ISO 9001:2008 Permissible Exclusions

[Jim Wynne]

Re: ISO 9001:2008 Exclusions

Hi All,

I too have a question in relation to "permissable exclusions". We are a machine shop that supports the Petroleum/Natural Gas Industry by building/providing support equipment.

My question is this...Our customers/business does not require the use of "Contracts".
Can Contract Review be a permissable exclusion? They do not require a review of requirements, other than the product works. We do have design authority if that makes a difference.

Any input would be greatly appreciated.

Thank you

ETA: Welcome to the Cove.
No business that sells things operates without contracts, even if the contract isn't written. I'm sure your business deals with purchase orders from your customers, and those POs are contracts. The agreements between your company and your customers are contracts.

Also, it shouldn't be an issue of whether your customers require review. You have requirements that are communicated by customers (and potential customers) and someone decides whether or not the requirements can or will be accepted and fulfilled. That's contract review.

 

[Sidney Vianna]

Re: ISO 9001:2008 Exclusions

Let me offer a simple example:Imagine your client orders 10 parts to be delivered in 2 weeks. You don't have the parts in stock and your lead time to produce them is a month.

When you are communicating with that customer, you should let them know of that. "Contract review" (a term that is no longer part of ISO 9001) does not require a "traditional" contract. Even verbal orders must be reviewed for the supplier ability in delivering it.

Even though McDonald's is committed to customer satisfaction, if you order Mcsteak Tartar, they won't be able to deliver it. Simply because the item is not in their menu.

 

[Big Jim]

Re: ISO 9001:2008 Exclusions

You said:



So based on this, the product including its electroplating treatment are inspected. The product is OK. So why would 7.5.2 apply?

Stijloor.

7.5.2 applies because you CANNOT tell the outcome of plating from simple inspection.

How can you tell that plating went as expected? Because you ask the plater to follow a plating spec (the recipe) and ask for a certification of conformance showing that he followed the recipe.

To back up the cert, the plater maintains records showing that he did indeed follow the recipe. He keeps tank chemistry logs. He also records (usually on the traveler) the rectifier settings, tank temperature, and length of time in te tank.

 

[Stijloor]

Re: ISO 9001:2008 Exclusions

7.5.2 applies because you CANNOT tell the outcome of plating from simple inspection.

How can you tell that plating went as expected? Because you ask the plater to follow a plating spec (the recipe) and ask for a certification of conformance showing that he followed the recipe.

To back up the cert, the plater maintains records showing that he did indeed follow the recipe. He keeps tank chemistry logs. He also records (usually on the traveler) the rectifier settings, tank temperature, and length of time in te tank.

Jim,

The fact that plating may possibly require more elaborate process controls does not make it a special process. The only criterion is this one:

7.5.2 Validation of processes for production and service provision

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.

Plating material and thickness can be measured.

Stijloor.

 

[Big Jim]

Re: ISO 9001:2008 Exclusions

Jim,

The fact that plating may possibly require more elaborate process controls does not make it a special process. The only criterion is this one:



Plating material and thickness can be measured.

Stijloor.

And somehow you think that thickness is the only criteria for quality plating?

Far from it. When platers become overly concerned with appearance and tip in too much brightner into the vat, the plating can become brittle and flake or peal. Not paying attention to vat or part cleanliness can lead to flaws in the plating, not all of which are visable. Plating with improper rectifier settings can lead to porisity and bubbles in the plating.

What do you think the process controls are for? They are there to validate the process.

 

[Big Jim]

Re: ISO 9001:2008 Exclusions

Jim,

The fact that plating may possibly require more elaborate process controls does not make it a special process. The only criterion is this one:



Plating material and thickness can be measured.

Stijloor.

It is hard for me to believe that thickness is the only criteria of concern. It certainly should not be. You need to know that the things you cannot measure or inspect were accounted for so the plating will be robust.

The a, b, & c portions of 7.5.2 tell you how it can be done. All three fit plating, but especially c.

"The organization shall establish arrangements for these processes including, as applicable,
a) defined criteria for review and approval of the processes,
b) approval of equipment and qualification of personnel,
c) use of specific methods and procedures . . . "

And d is also helpful in most cases so there is evidence of the validation.

"d) requirements for records . . . "

 

[Sidney Vianna]

Folks, if you remember the Welding - Is welding always a special process per ISO9001:2000 Clause 7.5.2 thread thread, just because a process needs validation in many cases, it does not mean that process ALWAYS needs validation. There is "cosmetic" plating that the basic approval criteria at the end is for the part to be "shiny". In those cases, no need to validate that process, because someone can inspect the parts at the end and reach a conclusion about the part being shiny or not.

 

[Big Jim]

Folks, if you remember the Welding - Is welding always a special process per ISO9001:2000 Clause 7.5.2 thread thread, just because a process needs validation in many cases, it does not mean that process ALWAYS needs validation. There is "cosmetic" plating that the basic approval criteria at the end is for the part to be "shiny". In those cases, no need to validate that process, because someone can inspect the parts at the end and reach a conclusion about the part being shiny or not.

Your are right. Many times the determination of the need for validation could be an "it depends".

Plating can fall into that catagory. I do have a client that has black anadizing done on some small parts with the only criteria that the parts end up black. In that case, no validation would be needed.

I still have a hard time with thickness being the only criteria. If it is, thickness can be measured by xray or by gauging the part before and after.

Perhaps the question needs to be answered "what is the purpose of the plating" and then a determination can be made as to if validation is needed or not.

 

[Jim Wynne]

Perhaps the question needs to be answered "what is the purpose of the plating" and then a determination can be made as to if validation is needed or not.

Not "what is the purpose," but "what are the requirements?"
We shouldn't infer (strictly from the type of plating) what the purpose of the plating might be.

 

[AndyN]

Folks, if you remember the Welding - Is welding always a special process per ISO9001:2000 Clause 7.5.2 thread thread, just because a process needs validation in many cases, it does not mean that process ALWAYS needs validation. There is "cosmetic" plating that the basic approval criteria at the end is for the part to be "shiny". In those cases, no need to validate that process, because someone can inspect the parts at the end and reach a conclusion about the part being shiny or not.

So this plating doesn't have to 'stick' to the substrate? It's OK for it to be shiny but not to adhere for any length of time? I think not!

It's the adhesion which is as much a component of the plating process if not more, so how does one inspect that, Sidney? Pull test? Scratch test? It's going to make a mess of your shiny surface!

As with many 'special processes' they rarely have one attribute - shiny - without some (obvious) others to go with them. Some cannot be inspected as you suggest!