ISO 9001 Clause 7.5.2 Validation of Processes - How to comply?

[Aussie99]

Re: 7.5.2 Validation of Processes - How to do this?

This may be a side step from this discussion, but hopefully it's a relevant question........

If my company was to outsource a process, lets use non destructive testing of a weld for an example, that process still needs to be validated. We can validate that process by:
? checking the competency/qualifications of the company/individual carrying out the testing to ensure they comply with the relevant standard
? Checking the calibration status of any equipment being used in the testing
? checking the level and process of testing is in accordance with customer/API/industry standards or specifications

Alternatively, if the testing company was certified to Q1 or ISO 9001, does this negate the need for any validation on our part? If they are holding accreditation to either of these specifications, wouldn't the processes already be validated as part of their accreditation?

Thanks in advance.

 

[Big Jim]

Re: 7.5.2 Validation of Processes - How to do this?

This may be a side step from this discussion, but hopefully it's a relevant question........

If my company was to outsource a process, lets use non destructive testing of a weld for an example, that process still needs to be validated. We can validate that process by:
? checking the competency/qualifications of the company/individual carrying out the testing to ensure they comply with the relevant standard
? Checking the calibration status of any equipment being used in the testing
? checking the level and process of testing is in accordance with customer/API/industry standards or specifications

Alternatively, if the testing company was certified to Q1 or ISO 9001, does this negate the need for any validation on our part? If they are holding accreditation to either of these specifications, wouldn't the processes already be validated as part of their accreditation?

Thanks in advance.

Certification to a quality management system standard (Q1 or ISO 9001) will not be enough. All that is certified is their system, not their products or services.

You need to tell the supplier what is needed for validation in purchasing documents (purchase orders, contracts, etc). Typically you give them a spec to perform to, what records you expect them to retain, and they provide a certificate of conformance as evidence that they have done so.

Like any other supplier, you need to approve them. The level of scrutiny you apply to them prior to approval and as you are using them needs to be determined. That may include site visits to observe how they are handling the special process that needs validation and to review any records that support that it was done correctly.

The primary evidence that they validated the special process is the certification of conformance, but it is worthless if you have not properly vetted them and continue to monitor their performance.

 

[Aussie99]

Re: 7.5.2 Validation of Processes - How to do this?

I understand what you're saying Jim. It just seems to defeat the whole purpose of them holding any sort of Quality accreditation if you have to vet their processes anyway. Isn't API or a similar body carrying out annual audits on their systems to ensure they are doing everything right, including complying with clause 5.7.1.5 - Validation of Processes for Production and Servicing?

API make a big song and dance about what it means to be Q1 accredited, and so do a lot of the bigger oil and gas companies like Shell, Conoco, Haliburton etc.
However, it seems kind of pointless if that accreditation cant be taken as evidence that your processes are being controlled in such a way to conform to the customer, industry and statutory requirements.

In an attempt to sabotage my own argument here, I have to say that a lot of the bigger companies we deal with who have Q1 or ISO 9001 accreditation, display the worst behaviours with conforming to the Quality requirements. But that's another story for a separate thread.

Thanks for your input Jim.

 

[John Broomfield]

Re: 7.5.2 Validation of Processes - How to do this?

Okay, thanks again everyone. I've found some resources online now that I have limited my question to "what is validation?"

Jandro,

Testing to verify the conformity of the product may be impracticable, very expensive or it may destroy the product.

You can verify the process was carried at as specified by its procedure, but you still do not know if the product meets requirements until you have validated the process and its procedure.

For this you would test the product after designing the process and its procedure. For example, we validate a welding process by tensile testing and other types of destructive testing. This testing validates the process and the design of its procedure.

If you change any aspect of the process or its procedure then you would need to revalidate the process to be able to accept its products.

Another example of validation. Imagine the Starbucks Barista having to taste your cup of coffee before handing it to you! Of course, this makes no sense. Therefore, Starbucks ensures its coffee is made according to a validated process and procedure that is known to result in acceptable coffee. In making coffee that is acceptable to customers, they test the coffee-making inputs, resources (including the Barista's qualifications) and measure its process controls so they do not need to verify the product.

Verify before validating. Please note that you verify conformity of the process to its procedure before validating the process and its procedure. Study clause 7.3, the design process, for more insights.

I hope this helps,

John

 

[harry]

Re: 7.5.2 Validation of Processes - How to do this?

I understand what you're saying Jim. It just seems to defeat the whole purpose of them holding any sort of Quality accreditation if you have to vet their processes anyway. Isn't API or a similar body carrying out annual audits on their systems to ensure they are doing everything right, including complying with clause 5.7.1.5 - Validation of Processes for Production and Servicing?

API make a big song and dance about what it means to be Q1 accredited, and so do a lot of the bigger oil and gas companies like Shell, Conoco, Haliburton etc.
However, it seems kind of pointless if that accreditation cant be taken as evidence that your processes are being controlled in such a way to conform to the customer, industry and statutory requirements.

In an attempt to sabotage my own argument here, I have to say that a lot of the bigger companies we deal with who have Q1 or ISO 9001 accreditation, display the worst behaviours with conforming to the Quality requirements. But that's another story for a separate thread.

Thanks for your input Jim.

Sorry, but from what you described, you should really be looking at ISO 17020 (General Criteria for the Operation of Various Types of Bodies Performing Inspection) or API Q2 (Specification for Quality Management System Requirements for Service Supply Organization for the Petroleum and Natural Gas Industries) provided they are certified or accredited for the scope or type of service that you require.

ISO/IEC 17020:2012 specifies requirements for the competence of bodies performing inspection and for the impartiality and consistency of their inspection activities.

It applies to inspection bodies of type A, B or C, as defined in ISO/IEC 17020:2012, and it applies to any stage of inspection.

API Spec Q2 is the first international quality management system standard for service supply organizations offered by the American Petroleum Institute. Published in December 2011, API Spec Q2, Specification for Quality Management System Requirements for Service Supply Organizations for Petroleum and Natural Gas Industries outlines fundamental quality management system requirements that are critical to upstream operations. The industry-written specification applies to critical activities such as well construction, intervention, production, abandonment, well servicing, equipment repair and maintenance, and inspection activities.

Service supply organizations will implement the requirements of API Spec Q2 throughout their quality management systems, creating a larger, more qualified service supply base. Compliant service supply organizations will boast superior quality management systems that control all operational processes, provide consistent results, manage change effectively, continually improve, reduce operational downtime, and increase customer satisfaction.

 

[AndyN]

Re: 7.5.2 Validation of Processes - How to do this?

I understand what you're saying Jim. It just seems to defeat the whole purpose of them holding any sort of Quality accreditation if you have to vet their processes anyway. Isn't API or a similar body carrying out annual audits on their systems to ensure they are doing everything right, including complying with clause 5.7.1.5 - Validation of Processes for Production and Servicing?

API make a big song and dance about what it means to be Q1 accredited, and so do a lot of the bigger oil and gas companies like Shell, Conoco, Haliburton etc.
However, it seems kind of pointless if that accreditation cant be taken as evidence that your processes are being controlled in such a way to conform to the customer, industry and statutory requirements.

In an attempt to sabotage my own argument here, I have to say that a lot of the bigger companies we deal with who have Q1 or ISO 9001 accreditation, display the worst behaviours with conforming to the Quality requirements. But that's another story for a separate thread.

Thanks for your input Jim.

Certification - not accreditation - is simply stating that the organization has some basic quality management system in place, nothing else. The purpose of this is to cut down the need for multiple supplier quality audits and also for a customer to have to perform supplier development. I think you may be expecting too much from ISO 9001 certification (not accreditation, CBs are accredited, which is different)

 

[Jandro]

Re: 7.5.2 Validation of Processes - How to do this?

Thanks for the new info John. Suffice it to say we are not very fluent in "Design" here as we produce our material to customer specifications and within their tolerances. As a matter of fact, we took exclusion to 7.5.3 before my time.

So, is it enough to say that we inspect samples of our material to verify their conformity to specification and do not need to validate as there are no "special" processes involved that we are unable to verify? Or must we do validation because we don't inspect 100% of our product?

Amazing to see this thread brought back up, but I will learn something from it while I can!

Thanks again!

 

[Aussie99]

Re: 7.5.2 Validation of Processes - How to do this?

Thankyou Andy (and Jim):thanks.............that makes things a little clearer for me. I think the difference between accreditation and certification was lost on me.

Regards

 

[Big Jim]

Re: 7.5.2 Validation of Processes - How to do this?

Thanks for the new info John. Suffice it to say we are not very fluent in "Design" here as we produce our material to customer specifications and within their tolerances. As a matter of fact, we took exclusion to 7.5.3 before my time.

So, is it enough to say that we inspect samples of our material to verify their conformity to specification and do not need to validate as there are no "special" processes involved that we are unable to verify? Or must we do validation because we don't inspect 100% of our product?

Amazing to see this thread brought back up, but I will learn something from it while I can!

Thanks again!

Validation is for when you can't verify because doing so would destroy the product.

 

[John Broomfield]

Re: 7.5.2 Validation of Processes - How to do this?

Validation is for when you can't verify because doing so would destroy the product.

Process validation is also good for when you do not want waste money verifying its products.