FMEA Severity of 9 or 10 - Shower does not operate

Randy

Super Moderator
#11
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)?
Nope...everything is based on worst case scenario.

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.
Just tell them what the law requires and include the ANSI reference information below.
(The American National Standards Institute (ANSI) developed the ANSI standard Z358.1-1990 and was revised in 2004. This "Emergency Eye Wash and Shower Equipment" standard helps the user in selecting and installing emergency equipment to meet OSHA requirements.

The following specifications are taken directly from the ANSI Z358.1-2004 standard.

SHOWERS (Plumbed and Self-Contained)

Plumbed Shower: An emergency shower permanently connected to a source of potable water.

Self-Contained Shower: A shower that contains its own flushing fluid, and must be refilled or replaced after use.

The specifications below are for plumbed showers only.

1. Heads

A. Positioned 82"--96" from floor.
B. Spray pattern will have a minimum diameter of 20" at 60" above the floor.
C. Flow Rate=20 gallons per minute (GPM) at 30 pounds per square inch (PSI).
D. The center of the spray pattern shall be located at least 16 inches from any obstruction.

2. Valves

A. Activate in 1 second or less.
B. Stay-open valve (no use of hands).
C. Valve remains on until the user shuts it off.

3. Installation

A. Shower shall be located in an area that requies no more than 10 seconds to reach.
*Consult a medical professional to determine the appropriate distance for harsh acids and caustics (high hazard=closer distance).
B. Shower location shall be in a well-lit area and identified with a sign.
C. Shower shall be located on the same level as the hazard.

4. Maintenance and Training

A. Plumbed showers will be activated weekly to verify correct operation.
B. All employees who might be exposed to a chemical splash shall be trained in the use of the equipment.
C. All showers shall be inspected annually to make sure they meet with ANSI Z358.1 requirements.


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

remsqa

#12
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.
Hai

The situation is clear that you can mean severity 9 or 10 if it clearly violate the govt or statuary and regulation requirement violation .

Say example if your co is certified for the ISO 14000 or OSHA .then it is your responsibility to rate it as 9 or 10.

And you have focus on the occurrence and the detection controls, to reduce the RPN.

This is my view to this situation.
 

Randy

Super Moderator
#13
Hai

The situation is clear that you can mean severity 9 or 10 if it clearly violate the govt or statuary and regulation requirement violation .

Say example if your co is certified for the ISO 14000 or OSHA .then it is your responsibility to rate it as 9 or 10.

And you have focus on the occurrence and the detection controls, to reduce the RPN.

This is my view to this situation.
Not entirely correct there pardner. The RPN must be at the highest because of the potential consequences. There is a slightly different perspective here in the US on product liability
 
W

Watchwait

#14
This may or may not be the best place to post this question but I'll jump in anyway...

Let's suppose this is now a residential bath shower head, whose only function is to disperse water onto the user. We have identified a failure mode wherein the water abruptly stops and necessitates physically removing the shower head from the connecting pipe to resolve the problem.

Customer is seriously inconvenienced and extremely dissatisfied. However, he has not incurred any health/safety risk as a result of the failure mode (ignore for a moment the potential of a clogged pipe, etc). In this case, what is the Severity Level of the failure mode? 10 for complete loss of functionality or 0 (zero) for no health and safety impact to the user?

Again, this may be a poor example, but not an untypical case. Many product failure modes could result in complete loss of functionality while not at all exposing the user to a health/safety risk. Now, if we consider "Major Inconvenience" to be part of the Severity Scale then maybe it's a 3. But even then it seems including any degree of "user dissatisfaction" to a health/safety scales is definitely mixing apples and oranges.

My curiosity goes beyond being academic, as we have products where this dichotomy currently exists and are wrestling with how to handle it using the conventional FMEA model.
 
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