Dear all,
thank you very much for your comments and advice.Yes, during the interview the auditor stated it clearly that soldering is a special process and should be validated as such; this particular NC - about controlling the soldering station - is part of bigger issue which we will have to address.
As for the question whether the stations maintain proper temperature - the answer is, alas - WE ARE NOT SURE. The stations are equipped with temperature indicator and the indications are within limits - but whether this indication is proper, we cannot know without calibrating these thermocouples.
In current circumstances, the soldering stations just exist, without any control - and I believe taht total lack of any control was the direct cause for NC.
Thank you for the explanation.
There are many auditors here, with many different approaches. Again, this is my opinion....
So the auditor goes to the lunchroom, and all the vending machines are empty and the cord on the microwave appears frayed. That's a complete failure on the part of management: NC. Looks like there are some chemical drums not stored like they should. Another NC. Why don't those flourescent lights have plastic protectors? Someone could get hurt. NC....
An auditor should be a person welcomed by the organization. A fresh, independent set of eyes to view their process. Hopefully they deserve parts of the process that do not conform to the stated Quality Management System or requlatory requirements. They issue a non-conformance, because something needs to be fixed.
Auditors (again, IMHO) should make observations for their client. Suggestions of areas that appear that improvement could be made and improve the process. The client can accept the observations, act or ignore them, but always be appreciative.
If the auditor cannot cite from your document system, regulatory requirement, or an industry standard that is a requirement for you, what section you are not complying with, then it is not a non-conformance, but an observation. As such, you can choose to take their good advice or not.
But now... they said "Oh big problem... NC". Yet... you legitimately have no idea what needs to be corrected, so confusion and frustration ensue. Then, typically a bunch of things are thrown into place, many that are not needed.
Again, I'm a calibration guy, so everything down to the stapler should be calibrated!
Seriously, if you're soldering iron has a temperature indicator, I would at least verify its accuracy like Andy mentioned. But in the end, you need to do the things that are required to better your process.My opinion? I would take the NC and use it to improve your process. Find out what soldering requirements you have for what you are doing. If you have some, then implement them. I would bet somewhere you have some requirements.
One of my customers wanted me to certify a heat gun. OK, "what are your requirement?" They did not know. OK, so I basically measured temperature at different distances, and wrote it up as a verification of sorts. After asking multiple times, they finally dig some digging. Guess what??:mg: They had the heat gun way way too close to the shrinking area (too big of a hurry). This led to fixing another big problem they had: the heat was damaging some of the solder joints. Now the solder joints were yet another matter (gun temperature, exposure, solder diameter, etc.)
Talk to the mfg. of the material that you are working with, the parts you solder, customers, etc. I bet there are some requirements that may not yet be realized.
Last edited:
