Shipping by our own truck as part of an FMEA - Where FMEAs should end

P

PRODENG

#1
We have an ongoing debate at my facility as to where our FMEAs should end. Some say it should We ship to our customer via our own truck. Should we include this as part of our FMEA? Currently our FMEAs only go up to packing...
 
Elsmar Forum Sponsor
P

PRODENG

#2
Oops....when I said, "Some say it should We ship to our customer via our own truck", I meant to say

"some say it should end with Shipping and other say it should end with Packaging. we ship to our customer..."
 
A

Al Dyer

#3
I would say that shipping should be considered. It is part of the process of getting your customer what they contracted to receive.

There are instances where product that is properly packaged can be damaged during transport.

MHO

ASD...
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
You posted this in the QS-9000 forum.

For QS-9000 folks, shipping is required in FMEAs as is receiving.
 
T

tim banic

#6
Just slightly off topic...

When writing your FMEA, do you review every step of your process?

Or do you just look at the potential Failures that could reach your customer?

Our auditor told us the 2nd way was required. Just need some clarification.

Thanks Tim
"If it moves, train it...if it doesn't move, calibrate it...if it isn't written down it never happened!"
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#7
-> When writing your FMEA, do you review every step of your
-> process?

Yes.

-> Or do you just look at the potential Failures that could
-> reach your customer?

What about internal failures which could affect subsequent process steps?

I guess its a matter of whether you want to do a proper FMEA or if you're just trying to be compliant. However, I have never before heard of an auditor who would allow a company to only address problems which would reach the customer. This negates, to a large degree, the need to address receiving - a required part of an FMEA according to QS-9000 requirements as I understand them.
 
Thread starter Similar threads Forum Replies Date
bryan willemot Shipping Aerospace parts without Stress certs Manufacturing and Related Processes 20
Nicole Desouza Are Shipping Companies Suppliers? Manufacturing and Related Processes 4
J Requirements for Layered Process Audits including Maintenance, Shipping, Receiving IATF 16949 - Automotive Quality Systems Standard 4
smryan Shi##y Shipping Stories Coffee Break and Water Cooler Discussions 5
K REF code and Consult IFU in Shipping carton boxes. EU Medical Device Regulations 1
C Shipping Medical Devices to US before pre market clearance US Food and Drug Administration (FDA) 1
E CSR SHIPPING - Need suggestions for making SOP/WI for our shipping dept (automotive)... Customer and Company Specific Requirements 11
I IATF 16949 - 8.4.2.3 - Applicability to Shipping Suppliers IATF 16949 - Automotive Quality Systems Standard 11
G Medical Device export Shipping documents for US, EU and Asia Other Medical Device Regulations World-Wide 0
C ISO 11607-1 Packaging System - Temperature and shipping conditioning Other Medical Device Related Standards 4
H Who is the Legal / Labeled Manufacturer? (Contract Manufacturers shipping to the EU) ISO 13485:2016 - Medical Device Quality Management Systems 1
M UN/Dot 38.3 Questions - Shipping Lithium Batteries Canada Medical Device Regulations 3
I Shipping Product from Canada to China - Where to obtain the Certificate of Origin? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
I Control of Outsourced Process - Shipping ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
R Warehouse and shipping/receiving activities need to be part of our scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
I Requirements for shipping items that fall under the Cartagena Protocol Various Other Specifications, Standards, and related Requirements 4
S CS2 (Controlled Shipping Level) by GM - CB notified. What about other customers? IATF 16949 - Automotive Quality Systems Standard 1
J Shipping Investigational-Use Only Devices to New Zealand Other Medical Device Regulations World-Wide 4
L Is calibration required for weighing scales used for shipping purposes ? Misc. Quality Assurance and Business Systems Related Topics 10
C Need examples for Controlled Shipping I and II (CSL) IATF 16949 - Automotive Quality Systems Standard 3
G Shipping of goods without customer inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
L Audit Nonconformity for FMEA - Transit, Warehousing and Shipping ISO 13485:2016 - Medical Device Quality Management Systems 4
R Shipping Stability for Class III IVD (Non Sterile) Medical Device Other Medical Device Related Standards 7
L Client's Order Dock Inspection before Shipping Manufacturing and Related Processes 5
C Restrictions on shipping electronic goods into China China Medical Device Regulations 6
Sean Kelley Measurables for Shipping Process Management Review Meetings and related Processes 2
R Is IMDS required for Shipping cap received from our suppliers RoHS, REACH, ELV, IMDS and Restricted Substances 7
R Where are shipping & receiving processes covered under TS 16949 IATF 16949 - Automotive Quality Systems Standard 3
J Shipping Liquids (Small Bottles of Ultrasound Gel) to Europe EU Medical Device Regulations 4
D Change in Medical Device Shipping Box - Transport Test Required? Other Medical Device Related Standards 1
A Controlled Shipping Level - Supplier reporting themselves to their Registrar Customer and Company Specific Requirements 10
A Flowcharts in General and Flowcharts for 7.5.1 Production and Shipping Process Maps, Process Mapping and Turtle Diagrams 9
L Shipping Medical Devices and Pharmaceuticals Direct to Physicians - Puerto Rico US Food and Drug Administration (FDA) 4
M Shelf Life of Mineral Oil USP (put on cutting burrs before shipping) Manufacturing and Related Processes 19
K Desiccants & Humidity Control inside ocean going Shipping Containers Supplier Quality Assurance and other Supplier Issues 5
T Outsourcing Shipping Product directly from our Warehouse to the End Customer ISO 13485:2016 - Medical Device Quality Management Systems 2
G Is Controlled Shipping requirement Sampling Based or 100% Inspection? Misc. Quality Assurance and Business Systems Related Topics 3
A Shipping Procedure template - To include picked, verified and shipped by information Document Control Systems, Procedures, Forms and Templates 3
L Writing a Shipping and Receiving Procedure - Designated Warehouse Locations ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Brizilla Control Plans and the Shipping Process FMEA and Control Plans 13
S Shipping Release Documentation Samples Document Control Systems, Procedures, Forms and Templates 2
Q Shipping Measurements (Measurables) other than On-Time Delivery ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Outside Manufacturer = non-ISO (Outsourced Processing and Shipping) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S ISO/TS 16949:2009 and Shipping Scale Calibration Requirements IATF 16949 - Automotive Quality Systems Standard 6
T Shipping Additional Product ("Bundle") with a Class 2 Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K When to do Final Release if Medical Device goes off site prior to shipping? ISO 13485:2016 - Medical Device Quality Management Systems 5
J Root Cause Failure Analysis of a Shipping Error Problem Solving, Root Cause Fault and Failure Analysis 37
Q Control plans for Incoming, Warehouse and Shipping process FMEA and Control Plans 5
Marc Cyber Cafe in a Shipping Container After Work and Weekend Discussion Topics 0
1 Putting Quality in place before shipping product Quality Manager and Management Related Issues 18
Similar threads


















































Top Bottom