Discussion on TC 176 and ISO 9001:2015 8.7.1

[Big Jim]

Re: Who is registered to ISO 9001:2015?

So where, exactly did I quit? In Sidney's post he directed you to an interpretation on ISO 9001:2008 where someone asked the very specific question (linked in Sidney's post):
The TC 176 answer, correctly, is that the standard doesn't require it and nothing in the 2015 edition changes that.


I'm not aware of a request for interpretation on this matter. Perhaps most users don't see it the same way as you?
Perhaps you could contact ANSI and see if you can get the question raised.


The first mention of a manual was in your post - here - where you spoke about changing the order of clauses from those in ISO 9001.

You shouldn't be surprised to see that I am not impressed that someone recommends following ISO clause numbering in the structure of their manual - I've been saying this for years, through multiple clause number structures.

You've taken it personally, your prerogative. I don't need to see a manual if you've already told me you follow ISO clause numbering.

So where are these bad and broad assumptions?

I have been very specific in my responses and try to link my responses to sections of your post to keep the discussion together.

• 8.1 is a valid clause to have before 8.2 as it covers 'big picture'
• I don't like manuals that follow ISO Clause structure or regurgitate standard requirements - by your posts it seems you do at least like ISO clause numbering in manuals - we don't have any information on whether you regurgitate standard requirements I don'
• t believe there is any glaring error in clause 8.7, you do
• I understand clause 8.7.1 requires more than just informing the customer but you think that option 8.7.1 c would be allowable on its own (even if not desirable)
• We agree the manual shouldn't be used as a checklist. My criticism here was of you looking at 8.7.1 c in isolation of all the other standard clauses I listed.

I don't believe there is a misunderstanding. I have responded to every point you have made and you choose to change the argument and cry foul.

Untrue. I never said any such thing. ISO 9001 provides a flexible framework for responding to nonconformance, I don't see any inadequacy.

As ever, Jim, all I did was repeat your words back to you and comment on them.


I don't like manuals that follow standard clause structure - happy to agree to disagree.. again, if you want a review, please feel free to post an example - take out anything personal to your client of course.

I'd be interested in where you find the circular logic. I go out of my way to break your responses down and reply to each point individually, not the case for your replies.

"I agree with you that an organisation always has to do more than inform the customer."

"I don't believe there is any glaring error in clause 8.7, you do"

That looks like circular logic. First you say you agree then you say you don't.

Back on the topic of how I write a manual.

"I don't need to see a manual if you've already told me you follow ISO clause numbering."

From my comment that it doesn't hurt what the order is you seem to have already made up your mind that it is a bad manual, or perhaps just a bad approach to writing a manual. That's an awfully arrogant attitude. Sight unseen it was condemned because it is not your preferred method. That is a broad brush condemnation.

With as much fun as you have had over there is no problem addressing the requirements out of order, I'm certainly not willing to send you a copy of one of the manuals I have written. You have had enough fun with the little tiny piece you think you have.

 

[Paul Simpson]

Re: Who is registered to ISO 9001:2015?

"I agree with you that an organisation always has to do more than inform the customer."

You can use the quote facility on the Cove you know ...

Now this quoting is exactly why I listed the clauses of ISO 9001 as it shows all the commitments the organisation has made in terms of supplying conforming products and services. The fact that we are talking about non-conforming means the organisation has not met its commitments.

Are you following me so far?

If non-conforming product / service has been provided then the following clauses come into play (as a minimum):

• All of clause 8.7 - especially the bit about "The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery."
• 8.2.1 e "establishing specific requirements for contingency actions, when relevant"
• 10.2. Nonconformity and corrective action - all of it

There may be others that come in but the above is enough to make my point. All of these clauses have requirements for handling nonconformity so the line of mine you have quoted is correct and I stand by it, ipso facto the organisation has to do more that is required in 8.7.1.

"I don't believe there is any glaring error in clause 8.7, you do"

So the lead in to requirement bullets a - d says these are examples of what an organisation must do to deal with nonconformity. It doesn't say you must do one thing. So, again, I stand by it.

That looks like circular logic. First you say you agree then you say you don't.

Hopefully I have explained how my two statements are not inconsistent. If this doesn't do it I'm not sure what else I can do.

Back on the topic of how I write a manual.

"I don't need to see a manual if you've already told me you follow ISO clause numbering."

From my comment that it doesn't hurt what the order is you seem to have already made up your mind that it is a bad manual, or perhaps just a bad approach to writing a manual. That's an awfully arrogant attitude. Sight unseen it was condemned because it is not your preferred method. That is a broad brush condemnation.

Once again you seem to have read more into a comment than was intended. In my previous post I sent you a link to the post where you raised the issue of manuals and my dislike for following ISO 9001 structure:

You shouldn't be surprised to see that I am not impressed that someone recommends following ISO clause numbering in the structure of their manual - I've been saying this for years, through multiple clause number structures.

Hardly 'broad brush' or 'condemned'.

You can call it arrogance if you wish.

With as much fun as you have had over there is no problem addressing the requirements out of order, I'm certainly not willing to send you a copy of one of the manuals I have written. You have had enough fun with the little tiny piece you think you have.

You think this is fun?
Arguing with you is like trying to nail jello to a wall.

 

[Big Jim]

Re: Who is registered to ISO 9001:2015?

You can use the quote facility on the Cove you know ...

Now this quoting is exactly why I listed the clauses of ISO 9001 as it shows all the commitments the organisation has made in terms of supplying conforming products and services. The fact that we are talking about non-conforming means the organisation has not met its commitments.

Are you following me so far?

If non-conforming product / service has been provided then the following clauses come into play (as a minimum):

• All of clause 8.7 - especially the bit about "The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery."
• 8.2.1 e "establishing specific requirements for contingency actions, when relevant"
• 10.2. Nonconformity and corrective action - all of it

There may be others that come in but the above is enough to make my point. All of these clauses have requirements for handling nonconformity so the line of mine you have quoted is correct and I stand by it, ipso facto the organisation has to do more that is required in 8.7.1.

So the lead in to requirement bullets a - d says these are examples of what an organisation must do to deal with nonconformity. It doesn't say you must do one thing. So, again, I stand by it.

Hopefully I have explained how my two statements are not inconsistent. If this doesn't do it I'm not sure what else I can do.

Once again you seem to have read more into a comment than was intended. In my previous post I sent you a link to the post where you raised the issue of manuals and my dislike for following ISO 9001 structure:
Hardly 'broad brush' or 'condemned'.

You can call it arrogance if you wish.

You think this is fun?
Arguing with you is like trying to nail jello to a wall.

I'm amused that you keep trying to defend the undefensible.

On it's own, 8.7.1c is just plain wrong. It provides license for abuse. It is clearly written. Any ambiguity comes from outside of 8.7.1. It is in conflict. It can create a source of confusion.

I'm not having fun with this.

 

[Paul Simpson]

Re: Who is registered to ISO 9001:2015?

I'm amused that you keep trying to defend the undefensible.

Glad to see you're amused, Jim. If anything was indefensible I wouldn't defend it.

On it's own, 8.7.1c is just plain wrong. It provides license for abuse. It is clearly written. Any ambiguity comes from outside of 8.7.1. It is in conflict. It can create a source of confusion.

I will say it here once more, S L O W L Y: Do not read 8.7.1 c on its own.

The requirement is part of a bigger clause that is part of the standard as a whole. Any quality professional or consultant worth his / her salt will ensure that the systems they recommend an organisation implements are based around meeting customer requirements and, in the event a nonconformity arises, the organisation does the right thing by their commitments to their customer.

You see abuse, ambiguity, conflict and confusion where there is none. I have tried to show you where this clause fits in with all other relevant ISO 9001 requirements.

If you still feel there is an error use your NSB, ANSI, to raise it with TC 176. My guess is you won't get over the first hurdle.

I'm not having fun with this.

Of course you're not having fun, nobody said you were, this was my response to your assertion that I am enjoying this ridiculous exchange.

<snip>With as much fun as you have had over there ... </snip>

If you can't even follow a simple thread where the person you're debating with takes the trouble to line up answers with the exact point that led to the answer ... sigh.

Still, even if you're not having fun, at least you're amused.

 

[Big Jim]

Re: Who is registered to ISO 9001:2015?

Glad to see you're amused, Jim. If anything was indefensible I wouldn't defend it.

I will say it here once more, S L O W L Y: Do not read 8.7.1 c on its own.

The requirement is part of a bigger clause that is part of the standard as a whole. Any quality professional or consultant worth his / her salt will ensure that the systems they recommend an organisation implements are based around meeting customer requirements and, in the event a nonconformity arises, the organisation does the right thing by their commitments to their customer.

You see abuse, ambiguity, conflict and confusion where there is none. I have tried to show you where this clause fits in with all other relevant ISO 9001 requirements.

If you still feel there is an error use your NSB, ANSI, to raise it with TC 176. My guess is you won't get over the first hurdle.

Of course you're not having fun, nobody said you were, this was my response to your assertion that I am enjoying this ridiculous exchange.

If you can't even follow a simple thread where the person you're debating with takes the trouble to line up answers with the exact point that led to the answer ... sigh.

Still, even if you're not having fun, at least you're amused.

It must be those jello nails you are using.

At the very least, 8.7.1c is in conflict with the other topics you have listed and that should not be.

You just can't get around that, no matter how circular your logic is and how many times you go into that circle.

This is a weakness and TC-176 should not have allowed it to happen. The proof reader must have been asleep.

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.

Give it up!

 

[Sidney Vianna]

Re: Who is registered to ISO 9001:2015?

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.

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.

 

[Tyler C]

Re: Discussion on TC 176 and ISO 9001:2015

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.

 

[Tyler C]

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.

 

[Big Jim]

Re: Who is registered to ISO 9001:2015?

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.

 

[Paul Simpson]

Re: Who is registered to ISO 9001:2015?

It must be those jello nails you are using.

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.

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.

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

... abuse, ambiguity, conflict and confusion where there is none.

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).

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.