How to handle the case that the recommended action cannot be determined??

In some case that the recommended action cannot be determined, I put the statement "There is no proper recommended action can be determined in this round, this will be reviewed in the next round of FMEA review" in the recommended action column as a note for the team to revisit ij the next round.
However, customer do not accept this practice but force me to determine the recommended action which I am not able to do.
Please advise what should be the proper way to handle this case.

 

If I understand correctly, you have identified a risk with a risk score / risk priority number that is too high to be accepted and needs a control measure. However, at this moment it is not possible to eliminate the root cause, or increase the detection?

In some cases, residual risk cannot be reduced. In that case, objective evidence such as data and literature can be gathered and reviewed on the benefits of the intended use / intended purpose to determine if they outweigh the residual risk. Sometimes a “state of the art” argument can be made to demonstrate that less hazardous alternatives do not exist and the benefits outweigh the risks.

I can understand the standpoint of your customer, if you have identified a risk but are unable to provide control measures.

Should you be able to share some information about the type of product or risk you are having trouble with, the people here may be able to give some more specific advise.

 

Thanks for your reply.
Your understanding is correct. One thing is that customer need me to determine recommended action for any RPN >84. There are several line items that has RPN >84. I can determine action for some item but there is no any idea for some item. I just need to know how to handle the case that I have no any idea on how to improve the RPN to be less than 84 for the time being. Some customer can accept such note that I put but some customer did not accept. I still have no idea how to handle this case.

 

If there really is no way to improve the RPN without major changes to the current setup (As Low As Reasonably Possible) or without blowing up costs (As Far As Possible), I think it is important to clearly communicate this to your customer.
One option is to present them with a review of the residual risk, with justification for (mutual) acceptance. Of course there is a difference if your RPN is only a couple of points over 84 or much higher.


It will not be possible to accept the risk as ,,will be reviewed in the next round''
Your options are:
- Accept risk with justification.
- Lower RPN. (Extra QC, change of design, product only to be used by trained personell etc.)

What solution will work for you is difficult to say. This will depend on your product, intended use and relationship with your customer.

 

An example of RPN >84 is from D=6, O=4 and D=5 (RPN = 120)
Base on AIAG FMEA Manual 4th edition, I am focusing on S= 9 and 10 and D= 9 and 10

 

An example of RPN >84 is from D=6, O=4 and D=5 (RPN = 120)

 

Really thanks Bev for helping me always to find the way out.
My obstruction now is that there are several line items with RPN>84, I am not able to provide recommended action completely for all those line items. Missing only 1 item is not acceptable by customer. I have feedback to customer to stop using RPN to trigger the action determination but customer deny to do so.
I do not know how to handle some line item that I still have no proper action to reduce RPN. Putting the statement "this item will be revisit in the next round (6 months) of FMEA review is also not acceptable by customer.
I need to get advice from you as follows:
- How to convince customer to use RPN >84 as a threshold for action priority?
- How to handle the case of RPN>84 but no proper action to be determined for the time being.

 

The customer is driving the silly RPN thing. Not much you can do about that. What I usually do, when we have done everything reasonably possible, it use the notation "no cost effective action feasible" or something similar. You can always do something, the real issue is the cost of such action -- i.e.; I can't possibly set up automated visual inspection for all of my parts. Good luck.

 

Thanks, we are in the same boat.