ISO 9001:2015 - 8.5.2 Identification and Traceability

Mike S.

An Early 'Cover'
Trusted
#11
Does anyone have a similar process? How do you create compliance to the requirement mentioned in the initial statement?
Most manufacturers I am familiar with either mark the parts somehow or use a uniquely identified router tied to the parts to verify inspection status. You have said that doesn't work for you.

Any method you use assumes the process is working or is going to work as intended. If for some reason you suspect that certain steps won't be completed on certain parts as intended, you have a different problem.
 

DanteCaspian

Quite Involved in Discussions
#12
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?


Our solutions in our facility were this:
All boards or panels are serial numbered at time of kitting. No exceptions.
We built and SPC systems (over the last three years) to gather the defect data/event and its location. While we do use red or yellow arrow stickers to assist in the rework process (visual indicators), the data is captured in software by scanning the barcode and recording the issue with a couple of mouse clicks. Like you, our AOI was no good for the data. It has the data, but extracting it to be useful was not feasible.
Prior, it was with cards, tags and paperwork-- all of which were costly and introduced a number of ESD concerns.
How it is now, is the most streamlined way can capture data, ensure information is transfer properly and deal with all of the nuances of traceability for the purposes of continuous improvement.
From the metrics we are getting, we are now able to target frequent or more costly issues so as to engineer the defects out entirely. And the symptoms of, such as stickers, scans, clicks, labour and parts to repair.
Our motivation was not to satisfy ISO 9001: 2015 8.5.2, but to reduce/eliminate defects. In regards to that standard, we (prior to what we have now) we were satisfying the standard as the records at AOI were not deemed part of needed traceability by our customers or us. We changed the intentions, and now they are absolutely essential.
Without serializing all boards, I don't know how you would do this. Perhaps in lot numbers. Where a rack or tray of boards would have a particular lot #. Though, you then would be forced to keep a lot together. So if you had one PCB deficiency flagged for rework, then all the boards in the tray/rack would be held captive.
A common element of PCB assembly is the 'acceptance of rework' as part of the process.... I encourage you to be challenged on the elimination of such wastes rather than the common management of them. It may require more capital investment and challenging the industry norms, however.
 
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#13
Thank you very much for the plentiful help it is highly appreciated.

Conclusion:

We will not place general witness markings on our 100 pcs. arrays. The absence will indicate a passed condition. Here is the wording:

“When individual boards are not required to be initialed, a label or permanent marking is placed on defect/suspected assemblies to indicate a failed output. The absence of such a label or marking indicates a passed test. “
 

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