IATF 16949:2016 is an international standard for quality in the automotive sector, jointly developed by IATF (International Automotive Task Force) and ISO (International Organisation for Standardisation). It complements the requirements of ISO 9001:2015 and adds specific requirements for the automotive sector.

What the standard requires

Requirement 8.5.6.1.1 deals with 'Change Control'. This requirement focuses on the need to control and document changes to production and service processes, products and components. This is what the standard calls for:

1. Ensure that changes, including temporary changes, are identified, documented, reviewed and approved prior to their implementation.

2. Clearly identify the expected duration of the temporary change.

3. Identify and maintain a list of changes, including data and reasons for the changes.

4. Assess the impact of changes on the products and processes involved.

5. Ensure that the changes made do not adversely affect the conformity of products and processes with customer requirements and applicable regulations.

6. Ensure that changes are communicated to all relevant stakeholders.

In summary, the standard requires the organisation to have a structured process for identifying, documenting, reviewing, approving and communicating changes to production and service processes, as well as products and components, to ensure that changes do not adversely affect product quality and conformity.

Some practical examples

Let's imagine an Italian company that produces truck refrigerators and wants to implement requirement 8.5.6.1.1 of IATF 16949:2016. Here are some practical examples on how to apply this requirement:

Example 1: Changing the insulation material

The company decides to replace the insulation material used in refrigerators to improve energy efficiency. To correctly apply requirement 8.5.6.1.1, the company must:

1. Identify and document the change, including the reasons behind the choice of the new insulation material and the revision of the technical specifications.

2. Assess the impact of this change on the product, production processes and any applicable customer or regulatory requirements.

3. Obtain approval of the change from the quality and production managers.

4. Communicate the change to all interested parties, such as insulation material suppliers, production personnel and the sales team.

Example 2: Updating the temperature control software

The company introduces a new version of the temperature control software to improve the accuracy and stability of the temperature inside the refrigerator. To apply requirement 8.5.6.1.1, the company must:

1. Identify and document the change, including the reasons for updating the software and revisions to technical specifications.

2. Assess the impact of the change on the product and the processes involved, such as production, installation and maintenance.

3. Ensure that the change is approved by the quality and production managers.

4. Plan and document the training of personnel involved in the use and maintenance of the new software.

5. Communicate the change to all interested parties, such as customers, software suppliers and production and service personnel.

Example 3: Temporary modification to cope with a component shortage

Due to a shortage of a specific component, the company decides to use an alternative component for a limited period. To comply with requirement 8.5.6.1.1, the company must:

1. Identify and document the temporary change, including the reasons for the component shortage and the selection of the alternative component.

2. Establish the expected duration of the temporary change.

3. Assess the impact of the temporary change on the product and processes involved.

4. Obtain approval of the temporary change from the quality and production managers.

5. Communicate the temporary change to all interested parties, such as component suppliers, production personnel and customers.