Step 1: Identification of Needs for Changes
The needs for changes may come internally or externally. Internal needs arise from process improvement, capacity expansion, cost reduction, risk management, etc. External needs arise from customer request, customer claims, governmental and legal requirements, etc. It should be noted that the scope of product and process changes is really broad. It’s not limited to the changes in product specification or process parameters which directly impact the product quality. It also includes changes such as new suppliers, new machines, new production line, new control limits of a process, and even new frequency for preventive maintenance. In general, any change in machine, material, measurement, method and environment should be included in the scope of the change control procedure. Regarding to the changes in man, as IATF16949 already have separate requirements in employees qualification, it can be excluded from change control procedure.
Step 2: Change Application
When the need for change is identified, an owner for the change should be assigned and the owner should submit an application of the change proposal to a Change Review Board. The Change Review Board should be a cross-functional team consisting of people from different departments.
When the owner submits the change application, he should identify the content of the change, the purpose of the change, the change level (if a company has a pre-established classification of change levels) and the proposed date of implementation. He should also indicates whether it is a temporary change, and the proposed end date of the change if the answer is “yes”. In automotive industry, customers usually require that suppliers should notify them in advance of product or process changes. In this case, the owner should indicate as well, according to customer requirements, whether the proposed change needs customer notification. Shown below is the suggested information which can be included in a change application.
Step 3: Internal Review on the Change Application
After the Change Review Board receives the application, the members should review the application. If the application is not accepted, the board can terminate the flow. If the application is accepted, it must go to Step 4 if customer notification is needed before further action.
After accepting the application and completing Step 4 if necessary, the board needs to determine whether verification is needed for the changes. If no, then the owner can just implement the change as proposed, and the process stops here. If yes, it goes to Step 5 for change verification.
Step 4: Customer Notification of the Change Proposal
If customer notification is needed according to customer requirements, the customer contact window in the company should send a change notification to the impacted customers, in the format required by the customers. Customer feedback must be received before further action. If customers approve the application, it goes back to Step 3 for internal review on the need of change verification. If customers decline the application, the process stops here.
Step 5: Change Verification
If the change needs verification before implementation, the owner should identify evaluation items and the acceptance criteria, and conduct verification accordingly to determine whether the change can achieve the desired result and cause no negative impact. The owner can consider use the following table to summarize the verification results.
After completing the verification activities, the owner submits the verification reports to the Change Review Board.
Regarding the verification needed for the change, the company or the customers may have a pre-defined list of evaluation items for each type of change. A good example is the Delta Qualification Matrix suggested by ZVEI (German Electrical and Electronic Manufacturers' Association). If such list exists, the owner can also include the evaluation items and acceptance criteria in the change application in Step 2.
Step 6: Internal Review on the Verification Report
After receiving the verification report, the Change Review Board should review the verification activities and results and decide whether the change is acceptable. If not, the change should be rejected and the process stops here. If yes and customer notification is needed, it should go to Step 7 before further action. Otherwise, the change is approved and the owner can start the change implementation (Step 8).
Step 7: Customer Notification of the Verification Report
If customer notification is needed, the verification report should be submitted to the customers after internal approval. If the customers approve the change based on the verification report, it can then be implemented internally as described in Step 8. If the customers reject the change, the process should be terminated here.
Step 8: Implementation of Changes
After the change is approved by the Change Review Board and customers if necessary, the owner can then start the change implementation. The owner should identify what documents should be updated based on the change and notify the document owners to update them accordingly. The owner should also verify the change is implemented according to the planned date. If not, it should be updated with the customers for the proposed new date. Also, the owner should further follow up the product and process after change, and see whether the change achieve the desired objective and whether any negative impact is resulted from the change.
Above, the full process of a change control is described. As some final words of this article, if customer notification is needed, it is suggested that an application should always be submitted before any verification activities. Some companies tend not to notify their customers before they have the verification results. However, if the verification is done and even the results is good, the customers still may reject the change for some other concern. In such case, the verification done is just a waste of resource.
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