TE Supplement and FMEA's

D

Dan De Yarman

#1
The TE Supplement states: "Internal processes should be addressed using this discipline." (pg. 5) The FMEA manual states: "The FMEA discipline will also assist in developing new machines or equipment. The methodology is the same, however, the machine or equipment being designed is considered the product." (pg. 29)

It appears to me that the FMEA wants us to use a Design FMEA, while the TE Supplement wants us to use a Process FMEA. Which FMEA are we suppose to use, or are we suppose to use both methods?

Any help is always appreciated.

Thank you,

Dan
 
Elsmar Forum Sponsor
T

Tom Goetzinger

#2
Our registrar said we needed to have evidence of using both design and process FMEAs as quality planning tools. They can be generic, if that is appropriate to your product line.
We had recognized FMEA's as a good tool, and had an formal action request in our system to train our engineers in their use, but the auditors wanted to see samples of them prior to recommending us for registration to TE. That's the last thing on our non-conformance list and I'm currently waiting for our engineering dept to finish the design FMEA so I can submit the action plans to our Lead Auditor.
As I side note, has anyone used AIAG's self-tutorials on Design and Process
FMEA development? Would be interested in your opionions on it.
 
R

Roger Eastin

#3
Do you design the equipment that you are making? If you are, then you need to do a DFMEA. If you are not, then the company that does design the equipment should do a DFMEA and let you see the results. The DFMEA should have areas in it that you'll find useful for inputs to your PFMEA.
 
S

Sean D Bannister

#4
Are you aware of the supplement guidelines for Machinery FMEA. They are essentially Design FMEA specifically biased towards machinery design, but requires knowledge of the intended process. We do not conduct process FMEA as a seperate activity. This can only be effectively conducted with the customer engineering team.
I have the Machinery FMEA Handbook in pdf if you wish a copy.
Sean
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
I sure would like a copy of the handbook you have.

I might also add the recent asqc rag has an article on equipment fmea's.
 
D

Dan De Yarman

#6
I would like to thank all of you for your input. However, I will address each of you individually, here in this forum.

Roger, we do design our equipment here. In fact, we typically take the equipment from the development stage (pre-design) all the way through to servicing; we are fully capable. According to Tom, I need to do both, is this correct? I would think that it is, with one exception (see next paragraph).

Tom, your company manufactures repetative product, correct? You can make changes to the design and processes and see improvements in the suceeding products, right? Even though we do make some standard products, the majority of our machinery and vast majority of revenue comes from custom machinery. Almost every machine we design, build, install, and service is different. Some machines are similar, but there are practically no two machines of ours that our exactly the same. Even if built under the same purchase order and at the same time, "duplicate" machines are different. The first machine goes through more rework and debug so the second machine benefits from it. Therefore, the second machine will be different from the first one, possibly even some details in the design. We do not do enough repeat business of the exact same machine for FMEAs to be truly useful as they were intended. The only benefit I can see for us to do FMEAs, is to practice so we can show that we can do one. All we will be doing is going through the motions, and not gaining any real significant return on the investment (meaning time spent on FMEAs). Tom, if I am wrong about your process, please let me know how you are dealing with this issue.

Sean, I just had one of my internal auditors, who happens to be an engineer, take a FMEA class last Friday (that was provided by Plexus) and he was never told about any supplement guidelines for Machinery FMEA. I would love to have a copy, thanks. My question to you is, has this guideline been accepted by the big three and the AIAG? Where did you get it from? I'm assuming, if we say we comply to the guideline, then I will have to have a good, controlled copy, just like the 7-pack from the AIAG.

Mark, thank you for establishing this wonderful forum so people like me can try and get up-to-speed on these quality issues. I am currently not a member of ASQ, even though I work on the north side of Milwaukee, WI (Glendale actually), is becoming a member difficult? What are some of the benefits? Can I get a copy of the ASQ newsletter, or whatever it is, without being a member?

Thank you again to everyone!

Dan

[This message has been edited by Dan De Yarman (edited 15 December 1999).]
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#7
Well, I won't go into details, but I'm not a big ASQC proponent. I am a member, however. I'm not sure how you can get a news letter without belonging. I will say the monthly magazine is probably worth the yearly 'dues'.
I think it's like US$80 a year.
 

barb butrym

Quite Involved in Discussions
#8
go to www.ASQ.org to get the answers about whats available to members and the general public. the membership is about $80 plus division fees (typically <$10) if you opt to join any...as in the 'automotive division'
most sections and divisions have web sites open to the public with their newsletters posted (can access from the asq site)....and then of course there is the 'asq.net' (search/info stuff) available to members only.

AS in any society you need to choose what is of value and seperate the BS. They have improved their services over the years, but still have room for more growth...LOL

Glendale...hmmmm. I was there last week doing Internal auditor training.
 
T

Tom Goetzinger

#9
Dan,
Our product line (induction heating and melting equipment) is much like yours. Almost every unit is different from the others built, yet they all have similarities to previously designed and built units. Use your FMEAs to address designs more generically. In reality, your engineering department is probably doing much of the thought process required by FMEAs; they are just not documenting it using that format. By documenting it, you may find that you can continually improve on the process and eliminate some redundant efforts.
I found that the use of a good consultant was extremely valuable to our registration process. Our companies are located in the same area, and I can recommend a good local consultant if you are interested.
Hope I've cleared it up a little.
Tom Goetzinger

[This message has been edited by Tom Goetzinger (edited 17 December 1999).]
 
Thread starter Similar threads Forum Replies Date
Z FMEA Requirements in QS-9000's TE Supplement QS-9000 - American Automotive Manufacturers Standard 1
D Does anyone know of a good FMEA training class for TE Supplement suppliers? Training - Internal, External, Online and Distance Learning 2
D Machinery FMEA (MFMEA) Training for a QS-9000 TE Supplement company Training - Internal, External, Online and Distance Learning 5
P Ford Fmea Handbook Supplement QS-9000 - American Automotive Manufacturers Standard 2
T Ford's FMEA Handbook Supplement QS-9000 - American Automotive Manufacturers Standard 4
Anonymous16-2 Dietary Supplement Raw Material/Component Storage and Production Manufacturing and Related Processes 1
D API Q1 Supplement Audit Format Internal Auditing 0
Ajit Basrur FDA News FDA Guidance Document: Manufacturing Site Change Supplement US Food and Drug Administration (FDA) 0
D FDA Registration - MD, OTC or Dietary Supplement US Food and Drug Administration (FDA) 0
Q 21 CFR Part 111 - Requirements for Dietary Supplement Manufacturing Water Quality Document Control Systems, Procedures, Forms and Templates 1
D DFARS (Defense Federal Acquisition Regulation Supplement) Raw Material Information Various Other Specifications, Standards, and related Requirements 1
Q Weighing Dietary Supplement Powder during manufacturing US Food and Drug Administration (FDA) 2
S Z299 Special Process Supplement Document Manufacturing and Related Processes 1
AnaMariaVR2 FDA GMP Inspectors Cite 70% of Dietary Supplement Firms Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
A Dietary Supplement Supplier Re-qualification Frequency and Criteria? Supplier Quality Assurance and other Supplier Issues 2
L Implementing ISO 9001: 2008 in a Dietary Supplement Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
V Is Dissolution Test Mandatory for Dietary Supplement? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
N Writing our Standard Operating Procedures for Dietary Supplement Co - Examples wanted Document Control Systems, Procedures, Forms and Templates 7
O Requalification/Revalidation Activities - Dietary Supplement Manufacturing Equipment Design and Development of Products and Processes 3
Q DFARs 252-225-7014 (7008, 7009) (Defense Federal Acquisition Regulation Supplement) Various Other Specifications, Standards, and related Requirements 1
V Suggest an expert in Food Supplement Quality Standards in India Food Safety - ISO 22000, HACCP (21 CFR 120) 1
AnaMariaVR2 New NIST reference materials available for popular diet supplement Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
V DFARS (Defense Federal Acquisition Regulation Supplement) Licensing? Bulgaria Various Other Specifications, Standards, and related Requirements 14
R PMA (Parts Manufacturing Approval) Supplement - Labeling Software Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Customer requesting NQA-1 supplement, ZS-1 w/appendix, ZA-1 compliance Various Other Specifications, Standards, and related Requirements 4
T ASME NQA-1-1994 Standard Supplement 17S-1: Dual Storage Various Other Specifications, Standards, and related Requirements 5
Q COAs for 21 CFR 111 - Identity, Purity, Strength - Dietary Supplement Industry US Food and Drug Administration (FDA) 4
Q R&D line being used to supplement Manufacturing line IATF 16949 - Automotive Quality Systems Standard 1
M ASME NQA-1-1994 Standards - Struggling with the supplement references Various Other Specifications, Standards, and related Requirements 16
S Final draft Supplement 1 to the GUM Measurement Uncertainty (MU) 3
A Dietary supplement: GMP or HACCP? Food Safety - ISO 22000, HACCP (21 CFR 120) 5
J Definition What is DFARS - Defense Federal Aquisition Regulation Supplement Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
M Fate of T&E (Tooling and Equipment) supplement from QS 9000 Various Other Specifications, Standards, and related Requirements 2
Q PFMEA and Semi Conductor Supplement - ISO/TS 16949 Clause 7.3.3.2S FMEA and Control Plans 3
M OLD Standard Documentation QS-9000 & TE (Tooling and Equipment suppliers supplement) Document Control Systems, Procedures, Forms and Templates 12
S Supplier Self certification - DCX Forever Requirements supplement IATF 16949 - Automotive Quality Systems Standard 2
S ISO 14971 and 13485 - Is ISO14971 just a supplement to ISO13485? ISO 14971 - Medical Device Risk Management 2
D Gage RR to train operators? QS-9000 Semiconductor Supplement 4.11.4.S Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
Q 6 Weeks to convert from QS-9000 TE Supplement to ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Manix Template of Supplement K from the QS9000 APQP manual APQP and PPAP 11
V TS 16949 Semiconductor Supplement Status - Obsolete? IATF 16949 - Automotive Quality Systems Standard 1
V Semiconductor Supplement to TS 16949 - Is the Semiconductor Supplement obsolete? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 24
O Quality Systems Manual Ideas - Moving from QS-9000 / TE Supplement to ISO 9001:2000 Quality Management System (QMS) Manuals 8
C Semiconductor Commodity Supplement 7.3.2s - Leadframe for semiconductors Customer and Company Specific Requirements 0
W Is the AIAG's Automotive Semiconductor Supplement Obsolete?? IATF 16949 - Automotive Quality Systems Standard 10
R QS-9000 / TE Supplement Audits changed to Process Oriented Approach QS-9000 - American Automotive Manufacturers Standard 3
L Is there a requirement for Directors meetings as a supplement to management reviews? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
D First Pass Design Success - TS 16949 Semiconductor Supplement Design and Development of Products and Processes 5
R Can We Drop Our TE Supplement? QS-9000 - American Automotive Manufacturers Standard 8
K The "Shalls" of QS9000 T&E Supplement QS-9000 - American Automotive Manufacturers Standard 4

Similar threads

Top Bottom