ISO 9001:2015 - 8.5.2 Identification and Traceability

[Stefan Mundt]

We are a small organization specialized in Printed Circuit Board assembly.
In between production processes, the boards go through various inspection steps.

The ISO 9001:2015 standard requires in section 8.5.2 that: "The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision."

One such inspection step is an automated optical inspection (AOI). Any solder defects are displayed on a screen. The operator places a handwritten witness mark on the board to indicate a passed test. Electronic records are not created due to the fact that the machinery is too old and some of the boards are not serialized.

The difficulty is, that some of our boards are sent through such inspection steps in e.g. 100 pcs. arrays with no space on the boards to place a witness mark. The inspection takes sometimes only one minute. It was suggested to place a color code on the rim of the individual boards, which would take way more time to complete and is a non added value.

Here is my question:

The above described arrays come with a frame to hold everything together during the initial production steps. Is it possible to place a witness mark on this frame? However, the frame would be lost when the array is broken apart. Our travelers/move-tags get thrown away as well. New move tags are created for consecutive work steps because previous sub level lots are broken down into smaller quantities which are processed individually. the information if a test was complete would not be available "throughout production and service provision"

Is this still possible? Any suggestions?

 

[AndyN]

To try and answer you, you missed another quote from the standard - the one before...

 

[Mike S.]

What if you kept the first traveler (for the 100 pieces) even if only electronically, and added the first traveler's identification number to the second and subsequent travelers when the 100 piece lot was broken up into smaller sublots?

 

[Stefan Mundt]

What if you kept the first traveler (for the 100 pieces) even if only electronically, and added the first traveler's identification number to the second and subsequent travelers when the 100 piece lot was broken up into smaller sublots?

Sadly there are too many consecutive stations involved including further test steps (e.g. flying-probe, ICT, AQL etc. ) and we are not confident that everyone in the process would do the handshake correctly. Our travelers do not have a unique ID#.

Could we, for example, mark only "failed" or "to be repaired" units instead. Any non-existing marking would indicate a passed test? But how would we distinguish between consecutive test steps? The final AQL inspection would not have any means to indicate if a certain board/lot passed test step A, B, C and D. ???

 

[Eredhel]

Without a requirement for incremental part numbering that's not possible anyway. Is there a section in the standard that makes you think you need to do that?

 

[Stefan Mundt]

numbering that's not possible anyway

Without a requirement for incremental part numbering that's not possible anyway. Is there a section in the standard that makes you think you need to do that?

Hi Eredhel, could you please explain in more depth what you mean? To which of the previous statements are you referring to?
Thank you very much. Your contribution is highly appreciated!

 

[Mike S.]

I don't know your process, but I assume you need to know which boards conform and which don't after some inspection step. If "bad" boards are identified in some way (say, a color-coded marking that can later be removed if rework is done) then IMO it is reasonable to say unmarked boards are "good" and ready for further processing.

 

[Eredhel]

I think you have defined needs that are more specific than the standard requires, but I wouldn't swear to it without understanding your process better. I'll be curious to see if Mike's suggestion is close to what you're trying to do.

 

[Stefan Mundt]

Does anyone have a similar process? How do you create compliance to the requirement mentioned in the initial statement?

It rather seems to me that I need a record for every single board/product, since in our facility initial lots are broken down. some parts may go into differed end-products than others, and are processed at different times. My earlier statement about marking only failed boards was me brainstorming. I guess the earlier statement would only work in in a perfect world. If you can assure that every single process is not missed and that operators wont make any mistakes.

Once you suspect that a certain test step was not completed due to a human error the whole thing falls apart, since you need a positive confirmation as verification.

Any thoughts?

 

[Sidney Vianna]

Could we, for example, mark only "failed" or "to be repaired" units instead.

Of course. Only flagged boards that failed inspection would have some sort of temporary marking.

Any non-existing marking would indicate a passed test? But how would we distinguish between consecutive test steps?

The physical location along the process would be an indication that the boards have passed the previous checks. By actually reaching the different stages on the line without being flagged as nonconforming, it is the indication of the board conformity status.