Validation of process for production and servicing 5.7.1.5 API Spec Q1, 9th Edition

#1
Hello Everyone,

Recently a NC has raised in Validation of the process, special processes in our organization such as NDE (Liquid Penetrant Test), Welding (Overlay) and Post Weld Heat Treatment (Stress Relieving). Auditor has raised NC that many gaps are observed in the validation process especially in PWHT. Here my query is how to validate PWHT process and personnel? Like to validate NDE, Level-III person is required to validate our process and personnel (Level-II). We want to validate the process and personnel so anyone help us how can we validate and re-validate? Requirements of PWHT, Can anyone explain this?
 
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Thee Bouyyy

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#2
Can you let me know that which PWHT process you are using?

1. PWHT in furnace
2. PWHT with localized heating with flexible coil
3. PWHT with localized heating with readymade heating pads.

Each applicable part shall be validated prior to use on production jobs. Production manager, Welding engineer and PWHT technician are mainly responsible personnel. Follow ISO 17662:2005(E) table 45, for the validation requirements.
 
#3
Our business is valves servicing for this we using PWHT with localized heating with flexible coil.

Thanks for the information that may help us.
 

Thee Bouyyy

Involved In Discussions
#4
For PWHT with localized heating with flexible coil,

Following steps might be helpful:

Step 1 - Identify the equipment. i.e. Heating coil, Temperature controller unit, Temperature chart recorder, Thermocouples (be specific for the type of thermocouples), etc. - All equipment including thermocouple wire shall have valid calibration.
Step 2 - Surface preparation
Step 3 - Attachement of thermocouple
Step 4 - Placement of heating coil
Step 5 - Adjustment of temperature controller unit etc...

For re-validation, identify the change in essential parameters.
 
#5
Hi All!
I need a clarification wrt 5.7.1 - Validation of special processes.

We procure forgings, castings and fasteners with NDE requirements. Suppliers conduct tests at their ends and report the results in test certificates.

1. Is it mandatory for us, the buyer, to validate the special processes done by suppliers or is it enough for us to verify the validation procedures and records of the suppliers.

2. In case of bought-out items like fasteners, threaded hangers etc., our suppliers do not conduct NDE but procure raw material from their suppliers meeting our requirements. Should we the buyer verify the validation procedure and records of our supplies supplier? If so, won't this become a routine task since supplier always has the luxury to change his supplier?

Thanks in advance.

Navaneeth
 

jmech

Trusted Information Resource
#6
API has issued an interpretation (see page 4 of the attached, also available from the address below) that addresses this question.

https://mycommittees.api.org/standards/techinterp/mspecs/Shared Documents/Q1.pdf

Question: Purchased materials – When materials such as forgings and wrought materials are purchased from steel manufacturers (who perform the heat treatment and in some cases NDT), is it a requirement of API Spec Q1, 9th Edition, Section 5.7.1.5 for the licensee to also validate the steel manufacturer’s process controls for processes requiring validation?
No. Based on the information provided, this is a purchase issue and therefore all that is required is verification of that the product meets the contract requirements on receipt (5.6.3). Outsourcing (5.6.1.6) and validation (5.7.1.5) do not apply since the product requirements do not expect that the organization perform the forging activity itself, but simply to use forged product. Therefore, by extension, validation of those processes such as forging does not apply. Note however, that validation of a supplier’s processes is likely to be required in two cases: a) When this is included in the process of the initial qualification of a critical supplier per 5.6.1.2 and for reevaluation (optionally) per 5.6.1.4; or b) When the activity does become one of outsourcing (Section 5.6.1.6), i.e. the supplier is performing the activity on behalf of the organization when such an activity is required by the product spec or other obligation (contract).
If you are purchasing (and not outsourcing; API Q1 differentiates between these) the forgings, castings and fasteners, then you generally do not need to validate the special processes performed by the suppliers.

However, if you have decided to make special process validation a critical supplier (re-)evaluation requirement (this is not specified by API Q1 but you can choose to do so) or if the supplier is performing an activity on your behalf (for example, you are a forging manufacturer who outsources NDE on your forgings), then you are required to validate the process. Reviewing the supplier's validation records is generally sufficient for this - their personnel will be performing the process, so it often doesn't make sense for you to do a separate validation (you commonly don't have personnel to do it yourself anyway and you want to validate the supplier's process using the supplier's personnel).

For the second question, you are not required by API Q1 to do what you mention. However, per API Q1 9th Edition Addendum 2 5.6.1.1 c, you are required to address "type and extent of control applied to the supply chain for critical products, components or activities" and per 5.6.1.2 b and 5.6.1.4, you are required to verify "the type and extent of control applied by the supplier, internally and to their supply chain, in order to meet the organization’s requirements". Depending on risk, in some cases it may make sense for the Q1 organization to specify and verify controls on the supplier's supplier of raw material (and you could specify in your contract that your supplier only use raw material suppliers that you have approved). However, it is not a Q1 requirement to specify this and you can specify other controls, preferably that are appropriate for the risks associated with your product.
 

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#8
Thanks a lot for your detailed answer @jmech.

I'm clear now after your answer for my second question. But I still need a bit more clarity for the first one.

During the previous audit we faced, we had not made it a mandatory requirement for critical suppliers to submit their special process validation reports for our review. But API auditor had raised a major NC for that. Until then, our understanding was that we are procuring forgings and castings as a complete product complying to our quality requirement that includes NDE. Auditor's impression was that we have outsourced the NDE process. Hence, we are running behind almost 50 suppliers now.

This is where I need extra clarity. Will the auditor accept if we say that validation of special process as a supplier is not a requirement as per our written procedure or must the NDE process in supplier's scope be treated as out-sourced as told by the auditor?
 

jmech

Trusted Information Resource
#9
During the previous audit we faced, we had not made it a mandatory requirement for critical suppliers to submit their special process validation reports for our review. But API auditor had raised a major NC for that. Until then, our understanding was that we are procuring forgings and castings as a complete product complying to our quality requirement that includes NDE. Auditor's impression was that we have outsourced the NDE process.
This has been a common misunderstanding between auditors and licensees. The way that we have resolved this is by appealing the finding to API with a reference to the interpretation that I mentioned earlier.

It is not possible to predict what the auditor will accept. If the audit is not yet complete, then I would show the auditor that interpretation and discuss it further with them, including telling them that you will appeal the finding if they write it. If they drop the finding, then your problem is solved. If the audit closing meeting has already occurred, then your only option is to appeal it to API (the auditor does not review your finding responses; API audit review staff does).
 
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