PFMEA Severity (9-1) mitigation needed?

Jen Kirley

Quality and Auditing Expert
Leader
Admin
I would agree with Jim except for the so-called general duty clause. If an organization can show they thought of a risk and took action, should something bad nonetheless occur the effort can be recogized and appreciated as some degree of due diligence.
 

Jim Wynne

Leader
Admin
I would agree with Jim except for the so-called general duty clause. If an organization can show they thought of a risk and took action, should something bad nonetheless occur the effort can be recogized and appreciated as some degree of due diligence.
Where can this clause be found?
 

Jim Wynne

Leader
Admin
It is in Section 5 of OSH Act of 1970.
Quoting from that source. with emphasis added:
Each employer --
(1)
29 USC 654
shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees;
(2)
shall comply with occupational safety and health standards promulgated under this Act.
(b)
Each employee shall comply with occupational safety and health standards and all rules, regulations, and orders issued pursuant to this Act which are applicable to his own actions and conduct.
I think the word "likely" is key here.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Quoting from that source. with emphasis added:

I think the word "likely" is key here.
Yes.

To be clear, my suggestion is to show the organization is cognizant and responsive of risks. If they can show they recognized and responded to risks, if something else occurs their case may be helped by being able to show they are not ignoring risks. This perspective comes from my previous experience with an employer whose stated strategy was to try to look like they did not recognize risks so they wouldn't be as likely to be held responsible for them.
 

Jim Wynne

Leader
Admin
My whole point was that a determination has to be made, based on likelihood, as to whether a given risk or set of risks should be included in a PFMEA document. It could be that in the current situation it's reasonable, but you have to draw a line somewhere. Including everything anyone can think of that might become hazardous is not a good strategy, and indicates that the PFMEA team might not understand what they're doing.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Jim, I do agree and I would not want to see the pFMEA populated with potential hazards. And it is easy to go off into the horizon once getting started. The only point I was trying to make is that it seems to me to make sense to go ahead and take credit for severe hazards that have been eliminated versus being silent.

It is always a choice in the end. One one hand we run the risk of saying too much, and on the other hand we run the risk of saying too little. An auditor I know of is legendary for asking "Did you consider plane crash?" when squinting up at a plane traveling overhead at more than 10,000 feet. But for some the risk is real, such as a Semiconductor manufacturer positioned right next to an airport. They installed a giant hydrogen tank out there...

That example is obvious. Some are less so. The pFMEA team will need to learn to consistently categorize and assess risks. I find a lot of people are not giving themselves enough credit for what they are doing.
:2cents:
 

Jim Wynne

Leader
Admin
="Jen Kirley, post: 672517, member: 297858"
It is always a choice in the end. One one hand we run the risk of saying too much, and on the other hand we run the risk of saying too little. An auditor
If it were easy, anyone could do it.
 

morteza

Trusted Information Resource
We are working on a PFMEA where there is a potential failure mode than can expose operators to a hazard and it currently has severity of 9. The cause is identified as "equipment failure" and preventive maintenance is current control prevention, with occurrence = 2. If the equipment fails, the entire system shuts down to protect the operators, so we gave detection a 1.

We've debated internally on whether 9 is correct or if we even need this failure mode because in reality this is extremely unlikely to happen due to system shutdown if equipment fails.

Do we still need an action plan or can we accept this risk, knowing that the interlock will shut down the system?

Thanks.

Hi all

I think the situation described above, is not related to the process FMEA. Based on clause 3.4.5 of AIAG-VDA FMEA handbook, failure mode has been defined as follows:
"A (Process) Failure Mode is defined as the manner in which the process could cause the product not to deliver or provide the intended function."
Based on the above definition failure modes are related to the products functions/requirements, so failure of machine is not a failure mode. it is a failure cause. Failure effects are the impact of failure mode not failure cause. Failure Effects are related to functions of the process item (System, Subsystem, Part Element or Name of Process).
Operators injury due to equipment failure, equipment sound level, etc. does not include in the PFMEA scope, they should to be investigated in safety management systems. Injury of personnel due to product nonconformity includes in the PFMEA scope, e.g. loosing fasteners in a a assembled product may hurt the operator at the final test operation.

Is my understanding right?
 

Jim Wynne

Leader
Admin
Hi all


"A (Process) Failure Mode is defined as the manner in which the process could cause the product not to deliver or provide the intended function."
Based on the above definition failure modes are related to the products functions/requirements, so failure of machine is not a failure mode. it is a failure cause. Failure effects are the impact of failure mode not failure cause. Failure Effects are related to functions of the process item (System, Subsystem, Part Element or Name of Process).
The bit you quoted clearly says that a failure mode is based on process failures.
 
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