Is our method of Traceability sufficient?

[CATERAF]

Hi,

I'm trying to look at the identification and traceability throughout the product realisation process for my business. I'm finding it suprisingly challenging though!

We don't have any simple processes and everyone in the company wears a million hats so trying to differentiate what they do is tricky.

The problem though, is that for hardware (manufacturing) i can't work out if they trace the product enough.

I remember reading in the clause that if you can't test your product until the end, then you need a way to keep track of the product through it's development so if something goes wrong you can go back and look at it. (Not sure where the clause is - i've been hunting for it but have yet to see it again!).

For our manufacturing, they first have part numbers for every part. There is also a number for the whole part they're building. Let's call it the serial number for ease of distinction. This serial number has .00 on the end which signifies it's a draft and is in the process of being made. This then changed to .01 when it is complete and validated.
Throughout this whole process though, they only way they track what is happening is at weekly meetings where they keep minutes and a gantt chart.
Is this sufficient to trace the changes of the product? I don't feel like it is based on the clause that you need to know what has been changed at each step? Maybe it is sufficient though? No idea!

If I look at software design, they keep a lot of records of changes and what has been fixed when so that's why I'm questioning hardware.

Hopefully that made sense! If anyone could shed some light on it, that would be extremely helpful!!

Thanks

Does anybody have any idea?

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

[Ninja]

In Reply to Parent Post by CATERAF

The problem though, is that for hardware (manufacturing) i can't work out if they trace the product enough.

For our manufacturing, they first have part numbers for every part. There is also a number for the whole part they're building. Let's call it the serial number for ease of distinction. This serial number has .00 on the end which signifies it's a draft and is in the process of being made. This then changed to .01 when it is complete and validated.

A question if I may.

Is there ever a change to the part, or any subsection of the part, that:
1. Does NOT change the suffix to .01 and
2. has no record in any of the minutes?

Asking the same question a different way:
Can it happen that design or fab decisions are made with no record of that decision and no change to the serial number? (ie. no traceability)

A different set of questions: Is the current process meeting the needs of the company? Would a different way of record keeping make the design or fab process more cost efficient by reducing the time spent looking for the documentation?