Actions Taken - Updating a FMEA for the addition of a downstream poke yoke

qcman

Registered Visitor
#1
I have a question about updating a FMEA for the addition of a downstream poka yoke to detect the presence of a feature made upstream. Our FMEA's are arranged by process steps. Do you normally put the action taken ( poka yoke installed) on the FMEA where its installed or where the feature is made? In other words if step #1 makes a hole and I poka yoke that hole on step #2 do I document this action taken on process step #2?
 
Last edited by a moderator:
Elsmar Forum Sponsor
Z

Zbigniew Huber

#2
IMO

Put the "recommended action" and then "action taken" in the "row" for operation #1 (where failure occurs). The poka-yoke at downstream is a "post processing" detection method. If the poka-yoke prevents further processing then detection ranking is 4 according to AIAG FMEA Rev.4
 
G

Grimaskr

#3
I'm not sure I follow the question, but usually the action is tied to the step that is error-proofed.

For example:
Step 1 is "Create Hole", Failure is "No Hole Created".
Step 2 is "Stick something in Hole", Failure is "No Hole Available".

If I were to error-proof Step 1, we could never get a part where no hole was created. The poka-yoke action would be at Step 1. You could then remove "no hole available" as a failure mode in Step 2, if it can no longer occur in Step 1.

If I were to put in a vision system at Step 2, so that I could never fail Step 2 because we catch "no holes" before we try to stick something in them... that would be poka-yoke for Step 2. I could still have failures at Step 1, they just wouldn't cause failures at Step 2.
 
Z

Zbigniew Huber

#4
IMO

FMEA sheet should looks like it:

Step #1
----------------------------------------------------------
Process step: #1 Drill hole
Function/Requirement: "Drill hole, dia. XX etc"
Failure mode: "no hole"
...
Cause: tool broken
...
Detection controls: 100% visual inspection at step #1 (7)
Det: 7
...
Recommended action: Install mistake-proof (poka yoke) at step #2
Actions taken: Poka-yoke installed at step #2. 03/03/2015
Sev: same as before
Occ: same as before
Det: 4
RPN: recalculate
----------------------------------------------------------

As a general rule in PFMEA assume incoming material and products from upstream as "conforming" when analysing downstream step. So in step #2 you should not consider "no hole drilled in step #1",because it is a failure mode in step #1.

Of course the FMEA team may decide to include some failures from upstream as causes in downstream step but it is exemption from the rules and can be used only for known, hard to solve issues in upstream or at suppliers.

During analysis of step #1 detection controls - include all detection controls for cause and failure mode at the station (at source) and failure mode detection in subsequent stations (post processing). Put rank for each controls (as a part of the description) and record the lowest ranking in detection (Det) column.

Example:

Step #1 (when poka-yoke is already "current" controls)
----------------------------------------------------------
Process step: #1 Drill hole
Function/Requirement: "Drill hole, dia. XX etc"
Failure mode: "no hole"
...
Cause: tool broken
...
Detection controls: 100% visual inspection at step #1 (7), poka-yoke at step#2 (4)
Det: 4
...


Please note that Poka-Yoke could be "mistake-proofing" (detection device) or "error-proofing" (prevetion device). In you case it detects failure mode from step #1 in post processing (at next station) and block it. According to AIAG FMEA it is detection level = 4.

Prevention type poka-yoke (error-proofing) is a solution that prevents failure mode from occurring because it prevents the cause from occurring. When it prevents cause then in must be in the FMEA row where given (prevented) cause is stated.

Hope it helps.
 
Thread starter Similar threads Forum Replies Date
S ISO 9001 7.1.5.2 - Actions Taken When Measuring Equipment is Found to be Unfit for Use General Measurement Device and Calibration Topics 9
S FMEA Revisions - Recommended Actions to Actions Taken FMEA and Control Plans 5
B MSA (Measurement System Analysis) - Results and Actions Taken Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
S Subsequent Actions Taken - ISO 9001 Clause 8.3 Clarification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Containment Actions to be taken when a non conformance is presented Nonconformance and Corrective Action 3
M FMEA RPN Recalculation after Actions are (or are not) Taken FMEA and Control Plans 6
J Records of the Results of Action Taken (8.5.2e) - Software Corrective Actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A What actions to be taken to meet RoHS regulations? RoHS, REACH, ELV, IMDS and Restricted Substances 2
R 13485 6.2.2 c) "evaluate the effectiveness of the actions taken" (training) ISO 13485:2016 - Medical Device Quality Management Systems 4
Douglas E. Purdy 6.2.2 b) & c) Effectiveness of Actions Taken ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L Process FMEA - No evidence that actions are considered or taken - High RPNs FMEA and Control Plans 2
qualprod Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
M Risk and Corrective actions - Currently no FMEA's - Car systems Risk Management Principles and Generic Guidelines 8
qualprod Do we have to document all corrections and corrective actions in ISO 9001 10.2.2 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
G Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions ISO 13485:2016 - Medical Device Quality Management Systems 16
E Different types of Actions? CARs, OFIs or N/A ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Vigilance Reporting - Requirements for manufacturer Field Corrective Actions (FCAs) Other Medical Device Regulations World-Wide 5
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
I Audit Nonconformances - Can reported corrective actions be incomplete? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A PFMEA - How long should the recommended actions remain in the recommended actions column? APQP and PPAP 3
E ISO 9001:2015 Clause 10.2.2 - Evidence of all nonconformities and actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
T Root causes - operator's actions Problem Solving, Root Cause Fault and Failure Analysis 17
M FDA News USFDA Digital Health Update – New actions and documents Medical Device and FDA Regulations and Standards News 0
E ISO 9001:2105 - Are OFI or Corrective actions required? Preventive Action and Continuous Improvement 55
B ISO 17025 8.5 Actions to address risks and opportunities ISO 17025 related Discussions 7
A Who pays for correction and removal actions? Other Medical Device Regulations World-Wide 2
I Cleanroom Actions in case of Actions Limit Alarm Qualification and Validation (including 21 CFR Part 11) 3
Uriel Alejandro Evaluation of the effectiveness of correction actions General Auditing Discussions 15
M Informal Corrective Actions - AS9100DCl. 10.2.1 A-H Nonconformance and Corrective Action 12
qualprod ISO9001:2015 Cl. 9.1.1 and 9.1.3 evidenced with only improvement actions? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J ISO 9001:2015 Cl. 8.1 - 'and to implement the actions determined in clause 6' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
O Updating "opportunities" resulting from Corrective Actions Nonconformance and Corrective Action 2
Q ISO 14001:2015 Clause 6.1: Actions to address Risks & Opportunities ISO 14001:2015 Specific Discussions 2
MarilynJ6354 Missing Corrective Actions - Workforce does not trigger corrective action requests General Auditing Discussions 6
C Complaint Training - FDA - How to recognize complaints and what actions to take 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Q Timeframe to resolve Corrective Actions (Undue Delay) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Specific Actions where Timely and/or Effective Actions are not Achieved Nonconformance and Corrective Action 6
R DFMEA Severity 9-10 with Occurrence 3 and Detection 3 - Actions FMEA and Control Plans 3
R Actions To Address Risks and Opportunities IATF 16949 - Automotive Quality Systems Standard 1
G Non Value Added Corrective Actions IATF 16949 - Automotive Quality Systems Standard 15
A Difference Between Complaints and Feedbacks in terms of Follow-Up Actions Needed Customer Complaints 3
S ISO 9001:2015 Clause 8.2.1 e) - Requirements for Contingency Actions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
MarilynJ6354 Internal Audit Corrective Actions Internal Auditing 5
J Where to get meddev FSCA (Field Safety Corrective Actions) trainings EU Medical Device Regulations 7
B Verification of Corrective Actions based on Quantities Nonconformance and Corrective Action 6
M Benchmarking - Timely Closure of Corrective Actions Nonconformance and Corrective Action 3
M Singapore - New Field Safety Corrective Actions (FSCA) Process Other Medical Device Regulations World-Wide 1
W Corrective /Preventative/Rectification actions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
S TS 16949 - 8.5.2.4 - When are Corrective Actions required IATF 16949 - Automotive Quality Systems Standard 5

Similar threads

Top Bottom