Outsourcing Special Processes - Clause 7.5.2

[Finatik]

If I don't have special processes in-house can I take an exemption to this clause even though I might have welding being done at an outside vendor? I couldn't imagine that I would have to validate subsections a) - e) at a vendors facility. I would aurgue that this would be handled through the vendor approval process through an audit. An audit is way different then validation. Am I off base here?

 

[Jim Wynne]

Re: 7.5.2 Special Processes clause

If I don't have special processes in-house can I take an exemption to this clause even though I might have welding being done at an outside vendor? I couldn't imagine that I would have to validate subsections a) - e) at a vendors facility. I would aurgue that this would be handled through the vendor approval process through an audit. An audit is way different then validation. Am I off base here?

Welcome to the Cove

For starters, you might want to have a look at this interesting discussion thread on the subject of 7.5.2.

Just to play devil's advocate, what would prevent you from having your supplier do the validation, assuming validation is necessary?

 

[Sidney Vianna]

Re: 7.5.2 Special Processes clause

Am I off base here?

Based on what you describe, my concern would be: how do you ensure that this outsourced process will be validated adequately? Even if you are not the one doing the validation, you should:

• know what the validation requirements are
• ensure that you flow down the requirements for validation to the supplier
• ensure that evidence of validation and re-validation (as applicable) exists.

 

[Bob the QE]

Re: 7.5.2 Special Processes clause

To Sidney's point, I would also look in 7.4.3, there are requirements for delagating validation to suppliers.
We also do not have special processes in house, however, it is my understanding that if I exclude it and we want to bring one in house we need to change the scope of our registration just as if we wanted to include design activities. That is why we didn't exclude it.
If there are no process there are no records required so the auditor will not find evidence of non-conformance would they?

 

[Finatik]

Re: 7.5.2 Special Processes clause

Since were a contract manufacturer and don't have those process nor would be bringing these I, I think varification of the subcons process should suffice and claim exclusion.

 

[Sidney Vianna]

Re: 7.5.2 Special Processes clause

I think varification of the subcons process should suffice and claim exclusion.

Outsourcing of a process is NEVER a good justification for exclusion.

 

[domingue]

Re: 7.5.2 Special Processes clause

Sidney is right. Clause 1.2 states that you can only take exclusions if they "do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements." Even though you are outsourcing the process, you are still responsible for it per clause 7.4.1, so you cannot justify the exclusion.