IATF 16949:2016 Clause 8.5.6.1 Control of changes

This clause requires the organization to implement a process for responding to unplanned changes that are considered essential in order to ensure that products or services continue to meet their specified requirements, in such a way that conformity with requirements is maintained.Changes should be documented and information retained about the changes, including who authorized the change and the actions arising from the change. Change control is defined as ‘activities for the control of the output after formal approval of its product configuration information’. The clause requires an organization to make changes in a thoughtful manner and to consider the potential impact to other process, products and possibly the customer. Key items to consider are:

  1. Is the impact of the change evaluated to determine its affects to work in process or products already delivered?
  2. What process control documentation (procedures, travellers, forms, etc.) will need updating as the result of change to be implemented?
  3. Was the change approved prior to implementation including, where applicable, approval by the customer, statutory or regulatory authority?
  4. Does retained documented information indicate the source of change and information on necessary actions and approvals?

Change control is a very important part of the product realization process. It applies to any change in product realization and includes product and manufacturing process changes. Uncontrolled changes lead to both customer and internal quality problems. The defined process must include authority for change and consistency of implementation and communication. For effective change control, follow the applicable requirements of the APQP methodology for assessing, verifying and validating product realization changes before implementing. Comply with any customer requirements for notification and approval of changes. Your change control process must include – responsibility; evaluation; verification and validation; frequency; timing; method; communication; training; documentation; update of affected activities and documents; implementation; use of multi-disciplinary approach; checklists; etc., for product realization changes. Changes may arise from customer complaints; feedback from the field; new technology; supplier and material changes; internal or customer driven changes; process improvements; SPC data; etc. Product realization changes may affect several linked activities and documents. . These cover customer engineering specifications; FMEA’s (design and process); Control Plans; design record; inspection instructions; machine process parameters; material specifications; measuring equipment; part approval requirements; technical drawings; and work instructions.

In addition to the requirements given in ISO 9001:2015 clause 8.6.1 Control of change, Clause 8.6.1.1 requires that organization must have a documented process to control and react to changes that impact product realization. The effects of any change, including those changes caused by the organization, the customer, or any supplier, shall be assessed.   The organization shall define verification and validation activities to ensure compliance with customer requirements; validate changes before implementation; document the evidence of related risk analysis; retain records of verification and validation. Changes, including those made at suppliers, should require a production trial run for verification of changes (such as changes to part design, manufacturing location, or manufacturing process) to validate the impact of any changes on the manufacturing process.   When required by the customer, the organization will notify the customer of any planned product realization changes after the most recent product approval and obtain documented approval, prior to implementation of the change. It must complete additional verification or identification requirements, such as production trial run and new product validation

Please click here for ISO 9001:2015 clause 8.6.1 Control of change

Having a documented process to control and react to changes that impact product realization is a critical aspect of effective quality management systems in various industries, including the automotive sector. This process ensures that any changes, regardless of their source, are thoroughly evaluated, managed, and implemented to prevent negative impacts on product quality, customer satisfaction, and overall business performance. Here are the key components of such a process:

  1. Change Identification: Establish a system to identify and document all potential changes that could impact product realization. This includes changes initiated by the organization, the customer, or any suppliers involved in the supply chain.
  2. Change Impact Assessment: Conduct a comprehensive impact assessment for each identified change. Evaluate the potential effects on product quality, safety, compliance with requirements, and customer satisfaction. Consider the risks and opportunities associated with the proposed change.
  3. Risk Analysis: Perform a risk analysis to identify and assess potential risks associated with the proposed changes. Prioritize and address high-risk changes more effectively to prevent undesirable consequences.
  4. Change Authorization: Obtain appropriate authorization and approvals from relevant stakeholders, including management, engineering, quality, and other relevant departments, before implementing changes.
  5. Validation and Testing: When necessary, conduct validation or testing of the proposed changes in a controlled environment before full implementation. This helps ensure that any adverse effects are identified and addressed before reaching customers.
  6. Document Control: Maintain accurate and up-to-date documentation of all approved changes, including the reasons for the change, the scope, and the results of impact assessments and risk analyses.
  7. Communication: Establish effective communication channels to inform all relevant stakeholders about the approved changes, their implications, and the implementation timeline.
  8. Training: Provide necessary training to employees involved in implementing the changes. Ensure that they understand the reasons for the change, its implications, and the proper procedures for implementation.
  9. Monitoring and Measurement: Monitor the implementation of changes and measure their effectiveness in achieving the desired outcomes. This includes ongoing evaluation of product quality, customer feedback, and compliance with relevant standards.
  10. Continuous Improvement: Encourage feedback from employees and customers regarding the impact of changes on product realization. Use this feedback to drive continuous improvement in the change management process.
  11. Defining Verification and Validation Activities: The organization must establish clear and well-defined verification and validation activities to ensure compliance with customer requirements. Verification involves checking that processes, products, or services meet specified requirements, while validation ensures that the final output meets the intended use or application.
  12. Validating Changes before Implementation: Before implementing any changes to processes, products, or services, the organization must validate these changes. This involves assessing the impact of changes on product quality, safety, performance, and customer requirements. Changes should be thoroughly evaluated and tested in a controlled environment to ensure that they do not adversely affect the desired outcomes.
  13. Documenting Evidence of Related Risk Analysis: When performing validation activities, the organization must document the evidence of related risk analysis. This means conducting a comprehensive risk assessment to identify potential risks associated with the changes and implementing appropriate risk mitigation strategies. The documented evidence ensures that risks have been adequately considered and addressed.
  14. Retention of Records of Verification and Validation: The organization must maintain records of all verification and validation activities. These records serve as evidence that the processes, products, or services have been verified and validated to meet customer requirements and comply with relevant standards. The retention of records is crucial for audits, reviews, and continuous improvement efforts.

By having a well-defined process to control and react to changes impacting product realization, organizations in the automotive industry can ensure that changes are managed effectively and lead to positive outcomes. This systematic approach minimizes risks, maintains product quality, and fosters a culture of continuous improvement in the organization’s processes.

Production trial run for verification of changes

Conducting a production trial run is an essential step in verifying changes, especially those made at suppliers, in the automotive industry. This practice helps ensure that changes, such as part design modifications, changes in manufacturing locations, or alterations to the manufacturing process, do not adversely affect the manufacturing process, product quality, or customer requirements. Here’s why a production trial run is crucial:

  1. Risk Mitigation: A production trial run allows the organization to identify and mitigate potential risks associated with the proposed changes. It provides an opportunity to address any unforeseen issues or challenges before full-scale implementation, reducing the risk of disruptions or non-conformances.
  2. Process Validation: The trial run validates the changes’ impact on the manufacturing process and helps ensure that the process remains stable, efficient, and capable of producing products that meet the required specifications.
  3. Product Quality Assurance: Verifying changes through a trial run ensures that the modified parts or products meet the intended quality standards and do not compromise product performance, safety, or reliability.
  4. Customer Requirements Compliance: The trial run allows the organization to validate that the changes align with customer requirements and expectations. Ensuring compliance with customer specifications helps maintain customer satisfaction.
  5. Supply Chain Integration: In cases where changes are made by suppliers, a production trial run helps integrate the supplier’s modifications into the overall manufacturing process smoothly and efficiently.
  6. Cost and Time Optimization: Identifying and resolving issues during the trial run phase is more cost-effective and time-efficient than dealing with problems after full-scale implementation.
  7. Continuous Improvement: The insights gained from the trial run contribute to the organization’s continuous improvement efforts. Lessons learned can be used to enhance processes, reduce waste, and optimize overall production efficiency.
  8. Data Gathering and Analysis: The trial run provides valuable data for analyzing the effects of the changes on various aspects of the manufacturing process, allowing for evidence-based decision-making.

By requiring a production trial run for verification of changes, organizations in the automotive industry can proactively manage the impact of modifications and maintain process stability and product quality. This systematic approach ensures that any changes made, whether in-house or by suppliers, are thoroughly validated and contribute to the organization’s overall quality and performance objectives.

Notifying the customer

the organization is obligated to inform the customer of any planned changes in product realization after obtaining the most recent product approval. Additionally, the organization must obtain documented approval from the customer before implementing the proposed changes. This requirement ensures that customers are kept informed about any modifications that might affect the product and that their consent is obtained before moving forward. Here are the key elements of this process:

  1. Notifying the Customer: The organization must communicate with the customer about any planned changes in product realization. This notification should include the nature and scope of the proposed changes, as well as the reason for the change.
  2. Obtaining Documented Approval: After notifying the customer, the organization must obtain documented approval from the customer before implementing the proposed changes. This approval provides formal consent from the customer and serves as evidence that the customer is aware of and agrees to the changes.
  3. Verification and Validation Requirements: Depending on the nature and scope of the proposed changes, additional verification or validation requirements may be necessary. For significant changes, such as changes to part design, manufacturing location, or manufacturing process, a production trial run and new product validation may be required.
  4. Production Trial Run: A production trial run involves producing a limited quantity of the modified product or using the new process in a controlled environment to verify its effectiveness and identify any issues that need to be addressed before full implementation.
  5. New Product Validation: If the changes involve the introduction of a new product, a formal validation process may be necessary to ensure that the new product meets all specified requirements and customer expectations.
  6. Continuous Improvement: The insights gained from the verification and validation activities, including the production trial run and new product validation, contribute to the organization’s continuous improvement efforts.

By following this process, the organization ensures that changes in product realization are communicated to the customer, customer approval is obtained, and any potential risks associated with the changes are addressed before full implementation. This approach helps maintain customer satisfaction, product quality, and compliance with customer requirements and relevant standards.

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