Control Plan or FMEA - Which comes first?

Helmut Jilling

Auditor / Consultant
#21
Re: What comes first? Control Plan or FMEA?

Folks,

All books and literatures about Control plans would tell you that it is generated after your FMEA. Your FMEA should drive your control plan since your critical and significant characteristics shall be defined during FMEA brainstorming. The best way is to make a SIPOC , then FMEA , then the control plan, then do a proactive review of your leading indicators, then review and update the FMEA again and again..
I agree this is the generally correct approach, but do bear in mind they both kind of develop concurrently, depending on what information is available and when. But, yes, in finalizing, the PFMEA should be finalized first, because it directs the control plan.
 
Elsmar Forum Sponsor
Q

qualityforlife

#23
The sequence of events is: Design FMEA, Process FMEA, and then Control Plan. FMEAs determine what characteristics need to be controlled and the Control Plan describes how to control it. Ford's Dynamic Control Plan actually combines the PFMEA and the Control Plan.
I'd look at current D,P FMEAs and control plans from a similar product first, saves alot of time... Without DFMEA you cant really set specs for parts, without clearly specified part process cant be defined, part and process not defined nothing to control!
 

Wes Bucey

Quite Involved in Discussions
#24
Re: What comes first? Control Plan or FMEA?

I agree this is the generally correct approach, but do bear in mind they both kind of develop concurrently, depending on what information is available and when. But, yes, in finalizing, the PFMEA should be finalized first, because it directs the control plan.
Wow! reviving a seven-year-old thread!

FWIW (for what it's worth):
I always thought of the FIRST step as Contract Review where supplier and customer reach agreement on the exact requirements for the product or service.
For the benefit of newbies and latecomers:
DFMEA = Design Failure Mode and Effects Analysis
PFMEA = potential (OR process) failure mode and effects analysis
FMEA = Failure Modes & Effects Analysis
PPAP = Production Parts Approval Process OR Program
APQP = Advanced Product Quality Planning
Control Plan = the overall plan for producing a conforming part or service, which may include minutiae such as speeds, feeds, machine and jig design, in-process inspection, final inspection, packaging, labeling, documentation, etc. etc.

(ignoring specific industry requirements for PFMEA, FMEA, and PPAP), it seems to me the next logical step after reaching agreement on the requirements for the finished product or service, including critical characteristics of form, fit, and function, the supplier maps out a preliminary plan for producing the product or service. As part of that plan, the supplier asks, "Where can this plan screw up and produce non-conforming service, material, or scrap (PFMEA and FMEA)?" After making decisions about the frequency and severity of those possible screwups, the supplier concocts a final control plan, considering the most efficient and profitable method of producing the conforming product or service after taking into account all the soft costs of dealing with any nonconforming parts that may slip through (returns, rework, scrap, recall, lawsuits, government sanctions, customer loss, etc.)

Sometimes, despite the best planning, the process still has glitches, so folks have to go back over every step. The real answer, it seems to me, is that the entire process of Contract Review, FMEA, PFME, FMEA, APQP, PPAP, Control Plan is continually fluid, always subject to improvement or "tweaking," continually searching for maximum efficiency and thus maximum profitability. Therefore, which exact stage of the process where one begins is moot because it's all part of one big circle, just like Deming's PDCA (Plan, Do, Check, Act.)
 
M

mustafa siddiqui

#25
Your control plan evolves. As I said, I start a control plan first and put customer defined critical characteristics on it. To get your critical characteristics you look at everything from industry standards on. Y9ou might machine a part and for that part to go in an assembly it may require a hole be placed within a certain area. It may be that area is critical, or it may not. You simply have to use your judgement and experience. There is no list you can go to.

I don't think the path is that critical. There is almost always overlap - as the DFMEA is being done quite often a PFMEA team (or person {reality, folks} is doing the Process FMEA. You have to understand the process, however. Sometimes there are DFMEA entries that are carried over to the PFMEA (not often, but it does happen from time to time).

I prefer to have a projected process flow diagram before starting the PFMEA as I believe you have a better idea of what to look at.

I wouldn't let the sequence bog you down. If you do the PFMEA before the DFMEA (which is very, very common - but I would say it is not the 'smartest way' to do it), it's a matter of reviewing the two together and checking to see if anything from the DFMEA should be added to the PFMEA.

If you review the APQP document I linked above and still have questions, come on back and ask more questions.

Gotta run. I'm leaving for Tampa in a couple of hours.
Marc,
Agreed to your suggestion on the decision to do that way. It is fine as long as the technology is a carry over one, like maybe the transmission of the vehicle, anything from existing production. Say if there is a New concept like a Hybrid technology, then you want to follow the sequence of DFMEA, DVP & R, DFMA(virtual design), then the process documents (PFD,PFMEA and Control PLan).
We have seen both the scenarios like carryover technology and new technology.
Thanks
Mustafa Siddiqui
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
D Link between FMEA, flow chart and control plan FMEA and Control Plans 10
S Family / Generic type of FMEA & Control Plan and Symbols FMEA and Control Plans 3
T Software for linking Process Flow Diagram, Process FMEA and Control Plan APQP and PPAP 9
C List Error Proofing in the Process FMEA or the Control Plan FMEA and Control Plans 2
K FMEA and Control Plan Header Content FMEA and Control Plans 6
Q Chrysler required FMEA and Control Plan Document Audit Forms and Process Audit Check FMEA and Control Plans 7
S FMEA and Control Plan in a Cord Blood Bank FMEA and Control Plans 2
R FMEA and Control Plan Linkage FMEA and Control Plans 3
Z Control Plan & FMEA Specifications - Level of Details FMEA and Control Plans 4
R Which parameters to be addressed in Control Plan from FMEA? FMEA and Control Plans 2
K FMEA and Control Plan In-House or send to Customer? APQP and PPAP 9
R Criteria for defining FMEA & Control Plan Critical and Significant Characteristics FMEA and Control Plans 10
D Control Plan & FMEA for Supplier Assembled Parts FMEA and Control Plans 3
P Robots in a Production Line - Control Plan and Process FMEA Manufacturing and Related Processes 9
T Current Process Controls Prevention - Process FMEA before Control Plan FMEA and Control Plans 5
D Process Diagram - FMEA - Control Plan Software APQP and PPAP 5
T Our products are Security Cabinets - FMEA & Control Plan Quality Planning help FMEA and Control Plans 1
D How does "outsourcing" get included in the FMEA and Control Plan? FMEA and Control Plans 4
Q Does every Process Control listed in FMEA have to be listed in the Control Plan FMEA and Control Plans 4
P FMEA & Control Plan for painting of plastic parts - Example wanted FMEA and Control Plans 3
ScottK Retroactive FMEA and Control plan - is this a common thing? FMEA and Control Plans 12
P FMEA and Control Plan for Plastic Injection Moulding/Painting Process FMEA and Control Plans 13
L Is FMEA revision the only input for Control Plan revision? FMEA and Control Plans 15
D The relationship between the FMEA and Control Plan FMEA and Control Plans 4
M Flow chart, FMEA, Control Plan for cable assembly for Automative industry IATF 16949 - Automotive Quality Systems Standard 3
E Control Plan and FMEA (non automotive) FMEA and Control Plans 9
Q FMEA (Failure Modes and Effects Analysis) and Control Plan Process Diagrams FMEA and Control Plans 3
Kales Veggie Informational How to develop a Control Plan from a PFMEA (Process FMEA) FMEA and Control Plans 61
J The real Link between a PFMEA (Process FMEA) and the Control Plan FMEA and Control Plans 19
M Connections between PFMEA (Process FMEA) and the Control Plan. FMEA and Control Plans 20
T ISO9001 or TS16949 FMEA and CONTROL PLAN For Tannery / Leather Industry FMEA and Control Plans 1
J How to connect FMEA, Control Plan, G8d, 5Whys and Draw the pareto Nonconformance and Corrective Action 0
D FMEA and Control Plan Characteristics Column - Product / Process Information FMEA and Control Plans 2
M Software to Handle All "Quality" Processes? APQP, Control Plan, FMEA, MSA, PPAP, etc. Quality Assurance and Compliance Software Tools and Solutions 1
C Process Flow Diagram, FMEA and Control Plan Attached - Please Review FMEA and Control Plans 6
B Links between Process Flow, Process FMEA and Control Plan IATF 16949 - Automotive Quality Systems Standard 22
R Layered Audits - Where to tie the layered audit process back to FMEA & Control Plan FMEA and Control Plans 10
R Dock audits on Process FMEA, Control Plan and Process Flow Diagram FMEA and Control Plans 5
J Software which links Process FMEA (PFMEA), Control Plan and Flow Chart Quality Assurance and Compliance Software Tools and Solutions 9
A How to establish linkage between specs/control plan/FMEA/process flow? Document Control Systems, Procedures, Forms and Templates 10
R ISO 9001 Vs. QS-9000 - Does ISO 9000 not require a Control Plan, FMEA, etc.? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
apestate Short FMEA and Control Plan - What am I doing wrong? FMEA and Control Plans 5
apestate Multiple Attachments: FMEA and Control Plan Forms Document Control Systems, Procedures, Forms and Templates 14
S Control Plan and Design FMEA (DFMEA) Links FMEA and Control Plans 4
A Microsoft Access APQP type database for Process Flow, FMEA, Control Plan, etc. Quality Assurance and Compliance Software Tools and Solutions 44
M FMEA and Control Plan Software - Seeking advice Quality Assurance and Compliance Software Tools and Solutions 12
A Prototype control plan FMEA and Control Plans 2
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 1
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3

Similar threads

Top Bottom