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< 1 min reading time
Hello! I’d like to get some advice from industrial leaders on my inquiry. I am establishing complaint handling process reflecting ISO 13485:2016 requirement and FDA QSR, and one of new step is “Evaluation” for complaints which is many global companies are already doing. I created risk assesment table for evaluation to determine its risk level (e.g. low or high) so that we can systematically utilize our limited resource for determination of investigation needs. But today my new manager requested me to provide the way to “exempt to perform risk assessment” and I don’t get it because risk assessment for evaluation is Legal Requirement to perform to all complaint and itself is the tool to distinguish the risk as low or high. She told me some example that product packaging defected issue during delivery is not requiring risk assessment but I don’t accept her concept. Can anybody give me some advice how to deal with it? Is there any case risk assessment exempted for product complaint? Thank you so much! source: https://www.linkedin.com/groups/2070960/2070960-6193853590155591681 Marked as spam
 Posted by Asked on October 17, 2016 12:00 am
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Private answer
Rob Packard
There is a sequence for this process that begins with gathering feedback from the customer and ends with risk assessment, but it is possible that a risk assessment may not be necessary if the risk has already been identified and there is no change to the severity of effect or the frequency of occurrence. I recommend that you and the ability to cross-reference new complaints with existing risks that have already been identified. If the risk has not already been identified, it should not be exempted--regardless of how low the risk is. This is especially important for CE Marked products where it is not allowed to consider risks "negligible."
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Ronald Boumans
The evaluation of a risk may lead to the conclusion that the risk is acceptable when weighed against the clinical benefits (don't go for 'high' or 'low' risks). If the risk has already been identified, and this new event will not change the original evaluation, there is no need to further investigate.
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Hyemi Shin (신혜미,차장)
Robert Packard I fully agree with you. Thanks for the advice!
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Private answer
You have been tasked with something that is not possible. While Rob suggests a manner in which one can streamline the process by comparing to other similar complaints, the assessment takes place by analyzing the event and determining the similarity, whether it's low risk or high risk. It's inherent to the quality process. Sorry!!
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G M Butcher
As indicated above if the event has already been considered and the frequency is still acceptable a reference to this should allow 'exemption'. But this is not really an exemption, it is a reference to existing risk determination. For the example given, the risk of label defect should already exist in the transport chain/delivery risk exercise.
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Sue Soderholm
Create a trend alert and gather data to assess what falls within known failure modes and is of no risk to patients. Full investigations when you hit your trigger level that you establish. Simplified but a starting point.
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Luis Chavarria
Any attempt to write an SOP for your QSR and cGMP that intentionally omits risk consideration/assessment is destined to be ineffective SOP and shows poor command of the entire Quality Management System. In addition it will be low hanging fruit for an FDA auditor to built a solid regulatory case against the company. Any firm must be able to clearly articulate and practice risk assessment in all their operations that impact the safety and effectiveness of their device.
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Hyemi Shin (신혜미,차장)
Ronald Boumans Thanks for your comment. It seems to me that you advise based on risk management perspective. I support your recommendation and may apply to our complaint handling process. Thanks!
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Hyemi Shin (신혜미,차장)
Jean Tenuta Thanks for your comment. Yes I agree with your opinion as well since my company process has not been well established yet. I think I need some time to overcome many things for compliance of inherent quality process.
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Hyemi Shin (신혜미,차장)
Luis Chavarria Thanks for comment. Yes I 100% agree that my effort sould be for actual practice not just for audit itself. That's why I am studying ASQ books and trying to apply to our QMS. But it is difficult...
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Hyemi Shin (신혜미,차장)
G M Butcher Yes, I am aware that the exemption is not exemption actually! Thanks for advice.
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Hyemi Shin (신혜미,차장)
Sue Soderholm I am not familiar what you adviced but It seems that I need to gather the data first to know trending and thed I can set up appropriate assessment criteria. Thank you.
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Konrad Kobel
In my opinion, the asessment of risks in the complaint process must be oriented on the risk evaluation which must take place during the design stage. There, the risks for the patients must be evaluated based on severity and harm and occurence. As Long as there are no additional risks coming from the market place and the occurenec of complaints for the same risk is not overriding the evaluation during the design stage, no additional assessment may be necessary. However the documentation must be clear and must reference the risk assessment during development.
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