Validation of Processes - Resulting Output can not be Verified - Exclusion to 7.5.2

L

Louis Reimer

#1
:confused: Have a quesition for everyone.

A company makes a product that requires a process that the resulting output can not be verified by subsequent monitoring or measurement. Since the company does not have the ability to perform this process in-house, they have outsourced it out.

Based on this, they have taken exclusion to 7.5.2 validation of processes,
Is this exclusion allowed.
 
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Sidney Vianna

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Staff member
Admin
#3
Louis Reimer said:
:confused: Have a quesition for everyone.

A company makes a product that requires a process that the resulting output can not be verified by subsequent monitoring or measurement. Since the company does not have the ability to perform this process in-house, they have outsourced it out.

Based on this, they have taken exclusion to 7.5.2 validation of processes,
Is this exclusion allowed.
I will answer the question, assuming that you are inferring that this organization is claiming compliance and/or seeking certification to ISO 9001.

And the answer is: ABSOLUTELY NOT. Just because they outsourced the special process, they can NOT claim exception to it. They have to ensure that the supplier is adequately validating the special process.
 

samer

Involved - Posts
#4
Sidney Vianna said:
And the answer is: ABSOLUTELY NOT. Just because they outsourced the special process, they can NOT claim exception to it. They have to ensure that the supplier is adequately validating the special process.

if the organization has to make sure that the outsourced process is cotrolled as appropriate ,that doesnt necessary mean to include the activities of the outsouced process to its QMS ? I mean here ,the exclusion of 7.5.2 could be accepted since the supplier is the party that is responsible for the validation of the poduct? is that true ?
the organization shall control over the whole outsourced process , this will lead to ask if the supplier want to be an ISO 9001:2000 certified , shall he inculde 7.5.2 in his QMS for the same outsourced process ???

samer
 
M

Martijn

#5
Sidney is right here, you can't exlude it just because you outsourced it. Outsourcing does not mean it's not part of your process anymore. Exclusion of 7.5.2 feels contradictory with the principle of process approach.

Look at it from a customers point of view, if they'd have a complaint, they'd look at you, and you hopefully won't tell them to have a chat with your test service provider instead. Your product, your responsibility, all your processes.
 

samer

Involved - Posts
#6
thanks for the answere

but this is just a question ,do you think that if an organization outsoursed a process to a certified ISO 9001:2000 supplier .would this influent on the extent of the required controlling on that outsourced process by the organization ?

samer
 
L

Louis Reimer

#7
Marc
To validate the process, they are doing destructive testing on product?

If you can perform non destructive testing, this is a monitoring or measurement process, now the process would not be special, correct?

A company performs sterilization of a product, since they take samples from each batch, it is not a special process and they do not need to validate this process.

I strongly disagree with this, is my position correct?
 
B

bluepagen

#8
I understand the standard to offer exclusion to only the area of 7.3, for those that have no design functions within their company.
 

Jim Wynne

Staff member
Admin
#9
Louis Reimer said:
Marc
To validate the process, they are doing destructive testing on product?

If you can perform non destructive testing, this is a monitoring or measurement process, now the process would not be special, correct?

A company performs sterilization of a product, since they take samples from each batch, it is not a special process and they do not need to validate this process.

I strongly disagree with this, is my position correct?
This is getting a little confused, but I certainly agree with Sidney. If there is a "special" process, it must be validated, and the outsourcing entity is responsible for verifying the processes of its suppliers. In answer to Samer's question regarding the company doing the work being ISO registered, knowledge of registration is not an acceptable substitute for direct knowledge of the efficacy of the sub-supplier's process validation for the product in question.
 

Sidney Vianna

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#10
Louis Reimer said:
A company performs sterilization of a product, since they take samples from each batch, it is not a special process and they do not need to validate this process.

I strongly disagree with this, is my position correct?
At first glance, I also disagree that the sterilization process would NOT need to be validated. Sampling the batches of sterile products would not guarantee 100% sterilization. Just like performing NDT examination of structural welds does not guarantee their soundness, dropping the requirement for validation of the welding processes.

Sterilization process are normally associated with highly regulated products, such as medical devices. Validation of sterilization processes is a typical requirement in this context. Actually, if you look at ISO 13485:2003, you will find specific requirements associated with validation of processes.

There are several norms dealing with this issue. http://www.nelsonlabs.com/medical-device/sterilization-validation.jsp
 
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