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Internal NCR - API Q1 5.4.2b - API 16C Clause 4.1.3

Thee Bouyyy

Involved In Discussions
#1
Description : Choke and kill systems are generally mobile and can be used in areas where sour service conditions could be encountered. Metallic materials that are exposed to the well fluid shall meet the requirements of NACE MR0175/ISO 15156, including partial pressure rating for H2S of 1.5 psia (10.34 kPa) or higher.

Objective Evidence :
In the design package# Rigid Choke and Kill Lines Size:2” Fig 1502, 10’ Long 15000 psi below gaps observed:
a)The design input has not considered the correct Fluid service condition as per API 16C requirement. The facility has considered as standard service, however, as per API 16C the choke and kill lines are always mobile so the facility shall consider the conditions as per sour service. Design input was not found considered as per product specification (API 16C) requirement.
b)Design input document was found addressing the articulated choke and kill lines, however, the design package was verified for the rigid choke and kill lines. On verification it was found as typographical error.

Nonconformance/Concern Description:
The design input was not found addressing correctly the product specification requirement.

Correction :
(a) i.)Design Package for API 16C Rigid choke & kill line is revised to include the requirement of considering sour service by addressing correctly the product specification requirements.

ii) All other packages for other products which are under the scope of registration have been reviewed for similar issue & confirmed fulfiling as per the standard requirement.

iii) This is a initial sample product manufactured to demonstrate manufacturing capability & no API Monogram was applied.
We have not manufactured and / or delivered any other product under the QMS with incorrect inputs .Hence we can say that there was no negative impact on the products. The above is confirmed Jointly with Engineering Manager + QA Manager + Production Manager as per MOM dated 22.01.2021

(b) i.) The typographical error has been corrected in Design input document, L/XXX/03, rev01 to identify Rigid choke & kill line instead of articulated choke & kill line.
ii) All other documents for other product packages which are under the scope of registration have been reviewed & no typographical error is observed.
Hence it is assured that there is no negative impact on product conformity.
Date of completion:-08.02.2021
Date of implementation:-12.02.2021

Root Cause:
(a) i.) In Design Input list, L/XXX/03, rev.01, sour gas was not considered for the service condition as per API 16C requirement.

ii) In Design input list,L/XXX/03, rev.01, the requirements were reviewed by a single authority to identify Design & development inputs in line with the requirements.

Corrective Action:
(a) i.) Design Input list, L/XXX/03, rev.01 for API 6A & 16C packages is additionally reviewed by Operations & Business development Executive.
The above is also recorded in minutes of meeting, F/XX/04, rev. 0, dated 22.01.2021 .

ii) One round of special process evaluation, dated 13.02.2021 is conducted for verifying the effectiveness of the actions & to prevent recurrence.


Date of completion:-08.02.2021

Date of implementation:-13.02.2021

Auditor require further explanation:

The correction states, "This is a initial sample product manufactured to demonstrate manufacturing capability & no API Monogram was applied".

How have you identified the noted condition of this product in accordance with your QMS to prevent it from being mistakenly shipped to a customer?

What should I reply now ? I tried my best to answer corrective action and root cause. Now I am blank for his next question answer. Experienced personnel views require on this.
 
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jmech

Trusted Information Resource
#2
Thanks for providing the complete finding text and dialog - this makes it much easier to answer your question.

I'm a bit surprised that they don't seem to be asking about the corrective action or root cause, both of which I think could use improvement (Why was the API 16C sour gas requirement not considered and what action will you take to prevent this and similar non-considerations in the future?), but you seem to have gotten lucky here that all API wants is assurance that there is no chance the product will be shipped to a customer.

Simply explain what you've done to ensure that the defective product (not suitable for sour service) will not be sent to a customer. The most robust option is to mutilate the product so that it could never be pressurized and is visibly unusable (take a disc grinder through any threads, drill holes in it, etc.). If you do this and describe to API (you can even provide pictures), they are almost guaranteed to accept your response.

Another option is to mark or tag it as nonconforming and unsaleable, but this can be removed or missed, so they may or may not accept it.
 

Thee Bouyyy

Involved In Discussions
#3
Thanks for providing the complete finding text and dialog - this makes it much easier to answer your question.

I'm a bit surprised that they don't seem to be asking about the corrective action or root cause, both of which I think could use improvement (Why was the API 16C sour gas requirement not considered and what action will you take to prevent this and similar non-considerations in the future?), but you seem to have gotten lucky here that all API wants is assurance that there is no chance the product will be shipped to a customer.

Simply explain what you've done to ensure that the defective product (not suitable for sour service) will not be sent to a customer. The most robust option is to mutilate the product so that it could never be pressurized and is visibly unusable (take a disc grinder through any threads, drill holes in it, etc.). If you do this and describe to API (you can even provide pictures), they are almost guaranteed to accept your response.

Another option is to mark or tag it as nonconforming and unsaleable, but this can be removed or missed, so they may or may not accept it.
Process : No defective product (not suitable for sour service) deliver to customer
Risk : Delivering defective product to customer
Impact : Product delivery and market reputation in business
Occurrence (O) : 1 - Possible but very unlikely, experience/records indicate that it has not happened in past.
Severity (S) : 2 - An incident, which could causes serious inconvenience to customer or result in moderate loss of business for company.
Risk Rating (OxS) : 2*1 = 2
Mitigation Plan :
1. To mutilate the product so that it could never be pressurized and is visibly unusable(take a disc grinder through any threads, drill holes in it, etc..
2. To mark or tag it as nonconforming and unsaleable.
Responsibility for mitigation : QA Manager, Production Manager, Engineering Manager and Top Management
Action results : Occurrence (O) : 1, Severity (S) : 1, Risk Rating (OxS) : 1*1 = 1

Is it sufficient ? I am putting this data in risk assessment form.
 

jmech

Trusted Information Resource
#4
I thought this was from an API (external) audit, but now I see that the title references internal NCR, so now I'm not sure what the scenario is.

If it is an external NCR from API, then the plan needs to be carried out prior to reporting it to API. Include the date it was completed with your response and what you actually did (i.e. don't say that you marked or tagged it; say which one you did). As well, all that API is likely to care about is that the actions in what is listed in your mitigation plan are completed - the rest is unnecessary.
 

Thee Bouyyy

Involved In Discussions
#5
I thought this was from an API (external) audit, but now I see that the title references internal NCR, so now I'm not sure what the scenario is.

If it is an external NCR from API, then the plan needs to be carried out prior to reporting it to API. Include the date it was completed with your response and what you actually did (i.e. don't say that you marked or tagged it; say which one you did). As well, all that API is likely to care about is that the actions in what is listed in your mitigation plan are completed - the rest is unnecessary.
To mutilate the product so that it could never be pressurized and is visibly unusable(take a disc grinder through any threads, drill holes in it, etc.. - My management team is denying this to write. Is there any alternative.
 

jmech

Trusted Information Resource
#6
How have you identified the noted condition of this product in accordance with your QMS to prevent it from being mistakenly shipped to a customer?
How does your QMS say that you are supposed to identify nonconforming product to prevent it from being mistakenly shipped to a customer? Do that and write that you did it (with the date it was completed).
 

Thee Bouyyy

Involved In Discussions
#7
How does your QMS say that you are supposed to identify nonconforming product to prevent it from being mistakenly shipped to a customer? Do that and write that you did it (with the date it was completed).
This is what we are following and this is sufficient for my response to auditor.
  • We defined the requirement for product identification at all stages by tagging the product name, job card no. quantity, heat number, supplier name / code, and status in the Procedure for Identification & Traceability, xxxx, rev xx.
  • The criteria for ensuring that only product that meets the specifications or is approved under concession is released for which tags and colour codes are used is already identified in the Procedure for Product Inspection / Test Status, xxxx, rev. xx. It involves products in various stages such as WIP, Accepted, Under Inspection, Rework, Hold, and Rejection.
  • Also, according to our Procedure for Product Release, xxxx, rev xx, the QA Manager shall release the product to the customer only after all expected arrangements have been satisfactorily completed and registered in Product Release Checklist, xxxx, rev. xx, and approved by a relevant authority and, where appropriate, by the customer.
  • All of the above-mentioned requirements have already been written into our QMS, and we are adhering to them, ensuring that the incorrect product is not sent to a customer.
 

Thee Bouyyy

Involved In Discussions
#8
****Just to close this thread****

This non-conformance was closed by our final response to the auditor:

The noted condition of this product has been identified by tagging it as "sample product only- not for sale". We also have Procedure for Identification & traceability, xxx/xxx/xx, rev xx ,including various controls for identification of products at various stages. Still we have done risk assessment considering below aspects:

1. Not covering all applicable conditions for design planning
2. Not verifying design criteria at review stage
3. Not preventing non monogram product mistakenly shipped to customer

The results were found satisfactory along with its risk & impact, occurrence, severity and mitigation plan, x/xx/xx, rev xx. Training is given to all the concern personnel & recorded in form, x/xx/xx, rev xx, dated xx.05.2021. Effectiveness of the training has been evaluated in training effectiveness evaluation form x/xx/xx, rev x, dated,xx.05.2021 and result found satisfactory. This risk identification, assessment and mitigation plan is approved by M.R. on xx.05.2021
 

lanley liao

Involved In Discussions
#9
Hi, Thee,
In fact, The question asked by the API auditor is that what gap in your quality management system resulting in this nonconformance. what actions you need to prevent it happen again in the futre?
it should be considered in three aspects: planning, implementing, and checking. but the planning should be considered in two aspects: you need to know whether have the corresponding operation stipulates if have, this stipulates whether is proper, undetailed, poor operation, then you should revise it according to variable conditions. if you don`t have stipulated regarding this planning(such as procedures documents, plan, work instruction, etc.), then you should prepare corresponding operation stipulates and organized the training for relevant department and persons. if this planning has no question, then you should take into consideration the reason for implementation if have specified but no abided by, the implementing person does not be aware of or not be unfamiliar with the corresponding operation rules, then the training was made to this implementation person, or give this text of this rules to the operator. if the operator is aware of or is familiar with corresponding rules, then whether the responsibility was not clear——specific responsibility specifed, whether the ability of person was poor enough——enhance it by training or reassignment job. whether the sources were not enough——finance,materials,HR,and technical resources, etc. The last reason for this NCR is the checking aspect, the analysis is as same as mentioned above.
I hope that this can help you.
 
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