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View Full Version : Where did 4.10.2.3 - Positive Recall - At Risk - go?


Michel Saad
7th May 2003, 04:33 PM
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,

Claes Gefvenberg
7th May 2003, 04:54 PM
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

David Hartman
7th May 2003, 05:13 PM
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.:)

Al Dyer
7th May 2003, 05:21 PM
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.
7th May 2003, 05:29 PM
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.

David Hartman
7th May 2003, 05:36 PM
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.

energy
7th May 2003, 05:41 PM
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:

Claes Gefvenberg
8th May 2003, 06:44 AM
ddhartma said:

I believe that you'll find what your looking for in 8.2.4 Monitoring and measurement of product

So it does. Right on, David... I was going after those "other activities necessary".

/Claes

Michel Saad
8th May 2003, 09:51 AM
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,

David Hartman
8th May 2003, 10:02 AM
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:

Mike S.
8th May 2003, 10:07 AM
IMO 8.2.4 covers the early release/positive recall of produced product (produced or in some way modified from the original state by you) while, as Claes points out, 7.4.3 covers (or can be construed to cover) the early release/positive recall of incoming product. As dd points out, IMO there are good reasons to do this at times.

IMO you can use these sections to pretty much do whatever you want or need to do -- finding something that works for you and does not conflict with ISO -- within reason. You cannot, and should not, IMO, use it as an excuse to send untested/unapproved product to the customer (unless of course the customer approves).

Claes Gefvenberg
8th May 2003, 10:25 AM
Mike S. said:

IMO 8.2.4 covers the early release/positive recall of produced product (produced or in some way modified from the original state by you) while, as Claes points out, 7.4.3 covers (or can be construed to cover) the early release/positive recall of incoming product. As dd points out, IMO there are good reasons to do this at times.


Yeah. Concerning early release of our finished products, we have one customer that actually demands that we do this in order to speed up the flow. They have their facilities appr 300 yards from our dispatch area. It's been done that way since before I joined the company, and works well.

/Claes

Marc
8th May 2003, 11:32 AM
Al Dyer said:

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:

I'm not sure what you mean here. I'm not sure the question is about how you inspect (what plan you use, sample size, etc.) . I believe the question is about the absence of inspection prior to use. I'm not sure there's a question of skirting any standard.

I agree that the Positive Recall requirement is is carried over in 8.2.4 as several here have pointed out.

Al Dyer
8th May 2003, 02:02 PM
True Marc, not what to inspect but how to inspect. My post was to say that even if there is uninspected material that is to be released to production there needs to be an internal method of determining if the final product is acceptable.

It might include reduced initial inspection level, visual inspection by trained personnel that have dealt with the product previously, or common sense.

Under such circumstances there should be a plan for increased verification during the other phases of the process that lead to the final product.

Al...:bigwave:

Mike S.
8th May 2003, 02:39 PM
Claes Gefvenberg said:

Yeah. Concerning early release of our finished products, we have one customer that actually demands that we do this in order to speed up the flow. They have their facilities appr 300 yards from our dispatch area. It's been done that way since before I joined the company, and works well.

/Claes

Wanna hear something worse? We used to have an overseas customer, during the boom years, whose demand we could hardly keep up with. The final test took about 30 hours. Sometimes we would "early release" product to the shipper's truck prior to the final test result knowing that it would not get on the plane for about 36 hours after it left our door. If the final test would fail (luckily, it never did) we would have to have the shipper re-load it on their truck and bring it back. I made sure it could never reach the customer's dock prior to the final test so we truly did have "positive recall", but even so it made me darn nervous.