SBS - The Best Value in QMS software

Connection between DFMEA and PFMEA - What must be transferred to the PFMEA?

M

mahoc

#1
Someone could tell me what is the DFMEA information that must or may transfer to the PFMEA?
Do you know if there are any manual that I canverify this data?:
- All the DFMEA causes must be moved to the PFMEA like Potential Failure Modes
- For these Pot. Failure Modes I must put the same DFMEA Effects?
- The severity for theses effects must be the DFMEA ones?

Waiting your comments. Regards
 
Elsmar Forum Sponsor
M

maosm

#2
My norm interpretation is:
The connection between DFMEA y PFMEA is important as reference such as other PFMEA, because works like a preliminar PFMEA and improvement efficiency the final results.
If DFMEA is available, the connection must be done, even though the norm said "should".
 
Last edited by a moderator:
D

dokes

#3
dFMEA and pFMEA connections

Primary info that is same in both FMEAs is the Effect and the related Severity rating. It doesn't matter if, for example, a radius was designed undersize or manufacturered undersize, the effect on the product/customer will be the same. Since the effect is the same the severity of the impact is the same.
 
Q

qualitygoddess - 2010

#5
Differences

mahoc said:
Someone could tell me what is the DFMEA information that must or may transfer to the PFMEA?
Do you know if there are any manual that I canverify this data?:- All the DFMEA causes must be moved to the PFMEA like Potential Failure Modes
- For these Pot. Failure Modes I must put the same DFMEA Effects?
- The severity for theses effects must be the DFMEA ones?

Waiting your comments. Regards
There are many books and references on the subject. Typically, Design FMEA and Process FMEA are different documents, since the design process is typically different from the process to make something. I suppose each one could contain the same or similar information, depending on the product or service that is being designed or processed. I would recommend that you take a look at some reference books. If you are working with an automotive customer, ask them for a copy of the FMEA manual from Automotive Industry Action Group (AIAG). This is very helpful to understand the difference between DFMEA and PFMEA.

Otherwise, you can pick up books on FMEA from a technical library on a college campus or do a search on ASQ's website.
 
C

chalapathi

#6
mahoc said:
Someone could tell me what is the DFMEA information that must or may transfer to the PFMEA?
Do you know if there are any manual that I canverify this data?:
- All the DFMEA causes must be moved to the PFMEA like Potential Failure Modes
- For these Pot. Failure Modes I must put the same DFMEA Effects?
- The severity for theses effects must be the DFMEA ones?

Waiting your comments. Regards
Designer's limitations are passed on to Process FMEA team. For example, a scotter design engineer is analyzing "Flat Tyre" as a failure. He can give tube less tyres, but that will increase the cost and he can not do (this is a design constraint). Can some thing be done in the process to take care of this constraint.

Similarly, when doing Process FMEA, they may have some failure, which designer can modify the design to eliminate the cause or reduce the cause or reduce the impact. For example, if there is problem in loding components correctly in a machine. The designer can provide some kind of fixture/jigs.

Hope I could clarify some of your questions.
 

antoine.dias

Quite Involved in Discussions
#7
PFMEA versus DFMEA

The AIAG manual on FMEA is describing the differences and the connections.
you may also find SAE J 1739 useful to understand the differences and connections.

Best regards,

Antoine
 
M

Michael Walmsley

#8
The primary connection is in the area of special characteristics, if applicable.

eg In a design component FMEA we may have a diameter that is critical such that it has a special characteristic associated with it (along with showing up on the print). You then need find in the PFMEA where the diameter is machined or manufactured. At this point where the station and operation is defined , the characteristic had better be assigned.

In general,Severity of effects may differ in the DFMEA and PFMEA. In the DFMEA the effect is to the end user. In the PFMEA the effect is to the process (unless of course you would like to embed the effect to end user also for traceability purposes).

If the severity of effect to the process is greater than the severity to the end user , you may have a different characteristic assigned.

See attached
 

Attachments

Jim Wynne

Staff member
Admin
#9
Michael Walmsley said:
The primary connection is in the area of special characteristics, if applicable.

eg In a design component FMEA we may have a diameter that is critical such that it has a special characteristic associated with it (along with showing up on the print). You then need find in the PFMEA where the diameter is machined or manufactured. At this point where the station and operation is defined , the characteristic had better be assigned.

In general,Severity of effects may differ in the DFMEA and PFMEA. In the DFMEA the effect is to the end user. In the PFMEA the effect is to the process (unless of course you would like to embed the effect to end user also for traceability purposes).

If the severity of effect to the process is greater than the severity to the end user , you may have a different characteristic assigned.

See attached
Good advice :agree1: especially about differentiating effects between the D- and PFMEAs. I'll add that sometimes there's no access to a DFMEA when a PFMEA is done, so the customer's critical characteristics must be identified on the drawing. If the DFMEA is done properly, and the specifications are properly constructed and communicated as a result, it's not necessary to have access to the DFMEA when doing the DFMEA, especially in the case of job shops.
 
T

The Kidd

#10
Consider the DFMEA a design system element. Consider the PFMEA a process sytems element. In linking system elements: Failure Modes in higher level system elements are Effects in lower level system elements. Failure Modes in lower level system elements are Causes in higher level system elements. Do not violate the incoming quality rules and you can link any number of sytem, subsystem, components down to the manufacturing process.
 
Thread starter Similar threads Forum Replies Date
S Is there any connection between PFMEA and Acceptance Plan FMEA and Control Plans 1
L Connection between IEC 62304 and Chapter 14 of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
F Functional connection between ME and non-medical equipment in different rooms IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
optomist1 Contour vs. Profile - Is there a connection between "Contour" & "Profile"? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
S What is the connection between Ford's phased PPAP and edition 4 from AIAG APQP and PPAP 4
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D Defibrillation protection for patient connection except for electrodes IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B USB-Connection - Creepages and Clearances IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
U PATIENT CONNECTION for HAND-HELD Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B Detachable Power Supply Cable Connection ESD Clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
R Connection to a generic separate power supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Q ME System - Is a Wireless Connection a "Functional Connection"? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
R Appliance Connection for IEC 60601-1-11 Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Is protective earth connection regarded as a part of the applied part? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Wes Bucey Slow Internet Connection After Work and Weekend Discussion Topics 3
P Test Voltages for a Pulse Transformer used to Isolate the Patient Connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
I Connection of Secondary Circuits to Medical Weight Scale Enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
W Patient Circuits / Patient Connection / Applied Parts - Medical Device Definitions IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Jim Wynne Tech Guy Radio: Woman Wants Help in Getting Her Stolen Internet Connection Back After Work and Weekend Discussion Topics 2
Colin Cost of Internet connection in hotels Travel - Hotels, Motels, Planes and Trains 55
L Is there any connection betweeen ISO 14001 and RoHS? RoHS, REACH, ELV, IMDS and Restricted Substances 6
T PPAP Appendix F.3 "Customer Plant Connection" - Bulk Materials - Steel Coil Supplier APQP and PPAP 4
A What is different between Field Safety Notice and Advisory Notice in U.S and EU? Document Control Systems, Procedures, Forms and Templates 0
R Whats different between these position CE Marking (Conformité Européene) / CB Scheme 10
G What's the difference between 1.32 and 1.33 Cpk? Capability, Accuracy and Stability - Processes, Machines, etc. 18
U How to pick between ANSI Z1.4 vs. ISO2859-1 for AQL Inspection? What are the major differences? AQL - Acceptable Quality Level 4
H Independence between the development and testing IEC 62304 - Medical Device Software Life Cycle Processes 6
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
N R&R for Differences between 2 measurements Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
S Distinction between a critical supplier and a Virtual manufacturer EU Medical Device Regulations 2
I Сorrespondence between hazards and risks ISO 14971 - Medical Device Risk Management 2
W What is the difference between TYPE B and TYPE BF? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
Q Terminal Lugs sizes - Difference between 225/24 vs. 275/24 lugs Manufacturing and Related Processes 2
T Relationship between ISO 9001 and ISO – IEC BS EN 870079- 34 2020 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Difference between "Production Trial Run" and "Run at Rate" IATF 16949 - Automotive Quality Systems Standard 8
Ron Rompen Surface Finish Correlation between Ra, Rz and Tp (bearing surface ratio) General Measurement Device and Calibration Topics 3
L MRA between EU and Switzerland - 1/2021 EU Medical Device Regulations 2
D Difference between Test Method Validation and Gage R&R Qualification and Validation (including 21 CFR Part 11) 18
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
C Is my software an accessory? Telecommunication between HCP and patients EU Medical Device Regulations 10
K Verify Software Architecture - supporting interfaces between items IEC 62304 - Medical Device Software Life Cycle Processes 2
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
DuncanGibbons How is the arrangement between Design and Production organisation envisaged? EASA and JAA Aviation Standards and Requirements 4
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
T Difference between a subcontractor and a supplier ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
K %GRR was between 10-30% so we have to have a "backup plan" per auditor IATF 16949 - Automotive Quality Systems Standard 15

Similar threads

Top Bottom