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Usage of Parts from OQ (Operational Qualification) Mold Validation

B

barak.tzachar

#1
Dear forum members.

I am familiar with the methodologies of mold validations, and in the process of establishing a new procedure in my workplace.

Does anyone know is there is a restriction to use the plastic parts manufactured during the OQ phase?

Will appreciate any help you can offer.

Best,

Barak.
 
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kuyakut

Involved In Discussions
#2
Re: Usage of Parts from OQ mold validation

There is no restriction on the usage of parts produce in OQ. The parts produce during OQ run are good parts. Since it was produced in 2 extreme parameters (Min/Max) , the parts produced on Max setting may have dimension that are on the high side of the parts specification same with parts produce on the Min setting. The OQ parts are normally use as a test run samples in the assembly line.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Dear forum members.

I am familiar with the methodologies of mold validations, and in the process of establishing a new procedure in my workplace.

Does anyone know is there is a restriction to use the plastic parts manufactured during the OQ phase?

Will appreciate any help you can offer.

Best,

Barak.
Hi Barak and welcome to (posting on) the Cove :bigwave:

If these are for medical devices and by "use" you mean place on the market then it is advisable to withhold those parts until the entire validation (including PQ) is finalised.

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#4
Welcome barak ~~~
The OQ is the process to establish the optimum process parameters. You may have parts from OQ coming from outside limit processes also. You need to have traceability and make technical judgements. Successful PQ completes the validation, after which these OQ parts can be assessed. Its again a risk based decision one needs to take.
 

TWA - not the airline

Trusted Information Resource
#5
Do you

1) want to use parts from the OQ of your component supplier to manufacture products which will be marketed in your responsibility
2) want to sell OQ parts to your customer who then makes products from them
3) want to use parts from the OQ of your own in-house qualification to manufacture products which will be marketed in your responsibility

Things might depend heavily on your answer. In any case you need to determine the requirements that apply to your situation: your own quality system, your customers specs and contract/quality agreement, other regulatory requirements etc.

P.S. Just saw that this was posted under "Medical device/ISO13485". I would therefore strongly recommend to heed Ronen's advice to withhold the parts until PQ is finished. I personally would normally not use OQ parts for regular production at all and especially I would not use OQ parts that were manufactured outside final process limits for anything else than tests to investigate how such a thing affects the final device (hoping of course to be able to show that there is no effect...). If you want/need to use them, then do as Somashekar suggested; you can use data from the OQ (like e.g. measured dimensions etc.) and regular controls that were run on the parts to beef up the risk assessment and technical justification/rationale. If during OQ not all process and parts control steps were performed (like for PQ or regular production) you should repeat those...
 
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