IQ and OQ for Electro-Discharge Machining

Candi1024

Quite Involved in Discussions
#1
Does anyone have any experience writing an IQOQ (Installation qualification/ Operational qualification) for an Electro-Discharge Machine?
 
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kuyakut

Involved In Discussions
#2
For IQ,
You should states what are your installation requirements such as Electrical - power supply - 220 or 240, does it needs air supply how many bar? Does the EDM need to be fixed on the floor and so on.
Write all those requirements and when installation is done check the EDM installation based on your written requirements.

For OQ
You have to decide what is the Minimum and Maximum of the following:
Working Voltage
Current
Pulse Time
Gap between work piece and tool and so on
You need a baseline for your surface finish. For comparison with your Min OQ run and Max OQ run
 

Candi1024

Quite Involved in Discussions
#3
How on earth do I measure these items though? Pulse time is extremely short (don't have the specs in front of me). The manual is no help. The fact that I know so little about how this equipment works doesn't help. The operator doesn't use any set process parameters, it's stated that it's run through operator experience. What kind of test equipment would be used?

The IQ is no problem.

We were thinking of just doing more of a PQ. Make a random part and measure to specs. We have a CMM for accurate measurements.

** If knowing the application helps, we create molds for medical device manufacture. The molds and/or the final product is FAI'd. (again, I would need to check into this further. I'm just assisting someone on this project and am trying to invest as little time as possible, lol)
 

Ajit Basrur

Staff member
Admin
#4
How on earth do I measure these items though? Pulse time is extremely short (don't have the specs in front of me). The manual is no help. The fact that I know so little about how this equipment works doesn't help. The operator doesn't use any set process parameters, it's stated that it's run through operator experience. What kind of test equipment would be used?

The IQ is no problem.

We were thinking of just doing more of a PQ. Make a random part and measure to specs. We have a CMM for accurate measurements.

** If knowing the application helps, we create molds for medical device manufacture. The molds and/or the final product is FAI'd. (again, I would need to check into this further. I'm just assisting someone on this project and am trying to invest as little time as possible, lol)
It depends on what your IQ / OQ procedure dictates. Typically, the EDMs fall under the "support equipment" and may not require IQ, OQ, and PQ, and they may be calibrated at pre-determined requirements. Some of the other equipment that fall in this category could be Lathes, CNC, and certain measuring instruments like calipers, gages etc.
 

kuyakut

Involved In Discussions
#5
Please do bear in mind that the electrode also has an impact on the outcome of the part. We have also a mold making facility for medical molding. As far as I can remember we only do IQ and PQ.
For PQ we only focus on the electrode , on how many times it can be use to make a certain inserts. The insert will be then measure for FAI. On the new revised company validation programme all mold making equipment were remove from the validation list.
 
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