Validation and Qualification when moving to another Facility

S

sturey45

#1
#1
I am new to Quality Control. I have been researching Validation,Qualification etc. because we are moving facilities and I understand we need to ensure our processes/machines are not compromised in the move.

We do not have any special processes, so I feel a full on full on revalidation is not necessary. I was thinking a machien qualification would do the trick. I came up with a IQ worksheet that I feel is adequate. However, moving into OQ i don't know what to do or measure. We technically do not monitor machine peformance with control limits. We make textiles, machines run, we verify specifications etc, and look for visual defects and that is about our process. Any guidance would be greatly appreciated.

Thanks,
Stu
 
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Jen Kirley

Jen Kirley

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#2
#2
It pretty much comes down to your ability to provide the same levels of quality as before. What impacts new facilities would have, good or adverse, can be part of the new quality plan. Installation controls to ensure capability to deliver the same quality and quantity can even mean no needed machines are OOC due to damage or lost components from the move.

Will the new environment have an effect on your activities due to temperature, humidity etc? Will difference in water hardness be an issue? Does the area tend to experience power outages? Validation may include these peripheral considerations as well as the machines themselves producing the textile goods.
 
G

GTJunghoon

#3
#3
I'm currently working on a relocation project for an assembly line. Below is a summary of the requalification

IQ: Equipment is installed properly and hooked up to the utilities. No damage to equipment during relocation.

OQ: There are a range of settings for each equipment that produce an acceptable output. Verify the range.

PQ: Test the settings that'll be used during manufacturing.
 
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