: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.

To validate the process, do they have to do destructive testing on product?

: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.

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

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.

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

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?

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

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.

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

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?
That is how I understand it.

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?
To verify that a sterilization process is working isn't a problem and is not a 'special' process. One can swab the item or rinse the item with a sterile solution and test the solution. The item can still be sold as you are not damaging it.

I asked about destructive testing because to me the only time when one cannot fully verify a process is when product from the process must be destroyed to verify that it works such as an airbag module for a car. You can take a sample and test them, but you won't have a high sample rate because of cost - The test destroys the product being tested. The 'old' analogy was welds. You could only verify them if you cut them to check penetration, etc. But since I was young other weld test methods have been devised which are not destructive.

However, none of this has to do with Exclusion. It has to do with trained operators such as certified welders in the case of welding.

That is how I understand it.


To verify that a sterilization process is working isn't a problem and is not a 'special' process. One can swab the item or rinse the item with a sterile solution and test the solution. The item can still be sold as you are not damaging it.

I asked about destructive testing because to me the only time when one cannot fully verify a process is when product from the process must be destroyed to verify that it works such as an airbag in a car. You can take a sample and test them, but you won't have a high sample rate because of cost and because it destroys the product being tested. The 'old' analogy was welds. You could only verify them if you cut them to check penetration, etc. But since I was young other weld test methods have been devised which are not destructive.Sterilization is a special process as the items are packaged sterilized. To verify the Sterility Assurance Level (SAL), you must break the seal and compromise the sterility, i.e. the item is no longer considered sterile.

Good point, Al.

My answer was from about 15 years ago where the company routinely broke packages open and tested the product and inside the packaging for contamination. Afterwards the product was put back in the line for the sterilization step and repackaged so the only loss was the packaging.

I understand the standard to offer exclusion to only the area of 7.3, for those that have no design functions within their company.Not so. Any requirement in clause 7 with justification that it will not impact meeting customer or regulatory requirements. Read 1.2 again.

Also see:

Special Processes - Can anyone give me a good definition of what they are? (http://elsmar.com/Forums/showthread.php?t=11429)
and
Special Processes - Can someone help us with a definition? (http://elsmar.com/Forums/showthread.php?t=507)

Summary: A special process is any production or service delivery process that generates outputs that cannot be measured, monitored, or verified until it's too late. It's often too late because deficiencies may not be obvious until after the resulting products have been used or services have been delivered. In order to prevent output deficiencies, these special processes must be validated in order to prove that they can generate planned results.

Not so. Any requirement in clause 7 with justification that it will not impact meeting customer or regulatory requirements. Read 1.2 again.:agree1: Yep. The standard that only allows 7.3 as a possible exclusion is ISO/TS - 16949.

:agree1: Yep. The standard that only allows 7.3 as a possible exclusion is ISO/TS - 16949.One of the few not in my repertoire.:rolleyes:

Thanks for the feedback everyone, In reference to Sidney's direction to 13485 on sterlization, the product is not medical, it is used in the semiconductor enviroment, "carriers" in the cleaning process they require sterization before they can be reused, if this process is not correct, it would cause failures in the mfg of the chips. Based on this reasoning, sampling only testing without validation of the process would be unacceptable. I have had been getting different opinions on this.

I'm finding that the subject of validation with some of my peers has led to long conversations.

Thanks for the feedback everyone, In reference to Sidney's direction to 13485 on sterlization, the product is not medical, it is used in the semiconductor enviroment, "carriers" in the cleaning process they require sterization before they can be reused, if this process is not correct, it would cause failures in the mfg of the chips. Based on this reasoning, sampling only testing without validation of the process would be unacceptable. I have had been getting different opinions on this.

I'm finding that the subject of validation with some of my peers has led to long conversations.Thanks for clarifying this. I committed the "auditor's cardinal sin" of assuming. Since there are no regulatory requirements associated with the sterilization process in this case, it boil downs to how much confidence the entity requiring the sterilization process wants to have in the outcome of the process. Looks like a somewhat subjective call on how much control you want to have over the process and a cost benefit analysis could help.

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

We exclude 7.5.2, because we do monitor and measure resulting output and do not have to address a special process whose output cannot be verified by subsequent monitoring/measurement.

We exclude 7.5.2, because we do monitor and measure resulting output and do not have to address a special process whose output cannot be verified by subsequent monitoring/measurement.
i positively agree with you. you have no special processes, you can safely exclude 7.5.2.

aqh

ISO 9001:2000 is a QMS requirements compliance for any company, it is not with respect to any particular product or process certificattion. If you look at from customer's persepective, the order / product is not offered to your supplier, it is you who has to take care the product / process while it is outsourced. In this case you have to validate the process at supplier end & continoulsy monitor the adherence. So, here there is no question of EXCLUSION at all, also you can refer the clause 4.1 - where an organization chooses to outsources any process that affects product conformity with requirements, the organization shall ensure CONTROL over such processes.

I totally agree with Senthil Kumar in that ISO is just a system and not talking about the product. In one earlier thread, read that since sampling will be performed for every batch, thye validation will not be performed. Does this not sound funny ?

If I were the customer / auditor, I would be more comfortable to see that the process is validated first followed by the batch wise sampling to satisfy the product specifications of meeting sterility (or sterilisation) requirements. If the product happens to be a medical device undergoing sterilisation, validation is a must.

: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.


My reaction to this is why does it matter?

If the situation is not covered under 7.5.2 it will need to be covered under 7.4.2, 7.4.3 etc. If you just make sure the process is controlled properly and in a way that gives you confidence, let other people with more time on their hands worry about which clause you're working to.

I think the whole thing should boil down to the fact that you should ensure that your supplier's process should be monitored and controlled one way or the other through, having certain work instructions and and periodical reports to be submitted regarding all the resources and processes he has that directly affect your product, call it validation, call it outsourcing control, call it whatever you call it, what matters is that in the end you add some value to what you're doing.

As of how i think it should be presented to the auditors, i think its more of control and monitoring of an outsourced process that requires validation.