Q1 Clause 5.7.1.5 - Validation of process

A

Aussie99

#1
Hi,
with regards to Q1 clause 5.7.1.5 - "The organisation shall validate processes for production and servicing where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use or the servicing has been delivered."..............

The company I work for has been hardbanding drill pipe and collars for over 20 years now. Initially for the mining industry, and over the last six years, for the Oil and Gas industry as well.

We have never carried out any form of testing other than the "test of time and usage" to validate our process. We know it works, and our customers know it works, but is that enough? Are we able to comply with clause 5.7.1.5 using some form of "grandfathering" for our process, which was developed many years ago. Tried, tested and evolved into what it is today?:confused:

Thanks in advance
 
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sagai

Quite Involved in Discussions
#2
Re: Validation of process

So what is the "resulting output cannot be verified by subsequent monitoring or measurement" in your case?
Cheers!
 

somashekar

Staff member
Super Moderator
#3
Re: Validation of process

Hi,
with regards to Q1 clause 5.7.1.5 - "The organisation shall validate processes for production and servicing where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use or the servicing has been delivered."..............

The company I work for has been hardbanding drill pipe and collars for over 20 years now. Initially for the mining industry, and over the last six years, for the Oil and Gas industry as well.

We have never carried out any form of testing other than the "test of time and usage" to validate our process. We know it works, and our customers know it works, but is that enough? Are we able to comply with clause 5.7.1.5 using some form of "grandfathering" for our process, which was developed many years ago. Tried, tested and evolved into what it is today?:confused:

Thanks in advance
HARDBANDING is a process.
You know your process best, but please read the details ABOUT HARDBANDING to decide what tests you can do to confirm that your 20 year old process is assured to be good.
Then maintain your process to stand by it and with assurance say that your process of hardbanding is validated to meet the customer requirement.
Add some data to your 'grandfathering' for assurance in your quality management system. That will be a day to learn and wish you good luck ~~~
 
A

Aussie99

#4
Re: Validation of process

HARDBANDING is a process.
You know your process best, but please read the details ABOUT HARDBANDING to decide what tests you can do to confirm that your 20 year old process is assured to be good.
Then maintain your process to stand by it and with assurance say that your process of hardbanding is validated to meet the customer requirement.
Add some data to your 'grandfathering' for assurance in your quality management system. That will be a day to learn and wish you good luck ~~~
Thanks Somashekar.............that's exactly what I was trying to avoid! But in my heart I think I knew some destructive testing would be the only way to truly satisfy an API auditor that our process has been validated.

We know the wear rates are good, (for several different wire types we use), and we know we have good adhesion and pretty much nil porosity, (from viewing our product after many years in the field when it has worn back to the parent metal). In hindsight we could have documented this by tracking the pipe numbers and taking photos when they returned to the facility.

I think our simplest method of validation might be to complete a test piece, and skin the hardbanding back on the lathe, 1mm at a time to examine the hardbanding at different levels all the way through. We could take photos at each "skinning".

Regards
 

somashekar

Staff member
Super Moderator
#5
Re: Validation of process

Thanks Somashekar.............that's exactly what I was trying to avoid! But in my heart I think I knew some destructive testing would be the only way to truly satisfy an API auditor that our process has been validated.

We know the wear rates are good, (for several different wire types we use), and we know we have good adhesion and pretty much nil porosity, (from viewing our product after many years in the field when it has worn back to the parent metal). In hindsight we could have documented this by tracking the pipe numbers and taking photos when they returned to the facility.

I think our simplest method of validation might be to complete a test piece, and skin the hardbanding back on the lathe, 1mm at a time to examine the hardbanding at different levels all the way through. We could take photos at each "skinning".

Regards
You are free to define your sound and scientific criteria for review and approve of the process. If you have international standards or industry benchmark / guideline these can also be your source for criteria.
For several different wire type, is your process slightly different for each wire type or the same ?
Remember that your are validating the process for a defined set of inputs.
This is where revalidation requirements comes into play.
If the process is the same, then have your records with each type of wire. This will show that with only the wire change, the process still is good without a change.
If each wire type have a slight difference in the process, then obviously you have each as a seperate validation record.
The defined criteria for all can still be the same.
SO.
Same process, change in one material, criteria is met, process is validated good.
Different process, unique for each type of wire, criteria is met, process is validated good.
When any input changes, be sensitive to re-validate and confirm process is good.
 
A

Aussie99

#6
Process doesn't change Somashekar................just various inputs which we have on set up sheets relative to pipe diameters, wire types and hardband widths etc.
:thanx:
 
A

Aussie99

#7
Re: Validation of process

Sorry Sagai for not replying earlier.......
Processes which could not be verified in this case would be hardbanding wear rates, weld adhesion, weld porosity etc.
 

somashekar

Staff member
Super Moderator
#8
Process doesn't change Somashekar................just various inputs which we have on set up sheets relative to pipe diameters, wire types and hardband widths etc.
:thanx:
Hi my friend ...
Process doesn't change ??
For example, when the pipe dia changes, do you not change the RPM suitably ?
When wire type changes, do you not change the weld current suitably ?
When hardband width changes, do you not change the RPM and / or current / feedrate / wire diameter suitable ?
From your point of view, I agree that the process of hardbanding does not change.
But when I look at validation, each change in input leads to a process change, that you will aim to get the optimum result. Finding this is the purpose of validation.
 
Last edited:
A

Aussie99

#9
I see what you are saying Somashekar..............if I take that road it means many different validations.
 

somashekar

Staff member
Super Moderator
#10
I see what you are saying Somashekar..............if I take that road it means many different validations.
OK...
So be it.
How many ?
We are not re-inventing the wheel all over again every time.
Use your learnings from the first validation into next.
Think optimizing process, if you do not require such fineness of process variations when any change takes place. Use your Risk assessment, technology and experience.
Then perhaps 15 different validations may be just 5.
Let us know again that you are doing these to establish the process and then the process begins to repeat in the best possible way for your outputs.
it is not a hard task when we approach validation with purpose.
 
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