API Certification - In Process Control

A

anderson2015

#1
First of all hello, I am relatively new to this forum and this is my first time posting (hopefully of many).


I have recently started working for a manufacturer of hoses for the oil and gas industry (high pressure).


We are in the process of applying for API Q1 status as well as accreditation to specs 7k, 16c and 17k.


Our sister site in China recently had a 17k audit and received an NCR regarding in process control.


We have an autoclave (which is used for curing the rubber) which is 64m long. Within this autoclave we have 4 temperature probes to monitor the process. The site in China has the same however less probes.


The API auditor stated that due to the lack of probes - the process control was insufficient.


Is it specified anywhere how much / what level of process control is required? How many temperature probes should we have for a 64m length process (bearing in mind the auditor stated to gain acceptance we can have a maximum of 2 degrees difference from 1 end to the other)


Appreciate the help


Let me know if I need to provide any additional information
 
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B

bluepagen

#3
Is it specified anywhere how much / what level of process control is required? How many temperature probes should we have for a 64m length process (bearing in mind the auditor stated to gain acceptance we can have a maximum of 2 degrees difference from 1 end to the other)


Did your company purchase the autoclave? If so, I would check with the manufacturer to ask this question.

Hope this helps.
 
A

anderson2015

#4
I am in the process of contacting the supplier of the autoclave.


Our sister site in China has recently underwent an API audit and they were informed of the same thing.


I don't recall reading anywhere in the standard that there is a set guideline for process control (that is as detailed as informing you at how many m you must take a measurement)
 

Steve Prevette

Deming Disciple
Leader
Super Moderator
#5
What do the data indicate? You stated a 2 degree requirement from one end to the other. Does your autoclave with a higher level of instrumentation show you meet that requirement routinely? Have you done a set of statistical analyses to validate the equipment meets the requirements or does not meet?

I would say you should be able to make the case that if you have the equivalent of a good R&R study (and some ongoing SPC monitoring) that the 2 degree requirement is routinely met, and the functionality of the autoclave with less instrumentation is otherwise exactly the same, then you are "in process control".
 
A

anderson2015

#6
What do the data indicate? You stated a 2 degree requirement from one end to the other. Does your autoclave with a higher level of instrumentation show you meet that requirement routinely? Have you done a set of statistical analyses to validate the equipment meets the requirements or does not meet?

I would say you should be able to make the case that if you have the equivalent of a good R&R study (and some ongoing SPC monitoring) that the 2 degree requirement is routinely met, and the functionality of the autoclave with less instrumentation is otherwise exactly the same, then you are "in process control".
We have warning alarms if the autoclave goes outside of the allowed limits in terms of temperature and pressure.


I will speak with the engineering department and maintain the documentation and process data for this and use it as a basis of our case for being "in process control"


Thank you all for your help!!
 
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