FMEA Severity of 9 or 10 - Shower does not operate

S

Stanley P

#1
Bare with me as some of this FMEA is somewhat new to me. There may be an obvious answer to this.

I am unsure as to how to score the severity on a chemical decontamination shower. For a failure where the shower does not operate, would this be considered a severity of 9 or 10. The primary function is to rinse potentially harmful chemicals in a possible emergency situation. My dilema is whether the shower not functioing causes bodily harm. The shower itself is not causing any harm, it just lost it's ability to serve it's primary function. (An 8 then?)

I have already been lectured from someone in the company that if we identify any products as a 9 or 10 we are opening the company up to liability if we don't take appropriate action. I'm feeling ethical pressure to call as I see it. Am I looking at this incorrectly?

If a 9 or 10 is appropriate, then are many safety products like these a 9 or 10 if they lose primary function.

Any advice is appreciated.
 
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G

grismosw7

#2
Severity is what it is, you are just as liable I would think if you made it an 8 when it should be a 9.

Occurance and Detection are the areas you should focus on to reduce your RPN. Your opening the company up to liability if you do not take action to reduce Occurance and improve Detection.

Anytime I have a supplier PFMEA with 9 or 10 for Severity I shoot for action to be taken to reduce Occurance and improve Detection regardless of RPN unless both are already at 1 or 2. I don't require it, unless it fails to meet the RPN threshold.
 
D

D.Scott

#3
Bare with me as some of this FMEA is somewhat new to me. There may be an obvious answer to this.

I am unsure as to how to score the severity on a chemical decontamination shower. For a failure where the shower does not operate, would this be considered a severity of 9 or 10. The primary function is to rinse potentially harmful chemicals in a possible emergency situation. My dilema is whether the shower not functioing causes bodily harm. The shower itself is not causing any harm, it just lost it's ability to serve it's primary function. (An 8 then?)

I have already been lectured from someone in the company that if we identify any products as a 9 or 10 we are opening the company up to liability if we don't take appropriate action. I'm feeling ethical pressure to call as I see it. Am I looking at this incorrectly?

If a 9 or 10 is appropriate, then are many safety products like these a 9 or 10 if they lose primary function.

Any advice is appreciated.
Welcome to the Cove Stanley.

I think you are right to class failure as a 9 or a 10. If you were making engines for a plane and the engine failed, the engine itself wouldn't cause any harm but the sudden stop when hitting the ground certainly would.

You have to realistically evaluate the effect of failures in all three areas of an FMEA. Remember, you can not normally reduce the Severity with quality tools. Reduction there usually requires a design change. If your customer has design responsibility, their attention needs to be directed to that failure mode. If the design responsibility rests with your company, it won't matter if you define the failure mode as a 1 or a 10. Your company will still be legally responsible if it fails. It is better to identify a problem and fix it now.

Having said that, don't "invent" failure modes that have already been engineered out. For example - if the shower doesn't function "as it should" but still provides a rinse, does the failure still result in burns? When organizing an FMEA, be sure the failures you define can reasonably occur.

Dave
 

Kales Veggie

People: The Vital Few
#4
welcome to the cove.

You might already have thought of this.

What can be done, so that the shower is not needed, what prevention methods can be implemented so that chemicals are not spilled and can not get in contact with human skin.

The shower is needed, because a step in the process failed.

(OSHA or similar might still require that you have a shower).
 
G

Geoff Withnell

#5
Bare with me as some of this FMEA is somewhat new to me. There may be an obvious answer to this.

I am unsure as to how to score the severity on a chemical decontamination shower. For a failure where the shower does not operate, would this be considered a severity of 9 or 10. The primary function is to rinse potentially harmful chemicals in a possible emergency situation. My dilema is whether the shower not functioing causes bodily harm. The shower itself is not causing any harm, it just lost it's ability to serve it's primary function. (An 8 then?)

I have already been lectured from someone in the company that if we identify any products as a 9 or 10 we are opening the company up to liability if we don't take appropriate action. I'm feeling ethical pressure to call as I see it. Am I looking at this incorrectly?

If a 9 or 10 is appropriate, then are many safety products like these a 9 or 10 if they lose primary function.

Any advice is appreciated.
I am very glad you are feeling ethical pressure to call it as I see it. My suggested response to the lecturer would be that we have a positive ethical/moral obligation to protect our staff and others in the area of the hazardous material, and if we do that properly, a liability issue will not arise. As an added response, it is quite proper to add the liability to the "effects" caused by the failure.

Geoff Withnell
 

Randy

Super Moderator
#6
Bare with me as some of this FMEA is somewhat new to me. There may be an obvious answer to this.

I am unsure as to how to score the severity on a chemical decontamination shower. For a failure where the shower does not operate, would this be considered a severity of 9 or 10. The primary function is to rinse potentially harmful chemicals in a possible emergency situation. My dilema is whether the shower not functioing causes bodily harm. The shower itself is not causing any harm, it just lost it's ability to serve it's primary function. (An 8 then?)
The need for the shower is an OSHA requirement and is only "required" when a corrosive is involved. It's considered a best practice for showers to be available for all chemicals

(29 CFR1910.151(c)
Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use.




I have already been lectured from someone in the company that if we identify any products as a 9 or 10 we are opening the company up to liability if we don't take appropriate action. I'm feeling ethical pressure to call as I see it. Am I looking at this incorrectly?
You have liability no matter what you do and how well you do it.


If a 9 or 10 is appropriate, then are many safety products like these a 9 or 10 if they lose primary function.
It would depend upon the material, but probably yes. How are 9 and 10 defined? Do the numbers mean anything? What's the difference?

Any advice is appreciated.
My undergrad degree is in Occupational Safety and Health and I've managed safety programs. This is safety/regulatory and not a quality issue
 
R

reigelser

#7
Hi and welcome to the cove!

After reading the posts there were many good points. To clarify it would be interesting to know: are you the user of that shower or do you manufacture the shower?

Joachim
 
D

D.Scott

#8
Stanley,

Just for clarification, is this a shower in your plant or does your company make and sell the shower?

Thanks,

Dave
 

Randy

Super Moderator
#9
Good questions do you make or use the shower?

Here's you answer guys. It doesn't matter because you have to consider worst case scenario when personal safety is involved. Ask any safety professional...wait a minute I am a safety professional!
 
S

skuziej

#10
Role: Our company will be the producer of the shower.

Thanks to all for the insightful comments.
It's reinforcing my stand for 9's or 10's.
I also appreciate the comment on whether the thought of failure modes are possible. I'm not the expert on the product so I'll will pose this question to the appropriate parties.

Some other comments that have been brought up are:

Customers are required by OSHA to test the shower on a weekly basis. Does this reduce our severity score at all? From failure without warning (10) to failure with (9)?

What about our warnings in the product instructions about testing the unit for operation at installation and communicating the OSHA requirements of testing once per week.

I appreciate the help as this is one of the 1st uses of FMEA for our company.
 
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