Do you need FMEA for QS 9000

Elsmar Forum Sponsor
C

Christian Lupo

#2
FMEA's are necessary before you can be QS-9000 registered. FMEA's can be one of the most useful requirements of the standard.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
Both Design and Process FMEAs are required.

Don't forget control plans and the entire APQP process. In addition, you must be a tier 1 to Ford, GM and/or Chrysler or the requirement must be flowed down. It's not a 'cake walk'.
 
D
#4
I have been led to believe FMEA's are required only when requested by the customer. I do not have my FMEA book with me, but this also has been verified with consultants. Am I in for a rude awakening? FMEA's are very good for a company, but also very costly to a small comapany;extremely time consuming.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
QS9000 unambiguously requires:

Design FMEA
Process FMEA
Process Control Plan
Process Flow Diagram

No exceptions.

What consultant says you can register to QS9000 without these documents?

I beg to differ with you about the cost. If you do your documentation on your equipment you only do it once. Thereafter there will be regular minor updates as problems are solved and as other problems surface - but the main work is done during the initial effort.

Yes - if you believed otherwise you are in for a surprise. I know of no company which has been excused from this with the exception of design FMEAs for designs older than 5 years - which is in its self suspect, actually.

ISO9001 does NOT specifically require them but it does required a defined design process.

[This message has been edited by Marc Smith (edited 10-04-98).]
 
C

Christian Lupo

#6
Listen to Marc and not your consultant. PPAP requires FMEA. It may be implied in other areas but if you read the PPAP manual FMEA is required.

Although I agree that FMEA's are time consuming they save so much time and money in the long run, they are well worth the effort. An ounce of prevention.....
 
B

BRoyal

#7
I work in procurement quality in aerospace, a fairly long way from QS9000. Many of my suppliers are small jobs shops, 10-25 employees.

However, when working with the quality managers, I haul out the QS manuals on FMEA and APQP and touch on some of the concepts.

The manuals present logical and structured approach to providing quality product that, in the long run, is cheaper for the supplier and my company.

By no means do I expect them to do full blown FMEAs, control plans, etc.;I may order 250 separate parts a year from a shop in small lots of 6 - 12 pieces.

But manuals do get the management of these small shops thinking about quality from a systems/process approach. And that can hurt either of us.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#9
Dawn,

You wouldn't need FMEAs for every shop order on the floor. Compliance is determined by your PPAP/APQP records. You need to produce Design and Process FMEAs as part of your PPAP preparation and submittal for products sold to your OEM. They are living documents that need to be revisited periodically to determine if RPN values have changed and that all possibilities have been considered.

As others have stated before, this is a great tool in risk analysis for any product, OEM or otherwise. I recommend them strongly. Good luck.
 
B

Bryon C Simmons

#10
Hi.

My company ( job shop environment), produces an average of 100 different part numbers a day. We are QS-9000 compliant, etc. etc. I do NOT have FMEA, etc. for everything. It would take me years to do that.

What I have done, is what was mentioned....for jobs that are sold DIRECTLY to Chrysler/Ford/GM...for PPAP purposes, I have FMEA, etc. This constitutes about 50 different FMEA/Control Plans for me. I am starting to get requests from other non-Big Three customers, requesting FMEA.....my database is starting to grow. A good, well-planned FMEA can work wonders for you. It is a good practice to get into. Also, Ford requires that Ford engineers sign off on your FMEA/Control Plans. Don't forget that.

As part of your normal APQP activities, you would be developing FMEA and Control Plans.....especially if you submit for PPAP.

Hope this helps.

Bryon
 
Thread starter Similar threads Forum Replies Date
D Do you need requirements for a Design FMEA FMEA and Control Plans 1
K Need feedback: FMEA Web Application FMEA and Control Plans 5
A Will Inspection Process need an FMEA? FMEA and Control Plans 7
C AIAG FMEA 4th Ed "Design Assumption" - I Need Examples FMEA and Control Plans 15
S Does a FMEA need to fall into the ISO Documentation? FMEA and Control Plans 13
E FMEA Severity, Occurrence, and Detection Rating - I am in need of some examples FMEA and Control Plans 19
B Machining FMEA - I need help for good example FMEA and Control Plans 2
Q Process FMEA - Need help to clarify O (Occurrence) and D (Detection) rankings FMEA and Control Plans 26
J Do the inspection stages in flow chart also need to come out the FMEA? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
B Logistics FMEA - Never Have done One - Need Ideas FMEA and Control Plans 12
I Need Help with Process FMEA Basics - Feasibility Analysis Outputs are Inputs to FMEA? FMEA and Control Plans 25
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
N IPC-A-630 - Is this free or do i really need to pay for it? Manufacturing and Related Processes 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
P Need a programmer for QVI's VMS software for optical inspection machine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
silentmonkey How to decide what characteristics need to be verified during incoming inspection? ISO 13485:2016 - Medical Device Quality Management Systems 5
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 2
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Proof of Concept Studies - Do we need to comply with SAE reporting? Medical Device and FDA Regulations and Standards News 3
gunnyshore Adding a new facility - do I need to submit an amendment to the MDL or MDEL, or both? Canada Medical Device Regulations 3
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
A Demonstration of Equivalence - Need for comparing biological characteristics for an SamD EU Medical Device Regulations 1
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
W Need for current design or process control FMEA and Control Plans 2
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
S Need help with analysing a survey on minitab Using Minitab Software 1
M IATF 16949 8.5.1.3 Verification of job set-ups - Do we need secondary check? IATF 16949 - Automotive Quality Systems Standard 7
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
G Need resources / tutorials about OPS (Operation) for ISO IT (Information Technology) Service Management 8
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
K A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
G Do we need to QA cert? We only plan to supply reagents Medical Device and FDA Regulations and Standards News 3
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
R Evaluating the need for preventive action Preventive Action and Continuous Improvement 3
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
8 Need Help - Runout - Function Gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom