Understanding of Process Validations - ISO 9001 Clause 7.5.2 Validation

[SarahSD]

Hi all,

I need to have a better understanding of process validations - validation vs. verification, master validation plans, IQ/OQ/PQ, etc. Any suggestions on books, articles, or other resources that you could point me to? I would really like something that is not specific to medical devices.

Thanks in advance,
Sarah

 

[arios]

I know you are looking for non-MD guidance or examples on this topic, but I still have the impression that the approach of the Medical device & Pharma sectors with regards to Process Validation could be considered a benchmark for other industries.

Consider taking a look on this GHTF document:

http://www.ghtf.org/sg3/sg3-final.html

 

[Hanr3]

Welding is a process that needs validation. You cannot verify a weld is correct. You can visually inspect it, x-ray inspect, however that doesn't ensure you have good penetration and adhesion. The only way to ensure good penetration/adhesion is a destructive test, and once you destroy it, it is no longer a functional part. So the process has to be validated to ensure a consistent weld every time.

To control the welding process, at minimum you have to control the machine settings, type of consumables (rod, gas), the material being welded, and cerify the operator as competent to weld that process.

 

[somashekar]

Hi all,

I need to have a better understanding of process validations - validation vs. verification, master validation plans, IQ/OQ/PQ, etc. Any suggestions on books, articles, or other resources that you could point me to? I would really like something that is not specific to medical devices.

Thanks in advance,
Sarah

How about an example of cooking rice in a pressure cooker ... ?
For the specific raw rice that you have and want to cook just good and soft, not too pasty or not undercooked, consider the following.
The pressure cooker is good and the gasket is fine and so is the weight knob.
Determination of the quantity of water to the quantity of rice.
Determination of the soaking time of rice in water before cooking.
Determination of the quantity of water for the steaming and pressure within the cooker.
Determine if the flame knob position has to be to high flame or medium ?
Determination of the number of steam whistles after which to put off the burner.
Determination of the time for the pressure to slowly drop to be safe to open cooker.
Well if you are able to fix all these and operate you would most probably get a consistant and right cooked rice every time.
You have a validated process to cook rice. If your rice changes you will need to alter some parameters OR if you need say pasty rice, again you will have to alter or tune your parameters (some or all)
If you use a new cooker perhaps you may have to check and ensure some details.
These are re-validation.
Apply this to any situation which falls in line with cooking rice

 

[SarahSD]

Thanks for the information. The GHTF document has definitely been the most helpful I have read so far.

My general understanding at this point would be that it would be entirely up to our company what would be included in our master validation plan (taking into consideration any regulatory/statutory requirements). It seems logical to me to use a risk-based approach for revalidations - both for determining their frequency and what we would do to perform the revalidation. I suspect that in most cases a recheck of the initial OQ requirements and a limited scope PQ would suffice. Does this seem reasonable?

I'm still not confident about the differences between verification and validation. For example, a change in bottling materials. If the fill process is not changing, I would suggest that the materials just need to be verified (equivalency demonstrated). But if the verification involves a test fill and destructive testing to ensure that the filled materials have not been affected, is it still a material verification or is it a revalidation of the process?

I'm sorry if my questions are elementary and I'm happy to do more reading on my own if anyone can point me to additional resources.

Thanks again.

 

[trainerbob]

Sometimes it is easier to think of it in terms of making a part. If we machine a part we can verify that it is made according to the blueprint by measuring the part and comparing the measurements to the blue print. If the dimensions of the part are the same as the blueprint then we have verified that the part is made according to the print.
But we can't stop there. We must know that the part will perform as it is supposed to when it is put into the assembly that it goes in. If the part performs as it is supposed to then we have validated that it works properly.
It dosen't do us any good to make thousands of parts according to the print(even though our contract calls for it) if the the parts will not function as they are supposed when they interface with other parts. Very often a customer will have a specification for the validation of a particular part. sometimes it must function for a specific period time, sometimes for a specific number of cycles, sometimes for a number of miles, etc.
Maybe a little wordy, but this the way I usually explain verification and validation.

 

[Sartaj Bedi]

Hi all,

I need to have a better understanding of process validations - validation vs. verification, master validation plans, IQ/OQ/PQ, etc. Any suggestions on books, articles, or other resources that you could point me to? I would really like something that is not specific to medical devices.

Thanks in advance,
Sarah

Hi,
Verification refers to inputs and validation to output.
Verification mean " are you doing what you said you would do to achiev your objectives"
Validation means " have you been EFFECTIVE and have actually achieved your objective"

Eg let's say you have an objective of making a tasteful food
The iputs you use is a standard recpie and tools
The verification is to check that you are using a stanard recpie and the tools you said that you would us
The validation is to check if the dish is tasteful.

If the dish is distasteful, it eamns that you need a new recpie.

Validation concept is very powerful.

I beileve it can actually make an organisation better.

If a solution you found was eventually ineefective in solving the problem,, you need to relook at the soln u thght in the first place.

There are "special process" which cannot be validated befoe they are given to custoner.
Thus, in these can be reviwed by the customer themsleves via feedback forms.
In a restaurant environment quality of service, taste of food etc is reviwed by the custmer. Andthus validaed.

Hope this helps!!!

 

[Ajit Basrur]

Sarah,

I have moved your question to this forum. Pl take a look at other threads too - we have lot of information on Process Validations.

Additionally, refer this link for more info - Process validation

 

[Jen Kirley]

Thanks for the information. The GHTF document has definitely been the most helpful I have read so far.

My general understanding at this point would be that it would be entirely up to our company what would be included in our master validation plan (taking into consideration any regulatory/statutory requirements). It seems logical to me to use a risk-based approach for revalidations - both for determining their frequency and what we would do to perform the revalidation. I suspect that in most cases a recheck of the initial OQ requirements and a limited scope PQ would suffice. Does this seem reasonable?

I'm still not confident about the differences between verification and validation. For example, a change in bottling materials. If the fill process is not changing, I would suggest that the materials just need to be verified (equivalency demonstrated). But if the verification involves a test fill and destructive testing to ensure that the filled materials have not been affected, is it still a material verification or is it a revalidation of the process?

I'm sorry if my questions are elementary and I'm happy to do more reading on my own if anyone can point me to additional resources.

Thanks again.

Hello Sarah,

The question of validation versus verification is valid, however tempting it is to declare the terms are interchangeable. They aren't.

Quality Digest ran an interesting article on the subject, titled
Verification vs. Validation; You can verify and confirm, but that doesn’t mean it’s right.

I hope this helps! I am not affiliated with Quality Digest.

 

[blueboat]

so excellent interpretation！