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In Element 4.9.HV.1 it state that each time a significant change is made in the established operation (eg. A new operator, new machine, or new technique) a critical examination shall be made on the first units processed after the change.
We are in PCB assembly manufacturing. Our team members were deliberating over what is meant by ‘significant changes’. We were further confuse by the example given above such as new operator. Someone say that when there is a change in shift (‘new’ operator) the first unit processed has to be examined. Others argue that it should not be the case unless there is a product or model change. In a situation when there is a model change where 95% of the piece part/process are similar and only 5% are different would that consider a significant change? What is the right interpretation for ‘significant changes’?
Pls. advised.

We are in PCB assembly manufacturing. Our team members were deliberating over what is meant by ‘significant changes’. We were further confuse by the example given above such as new operator. Someone say that when there is a change in shift (‘new’ operator) the first unit processed has to be examined. Others argue that it should not be the case unless there is a product or model change. In a situation when there is a model change where 95% of the piece part/process are similar and only 5% are different would that consider a significant change? What is the right interpretation for ‘significant changes’?
Pls. advised.