GHTF/SG3/N15R8 - Process Validation and Risk Analysis

L

Lasers

#1
Hi,
GHTF/SG3/N15R8 Implementation of risk management principles and activities within a Quality Management System defines in chapter 10.3. Process Validation:
Process validation and the determination of the need for revalidation may be influenced by the results of risk management activities. When performing process validation, risk management tools, such as FTA, FMEA, HAZOP, HACCP, PAT, or others, should be considered. Results of process validation or revalidation may identify the need for additional risk control measures. One example may be confirming or refining specific process
parameters and controls when the source of an identified hazard is process variability.
When process changes are undertaken, current risk control measures should be reviewed for suitability. This review should also ensure that no new hazards were introduced.


I have a question regarding where these risks related to process validation should be documented. Is the correct place the documentation for process validation (eg. Validation plan) with references to risk analisys for the product or is the correct place in risk analisys for the product?
What about the buissines risks? Is there any regulatory requiremet for producer of medical devices that he sould have documented risk analisys also for validation tasks that come from buissines risk?

Thank you very much for answers and/or tipps.
Maja
 
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somashekar

Staff member
Super Moderator
#2
Re: Process validation and Risk analysis

~~~ Warm WELCOME to the COVE Maja ~~~
I have a question regarding where these risks related to process validation should be documented.
The need for a process to be validated comes from the outputs of risk management. The validation process may identify further risk control measures.
So the risk analysis of the product will identify areas of process validation.
Risk is a big word. Here in ISO13485 and ISO14971 we talk about product realization processes.
 
L

Lasers

#3
Re: Process validation and Risk analysis

Thank you for anwser.
I still have questions:
In our company we have risk management file for each medical device. In these files we have also requests for processes validations that come from risks for patient or user of device. Then we have in our Validation plan for each production process reference to these risk in risk management file for medical device.
Besides of these validations that come from risk management for medical device we have also validations that are performed due to buissines risks. We have that described in general in validation plan for each process.
In this year ISO audit we got a remark that risks that are defined in risk management file for product and demand process validation are to general and that detailed risk analysis for each validation task that is included in validation protocol should have their own detailed risk analysis. Auditor suggested that each validation plan should have his own detailed risk analysis, like one test one risk.
Now I am confused if these detailed risk analysis should be made also for buissines risks. Who should perform these risk analysis for production processes (Can it be only people from production or also people from R&D?).
Sorry for the word risk but these is the fastet way to wright it down. I hope my question is understundable.
Thanks.
Maja
 

somashekar

Staff member
Super Moderator
#4
Re: Process validation and Risk analysis

Seems to be going in circles ....
Its simple.
Risk assessment determines the controls, and the residual risks that still exist which are considered acceptable to bear with.
Process validation is one such control. You plan this and execute the validation to determine the optimum process performance limits, and then operate the process within the determined limits. You also keep a watch for any changes that will require a re-validation.
Business risks when analysed will help your company in strategy and set direction towards meeting your company goals with least roadblocks.
 

v9991

Trusted Information Resource
#5
Re: Process validation and Risk analysis

Auditor suggested that each validation plan should have his own detailed risk analysis, like one test one risk.
Now I am confused if these detailed risk analysis should be made also for buissines risks. Who should perform these risk analysis for production processes (Can it be only people from production or also people from R&D?).
as Somashekar, indicated, risk assessment will put in place the existing controls, basis to say that controls are adequate or acceptable risk.

And, yes, from a compliance stand point, PV to be backed up by risk-assessment, whether its process-risk, product-risk or business-risk.

Further, Looks like, you have clarity on the answers of product/process-risk; it has to be done by R&D(Product) - production(Process) etc., hence, similarly, business risk would involve all stake holders.and outcome of risk-assessment would flow into your validation plan.


Process validation is one such control. You plan this and execute the validation to determine the optimum process performance limits, and then operate the process within the determined limits.
usually, the optimum performance parameters are established as part of scale up processes... and PV will only establish/confirm the reproducibility of same. request for clarification on above point.

usually, we release the process validation batches for commercialization. (subject to successfull/adequate stability data available from previous batches) Hence, if we determine the optimum process performance limits from PV, AND in case they fail, it might be quite a hit on the batch?
 
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