooms with climate control systems, air filtration, and anti-vibration features.
Regular Maintenance and Calibration
Perform regular maintenance on environmental control systems to ensure they function correctly.
Calibrate environmental sensors and monitoring equipment periodically to maintain accuracy.
Standard Operating Procedures (SOPs)
Develop and enforce SOPs for maintaining suitable environmental conditions during the use, storage, and calibration of TMMDE.
Include guidelines for responding to environmental deviations and ensuring corrective actions are taken promptly.
Training and Awareness
Train personnel on the importance of maintaining suitable environmental conditions and the impact of environmental factors on TMMDE performance.
Conduct regular refresher courses and audits to ensure compliance with environmental control procedures.
Example of an Environmental Monitoring Log
Date
Time
Temperature (°C)
Humidity (%)
Vibration (m/s²)
Inspected By
Comments
2024-01-15
08:00
22
45
0.05
aa
Conditions stable
2024-01-15
12:00
23
46
0.05
ss
No issues
2024-01-15
16:00
22
44
0.04
qq
Minor humidity fluctuation
2024-01-16
08:00
22
45
0.05
qq
Conditions stable
Ensuring suitable environmental conditions for TMMDE is essential to maintain the accuracy and reliability of measurements, calibrations, and tests. By monitoring key environmental factors such as temperature, humidity, vibration, cleanliness, and lighting, and implementing control measures, organizations can ensure that their TMMDE performs optimally. Developing SOPs, providing training, and maintaining detailed logs are also critical steps in managing the environmental conditions for TMMDE effectively.
When used in the testing, monitoring, measurement, or detection of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed prior to initial use and reconfirmed, as necessary.
When computer software is used in testing, monitoring, measurement, or detection activities, it is crucial to ensure that the software can effectively satisfy the specified requirements. This involves both initial confirmation before the software is put into use and periodic reconfirmation to maintain its reliability and accuracy.
Importance of Confirming and Reconfirming Software Ability
Accuracy: Ensures that the software produces correct and reliable results.
Compliance: Meets industry standards and regulatory requirements.
Reliability: Maintains consistent performance over time.
Quality Assurance: Supports the integrity of the quality management system.
Risk Management: Minimizes risks associated with software errors or failures.
Steps for Confirming and Reconfirming Software Ability
1. Initial Confirmation
Before using the software, perform the following steps to confirm its ability to meet specified requirements:
Requirements Analysis: Clearly define the requirements the software needs to satisfy, including accuracy, precision, and functionality.
Validation Testing: Conduct validation tests to compare the software’s output against known standards or benchmarks. This includes:
Functional Testing: Ensuring that the software performs all intended functions correctly.
Performance Testing: Verifying that the software operates efficiently under expected conditions.
Accuracy Testing: Checking the software’s outputs for accuracy against known standards.
Documentation: Document the validation process, including test procedures, results, and any corrective actions taken.
User Training: Train users on how to correctly use the software and interpret its outputs.
2. Periodic Reconfirmation
To maintain confidence in the software’s ability, conduct regular reconfirmation:
Scheduled Revalidation: Perform periodic revalidation at intervals defined by organizational policy or industry standards. This could be annually, bi-annually, or at another frequency based on risk assessment.
Change Management: Revalidate the software whenever there are significant changes to the software, hardware, or operating environment.
Performance Monitoring: Continuously monitor the software’s performance during use to detect any anomalies or deviations from expected behavior.
User Feedback: Collect and analyze feedback from users to identify potential issues and areas for improvement.
Audit and Review: Regularly audit and review the validation and revalidation records to ensure ongoing compliance and effectiveness.
Example of a Software Validation Log
Date
Software Version
Validation Type
Test Performed By
Results
Comments
2024-01-15
2.0
Initial
aa
Passed all tests
Ready for initial use
2024-06-01
2.0
Scheduled
ss
No issues found
Performance consistent
2024-08-10
2.1
Post-Update
aa
Minor bug fixed
Update verified
2024-12-01
2.1
Scheduled
gg
All tests passed
Software remains reliable
Confirming and reconfirming the ability of computer software used in testing, monitoring, measurement, or detection activities is vital for ensuring accurate and reliable results. This process involves initial validation before use and ongoing revalidation at specified intervals or after significant changes. By systematically validating and monitoring software performance, organizations can maintain compliance with industry standards, ensure the reliability of their quality management system, and minimize risks associated with software errors.
The organization shall maintain a documented procedure for the control of TMMDE. The procedure shall include requirements for the specific equipment type and shall address: a) unique identification; b) calibration status; c) traceability to international or national measurement standards; where no such standards exist, the basis used for calibration shall be recorded; d) calibration method and acceptance criteria; e) frequency of calibration, and when the calibration interval begins; f) documentation of the calibration measurements prior to adjustment and measurements after any adjustments during calibration; NOTE Calibration measurements prior to adjustment can be referred to as ‘as-found’. Calibration measurements after any adjustments can be referred to as ‘as-left’. When no adjustments are made, ‘as-found’ and ‘as-left’ are the same. g) actions taken to prevent unintended use of TMMDE identified as out-of-calibration, beyond calibration interval, or not in-service; h) when the TMMDE is found to be out of calibration, an assessment of the validity of previous measurements and actions to be taken on the TMMDE and product, including maintaining records and evidence of notification to the customer if suspect product has been shipped; i) use of third-party, proprietary, employee-owned, and customer-owned TMMDE; j) maintenance; and k) suitability for the planned monitoring and measurement activities.
Controlling testing, measuring, monitoring, and detection equipment is critical for several reasons in the oil and gas industry:
Accuracy and Reliability: Ensuring that measurements and test results are accurate and reliable is essential for maintaining product quality, safety, and regulatory compliance.
Compliance: Adherence to industry standards and regulatory requirements often mandates strict control over such equipment to avoid legal and financial penalties.
Safety: Accurate monitoring and detection equipment are vital for ensuring safe operations, preventing accidents, and protecting personnel and the environment.
Operational Efficiency: Well-maintained and calibrated equipment helps in achieving operational efficiency, minimizing downtime, and reducing maintenance costs.
Quality Assurance: Controlling equipment ensures that products meet specified requirements and customer expectations consistently.
Steps to Control Testing, Measuring, Monitoring, and Detection Equipment
Identification:
Assign unique identification numbers or codes to each piece of equipment.
Maintain an inventory list with detailed information about each item, including manufacturer, model, serial number, and location.
Calibration:
Establish and document calibration intervals based on manufacturer recommendations, industry standards, historical performance data, and risk assessments.
Use calibration standards traceable to national or international standards.
Record calibration dates, results, and any adjustments made.
Maintenance:
Implement a preventive maintenance program specifying the type, frequency, and responsibilities for maintaining equipment.
Keep detailed maintenance records, including dates, types of maintenance performed, and results.
Verification and Validation:
Perform periodic verification checks to ensure equipment remains within specified tolerances.
Validate new or repaired equipment before putting it back into service to ensure it meets all required standards.
Handling and Storage:
Develop procedures for the proper handling of equipment to prevent damage.
Store equipment in designated areas with appropriate environmental controls to protect it from conditions that could affect its accuracy and longevity.
Out-of-Tolerance Equipment:
Clearly identify and label equipment that is found to be out of tolerance.
Remove out-of-tolerance equipment from service and take corrective actions, such as recalibration or repair.
Assess the impact on previous measurements and document all actions taken.
Training:
Provide training to personnel on the proper use, calibration, and maintenance of equipment.
Maintain records of training and competence assessments.
Record-Keeping:
Maintain comprehensive records of all calibration, maintenance, verification, and validation activities.
Ensure records are easily accessible and regularly updated.
Regular Audits:
Conduct regular audits of the control processes to ensure compliance with internal procedures and external standards.
Use audit findings to continuously improve the equipment control processes.
Equipment Required by Oil and Gas Industries
In the oil and gas industry, a wide range of equipment is used for testing, measuring, monitoring, and detection. Some common types include:
Testing Equipment:
Pressure Testers
Flow Testers
Leak Detectors
Measuring Equipment:
Pressure Gauges
Flow Meters
Temperature Sensors
Level Meters
Dimensional Calipers
Monitoring Equipment:
Condition Monitoring Systems (vibration, temperature, pressure)
Environmental Monitors (air quality, water quality)
Data Loggers
Detection Equipment:
Gas Detectors (methane, hydrogen sulfide, carbon monoxide)
Smoke Detectors
Flame Detectors
Ultrasonic Leak Detectors
Controlling testing, measuring, monitoring, and detection equipment is crucial for ensuring the accuracy, reliability, safety, and compliance of operations in the oil and gas industry. By implementing systematic steps such as identification, calibration, maintenance, verification, proper handling, and thorough record-keeping, organizations can maintain high standards of quality and safety. Additionally, a variety of specialized equipment is required to support these activities, tailored to the specific needs of the oil and gas sector.
The organization must maintain a documented procedure for the control of TMMDE.
Maintaining a documented procedure for the control of testing, measuring, monitoring, and detection equipment is crucial for ensuring compliance, consistency, quality, efficiency, and risk management. By developing comprehensive procedures that cover all aspects of equipment control, from identification to verification and record-keeping, an organization can ensure its operations are reliable, safe, and efficient. This not only helps in meeting regulatory and industry standards but also supports the overall quality and performance of the organization’s products and services. The Organization must maintain a documented procedure for the control of testing, measuring, monitoring, and detection equipment for the following reasons:
Compliance with Standards and Regulations:
API Q1 and Other Standards: Maintaining a documented procedure is often a requirement of industry standards such as API Q1, ISO 9001, and other regulatory frameworks. This ensures that the organization adheres to best practices and meets legal obligations.
Regulatory Compliance: Ensures compliance with governmental and industry regulations, thereby avoiding legal penalties and ensuring the safety and reliability of operations.
Consistency and Reliability:
Standardized Processes: Documented procedures provide a standardized approach to equipment control, ensuring that all personnel follow the same methods, which enhances consistency and reliability of measurements.
Minimized Errors: Reduces the likelihood of human error by providing clear instructions and guidelines for equipment use, calibration, maintenance, and verification.
Quality Assurance:
Product Quality: Ensures that products meet the required specifications and quality standards by maintaining accurate and reliable testing and measurement equipment.
Traceability: Provides traceability of measurements and calibrations, which is essential for quality assurance and auditing purposes.
Operational Efficiency:
Preventive Maintenance: Scheduled maintenance and calibration prevent unexpected equipment failures, reducing downtime and associated costs.
Effective Resource Management: Efficient use of resources by ensuring that equipment is only out of service for calibration and maintenance when necessary.
Risk Management:
Safety: Ensures the safety of operations by verifying that monitoring and detection equipment function correctly, preventing accidents and hazardous situations.
Risk Mitigation: Identifies potential issues before they lead to significant problems, thereby mitigating risks to the organization and its stakeholders.
How to Maintain a Documented Procedure for the Control of Testing, Measuring, Monitoring, and Detection Equipment
Developing the Procedure:
Scope and Purpose: Clearly define the scope and purpose of the procedure, specifying the types of equipment covered and the goals of the control process.
Responsibilities: Assign responsibilities for equipment control, including calibration, maintenance, and record-keeping, to specific roles within the organization.
Identification and Documentation:
Equipment Identification: Establish a system for uniquely identifying each piece of equipment, including its location, manufacturer, model, and serial number.
Documentation System: Implement a documentation system (manual or electronic) to record all relevant information about each piece of equipment, including calibration schedules, maintenance records, and verification results.
Calibration and Maintenance:
Calibration Schedule: Define and document calibration intervals based on manufacturer recommendations, industry standards, and historical data.
Maintenance Plan: Develop and document a preventive maintenance plan that outlines the type, frequency, and procedures for maintaining each piece of equipment.
Verification and Validation:
Verification Checks: Document procedures for periodic verification checks to ensure ongoing accuracy and reliability of equipment.
Validation Processes: Include validation processes for new or repaired equipment to confirm they meet all required specifications before use.
Handling and Storage:
Handling Procedures: Document procedures for the proper handling of equipment to prevent damage and ensure accuracy.
Storage Conditions: Specify and document appropriate storage conditions to protect equipment from environmental factors that could affect performance.
Out-of-Tolerance Equipment:
Identification and Labeling: Clearly document how out-of-tolerance equipment will be identified and labeled.
Corrective Actions: Outline the steps to be taken when equipment is found out of tolerance, including recalibration, repair, and impact assessment.
Training and Competence:
Training Programs: Document training programs to ensure personnel are competent in using, calibrating, and maintaining equipment.
Competence Records: Maintain records of training and competence assessments for all relevant personnel.
Record-Keeping:
Detailed Records: Document the requirement for maintaining detailed records of all calibration, maintenance, verification, and validation activities.
Audit Trail: Ensure the documentation system provides a clear audit trail for internal and external audits.
Review and Improvement:
Periodic Reviews: Schedule and document periodic reviews of the equipment control process to ensure it remains effective and up-to-date.
Continuous Improvement: Document procedures for incorporating feedback and audit findings into process improvements.
Example of a Procedure for Control of Equipment
1. Purpose: To ensure all testing, measuring, monitoring, and detection equipment is controlled, calibrated, and maintained to produce accurate and reliable measurements.
2. Scope: This procedure applies to all equipment used in the inspection, testing, monitoring, and detection processes within the organization.
3. Responsibilities:
Quality Manager: Overall responsibility for equipment control and compliance with API Q1 requirements.
Calibration Technician: Responsible for performing calibrations, maintenance, and keeping records.
Department Managers: Ensure equipment within their departments is properly used, maintained, and calibrated.
4. Procedure:
4.1 Identification and Traceability:
Assign a unique identification number to each piece of equipment.
Record the identification number, manufacturer, model, serial number, date of acquisition, and location in the equipment database.
4.2 Calibration:
Calibrate equipment at intervals defined by the calibration schedule.
Use calibration standards traceable to national or international standards.
Record calibration results, including any adjustments made.
4.3 Maintenance:
Perform preventive maintenance according to the maintenance schedule.
Document maintenance activities, including the date, type of maintenance, and results.
4.4 Verification and Validation:
Conduct periodic verification checks to ensure ongoing accuracy.
Validate new or repaired equipment before use in production.
4.5 Handling, Storage, and Preservation:
Handle equipment with care to prevent damage.
Store equipment in designated areas with controlled environmental conditions.
Implement preservation measures for equipment not in use.
4.6 Out-of-Tolerance Equipment:
Clearly label equipment that is out of tolerance and remove it from service.
Investigate and document the impact of out-of-tolerance equipment on previous measurements.
Take corrective actions, including recalibration or repair.
4.7 Training:
Provide training for personnel on proper use, calibration, and maintenance of equipment.
Maintain records of training and competence assessments.
5. Records: Maintain records of all calibrations, maintenance activities, verification checks, out-of-tolerance investigations, and training.
6. Review and Audit: Conduct regular reviews and audits of equipment control processes to ensure compliance and identify areas for improvement.
The procedure must include requirements for the specific equipment type.
To include requirements for specific equipment types in the control of testing, measuring, monitoring, and detection equipment, an organization should develop a detailed and structured approach. This involves several steps to ensure that all relevant factors are considered and that procedures are tailored to meet the needs of different equipment categories.
Equipment Identification and Classification:
Inventory Management: Create and maintain an inventory of all equipment, including details such as type, manufacturer, model, serial number, and location.
Categorization: Classify equipment based on their type (testing, measuring, monitoring, detection), criticality, and application. This helps in tailoring specific requirements for each category.
Requirement Definition:
Regulatory and Standards Compliance: Identify relevant standards (e.g., API Q1, ISO 9001) and regulatory requirements that apply to each equipment type.
Manufacturer Guidelines: Incorporate manufacturer recommendations for calibration, maintenance, and use.
Risk Assessment: Conduct risk assessments to determine the criticality of each equipment type and its impact on product quality and safety.
Developing Detailed Procedures:
Calibration: Define specific calibration requirements for each equipment type, including:
Frequency: Based on usage, manufacturer guidelines, and risk assessment.
Standards: Use of traceable standards for calibration.
Documentation: Recording calibration results, adjustments, and calibration certificates.
Maintenance: Establish maintenance procedures specific to each equipment type, including:
Preventive Maintenance: Scheduled activities such as cleaning, part replacement, and lubrication.
Corrective Maintenance: Procedures for addressing and documenting repairs and adjustments.
Verification and Validation: Set up verification and validation processes for ensuring ongoing accuracy and reliability, including:
Periodic Checks: Regular verification intervals.
Initial Validation: Validation of new or repaired equipment before use.
Handling and Storage: Develop handling and storage guidelines to prevent damage and degradation, specific to the needs of each equipment type.
Documentation and Record Keeping:
Procedure Manuals: Develop and distribute detailed procedure manuals for each equipment type, outlining the specific requirements and steps to be followed.
Record Templates: Create standardized templates for recording calibration, maintenance, verification, and validation activities.
Audit Trails: Ensure that all documentation provides a clear audit trail for internal and external audits.
Training and Competence:
Training Programs: Develop and implement training programs tailored to the specific requirements of each equipment type.
Competence Assessment: Regularly assess the competence of personnel in handling, calibrating, and maintaining different types of equipment.
Refresher Courses: Offer periodic refresher courses to keep personnel updated on best practices and procedural changes.
Monitoring and Review:
Performance Monitoring: Continuously monitor the performance and condition of equipment to ensure compliance with specific requirements.
Internal Audits: Conduct regular internal audits to verify adherence to procedures and identify areas for improvement.
Feedback Mechanism: Establish a feedback mechanism for operators and maintenance personnel to report issues and suggest improvements.
Continuous Improvement:
Data Analysis: Analyze data from calibration, maintenance, and verification records to identify trends and areas for improvement.
Procedure Updates: Regularly update procedures based on audit findings, feedback, and technological advancements.
Best Practices: Incorporate industry best practices and lessons learned into procedures and training programs.
– Monthly cleaning – Bi-annual inspection – Record maintenance
– Quarterly checks – Initial validation
– Store upright – Protect from dust and moisture
– Installation and use – Calibration methods
Gas Detectors
– Calibrate before each use – Follow manufacturer guidelines – Record calibration
– Weekly functional checks – Annual service – Record activities
– Pre-use verification – Validate after repair
– Store in controlled environment – Avoid exposure to contaminants
– Safety protocols – Maintenance and calibration
By following these structured steps and using a framework like the one outlined above, an organization can effectively include and manage the specific requirements for different types of testing, measuring, monitoring, and detection equipment. This ensures that all equipment operates correctly, reliably, and in compliance with industry standards and regulatory requirements.
The procedure must include unique identification.
Including unique identification in the control of testing, measuring, monitoring, and detection equipment is crucial for maintaining accurate records, ensuring traceability, and managing calibration and maintenance schedules. Here’s a structured approach to achieving this:
Steps to Include Unique Identification
Assign Unique Identification Numbers:
ID System: Develop a system for assigning unique identification numbers to each piece of equipment. This system could include a combination of letters and numbers to denote the type of equipment, the location, and a serial number (e.g., PG-001 for Pressure Gauge number 1).
Database Registration: Record these unique IDs in a centralized database, along with detailed information about each piece of equipment.
Labeling and Tagging:
Permanent Labels: Attach durable, permanent labels or tags to each piece of equipment. These labels should be resistant to environmental conditions such as moisture, heat, and chemicals.
Barcodes/QR Codes: Include barcodes or QR codes on the labels to facilitate easy scanning and quick access to the equipment’s history and status in the database.
Inventory Management:
Database Integration: Integrate the unique IDs into an inventory management system that tracks the equipment’s location, status, calibration dates, maintenance records, and usage history.
Regular Updates: Regularly update the database to reflect any changes in equipment status, location, or ownership.
Tracking and Monitoring:
Electronic Tracking: Use electronic tracking systems to monitor the location and status of each piece of equipment in real-time.
Movement Logs: Maintain logs of equipment movements between locations or departments, ensuring that the unique ID is recorded in each log entry.
Documentation and Record Keeping:
Detailed Records: Keep detailed records for each piece of equipment, including purchase date, manufacturer, model number, unique ID, calibration history, maintenance records, and any incidents or repairs.
Accessible Records: Ensure that these records are easily accessible to relevant personnel for reference and audits.
Training and Awareness:
Personnel Training: Train staff on the importance of unique identification, how to read and use the IDs, and how to update the system when changes occur.
Standard Operating Procedures (SOPs): Develop and implement SOPs that detail the processes for assigning, labeling, and maintaining unique IDs.
Audits and Verification:
Internal Audits: Conduct regular internal audits to verify that all equipment is correctly identified and that records are up-to-date.
Verification Processes: Implement verification processes to ensure the accuracy and consistency of unique IDs across all records and physical equipment.
Example of Unique Identification Records
Equipment Type
Unique ID
Manufacturer
Model Number
Location
Last Calibration Date
Next Calibration Due
Pressure Gauge
PG-001
ABC Instruments
PG-X100
Lab 1
2024-01-10
2025-01-10
Flow Meter
FM-002
XYZ FlowTech
FM-2000
Lab 2
2023-12-15
2024-06-15
Gas Detector
GD-003
GasSafe Inc.
GD-300
Storage Room
2024-05-01
2024-05-31
Temperature Sensor
TS-004
TempCo
TS-4000
Lab 3
2023-11-01
2024-11-01
Multimeter
MM-005
MultiMeasure
MM-500
Workshop
2024-03-20
2024-09-20
Implementation Tips
Consistent Application: Ensure the unique identification system is consistently applied to all relevant equipment.
Technology Utilization: Use technology (such as RFID tags or QR codes) to streamline tracking and information retrieval.
Regular Reviews: Periodically review and update the unique identification system to accommodate new equipment and retire old or obsolete items.
Cross-Department Coordination: Coordinate between departments to ensure that all relevant equipment is included in the unique identification system and that records are harmonized.
The procedure must include calibration status.
Including calibration status in the control of testing, measuring, monitoring, and detection equipment is essential for ensuring the accuracy and reliability of measurements and tests. Here’s a structured approach to achieve this:
Steps to Include Calibration Status
Identification and Labeling:
Calibration Tags/Labels: Attach calibration tags or labels to each piece of equipment indicating its calibration status. The label should include the last calibration date, the next due date, and the unique identification number of the equipment.
Color Coding: Use color-coded labels to quickly identify the calibration status (e.g., green for calibrated, yellow for nearing due date, red for overdue).
Documentation and Records:
Calibration Certificates: Maintain calibration certificates for each piece of equipment, detailing the calibration results, date, and the person who performed the calibration.
Calibration Logs: Keep a log of all calibrations, including dates, results, any adjustments made, and the next due date for calibration. This log can be maintained electronically or in physical form.
Automated Systems and Software:
Calibration Management Software: Implement software to manage calibration schedules, send reminders for upcoming calibrations, and store calibration records. This software can provide real-time status updates and generate reports.
Barcoding and Scanning: Use barcodes or QR codes on equipment labels to link directly to calibration records in the management system, making it easy to access and update information.
Schedule and Planning:
Calibration Schedule: Develop a calibration schedule based on the manufacturer’s recommendations, industry standards, and the criticality of the equipment. The schedule should be detailed and include all equipment that requires calibration.
Frequency Determination: Determine calibration frequency based on usage patterns, equipment stability, past performance, and risk assessment.
Training and Awareness:
Personnel Training: Train personnel on the importance of calibration, how to read calibration labels, and how to update calibration status. This ensures that everyone is aware of the calibration status and follows the proper procedures.
Awareness Programs: Conduct regular awareness programs and refresher courses to emphasize the significance of maintaining accurate calibration status.
Monitoring and Verification:
Periodic Checks: Conduct periodic checks to verify that the calibration status is up-to-date and that labels are correctly attached. This can be part of regular internal audits.
Audit Trails: Ensure that there is an audit trail for each piece of equipment, documenting all calibrations, adjustments, and status changes.
Non-Conforming Equipment:
Identification and Isolation: Clearly identify and isolate any equipment that is out of calibration or overdue for calibration. This equipment should be labeled as “Out of Service” and should not be used until recalibrated.
Corrective Actions: Implement corrective actions for any non-conforming equipment, including recalibration and investigation of potential impacts on past measurements.
Example of Including Calibration Status
Equipment
ID Number
Last Calibration Date
Next Calibration Due
Calibration Status
Comments
Pressure Gauge
PG-101
2024-01-10
2025-01-10
Calibrated
–
Flow Meter
FM-202
2023-12-15
2024-06-15
Calibrated
–
Gas Detector
GD-303
2024-05-01
2024-05-31
Nearing Due
Calibration due soon
Temperature Sensor
TS-404
2023-11-01
2024-11-01
Calibrated
–
Multimeter
MM-505
2024-03-20
2024-09-20
Calibrated
–
Implementation Tips
Consistency: Ensure consistent labeling and record-keeping practices across all equipment.
Automation: Leverage automation tools to manage calibration schedules and records efficiently.
Accessibility: Make calibration records easily accessible to relevant personnel for quick reference and verification.
Regular Audits: Conduct regular audits to ensure compliance with calibration procedures and to identify any discrepancies.
The procedure must include traceability to international or national measurement standards, where no such standards exist, the basis used for calibration shall be recorded.
To ensure traceability to international or national measurement standards in the control of testing, measuring, monitoring, and detection equipment, an organization must establish and document a systematic approach. Here’s how to include this traceability, and handle situations where no such standards exist:
Steps to Ensure Traceability
Identify Relevant Standards:
International/National Standards: Identify applicable international (e.g., ISO, IEC) or national (e.g., NIST in the USA, NPL in the UK) measurement standards for each type of equipment.
Industry Standards: If international or national standards are not available, refer to industry-specific standards or guidelines.
Accredited Calibration Services:
Accredited Laboratories: Use calibration services from laboratories accredited by recognized accreditation bodies (e.g., ISO/IEC 17025 accredited labs) to ensure that calibrations are traceable to national or international standards.
Certification and Documentation: Obtain and maintain calibration certificates from these laboratories that explicitly state the traceability to recognized standards.
Documentation of Traceability:
Calibration Certificates: Ensure that calibration certificates include references to the standards used for calibration.
Traceability Records: Maintain detailed records showing how each calibration is traceable to national or international standards. This should include the calibration certificate, the date, the standard used, and the laboratory details.
Calibration Procedures:
Standard Operating Procedures (SOPs): Develop SOPs that outline the process of calibration, including references to the standards used.
In-House Calibration: If calibration is performed in-house, ensure that the procedures and equipment used are traceable to recognized standards, and document this traceability.
Handling Non-Standard Situations:
Alternative References: When no national or international standards exist, identify and document alternative references or methods used for calibration.
Documentation of Basis: Record the basis used for calibration, including the method, any internal standards developed, and validation data supporting the accuracy and reliability of these methods.
Regular Review and Verification:
Periodic Review: Regularly review and verify calibration records and traceability documentation to ensure ongoing compliance.
Audit and Validation: Conduct internal audits and validation checks to confirm that all calibrations are correctly documented and traceable.
Example of Traceability Documentation
Equipment
ID Number
Calibration Date
Next Calibration Due
Standard Used
Calibration Certificate
Notes
Pressure Gauge
PG-101
2024-01-10
2025-01-10
NIST Standard 1234
Cert# NIST-1234-2024
Calibrated by ABC Labs
Flow Meter
FM-202
2023-12-15
2024-06-15
ISO 5167-1:2003
Cert# ISO-5167-2023
Calibrated by XYZ FlowTech
Gas Detector
GD-303
2024-05-01
2024-05-31
Internal Method (No Standard)
Cert# INT-GD-2024
Based on manufacturer’s guidelines
Temperature Sensor
TS-404
2023-11-01
2024-11-01
ASTM E230
Cert# ASTM-230-2023
Calibrated by TempCo
Multimeter
MM-505
2024-03-20
2024-09-20
IEC 61010-1
Cert# IEC-61010-2024
Calibrated by MultiMeasure
Implementation Tips
Comprehensive Records: Ensure that records are comprehensive and include all relevant details such as the calibration standard, method, date, and certificate number.
Clear Documentation: Clearly document any deviations or use of alternative methods, providing justification and validation for these approaches.
Regular Training: Train personnel on the importance of traceability and how to maintain accurate records.
Quality Management System Integration: Integrate traceability documentation into the organization’s quality management system to ensure consistency and compliance.
The procedure must include calibration method and acceptance criteria.
To include the calibration method and acceptance criteria in the control of testing, measuring, monitoring, and detection equipment, an organization should follow a structured approach that integrates these elements into their standard operating procedures (SOPs) and quality management system. Here’s a detailed guide on how to achieve this:
Steps to Include Calibration Method and Acceptance Criteria
Develop Standard Operating Procedures (SOPs):
Calibration Method Documentation: Clearly document the calibration method for each type of equipment. This should include step-by-step instructions on how the calibration is performed, reference standards used, and any specific techniques or tools required.
Acceptance Criteria Definition: Define the acceptance criteria for each piece of equipment. This should include the permissible tolerance levels, measurement uncertainty, and any specific performance indicators that the equipment must meet to be considered calibrated.
Integration into Quality Management System:
Quality Manual Inclusion: Incorporate the calibration methods and acceptance criteria into the organization’s quality manual or relevant quality management documents.
Procedure References: Ensure that the SOPs for calibration reference the quality manual and vice versa, creating a cohesive system of documentation.
Calibration Records:
Detailed Records: Maintain detailed calibration records that include the calibration method used and whether the equipment met the acceptance criteria. These records should capture the date of calibration, the person who performed the calibration, the equipment details, and the results.
Traceability: Ensure that each calibration record is traceable to the specific equipment through unique identification numbers.
Training and Competency:
Staff Training: Train personnel on the specific calibration methods and acceptance criteria for the equipment they handle. Ensure they understand how to document the calibration process and results accurately.
Competency Verification: Regularly verify the competency of personnel conducting calibrations through assessments and audits.
Regular Review and Updates:
Periodic Review: Regularly review the calibration methods and acceptance criteria to ensure they remain current with industry standards and best practices.
Continuous Improvement: Update the SOPs and quality manual as needed based on feedback, audit findings, and advancements in calibration techniques.
Example of Calibration Method and Acceptance Criteria Documentation
Calibration Method for Pressure Gauge
Objective:
To calibrate the pressure gauge and ensure its accuracy within specified tolerances.
Equipment Required:
Reference pressure standard (traceable to NIST)
Pressure pump
Data recording device
Procedure:
Connect the pressure gauge to the pressure pump.
Incrementally increase the pressure and record the gauge reading at each step (e.g., 0 psi, 10 psi, 20 psi, etc.).
Compare the readings of the pressure gauge with the reference standard.
Record the deviations at each pressure level.
Acceptance Criteria:
The pressure gauge readings must be within ±1% of the reference standard across the entire pressure range.
Any reading outside this tolerance indicates a need for adjustment or repair.
Calibration Method for Temperature Sensor
Objective:
To calibrate the temperature sensor and ensure its accuracy within specified tolerances.
Equipment Required:
Reference temperature standard (traceable to NIST)
Temperature-controlled bath
Data recording device
Procedure:
Immerse the temperature sensor and the reference standard in the temperature-controlled bath.
Stabilize the bath at specific temperatures (e.g., 0°C, 25°C, 50°C, etc.).
Record the readings of the temperature sensor and the reference standard.
Compare the readings and calculate the deviations.
Acceptance Criteria:
The temperature sensor readings must be within ±0.5°C of the reference standard at all tested temperatures.
Deviations outside this range require recalibration or sensor replacement.
Example of Calibration Record in Tabular Form
Equipment Type
ID Number
Calibration Date
Calibrated By
Method Used
Acceptance Criteria
Result
Next Calibration Due
Pressure Gauge
PG-101
2024-01-10
John Smith
Incremental Pressure Comparison
±1% of reference standard
Within Tolerance
2025-01-10
Temperature Sensor
TS-202
2023-12-15
Jane Doe
Temperature-Controlled Bath
±0.5°C of reference standard
Within Tolerance
2024-12-15
Multimeter
MM-303
2024-05-01
John Smith
Electrical Measurement
±2% of reference standard
Outside Tolerance (Recalibrated)
2024-11-01
Flow Meter
FM-404
2023-11-01
Jane Doe
Flow Rate Comparison
±2% of reference standard
Within Tolerance
2024-11-01
Gas Detector
GD-505
2024-03-20
John Smith
Gas Concentration Comparison
±0.5% of reference standard
Within Tolerance
2024-09-20
Implementation Tips
Consistency: Ensure that calibration methods and acceptance criteria are consistently applied across all relevant equipment.
Clear Communication: Communicate the importance of adherence to calibration methods and acceptance criteria to all relevant personnel.
Periodic Audits: Conduct regular audits to ensure compliance with documented calibration procedures and acceptance criteria.
Record Accuracy: Maintain accurate and detailed calibration records that are easily accessible for review and audits.
The procedure must include frequency of calibration, and when the calibration interval begins.
To include the frequency of calibration and the start date of the calibration interval in the control of testing, measuring, monitoring, and detection equipment, an organization should integrate these details into their documented procedures and quality management system. Here’s how to effectively manage these aspects:
Steps to Include Frequency of Calibration
Determine Calibration Frequency:
Manufacturer Recommendations: Base the initial calibration frequency on the equipment manufacturer’s guidelines.
Industry Standards: Follow industry standards and best practices for specific types of equipment.
Usage History: Adjust the frequency based on the equipment’s usage history and past performance.
Risk Assessment: Perform a risk assessment to determine the impact of equipment failure on product quality and safety. Higher risk may necessitate more frequent calibration.
Document the Calibration Frequency:
Calibration Schedule: Develop a calibration schedule that specifies the frequency for each piece of equipment.
Quality Manual: Include the calibration frequency in the organization’s quality manual or relevant SOPs.
Calibration Records: Ensure that calibration records explicitly state the calibration frequency.
Steps to Determine When Calibration Interval Begins
Date of First Use:
Initial Calibration Date: Document the date of the initial calibration.
First Use Date: If the calibration interval is based on the date of first use, record this date accurately.
Subsequent Calibration Dates:
Scheduled Intervals: Determine subsequent calibration dates based on the initial calibration date or the first use date and the specified calibration interval.
Event-Based Triggers: In some cases, calibration intervals may be adjusted based on specific events, such as equipment repair or relocation. Document these events and their impact on the calibration schedule.
Tracking and Notifications:
Calibration Management System: Use a calibration management system to track calibration due dates and send notifications for upcoming calibrations.
Log Entries: Maintain a calibration log that records each calibration event, including the date, the technician who performed the calibration, and the next due date.
Implementation in the Quality Management System
Standard Operating Procedures (SOPs):
Detailed Procedures: Develop SOPs that detail the process for determining and documenting calibration frequency and intervals.
Templates and Forms: Use standardized templates and forms to capture calibration dates and intervals consistently.
Training and Competency:
Staff Training: Train personnel on how to determine calibration frequency and document calibration intervals accurately.
Competency Checks: Perform regular competency checks to ensure that personnel follow the documented procedures correctly.
Regular Review and Adjustment:
Periodic Review: Regularly review calibration frequencies and intervals to ensure they remain appropriate based on equipment performance and changes in usage or risk.
Adjustments: Adjust calibration schedules as needed based on review findings and ensure that all changes are documented and communicated.
Example of Calibration Schedule Documentation
Equipment Type
ID Number
Calibration Frequency
Initial Calibration Date
Date of First Use
Next Calibration Due
Calibrated By
Notes
Pressure Gauge
PG-101
Annually
2024-01-10
2024-01-15
2025-01-10
John Smith
N/A
Temperature Sensor
TS-202
Semi-Annually
2023-12-15
2024-01-05
2024-06-15
Jane Doe
Adjusted frequency based on risk
Multimeter
MM-303
Every 6 months
2024-05-01
2024-05-03
2024-11-01
John Smith
New equipment
Flow Meter
FM-404
Annually
2023-11-01
2023-11-05
2024-11-01
Jane Doe
N/A
Gas Detector
GD-505
Quarterly
2024-03-20
2024-03-25
2024-06-20
John Smith
High-risk equipment
Key Points for Implementation
Clear Documentation: Ensure that all relevant dates and frequencies are clearly documented in calibration records.
Consistency: Maintain consistency in recording and tracking calibration intervals across all equipment.
Proactive Management: Use a proactive approach to manage calibration schedules, ensuring that no equipment goes past its due calibration date.
Integrated Systems: Leverage integrated calibration management systems to automate tracking and notification processes.
The procedure must include documentation of the calibration measurements prior to adjustment and measurements after any adjustments during calibration.
To ensure comprehensive control of testing, measuring, monitoring, and detection equipment, an organization must document calibration measurements both before and after any adjustments. This process enhances traceability and ensures the accuracy and reliability of equipment. Here’s how an organization can include this documentation in their calibration control process:
Steps to Include Documentation of Calibration Measurements
Establish Clear Procedures:
Calibration SOPs: Develop detailed standard operating procedures (SOPs) that specify how calibration measurements should be recorded. These SOPs should outline steps for both pre-adjustment and post-adjustment measurements.
Documentation Templates: Create standardized templates or forms to capture all necessary information during calibration.
Pre-Adjustment Measurements:
Initial Reading: Before making any adjustments, record the initial measurements of the equipment. This step provides a baseline to understand how far the equipment has deviated from the standard.
Documentation: Ensure that these measurements are documented accurately in the calibration log or record form.
Adjustments:
Record Adjustments: If adjustments are needed to bring the equipment into compliance, document the nature of these adjustments. This includes detailing what changes were made and why.
Procedure for Adjustments: Include a step-by-step guide in the SOPs for making adjustments, ensuring consistency across all calibrations.
Post-Adjustment Measurements:
Final Reading: After adjustments, record the final measurements to confirm that the equipment now meets the required standards.
Documentation: These post-adjustment measurements should also be documented clearly and compared with the pre-adjustment measurements.
Verification and Approval:
Review Process: Implement a review process where a qualified individual checks the calibration records to ensure accuracy and completeness.
Approval: Have the calibration records approved by a supervisor or quality manager to validate the calibration process.
Integration into Quality Management System
Quality Manual and SOPs:
Include Calibration Documentation Requirements: Ensure that the quality manual and SOPs explicitly state the need for documenting both pre-adjustment and post-adjustment measurements.
Update Regularly: Regularly update these documents to incorporate any changes in calibration processes or equipment.
Training and Competency:
Personnel Training: Train personnel on the importance of documenting calibration measurements accurately. Ensure they are familiar with the SOPs and templates.
Competency Checks: Conduct periodic competency checks to ensure personnel follow the documented procedures correctly.
Audit and Review:
Internal Audits: Perform regular internal audits to verify that calibration records are maintained accurately and consistently.
Continuous Improvement: Use audit findings to improve calibration processes and documentation practices.
Example of Calibration Record Form
Equipment Type
ID Number
Calibration Date
Calibrated By
Pre-Adjustment Measurement
Adjustment Details
Post-Adjustment Measurement
Comments
Next Calibration Due
Pressure Gauge
PG-101
2024-01-10
John Smith
101 psi
Adjusted needle
100 psi
N/A
2025-01-10
Temperature Sensor
TS-202
2023-12-15
Jane Doe
26.5°C
Recalibrated sensor
25.0°C
N/A
2024-06-15
Multimeter
MM-303
2024-05-01
John Smith
12.2V
Adjusted dial
12.0V
N/A
2024-11-01
Flow Meter
FM-404
2023-11-01
Jane Doe
102 L/min
Calibrated valve
100 L/min
N/A
2024-11-01
Gas Detector
GD-505
2024-03-20
John Smith
0.52%
Replaced sensor
0.50%
N/A
2024-09-20
Key Points for Implementation
Consistency and Accuracy: Ensure that all calibration measurements, both pre-adjustment and post-adjustment, are consistently and accurately documented.
Traceability: Maintain clear traceability by linking each calibration record to the specific equipment through unique identification numbers.
Clear Documentation: Use standardized forms and templates to ensure uniform documentation across all calibration activities.
Regular Audits: Conduct regular audits to verify that the documentation process is being followed correctly and that records are complete and accurate.
Continuous Training: Provide ongoing training to personnel to emphasize the importance of thorough documentation and adherence to procedures.
Calibration measurements prior to adjustment can be referred to as ‘as-found’. Calibration measurements after any adjustments can be referred to as ‘as-left’. When no adjustments are made, ‘as-found’ and ‘as-left’ are the same.
Calibration measurements taken prior to any adjustments are typically referred to as “as-found” measurements, while those taken after adjustments are referred to as “as-left” measurements. If no adjustments are made, the “as-found” and “as-left” measurements will be the same. This terminology helps clearly document the state of the equipment before and after calibration and provides a transparent record of the calibration process. Here’s how an organization can integrate this into their control of testing, measuring, monitoring, and detection equipment.
Integrating ‘As-Found’ and ‘As-Left’ Measurements
Establish Clear Procedures:
SOPs: Develop Standard Operating Procedures (SOPs) that clearly outline the requirement to record “as-found” and “as-left” measurements during the calibration process.
Documentation Templates: Create templates for calibration records that include specific fields for both “as-found” and “as-left” measurements.
Recording ‘As-Found’ Measurements:
Initial Measurement: Take and document the initial measurement of the equipment before any adjustments are made. This “as-found” measurement serves as the baseline.
Documentation: Use the designated section in the calibration record template to enter the “as-found” measurement.
Adjustments:
Document Adjustments: If adjustments are necessary, record the nature and extent of these adjustments. This documentation should detail what changes were made to correct any deviations.
Procedure for Adjustments: Ensure that the SOPs provide step-by-step instructions on how to perform and document adjustments.
4. Recording ‘As-Left’ Measurements:
Final Measurement: After adjustments, take a final measurement to confirm the equipment meets the required standards. This is the “as-left” measurement.
Documentation: Enter the “as-left” measurement in the designated section of the calibration record template.
No Adjustments Scenario:
Same Values: If no adjustments are necessary, the “as-found” and “as-left” measurements will be the same. Document both as identical values.
Example of Calibration Record Form
Equipment Type
ID Number
Calibration Date
Calibrated By
As-Found Measurement
Adjustment Details
As-Left Measurement
Comments
Next Calibration Due
Pressure Gauge
PG-101
2024-01-10
John Smith
101 psi
Adjusted needle
100 psi
N/A
2025-01-10
Temperature Sensor
TS-202
2023-12-15
Jane Doe
26.5°C
Recalibrated sensor
25.0°C
N/A
2024-06-15
Multimeter
MM-303
2024-05-01
John Smith
12.2V
Adjusted dial
12.0V
N/A
2024-11-01
Flow Meter
FM-404
2023-11-01
Jane Doe
102 L/min
Calibrated valve
100 L/min
N/A
2024-11-01
Gas Detector
GD-505
2024-03-20
John Smith
0.52%
Replaced sensor
0.50%
N/A
2024-09-20
Key Points for Implementation
Consistency and Accuracy:
Ensure that all “as-found” and “as-left” measurements are consistently and accurately documented.
Use standardized forms to maintain uniformity in documentation across all calibration activities.
Traceability:
Maintain clear traceability by linking each calibration record to the specific equipment through unique identification numbers.
Ensure that calibration records include the date, the technician who performed the calibration, and any adjustments made.
Clear Documentation:
Include detailed fields for “as-found” and “as-left” measurements in the calibration records.
Document any adjustments made during calibration comprehensively.
Regular Audits:
Conduct regular audits to verify that the documentation process is being followed correctly and that records are complete and accurate.
Use audit findings to improve calibration processes and documentation practices.
Continuous Training:
Provide ongoing training to personnel on the importance of thorough documentation and adherence to procedures.
Emphasize the need to accurately record both “as-found” and “as-left” measurements.
By following these steps, an organization can effectively document “as-found” and “as-left” measurements, ensuring comprehensive control over testing, measuring, monitoring, and detection equipment. This practice supports compliance with API Q1 requirements and helps maintain high standards of equipment performance and product quality.
The procedure must include actions taken to prevent unintended use of TMMDE identified as out-of-calibration, beyond calibration interval, or not in-service.
To ensure the proper handling of Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) identified as out-of-calibration, beyond calibration interval, or not in-service, here are the steps the organization can take:
Steps to Prevent Unintended Use of Out-of-Calibration TMMDE
Identification and Segregation
Tagging and Labeling: Clearly mark any TMMDE that is out-of-calibration, beyond its calibration interval, or not in-service with a prominent tag or label indicating its status.
Segregation: Physically separate such equipment from calibrated and in-service TMMDE. Designate specific areas or storage locations for out-of-calibration and non-serviceable equipment to prevent accidental use.
Documentation and Record-Keeping
Log Records: Maintain a log that records the status of all TMMDE, including those out-of-calibration or not in-service. This log should include details such as the date the equipment was identified as out-of-calibration, the reason, and any actions taken.
Update Records: Ensure that all changes in equipment status are promptly recorded in the inventory management system.
Notification and Communication
Internal Notification: Notify relevant personnel, including operators, technicians, and supervisors, about the status of the out-of-calibration TMMDE. Use internal communication channels such as emails, bulletin boards, or digital dashboards.
Signage: Place clear signage in areas where TMMDE is used, reminding personnel to check the calibration status before using any equipment.
Calibration and Maintenance Scheduling
Scheduled Calibration: Develop and maintain a calibration schedule that ensures all TMMDE is calibrated at regular intervals. Track upcoming calibration dates to prevent equipment from going beyond its calibration interval.
Preventive Maintenance: Include TMMDE in the preventive maintenance program to ensure regular checks and timely calibration.
Access Control
Restricted Access: Implement access controls to areas where TMMDE is stored. Limit access to authorized personnel who are aware of the calibration status and usage protocols.
Sign-Out Procedures: Establish sign-out procedures for TMMDE, ensuring that equipment is checked for calibration status before it is used.
Training and Awareness
Staff Training: Regularly train staff on the importance of using calibrated equipment and the procedures for handling out-of-calibration TMMDE. Emphasize the potential risks and consequences of using such equipment.
Awareness Programs: Conduct awareness programs to keep staff informed about calibration practices and the identification of out-of-calibration equipment.
Example of a Process for Handling Out-of-Calibration TMMDE
Identification Process
Routine Checks: Perform routine checks to identify any TMMDE that is out-of-calibration, beyond its calibration interval, or not in-service.
Tagging: Attach a red “Out-of-Calibration” tag to any TMMDE identified as such.
Segregation and Storage
Dedicated Area: Move the tagged TMMDE to a designated quarantine area specifically for out-of-service equipment.
Labeling: Ensure the storage area is clearly labeled and only accessible to authorized personnel.
Documentation and Record-Keeping
Log Entry: Make an entry in the TMMDE status log, recording the equipment ID, date identified, reason for out-of-calibration, and any immediate actions taken.
Update Inventory: Update the equipment inventory to reflect the status change.
Notification and Communication
Internal Notification: Send a notification to relevant departments (e.g., quality control, production, maintenance) informing them of the status change.
Post Signage: Place signs near workstations and storage areas, reminding staff to verify calibration status before use.
Scheduling and Preventive Maintenance
Calibration Scheduling: Schedule the out-of-calibration TMMDE for recalibration or maintenance as soon as possible.
Preventive Checks: Include the equipment in the preventive maintenance schedule to ensure regular status checks.
Access Control and Usage
Restricted Access: Limit access to the quarantine area to maintenance and calibration personnel.
Sign-Out Procedure: Implement a sign-out procedure that includes a calibration status check before any TMMDE is used.
Training and Awareness
Regular Training: Conduct training sessions for all relevant personnel on handling out-of-calibration TMMDE.
Refreshers and Updates: Provide regular updates and refresher courses on the importance of using calibrated equipment.
Example of an Out-of-Calibration Log (Tabular Form)
Equipment ID
Type
Date Identified
Status
Reason
Action Taken
Next Calibration Date
Responsible Person
Comments
PG-101
Pressure Gauge
2024-05-10
Out-of-Calibration
Deviated readings
Tagged and moved to quarantine
Scheduled for 2024-06-01
John Smith
N/A
TS-202
Temperature Sensor
2024-05-12
Beyond Calibration Interval
Missed calibration schedule
Tagged and removed from service
Scheduled for 2024-05-20
Jane Doe
N/A
MM-303
Multimeter
2024-05-15
Not in-Service
Not required for current project
Stored in quarantine area
N/A
John Smith
Recalibration needed before next use
FM-404
Flow Meter
2024-05-17
Out-of-Calibration
Inconsistent flow readings
Tagged and segregated
Scheduled for 2024-05-25
Jane Doe
N/A
GD-505
Gas Detector
2024-05-20
Not in-Service
Equipment retired
Documented and archived
N/A
John Smith
New equipment ordered
By systematically tagging, segregating, documenting, communicating, scheduling, controlling access, and training personnel, an organization can effectively prevent the unintended use of out-of-calibration, beyond calibration interval, or not in-service TMMDE. This approach ensures compliance with API Q1 requirements and maintains the integrity of the product realization process.
The procedure must include when the TMMDE is found to be out of calibration, an assessment of the validity of previous measurements and actions to be taken on the TMMDE and product, including maintaining records and evidence of notification to the customer if suspect product has been shipped.
When equipment is found to be out of calibration, it is crucial for the organization to assess the validity of previous measurements and take appropriate actions to address any potential impact on the equipment and products. Here’s how the organization can include this assessment and related actions in their process, along with maintaining records and evidence of notification to the customer if suspect product has been shipped:
Assessment of Validity of Previous Measurements
Review Calibration Records: Examine the last known valid calibration date and compare it with the dates of the measurements taken using the equipment.
Historical Data Analysis: Analyze historical measurement data to identify any anomalies or deviations that could indicate the time frame when the equipment may have started to produce inaccurate measurements.
Impact Analysis: Assess the impact of potentially invalid measurements on the product’s quality and conformity. This involves determining which products were tested or measured using the out-of-calibration equipment and evaluating the risk associated with those products.
Actions to Be Taken on the Equipment
Immediate Segregation: Remove the out-of-calibration equipment from service immediately to prevent further use.
Recalibration: Schedule the equipment for recalibration as soon as possible.
Post-Recalibration Verification: After recalibration, verify the accuracy of the equipment before putting it back into service.
Actions to Be Taken on the Product
Product Recall or Hold: If there is a risk that suspect products were shipped, consider initiating a product recall or placing the products on hold until further investigation is complete.
Retesting: Where feasible, retest or remeasure products that were tested with the out-of-calibration equipment using properly calibrated equipment.
Quarantine: Quarantine any products that may have been affected by the out-of-calibration equipment until a thorough assessment is completed.
Maintaining Records
Incident Report: Document the incident, including the identification of the out-of-calibration equipment, the date it was found out-of-calibration, and the last valid calibration date.
Assessment Records: Maintain detailed records of the validity assessment, including the analysis of historical data and the impact on product quality.
Corrective Actions: Document all corrective actions taken, including recalibration, product recall, retesting, and any changes to processes to prevent recurrence.
Notification to the Customer
Customer Notification: If suspect products have been shipped, notify the customer immediately. Provide them with details about the potential issue, the risk involved, and the actions being taken to address it.
Evidence of Notification: Maintain records of all communications with customers, including emails, letters, and phone call summaries, to provide evidence of the notification.
Example of a Process for Addressing Out-of-Calibration Equipment
Detection and Initial Response
Detection: Identify equipment that is out of calibration through routine checks or during use.
Tag and Segregate: Tag the equipment as out-of-calibration and segregate it from other equipment.
Assessment of Impact
Review Records: Review calibration records and historical measurement data.
Determine Impact: Identify products tested with the out-of-calibration equipment and assess the potential impact on product quality.
Actions on Equipment
Recalibration: Schedule the out-of-calibration equipment for immediate recalibration.
Verification: Verify equipment accuracy post-recalibration before returning it to service.
Actions on Products
Product Recall: If necessary, initiate a product recall or hold products until further testing.
Retesting: Retest products using calibrated equipment.
Quarantine: Quarantine affected products until assessment is complete.
Documentation and Communication
Incident Report: Document the incident and the results of the impact assessment.
Corrective Actions: Record all corrective actions taken.
Customer Notification: Notify customers about the potential issue and actions taken. Maintain records of all communications.
Example of Records to Maintain
Incident Report (Tabular Form)
Equipment ID
Type
Date Detected
Detected By
Last Calibration Date
Impact Assessment Summary
Actions Taken
Next Steps
PG-101
Pressure Gauge
2024-05-10
John Smith
2023-11-10
Potential impact on batch 12345
Equipment tagged and recalibrated
Retesting of batch 12345
TS-202
Temperature Sensor
2024-05-12
Jane Doe
2023-12-12
Reviewed 2 months of production data
Equipment removed from service
Notification to customers
Customer Notification Log (Tabular Form)
Customer ID
Customer Name
Product ID
Issue Description
Notification Date
Notified By
Customer Response
Follow-Up Actions
C-1001
ABC Oil Co.
P-12345
Potential pressure gauge issue
2024-05-11
John Smith
Acknowledged, awaiting further details
Recalibration and retesting results to be sent
C-1002
XYZ Energy
P-67890
Temperature sensor out of calibration
2024-05-13
Jane Doe
Requested immediate status update
Detailed impact assessment report to be provided
By implementing a comprehensive process that includes assessment of the validity of previous measurements, actions on equipment and products, maintaining detailed records, and notifying customers, the organization can effectively manage the risks associated with out-of-calibration equipment. This ensures compliance with API Q1 requirements and maintains the integrity of the product realization process.
The procedure must include use of third-party, proprietary, employee-owned, and customer-owned TMMDE.
To ensure comprehensive control over all types of equipment used in product realization, an organization must address the use of third-party, proprietary, employee-owned, and customer-owned equipment within its documented procedures. Here’s how the organization can include these equipment types:
Third-Party Equipment
Identification: Clearly identify and record all third-party equipment used within the organization.
Calibration and Certification: Ensure third-party equipment is calibrated and certified according to the organization’s standards and maintain records of calibration certificates.
Usage Agreement: Establish agreements with third-party providers that outline the requirements for equipment maintenance, calibration, and performance standards.
Verification: Verify the accuracy and suitability of third-party equipment before use and periodically thereafter.
Proprietary Equipment
Documentation: Maintain detailed documentation of proprietary equipment specifications, calibration requirements, and maintenance procedures.
Calibration: Establish a calibration schedule that aligns with the equipment manufacturer’s guidelines and industry standards.
Security: Implement measures to protect proprietary information associated with the equipment.
Training: Ensure personnel are adequately trained in the use and maintenance of proprietary equipment.
Employee-Owned Equipment
Approval Process: Develop a formal approval process for the use of employee-owned equipment, including an initial inspection and verification of suitability.
Calibration and Maintenance: Require employee-owned equipment to meet the same calibration and maintenance standards as organization-owned equipment. Maintain records of these activities.
Agreement: Have employees sign an agreement that outlines their responsibilities for maintaining and calibrating their equipment according to organizational standards.
Periodic Checks: Conduct periodic checks to ensure ongoing compliance with the organization’s standards.
Customer-Owned Equipment
Inventory Management: Keep a detailed inventory of all customer-owned equipment used within the organization.
Inspection and Verification: Conduct initial and periodic inspections to verify the condition and calibration of customer-owned equipment.
Documentation: Maintain records of customer-owned equipment, including calibration certificates, maintenance logs, and usage history.
Communication: Establish clear communication channels with customers regarding the status and maintenance requirements of their equipment.
Usage Authorization: Ensure that the use of customer-owned equipment is authorized and documented, with clear guidelines on handling and maintenance responsibilities.
The procedure must include maintenance.
To include the maintenance of equipment in the control of equipment, the organization must establish a detailed and documented procedure that encompasses all aspects of maintenance. This ensures equipment reliability, accuracy, and compliance with API Q1 requirements. Here are the key elements to include in such a procedure:
Key Elements to Include in the Maintenance of Equipment Procedure
Identification and Documentation
Equipment Inventory: Maintain a detailed inventory of all equipment requiring maintenance, including third-party, proprietary, employee-owned, and customer-owned equipment.
Unique Identification: Assign a unique identification number or code to each piece of equipment for easy tracking and reference.
Maintenance Records: Keep comprehensive records for each piece of equipment, documenting maintenance activities, schedules, and histories.
Maintenance Schedules
Frequency: Establish maintenance schedules based on manufacturer recommendations, industry standards, usage history, and risk assessments.
Preventive Maintenance: Implement a preventive maintenance program to minimize equipment failures and extend equipment life. This should include routine inspections, cleaning, lubrication, and part replacements.
Predictive Maintenance: Use predictive maintenance techniques, such as vibration analysis and thermal imaging, to identify potential issues before they lead to equipment failure.
Maintenance Procedures
Standard Operating Procedures (SOPs): Develop SOPs for each type of maintenance activity. These should detail the steps required to perform maintenance, the tools and materials needed, and safety precautions.
Corrective Maintenance: Define procedures for addressing equipment failures or malfunctions, including troubleshooting, repair, and verification of functionality after repairs.
Calibration Maintenance: Include specific procedures for maintaining the calibration of measuring and testing equipment, ensuring it remains within specified tolerances.
Responsibilities and Training
Personnel Responsibilities: Clearly define the roles and responsibilities of personnel involved in equipment maintenance, including technicians, supervisors, and managers.
Training Programs: Provide training programs for maintenance personnel to ensure they have the necessary skills and knowledge to perform maintenance tasks effectively and safely.
Monitoring and Reporting
Condition Monitoring: Implement condition monitoring techniques to track the health and performance of critical equipment. Use data collected to inform maintenance decisions.
Maintenance Logs: Maintain detailed logs of all maintenance activities, including the date, description of work performed, parts replaced, and the name of the technician who performed the work.
Reporting: Establish reporting mechanisms for maintenance activities, including regular maintenance reports and summaries for management review.
Spare Parts Management
Inventory Management: Maintain an inventory of critical spare parts to ensure timely availability for maintenance and repairs.
Part Replacement Records: Document all spare parts used during maintenance activities, including part numbers, quantities, and the equipment they were used on.
Review and Improvement
Periodic Review: Conduct periodic reviews of the maintenance program to identify areas for improvement and to ensure compliance with standards and regulations.
Continuous Improvement: Implement a continuous improvement process to enhance maintenance practices based on feedback, performance data, and technological advancements.
Example of a Maintenance Record Log (Tabular Form)
Equipment ID
Equipment Type
Last Maintenance Date
Next Scheduled Maintenance
Maintenance Activity
Technician
Parts Replaced
Comments
EQ-001
Pressure Gauge
2024-05-01
2024-11-01
Calibration and cleaning
aa
None
Calibration within tolerance
EQ-002
Temperature Sensor
2024-04-15
2024-10-15
Sensor inspection and testing
ss
Sensor probe
Replaced sensor probe
EQ-003
Flow Meter
2024-03-20
2024-09-20
Flow calibration
zz
None
Calibration needed adjustments
EQ-004
Employee-owned Laptop
2024-05-05
2024-11-05
Software update and testing
qq
None
Updated to latest version
EQ-005
Customer-owned Pump
2024-04-30
2024-10-30
Performance testing and lube
hhh
Lubricant
Lubricated all moving parts
Including the maintenance of equipment in the control of equipment involves establishing a comprehensive and documented procedure that covers identification, scheduling, detailed maintenance activities, responsibilities, monitoring, and continuous improvement. By doing so, the organization ensures that all equipment is maintained effectively, enhancing reliability and compliance with API Q1 requirements. This approach not only helps in preventing equipment failures but also supports the consistent delivery of quality products.
The procedure must include suitability for the planned monitoring and measurement activities.
To include suitability for the planned monitoring and measurement activities in the control of equipment, the organization must ensure that the equipment used is appropriate for its intended purpose and capable of providing accurate and reliable results. This involves several key steps:
Key Steps to Ensure Suitability
Assessment of Requirements
Identify Measurement Needs: Clearly define the monitoring and measurement requirements based on the product specifications, process requirements, and quality standards.
Select Appropriate Equipment: Choose equipment that meets the accuracy, range, and resolution requirements for the intended monitoring and measurement activities.
Qualification of Equipment
Initial Verification: Perform an initial verification to ensure that the selected equipment meets the required specifications and is suitable for its intended use.
Calibration: Ensure all equipment is calibrated to national or international standards before use. This includes establishing traceability to recognized standards.
Validation: Validate the equipment’s performance under actual operating conditions to confirm it meets the necessary requirements.
Documentation and Record Keeping
Equipment Specifications: Maintain detailed records of equipment specifications, including accuracy, range, resolution, and any other relevant parameters.
Calibration Certificates: Keep calibration certificates and records for all equipment, documenting calibration dates, results, and next calibration due dates.
Validation Reports: Document the results of validation activities, including any tests conducted to verify the suitability of the equipment.
Ongoing Monitoring and Maintenance
Periodic Calibration: Establish a schedule for regular calibration of equipment to ensure ongoing accuracy and reliability.
Performance Monitoring: Implement procedures to continuously monitor the performance of equipment, identifying any deviations or issues promptly.
Maintenance Procedures: Develop and follow maintenance procedures to keep equipment in optimal condition, addressing wear and tear, and other potential issues.
Training and Competence
Operator Training: Ensure personnel are trained in the proper use, calibration, and maintenance of the equipment.
Competence Assessment: Regularly assess the competence of personnel handling the equipment to ensure they can accurately perform the required monitoring and measurement activities.
Review and Improvement
Regular Review: Conduct regular reviews of equipment performance and suitability, using feedback from monitoring activities to identify areas for improvement.
Continuous Improvement: Implement continuous improvement processes to enhance the suitability and performance of the equipment based on review findings and technological advancements.
Example of an Equipment Suitability Record (Tabular Form)
Equipment ID
Equipment Type
Measurement Range
Accuracy
Calibration Date
Next Calibration Date
Validation Status
Validation Date
Validated By
Comments
EQ-101
Digital Caliper
0-150 mm
±0.02 mm
2024-01-15
2024-07-15
Suitable
2024-01-16
aa
Validated for precision
EQ-102
Pressure Gauge
0-10 bar
±0.1 bar
2024-02-10
2024-08-10
Suitable
2024-02-11
zz
Accurate within range
EQ-103
Temperature Sensor
-50 to 150°C
±0.5°C
2024-03-20
2024-09-20
Suitable
2024-03-21
qq
Validated for full range
EQ-104
Flow Meter
0.1-10 L/min
±0.01 L/min
2024-04-05
2024-10-05
Suitable
2024-04-06
cc
Meets all specs
Summary
Ensuring the suitability of equipment for planned monitoring and measurement activities involves careful selection, qualification, ongoing calibration, and maintenance of equipment. By including these aspects in the documented procedures, the organization can ensure that all equipment used is appropriate for its intended purpose and capable of providing accurate and reliable results, thus meeting the API Q1 requirements. This comprehensive approach helps maintain the integrity of the measurement processes and ensures consistent product quality.
The organization shall determine the testing, measuring, monitoring, and detection requirements and the TMMDE needed to provide evidence of conformity to those requirements. TMMDE owned and maintained by the organization, employee-owned equipment, and TMMDE from other sources (e.g. third-party, proprietary, and customer-owned) used to provide evidence of product conformity and/ or monitor process parameters identified by the organization that impact product conformance shall be controlled. TMMDE shall be calibrated at specified intervals. When the specified interval is based on the date of first use, the date of first use shall be documented.
In API Q1, Testing Equipment, Measuring Equipment, Monitoring Equipment, and Detection Equipment are all types of tools or instruments used in quality control and assurance processes. Testing equipment performs tests or experiments to evaluate properties, while measuring equipment quantifies physical characteristics. Monitoring equipment observes and records changes in processes or conditions, and detection equipment identifies specific substances or conditions. Testing and measuring equipment are commonly used in quality control and assurance processes to assess product quality and compliance. Monitoring equipment is used to oversee processes and conditions, while detection equipment is used for identifying defects, hazards, or contaminants. Monitoring equipment typically operates continuously or periodically to provide real-time data, while testing, measuring, and detection equipment are often used at specific points in time or for discrete measurements or tests. While testing, measuring, monitoring, and detection equipment all play essential roles in quality control and assurance processes, they serve distinct functions and purposes within the context of API Q1 and other quality management systems.
Testing Equipment:
Definition: Testing equipment refers to tools or devices used to conduct tests or experiments on materials, products, or components to evaluate their properties, performance, or behavior.
Purpose: It is used to verify compliance with specifications, standards, or requirements and to ensure the quality and reliability of products.
Definition: Measuring equipment is used to quantify physical characteristics or dimensions of materials, products, or components with precision and accuracy.
Purpose: It is used for dimensional inspection, quality control, and assurance to ensure that products meet specified tolerances and standards.
Definition: Monitoring equipment is designed to continuously or periodically observe and record changes or variations in processes, conditions, or parameters.
Purpose: It is used to monitor and control production processes, environmental conditions, or equipment performance to ensure consistency, efficiency, and compliance.
Examples: Temperature sensors, pressure sensors, flow meters, level sensors, vibration monitors, and humidity meters.
Detection Equipment:
Definition: Detection equipment is used to identify or detect the presence, absence, or characteristics of specific substances, defects, or conditions.
Purpose: It is used for quality control, safety, and security purposes, such as detecting defects, contaminants, leaks, or hazards.
Examples: Metal detectors, X-ray machines, ultrasonic flaw detectors, gas detectors, moisture analyzers, and particle counters.
The organization shall determine the testing, measuring, monitoring, and detection requirements and the TMMDE needed to provide evidence of conformity to those requirements.
In the oil and gas industry, ensuring the quality, safety, and compliance of products and processes is paramount. The requirements for testing, measuring, monitoring, and detection are designed to achieve these goals. Below are the key requirements for each category:
Testing Requirements: To verify the properties, performance, and safety of products and materials.
Mechanical Testing: Includes tensile strength, hardness, impact resistance, and fatigue testing to assess the mechanical properties of materials.
Chemical Testing: Ensures the chemical composition of materials meets specifications, including tests for corrosion resistance and chemical stability.
Non-Destructive Testing (NDT): Techniques such as ultrasonic testing, radiography, magnetic particle inspection, and dye penetrant testing to detect surface and subsurface defects without damaging the product.
Pressure Testing: Verifies the integrity and strength of pressure vessels, pipelines, and other components subjected to high pressures.
Performance Testing: Assesses the functionality and reliability of equipment and systems under operational conditions.
Environmental Testing: Evaluates the product’s performance under different environmental conditions, such as temperature extremes, humidity, and exposure to corrosive substances.
Measuring Requirements: To accurately quantify physical dimensions, properties, and conditions.
Dimensional Measurement: Using tools such as calipers, micrometers, gauges, and coordinate measuring machines (CMMs) to ensure products meet specified dimensions and tolerances.
Weight and Volume Measurement: Scales, balances, and volumetric devices to measure weight and volume accurately.
Flow Measurement: Devices like flow meters and flow gauges to measure the rate of fluid flow in pipelines and systems.
Temperature Measurement: Thermocouples, infrared thermometers, and thermal cameras to monitor and control temperature.
Pressure Measurement: Pressure gauges, transducers, and manometers to measure and monitor pressure levels.
Monitoring Requirements: To continuously or periodically observe and record conditions or parameters to ensure process control and stability.
Process Monitoring: Continuous monitoring of critical process parameters such as temperature, pressure, flow rate, and chemical composition using sensors and automated systems.
Condition Monitoring: Techniques such as vibration analysis, oil analysis, and thermography to monitor the condition of machinery and equipment, predict failures, and plan maintenance.
Environmental Monitoring: Monitoring of environmental conditions such as air quality, water quality, and emissions to ensure compliance with regulatory standards and minimize environmental impact.
Safety Monitoring: Use of gas detectors, fire alarms, and emergency shutdown systems to ensure safety and respond to hazardous conditions.
Detection Requirements: To identify the presence or absence of specific conditions, defects, or substances.
Leak Detection: Use of ultrasonic detectors, pressure decay tests, and gas sniffers to detect leaks in pipelines, tanks, and equipment.
Contaminant Detection: Techniques such as particle counters, moisture analyzers, and chemical sensors to detect contaminants in fluids and gases.
Defect Detection: Non-destructive testing (NDT) methods to detect and characterize surface and subsurface defects.
Corrosion Detection: Methods such as corrosion probes, ultrasonic thickness gauges, and electrochemical techniques to detect and monitor corrosion.
How to Determine Requirements
To ensure that the testing, measuring, monitoring, and detection requirements are met, an oil and gas organization should follow these steps:
Review Industry Standards and Regulations: Adhere to API standards, ASME codes, and other relevant industry standards and regulations. Ensure compliance with environmental and safety regulations.
Define Quality and Safety Objectives: Establish clear quality and safety objectives based on industry standards, customer requirements, and internal policies.
Identify Critical Control Points: Conduct a thorough analysis of processes to identify critical control points where testing, measuring, monitoring, and detection are essential. Use risk assessment techniques such as Failure Mode and Effects Analysis (FMEA) to prioritize areas.
Select Appropriate Equipment: Choose equipment that meets the required precision, accuracy, and reliability standards. Ensure equipment is suitable for the specific environmental and operational conditions.
Implement and Validate Procedures: Develop and implement documented procedures for testing, measuring, monitoring, and detection activities. Validate these procedures to ensure they effectively meet the defined objectives.
Train Personnel: Provide comprehensive training to personnel on the correct use of equipment and adherence to procedures. Ensure ongoing training to keep skills and knowledge up to date.
Maintain and Calibrate Equipment: Establish a regular maintenance and calibration schedule to ensure the accuracy and reliability of equipment. Keep detailed records of maintenance and calibration activities.
Continuous Improvement: Regularly review and update testing, measuring, monitoring, and detection practices based on feedback, audit results, and technological advancements. Implement corrective actions to address any identified issues or deficiencies.
By following these steps, an oil and gas organization can effectively determine and meet the requirements for testing, measuring, monitoring, and detection, ensuring product quality, safety, and compliance with API Q1 and other relevant standards.
TMMDE owned and maintained by the organization, employee-owned equipment, and TMMDE from other sources (e.g. third-party, proprietary, and customer-owned) used to provide evidence of product conformity and/ or monitor process parameters identified by the organization that impact product conformance shall be controlled.
Controlling testing, measuring, monitoring, and detection equipment is crucial for an oil and gas organization for several reasons:
Ensuring Product Quality and Safety
Accurate Measurements: Reliable equipment provides accurate measurements, which are essential for ensuring that products meet specified quality and safety standards.
Consistency: Consistent performance of equipment ensures that every batch of product conforms to the same high standards, reducing variability and defects.
Compliance with Standards and Regulations
Regulatory Requirements: Many standards, including API Q1, ISO, and other industry-specific regulations, mandate strict control over equipment to ensure accurate testing and measurements.
Audit Readiness: Proper control of equipment ensures that the organization is always ready for external audits and inspections, thereby avoiding non-compliance penalties.
Operational Efficiency and Cost Control
Prevent Downtime: Regular maintenance and calibration prevent unexpected equipment failures that can lead to costly production downtime.
Cost Savings: Well-maintained equipment reduces the need for expensive repairs and replacements, thus controlling operational costs.
Data Integrity and Reliability
Traceable Results: Accurate and reliable data from well-maintained equipment supports traceable and verifiable test results, which are critical for decision-making and reporting.
Historical Data: Maintaining accurate records of equipment performance helps in analyzing historical data for process improvement and quality assurance.
Risk Management
Minimize Errors: Controlled equipment minimizes the risk of measurement errors that could lead to product failures, safety incidents, or environmental harm.
Predictive Maintenance: Monitoring the condition of equipment allows for predictive maintenance, reducing the risk of unexpected failures.
Customer Satisfaction and Trust
Meeting Expectations: By ensuring that products consistently meet quality and safety specifications, the organization meets or exceeds customer expectations.
Building Trust: Reliable and accurate testing and measurement build customer trust and confidence in the organization’s products and processes.
Support for Continuous Improvement
Feedback Loop: Proper control and monitoring provide valuable data that can be used to identify areas for process improvement.
Innovations: Consistent and accurate measurement supports innovations and improvements in product design and manufacturing processes.
How to Control the Equipment
To effectively control testing, measuring, monitoring, and detection equipment, an organization should implement the following practices:
Documented Procedures:
Establish comprehensive procedures for the calibration, maintenance, and use of equipment.
Ensure that these procedures are accessible and understood by all relevant personnel.
Calibration and Maintenance:
Develop a schedule for regular calibration and maintenance based on manufacturer recommendations, industry standards, and operational needs.
Use certified calibration services and maintain traceability to national or international standards.
Record Keeping:
Maintain detailed records of all calibration, maintenance, and repair activities.
Include information such as the date of service, results of calibration, adjustments made, and the technician who performed the work.
Training and Competence:
Provide training for personnel on the correct use, maintenance, and calibration of equipment.
Conduct regular assessments to ensure ongoing competence.
Verification and Validation:
Perform regular checks to verify that equipment is functioning correctly between calibration intervals.
Validate the performance of new equipment before it is put into service.
Handling and Storage:
Implement procedures for the proper handling and storage of equipment to prevent damage and ensure it is kept in optimal condition.
Control environmental factors such as temperature and humidity that could affect equipment performance.
Continuous Monitoring:
Use monitoring tools to continuously assess the condition and performance of critical equipment.
Implement condition-based maintenance strategies to address issues before they lead to failures.
Auditing and Improvement:
Conduct regular internal audits to ensure compliance with control procedures and identify opportunities for improvement.
Use audit findings and feedback to refine and improve equipment control processes.
Summary Table for Controlling Equipment
Step
Action
Establishing Requirements
Documented procedures, equipment identification, calibration and maintenance schedules
By controlling testing, measuring, monitoring, and detection equipment effectively, an organization ensures that its operations are reliable, compliant, and efficient, thereby maintaining high standards of product quality and safety.
TMMDE shall be calibrated at specified intervals.
Determining the appropriate calibration intervals for equipment in an oil and gas organization involves a combination of several factors, including manufacturer recommendations, industry standards, regulatory requirements, historical data, and the specific operational context of the equipment. Here’s a detailed approach to determining these intervals:
Manufacturer Recommendations
Initial Guidance: Start with the calibration intervals recommended by the equipment manufacturer. These recommendations are based on the manufacturer’s knowledge of the equipment’s performance and reliability.
Manufacturer Documentation: Review the user manuals and technical documentation provided by the manufacturer for suggested calibration frequencies.
Industry Standards and Regulatory Requirements
Compliance: Adhere to relevant industry standards and regulatory requirements that specify calibration intervals. For example, API Q1, ISO standards, and other industry-specific guidelines often include recommendations or mandates for calibration frequencies.
Benchmarking: Compare your practices with industry best practices and standards to ensure your calibration intervals are in line with industry norms.
Historical Data and Equipment Performance
Performance History: Analyze historical data on the performance of the equipment. Look at previous calibration records, accuracy drift, and failure rates to determine if the recommended intervals are appropriate or need adjustment.
Trend Analysis: Conduct trend analysis to identify any patterns in equipment drift or failure. Shorten intervals for equipment that frequently drifts out of tolerance and lengthen intervals for stable, reliable equipment.
Risk Assessment
Criticality Assessment: Assess the criticality of the equipment in your processes. Equipment that is critical to safety, compliance, or product quality should have more frequent calibration intervals.
Risk Analysis: Perform a risk analysis to evaluate the potential impact of equipment failure or inaccuracy. Equipment with higher associated risks should be calibrated more frequently.
Usage Intensity and Environmental Conditions
Usage Frequency: Consider how often the equipment is used. Equipment that is used frequently may require more frequent calibration.
Operational Environment: Assess the environmental conditions in which the equipment operates. Harsh conditions (e.g., high temperatures, humidity, corrosive environments) can affect equipment performance and necessitate more frequent calibration.
Feedback from Calibration and Maintenance Activities
Calibration Results: Regularly review the results of calibration activities. If equipment frequently fails to meet calibration standards, reduce the interval between calibrations.
Maintenance Records: Incorporate feedback from maintenance records. Equipment that often requires adjustments or repairs may benefit from more frequent calibration.
Technological Advancements
New Methods: Stay updated on new calibration techniques and technologies that might allow for extended calibration intervals without compromising accuracy.
Equipment Upgrades: Consider upgrading to newer equipment that offers better stability and requires less frequent calibration.
Implementing and Adjusting Calibration Intervals
Initial Setup: Begin with the manufacturer’s recommended intervals. Adjust based on initial risk assessments and compliance requirements.
Ongoing Review: Monitor equipment performance and calibration results continuously. Adjust intervals based on historical performance data and trend analysis.
Feedback Loop: Establish a feedback loop where calibration and maintenance teams report their findings. Use this feedback to make data-driven decisions about adjusting calibration intervals.
Documentation and Record-Keeping: Maintain detailed records of calibration activities, including dates, results, adjustments, and any deviations observed. Document the rationale for any changes to calibration intervals.
Example Table for Determining Calibration Intervals
Equipment
Manufacturer Recommended Interval
Industry Standard Interval
Historical Data
Risk Assessment
Environmental Factors
Final Interval
Pressure Gauge
12 months
12 months
No drift observed
High criticality
Moderate
12 months
Flow Meter
6 months
6 months
Slight drift
Medium criticality
Harsh
4 months
Temperature Sensor
12 months
12 months
Stable
Low criticality
Controlled
12 months
Gas Detector
3 months
3 months
Frequent drift
High criticality
Harsh
2 months
Dimensional Caliper
12 months
12 months
Stable
Medium criticality
Controlled
12 months
By systematically evaluating these factors, an oil and gas organization can determine appropriate calibration intervals that ensure equipment accuracy and reliability while balancing operational efficiency and compliance requirements.
When the specified interval is based on the date of first use, the date of first use shall be documented.
When the specified calibration interval is based on the date of first use, it’s essential to document this date to ensure accurate tracking and scheduling of future calibrations. Here’s how an organization can manage this process effectively:
Importance of Documenting the Date of First Use
Accurate Calibration Scheduling:
Initial Reference Point: The date of first use provides a reference point for calculating the next calibration date, ensuring timely calibrations.
Compliance: Ensures compliance with standards and regulatory requirements by maintaining accurate records.
Equipment Lifecycle Management:
Performance Tracking: Helps in tracking the performance and reliability of equipment over time.
Maintenance Planning: Aids in planning preventive maintenance and replacements.
Risk Management:
Minimizing Failures: Regular calibration based on the date of first use reduces the risk of equipment failure and inaccuracies.
Quality Assurance: Ensures that products meet quality standards consistently.
Steps to Document the Date of First Use
Establish a Documentation Procedure:
Procedure Development: Develop a documented procedure that specifies how and where the date of first use should be recorded.
Training: Train personnel on the importance of documenting the date of first use and the procedures to follow.
Recording the Date of First Use:
Initial Entry: When equipment is put into service for the first time, record the date in the equipment’s logbook, database, or tracking system.
Labeling: Physically label the equipment with the date of first use if possible, using durable tags or stickers.
Integration with Calibration Records:
Database Management: Integrate the date of first use into the organization’s calibration management software or database.
Tracking System: Use a tracking system that automatically schedules calibrations based on the date of first use.
Documentation Formats:
Logbooks: Maintain logbooks for each piece of equipment where the date of first use is recorded along with other relevant information.
Electronic Records: Utilize electronic record-keeping systems that allow for easy access, updates, and retrieval of the date of first use.
Regular Reviews and Audits:
Periodic Reviews: Regularly review the records to ensure accuracy and completeness.
Internal Audits: Conduct internal audits to verify that the dates of first use are being correctly documented and utilized for calibration scheduling.
Example Table for Documenting the Date of First Use
Equipment ID
Description
Date of First Use
Calibration Interval
Next Calibration Due
Remarks
EQ-001
Pressure Gauge
2024-06-01
12 months
2025-06-01
Initial calibration on 2024-06-01
EQ-002
Flow Meter
2024-07-15
6 months
2025-01-15
Slight drift observed during last calibration
EQ-003
Temperature Sensor
2024-08-10
12 months
2025-08-10
Stable performance
EQ-004
Gas Detector
2024-05-20
3 months
2024-08-20
Frequent drift, re-evaluate interval
EQ-005
Dimensional Caliper
2024-09-05
12 months
2025-09-05
In controlled environment
Documenting the date of first use is a critical step in managing the calibration of testing, measuring, monitoring, and detection equipment. It ensures accurate scheduling, compliance with standards, and effective lifecycle management. By following a structured procedure and maintaining detailed records, an organization can ensure that all equipment is calibrated at appropriate intervals, thus maintaining high levels of accuracy, reliability, and safety in operations.
