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API Q1 5.7.1.5 Process Validation - Machining, heat treating, Manganese Phosphate and Zinc Plating

#1
The company I work for is ISO 9001:2015 and API Q1 Certified. I am having a hard time understanding exactly how to validate procedures/processes, it has been a short coming (along with supplier management, many of the threads on here have been of great help for that) since before my time and never caught and I am trying to figure out how to fix it.

API Q1 5.7.1.5:
The organization shall validate those processes identified by applicable product specification as requiring validation. If these processes are not identified, or there is no product spec. involved, the processes requiring validation (if applicable to the product) shall include: NDE, welding, Heat treating; and coating/plating (when identified as critical to product performance by product spec or the organization).
We outsource machining (so by extension, heat treating) and sometimes Manganese Phosphate and always Zinc Plating. In house we have welding and NDE and are beginning Phosphate. I really don't understand how to validate these processes. I am trying to decide whether or not to exclude coating and plating from or processes requiring validation by having our engineering team document that they are not critical to product performance as the product will perform the same way with or without the coating/plating but it won't last as long in the field.

As for how to validate NDE, Welding, and Heat Treating (which Heat Treat is our suppliers, suppliers processes) any input would be greatly appreciated.

Thank you for you time.
 
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#2
The first paragraph in API Q1 5.7.1.5 states:
Validation shall demonstrate the ability of these processes to achieve planned results.

Essentially, your validation has to show that if you follow your procedure/process, you can get the results that are required of the process. In some cases, you might not know the results that are required of the process, in which case the process might not be critical to product performance or you might have to figure out which results are actually required.

For coating and plating, it would depend on whether the requirements of the process are a specific coating thickness, corrosion resistance, or something else. Run a test coupon following your process (or use a sacrificial part that went through the process) and then test that part to determine if the applicable requirement(s) were achieved.

For welding, you want to demonstrate that a weld produced by following the weld procedure has the required strength, ductility, hardness, etc. This is normally documented on the Procedure Qualification Record (PQR) which is required by ASME BPVC Sec IX. If you've qualified your weld procedure per ASME BPVC Sec IX and the applicable construction code, and you've maintained the PQR as a record, this should be all you need for the welding validation.

For NDE, you want to demonstrate that you can find the flaws that your NDE procedures are intended to find. You can use a special specimen with known flaws for this demonstration. It is a bit hokey and many NDE professionals that I've talked to about this hadn't heard of a need for it before (they assumed that following procedures written/approved by a Level III examiner, ensuring that everything is calibrated, ensuring the NDE personnel are Level II and have current eye tests, etc., is sufficient and validation testing is not required). However, it can be done and provides the required evidence. The type and number of specimens/flaws that you should use for the demonstration is debatable.

Outsourcing machining does not necessarily mean outsourcing heat treating. If you are buying finish machined parts from a machine shop, who buys heat treated bar from a distributor or mill, then this is considered purchasing and not outsourcing, so API Q1 does not require you to have validation records. However, the line between purchasing and outsourcing is sometimes not clear, and auditors sometimes try to classify it as outsourcing when it should be classified as purchasing. To make it even more confusing, if you are manufacturing to an API product spec and the product spec requires validation of the process for those parts, you will be required to have validation records even if they would be classified as purchased.

For heat treating validation, you again want to demonstrate that the heat treating process can achieve the required results. For postweld heat treatment (PWHT), this might be the hardness of the weld after PWHT, which can be qualified together with the weld procedure and shown on the PQR. For other heat treatment (normalize, quench and temper, etc.), mechanical, impact, and hardness testing, as applicable, of a test coupon is essentially validating the process for every heat, even though this has traditionally not been considered validation.
 
#3
Thank you very much for the information. That helps me a ton, I appreciate it. I knew I was going to be glad I joined this forum.

Edit:
Do you believe that an auditor can consider any of these mentioned above as outsourced due to the change in terminology from "supplier" to now "supply chain".

API Q1 3.1.22 Supply Chain: Suppliers and associated sub-supplier(s) required for product realization.

As per API Q1 5.6.1.5 Outsourcing Note: See 5.7.1.5 for requirements when a process requiring validation is outsourced with in the supply chain.

Supply chain is also mentioned in 5.7.1.5 Validation of Processes.

From what I understand the change from "supplier" to "supply chain" makes a huge difference and makes API Q1 Certified companies push a lot more into controlling their suppliers (and sub-suppliers) but doesn't really guide to how far down the chain I would have to control. For Heat Treat, if the machine shops I buy from, buy from a distributor, that buy from the actual mill or forge, do I have to go all the way to the forge level and control that (thereby having to validate their process of heat treat)? In my opinion that is way outside what my company should have to extend control over.

Again, any input would be greatly appreciated. :thanx:
 
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