API Q1 5.7.1.5.a and API 6A10.4.2.12.2 AAR in API audit

Hello, Good Morning to all of you. We got a non conformance in API audit and I have prepared the draft for submission but still somehow I am not confident enough to submit. I need expert inputs for the review of my draft and any new RC, CA and Correction if you have in mind.

Clause 5.7.1.5a Description -The organization shall maintain a documented procedure to address methods for review and approval of the processes including required equipment.
API 6A Clause 10.4.2.12.2 Ultrasonic Examination Test Method Description - For PSL 3 and PSL 4 wrought material, ultrasonic examination shall be performed in accordance with the flat-bottom hole procedures specified in ASTM A388/A388M (except that the immersion method may be used) and ASTM E127.
Objective Evidence - Inspection report dated XX.XX.XXXX for the flat bottom hole reference blocks SQ7 25%, 50% and 75% do not evidenced conformance to requirements of Fig 1 of ASTM E428-08 (referred in the standard ASTM A388). Verification of the surface finish, parallelism and perpendicularity requirements is not evidenced.
Nonconformance/Concern Description - Conformance of Flat bottom hole reference indicator blocks to the requirements of applicable standard ASTM E-428:08 is not evidenced.

Correction :
1. We procured the materials for reference blocks and outsourced the machining as per the requirements of ASTM E127-20.
2. The reference blocks are checked at our end on dated xx.xx.xxxx (Inspection report no # xxx) and found OK as per the ASTM E127-20 requirements.

Root Cause :
1. The requirements to procure the NDT reference blocks was not made clear.
2. No specification / drawing was established to use as reference to verify the blocks as per requirement.

Corrective Action :
1. Acceptance criteria to procure the reference blocks is established and communicated to purchase by QA Manager.
2. Drawing is established to use as a reference for incoming standard blocks.
3. UT procedure Doc No. WI/QA/XX is revised to include the reference of ASTM E127-20 and ASME SEC V.
4. The concerned are trained on revised procedure on dated xx.xx.2022.
5. Effectiveness evaluation of training is done by conducting the examination on dated xx.xx.2022 and found satisfactory.
6. Spec ASTM E127-20 is reviewed by QA Manager + Engineering Manager to review the product spec requirements as applicable.
7. Process evaluation is conducted to review effectiveness verification of the actions taken.

I have two doubts:
1 - Not confident on what I wrote above for submission.
2 - Do we have to make reference blocks for ALL the products in the API 6A in our product scope or only the ones that we get the order for? Because if we consider ALL the size ranges for cross over connectors, adaptor spools, blind flange etc. it's coming out to be MORE than 40 reference blocks as per ASTM E127-20 and the cost factor is also matters.

Thanks in advance guys.

You can make Blocks with your regular manufacturing Material Grade wise. Confirm FBH as specified in API 6A

You only have to make the reference blocks that are required for inspecting the products you manufacture.

Your corrective action should ensure that you will use the appropriate reference block for the products being manufactured (including buying or making a new reference block if you don't already have the required size for a new order).

Here are a few suggestions to improve the nonconformance response:

1. The correction and root cause analysis look good overall. However, for the root cause, consider adding something about lack of clarity on requirements for procuring and verifying reference blocks. This seems to be an underlying issue.
2. For the corrective actions, make sure to include actions to prevent recurrence, such as updating procedures to specify requirements, training personnel, and verifying effectiveness.
3. Regarding your question on reference blocks - I would recommend maintaining a risk-based approach. Identify the products and sizes you manufacture most frequently and focus on having blocks available for those. For less common items, you can consider procuring blocks when needed for specific jobs. The key is having clear requirements and verification methods defined in your procedures.
4. Also consider process controls and audits to ensure your suppliers are providing acceptable reference blocks per the applicable specifications.
5. Review industry best practices and regulations to determine what is reasonably expected for an organization like yours. Scale your reference block library and controls accordingly.
6. Document your rationale for the approach you take. Show regulators and auditors you have thought through this systematically and are managing risks.

API 6A clause : 7.4.2.3.15 Refers to the hot worked parts - calibration : various sizes of the flat bottom hole for the different size of thickness of the Raw material sizes and for the weld Overlay as per the clause7.4.2.1.7 b) only one size of Flat bottom hole (3.2mm) is sufficient and not required for each kind of product as long as you are manufacturing with same material grade

Inshorts said:

Hello, Good Morning to all of you. We got a non conformance in API audit and I have prepared the draft for submission but still somehow I am not confident enough to submit. I need expert inputs for the review of my draft and any new RC, CA and Correction if you have in mind.

Clause 5.7.1.5a Description -The organization shall maintain a documented procedure to address methods for review and approval of the processes including required equipment.
API 6A Clause 10.4.2.12.2 Ultrasonic Examination Test Method Description - For PSL 3 and PSL 4 wrought material, ultrasonic examination shall be performed in accordance with the flat-bottom hole procedures specified in ASTM A388/A388M (except that the immersion method may be used) and ASTM E127.
Objective Evidence - Inspection report dated XX.XX.XXXX for the flat bottom hole reference blocks SQ7 25%, 50% and 75% do not evidenced conformance to requirements of Fig 1 of ASTM E428-08 (referred in the standard ASTM A388). Verification of the surface finish, parallelism and perpendicularity requirements is not evidenced.
Nonconformance/Concern Description - Conformance of Flat bottom hole reference indicator blocks to the requirements of applicable standard ASTM E-428:08 is not evidenced.

Correction :
1. We procured the materials for reference blocks and outsourced the machining as per the requirements of ASTM E127-20.
2. The reference blocks are checked at our end on dated xx.xx.xxxx (Inspection report no # xxx) and found OK as per the ASTM E127-20 requirements.

Root Cause :
1. The requirements to procure the NDT reference blocks was not made clear.
2. No specification / drawing was established to use as reference to verify the blocks as per requirement.

Corrective Action :
1. Acceptance criteria to procure the reference blocks is established and communicated to purchase by QA Manager.
2. Drawing is established to use as a reference for incoming standard blocks.
3. UT procedure Doc No. WI/QA/XX is revised to include the reference of ASTM E127-20 and ASME SEC V.
4. The concerned are trained on revised procedure on dated xx.xx.2022.
5. Effectiveness evaluation of training is done by conducting the examination on dated xx.xx.2022 and found satisfactory.
6. Spec ASTM E127-20 is reviewed by QA Manager + Engineering Manager to review the product spec requirements as applicable.
7. Process evaluation is conducted to review effectiveness verification of the actions taken.

I have two doubts:
1 - Not confident on what I wrote above for submission.
2 - Do we have to make reference blocks for ALL the products in the API 6A in our product scope or only the ones that we get the order for? Because if we consider ALL the size ranges for cross over connectors, adaptor spools, blind flange etc. it's coming out to be MORE than 40 reference blocks as per ASTM E127-20 and the cost factor is also matters.

Thanks in advance guys.

Click to expand...

Welcome, Inshorts.

I would like to see more detail that would help to make sure this is not repeated with a different type of instrument.

Why were the requirements to procure the NDT reference blocks not made clear?
Why was no specification / drawing established to use as reference to verify the blocks as per requirement?

This is about process. Addressing these particular reference blocks is a correction only.

Additionally, have you reviewed to see if there are other types of inspection equipment that had not been thought of when developing the process? How does your organization determine what is needed?