Validation of existing equipment - Risk based approach example

duff999

Involved In Discussions
#1
Could you give me a risk based approach example. For example, we have a number of equipment that was just calibrated, I would assign a low risk to these because they were just calibrated and are in working order. For larger pieces equipment, such as a 3D printer that is used for the main production, it has not been validated but we do have 100% inspection on the final product through QC, what type of risk assessment do you assign to this and what is the rationale?

Thank you
 
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William55401

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#2
The equipment has be considered in context of what process it is used in. Can the equipment be listed in your process FMEA? Each line will get an as is and post action risk score. While calibration is important, it does not tell me if that gauge is used on a piece of automated final test equipment. To do this right (and once), establish a comprehensive pFMEA to drive your process validation (or not) and level of equipment controls. This will ensure your decisions and actions are well thought out and defendable.
 

JoshuaFroud

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#3
I have previously justified using no manufacturing process validation as everything is 100% inspected prior to release (large capital equipment). This has been accepted by several different auditors from different groups.

It is clause 7.5.6 that covers manufacturing validation and it states that processes only require validation if the subsequent monitoring and measurement will not detect the deficiencies.

The justification I used was that that the final QC testing procedures tested all aspects of the design and functionality of the device, therefore, any defects or deficiencies in the device would be detected prior to reaching the end-user.
 

Tidge

Quite Involved in Discussions
#4
This is solid advice (although you may not explicitly use pFMEA):

The equipment has be considered in context of what process it is used in. Can the equipment be listed in your process FMEA? Each line will get an as is and post action risk score. While calibration is important, it does not tell me if that gauge is used on a piece of automated final test equipment. To do this right (and once), establish a comprehensive pFMEA to drive your process validation (or not) and level of equipment controls. This will ensure your decisions and actions are well thought out and defendable.
There is a presumption that your product's risk file has identified the manufacturing controls necessary to control/minimize the risk associated with your products. The contribution of the equipment to the control of the risk could be used to determine the extent of the validation. If a piece of equipment is responsible for completely controlling a risk (e.g. a sterilizer to control the risk of infection) a full and complete validation of the process and equipment is expected.

And the followup...
I have previously justified using no manufacturing process validation as everything is 100% inspected prior to release (large capital equipment).
In the case JoshuaFroud describes, my expectation is that the inspection is explicitly identified as the risk control, and the inspection process has been validated to be effective at the necessary level to control the identified risks.

A word of caution about reliance upon only "100% inspection": If there becomes a reason to doubt the inspection process as an effective risk control (possibly because of "an escape", or the inspection process is identified as a root cause/contributing factor in a non-conformance) things can quickly go pear-shaped under review.
 
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