How to handle Incoming (Receiving) Inspection as a PFMEA item?

Z

ZLYDCOM

#1
If we make incoming inspection as one of the PFMEA item,how to describe the failure mode?
Does "inspector's mistake" right? or "material problem"?
I'm now confuse on it.
I need help!
 
Elsmar Forum Sponsor

Howard Atkins

Forum Administrator
Staff member
Admin
#2
Welcome to the cove:applause:
As I see it the incoming inspection is part of the FMEA, in simplistic terms the requirement is "acceptable material" the failure mode in "non conforming of a particular characteristic" the effect is "not able to produce"
"Inspectors mistake" affects the efficency of the detection
See also Process FMEA Scope - Does PFMEA cover incoming & dock audit?? and there are probable some more discussions if you search
 

Jim Wynne

Staff member
Admin
#4
ZLYDCOM said:
If we make incoming inspection as one of the PFMEA item,how to describe the failure mode?
Does "inspector's mistake" right? or "material problem"?
I'm now confuse on it.
I need help!
Speaking from a customer perspective, I want suppliers to consider the ways in which the process--receiving inspection--might fail. There are basically four bad things that can happen:
  • "Bad" material is accepted
  • "Good" material is rejected
  • Material is somehow misidentified or mislabeled
  • Material is damaged after receipt
Listing the ways the material supplier might err doesn't usually help because you have no control over that, which is why you have receiving inspection in the first place. A lot of people point to the language in the AIAG FMEA manual that says that in general, for each operation, incoming material should be assumed good. That advice doesn't apply to receiving inspection, though, because we have no way of knowing. It's meant to apply to manufacturing operations because if the process flow is followed in the order that production takes place, we've already dealt with the potential failure modes of operation #1 by the time we get to operation #2.
 
#5
How to handle incoming inspection as a PFMEA item?

On page 39 of FMEA third edition under 10) Potential failure Mode it states "However, in preparing the FMEA, assume that incoming part(s)/material(s) are correct."

It also states that exception may be made.

So unless you have already identiified deficiencies in incoming part quality why would you include incoming in a PFMEA? Most companies cannot afford the cost of incoming inspection and work with their suppliers on a "ship to stock" basis.
 

Jim Wynne

Staff member
Admin
#6
Rea said:
On page 39 of FMEA third edition under 10) Potential failure Mode it states "However, in preparing the FMEA, assume that incoming part(s)/material(s) are correct."

It also states that exception may be made.

So unless you have already identiified deficiencies in incoming part quality why would you include incoming in a PFMEA? Most companies cannot afford the cost of incoming inspection and work with their suppliers on a "ship to stock" basis.
In my previous post I explained why the language you refer to doesn't apply to receiving inspection. If there is no receiving inspection, then of course there's no need to consider it per se in the PFMEA. But if there is a receiving inspection function, it needs to be considered for precisely the same reason that other operations or processes need to be considered: there is potential for failure (within the operation itself) that can lead to customer unhappiness.
 

Howard Atkins

Forum Administrator
Staff member
Admin
#7
Rea said:
On page 39 of FMEA third edition under 10) Potential failure Mode it states "However, in preparing the FMEA, assume that incoming part(s)/material(s) are correct."

It also states that exception may be made.

So unless you have already identified deficiencies in incoming part quality why would you include incoming in a PFMEA? Most companies cannot afford the cost of incoming inspection and work with their suppliers on a "ship to stock" basis.
To restate what Jim has said

"incoming part(s)/material(s) are correct" to each operation
as said "It is a description of the non conformance at that specific operation"
The operation we are discussing is "incoming inspection"
 
Last edited by a moderator:
D

Daniella_Lima

#8
Re: How to handle incoming inspection as a PFMEA item?

I don't know how to describe the failure mode, because i need to consider the part it is conforming, so, i will be the Incoming FMEA about problem during the inspection. It is correct??

I'm very confuse!!! :mg:


Thanks
 

Miner

Forum Moderator
Staff member
Admin
#9
Re: How to handle incoming inspection as a PFMEA item?

Speaking from a customer perspective, I want suppliers to consider the ways in which the process--receiving inspection--might fail. There are basically four bad things that can happen:
  • "Bad" material is accepted
  • "Good" material is rejected
  • Material is somehow misidentified or mislabeled
  • Material is damaged after receipt
In addition to these, you might also have:

  • Wrong inspection status (i.e., not inspected, but indicated as such)
  • Released for urgent use prior to inspection, retained samples rejected upon inspection, unable to positively recall released material
  • Inspection samples returned to wrong containers (i.e., mixed)
  • Inspection report, incomplete, illegible, misfiled, etc.
  • Inspection requirements documents unclear, wrong revision, etc.
  • Inspector cannot interpret requirements (e.g., GD&T)
  • Inspector cannot measure to requirements (e.g., MSA deficiencies, lack of measuring devices, damaged measurement devices, etc.)
  • Inspection environment inadequate (e.g., lighting, temperature, humidity, soak time, etc.)
  • Control plan inadequate (e.g., sample size, frequency, measurement device, reaction plan , etc.)
  • Et cetera
 
D

DrM2u

#10
I'd say it depends how detailed you want your PFMEA to be. Best approach is to look at all the steps involved in the receiving process, from the moment the truck door is open until the product or mateial is released for use or placed in storage, or wherever you define the end of the process. Then at every step consider what requirements you have for the process and/or the product, what could go wrong at that step, the effect and the probability and the controls you have in place. For example:
When you open the druck door your first expectation could be that the shipment is in good condition. The failure mode is the containers could be damaged, resulting in rejection of shipment, production delays, delay of shipment to customer, etc (let's pick a rating of 5 following AIAG guidelines). The probability depends on your history (let's pick 2 in this case). The controls you have are the selection method for the carrier (prevention) and visual inspection (detection) with an overall effectiveness of 6. The resulting RPN would be 5*2*6, or 60. Think what else you would expect at this step then move to the next step after you are done. Don't spend much effort on low severity & low priority items as the RPN will be small. Hope this helps.
 
Thread starter Similar threads Forum Replies Date
K Different Indications for Use in Different Countries -- how to handle IFU? Other Medical Device Regulations World-Wide 4
K How to handle GTINs for different configurations of one device with one part number? Other Medical Device Related Standards 0
I How to handle pending FSN when incident happens? EU Medical Device Regulations 1
Jimmy123 Process disturbances and the repair - How do you handle this risk in your company? FMEA and Control Plans 18
GoSpeedRacer How to handle operator involvement in the non conformance ISO 13485:2016 - Medical Device Quality Management Systems 5
A How to Handle Documented Information in an online database for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
O How will you handle Clause 6.1 - Risks and Opportunities for AS9100 Rev. D Auditors? Risk Management Principles and Generic Guidelines 22
V Systems to Handle Development and Batch Analysis in same Laboratory Qualification and Validation (including 21 CFR Part 11) 3
dubrizo How do you handle damaged IM&TE in your organization? General Measurement Device and Calibration Topics 3
D MDD Classification of Bone Saw Handle ISO 13485:2016 - Medical Device Quality Management Systems 1
1 How to handle Nononformances in Clincal Manufacturing ? Nonconformance and Corrective Action 2
R How do we handle Training during transition and overlap from one system to other ? Training - Internal, External, Online and Distance Learning 4
Q How to handle different voltages for different countries Document Control Systems, Procedures, Forms and Templates 1
A How to handle complaints after end of specified medical device life-time ISO 13485:2016 - Medical Device Quality Management Systems 5
M How does Australia handle products that are EU PPE, but Australia Medical Devices? Other Medical Device Regulations World-Wide 7
C How to handle this Inspection conflict? Second Shift Inspector? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q How to handle customer request for changing specifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T How to handle Demo Units during an ISO 9001 Audit General Auditing Discussions 3
C ISO 9001 Nonconformances an how to handle them ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D How to handle a blood stained GMP document ? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
T How to handle 510(K) submisison in 2014 when the Fees were paid in FY13 ? US Food and Drug Administration (FDA) 3
C How to handle Action Results in a new FMEA Review once we have a new RPN? FMEA and Control Plans 1
Mikishots How to handle CAR (Corrective Action Request) Scope vs. Timely Response Nonconformance and Corrective Action 9
J Quality Procedure to handle some standard Medical Device Processes Document Control Systems, Procedures, Forms and Templates 1
L How to handle a Business Shutdown - Business Dissolution 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Plan & Procedure to handle a Product that's being Withdrawn from the Market 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Can you handle passivated parts without wearing gloves? Manufacturing and Related Processes 5
A How to handle the various Document Revisions Document Control Systems, Procedures, Forms and Templates 2
N How to handle Quality and Safety Deficiencies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L Client that refuses to help - How to handle ? Misc. Quality Assurance and Business Systems Related Topics 5
C How to handle Outsourcing with Same Site - Separate Cert ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B How to handle Medical Device Emergency Software Releases Software Quality Assurance 4
B How to handle/follow supervisor and department head with different supervisory style? Quality Manager and Management Related Issues 7
Z If this is a Nonconforming Product (Service) under clause 8.3? How do we handle it? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Responsibility of Distributor for Customer Complaints - How should we handle this Customer Complaints 5
R How to Handle 'Scrap and Replace' of Non-Conforming Products Nonconformance and Corrective Action 9
B Upper Management makes changes to a report - How do I handle this? Six Sigma 12
J SOP for How to Handle an Investigation wanted Document Control Systems, Procedures, Forms and Templates 1
J AS9100 C - 7.5.1.3 - How do you handle Production Equipment Maintenance? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
J Seeking advice on how to handle a Special Process Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
M How to handle the task of Organizing a Regulatory File Room Document Control Systems, Procedures, Forms and Templates 2
V ISO 26262 - How to handle OEM ASIL A (Automotive Software Integrity Requirements) Other ISO and International Standards and European Regulations 4
M How to handle Rejections of a Internal NCR event Nonconformance and Corrective Action 7
G Manufacturing Process Subcontracted - How do I handle Cl. 7.5? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
P How to handle Out of Tolerance during Calibrations and exceeded Alert Action Limits Quality Manager and Management Related Issues 4
M The importance of Document Control? How do you handle your Document Control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R How do you handle 'Contaminated Wood Pallets'? US Food and Drug Administration (FDA) 16
L Quality Objectives - How various device companies handle "Quality Objectives" ISO 13485:2016 - Medical Device Quality Management Systems 9
A How does your registrar handle 2 certificates, one for AS9100 and one for ISO9001? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
Le Chiffre Great article on how to handle continuous improvement Quality Manager and Management Related Issues 3

Similar threads

Top Bottom