Required PFMEA Content - Final QC Inspection

sinned

Registered Visitor
#1
Does TS16949 requires ALL production processing steps be included and studied in the PFMEA ?
If our QC final inspection, a) is not part of the fabricating process; b) does not require to be done on every part (ie. inspection only sampling basis; c) does not affect the part's quality, then we can omit it in the PFMEA. Is this saying correct ?

I ask because when we add "QC final inspection" in the PFMEA and concludes that it has no failure mode by putting "N/A", one of our customer raised this question to us: "You can't say "N/A" because you need to put those numbers. (RPN) There is no option of "N/A" in the FMEA manual."

If we does not include QC final inspection in PFMEA, no one make any noise ever. What is the better option ? :confused:
 
Elsmar Forum Sponsor

Bev D

Heretical Statistician
Leader
Super Moderator
#3
I am not familiar with the standard (I'm in a different industry) but in general, final QC inspection can be considered part of detection assessment and not a 'process' UNLESS the inspection includes testing that can pose a risk to the parts
 

sinned

Registered Visitor
#4
Thanks Bev D. I tend to agree with you.
By the mean time, i will dig into FMEA manual to look for any sentence that suggest otherwise.

Btw, i've encounted another question on PFMEA and want to know how others is doing in real world:
Do you put the control values and tol. in PFMEA ?
Do you put the control frequency and sample size in PFMEA ? (beside in control plan)
 

Bev D

Heretical Statistician
Leader
Super Moderator
#5
Do you put the control values and tol. in PFMEA ?
Do you put the control frequency and sample size in PFMEA ? (beside in control plan)
I wouldn't. there is no need to have the same information in multiple places. It only leads to the probability of error when the drawing or control plan are updated. the 3 documents go together but they hold unique information
 

Chennaiite

Never-say-die
Trusted Information Resource
#6
Does TS16949 requires ALL production processing steps be included and studied in the PFMEA ?
If our QC final inspection, a) is not part of the fabricating process; b) does not require to be done on every part (ie. inspection only sampling basis; c) does not affect the part's quality, then we can omit it in the PFMEA. Is this saying correct ?

I ask because when we add "QC final inspection" in the PFMEA and concludes that it has no failure mode by putting "N/A", one of our customer raised this question to us: "You can't say "N/A" because you need to put those numbers. (RPN) There is no option of "N/A" in the FMEA manual."

If we does not include QC final inspection in PFMEA, no one make any noise ever. What is the better option ? :confused:
Some possible failures when you have a separate Final Inspection station - NG parts mix-up, part damage during inspection, part packing issues, rust, etc. If your FMEA team does not see any meaning in considering them, just do away with the line indicating "N/A".
 
G

Grimaskr

#7
I'm no expert, but here's my initial thought when you ask this question, "If the QC Final Inspection has absolutely no effect on the customer, why do you even do the step?"

The implication of this question is that you have a final QC check for a reason.

For instance, at my company we double check labeling and packaging. Would we get customer complaints if we messed up labeling or sent stuff in damaged packaging? Absolutely! Do we occasionally catch something with messed up labeling or damaged packaging? Rarely, but it does happen.

So in my case, I include it in our PFMEA. Under AIAG RPN rules, I call it a Severity 2 (slight inconvenience to our shipping department to re-label/re-package if not caught by QC in-station), Occurrence 2 (happens rarely), Detection 8 (visual) for an RPN of 32.
 
Last edited:

sinned

Registered Visitor
#8
Thanks Chennaiite.

Today I found a FMEA where Final QC inspection are there, and the only failure mode is "missing inspection".


Hi Grimaskr,

Your asking reminded me of a question that i've thought about long time ago.
Suppose the final inspection does not damage the parts or have any negative effect to the products, putting a good part into inspection station will give you a good part. Putting a bad part into inspection station will still give you a bad part. Therefore, there is no value added to the product after the inspection !? So why need doing it ?
One possible reason i think is that we need to verify our process indirectly by checking the products. A bad part goes into checking will not change to good part, but it does also give you an additional piece of information whether the part meet spec or not.
Also, i was thinking that when you are given two identical products to choose from, one has a label "pass inspection" while the other does not, you probably will opt for the first one. It added a "good feeling" to the customer !
:D
 
Thread starter Similar threads Forum Replies Date
Casana Customer Changing requirements - PFMEA required in English not German APQP and PPAP 6
B AS9100:D - Purchase Order required if ordering paint on supplier portal? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
V Is it required to recalibrate reference- standard instruments after equipment qualification General Measurement Device and Calibration Topics 0
B Supplier Evaluation report - Validation required or not ISO 13485:2016 - Medical Device Quality Management Systems 2
H Registration for REACH required for Non-EU Down Stream Manufacturer? REACH and RoHS Conversations 1
P AS9100D clause 8.6 - Documentation required to show evidence of conformity AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Is IATF certification required when customer doesn't require it? IATF 16949 - Automotive Quality Systems Standard 19
Kevin Walters IAQG Required Audit Days Needed (Please help) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Is MDSAP Audit Required? ISO 13485:2016 - Medical Device Quality Management Systems 3
H Required explanation of sub clause 7.2.101.2 (Exception) of IEC 61010-2-020:2006 CE Marking (Conformité Européene) / CB Scheme 5
Ashland78 PPAP required for repair of machine? IATF 16949 - Automotive Quality Systems Standard 5
Y Is preventive action required for each CAPA initiated? ISO 13485:2016 - Medical Device Quality Management Systems 24
B Spreadsheet - Used for complaint investigation - Validation required or not ISO 13485:2016 - Medical Device Quality Management Systems 9
N 8.3.3.3 Special characteristics - Auditor said we are required to create our own, if no customer char. exist. IATF 16949 - Automotive Quality Systems Standard 10
P 9.2.2.2 & 9.2.2.3 Audit Cycle alignment required? IATF 16949 - Automotive Quality Systems Standard 1
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
I Are suppliers required to hand over process validation reports? ISO 13485:2016 - Medical Device Quality Management Systems 20
B Is 14971 Annex C checklist now in ISO/TR 24971 required to complete prior to 510k filing? ISO 14971 - Medical Device Risk Management 3
D IEC 60601-1-2: Is EMC immunity testing required for a device without essential performance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 25
V ISO 9001 or ISO 17065 required for an organization issuing 5 star rating certification of digital experience? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Is calibration really required? IATF 16949 - Automotive Quality Systems Standard 6
D Filling totes and pails - when is a calibrated scale / flowmeter required in ISO 9001 General Measurement Device and Calibration Topics 4
S Supplier performance required to be reported to supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Is the Design Service Provider required to be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 13
B What are "appropriate drawings" required for a MDR in 21CFR820? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Record approval- Signatures required ISO 13485:2016 - Medical Device Quality Management Systems 4
M MDSAP required for Device Initial Importer/Distributor into Canada? Other Medical Device Regulations World-Wide 11
I Is SRN required for a contract manufacturer (CE-Marking product)? EU Medical Device Regulations 2
O New GTIN (DI) required? Other US Medical Device Regulations 0
P Is the second factor authentication (2FA) required for external users? Qualification and Validation (including 21 CFR Part 11) 1
validationspec EN 868-5 pdf required. Medical Device and FDA Regulations and Standards News 1
F Uncertainty not Required Measurement Uncertainty (MU) 3
I How to find required testing for a specific device? Other US Medical Device Regulations 3
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
S Is it required to complete Internal Audits within one year? ISO 13485:2016 - Medical Device Quality Management Systems 29
D "certified" in ISO 19011, as well as IATF required? IATF 16949 - Automotive Quality Systems Standard 6
M Is validation required when consumables are changed Qualification and Validation (including 21 CFR Part 11) 7
B Is labeling on the device itself required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Scrap Material Scale Calibration Required? IATF 16949 - Automotive Quality Systems Standard 21
K Is Calibration Required for Non-Adjustable Commercial Inspection Devices? General Measurement Device and Calibration Topics 11
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
S For Parts Manufacturer Approval (PMA) Is 100% Inspection Required? Federal Aviation Administration (FAA) Standards and Requirements 2
B AS9102 - 3D printing a special tool required for assembly (counterfeit risk?) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
OpExPro AIAG VDA DFMEA Template Required FMEA and Control Plans 6
B PMA Supplement Required? US Food and Drug Administration (FDA) 3
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 4
S Required tests for Surgical gown US Food and Drug Administration (FDA) 1
R Is a FAIR required on parts that we design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom