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 | 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 | 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.
