Validation Form for CNC Program - API Q1

[donhan]

Dear Guys,

We are using a company System and CNC Programmer will upload CNC Programs on this System. The operator will load directly Program from the System to the CNC machine. The revision of CNC in the System is the lastest and only one.

Can anybody help to advise if any Validation form required for CNC Program? And what the API Auditor will ask on the audit for CNC program?

We are on the way to achieve the Monogram License for API 7-1 (Threading for Rotary Shouldered Connections).

Thank you very much for your support.

 

[jmech]

The output of machining can be verified by subsequent measurement, so machining is not a process requiring validation per API Q1 9th Edition Section 5.7.1.5. Therefore, no validation form should be required.

It is up to your organization to determine and implement the process control documents required by your organization (see 5.7.1.1 and 5.7.1.3).

I have not heard of an auditor requiring a validation form for a CNC program. The auditor might be interested in how you verify the outputs of the CNC program (i.e. first-off inspection) and how you control the program to ensure the correct version is used and to prevent unintended alterations. However, I do not think that CNC programs are normally considered to be documents that require control per 4.4.3, so Q1 does not have detailed requirements for them.

 

[donhan]

The output of machining can be verified by subsequent measurement, so machining is not a process requiring validation per API Q1 9th Edition Section 5.7.1.5. Therefore, no validation form should be required.

It is up to your organization to determine and implement the process control documents required by your organization (see 5.7.1.1 and 5.7.1.3).

I have not heard of an auditor requiring a validation form for a CNC program. The auditor might be interested in how you verify the outputs of the CNC program (i.e. first-off inspection) and how you control the program to ensure the correct version is used and to prevent unintended alterations. However, I do not think that CNC programs are normally considered to be documents that require control per 4.4.3, so Q1 does not have detailed requirements for them.

Hi Jmech,
I appreciate your feedback on this. For controlling of the NC program, do we need an Excel Form that stated all the NC programs of each product ? This form will mention the Part Number, Drawing Number and listed all CNC program names, revision, review and approved signature. In ISO 9001:2015, we don't have any specific form specializing for CNC Program control. The technician just uploaded the latest programs to the Server for each Part Number and tell the auditor that is the approved latest version, only the technician who responsible for this part number can change/ delete it. Then they don't ask anymore. But i don't know if the API auditor can be okay with this way or need a specific form for CNC programs controll of each product.

Thank you.

 

[jmech]

Hi Jmech,
I appreciate your feedback on this. For controlling of the NC program, do we need an Excel Form that stated all the NC programs of each product ? This form will mention the Part Number, Drawing Number and listed all CNC program names, revision, review and approved signature. In ISO 9001:2015, we don't have any specific form specializing for CNC Program control. The technician just uploaded the latest programs to the Server for each Part Number and tell the auditor that is the approved latest version, only the technician who responsible for this part number can change/ delete it. Then they don't ask anymore. But i don't know if the API auditor can be okay with this way or need a specific form for CNC programs controll of each product.

Thank you.

What requirement in API Q1 makes you think that you might need this?

 

[donhan]

What requirement in API Q1 makes you think that you might need this?

Hi Jmech,

I thinked that CNC numerical control programs need to be treated as 4.4.3 Control of Documents. And that need to be reviewed and approved prior to issue and use.

We backed up on a server for all the CNC machines we have. Our programs also have part number-rev, date, etc. to identify them as controlled. We also have a work instruction written that only the responsible engineer can load, update the programs and deletes the old revision. The operator only has access to the correct revision. The file server is considered the master list, showing all current revisions. Only allowed one program to be in the server at a time.

But the concern point is there’s no evidence for the approval from Engineering Manager before the Engineer issues programs to the server. And actually, there is no approval that’s actual done here because the engineer is the only one person responsible for his CNC program of one product. The manager has no time to review each CNC program so actually there was no approval of the second person on this.

That’s is my concern.

 

[jmech]

There is not a requirement in 4.4.3 that review and approval needs to be done by the engineering manager (or someone other than whoever wrote the program). If you want the engineer to be responsible for review and approval of the program (which it sounds like is your current reality), then write this in your procedure, and write in your procedure that the engineer only uploads programs that the engineer has reviewed and approved.

 

[donhan]

There is not a requirement in 4.4.3 that review and approval needs to be done by the engineering manager (or someone other than whoever wrote the program). If you want the engineer to be responsible for review and approval of the program (which it sounds like is your current reality), then write this in your procedure, and write in your procedure that the engineer only uploads programs that the engineer has reviewed and approved.

Thanks a lot, Jmech.
Your advice is actually what i need.

 

[lanley liao]

I strongly agree with Jmech's viewpoint. This is a typical question that Chinese API auditors like to ask. The key to this question is not the software version. The key is whether the CNC lathe can manufacture qualified parts according to the intended functionality. If so, there is no need to dwell on the software version. However, if the company wants to strengthen control in this area themselves, to avoid CNC machining risks, they can make their own stipulations in the documents. In fact, the standards do not have requirements in this regard. They only require confirmation of computer software used in the TMMDE, which is different from validation. This represents the typical thinking of Chinese API auditors, which has misled many people.