Link between FMEA, flow chart and control plan

#1
Hello everybody,

I am running a discussion with a newbie customer SQA regarding the link between FMEA, flow chart and control plan.

As per my knowledge, all the phases I identify in my flow chart shall be reported with the same number (or name) in my FMEA. In my control plan I should report only those phases where I have established a visual or a measureement check or whater cheks which might effect the quality of my product.

For example, if I have an internal Handling phase (#20) related to material movement from warehouse to machine and I have no checks on the material when arrive to press then I have nothibg to mention in the control plan, but ovviosly yes in the flow chart and FMEA.

Am I right?

Thanks in advacne and sorry for the stupid question.
 
Elsmar Forum Sponsor

outdoorsNW

Involved In Discussions
#2
Can you give more details about what the customer is asking for?

I am guessing the customer is concerned there is not a line in the control plan for something that is in the flowchart and FMEA. I have two thoughts. 1) You may actually have a weak control from verifying the part number, job number, outputting a computer generated delivery location, or similar for the material. 2) If you do not have any controls, which may be reasonable if there are good controls in other places, you may need a line with "none" or similar to indicate there is not an unintentional omission.
 

Jim Wynne

Staff member
Admin
#3
Hello everybody,

I am running a discussion with a newbie customer SQA regarding the link between FMEA, flow chart and control plan.

As per my knowledge, all the phases I identify in my flow chart shall be reported with the same number (or name) in my FMEA. In my control plan I should report only those phases where I have established a visual or a measureement check or whater cheks which might effect the quality of my product.

For example, if I have an internal Handling phase (#20) related to material movement from warehouse to machine and I have no checks on the material when arrive to press then I have nothibg to mention in the control plan, but ovviosly yes in the flow chart and FMEA.

Am I right?

Thanks in advacne and sorry for the stupid question.
It's not at all a stupid question, but it sounds like your customer might be asking one. You are correct. A big part of the APQP process is narrowing down, using experience and evidence, what needs to be controlled, and the extent or type of controls to use. This means that while in general the flow diagram and PFMEA should match 1:1, that's not necessarily the case with the control plan. The control plan should display what needs to be controlled, and not be cluttered up with a bunch of N/A entries.

Be aware (if you aren't already) that common sense often goes out the window when dealing with customer quality people. Despite best efforts in explaining why you do things, you might wind up having to do extra, nonsensical work in order to move forward.
 
Last edited by a moderator:

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Be aware (if you aren't already) that common sense often goes out the window when dealing with customer quality people.
Amen.... APQP

APQP Timeline.jpg


In so many years, things haven't changed (not withstanding some custtomer specific requirements).
 
#5
Thanks a lot for your feedback. Appreciated.
At the end I convinced the guy and avoid stupid NC. Anyhow Yesterday we did internal sysmet audit using external IATF auditor and I made the same question. He agreed with our statement but he also said that, ufortunately, the result of the discussion might be completly differnt because is linked with the auditor mindset.
Regards.
 
#7
Hello
Please i want to perform FMEA process , i started with making the organigram to see the components for which the process is being analyzed and to select the risks that can appear from this components
So my question is when i solve like that is not about FMEA design ?? or is already correct
 

Jim Wynne

Staff member
Admin
#8
Hello
Please i want to perform FMEA process , i started with making the organigram to see the components for which the process is being analyzed and to select the risks that can appear from this components
So my question is when i solve like that is not about FMEA design ?? or is already correct
I'm not sure what an organigram is, but it seems more like a DFMEA than a PFMEA. The latter is intended to deal with the risks of a manufacturing process rather than individual components. Please explain in more detail.
 
#9
I'm not sure what an organigram is, but it seems more like a DFMEA than a PFMEA. The latter is intended to deal with the risks of a manufacturing process rather than individual components. Please explain in more detail.
Thank you so much mr jim for your quick answer
The thing that i have special process ( macrography inspection) so FMEA analysis will let discovering the risks that can appear and effect the part inspected , so i want to solve with the compements for example ( tanks / heater / thermometer ... because the malfuction of this component will effect the parts ) this is why i want to perfom PFMEA but in DFMEA way , i don't know if it could be or not . the important think is to avoid risks on this macro-process
 

Jim Wynne

Staff member
Admin
#10
Thank you so much mr jim for your quick answer
The thing that i have special process ( macrography inspection) so FMEA analysis will let discovering the risks that can appear and effect the part inspected , so i want to solve with the compements for example ( tanks / heater / thermometer ... because the malfuction of this component will effect the parts ) this is why i want to perfom PFMEA but in DFMEA way , i don't know if it could be or not . the important think is to avoid risks on this macro-process
I'm not sure that I understand. "Macrography" is visual (naked eye) inspection. Are you concerned about the manufacturing process (in which PFMEA would be appropriate) or something related to the inspection itself?
 
Thread starter Similar threads Forum Replies Date
J The real Link between a PFMEA (Process FMEA) and the Control Plan FMEA and Control Plans 19
Q Do we have to prove a link between the mill and our raw material supplier? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
M What is the link between Poka Yoke and Firewall? General Auditing Discussions 2
K Link between Control of Documents, CPAR & Control of Non-Conforming Product Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
AnaMariaVR2 Link between failure to comply w/ Lab PPE standards & ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Link between Risk Management, Usability Engineering and R&D in Medical Devices ISO 14971 - Medical Device Risk Management 2
G What is the link between FDA and US Pharmacopeia? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
W Need a link to a thread here - Discussed the difference between lean and six sigma Registered Visitor Articles Archive 9
dgrainger Medical Device News MDR postponed - link to Official Journal of the European Union (24-4-2020) EU Medical Device Regulations 2
dgrainger Informational Corrigendum 2 OJ link Medical Device and FDA Regulations and Standards News 0
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
F IMDRF opened a Consultation on Annex E & F and the link to ISO 14971 ISO 14971 - Medical Device Risk Management 4
S FEE Registration LINK - EU Medical Device CE Marking (Conformité Européene) / CB Scheme 6
J Macro Question: Get Column Name by Column Number / or Use Text constant to link on a Using Minitab Software 1
K How to setup DDEs in Minitab to link a project to an Excel workbook Quality Tools, Improvement and Analysis 2
V The best practice to maintain & link Design and Process FMEAs FMEA and Control Plans 8
N Is there a formula to link words in Excel sheet to a graph? Excel .xls Spreadsheet Templates and Tools 5
T How to link Process Design Changes in Serial Production to Design & Development? Design and Development of Products and Processes 6
somashekar Link to important websites within the Cove Book, Video, Blog and Web Site Reviews and Recommendations 1
M Food Transportation the Weakest Link? Mixing cargo in food trucks Food Safety - ISO 22000, HACCP (21 CFR 120) 0
J How to Link Electronic Records (510k Documents) to Handwritten Signature Other Medical Device Regulations World-Wide 16
A SPC Software Packages - Real Time and can link to Databases including Oracle Statistical Analysis Tools, Techniques and SPC 7
T Dock to Stock Approval form, link or information Document Control Systems, Procedures, Forms and Templates 3
S Help needed to link accounting and ISO procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J0anne Link to find 502 (f)(1) which is quoted several times in 21 CFR 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S Quality Manual Review - Should the manual link all procedures Quality Management System (QMS) Manuals 5
Hershal Social groups...... See link at the top of the page Coffee Break and Water Cooler Discussions 1
L ISO 9001:2008 - What will it mean? An Article link ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Money available - but I need to link to 5s Lean in Manufacturing and Service Industries 5
M ISO 22000 and HACCP - Their link and basic steps in implementation Food Safety - ISO 22000, HACCP (21 CFR 120) 1
H Quality Control for Rubber Mixing and/or link to related forum Inspection, Prints (Drawings), Testing, Sampling and Related Topics 27
N Fuel Prices Link To The Oil Market - The Oil Tree World News 4
Fexjo How to Link Quality Management System, Manufacturing and Product Audits IATF 16949 - Automotive Quality Systems Standard 1
R Looking for a link to a story - Because Nobody did it, the project didn't get done Coffee Break and Water Cooler Discussions 4
J Link to a vitual MBA Managers skills course pdf file Book, Video, Blog and Web Site Reviews and Recommendations 0
A e System - Planning to computerize and link the systems IATF 16949 - Automotive Quality Systems Standard 1
I Need link to PDF file ISO TC/176/SC2 Home Page ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Are you looking for a plant link in Europe? Career and Occupation Discussions 1
Marc Elsmar Cove Forums Link Listed in Wikipedia.org Coffee Break and Water Cooler Discussions 6
B Quality and Health & Safety. How close is this link? Document Control Systems, Procedures, Forms and Templates 8
L Link to an example of a full 19 element PPAP example - Seeking APQP and PPAP 5
C How to "link" normal process variation and "triggers" for Internal CAs? Nonconformance and Corrective Action 6
A Folks take your time & rate your boss - A link to a 'test' on another site Coffee Break and Water Cooler Discussions 2
J Seeking: Process Link Chart example IATF 16949 - Automotive Quality Systems Standard 1
B What to do once an FDA Inspection is over - Seeking FDA site Link ISO 13485:2016 - Medical Device Quality Management Systems 7
C Useful Link (Dti) Department of Trade and Industry (UK) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S EMS Link to APQP - Added an EMS sign off to our Engineering Change Notice form Miscellaneous Environmental Standards and EMS Related Discussions 3
Marc KPMG is requiring permission to link their website Registrars and Notified Bodies 0
M GM specific requirements ISO/TS 16949 link Customer and Company Specific Requirements 4
T TE Supplement and QS9000 - The Link QS-9000 - American Automotive Manufacturers Standard 11
Similar threads


















































Top Bottom