IATF 16949 | Auditing 4M change control

Summary

This video showcases an IATF 16949 audit focused on managing production changes, specifically a new operator. The change is tracked using a 4M (Man, Machine, Material, Method) process, ensuring product conformity. The auditor observes the process, collects objective evidence, and ensures that all safety, equipment, and training protocols are followed. Temporary changes, like the new operator, are carefully monitored to maintain production quality. The video emphasizes the importance of auditors using observation and listening, alongside direct questioning, to ensure compliance with quality standards.

Takeaways

• 😀 The 4M change process (Man, Machine, Material, Method) is crucial for managing both temporary and permanent changes in production.
• 😀 Auditors should focus on understanding how changes are managed to ensure compliance with IATF 16949 standards, especially in the areas of personnel and machinery.
• 😀 Effective listening and observing are key skills for auditors to collect objective evidence during an audit. Asking questions is not always necessary.
• 😀 A clear process for monitoring new operators, including job observation and verification, helps ensure product conformity while training is ongoing.
• 😀 New operators may not meet production targets immediately, and it is important to monitor their progress and provide additional checks to ensure quality.
• 😀 Any non-conforming parts should be flagged with a quality alert and not removed from the line until fully checked and verified.
• 😀 In the 4M change process, it is important to document the change, including safety checks, personnel assignments, and equipment status.
• 😀 Customer-specific requirements for change notifications can vary. Typically, machine changes trigger customer notification, while changes in personnel may not.
• 😀 Effective change management involves monitoring temporary changes and ensuring that they do not compromise product quality or safety.
• 😀 Auditors should verify that all changes are managed according to the company's defined processes, as well as any relevant customer-specific requirements for change control.

Q & A

What is the primary purpose of the 4M change process in iATF 16949?

The 4M change process is used to manage temporary changes in the production process, specifically related to changes in Man, Machine, Method, or Material. This ensures that the quality of the product is maintained during the implementation of changes, such as when a new operator is introduced.

How does the auditor gather evidence during the audit process?

The auditor gathers evidence by listening, observing, and collecting objective data during the audit. The auditor does not always need to ask questions but can effectively collect evidence by following audit trails, reviewing documentation, and observing processes in action.

Why is it important for the auditor to check customer-specific requirements related to change management?

Different customers may have unique requirements for how changes, such as changes to the process or personnel, should be communicated. The auditor needs to verify that the organization is complying with these specific requirements to ensure the process remains aligned with customer expectations.

What role does the 4M change process play when a new operator is introduced?

When a new operator is introduced, the 4M change process helps manage the temporary change by ensuring the new operator's training and performance are carefully monitored. This includes checking if product conformity is maintained and if any adjustments to the process are needed.

What is the purpose of the safety aspects in the 4M change sheet?

The safety aspects in the 4M change sheet ensure that the new operator is working in a safe manner. This includes verifying that the operator has the correct personal protective equipment (PPE), that the machinery is operating safely, and that all safety protocols are followed during the process.

How does the auditor verify that the product conformity is maintained during the new operator’s training?

The auditor verifies product conformity by checking that the new operator's work is over-checked by a supervisor or key operator. This ensures that any potential issues with the product quality are identified early, especially during the operator's training period.

What is the significance of the quality alert sheet in the production process?

The quality alert sheet is used to notify other team members if there is an issue with a part during production. It ensures that no parts are removed from the line without being fully assembled, allowing for proper investigation and resolution of any issues before they affect the product quality.

What does the auditor mean by 'effective systems to manage temporary changes'?

Effective systems to manage temporary changes refer to the tools, procedures, and documentation in place to track and manage changes, such as the 4M change process. These systems help ensure that any changes do not negatively impact product quality and that any risks associated with changes are identified and mitigated.

Why is it important for the auditor to observe the operator performing the work?

Observing the operator performing the work provides the auditor with direct evidence of the operator's competency, the effectiveness of the training process, and the conformity of the product. This helps the auditor assess whether the training is successful and if the change is properly managed.

What are some of the key attributes an auditor should possess during an iATF 16949 audit?

Key attributes an auditor should possess include strong listening skills, attention to detail, the ability to observe and collect evidence without being intrusive, and an understanding of both the standards and customer-specific requirements. These qualities help ensure the audit is thorough and objective.