PFMEA Scope and Detection Controls

  • Thread starter QMSProgramManager
  • Start date
Q

QMSProgramManager

I work for a semiconductor company and am currently responsible for creating/managing our FMEA standards. We are having some difficulty in determining whether detection controls (from downstream electrical test steps) should be included as a detection control in the upstream processes (i.e. Dry Etch) where we can typically only identify physical or mechanical effects. Overall manufacturing process flow is Fab, Probe, Assembly, Test...where each of those major process areas has their own PFMEA and Control Plan, and have their own multiple operations within their respective area.

Electrical effects can typically only be detected once the chip is fully manufactured...1st opportunity is Probe and then later in backend Test. The FMEA teams in the fab process do not want to accept a detection of 10 (since they cannot detect at their step & operation), and they believe their detection is the downstream process step. Note, it is important to realize that the downstream detection could be 10, 20, 30 days away from the fab process that caused the issue...thus at best, it is not an effective control for the fab process since it is so far away.

The approach we are trying to drive and enforce, is that if the detection control is from a downstream process step that is outside of the scope of the PFMEA (in this case, Fab Process FMEA), then that control should not be listed in that FMEA. Instead, the Fab PFMEA team should be identifying this issue to the Test PFMEA team or via cross-functional review, so that this electrical failure effect and detection requirement can be properly assessed in the Test PFMEA.

Our registrar has indicated that identifying downstream detection controls that are outside the scope of the "step caused" FMEA, is not acceptable...and I tend to agree.

The question:
What are the views on the correct approach, or better yet, the most effective approach?
 
Z

Zbigniew Huber

Hello,

I my opinion:

Detection methods could be anything that can detect failure cause (in station) and failure mode (in station or post processing) to prevent shipment of defective product.

“In station” - in the process step where failure cause or failure mode occurred
“Post processing” – in subsequent processes in our factory (i.e. end of line functional test)

So the end of line test is valid detection method and I rank it:
Detection = 4 - if the tester locks defective product to prevent further processing
Detection = 5 – if the tester warns operator about failure, but does not lock the defective part.

Read AIAG FMEA Detection table – check “in station / at source” and “post processing” statements.

I see no reason to distinguish between test executed few minutes after manufacturing step or test executed 20 days later (as long as all products are tested/not omitted)

The purpose/function of the test process is to check product conformance with requirements and prevent shipment of defective products and this is a tool to decrease the manufacturing risk.

Limiting the detection to “in station controls” is in my opinion is an overkill and may decrease team open-minded thinking to detect defects, because:
- sometimes it is NOT possible to detect defects “in station”
- it may be very expensive to implement something “in station” and management will not agree, but it may be much cheaper to detect is later in the process.

Consider expanding FMEA scope to include all operations from receiving to shipping (and include testing) as the AIAG FMEA says.
Then the issue will be solved.

Best regards,
Zbigniew
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
Crimpshrine13 PFMEA Scope - Oversized Special Characteristic FMEA and Control Plans 4
V Simple Representation for Scope of DFMEA and PFMEA FMEA and Control Plans 4
B Process FMEA Scope - Does PFMEA cover Incoming (Receiving) Inspection & Dock Audit? FMEA and Control Plans 8
J PFMEA in relation to suppliers FMEA and Control Plans 7
N PFMEA for rework, disassembly (automotive). FMEA and Control Plans 7
Q Definitions of Function in PFMEA ISO 14971 - Medical Device Risk Management 2
A PFMEA detection for "none" FMEA and Control Plans 5
Q Risk Controls in PFMEA ISO 14971 - Medical Device Risk Management 12
M When is the Best Time to Initiate PFMEA? ISO 13485:2016 - Medical Device Quality Management Systems 11
O Process Flow Diagram, DFMEA, PFMEA, Control Plan integrated softwares FMEA and Control Plans 7
R Installation Activities in pFMEA? FMEA and Control Plans 4
D PFMEA IATF 16949 - Automotive Quality Systems Standard 5
N Must PFMEA Occurrence Factor be Changed Periodically? FMEA and Control Plans 17
A PFMEA - Minor Non-Conformance for field left blank IATF 16949 - Automotive Quality Systems Standard 56
M PFMEA bending of steel tube FMEA and Control Plans 11
I IEC 60812 or ISO 14971 for PFMEA? What should we use? ISO 14971 - Medical Device Risk Management 3
J PFMEA severity with no knowledge of operating conditions FMEA and Control Plans 3
T PFMEA vs MFMEA or DFMEA on equipment/machinery FMEA and Control Plans 19
C Inspection Operation in PFMEA FMEA and Control Plans 13
J PFMEA/control plan question- PLEASE HELP ! IATF 16949 - Automotive Quality Systems Standard 8
C Pass through characteristics on PFMEA FMEA and Control Plans 3
S Initial PFMEA FMEA and Control Plans 6
L PFMEA for test procedures (ISO 14971) ISO 14971 - Medical Device Risk Management 5
K PFMEA Severity (9-1) mitigation needed? FMEA and Control Plans 20
Sonja D AIAG VDA PFMEA and Control Plan training FMEA and Control Plans 9
J Error Proofing sensors in PFMEA FMEA and Control Plans 2
DuncanGibbons Process flow & PFMEA for production planning and simulation activities? Process Maps, Process Mapping and Turtle Diagrams 9
D PFMEA Software search Quality Assurance and Compliance Software Tools and Solutions 8
P Benefit risk analysis on pFMEA ISO 14971 - Medical Device Risk Management 10
P Equipment URS, pFMEA and dFMEA ISO 14971 - Medical Device Risk Management 3
W Pfmea function requirement and failure mode FMEA and Control Plans 6
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 10
M Material incoming to the production process reflected in PFMEA FMEA and Control Plans 9
R Power Failure or Cold Start Situation in PFMEA FMEA and Control Plans 6
M "Issue & continuous improvement" columns in AIAG-VDA PFMEA form FMEA and Control Plans 4
C AIAG-VDA PFMEA - 1st special Characteristics? [5step vs. 6step] FMEA and Control Plans 3
T Linking Control Plans and PFMEA's FMEA and Control Plans 3
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
R DFMEA/PFMEA mitigation of high severity (9-10) in low volume products IATF 16949 - Automotive Quality Systems Standard 1
T Annual Validation as a detection mode on a PFMEA? FMEA and Control Plans 5
P Understanding DFMEA and PFMEA - Supplier Related IATF 16949 - Automotive Quality Systems Standard 21
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
D Can PFMEA be used in disposition of NC material? ISO 14971 - Medical Device Risk Management 4
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
V Customer Print Specifications on PFMEA FMEA and Control Plans 13
blile Increasing PFMEA occurrence ranking after non-conformance FMEA and Control Plans 4
A PFMEA new AIAG FMEA and Control Plans 0
Q Is that any difficulty to do software DFMEA and PFMEA in ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 5
bobdoering Informational New AIAG PFMEA Process - Excel Template Attached FMEA and Control Plans 28
A Redesigning our process flow chart, PFMEA and Control Plan Process Maps, Process Mapping and Turtle Diagrams 4

Similar threads

Top Bottom