AS9100 8.5.6 – Control of Changes

Introduction

The AS9100 standard is a globally recognized quality management system (QMS) tailored for the aerospace industry. It outlines specific requirements and best practices for the design, development, production, and maintenance of aerospace products and services, ensuring the highest level of safety and reliability.

One crucial aspect of AS9100 is the control of changes (section 8.5.6), which plays a vital role in maintaining a robust QMS and ensuring the quality and safety of products and processes in the aerospace industry. The purpose of this blog is to provide professionals with up-to-date information on AS9100 8.5.6 and offer guidance on its implementation.

Understanding AS9100 8.5.6

Control of changes refers to the systematic management of all modifications made to products, processes, or the QMS itself. AS9100 8.5.6 emphasizes the need for organizations to establish appropriate controls to ensure that changes are identified, reviewed, and approved before they are implemented.

The key objectives of AS9100 8.5.6 include:

• Ensuring that changes are adequately planned and executed
• Evaluating the potential impact of changes on product quality, safety, and regulatory compliance
• Maintaining traceability and records of all changes made
• Ensuring that relevant personnel are informed, trained, and competent to carry out their responsibilities in relation to changes

Organizations must assign roles and responsibilities for controlling changes to ensure a structured and efficient approach to change management.

Steps for Implementing AS9100 8.5.6

Implementing control of changes in your organization should follow a systematic process that includes:

1. Establishing a change management process: Develop a formal process for managing changes that aligns with the requirements of AS9100 8.5.6, including clear procedures, roles, and responsibilities.
2. Identifying and documenting changes: Record any proposed changes to products, processes, or the QMS, including a clear description of the change and the rationale behind it.
3. Evaluating the potential impact of changes: Assess the potential consequences of each proposed change on product quality, safety, customer satisfaction, and regulatory compliance. This evaluation should include a risk assessment to identify and mitigate any potential negative effects.
4. Approving changes: Ensure that changes are reviewed and approved by authorized personnel before implementation. The approval process should be based on the results of the impact assessment and risk mitigation measures identified.
5. Implementing changes: Execute the approved changes according to the established plan, ensuring that all relevant personnel are informed and trained as necessary.
6. Reviewing and monitoring the effectiveness of changes: Regularly evaluate the effectiveness of implemented changes to ensure they have achieved the intended objectives and maintain compliance with AS9100 8.5.6.

Key Elements of an Effective Change Management Process

A successful change management process should incorporate the following elements:

• Clear communication of changes: Ensure that all relevant personnel are informed about proposed changes and their potential impact on their roles and responsibilities.
• Documentation and record-keeping: Maintain comprehensive records of all changes made, including details of the change, its rationale, impact assessment, approval, and implementation.
• Risk assessment and mitigation: Identify potential risks associated with proposed changes and develop strategies to minimize or eliminate these risks.
• Training and support for affected staff: Provide appropriate training and support for personnel whose roles may be affected by the change to ensure they can perform their duties competently.
• Continuous improvement: Regularly review the change management process to identify areas for improvement and implement enhancements as necessary.

Examples of Changes Requiring Control

Various types of changes may require control under AS9100 8.5.6, including:

• Design changes: Modifications to product designs, including materials, components, or specifications.
• Process changes: Changes to manufacturing, assembly, testing, or inspection processes.
• Supplier changes: Alterations to the selection or management of suppliers, including changes in materials or services provided.
• Changes in regulatory requirements: Updates or revisions to industry regulations or standards that affect the organization’s products or processes.
• Changes in customer requirements: Modifications to customer specifications, expectations, or contractual obligations.

Tips for Ensuring Compliance with AS9100 8.5.6

To maintain compliance with AS9100 8.5.6 and optimize your organization’s change management process, consider these tips:

• Regularly review and update your change management process: Periodically evaluate your change management process to identify areas for improvement and ensure alignment with the latest AS9100 requirements.
• Conduct internal audits to ensure compliance: Perform regular internal audits on your change management process to verify that it meets the requirements of AS9100 8.5.6 and effectively manages change.
• Engage with stakeholders to address concerns and gather feedback: Involve relevant personnel in the change management process by soliciting their input and addressing any concerns they may have about proposed changes.
• Stay informed on industry best practices and changes in regulations: Keep abreast of updates to AS9100 and other relevant industry standards, as well as changes in regulations that may impact your organization’s products or processes.

Conclusion

AS9100 8.5.6 emphasizes the importance of effective change management in ensuring the quality and safety of products and processes in the aerospace industry. By keeping up-to-date on the latest requirements and best practices, professionals can implement robust change management processes within their organizations, ultimately contributing to improved product quality, safety, and customer satisfaction.