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Basic questions about Installation, Operational & Performance Qualification - PCBA

H

hbfy0127

#1
#1
hello, everybody
Now I am generating the IQ-OQ-PQ for our new client. Actually, i am not familiar with it. Could anyone show me any suggestion, or give me any template? thanks in advance!
:agree:

yours
Jeff
 
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Ajit Basrur

Ajit Basrur

Staff member
Admin
#3
#3
Re: IQ-OQ-PQ generation

hbfy0127 said:
hello, everybody
Now I am generating the IQ-OQ-PQ for our new client. Actually, i am not familiar with it. Could anyone show me any suggestion, or give me any template? thanks in advance!
:agree:

yours
Jeff
Click to expand...
Welcome to the Cove Jeff :bigwave:

There is lot of info on Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) in the cove. I used the search function to get the posts - see HERE
 
H

hbfy0127

#4
#4
Re: Basic questions about IQ-OQ-PQ generation

hi, all
i do appreciate your help:)!
actually i am a newbie here. i realy do not know the steps of preparation of 3Q. would you kindly give me some basic instructions for them,
such as:
step 1:........
step 2:........

thank you and forgive me for my poor English!
:eek:
 
H

hbfy0127

#5
#5
Re: Basic questions about IQ-OQ-PQ generation

BTW, i am in PCBA field, one of my cutomer is an OEM of medical devices!
 
Ajit Basrur

Ajit Basrur

Staff member
Admin
#6
#6
Re: Basic questions about IQ-OQ-PQ generation

hbfy0127 said:
hi, all
i do appreciate your help:)!
actually i am a newbie here. i realy do not know the steps of preparation of 3Q. would you kindly give me some basic instructions for them,
such as:
step 1:........
step 2:........

thank you and forgive me for my poor English!
:eek:
Click to expand...
To start with, you should have a Level 2 procedure definingthe requirements of Qualification and validation. Equipments are QUALIFIED while the process is VALIDATED.

All Qualifications and Validation should be started with a Qualification / Validation protocol which defines how you will be going forward. Once the protocol is approved, carry out the requirements that have been mentioned in the protocol. If the requirements are successfully met, summarize in a Qualification / Validation Report.

For the contents of IQ, OQ and PQ, you could refer to the numerous threads that we have on the subject.

Best Luck :agree1:
 
H

hbfy0127

#7
#7
Re: Basic questions about IQ-OQ-PQ generation

Ajit Basrur said:
To start with, you should have a Level 2 procedure definingthe requirements of Qualification and validation. Equipments are QUALIFIED while the process is VALIDATED.

All Qualifications and Validation should be started with a Qualification / Validation protocol which defines how you will be going forward. Once the protocol is approved, carry out the requirements that have been mentioned in the protocol. If the requirements are successfully met, summarize in a Qualification / Validation Report.

For the contents of IQ, OQ and PQ, you could refer to the numerous threads that we have on the subject.

Best Luck :agree1:
Click to expand...
Thanks for that. I should try to do it by myself instead of asking again and again.
BTW, shall we make an appointment in Suzhou?
 
H

harry

Super Moderator
#8
#8
Re: Basic questions about IQ-OQ-PQ generation

hbfy0127 said:
BTW, i am in PCBA field, one of my cutomer is an OEM of medical devices!
Click to expand...
From your post, am I right to deduce that you are manufacturing just a component or part for a medical device/equipment?

Does a component or part need to undergo IQ-OQ-PQ?
 
H

hbfy0127

#9
#9
Re: Basic questions about IQ-OQ-PQ generation

harry said:
From your post, am I right to deduce that you are manufacturing just a component or part for a medical device/equipment?

Does a component or part need to undergo IQ-OQ-PQ?
Click to expand...
you just hit the keypoint, that's my confusion. But my client required that.
Actually, our company is a Electronic Manufacturing Service(EMS) company.
We just produce the PCBA inside the whole device. No samples can be referred.
thanks
 
H

harry

Super Moderator
#10
#10
Re: Basic questions about IQ-OQ-PQ generation

hbfy0127 said:
you just hit the keypoint, that's my confusion. But my client required that.
Actually, our company is a Electronic Manufacturing Service(EMS) company.
We just produce the PCBA inside the whole device. No samples can be referred.
thanks
Click to expand...
Seek further clarification from your client. We had been looking at IQ/OP/PQ from the medical device aspect but it could be requirements related to your product. Such as:
IPC 6012 - Qualification and performance specifications related to printed circuit boards
IPC 9701 - Performance test methods and Qualification Requirements for surface mount solder attachments
 
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