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
Staff member
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
Staff member
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
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6
K When is Bioburden Testing Required? Other Medical Device Related Standards 3
G Is repeatability required for equipment calibration? General Measurement Device and Calibration Topics 10
D Device functionality over service life - Objective evidence required? Design and Development of Products and Processes 10
M Quality management certification required by Health Canada Canada Medical Device Regulations 3
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
A Question on ISO 14001:2015 - Are annual audits required? ISO 14001:2015 Specific Discussions 8
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 11
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
V Manufacturing requirements for respiratory ventilators - clean room required? Medical Device and FDA Regulations and Standards News 6
A When there is a 2 year lapse in production, is a full FAI required? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C Is it required to put"Rx only" on the home page of an app? Medical Device and FDA Regulations and Standards News 4
B IEC 60601-2-10 - Accuracy of Pulse Parameters - Required Measurement Uncertainty IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Is Optical Parallel Set required calibration? ISO 17025 related Discussions 1
R Is it required to have an SOP for external audits? Medical Device and FDA Regulations and Standards News 7
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 20
M When is FAI required? AS9100 8.5.1.3 and 8.4.3 requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
J MDD to MDR transition - Time required for the implementation of the MDR EU Medical Device Regulations 7
Robert Stanley Required Documentation Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M ISO 9001:2015 8.2.1 Contingency Plan required for small Business? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M MDR - Under what circumstances is a PMCF not required? EU Medical Device Regulations 1
B AIAG-VDA FMEA - When the new format will be required FMEA and Control Plans 5
MrTetris Are GLP required for testing cytotoxicity and soil remaining after sterilization of MD? Other Medical Device Related Standards 8
Z EN 868-8 "required tests" - Rigid sterilization containers Other Medical Device Related Standards 0
D Design Verification - Is testing required? Design and Development of Products and Processes 5
M User manual / instructions for use for class II device always required? Medical Device and FDA Regulations and Standards News 3
A Calibration required by OEM General Measurement Device and Calibration Topics 2
S How many mandays required for the below mentioned standards IEC 27001 - Information Security Management Systems (ISMS) 3
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
D Required Checklist Showing Compliance to IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 11
C ETO Sterilised Class II Medical Device - Required Temperature Storage ISO 13485:2016 - Medical Device Quality Management Systems 1
P 21 CFR 807.81 When a premarket notification submission is required Other US Medical Device Regulations 0
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
D How to Identify the Risks and Opportunities required for QMS Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A Glass and brittle plastic Policy - Required per FSSC 220002-4? Food Safety - ISO 22000, HACCP (21 CFR 120) 0
S Is a specific day required in an expiration date? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
T MDR Adverse Events Assessments - What qualifications are required? Other Medical Device Regulations World-Wide 3
S Is Annual QMS Training Required? ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required EU Medical Device Regulations 3
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
P UDI-PI and the MDR - Is the UDI-PI required for all devices/classifications? EU Medical Device Regulations 8
S Is the document author required to be identified as part of Document Change Notice? ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom