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.
:confused:

Johnnybegood,

I'm confused. :confused:
There is no clause 4.9 in ISO 9001:2000.
Clause 4.9 in ISO 9001:1994 makes no mention of "significant change".

Where is this requirement coming from?

Regards,
Hank Fowler

I expect he's referring to a QS-9000 requirement, but I don't see it said there. I'm not sure what the HV.1 is coming from.

johnnybegood: We need more info.

Sorry guys. It was actually in TL9000 requirement.

I haven't seen many TL 9000 folks here. Sorry I can't help out.

I beleive that "new" operator refers to one who is new to the particular operation, not necessarly at a shift change. It may be necessary to check first off at a shift change but that would depend on the process.

4.9.HV.2 Operation Quilifactions would also be applicable to a new operator.

I've been out for vacation these last 3 weeks, notice lots! of posts so it will take time to get throught them all.

Johnny, you posted:
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.

My interpretation (what-is-right is just too arguable to claim) is: If your processes are protected to the point that a change in operators cannot affect the quality of the product being run...then there is little point in a critical examination.

To me - you should examine parts produced only when you need to do so to ensure the quality is being maintained (tooling change; product change-over (if multiple types are produced on same equipment); etc...). Your records should be taylored to identify, measure and be available to analyze what your specific needs are.

My questions would be: What do you have identified as 'critical or significant' characteristics for your parts? How do you ensure they continually meet spec? What fail-modes or defects have occured in each process? What are the turnbacks (extra handling of product or extra work done by operator to keep line running) in each process?

Based on the answers I would direct you to set up your examinations when a change occurs that has a high liklyhood (sp?) of causing/creating a quality issue. And as I stated before...your records should be set up so you can measure and analyze the occurance hazards you may deal with.