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

[Bluzman714]

I've been visiting this forum for several months now. This is my first post.

Clause 8.5.1 f) of ISO 9001: 2015 requires:
"the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement"

1) Is this referring to products that are supplied by our "external providers" to our customers?

2) If so, can you provide an example of verbiage to use to cover this requirement?

We are a wholesale distributor of industrial hoses, assemblies, and accessories.

 

[Big Jim]

I've been visiting this forum for several months now. This is my first post.

Clause 8.5.1 f) of ISO 9001: 2015 requires:
"the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement"

1) Is this referring to products that are supplied by our "external providers" to our customers?

2) If so, can you provide an example of verbiage to use to cover this requirement?

We are a wholesale distributor of industrial hoses, assemblies, and accessories.

It helps to attach the term for this that aerospace uses and also shows up in ISO 9000 where definitions are provided for quality management systems.

That term is "special processes". In layman's terms, special processes are those that cannot be easily verified and thus need to be validated.

8.5.1f is what is left after trimming this requirement down from ISO 9001:2008 7.5.2 where it included more detail on how to validate. Interestingly enough, AS9100D adds 7.5.2 (with a new clause number) back in.

This applies to manufacturing and those that control manufacturing. If you can't verify a manufacturing process, you need to validate it.

The poster child processes that usually fall into this category include: welding, brazing, soldering, plating, and heat treating. If any of those processes are taking place at your facility you need to validate them. If you outsource any of them you need to be in control of them.

If you are a distributor and you have no involvement with special processes you have nothing more to do. If you have involvement, you need to be involved with validating them.

 

[Bluzman714]

Even though we are a distributor there are many secondary processes that we provide prior to supplying products. They include welding, crimping, skiving, and assembling of hoses to meet customer requirements.

So what I am hearing you say is that we need to identify those secondary processes and validate they have been properly handled or applied. Our work instructions for those processes cover our control over them. Then our inspection procedures cover our validation of them. Is that sufficient?

 

[howste]

Welcome to the forums, Bluzman!

...our inspection procedures cover our validation of them. Is that sufficient?

Generally validation of "special" processes isn't done by normal inspection because they have characteristics that can't be inspected without destructive testing. For example, you may not know if the connector is crimped correctly without a pressure test to failure, or a pressure test well above normal operating pressures. Welds may look good at inspection but may have poor penetration that can only be seen by cutting, polishing, and etching the weld to see the grain structure.

The idea is that you establish controlled conditions for the processes, validate that the conditions will achieve acceptable product (with destructive testing), and then you monitor to ensure that the controlled conditions are maintained. As time goes on, tools may wear and other conditions may change so we periodically revalidate to be sure that product continues to meet requirements.

Assembly and skiving are probably not special processes.

 

[Big Jim]

Even though we are a distributor there are many secondary processes that we provide prior to supplying products. They include welding, crimping, skiving, and assembling of hoses to meet customer requirements.

So what I am hearing you say is that we need to identify those secondary processes and validate they have been properly handled or applied. Our work instructions for those processes cover our control over them. Then our inspection procedures cover our validation of them. Is that sufficient?

No.

Inspection is only verification. You need to include something that validates.

Basically when you outsource a special process you need your supplier to perform the validation. Your proof of that is the certifications they provide.

Give us a list of those outsourced special processes and we can help you determine how to have them validated.

 

[Buckyb]

No.

Inspection is only verification. You need to include something that validates.

Basically when you outsource a special process you need your supplier to perform the validation. Your proof of that is the certifications they provide.

Give us a list of those outsourced special processes and we can help you determine how to have them validated.

Big Jim in your post you state that a certification or a C of C from the supplier would serve to validate. I agree but ISO9001 addresses "periodic revalidation" too. What does that mean?....how is this to be interpreted? We require a cert each time we have a supplier perform a special process as part of our flow-down. We do have several internal special processes. Does this mean we need to periodically revalidate our in-house processes? Can I assume that periodic revalidation does not apply to outsourced suppliers who provide special processes as long as we receive a cert each time?

 

[Cari Spears]

We make aerospace tooling, which is categorized as "non-flight" hardware. Most of what we make is A36 steel, 6061 aluminum, or Invar.

We've classified Invar as our only critical material - it is critical because the nickel content makes it a specialty metal, which means it has to comply with DFAR 252.225. In addition, the nickel content is critical for functionality of our tools because of it's COE - we make bond tools that go into autoclaves.

We require mill certs from our source just as we do for all other material, but we also have independent testing performed for each new heat/lot we receive on just the Invar. We track the heat numbers that we have had tested. When we receive a new shipment, we check our log, and if that heat number has been tested, we approve and release - if it has not, then we cut off a chunk and send it out.

Hope this is a helpful example.

 

[Big Jim]

Big Jim in your post you state that a certification or a C of C from the supplier would serve to validate. I agree but ISO9001 addresses "periodic revalidation" too. What does that mean?....how is this to be interpreted? We require a cert each time we have a supplier perform a special process as part of our flow-down. We do have several internal special processes. Does this mean we need to periodically revalidate our in-house processes? Can I assume that periodic revalidation does not apply to outsourced suppliers who provide special processes as long as we receive a cert each time?

For in-house special processes, revalidation could be to perform the validation (such as a destructive test) at a reasonable interval.

For outsourced special processes most of that would be met by each fresh C of C, but it would be wise to do more, such as audit the supplier from time to time and confirm they are doing what they say they will. If it is a plating shop look over the tank chemistry logs, perhaps watch a plater at work, and so on.

Do whatever it takes for you to gain a reasonable level of comfort that the parts are being properly vetted.

 

[Buckyb]

Thanks Big Jim,

We intend to periodically revalidate our two in-house special processes and keep records. All outsourced special processes are accompanied with C of C. Site visits are possible but usually not performed. We have over 200 suppliers, most all are COTs. We will look into site visits on those within a reasonable distance for special processes. Again, thanks.