Method for Poka-Yoke (Mistake Proofing) Validation prior to SOP

L

luciano

#1
ear friends,
Are you using a method for poka-yoke validation prior to SOP ?
Until now we didn't use any kind of method, but one of ours OEM's required us a method for Poka-Yoke validation.
If you have defined one please share some ideas.
Thank you very much.
 
Elsmar Forum Sponsor

howste

Thaumaturge
Super Moderator
#2
You can have parts that are known good (painted green) and known bad (painted red) that you run through the poka yoke device. It must detect the bad parts and accept the good. Without knowing something about your product it would be difficult to provide ideas specific to your situation.
 
T

The Specialist

#3
You can have parts that are known good (painted green) and known bad (painted red) that you run through the poka yoke device. It must detect the bad parts and accept the good. Without knowing something about your product it would be difficult to provide ideas specific to your situation.

This will work if using a detection system other than visual inspection (human).

You could use 'invisible' marking techniques instead in these instances.

Or have I misinterpreted you there Howst (painted)? Ha Ha!
 
Last edited by a moderator:
T

The Specialist

#5
I wouldn't consider human visual inspection to be poka yoke.
Howste; I think I was having a 'moment' when I read your post!!


luciano; If you can be more specific about your process, we will be able to be more specific about methods of inspection/ poka yoke.
 
L

luciano

#6
Howste; I think I was having a 'moment' when I read your post!!


luciano; If you can be more specific about your process, we will be able to be more specific about methods of inspection/ poka yoke.
We are assembling different types of steering column locks, door locks and other locking and safety system for automotive industry. Many operations during process chain are tested on the work stations. The work stations are connected between then, so the product start to be assembled to one station and continue to the next stations.
 
T

The Specialist

#7
We are assembling different types of steering column locks, door locks and other locking and safety system for automotive industry. Many operations during process chain are tested on the work stations. The work stations are connected between then, so the product start to be assembled to one station and continue to the next stations.

What Howste describes, above, is often termed 'challenge testing'.

Where you determine the suitability/efficiency/validity of your inspection system or method by introducing known ‘defective’ product into your product stream (during validation) and confirm that the inspection system or method ‘rejects’ all known defective parts and allows ‘passing’ of ‘good’ parts.


I am not familiar with your process (I am a pharmaceuticals guy) however, the principle is the same.

e.g. determine what your potential failures/defects are and then ‘challenge’ the inspection system.

A simple example I can give you from a pharma packaging process…

A tablet blister filling machine places one tablet within each blister pocket (e.g. 8 pockets).

An In-line ‘vision system’ captures and image of the filled blister. The vision system confirms that it is a good pack or bad. (a ‘bad’ pack would have missing tablets or more than 1 tablet in each pocket and is ‘rejected’ – automation).

During validation, we ‘challenge’ the vision system to detect and reject ‘bad’ packs which are introduced to the product flow using multiple combination/scenarios (1 tablet, 2, 3 missing etc…) and confirm they are all rejected and that ‘good’ packs are not.


A similar system of validation can be used for your inspection process.
 
Thread starter Similar threads Forum Replies Date
W Suggest a Poka Yoke (Mistake Proof) Method for my Product Manufacturing and Related Processes 24
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Q Sampling method for Distributor verification activities EU Medical Device Regulations 1
D Difference between Test Method Validation and Gage R&R Qualification and Validation (including 21 CFR Part 11) 18
C Correct Calibration Method for Dial Depth Gage General Measurement Device and Calibration Topics 6
E Mentor for Test Method Validation (TMV) Design and Development of Products and Processes 2
earl62 IATF 16949 Clause 9.1.1.1 - What is the batch conformance to specification method? IATF 16949 - Automotive Quality Systems Standard 3
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
S What is the best method to bond urethane foam to urethane foam? Manufacturing and Related Processes 4
R BS EN 12060:1998 - Zinc and zinc alloys Method of sampling Specifications Manufacturing and Related Processes 4
M Test method validation - Is MSA (MSA1, MSA2, MSA3 and linearity) a good solution? Medical Device and FDA Regulations and Standards News 1
Pau Calvo How to motivate colleagues to use 8D method or similar Quality Manager and Management Related Issues 37
M Proper method to test flow of a regulator Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
V Minitab GRR crossed Xbar and r method macro needed Using Minitab Software 9
R Please share your method used for PEMS Validation IEC 62304 - Medical Device Software Life Cycle Processes 5
S AS9100D PEAR - Examples for organization's method for determining process results? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Y Post Market Surveillance Indicators and Analysis method EU Medical Device Regulations 1
silentmonkey Seeking efficient method to manage install base data Manufacturing and Related Processes 0
D 4M (Man, machine, method, materials) Management Manufacturing and Related Processes 3
Ron Rompen Measurement Method Challenge - Measure feature #91 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
M Issuing NCR for improper method statement submissions Internal Auditing 10
F Irradiation Sterilization Validation Maximum Dose - VDmax 25 method (ISO 11137) EU Medical Device Regulations 2
I "Method" vs "Process" - Differences Document Control Systems, Procedures, Forms and Templates 33
P Test Method Validation for Tensile Strength Tester Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
C ICP versus AA: How to determine appropriate specification for assay method verification Qualification and Validation (including 21 CFR Part 11) 1
I Flatness - Rectangular part using the three jack method Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
B AS9102 Supplier Flow Down Method AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
M Control Method correspondence between PFMEA and CP FMEA and Control Plans 8
qualprod Qualitative or Quantitative? Risk method evaluation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Ron Rompen Dual level holes - Measurement method suggestions wanted General Measurement Device and Calibration Topics 9
D Sampling method that is representative of the devices supplied by that distributor EU Medical Device Regulations 5
P Production Line Pump Cleaning Validation Method Question Qualification and Validation (including 21 CFR Part 11) 0
A Risks related to Method Validation and Stability Studies Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
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
Ron Rompen Ford Method - Position Capability with MMC Modifier Capability, Accuracy and Stability - Processes, Machines, etc. 14
J Inspection method for T10 Hex driver General Measurement Device and Calibration Topics 13
qualprod ISO 9001:2015 - Right method to address clause 6.1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S Stakeholder analysis Method Six Sigma 1
T ER Checklist - Method(s) of conformity EU Medical Device Regulations 1
T ISO 17025 Method Verification - One sided “F” test or two sided “F” test ISO 17025 related Discussions 1
B Dosimeter Calibration Method General Measurement Device and Calibration Topics 5
A Test method for presence or absence of hexavalent chromium on a metal coating RoHS, REACH, ELV, IMDS and Restricted Substances 4
S Response Surface Method to create design matrix in Minitab Using Minitab Software 5
T Method to assess Measurement System of a Continuous Process Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
G HPLC Method Equivalence between USP and EP Various Other Specifications, Standards, and related Requirements 1
S Test Method Validation or MSA for Batch Manufacturing Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
A Test Method Validation on Elongation Machine General Measurement Device and Calibration Topics 0
B Gage R & R on Visual Inspection using the Cross Tabulation Method IATF 16949 - Automotive Quality Systems Standard 4

Similar threads

Top Bottom