Detection level in PFMEA (Process FMEA) - Bulk Fluids

Casana

Blueberry Nut
#1
I have a customer that's questioning the detection levels in our PFMEA. The PFMEA is written in German which makes it hard to decide what's reasonable. But just looking at the #'s for detection, it appears about 25% of the potential failures have a detection leve of '1'.

Our German mfg plant is TS16949 certified and has been audited quite a bit by 2nd & 3rd parties, no one has ever brought this up this problem. And the customer's engineer that's raising the issue is a PIA "nitpick things to death" type. (He's the type that should be fed chocolate before being spoken to... :mad:)

SO does it sound reasonable to have 25% of failures classified as Detection level of '1'?:confused:

(I should probably clarify we make a FLUID in bulk as opposed to making distinct widgets...)
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
Re: Detection level in PFMEA

I have a customer that's questioning the detection levels in our PFMEA. The PFMEA is written in German which makes it hard to decide what's reasonable. But just looking at the #'s for detection, it appears about 25% of the potential failures have a detection leve of '1'.

Our German mfg plant is TS16949 certified and has been audited quite a bit by 2nd & 3rd parties, no one has ever brought this up this problem. And the customer's engineer that's raising the issue is a PIA "nitpick things to death" type. (He's the type that should be fed chocolate before being spoken to... :mad:)

SO does it sound reasonable to have 25% of failures classified as Detection level of '1'?:confused:

(I should probably clarify we make a FLUID in bulk as opposed to making distinct widgets...)
It depends on where the detection levels come from. Do you have data that supports your contention that defects will almost always be detected before shipment? Note that even if you've never had a problem with the material in question, you still have to estimate the probability of problems being detected.
 

Casana

Blueberry Nut
#3
Re: Detection level in PFMEA

For fluid production, there's quite a few controls to make sure things are right prior to shipment - ie the control tests are designed to identify things like wrong raw material usage, incomplete blend, etc. And there's checks before,during, & after production and before shipping.

My guess is that my German counterparts went a bit overboard identifying 'failure modes' (ie they listed stuff that would be pratically impossible to fail). But i can't read German and I have to trust they know what they do, since they've been audited by many OEM's (including German ones!) with no one identifying this as an issue.

I think what makes me most annoyed is that the failure modes with detection of '1' have RPN's of <10.... so.... logically, how much more are we 'improving' the PFMEA by revising the detection level? :frust:
 

Ron Rompen

Trusted Information Resource
#4
Re: Detection level in PFMEA

I ran into the same thing when audited by the OEM's. Their stance on a 1 for detection levels was that it had to be an automated error-proofed system which inspected 100% of the product.
If the detection system itself failed, it had to (by default) reject all the product, as well as provide notification (visible and/or audible alarms) that it was no longer functioning properly.
A 1 for SEV, OCC or DET is (IMNSHO) pretty hard to justify.
 

Casana

Blueberry Nut
#5
Re: Detection level in PFMEA

I ran into the same thing when audited by the OEM's. Their stance on a 1 for detection levels was that it had to be an automated error-proofed system which inspected 100% of the product.
If the detection system itself failed, it had to (by default) reject all the product, as well as provide notification (visible and/or audible alarms) that it was no longer functioning properly.
A 1 for SEV, OCC or DET is (IMNSHO) pretty hard to justify.

Which makes me wonder... why even offer the rating of a '1' if its so hard to justify?
 
D

David DeLong

#6
Re: Detection level in PFMEA

I ran into the same thing when audited by the OEM's. Their stance on a 1 for detection levels was that it had to be an automated error-proofed system which inspected 100% of the product.
If the detection system itself failed, it had to (by default) reject all the product, as well as provide notification (visible and/or audible alarms) that it was no longer functioning properly.
A 1 for SEV, OCC or DET is (IMNSHO) pretty hard to justify.
Using the AIAG standard here, yes, you are correct. A detection method of 1 should apply to error proofing where one confirms that the error proofing system is functioning.

In one company who spot weld threaded studs, there was a sensor that confirmed that all the threaded studs were in position prior to welding. If one stud was missing, then the automatic welder would not function. This company would confirm that this error proofing system is functioning each shift by removing 1 threaded stud and making sure that the machine would not weld. In their PFMEA, a number 1 was allotted for the detection.
 

Casana

Blueberry Nut
#7
How about something that is tested numerous times? The test equipment is not something that needs calibration, we take & test many samples during production. The only 'human' element is someone bringing the sample to be tested.

Would that be considered a detection of '1' for that activity?

:nopity: Rant Warning:
I think I'm still upset b/c the customer's engineer thinks he's an expert on FMEA's and is making a big fuss about something that will have NO impact on quality. All for the purchase of ONE drum of product once a year. Right nwo our only choice is to pencil whip the 1 to a 2. Just to make him happy and stroke his ego. Nevermind this FMEA has been audited numerous times by oem's and no one had a problem with it...
Rant Over.
 
D

David DeLong

#8
How about something that is tested numerous times? The test equipment is not something that needs calibration, we take & test many samples during production. The only 'human' element is someone bringing the sample to be tested.

Would that be considered a detection of '1' for that activity?
Not according to the AIAG standards it wouldn't. I would need more info on the test method but it looks to be about a 4ish so far but that is quite subjective.
 

Jim Wynne

Staff member
Admin
#9
Not according to the AIAG standards it wouldn't. I would need more info on the test method but it looks to be about a 4ish so far but that is quite subjective.
The AIAG "standards" aren't. They are suggestions. For example, look at the table (Cr3) on page 100 of the 4th Edition FMEA manual. It's labeled "Suggested Process FMEA Detection Evaluation Criteria." (Emphasis added)

On the previous page, under "Suggested Evaluation Criteria,", it says:
The team should agree on evaluation criteria and a ranking system and apply them consistently, even if modified for individual product analysis. Detection should be estimated using Table Cr3 as a guideline.
In the absence of a specific mandate by a customer to use the suggested criteria, it's perfectly permissible to use other criteria, when other criteria make more sense (which is usually the case).
 

Casana

Blueberry Nut
#10
In the absence of a specific mandate by a customer to use the suggested criteria, it's perfectly permissible to use other criteria, when other criteria make more sense (which is usually the case).
Jim - funny that you should mention that, its exactly what our German plant did. They wrote up their criteria for Detection etc. for their PFMEAs, and that's what they followed. It just so happens to NOT match AIAG's criteria exactly. Which is why my lovely customer is having kittens.

We've decided to pencil whip this just to shut him up. But I'll keep this info as an ace up my sleeve in case he goes on another ego trip.

:thanx:
 
Thread starter Similar threads Forum Replies Date
T FMEA for Service Provider - Detection Level Criteria - Batch Heat Treater FMEA and Control Plans 2
M Detection rank for sampling vs 100% inspection & 15x vs 400x magnification FMEA and Control Plans 4
T RPN Thresholds and How Detection Fits In ISO 14971 - Medical Device Risk Management 5
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
T Annual Validation as a detection mode on a PFMEA? FMEA and Control Plans 5
P Design FMEA - Detection Rating criteria ISO 14971 - Medical Device Risk Management 3
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A Literature review/HACCP validation of metal detection Food Safety - ISO 22000, HACCP (21 CFR 120) 0
Jimmy123 FMEA - Preventive vs Detection Control FMEA and Control Plans 7
B Detection of Orange peel Manufacturing and Related Processes 3
C Detection Action for Failure Effects - AIAG 4th Edition Layout FMEA and Control Plans 5
C PCBA Hardware Component different failure types - How to rate detection? FMEA and Control Plans 8
P Detection rating for a user (surgeon) related failure mode in DFMEA APQP and PPAP 3
S Are Defibrillator Protection and Pacemaker pulse detection features mandatory as per IEC 60601-2-25 or 2-27...? IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
Ashok sunder Is it possible to reduce FMEA Occurrence and Detection Ranking after corrective action taken for customer complaints? FMEA and Control Plans 6
D How to fill a Process FMEA - Three columns - Severity, occurrence and Detection FMEA and Control Plans 16
R DFMEA Severity 9-10 with Occurrence 3 and Detection 3 - Actions FMEA and Control Plans 3
K Creating together Standard Definition for Prevention and Detection FMEA FMEA and Control Plans 1
Q PFMEA Scope and Detection Controls FMEA and Control Plans 1
D Signal Detection-If Ppk>1, compare measurement system to process. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
L Environmental Gas Leak Detection Equipment Recomendations Miscellaneous Environmental Standards and EMS Related Discussions 2
J Control Chart Pattern Detection Statistical Analysis Tools, Techniques and SPC 3
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
C How to evaluate the Detection Ranking of a new Design Control FMEA and Control Plans 1
C Poka Yoke and FMEA Detection Ranking FMEA and Control Plans 3
K 4th Edition AIAG FMEA Occurrence, Severity and Detection Criteria for Plastics FMEA and Control Plans 1
Z PFMEA Detection Controls and Ranking - Prevent Shipment FMEA and Control Plans 3
S PCR suitable for detection of Salmonella Food Safety - ISO 22000, HACCP (21 CFR 120) 1
S FMEA Visual Inspection Detection Rating FMEA and Control Plans 5
J Moisture Detection and Measurement in Vacuum Oven (Plastic Dryness) General Measurement Device and Calibration Topics 2
E MSA of Attribute Gauges Signal Detection Method Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
B Calibrate Hole Presence Detection Device? General Measurement Device and Calibration Topics 5
T Root Cause - The difference between Occurence and Detection Problem Solving, Root Cause Fault and Failure Analysis 3
G Determining the "Detection" Number Component of the FMEA RPN FMEA and Control Plans 5
X Computer-Aided Detection for Mammography - Class A, B or C? IEC 62304 - Medical Device Software Life Cycle Processes 5
K Are 'Work Instructions' a Detection Control or Prevention Control? FMEA and Control Plans 8
P Removing Detection from DFMEA - Medical Device company using ISO 13485 FMEA and Control Plans 3
G ISO Registrars/CBs citing for use of "Detection" in Risk Management ISO 14971 - Medical Device Risk Management 27
R FMEA Detection Ranking for Testing Machines FMEA and Control Plans 8
S WEC/Nelson Detection Rules: Must process be in control? Statistical Analysis Tools, Techniques and SPC 1
K Defect Detection for Fresh Injection Molding Solid Parts Manufacturing and Related Processes 5
B "Detection, NOT Prevention!" - Relying on Final Inspection Quality Manager and Management Related Issues 48
M Customer requires Controls Detection to match Control Plan Control Method FMEA and Control Plans 2
M DFMEA Detection Ranking in AIAG FMEA Manual 4th Ed. - Explanation wanted IATF 16949 - Automotive Quality Systems Standard 6
Rameshwar25 Signal Detection Method Zone Classification Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
S MSA with Non Replicable Samples Measured at Detection Limit Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
A PFMEA (Process FMEA) Detection Rating - Actions to Reduce RPN FMEA and Control Plans 3
L FMEA Occurrence, Severity and Detection Criteria FMEA and Control Plans 3
V Detection ranking in FMEA FMEA and Control Plans 4
P Detection Rating in PFMEA and Process Controls FMEA and Control Plans 6

Similar threads

Top Bottom