IATF 16949:2016 Clause Calibration/verification records

Calibration and verification are important processes in the context of the International Automotive Task Force (IATF) standard, specifically in relation to clause This clause pertains to the calibration and verification of monitoring and measuring equipment used in the automotive industry.Calibration refers to the process of comparing the measurements of a given instrument or equipment with a known standard to ensure its accuracy. It involves adjusting or aligning the equipment to meet specific requirements or standards. Calibration is typically performed by using traceable standards or certified reference materials.Verification, on the other hand, is the confirmation through the provision of objective evidence that specified requirements have been met. In the context of IATF, verification involves checking whether the monitoring and measuring equipment used in automotive manufacturing or testing is capable of providing accurate and reliable results.Clause of the IATF standard emphasizes the importance of calibration and verification in maintaining the quality and reliability of measurement systems within the automotive industry. It requires organizations to establish and maintain processes for the calibration and verification of all relevant equipment used for monitoring and measuring product conformity.To comply with this clause, organizations must implement the following steps:

  1. Identify relevant monitoring and measuring equipment: Determine which equipment is critical for ensuring product conformity and quality within the organization’s processes.
  2. Establish calibration requirements: Define the specific calibration requirements for each identified equipment, including the frequency of calibration and the reference standards to be used.
  3. Perform calibration: Carry out the calibration activities according to the established requirements. This may involve adjusting or aligning the equipment to match the reference standards and ensuring its accuracy.
  4. Maintain calibration records: Document the details of each calibration performed, including the date, the personnel involved, the reference standards used, and the results obtained. These records serve as evidence of compliance with the calibration requirements.
  5. Conduct verification: Regularly verify the performance of the monitoring and measuring equipment to ensure its ongoing accuracy and reliability. This may involve periodic checks, inter-laboratory comparisons, or other appropriate methods.
  6. Document verification activities: Keep records of the verification activities conducted, including the methods used, the results obtained, and any actions taken to address identified discrepancies.

By adhering to these steps, organizations can demonstrate their commitment to maintaining accurate and reliable measurement systems as required by the IATF standard. Effective calibration and verification processes help ensure that the automotive products manufactured or tested meet the necessary quality and safety standards.

The standard requires the supplier to calibrate inspection, measuring, and test equipment used to demonstrate the conformance of product to the specified requirements. Calibration is concerned with determining the values of the errors of a measuring instrument and often involves its adjustment or scale graduation to the required accuracy. You should not assume that just because a device was once accurate it will remain so forever. Some devices, if well treated and retained in a controlled environment, will retain their accuracy for very long periods. Others, if poorly treated and subjected to environmental extremes, will lose their accuracy very quickly. Ideally you should calibrate measuring devices before use in order to prevent an inaccurate device being used in the first place and afterwards to confirm that no changes have occurred during use. However, this is often not practical and so intervals of calibration are established which are set at such periods as will detect any adverse deterioration. These intervals should be varied with the nature of the device, the conditions of use, and the seriousness of the consequences should it produce incorrect results. It is not necessary to calibrate all test and measuring equipment. Some equipment may be used solely as an indicator, such as a thermometer, a clock, or a tachometer; other equipment may be used for diagnostic purposes, to indicate if a fault exists. If such devices are not used for determining the acceptability of products and services or process parameters, their calibration is not essential. However, you should identify such devices as for “Indication Purposes Only” if their use for measurement is possible. You don’t need to identify all clocks and thermometers fixed to walls unless they are used for measurement. Having observed that you record the time when observations were made, a zealous assessor may suggest that the clock be calibrated. If the time is not critical to product or process acceptability, calibration is unnecessary. There are two systems used for maintaining the accuracy and integrity of measuring devices: a calibration system and a verification system. The calibration system determines the accuracy of measurement and the verification system determines the integrity of the device. If accuracy is important then the device should be included in the calibration system. If accuracy is not an issue but the device’s form, properties, or function is important then it should be included in the verification system. You need to decide the system in which your devices are to be placed under control and identify them accordingly. There are two types of devices subject to calibration: those that are adjustable and those that are not. An adjustable device is one where the scale or the mechanism is capable of adjustment (e.g. micrometer, voltmeter, load cell). For non-adjustable devices a record of the errors observed against a known standard can be produced which can be taken into account when using the device (e.g. slip gage, plug gage, surface table, thermometer). Comparative references are not subject to calibration. They are, however, subject to verification. Such devices are those which have form or function where the criteria is either pass or fail (i.e. there is no room for error) or where the magnitude of the errors does not need to be taken into account during usage. Such devices include software, steel rules/tapes, templates, forming and molding tools. Devices in this category need carry no indication of calibration due date. The devices should carry a reference number and verification records should be maintained showing when the device was last checked. Verification of such devices include checks for damage, loss of components, function. Some electronic equipment has self-calibration routines built in to the start-up sequence. This should be taken as an indication of serviceability and not of absolute calibration. The device should still be subject to independent calibration at a defined frequency.

Clause Calibration/verification records

In addition to the requirement given in ISO 9001:2015 7.1.5 Monitoring and measuring resources , addition requirement in clause are as follows. A documented process is needed to manage calibration/verification records. Records of the calibration/verification activity for all gauges and measuring and test equipment (including employee- owned equipment relevant for measuring, customer-owned equipment, or on-site supplier-owned equipment) needed to provide evidence of conformity to internal, legal, and customer requirements are to be maintained. Calibration/verification activities and records shall include the following details: a)revisions due to engineering changes; (b) incidents of out-of-calibration readings; (c) assessment of the risk caused by the out-of-calibration condition; (d), records previous measurement results obtained with this piece of test equipment, last calibration date and the next due dates; (e) notification to the customer if suspect product or material has been shipped; (f) statements of conformity to specification after calibration/verification; (g) verification that the software version used for product and process control is as specified; (h) records of the calibration and maintenance activities for all gauging; (i) production-related software verification used for product and process control

Please click here for ISO 9001:2015 7.1.5 Monitoring and measuring resources

Requirements for what needs to be measured and the acceptance criteria may come from the customer, regulatory, industry and your own organization. Clause 8.1 Operational planning and control must determine the following – what specific product and process characteristics needs to be monitored and measured; the criteria for product acceptance; the type of monitoring and measurement device needed; frequency – at what stages of realization to do it; sample size; etc. You must then determine what MONITORING AND MEASURING DEVICE is appropriate for each measuring or monitoring requirement. Consideration must be given to the measurement capability (precision) of the MONITORING AND MEASURING DEVICE which may have to be several times greater than the tolerance criteria for product measurement. This would depend on the industry you are in and the criticality of end use for the product (e.g. the precision requirements for an engine block or for ball bearings may be much greater than say for cutting leather to cover a car seat). Personnel using MONITORING AND MEASURING DEVICE’s must have competence and training in the use of MONITORING AND MEASURING DEVICE’s in terms of their function, range and precision of measurement, reliability, use and maintenance. MONITORING AND MEASURING DEVICE’s may include measurement and testing tools; equipment; hardware and software. They may be owned by your organization; your employees or the customer. MONITORING AND MEASURING DEVICE’s may be used to verify product as well as to measure process conformity (e.g. a temperature controller on an oven). Besides MONITORING AND MEASURING DEVICE’s used for product conformity, you may need to calibrate and control certain MONITORING AND MEASURING DEVICE’s used in related and peripheral processes such as production equipment; tooling; maintenance; etc. To ensure valid measurement and monitoring results, MONITORING AND MEASURING DEVICE’s must be controlled. A process is required, to control the selection; purchase; identification; status; calibration; use; verification or adjustment; use; handling; maintenance and storage; training; nonconforming MONITORING AND MEASURING DEVICE’s; calibration records; etc. Appropriate records need to be kept of the use of these controls. All MONITORING AND MEASURING DEVICE’s used for product verification must be capable of being calibrated, verified or both. Calibration is setting or correcting an MONITORING AND MEASURING DEVICE, usually by adjusting it to match or conform to a dependably known and traceable standard (e.g. adjusting a micrometer or caliper to conform to master blocks traceable to national standards). Verification is confirming that the MONITORING AND MEASURING DEVICE is meeting or performing to acceptable national measurement standards and does not involve any correction or adjustment (e.g. verifying a ruler or tape measure against a calibrated ruler that has been calibrated to a national standard). A ruler or tape measure is generally not capable of being calibrated and when it gets out of calibration its use must be discontinued. There are MONITORING AND MEASURING DEVICE’s that are capable of being both calibrated and verified (e.g. a CMM- coordinate measuring machine) and may require both to be done in specific situations based on frequency of use and criticality of measurement. This requirement also applies to the use of computer software whose calibration status must be established prior to initial use and reconfirmed (verified) at defined intervals. You must define the frequency and method of calibration for each type and level (shop floor; laboratory or standard) of MONITORING AND MEASURING DEVICE. Your calibration records must identify what standard you used for calibration and show traceability of the standards you use at your facility to national or international standards. In rare circumstances, national or international standards may not exist for calibrating a specific MONITORING AND MEASURING DEVICE. In such situations consider using industry, manufacturer or even your own organizational standard to validate the accuracy and reliability of your MONITORING AND MEASURING DEVICE. Consult with your customer if the contractual circumstances require it.

A multitude of software tools are available to manage and control MONITORING AND MEASURING DEVICE’s including all the record keeping details required . There are many acceptable methods to identify MONITORING AND MEASURING DEVICE’s and their calibration status. The methods you select must consider the manufacturers recommendations; frequency of use; environment the MONITORING AND MEASURING DEVICE is used in; etc. Where an MONITORING AND MEASURING DEVICE is found to be out of calibration, you must take appropriate correction action to contain and re-verify the product affected, to the extent practical. This is in addition to containing, repair and recalibration of the defective MONITORING AND MEASURING DEVICE. Customer or internal engineering changes may result in a change in product measurement, requirements and/or the MONITORING AND MEASURING DEVICE to be used.  These changes would normally be reflected in your control plan. Ensure that your calibration process shows clear linkage to your process for change control and control plan .

1) Calibration/verification activities due to revisions due to engineering changes

When engineering changes occur in a product or process, it may be necessary to perform calibration and verification activities to ensure that the monitoring and measuring equipment used is still accurate and reliable. Here are the steps typically involved in calibration/verification activities due to revisions caused by engineering changes:

  1. Identify the impact: Assess the engineering changes and determine which monitoring and measuring equipment are affected. Understand the nature of the changes and how they may influence the equipment’s calibration status.
  2. Review calibration requirements: Evaluate the existing calibration requirements for the affected equipment. Determine if any adjustments or additions need to be made to accommodate the engineering changes. Consider factors such as measurement ranges, accuracy tolerances, and new reference standards, if applicable.
  3. Update calibration procedures: Revise the calibration procedures to reflect the changes brought about by the engineering revisions. Document any new steps, adjustments, or additional measurements required to ensure accurate calibration.
  4. Perform calibration: Follow the updated calibration procedures to recalibrate the affected equipment. Make any necessary adjustments or alignments to ensure the equipment meets the new requirements. Use appropriate traceable standards or reference materials during the calibration process.
  5. Verify equipment performance: After calibration, conduct verification activities to confirm that the equipment is performing as intended. This may involve performing test measurements, comparing results against known standards, or conducting inter-laboratory comparisons to validate accuracy and reliability.
  6. Update calibration records: Record the details of the calibration and verification activities performed as part of the engineering change process. Include information such as the date of calibration, personnel involved, reference standards used, and verification results. Ensure that all records are updated to reflect the revised calibration status.
  7. Communicate changes: Inform relevant personnel and stakeholders about the engineering changes and the corresponding updates to the calibration and verification procedures. Ensure that everyone involved understands the revised requirements and follows the updated processes.
  8. Ongoing monitoring: Regularly monitor the performance of the recalibrated equipment to ensure its continued accuracy. Consider implementing a schedule for periodic re-verification to maintain confidence in the equipment’s reliability, especially when significant engineering changes occur.

By following these steps, organizations can effectively manage calibration and verification activities resulting from engineering changes. This helps maintain the accuracy and reliability of the monitoring and measuring equipment, ensuring the quality and conformity of the products or processes throughout the revised engineering implementation.Regenerate response

2) Incidents of out-of-calibration readings

When incidents of out-of-calibration readings occur in monitoring and measuring equipment, it is crucial to conduct calibration and verification activities to address the issue. Here are the steps typically involved in calibration/verification activities due to incidents of out-of-calibration readings:

  1. Identify the incident: Recognize and document any instances where the monitoring and measuring equipment has provided readings that are outside the acceptable calibration range or deviate from expected values. Identify the affected equipment and gather relevant data regarding the incident.
  2. Isolate the equipment: If possible, remove the equipment from service and isolate it to prevent its further use until calibration or verification is completed. This ensures that no inaccurate measurements are taken with the out-of-calibration equipment.
  3. Investigate the cause: Determine the cause of the out-of-calibration readings. This may involve analyzing factors such as environmental conditions, equipment handling, maintenance practices, or potential damage to the equipment. Identify any contributing factors to prevent future incidents.
  4. Assess the impact: Evaluate the impact of the out-of-calibration readings on product quality, safety, or compliance. Determine if any non-conforming products were produced as a result and take appropriate corrective actions if necessary.
  5. Perform calibration/verification: Depending on the nature of the incident and the equipment involved, perform calibration or verification activities. Calibration involves adjusting the equipment to meet specified accuracy requirements, while verification confirms the equipment’s performance against reference standards without making adjustments.
  6. Update calibration records: Document all calibration or verification activities performed in response to the incident. Include details such as the date, personnel involved, procedures followed, reference standards used, and the results obtained. This documentation helps maintain a traceable record of the equipment’s calibration status.
  7. Implement corrective actions: If the out-of-calibration incident was caused by specific issues, implement corrective actions to prevent recurrence. This may involve equipment maintenance, improved handling procedures, environmental controls, or staff training.
  8. Communicate and train: Inform relevant personnel about the incident, the corrective actions taken, and any revised procedures or requirements. Provide training if necessary to ensure proper equipment handling and usage to prevent future out-of-calibration incidents.
  9. Ongoing monitoring: Regularly monitor the performance of the recalibrated or verified equipment to ensure its continued accuracy. Implement a schedule for periodic re-calibration or re-verification to maintain confidence in the equipment’s reliability.

By following these steps, organizations can effectively address incidents of out-of-calibration readings and ensure the accuracy and reliability of their monitoring and measuring equipment. This helps maintain product quality, compliance with standards, and customer satisfaction.

3) Assessment of the risk caused by the out-of-calibration condition

Assessing the risk caused by an out-of-calibration condition is important to understand the potential impact on product quality, safety, and compliance. Here are some key steps in assessing the risk associated with an out-of-calibration condition:

  1. Identify potential risks: Consider the potential consequences of using equipment that is out of calibration. This could include inaccurate measurements, faulty product evaluation, non-compliance with regulations or standards, compromised safety, increased scrap or rework, customer dissatisfaction, or potential product recalls.
  2. Determine severity: Evaluate the severity of the potential risks identified. Assess the impact of inaccurate measurements or non-compliance on product performance, safety, or customer satisfaction. Classify the severity level based on the potential consequences, such as minor impact, moderate impact, or severe impact.
  3. Assess likelihood: Determine the likelihood of the identified risks occurring due to the out-of-calibration condition. Consider factors such as the frequency of equipment use, the criticality of measurements in the process, the level of control over the equipment, and the historical performance of the equipment. Classify the likelihood as low, medium, or high.
  4. Evaluate risk levels: Combine the severity and likelihood classifications to determine the overall risk level associated with the out-of-calibration condition. Use a risk matrix or similar tool to assess the risk level as low, medium, or high. This helps prioritize actions and resources for mitigating the identified risks.
  5. Mitigate risks: Develop and implement appropriate measures to mitigate the identified risks. This may involve actions such as recalibrating the equipment, replacing faulty components, implementing additional quality checks, adjusting process parameters, conducting additional inspections, or using alternative equipment. The specific mitigation measures will depend on the assessed risk level and the potential consequences.
  6. Monitor and review: Continuously monitor the effectiveness of the mitigation measures and regularly review the risk assessment. If necessary, adjust the mitigation actions or reassess the risk levels based on new information or changes in the operating conditions.
  7. Document and communicate: Document the risk assessment process, including the identified risks, their severity and likelihood classifications, and the implemented mitigation measures. Communicate the findings and actions to relevant stakeholders, including management, quality assurance personnel, and operators, to ensure awareness and compliance with the mitigation measures.

By conducting a thorough risk assessment, organizations can better understand the potential impact of an out-of-calibration condition and take appropriate measures to mitigate the associated risks. This helps maintain product quality, safety, and compliance while minimizing potential adverse effects on customer satisfaction and business operations.

4) Records previous measurement results obtained with this piece of test equipment, last calibration date and the next due dates;

When a piece of inspection, measurement, and test equipment is found to be out of calibration or defective, it is essential to retain documented information on the validity of previous measurement results obtained with that equipment. This documentation helps ensure traceability and provides information for decision-making regarding the impacted measurements. Here are the key details that should be retained:

  1. Equipment identification: Clearly identify the specific piece of equipment that was found to be out of calibration or defective. Include details such as the equipment’s unique identifier, model number, and any other relevant information for proper identification.
  2. Previous measurement results: Document the previous measurement results obtained using the equipment. Include information such as the date of the measurement, the specific measurement performed, and the recorded value. This information helps establish a record of the historical data obtained with the equipment.
  3. Calibration status: Note the calibration status of the equipment at the time of the previous measurements. Document the last calibration date and the associated calibration certificate or report. This provides information on the calibration state of the equipment during the previous measurement activities.
  4. Next due date: Record the next due date for calibration on the calibration report or certificate. This information helps schedule and plan future calibration activities for the equipment.

By retaining this documented information, organizations can:

  • Assess the impact: Determine the impact of the out-of-calibration or defective condition on the validity of the previous measurement results. This helps understand the potential inaccuracies or uncertainties associated with the affected measurements.
  • Take corrective actions: Use the documented information to decide on appropriate corrective actions. This may involve recalibration, repair, replacement, or any other necessary steps to address the out-of-calibration or defective condition.
  • Plan future calibration activities: By noting the next due date for calibration, organizations can schedule and plan the timely calibration of the equipment to ensure its continued accuracy and reliability.
  • Maintain traceability: The retained documentation enables traceability and provides an audit trail for the equipment’s calibration history and measurement results. This supports compliance with quality standards and regulatory requirements.

It is important to establish clear procedures for documenting and retaining this information, ensuring its accessibility and confidentiality as needed.

5) Notification to the customer if suspect product or material has been shipped

If a suspect product or material has been shipped to a customer, it is crucial to promptly notify the customer about the situation. Open and transparent communication helps maintain trust and enables the customer to take appropriate actions. Here’s a general guideline on how to handle the notification process:

  1. Gather information: Gather all relevant details about the suspect product or material, including its identification, batch or lot number, production or shipment dates, and any specific concerns or issues associated with it. This information will help provide a clear and accurate description of the situation to the customer.
  2. Assess the risk: Evaluate the potential risk or impact of the suspect product or material on the customer. Consider factors such as safety concerns, compliance with specifications or regulations, and any potential effects on the customer’s operations or end products. This assessment will guide the content and urgency of the notification.
  3. Prepare the notification: Craft a clear, concise, and factual notification message. Include the essential information such as the reason for the notification, a description of the suspect product or material, any known risks or concerns, and the actions being taken to address the issue. Provide contact information for further inquiries or assistance.
  4. Determine the communication method: Decide on the most appropriate method of communication based on the urgency and significance of the situation. Depending on the customer relationship, consider options such as phone calls, email notifications, written letters, or a combination of these channels. Choose a method that ensures timely and effective communication.
  5. Notify the customer: Contact the customer or send the notification message using the chosen communication method. Be proactive and ensure that the message reaches the appropriate person or department within the customer’s organization. Provide the necessary information to facilitate their understanding of the situation and enable them to take appropriate actions on their end.
  6. Offer support and solutions: Express a willingness to assist the customer in managing the situation. Offer support, provide guidance on potential next steps, and outline any corrective measures or remedial actions being implemented. Demonstrate a commitment to addressing the issue and minimizing any negative impact on the customer.
  7. Document the notification: Maintain a record of the notification sent, including the date, recipient, method of communication, and the content of the message. This documentation ensures that the communication process is properly documented for future reference or audits.
  8. Follow-up and resolution: Stay in regular communication with the customer to provide updates on the progress of investigations, corrective actions, or any further information that may arise. Work closely with the customer to resolve the issue to their satisfaction and ensure the necessary steps are taken to prevent similar incidents in the future.

Remember, it is important to adhere to any applicable legal or contractual requirements regarding customer notifications, such as specific time frames or obligations outlined in agreements or regulations.

6) Statements of conformity to specification after calibration/verification

fter calibration or verification of monitoring and measuring equipment, statements of conformity to specification can be issued to indicate that the equipment meets the specified requirements. These statements provide assurance that the equipment is accurate and reliable for use in measuring or monitoring processes. Here are some key points to include in statements of conformity:

  1. Equipment identification: Clearly identify the specific equipment for which the statement of conformity is being issued. Include details such as the equipment’s unique identifier, model number, and any other relevant information for proper identification.
  2. Calibration/verification information: State that the equipment has undergone calibration or verification activities, specifying the methods and standards used. Include the date of calibration or verification and reference the corresponding calibration certificate or verification report.
  3. Specification reference: Refer to the applicable specification, standard, or requirements against which the equipment was calibrated or verified. This may include industry standards, customer-specific requirements, or regulatory standards.
  4. Conformity statement: Declare that the equipment, after calibration or verification, conforms to the specified requirements. This statement signifies that the equipment is accurate, reliable, and capable of providing measurements within the specified tolerances.
  5. Measurement range: Specify the measurement range within which the equipment has been calibrated or verified. This ensures that users understand the valid range of measurements for which the equipment’s accuracy has been confirmed.
  6. Validity period: Indicate the period of validity for the statement of conformity. This refers to the duration for which the calibration or verification is considered valid. It is typically based on the recommended calibration interval or the specific requirements of the application.
  7. Authorized signature and contact information: Include the name, position, and signature of the authorized person issuing the statement of conformity. Provide contact information for further inquiries or requests related to the equipment’s calibration or verification.
  8. Additional details (optional): Include any additional relevant information, such as any limitations or restrictions on the use of the equipment, special handling requirements, or any specific conditions under which the statement of conformity is applicable.

It is important to ensure that the statements of conformity are accurate, complete, and in compliance with any applicable regulations, standards, or customer requirements. Proper documentation and record-keeping of these statements support traceability and demonstrate compliance with quality assurance practices.

7) Verification that the software version used for product and process control is as specified

To verify that the software version used for product and process control is as specified, organizations can follow these steps:

  1. Document software specifications: Clearly define and document the required software version(s) for product and process control. This includes identifying the specific software version number, any associated modules or components, and any other relevant details.
  2. Configuration management: Implement a robust configuration management process to track and control software versions used in the organization. This process should include procedures for identifying, acquiring, installing, and validating software versions.
  3. Software version tracking: Maintain a comprehensive record of the software versions used for product and process control. This can be done through a configuration management system or a designated document that lists the approved software versions and their corresponding specifications.
  4. Regular audits: Conduct periodic audits to verify that the software versions in use align with the specified requirements. Compare the software versions being used against the documented specifications to ensure compliance.
  5. Documentation review: Review relevant documentation, such as configuration records, system logs, or installation records, to confirm that the documented software versions are being consistently used in product and process control.
  6. Testing and validation: Perform testing and validation activities to verify that the specified software versions are functioning correctly and meet the intended purpose. This can involve conducting functional testing, performance testing, or other appropriate methods to ensure the software is working as expected.
  7. Change management process: Implement a robust change management process for software updates. Any changes to the software version used for product and process control should go through a controlled process, including evaluation, testing, and approval, to ensure the changes align with the specified requirements.
  8. Documentation and records: Maintain proper documentation and records of the software versions used for product and process control. This includes maintaining records of software installations, updates, validations, and any associated validation or verification results.

By following these steps, organizations can effectively verify that the software version used for product and process control aligns with the specified requirements. This helps ensure consistency, accuracy, and compliance in software usage, contributing to overall product quality and process efficiency.

8) Records of the calibration and maintenance activities for all gauging

Maintaining records of calibration and maintenance activities for all gauging equipment, including employee-owned equipment, customer-owned equipment, and on-site supplier-owned equipment, is crucial for ensuring traceability, compliance, and effective equipment management. Here are the key aspects to consider when documenting these activities:

  1. Equipment identification: Clearly identify each piece of gauging equipment involved, including its unique identifier, model number, and any other relevant information for accurate identification.
  2. Calibration and maintenance schedule: Establish a calibration and maintenance schedule for each piece of gauging equipment based on regulatory requirements, industry standards, and internal policies. This schedule should outline the frequency of calibration and maintenance activities.
  3. Calibration certificates and reports: Retain copies of calibration certificates and reports for all gauging equipment. These documents should include details such as the date of calibration, equipment condition before and after calibration, calibration standards used, calibration results, and any adjustments made during calibration.
  4. Maintenance records: Document all maintenance activities performed on the gauging equipment. This includes preventive maintenance, corrective maintenance, repairs, and adjustments made to ensure the equipment’s optimal performance. Record the date, nature of maintenance performed, parts replaced, and personnel involved.
  5. Calibration and maintenance logs: Maintain a centralized log or database to record all calibration and maintenance activities. This log should include information such as equipment identification, date of calibration/maintenance, the purpose of the activity, personnel responsible, and any relevant notes or observations.
  6. Employee-owned equipment: If employees use their own gauging equipment, establish procedures for documenting calibration and maintenance activities. Ensure that employees provide calibration certificates or maintenance records for their equipment, and retain these records as part of the overall equipment documentation.
  7. Customer-owned equipment: If the organization is responsible for calibrating or maintaining customer-owned gauging equipment, maintain separate records for each customer’s equipment. Document calibration and maintenance activities performed on customer-owned equipment, including any communication or approvals obtained from the customer.
  8. Supplier-owned equipment: If suppliers provide gauging equipment for on-site use, establish procedures for documenting calibration and maintenance activities for this equipment. Obtain and retain calibration certificates or maintenance records provided by the supplier.
  9. Record retention: Ensure that all calibration and maintenance records are securely stored and retained for the required period. This duration may be determined by regulatory requirements, industry standards, or organizational policies.
  10. Compliance audits: Regularly conduct internal audits to review the calibration and maintenance records for all gauging equipment. This helps ensure compliance with established procedures and provides an opportunity to identify any deviations or non-conformists.

By diligently documenting calibration and maintenance activities for all gauging equipment, organizations can ensure proper equipment management, compliance with standards, and traceability of measurement results.

9) Production-related software verification used for product and process control

Production-related software verification plays a critical role in ensuring the effectiveness and reliability of software used for product and process control. Here are the key considerations for verifying production-related software:

  1. Requirements verification: Verify that the production-related software meets the specified requirements. This involves ensuring that the software functionalities, features, and performance characteristics align with the intended use and organizational needs. Conduct a thorough review and analysis of the software requirements documentation to ensure completeness and accuracy.
  2. Functional testing: Perform functional testing to verify that the software functions as intended. This involves executing test cases or scenarios that validate the software’s functionalities and ensure it behaves correctly under different conditions. The testing should cover all critical aspects of the software’s operation and use.
  3. Performance testing: Conduct performance testing to assess the software’s performance under expected usage scenarios. This includes measuring response times, throughput, system scalability, and resource utilization to ensure the software can handle the expected workload efficiently.
  4. Integration testing: Verify the software’s compatibility and proper integration with other systems, modules, or components that it interacts with. This testing ensures smooth data exchange, functionality, and communication between different software components or systems.
  5. Data integrity and security: Verify the software’s ability to maintain data integrity and security. This includes validating data input and output, encryption mechanisms, access controls, and compliance with data protection regulations. Perform vulnerability assessments and penetration testing to identify and address potential security risks.
  6. User acceptance testing: Involve end-users and stakeholders in user acceptance testing to verify that the software meets their requirements and expectations. Gather feedback and insights from users to identify any usability issues, user interface concerns, or functional gaps that need to be addressed.
  7. Version control and change management: Implement robust version control and change management practices to ensure proper identification, tracking, and documentation of software versions and changes. This includes establishing procedures for software updates, maintaining a change log, and validating the impact of changes on product and process control.
  8. Documentation and records: Document all verification activities, including test plans, test results, issues identified, and any corrective actions taken. Maintain proper records to demonstrate compliance with verification processes and provide an audit trail for future reference.
  9. Compliance with standards and regulations: Ensure that the production-related software adheres to relevant industry standards, regulations, and quality management system requirements. This includes validating compliance with applicable standards such as ISO 9001, IATF 16949, or specific industry-specific standards.
  10. Ongoing monitoring and validation: Continuously monitor the performance of the production-related software and conduct periodic reviews and validations to ensure it remains effective, reliable, and aligned with changing requirements.

By following these steps, organizations can effectively verify production-related software used for product and process control, ensuring its reliability, functionality, and compliance with requirements.

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