API spec Q1 9th edition - Castings & Forgings

[SANTHSH]

I have a clarification with respect to clause no.5.7.1.5 (Validation of Processes for Production & Servicing)

We are procuring castings and forgings from our approved suppliers as per our specified technical requirements. The scope of the suppliers include Heat Treatment and NDE (Radiography, Ultrasonic Examination, LPT and MPT as applicable) also. The suppliers will be providing the reports and we will verify them at the time of material inspection at our works. Does the clause require that we should review and approve our raw material suppliers' procedure for Heat Treatment and NDE and their process validation records ? If so when this sould be done ? and whether we should maintain records of same ?

Our understanding is this requirement is applicable only for outsourced processes and not for purchased products. Is our understanding correct or not ?

 

[jmech]

You are correct that 5.7.1.5 applies to outsourcing and not to purchased products. If your company does not have production of castings and forgings inside its QMS scope, then this should be considered purchasing and not outsourcing.

Addendum 2 has caused more confusion on this issue. 5.7.1.5 now includes "Where an organization chooses to outsource a process that requires validation, the organization shall require that the supply chain conform to these requirements (see 5.6.1.6)." Read carefully, it should be clear that this only applies to when the organization outsources a process (for example, if you outsource welding and the welder uses a subcontractor to perform heat treating on the parts after welding, you need to require both the welder that you have a direct contract with and his subcontractor to meet 5.7.1.5). However, some people misinterpret 5.7.1.5 to mean that any purchased parts that have had these processes performed need to be controlled per 5.7.1.5, even if it is not outsourcing.

Further complication comes from the new requirements in 5.6.1.1c for the organization's purchasing procedure to address "type and extent of control applied to the supply chain for critical products, components or activities" and 5.6.1.2b for the organization's supplier evaluation to include "verification of the type and extent of control applied by the supplier, internally and to their supply chain, in order to meet the organization’s requirements". The intent of these requirements is that the organization defines the necessary type and extent of control (per 5.6.1.1c) and then verifies that the supplier meets the organization's requirement (per 5.6.1.2b). It is up to the organization to define the necessary type and extent of control. Whatever the organization defines as the type and extent of control needs to be verified (with records maintained) as part of your supplier evaluations / reevaluations.

The "type and extent of control" requirements are quite new and are also the subject of significant confusion and misinterpretation, including by auditors.

 

[Sidney Vianna]

A similar question was asked and answered by API. Check the API Spec Q1 FAQ document.

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[SANTHSH]

Thank a lot, jmech and Sidney.

At present the 'type extent of control' that we have on our casting & forging suppliers is limited to 'incoming inspection' as per the stated technical requirements. We do verify the Suppliers' QMS documentation and records, including the controls that our suppliers have on their suppliers during initial evaluation and re-evaluation. I understand that if we change that type and extent of control to include 'verification' or 'review and approval' of the supplier and sub-supplier 'procedures and process validation records' for NDE and Heat Treatment, then we are supposed to do the same for every initial and re-evaluation. Am I correct ?

 

[jmech]

I understand that if we change that type and extent of control to include 'verification' or 'review and approval' of the supplier and sub-supplier 'procedures and process validation records' for NDE and Heat Treatment, then we are supposed to do the same for every initial and re-evaluation. Am I correct ?

Yes.

The interpretation referenced by Sidney is helpful and relevant, but it was issued prior to Addendum 2 and should be understood within that context.