Outsourcing "passivation" - Clause 7.5.2 Validation of Processes

L

Lorenzo36

#1
Hello folks.
We are currently ISO9001:2008 certified with 7.5.2 as an exclusion. However, recently our customers have requested passivation of some of our products (which we didn't do before). I consider passivation a "special process" which means we'll have to remove the exclusion form our QA Manual - those are my plans for now. In addition to, my company will be outsourcing the "passivation" (we don't have the capabilities), all we'll be doing is verifying the process based on the supplier documentation. So, there's a debate with management here, do we remove the exclusion or do we leave it as is? I believe we need to remove the exclusion, but what do ya'll think?
 
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John Broomfield

Staff member
Super Moderator
#2
Re: 7.5.2 Validation of Processes

Hello folks.
We are currently ISO9001:2008 certified with 7.5.2 as an exclusion. However, recently our customers have requested passivation of some of our products (which we didn't do before). I consider passivation a "special process" which means we'll have to remove the exclusion form our ISO Cert - those are my plans for now. In addition to, my company will be outsourcing the "passivation" (we don't have the capabilities), all we'll be doing is verifying the process based on the supplier documentation. So, there's a debate with management here, do we remove the exclusion or do we leave it as is? I believe we need to remove the exclusion, but what do ya'll think?
Lorezo,

Update your purchasing procedure to specify the selection criteria for your passivation supplier. Evaluate your supplier against the criteria, quote your customer, win the job, specify the requirements, get your products passivated with any specified certifications, deliver to your customer, get paid, pay the supplier and decide how much more of this work you want to do.

Discuss the scope statement on your certificate with your registrar and update the scope of your management system and its certificate accordingly.

No need to agonize over a scope expansion.

John
 

somashekar

Staff member
Admin
#3
Re: 7.5.2 Validation of Processes

Hello folks.
We are currently ISO9001:2008 certified with 7.5.2 as an exclusion. However, recently our customers have requested passivation of some of our products (which we didn't do before). I consider passivation a "special process" which means we'll have to remove the exclusion form our QA Manual - those are my plans for now. In addition to, my company will be outsourcing the "passivation" (we don't have the capabilities), all we'll be doing is verifying the process based on the supplier documentation. So, there's a debate with management here, do we remove the exclusion or do we leave it as is? I believe we need to remove the exclusion, but what do ya'll think?
Passivation is a special process and since you are outsourcing same, you have to map your controls on outsourced processes in your QMS. Are you also outsourcing any other processes ?
Under purchasing or any other appropriate section, you may address how you exercise the controls on this process.
We have listed all our outsourced processes in our manual and each have a specific document as to how we extend controls over them. Perhaps you cannot justify the exclusion and so cannot exclude it ... It is only that the validation requirement is a part of your control over outsourced process.
 
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Miner

Forum Moderator
Staff member
Admin
#4
Re: 7.5.2 Validation of Processes

I agree with John. This sounds more like Control of Outsourcing, not Special Processes. If you did the passivation internally, Special Processes would definitely apply.
 

somashekar

Staff member
Admin
#5
Re: 7.5.2 Validation of Processes

I agree with John. This sounds more like Control of Outsourcing, not Special Processes. If you did the passivation internally, Special Processes would definitely apply.
My thinking is that validation of process is a requirement here, and it so happens that you are not able to execute it inhouse and so it is outsourced. Validation hence is a part of the controls exercised over the outsourced process. Responsibility of validation of this process is primarily with one who outsources the process and jointly with the outsourced supplier.
 
L

Lorenzo36

#6
We do not outsource any other "special processes" (welding, heat treat, plating, coatings, etc) - our product does not require none of those except now, passivation.
As far as the controlling method, that will come from the Purchase Order.
 
#7
You cannot claim exclusion for "special Processes" if you outsource them.

There are two TC176 Documents that define this. I would attache them but I don't know how. One is guidance for 1.2 "Application" and the other is "Guidance for Outsourced Processes".
 
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