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Discussion on TC 176 and ISO 9001:2015 8.7.1
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Discussion on TC 176 and ISO 9001:2015 8.7.1
Discussion on TC 176 and ISO 9001:2015 8.7.1
Discussion on TC 176 and ISO 9001:2015 8.7.1
Discussion on TC 176 and ISO 9001:2015 8.7.1
Discussion on TC 176 and ISO 9001:2015 8.7.1
Discussion on TC 176 and ISO 9001:2015 8.7.1
Discussion on TC 176 and ISO 9001:2015 8.7.1
Discussion on TC 176 and ISO 9001:2015 8.7.1
Discussion on TC 176 and ISO 9001:2015 8.7.1
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Discussion on TC 176 and ISO 9001:2015 8.7.1 - Page 3


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  Post Number #17  
Old 21st April 2017, 09:37 AM
Tyler C

 
 
Total Posts: 95
Re: Discussion on TC 176 and ISO 9001:2015

Quote:
In Reply to Parent Post by Big Jim View Post

The order in which the requirements are presented has little or nothing to do with how they are applied.

API Q1 prior to the 9th edition was in the same order as ISO 9001. With the 9th edition, API started marching more strongly to their own drum.

8.1 of ISO 9001:2015 is pretty much the same as 7.1 of ISO 9001:2008, and there planning (7.1) came before determining requirements (7.2 or even 7.3.2 about gathering requirements for design).

When writing a quality manual, I would sometimes put 7.2 in front of 7.1 because it better matched the flow of the organization.

Maybe API is more insightful than TC-176?
Hi Big Jim,

I haven't read through all of this thread and I am directing my response more towards your original post. I will try to have a civil discussion about this with you as I find it very interesting.

I believe this shows the beauty of ISO 9001 and the organizational freedom it allows. Looking at the 2008 version of the standard, my interpretation is that the original intent of the structure was along the lines of having the company determine the basic processes required to make the product. You have to start somewhere, right? For example:
The company I work at is a custom shop, however we also offer stock product. In this scenario, 7.1 would be utilized first to create the stock parts and design the initial flow of production.

Then, as custom orders come in, clause 7.2 comes into play, and we determine any special processes required by the customer or the regulatory/statutory requirements of their industry. Of course, we utilize 7.2.2 before confirming the agreement. During this 'planning' stage, we also set up the points of contact for both companies to meet requirements of 7.2.3.

All of this happens before clause 7.3, as we have to determine the 'what' (product requirements) before the 'how' (design and development). For example, if they require RoHS compliance, we have to design in the use of lead-free solder. If we design first, we would have to make a revision before the first article is produced.

Then, once we know 'what' and 'how', we can look into purchasing any necessary parts required (clause 7.4). So, for the company I work at, the current structure makes perfect sense.

However, I do agree that in some cases this may not make sense. There may be a company that is strictly custom, and they could require 7.2 before 7.1. I don't have any examples of this as I have not experienced it, but it makes sense that it could happen that way.

That is why I think this post brings to light the organizational freedom of ISO that most people seem to forget about. Unfortunately, it is so often "ISO makes us...", when really, all ISO makes us do is document what we say we do, communicate well with the customers, continually improve, and document our records! Things we should be doing anyways.
Thanks to Tyler C for your informative Post and/or Attachment!

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  Post Number #18  
Old 21st April 2017, 09:49 AM
Tyler C

 
 
Total Posts: 95
Re: Discussion on TC 176 and ISO 9001:2015

Also, here is my input on clause 8.7.

From the standard (2015 version): "The organization shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products and services."

In some cases, only utilizing c) is appropriate.

At the company I work at, of course we take action to correct the nonconformity. But, if the nonconformity is simply cosmetic (product marking location is different than customer design for example), we utilize option c). We inform the customer the mark location varies from the drawing, and that is the only action we take. 9/10 times, this results in obtaining customer authorization for acceptance under concession, d). If the customer does not authorize the variation, we then move to options a) and b). We segregate the nonconforming product and rework it (as the mark is permanent and irreversible). This is a correction to the nonconforming product.

By utilizing option c), it leads us to a different action, depending on what the customer wants to do.

However, if the nonconforming product jeopardizes the integrity of the product, we will automatically move to correction or rework without informing of the customer. In the end, the customer still gets what they wanted. We have been audited and approved by an ANAB accredited body and by several registered customers, and no one has had an issue with this.
Thanks to Tyler C for your informative Post and/or Attachment!
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  Post Number #19  
Old 21st April 2017, 10:50 AM
Big Jim

 
 
Total Posts: 2,828
Re: Who is registered to ISO 9001:2015?

Quote:
In Reply to Parent Post by Sidney Vianna View Post

Jim, you are misinterpreting the standard. The second paragraph in 8.7.1 clearly stipulates: "...The organization shall take APPROPRIATE action based on the nature of the nonconformity and its effect on the conformity of..."

Any reasonable quality professional knows that simply informing the customer that a shipment of nonconforming product is forthcoming is NOT an appropriate action and contravenes the whole intent of customer focus, an ISO 9000 principle, fully embedded in 9001.

I read my copy of the ISO/TS 9002 and it is pretty clear what 8.7.1 aims at.
"Any reasonable quality professional knows that simply informing the customer that a shipment of nonconforming product is forthcoming is NOT an appropriate action and contravenes the whole intent of customer focus, an ISO 9000 principle, fully embedded in 9001."

Actually, Sydney, this supports what I have been saying. Again, it is clearly admitted that simply telling the customer by itself is not adequate.

We are in full accord that it is not appropriate by itself, and yet there it is in black and white saying that it is.

I must emphasize that the standard was NOT written for the quality professional only, who, as you have pointed out probably knows better. It is written for the ordinary run-of-the-mill organization.

You can't put another spin on this no matter how hard you try. 8.7.1c was poorly written. It could have been easily fixed if they would have been awake.
  Post Number #20  
Old 21st April 2017, 12:26 PM
Paul Simpson's Avatar
Paul Simpson

 
 
Total Posts: 1,813
Re: Who is registered to ISO 9001:2015?

Quote:
In Reply to Parent Post by Big Jim View Post

It must be those jello nails you are using.


Quote:
In Reply to Parent Post by Big Jim View Post

At the very least, 8.7.1c is in conflict with the other topics you have listed and that should not be.
In conflict, Jim? How exactly, and no, don't repeat the words back to me for the nth time just explain the conflict between the clause and other clauses.

Quote:
In Reply to Parent Post by Big Jim View Post

You just can't get around that, no matter how circular your logic is and how many times you go into that circle.
No circular logic from me. The use of the clause is clear to me. I'm happy to chalk this one up as yet another 'Big Jim' experience and let it lie.

Quote:
In Reply to Parent Post by Big Jim View Post

This is a weakness and TC-176 should not have allowed it to happen. The proof reader must have been asleep.
As I mentioned earlier it appears that TC 176 would have to triple the number of words in 9001 (and hence its cost) and even then I guess you could manufacture some claim of
Quote:
... abuse, ambiguity, conflict and confusion where there is none.
Quote:
In Reply to Parent Post by Big Jim View Post

One more time:

"8.7.1 . . . The organization shall deal with nonconforming output in one or more of the following ways:

c) informing the customer . . .

That is one of the ways listed, and there is no way that you can read the Queen's English any other way.
See, this is the nub of the issue. You choose to read this as: 'For every instance of nonconformity if I choose to use just one of the list a - d then I satisfy the ISO 9001 requirement and have an effective quality management system.'

I, on the other hand read this as: 'For every instance of nonconformity you must choose one or more activities from the list a - d in order to meet your commitments to satisfying customer needs and expectations.'

Occasionally one will be enough, a) correction being a case in point but often you can't do one without doing another, so you can't get the customer's acceptance under concession (d) without first contacting them (c).

Quote:
In Reply to Parent Post by Big Jim View Post

Give it up!


I've given up trying to show you how the standard is intended to be used.

I won't, however, give up pointing out the errors of your posts and how some of your opinions are just wacky.
Thanks to Paul Simpson for your informative Post and/or Attachment!
  Post Number #21  
Old 21st April 2017, 05:22 PM
Big Jim

 
 
Total Posts: 2,828
Re: Discussion on TC 176 and ISO 9001:2015

Quote:
In Reply to Parent Post by Tyler C View Post

Hi Big Jim,

I haven't read through all of this thread and I am directing my response more towards your original post. I will try to have a civil discussion about this with you as I find it very interesting.

I believe this shows the beauty of ISO 9001 and the organizational freedom it allows. Looking at the 2008 version of the standard, my interpretation is that the original intent of the structure was along the lines of having the company determine the basic processes required to make the product. You have to start somewhere, right? For example:
The company I work at is a custom shop, however we also offer stock product. In this scenario, 7.1 would be utilized first to create the stock parts and design the initial flow of production.

Then, as custom orders come in, clause 7.2 comes into play, and we determine any special processes required by the customer or the regulatory/statutory requirements of their industry. Of course, we utilize 7.2.2 before confirming the agreement. During this 'planning' stage, we also set up the points of contact for both companies to meet requirements of 7.2.3.

All of this happens before clause 7.3, as we have to determine the 'what' (product requirements) before the 'how' (design and development). For example, if they require RoHS compliance, we have to design in the use of lead-free solder. If we design first, we would have to make a revision before the first article is produced.

Then, once we know 'what' and 'how', we can look into purchasing any necessary parts required (clause 7.4). So, for the company I work at, the current structure makes perfect sense.

However, I do agree that in some cases this may not make sense. There may be a company that is strictly custom, and they could require 7.2 before 7.1. I don't have any examples of this as I have not experienced it, but it makes sense that it could happen that way.

That is why I think this post brings to light the organizational freedom of ISO that most people seem to forget about. Unfortunately, it is so often "ISO makes us...", when really, all ISO makes us do is document what we say we do, communicate well with the customers, continually improve, and document our records! Things we should be doing anyways.
You and I are in accord. There are companies in which it makes sense for design to come first, some for which customer input comes first, and some where planning comes first.

The order presented in the standard seems to be an orderly way to present it, not a dictated way it has to flow.

Somehow in my answer Paul came to believe that I write a manual that regurgitates the standard because evidently it uses the clause numbers from the standard, and he doesn't like that.
  Post Number #22  
Old 21st April 2017, 05:28 PM
Big Jim

 
 
Total Posts: 2,828
Re: Who is registered to ISO 9001:2015?

Quote:
In Reply to Parent Post by Paul Simpson View Post



In conflict, Jim? How exactly, and no, don't repeat the words back to me for the nth time just explain the conflict between the clause and other clauses.

No circular logic from me. The use of the clause is clear to me. I'm happy to chalk this one up as yet another 'Big Jim' experience and let it lie.

As I mentioned earlier it appears that TC 176 would have to triple the number of words in 9001 (and hence its cost) and even then I guess you could manufacture some claim of

See, this is the nub of the issue. You choose to read this as: 'For every instance of nonconformity if I choose to use just one of the list a - d then I satisfy the ISO 9001 requirement and have an effective quality management system.'

I, on the other hand read this as: 'For every instance of nonconformity you must choose one or more activities from the list a - d in order to meet your commitments to satisfying customer needs and expectations.'

Occasionally one will be enough, a) correction being a case in point but often you can't do one without doing another, so you can't get the customer's acceptance under concession (d) without first contacting them (c).



I've given up trying to show you how the standard is intended to be used.

I won't, however, give up pointing out the errors of your posts and how some of your opinions are just wacky.
The Jello nails was in reference to you saying that trying to pin me down was like trying to nail Jello to a wall. Your reasoning seems to be like using Jello nails.

Once again, you are evading the exact wording from the standard and trying to justify an obvious mistake. You entered again into the vortex of circular logic.

It is simply not defensible.
  Post Number #23  
Old 22nd April 2017, 02:39 AM
Big Jim

 
 
Total Posts: 2,828
Re: Discussion on TC 176 and ISO 9001:2015 8.7.1

By the way, a corrected reading could have been as simple as:

The organization shall deal with nonconforming outputs in one or more of the following ways:
a) correction
b) segregation, containment, return or suspension of provision and services
c) obtaining authorization for acceptance by concession

Customers are informed when appropriate.

That's hardly a tripling of the number of pages. This one could be corrected without adding any lines at all.

The fear of making the standard too long by making it clearer is a non-starter. Any writing class stresses being clear, concise, and terse. If anything, following that strategy, could have made the standard shorter, not longer.
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