Parallelism, Perpendicularity and Concentricity

[QA Manager]

Video graphic evidences were presented to the auditor however auditor explained that we should use CMM machine, rather than using traditional measurement method of verification while job is clamped on CNC.

I doubt, it will come back as - "Auditor’s clarification indicates that he was not shown any satisfactory method of measurement of the dimensions mentioned in the Finding and that he did not recommend the use of a CMM machine. Please clarify this discrepancy."

 

[Jigyasa]

I doubt, it will come back as - "Auditor’s clarification indicates that he was not shown any satisfactory method of measurement of the dimensions mentioned in the Finding and that he did not recommend the use of a CMM machine. Please clarify this discrepancy."

In that scenario, my response would be like this,

We explained this to auditor at CNC machine ABCD, serial number 1234 where machine operator and production manager were present. Suggestion of purchasing CMM machine was discussed however to avoid conflict we withdraw this statement. FARO CMM is already purchased and in use.

 

[QA Manager]

@Jigyasa

1. What gaps in your Quality Management System contributed to lack of documentation needed to "validate and document conformity of the finished product to the specified requirements" per API Spec Q1 5.7.7.3?

2. Was an assessment performed to determine if there were any other areas where your facility lacked documentation?

3. What steps have you taken to ensure that, in the future, your facility maintains proper documentation to validate and document conformity to the spec requirements?

 

[Jigyasa]

1. What gaps in your Quality Management System contributed to lack of documentation needed to "validate and document conformity of the finished product to the specified requirements" per API Spec Q1 5.7.7.3?

These three characteristics were checked and verified during machining stage by QC inspector and at pre-assembly stage by assembly fitter to allow assembly of valve/choke.

Being a routine practice, it was taken for granted and not recorded in dimension inspection report. Verification was done at two stages but not recorded in dimension inspection report, is main gap. Reason of gap, was working team mentality to consider routine practice. This mentality developed gap in QMS system.

We already revised dimension inspection report form to record Parallelism, Perpendicularity and Concentricity. Additionally as described above CMM machine is already in use to assist these characteristics measurements and record.

2. Was an assessment performed to determine if there were any other areas where your facility lacked documentation?

In our QMS process, product realization start from contract review to final certificate data book and product release. Following stages are followed by us.

• Contract review
• Design and development
• Planning, procurement and receiving inspection
• Manufacturing and quality control
• In-process and final inspection
• Product release after blasting and painting.

While doing analysis of above stages, we corrected contract review stage. We used to do one time contract review against each order either upon email confirmation or against receipt of customer purchase order. We started doing contract review second time for such orders where order realization process started on email confirmation.

3. What steps have you taken to ensure that, in the future, your facility maintains proper documentation to validate and document conformity to the spec requirements?

For each customer order, we prepare following inspection and test documents to meet specified requirements of the finished products.

• Inspection Test Plan (ITP)
• Factory Acceptance Test (FAT) procedure
• Stage wise manufacturing drawing which includes tolerances
• Process routing sheet which includes dimension inspection
• Final pressure test report
• Blast and paint certificate
• Product release

Compilation of above procedure’s end result document will be certificate data book. We are making sure to maintain certificate data book which contains all stage wise process records.

 

[QA Manager]

This is sufficient information, you can submit your response to API.

 

[Matt's Quality Handle]

Clause description - The organization shall perform all final inspection and testing in accordance with the product quality plan (see 5.7.2) and/or documented procedures to validate and document conformity of the finished product to the specified requirements.
Personnel other than those who performed or directly supervised the production of the product shall perform final acceptance inspection at planned stages of the product realization process.

Objective evidence - Evidenced In process Inspection Report 115, Rev 00 dated 12 Nov 2019 for Machined Body Sl. Number 3018092587, 4-/16”, 5000 PSI, PSL3 API 6A Choke Body. There is no other record evidenced which demonstrates conformity to the requirements.

Thanks.

Being a routine practice, it was taken for granted and not recorded in dimension inspection report.

Can I offer the thought that the finding is less about the methods and more about not recording the results?

From the thread, it seems like you did have a method (although probably not an MSA) to measure the dimensions. If there is still the opportunity, I might probe the auditor further. The correction may be as simple as documenting your indicator checks.

EDIT TO ADD: You will run into the same problem if you buy a Faro, then fail to record evidence after you measure with the Faro.