SBS - The best value in QMS software

Traceability System to trace Failed Product for Corrective Action

Elsmar Forum Sponsor

Moncia

Quite Involved in Discussions
#32
Ohhh I know
I have been reading your posts for a year now. Got many good ideas from you guys. I just never posted anything before
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#33
Ohhh I know
I have been reading your posts for a year now. Got many good ideas from you guys. I just never posted anything before
Thanks for the compliment on the Cove, Moncia.

Ask as many questions you wish. We are here to help.
 
M

Michael T

#35
Re: Your current system

we keep track of lot number which roll was used to die cut the circles from. that is stamped on the traveler
the problem I have, I cannot trace a faulty product to the person within the production in the case of complaint-to do the corrective action properly
When conducting root cause analysis, it is best to look at the process first... what in the process allowed the operator to make the mistake? If one person can do it, then they all can do it. So... the corrective action is to correct the process utilizing your quality tools like poke-yoke, kanban or some other more appropriate tool.

Have you looked at utilizing Ishikawa (Fishbone) diagrams to determine potential causes of the error and then examining each of those causes to find the root cause? That might help also.

Unfortunately, the real difficulty comes in when you examine the process and the process is robust, yet, people still make mistakes. :confused: Then it comes down to an individual level. But this should be the last resort.

Hope this helps!!

Cheers!

Michael
 
P

prabhatchaddha

#36
Re: Your current system

For traceability best way would be to use a bar code system integrated with the ERP system.

for this you can have as following.

1. Traceability has to be maintained through raw material to the finished product.
2. Bar code system which is applied through out the manufacturing process from receiving to finish good.
3. Incoming material is bar coded at the time of receiving and all issues from store and in between must be controlled through the barcode/ERP system.( when ever the output is created a new sticker is printed having new barcode for input we need to scan the barcode of sticker on the input roll)
4. at every stage of production a barcode sticker has to be printed and WIP is moved into the next stage/Department/Section
5. The bar code sticker is put on each and every packed material Box/Roll.
6. In case of complaint each roll the traceability is done through the sticker on box or roll which contain all the relevant detail.
7. IN case sticker can be retained from the complaint box then simple scanning can get u all the relevant detail from raw material to process.

Regards
 
P

prabhatchaddha

#37
Re: Your current system

monica this system certainly requires cost. You can also maintain them in computer in excel sheet or in manual register.
With barcode system your time in making and retrieving will be saved a lot and changes of error will be negligent.

Regards
 

Moncia

Quite Involved in Discussions
#38
Re: Your current system

There is no way my boss will spend a penny to purchase bar code system
but thanks for the advice
 
D

David Hartman

#39
Re: Your current system

Monika, I will assume that the die cuts are done on a machine and that you have multiple machines. If this is correct track the machine and time/day that the product was cut, and track separately the operator assigned to the individual machines and the time/day they worked at that machine (this is something a supervisor could do). This should provide you with traceability back to a machine/process and you should be able to then tie that to a specific operator. If my assumptions are incorrect, I apologize.
 
Thread starter Similar threads Forum Replies Date
K Identification and Traceability with an ERP system - Barcode Labels? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Metrological Traceability and IVD Reference System ISO 13485:2016 - Medical Device Quality Management Systems 1
W Calibration Register - Traceability - Data Transfer to a New System General Measurement Device and Calibration Topics 7
K Barcode Traceability System - GS1 Food Safety - ISO 22000, HACCP (21 CFR 120) 1
K Towards ISO9001:2008 System Implementation for Traceability Purposes Supplier Quality Assurance and other Supplier Issues 3
T Rework Traceability System Manufacturing and Related Processes 8
J How to Create a Traceability System in Manufacturing Process Manufacturing and Related Processes 10
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S IATF 16949 - Partial traceability of Aftermarket products IATF 16949 - Automotive Quality Systems Standard 5
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Traceability of component parts - Bolts, screws and washers ISO 13485:2016 - Medical Device Quality Management Systems 3
R Traceability on Unmarked Parts - AS9100 requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
T Non conformance product identification and traceability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B Traceability of Thermoelement Batches ISO 17025 related Discussions 7
G ISO 17025:2017 Uninterrupted chain of traceability for test laboratories ISO 17025 related Discussions 6
J What is the minimum standard for automotive component traceability? Manufacturing and Related Processes 2
A Validation of Calibration Methods and Traceability - ISO 17025 ISO 17025 related Discussions 3
shimonv Design input/output traceability for mechanical parts ISO 13485:2016 - Medical Device Quality Management Systems 13
B PED 2014/68/EU - Is this Traceability audit finding correct? Other ISO and International Standards and European Regulations 4
N FDA Traceability Requirements - Component lots ISO 13485:2016 - Medical Device Quality Management Systems 2
Stefan Mundt ISO 9001:2015 - 8.5.2 Identification and Traceability Manufacturing and Related Processes 14
S How to maintain a design traceability matrix ISO 13485:2016 - Medical Device Quality Management Systems 2
N Requirements for the identification and traceability of demo product for sales force US Food and Drug Administration (FDA) 1
MrTetris Traceability in Medical Sofware Development Process IEC 62304 - Medical Device Software Life Cycle Processes 3
M Medical Device Traceability ISO 13485:2016 - Medical Device Quality Management Systems 9
G Where to list chain of traceability? ISO 17025 related Discussions 6
A AS5553B Counterfeit Prevention - Traceability requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
T In house Calibration? Measurement equipment traceability requirements - ISO9001 General Measurement Device and Calibration Topics 12
R ISO 9001:2015 Clause 7.1.5.2 - Is Measurement traceability applicable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Medical Device Traceability Matrix - Examples EU Medical Device Regulations 8
DeeDeeM IATF16949, clause 8.5.2.1 Identification and traceability-supplemental IATF 16949 - Automotive Quality Systems Standard 1
DeeDeeM IATF 16949 - Clause 8.5.2 Identification and Traceability IATF 16949 - Automotive Quality Systems Standard 7
D IATF 16949 - 8.5.2.1 Traceability Plan - Does anyone have an example? IATF 16949 - Automotive Quality Systems Standard 4
A UDI - Traceability of Products Other US Medical Device Regulations 1
B AS9100 Rev D - Traceability of Consumables AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Customer Identification and Traceability in Manufacturing Plans Manufacturing and Related Processes 5
S Traceability and the initiation of GMP Activities 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
N Calibration Traceability - Fluke 753 dpc with thermocouple Calibrated by Fluke ISO 17025 related Discussions 4
T Policy or Good Guidance for a Traceability Decision Tree (Serial and Batch Numbers) Misc. Quality Assurance and Business Systems Related Topics 4
J How to understand IATF 16949 Clause 8.5.2.1 - Traceability IATF 16949 - Automotive Quality Systems Standard 5
A Aluminum Die Casting Product Traceability Manufacturing and Related Processes 10
G Traceability - Checklist from NIST General Measurement Device and Calibration Topics 4
Raffy ISO 13485 NIST Traceability requirements for calibration of test equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
G Traceability of laser based x-y measuring machine General Measurement Device and Calibration Topics 5
A Power Traceability certificate for values for voltage, current and phase General Measurement Device and Calibration Topics 1
Q Allowed no manuals, technical instructions traceability in products ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Is NIST traceability required if a Refractometer calibration is done in-house? Calibration Frequency (Interval) 6

Similar threads

Top Bottom