Control Method correspondence between PFMEA and CP

#1
Hi everyone, I am looking forward for your input.

It is said (as per AIAG) that there should be correspondence between the PFMEA and CP in regards of the "control methods" for all characteristics (which has failure modes, effects and causes associated).

Before expressing my approach, I want to set the following assumptions:

a) Controls should be planned in the PFMEA in order to prevent ("ocurrence") and to detect ("detection") failures modes and/or their causes. With this, we pursue to keep ocurrence and detection ability in an aceptable level in accordance with "severity".
b) All Control Plans I have seen in the past only include one control, typically for detection and in few cases for prevention when there are poka-yokes involved.

My approach is that every characteristic in the CP should include both control methods (prevention/detection) defined in the PFMEA.


Please give me your point of view about what I am right and what I am wrong, since I have not found any compelling answer from customer representatives or consultants.

Best Regards
 
Elsmar Forum Sponsor

Sebastian

Trusted Information Resource
#2
Dear Mario,
there are three sources of requirements related to control plan content: AIAG APQP and Control Plan manual, IATF 16949 standard and Customer Specific Requirements. Unfortunately requirements are not "synchronised" so it is organization's job to satisfy all of them.
IATF 16949 section 8.5.1.1 says:
The organization shall have a control plan for pre-launch and production that shows linkage and incorporates information from the design risk analysis (if provided by the customer), process flow diagram, and manufacturing process risk analysis outputs (such as FMEA).
So literary not only PFMEA outputs shall be included in control, but also DFMEA. Only one thing I do not understand is why only when provided by customer when organization can be design responsible and therefore performs own design risk analysis.

All detection (no matter prevention/detection) activities who were listed in PFMEA as "in place" shall be transferred into control plan. Control plan shall be updated also with all recommended actions related to detection activities, when they are in place.
Regarding prevention, frequency of verification of error proofing methods shall be included in control plan, this is all as specified by IATF 16949 standard section 10.2.4.

I have seen not so much organizational control plans, but generally, what I've seen is not so encouraging. In most cases control plan were limited only to activities performed by humans. Manufacturing machine embedded steering systems, who control process parameters during every cycle were not mentioned there.

In my opinion your understanding is correct, but as long it is not literary written in manuals or standard, organizations will create control plans as they want.
 
#3
Thank you Sebastian

I guess it should suffice if the control plan references at leats one of the two controls listed in PFMEA (detection/prevention) for each characteristic, we would be in non-compliance if the control is another different than any of those stated in PFMEA.

In practical terms it does not have sense to me if we do not reference all controls defined, so we are putting aside some valuable controls that are not assured to be implemented and audited as they are not present in the CP.

Regards
 

Sebastian

Trusted Information Resource
#4
IATF 16949 section 9.1.1.1 says:
[...]The organization shall verify that the process flow diagram, PFMEA, and control plan are implemented[...]
Some might say it is clear evidence that not all detection methods from PFMEA shall be in transferred into control plan. I would say, that IATF is aware of poor quality of control plans and assign e.g. internal auditors to detect discrepancies between line conditions and these three documents. By the way PFMEA is a new element here comparing to ISO/TS 16949 section 8.2.3.1.
 

paccnc

Starting to get Involved
#5
Hi Mario, I hope you don't mind but I want to piggy back a question regarding control plans and error-proofing methods. We received a minor N/C for our control plans because we didn't list our error-proofing methods on the control plan per Annex A in the IATF 16949 Standard under Methods item b) error-proofing. I was interested in how other people are addressing this item? Thank you in advance for your assistance.
 

Sebastian

Trusted Information Resource
#6
Did you have it in PFMEA? If yes, so copy information from PFMEA "Requirement" column into Control Plan "Characteristic" (product or process).
Then copy information from PFMEA "Prevention" column into Control Plan "Control Method".
Does this answer your question?
 

paccnc

Starting to get Involved
#7
We didn't have it listed in the PFMEA. What the finding was is that we use a feed sensor and part out sensor on our die. When we set the job up our operators set up these sensors. We didn't have them listed on our control plan as an error proofing method. So I don't need to add a complete new column on the control plan called Error roofing, I just need to list it in the Control Method and list it as error proofing, correct?
 
#8
Paccnc

There are some questions that need to be answered.

1. Does that error proofing help to prevent any failure mode you have defined in your PFMEA?
2. If so, what is the current control you have declared in the "Control Method" column in your control plan for the characteristic associated to that failure mode?

For example:
If your failure mode in PFMEA is: wrong nut assembled
The associated product characteristic in the CP may be: correct nut 9/16"
The control method column in the CP may be: inspection, measuring, error proofing, etc.
 

paccnc

Starting to get Involved
#9
Paccnc

There are some questions that need to be answered.

1. Does that error proofing help to prevent any failure mode you have defined in your PFMEA?
2. If so, what is the current control you have declared in the "Control Method" column in your control plan for the characteristic associated to that failure mode?

For example:
If your failure mode in PFMEA is: wrong nut assembled
The associated product characteristic in the CP may be: correct nut 9/16"
The control method column in the CP may be: inspection, measuring, error proofing, etc.
Mario, Thanks you for your reply. Do you have an example that I might be able to look at so that I can get a clearer picture of what you mean?
 
Thread starter Similar threads Forum Replies Date
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
qualprod ISO 9001 Risk control method - What could be the better way to control risks? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Is RECORD a Control Method? APQP and PPAP 8
Q Method of Document Management (Control) in Engineering - Please Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Customer requires Controls Detection to match Control Plan Control Method FMEA and Control Plans 2
T Inspection Method and Control Method for Visual Inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T How to define the measurement technique and control method for manual soldering FMEA and Control Plans 10
J Quality Control of High Tension Steel Cable Bolt - Inspection Method Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
B Customer Required Control of Changes (Man, Machine, Method) IATF 16949 - Automotive Quality Systems Standard 10
K DCP (dynamic control plan) and PFMEA - Effectiveness of the DCP method FMEA and Control Plans 6
D Sampling method for u control chart - Medical Records Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
E S-Square Control Chart - Is anyone familiar with the S-Square Control Chart method? Statistical Analysis Tools, Techniques and SPC 2
B Six Sigma in Medicine - Method to improve quality control in hospitals Hospitals, Clinics & other Health Care Providers 20
L What SPC method that I've must to control characteristic tensile strength? Statistical Analysis Tools, Techniques and SPC 1
A The meaning of "Evaluation/Measurement Technique" & "Control Method" in Control Plan FMEA and Control Plans 19
T How to establish the 4M (Man Machine Method Material) change control Manufacturing and Related Processes 5
P Is the first piece inspection method supposed to be in the Control Plan? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 18
N Control Method - Diamond Drill Machining Operation Statistical Analysis Tools, Techniques and SPC 10
V References instead of Detail - Control Method and Reaction Plan FMEA and Control Plans 5
S Valid Control Method - Machine specific LOTO (LockOut TagOut) procedures Document Control Systems, Procedures, Forms and Templates 10
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Version/Revision Control of CAD files Document Control Systems, Procedures, Forms and Templates 2
earl62 What is the best way to control special characteristics in Control plan? Is it Mandatory to have SPC for IATF 16949? IATF 16949 - Automotive Quality Systems Standard 7
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Putting back excluded rows/data points in a control chart Using Minitab Software 0
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
D All Dimensions listed on control plan FMEA and Control Plans 10
W Need for current design or process control FMEA and Control Plans 2
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Control chart and sample time Statistical Analysis Tools, Techniques and SPC 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 4
J Control chart for huge sample size Statistical Analysis Tools, Techniques and SPC 9
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
L AS5553 Clause 3.1.7 e "Control packaging material ..................reused" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
T Attributes SPC study - Attributive control (Go gage) Statistical Analysis Tools, Techniques and SPC 5
K Process Mapping - Inputs/Outputs/Detail Activities/Control points/Measurement? Process Maps, Process Mapping and Turtle Diagrams 4
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
D Infrastructure: Equipment, Work Environment and Contamination Control ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Relabeler for patent expired product - design control responsibilities? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J How to make Quality Control plans Quality Tools, Improvement and Analysis 5

Similar threads

Top Bottom