Can somone walk me through the IQ/OQ/PQ process for a new injection molding mold?

[ricks5550]

Do you really need to do an IQ for this?

What if the parts have inserts that are fairly spendy? Seems like a lot of potential wasted dollars in setting up your process.

 

[NikkiQSM]

Hey there,

Here is a portion of our procedure which defines our process for IQ/OQ/PQ for when we have to move an Extrusion line. Maybe it can help?

[FONT=&quot]105.8.1[/FONT] [FONT=&quot]The objective of the IQ/OQ/PQ is to ensure that if a compounding line is moved, customer’s products can be made meeting the quality standards set by the company, as well as meeting customer’s product specifications. Customers will be alerted of the move 6 months prior or as specified by the customer.[/FONT]

In the event an extruder must be moved to another area, or building. The following will be conducted:

• Pre-IQ:
  • Verify that temperatures of each heating block are within calibration – and record the result.
  • Verify feeders are calibrated, and verify the through-put of the feeders.
  • Check the RPM of the extruder screws and side-stuffer screws – record result.
  • Ensure that the Dynisco and Melt Temp probe are working.
  • Ensure that the vacuum is at more than 12 inches of mercury.
• Operational Qualification Baseline
  • A compound has been selected to confirm the compounding results from “before” and “after” the move.
  • Half of the material was made before the move and the other half after.
• Installation Qualification:
  • Once the equipment has been moved, the equipment is re-tested in the same manner as the Pre-IQ. The test equipment is identical to the Pre-IQ results.
• Performance Qualification:
  • A product lot will be manufactured for the performance qualification. Quality checks will occur at the beginning, middle and end of processing. The process outputs including torque, melt temperature, die pressure, pellet size, and pellet quality will be measured, monitored and recorded. All product produced must meet customer specifications as well as all other internal requirements as established.

105.8.2 When the IQ / OQ / PQ is completed, a report will be generated with all the data collected. The Maintenance Manager and GM will decide if the move was successful or not.

105.8.3 The report will be passed onto customers to show that the product will not be affected due to the extrusion line being moved.

NOTE: IQ / OQ / PQ will also determine if the computer software is working correctly as well.

 

[Vthouta]

This is really needed to be executed when you move the line from one location to another location to justify that all process controls are working as expected.

IQ, OQ,PQ - is a document that supports and justifies what has been done when ever there is a transfer/move of equipment, either when a new equipment is introduced to the manufacturing line.

 

[kuyakut]

Do you really need to do an IQ for this?

What if the parts have inserts that are fairly spendy? Seems like a lot of potential wasted dollars in setting up your process.

Option # 1 Reduce the no of sample and the # of hours run at OQ and PQ.
Option # 2 Run parts in OQ with out inserts and only in PQ with inserts.
But you need to discuss it with your customer.