ISO 9001:2015 8.5.1 f - Scope with customer special process requirements

[qualprod]

Hi all
"Where the resulting output can't be verified"....
In deciding if it applies or not.
I have seen that in most of systems Is not applicable, when applicable, is in what is named "special processes" welding, and some other ,
But I wonder what are the basis?
Maybe it could apply in many cases, the problems is that scope is not clearly defined.
I'll explain it.

If into my processes, I Ensure Is ok, I mean , I met client needs, ok, such clause doesnt apply, one example, client needs plastic labels, blue color, x material, x dimensions. Ok, I completely can comply with it.
But if client specifies, that labels when in use must remain perfectly glued,no damage on plastic, lasting at least 6 months , supporting sun , rain,etc.(is not so common)

In this case , is not possible to Ensure it into my business, so in this case it applies 8.5.1.f, and for that, I will need to define how I'm going to comply with that beyond my business.
But in such case, the use in the customers, retailers,etc, is not in my control.

Or in this case, I may offer to client that is possible to comply , but using my supplier recommendations only, regarding glue effectiveness and lasting and not going beyond my business limits.
Please explain how to deal with this clause, which I dont find too much explanation in the net, but moreover is not widely used , or has a high non applicability.

Should I refuse the client needs, only choosing what is in my control?
Thanks

 

[Eredhel]

Without getting into "special processes" I think the labels can be done. Is that an actual situation you're dealing with or is it just an example?

 

[Marc]

1. There are things your company can do and things it can not do. "Scope" is what you can do and do do.
2. Customer requirements should be determined prior to contract acceptance (during contract review).
3. In your example of labels - I would think during contract review your team would determine whether or not you can meet the customer requirement(s). While you may never have done that type of label/packaging combination before, if you are interested in the business you would investigate whether it is feasible (not to mention the cost). This can be done in many ways.

NOTE: Over the years I have worked with various companies in taking on new projects/contracts using new processes and/or materials, for example, that they had never worked with before. Many times new equipment was purchased. Typically, prior to acceptance of a contract the company worked with the prospective customer in determining whether or not a new process and the probability of a good outcome was feasible.

AN EXAMPLE: Some years ago I worked with a company that did specialty deep draw metal stamping. A potential client was interested in a relatively low volume, irregularly shaped item, a specific aluminum alloy, then anodized, and then a screen printed logo. The low volume required a minimum of expense for automated equiptment for the screen printing so it would have to be a hand process. The company set a certain amount of money for making a hand print jig to test feasability. It was determeined that it was not economically feasible so the company did not accept the contract at the customer's price expectations.

SUMMARY: If you have not done something before, do a feasibility review prior to contract acceptance.

Thoughts:

When to perform a Feasibility Review

Business Risk Analysis requirements for a New Project

Feasibility Reviews clause 4.2.3.3 in QS9000

Add in RISK assessment: TS 16949 - Feasibility Review, including Risk Anaylsis vs. FMEA - Currrently a big ISO 9001 thing...

 

[qualprod]

Thanks Marc
But the origin of this clause, I think, is if products and services can be verified by monitoring and measurement.
I think is, if are we able to do it.
I'm not sure.

 

[Marc]

if client specifies, that labels when in use must remain perfectly glued,no damage on plastic, lasting at least 6 months , supporting sun , rain,etc

If this is a customer requirement, and you do not not know if you can meet it, you might have to do some testing to assure you can, but I have never personally seen the process of labeling as a "special process".

See: Control of Production and Service Provision - ISO 9001 Cl. 8.5.1 f)

See @Big Jim 's responses and @howste 's responses in particular.

As for labeling, you can tell if your process applies labels correctly. You can do periodic destructive tests for adhesion cheaply and frequently.

You would have to do periodic destructive tests to address "...remain perfectly glued, no damage on plastic, lasting at least 6 months , supporting sun , rain, etc...". Just to add, "etc." has to be defined. You could design an accelerated aging test to cover these, but - these are a function of the materials, not the process of label application.

Accelerated life testing - Wikipedia

 

[qualprod]

Without getting into "special processes" I think the labels can be done. Is that an actual situation you're dealing with or is it just an example?

Thanks, is an example, then What can be special processes, and really apply this clause?

 

[Marc]

First of all, your company determines what, in your company and its processes, are "Special Processes". For example, two companies may both have welding as one of its processes. Note that I say YOUR COMPANY DECIDES what its special processes are. A very good example is Special Process Suppliers - It is about special process suppliers, but it shows what processes Cessna (in this case) have defined as special processes related to their product parts. Once the parts have been installed on an airplane it typically takes destructive testing to validate that the process was effective - Which isn't realistic.

1. In Company 1 they weld a small widget which holds a shelf up in a small, short book stand. They would probably not consider welding a "special process". Failure woud not cause serious injury. Risk factor is low.
2. Company 2 welds motor bike frames. The risk factor for serious injury or death if any of their welds fail. They would definitely consider welding, in their scenario, a "special process". Extremely high risk factor.

See: Special Processes - Can anyone give me a definition of what a Special Process is?

I also highly recommend reading Don Brecken's article from around 2009: http://asq1001.org/papers/Identifying Special Processes.pdf

Also consider: Definition of Special Process - IADC Lexicon

 

[Marc]

Also of note: Special Process Assessments | AIAG

Just for emphasis:

Note that I say YOUR COMPANY DECIDES what its special processes are.

Special processes are typically determined during the Design FMEA (DFMEA) and Process FMEA (PFMEA) part of the APQP process.

 

[John Broomfield]

More and more organizations are designing their service and production processes so the results need no or virtually no verification.

So, don't allow parsing of the definition to blind you to the economic opportunities.

 

[Eredhel]

Thanks, is an example, then What can be special processes, and really apply this clause?

I think I'll let others tackle the special processes side of things. I just meant that I think there is a way to test the labels. Are the labels something you're actually dealing with?