Where did 4.10.2.3 - Positive Recall - At Risk - go?

M

Michel Saad

#1
Where did it go?

Hi folks,

In ISO9000(1994) or Qs9000 at section 4.10.2.3 there is text about releasing incoming material that has not yet been inspected.

Where did this requirement go in ISO9000(2000)? It is hard to beleive that it has gone away. IF not in ISO9000(2000), is it in the TS16949 additions?

Thanks,
 
Elsmar Forum Sponsor
#2
Good question Michel,

Let's discuss 7.4.3 Verification of purchased product:

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

Does it cover the old requirement? I think it does.

/Claes
 
D

David Hartman

#3
I believe that you'll find what your looking for in 8.2.4 Monitoring and measurement of product . The third paragraph reads,
Product release and service delivery shall not proceed until the planned arrangements (seed 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and , where applicable, by the customer.
This appears to be a simplified version of the requirement found in the `94 version that was repeated for Incoming, In-Process, and Final inspection.

Hope this helps.:)
 
A

Al Dyer

#4
Even if there is an agreement between standards, on how to skirt any issues, do the following for your company:

Inspect to your own requirements and those that reflect your customer expectations, not ISO/QS/TS etc... words of suggestion.

Your company will be judged by your performance, not parroting other standards.

Al... :bigwave:
 

Mike S.

Happy to be Alive
Trusted Information Resource
#5
Also, 9001-2000 section 8.2.4, third paragraph, kinda covers the "positive recall" from 1994 regarding in-process material.

7.4.3 doesn't address early-release of incoming material as clearly IMO, but I guess you can construe the "other activities" to cover it.
 
D

David Hartman

#6
Al, I agee that we should
Inspect to your own requirements and those that reflect your customer expectations, not ISO/QS/TS etc...
, but I do believe that there are instances where the requirement in question legitimately comes into play.

As an example: At a former employer's we had requirements for certain purchased materials to undergo extended (beyond the norm) testing. Instead of holding up production while we waited for these samples to finish their testing, we ensured that the materials met all of the applicable requirements to the best of our ability, and began producing product using those materials.

It was understood that product was being produced "at risk" and that there was a chance (though slight) that it may have to be recalled should the samples fail the extended testing.

This entire process was controlled, required management concurrence, and I can't recall an instance where it wasn't worth the risk. Especially if you do your homework as it relates to supplier and material selection.
 
E

energy

#7
Good answer

ddhartma said:

I believe that you'll find what your looking for in 8.2.4 Monitoring and measurement of product
Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and , where applicable, by the customer.
This appears to be a simplified version of the requirement found in the `94 version that was repeated for Incoming, In-Process, and Final inspection.

Hope this helps.:)
Your answer was dead on and everything else is frosting on the cake. Relevant authority is you! Bingo!:smokin:
 
M

Michel Saad

#9
Question

Thanks for all your responses.

Isin't "Product release and service delivery" the product you build (sell) vs the product you buy, or is it all the same?

Regards,
 
D

David Hartman

#10
Michal,

As I view it, it is all the same.

It is your responsibility to ensure that the product that your providing to your customer meets all of the defined/known requirements. That would include ensuring the adequacy of those outsourced components/materials/services that will form a part of your deliverable product.

The term "product" in this part of the standard really has dual meaning:

1. Procured materials/components/services that will form a part of your deliverable end item.

2. Your deliverable end item.

At least that's my interpretation, which you can adopt if you'd like. After all this really isn't a standard that we're dealing with, more like a guideline that really is open to interpretation.

Just make it work for you and then stand by and support your decisions.:bigwave:
 
Thread starter Similar threads Forum Replies Date
Marc Quiz - Where did the idea of an assembly line come from? Coffee Break and Water Cooler Discussions 4
S Where did FDA 510(K) form 3654 go? Other US Medical Device Regulations 4
Hershal Travel! Where have you been of late? What did you see? What do you think? Travel - Hotels, Motels, Planes and Trains 15
Q AS9100B Clause 7.5.1.5 - Where did it go in AS9100C? Servicing/Post Delivery Support AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Where did "breakpoint" analysis come from? AIAG MSA book Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
L Where did the name Elsmar come from? Coffee Break and Water Cooler Discussions 17
D TS 16949 - Where did the 16949 come from? IATF 16949 - Automotive Quality Systems Standard 4
D Where Did the Number 16949 Come From? IATF 16949 - Automotive Quality Systems Standard 2
G History of TQM? Where did Total Quality Management come from? Preventive Action and Continuous Improvement 18
shimonv Where do you place Human Factors report in a 510(k) application? Other US Medical Device Regulations 3
B Where do the definitions of the types of processes come from? IATF 16949 - Automotive Quality Systems Standard 9
Awais Where to get started on DFM / DFMA Manufacturing and Related Processes 2
S Where to start for MDSAP for Canada? Canada Medical Device Regulations 5
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
D Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
M Testing criteria - where to place Design and Development of Products and Processes 2
J UDI - Where to document it? EU Medical Device Regulations 8
J Where to get a Black belt certification ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 13
D Any recommendations on where to find experienced quality hires in Chicago area? Job Openings, Consulting and Employment Opportunities 2
J Where is the definition of a critical supplier? ISO 13485:2016 - Medical Device Quality Management Systems 5
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
B When Travel is allowed - Where are you going? Travel - Hotels, Motels, Planes and Trains 15
G Where to buy Template / sample SCSMS Manual, checklist Supply Chain Security Management Systems 1
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
M Quality Manual - Where does Revision History Section go? Document Control Systems, Procedures, Forms and Templates 8
C Where to draw the line for "sufficient evidence" to verify safety/performance of a device? CE Marking (Conformité Européene) / CB Scheme 2
L Where to place the what/when/how/who/where procedures in a multi-regulation AS9110C organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Where to acquire EN 868-5 required dye (Amaranth red)? Other Medical Device Related Standards 2
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
H Where to get EK MED 1927/16 Other Medical Device Regulations World-Wide 3
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
O EN 301 489-1 and EN 301 489-17 - Where do we get the information of the Published versions? CE Marking (Conformité Européene) / CB Scheme 1
A AS9100 Training - Where do I start? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
qualprod Records where apply and stop recording everything? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Gage R&R - Where am I going wrong? Part of a FAIR submission (Aerospace) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
G New to ISO 9001 - Where to begin? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
K No IFU, where the requirements would go? EU Medical Device Regulations 5
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
GreatNate Where to get a KPI dashboard for QMS processes Quality Tools, Improvement and Analysis 5
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Implementing ISO 20000-1 - Where to start Other ISO and International Standards and European Regulations 2
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29
qualprod Statistics - Where to start in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Calibration of InfraRan Vapor Analyzer - where to get calibration for SF6 General Measurement Device and Calibration Topics 2
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8

Similar threads

Top Bottom