Process FMEA - No evidence that actions are considered or taken - High RPNs

#1
During our last audit a nonconformance was issued "there is no evidence that actions are considered or taken for high RPN in PFMEA".

The PFMEA manual says that RPN's can be between 1 and 1000 and that "for higher RPN's the team must undertake efforts to reduce this calculated risk through corrective action(s)".

Higher RPN's is a vague requirement, what is higher? We had already established in our procedure a threshold of 100. We would react anytime the RPN goes above 100.

My current thought is to challenge our registrar. I would like to have other opinions before undertaking.
 
Elsmar Forum Sponsor

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#2
You ask a very common question. What is the answer though? I'm not exactly sure, but I'll toss out an idea or two.

The process requires that the FMEA document be a living document. This means periodic reviews, re-evaluation of original RPNs, and updates and amendments as necessary. I have seen the Pareto technique used to identify the "vital few" over the "trivial many". But what if the vital failure modes only generate numbers below the arbitrarily selected 100 score? Should no action be taken because it is not warranted?

A closer look at how the RPN was derived might be necessary. Severity plays a very important role, 9 and 10 rating should require addressing. Also, a longer term study needs to be done to determine if your arbitrarily selected threshold has any merit. You may find that a higher/lower number is more appropriate. So what is appropriate?

Based on individual organizational circumstances, what is appropriate for one may not be for another. Your organization is made up of many "experts" for your product or service. These experts need to determine the appropriate number if you decide to use the scaling method. I would suggest using a statistical method but give consideration to those "gutt feel" issues (i.e. what resources do we have/can afford?). The most important factor I believe is that you record the events leading up to your designated threshold as this would indicate that your organization approached this issue as objectively as possible and that your 'experts' have given due consideration.

For the record, we also had the 100 point threshold in our SOPs. Arbitrarily selected, but a reasonable estimation in retrospect (studies of past results has shown that this number floats between 70-160). I should mention though that if you do select a threshold that you run the risk of creating bias in generating the RPN value (keep it under 100 or we'll have to do CA!). Additionally, as a group of experts you may decide that an item with an RPN of a lower number requires attention while one that is higher goes untreated. An inherent problem with scaling systems, they are linear and cloud vision. As I mentioned earlier, items with 9 or 10 severity generally require CA. An S*O*D for an RPN may be 9-2-2=36, another being 5-5-5=125. Which do you address first? Or at all?

Hopefully I haven't muddled up the works for you. My suggestion, give consideration to the non-scaling method. Deal with the vital few and learn from the process. I believe the results will be better.

Regards,

Kevin
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
Have you looked at the APQP and FMEA files in the pdf_files directory? http://Elsmar.com/pdf_files/

This gets wishy-washy because judgement comes into play as pointed out already. But in addition, let's say the severity was the same for 2 separate line items but one line item has an RPN of 400 and the other line item has an RPN of 50. The one with the 400 RPN number you have determined will cost US$5,000,000 to bring down while the RPN 50 you can reduce to 30 with about US$2500. That one with the RPN of 400 may just stay there for a while.

The 'old' automotive RPN rule was attack anything over 60, as I remember, but over the last several years FMEAs have really been picked apart by virtue of QS9000 requirements. There are a lot of judgement calls in what you work on, what you do not work on and why.

[This message has been edited by Marc Smith (edited 13 October 1999).]
 
Thread starter Similar threads Forum Replies Date
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
C FMEA Process assessment In the Draft for the AIAG/VDA FMEA Manual is gone FMEA and Control Plans 0
Jimmy123 Example of a P-Diagram for Process FMEA - Uncontrollable noises FMEA and Control Plans 39
eule del ayre Merging FMEA and Quality Control Process Flow FMEA and Control Plans 0
K AIAG/VDA FMEA & Process Control Plans FMEA and Control Plans 0
S New AIAG FMEA Process - How to complete the new format FMEA and Control Plans 32
K PFMEA (Process FMEA) - Can be common for 3000 products? FMEA and Control Plans 2
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
N In-Process Production Test Stations in PFMEA (Process FMEA) FMEA and Control Plans 18
N Process FMEA Occurrence Ranking for New Process FMEA and Control Plans 3
G AIAG FMEA - Major customers of the FMEA process FMEA and Control Plans 3
E How do I create a FMEA for the Internal Audit process? Internal Auditing 11
D How to fill a Process FMEA - Three columns - Severity, occurrence and Detection FMEA and Control Plans 16
L Injection & Extrusion Process FMEA FMEA and Control Plans 1
S Pilot Process FMEA Occurence Rankings FMEA and Control Plans 4
K Process FMEA Ranking Table for for Landing Door of an Elevator FMEA and Control Plans 7
G Severity in Process FMEA for Rework Process FMEA and Control Plans 1
R Is PFMEA (Process FMEA) for OEM sufficient to address Risk? ISO 13485:2016 - Medical Device Quality Management Systems 7
H FMEA sample for complete CNC machining process FMEA and Control Plans 1
T Software for linking Process Flow Diagram, Process FMEA and Control Plan APQP and PPAP 9
V Process FMEA for Stamping Process FMEA and Control Plans 5
gembul FMEA for Steel Tube Process for Automotive FMEA and Control Plans 4
L Most appropriate Auditor to check the FMEA & PCP of a Manufacturing Process IATF 16949 - Automotive Quality Systems Standard 5
C List Error Proofing in the Process FMEA or the Control Plan FMEA and Control Plans 2
J Process FMEA w/ Contracted Manufacturing ISO 14971 - Medical Device Risk Management 2
B FMEA example for Cokemaking Process at a integrated Iron and Steelmaking Plant IATF 16949 - Automotive Quality Systems Standard 3
S FMEA Process Step or Current Control FMEA and Control Plans 3
Z Pass-Though Characteristics in PFMEA (Process FMEA) FMEA and Control Plans 2
Q Chrysler required FMEA and Control Plan Document Audit Forms and Process Audit Check FMEA and Control Plans 7
V Examples of Design and Process FMEA for Pharmaceutical Product Development ISO 14971 - Medical Device Risk Management 7
S Galvanize and Chrome Plating Process FMEA wanted FMEA and Control Plans 2
S Product FMEA vs. Process FMEA - Aerospace Industry Machine Shop FMEA and Control Plans 5
R PFMEA (process FMEA) for Incoming Material stage FMEA and Control Plans 3
P PFMEA (Process FMEA) Recommended Actions help FMEA and Control Plans 9
J What is Incorporation in Assembly/Manufacturing Process in FMEA? FMEA and Control Plans 4
A Will Inspection Process need an FMEA? FMEA and Control Plans 7
F Process FMEA for Welding and Laser Cutting FMEA and Control Plans 3
G Very Basic PFMEA (Process FMEA) Guidelines FMEA and Control Plans 17
R Process to use Special Characteristics as FMEA Inputs IATF 16949 - Automotive Quality Systems Standard 3
M PFMEA (Process FMEA) - What is the best approach? FMEA and Control Plans 14
F FMEA Optimization for our Die Setup Process FMEA and Control Plans 2
M PFMEA (Process FMEA) for Attribute Data Inspection Process FMEA and Control Plans 2
A Current Control Periodic Document Reviews - Process Updates in the FMEA FMEA and Control Plans 3
T PFMEA (Process FMEA) Recommended Actions Column FMEA and Control Plans 10
B Process FMEA (PFMEA) Same Multiple Causes for Different Effects FMEA and Control Plans 6
M Changing PFMEA (Process FMEA) RPN Values based on a Rejection FMEA and Control Plans 4
Chennaiite FMEA for Business Process Imported Legacy Blogs 6
K Does FMEA include Inspection Process? FMEA and Control Plans 11
Q Using a Custom Process FMEA (PFMEA) Form FMEA and Control Plans 4
H What should be included in a Machining Process FMEA? FMEA and Control Plans 8

Similar threads

Top Bottom