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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
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