Can 7.5.2 be excluded if you Outsources Special Processes?

[Big Jim]

Bob,

You should read the entirety of the document Sydney referenced. If you do you will see that it is crystal clear that you cannot exclude things that you outsource, be it special processes, design, purchasing, calibration, or anything else from section 7.

To back up Jane's point, I recently wrote a nonconformance during a CB audit on that very topic. They had several inappropriate exclusions. The inappropriate exclusions each said they were excluded because they were outsourced. I had a short talk with the CB before the audit telling them what I found and what my intentions were, and they supported that determination.

This is simply a topic that you will not win if you take it to your CB. The auditor is correct.

 

[somashekar]

I guess I still disagree. We are not ignoring it or excluding it from the QMS becaue we are covering it under 7.4.1 and 7.4.2. In fact we have to have more dudiligance because we are making it part of the contractual agreement with our sub-contractor and then the it is on our shoulders to make sure the controls are in place to assure the controls of the processes assure the quality of that output. So I guess the question is still out there if you do not ignore it or exclude it from your QMS can you exclude 7.5.2. And with all due respect I have not seen a point to make waiver on this.

When you say that the 7.5.2 process is interacting with the 7.4.1.and the 7.4.2 process., then you are including the 7.5.2 within your process interactions.
So where is the exclusion .....

 

[howste]

The long and short of it is, you must ensure that the requirements are met. If your controls for the special process(es) are met in your purchasing process, that's fine, but your organization is still responsible for their being done properly and validated.

Just as Big Jim has, I've also written invalid exclusions (like this one) as nonconformities during CB audits.

 

[Jim Wynne]

I guess I still disagree. We are not ignoring it or excluding it from the QMS becaue we are covering it under 7.4.1 and 7.4.2. In fact we have to have more dudiligance because we are making it part of the contractual agreement with our sub-contractor and then the it is on our shoulders to make sure the controls are in place to assure the controls of the processes assure the quality of that output. So I guess the question is still out there if you do not ignore it or exclude it from your QMS can you exclude 7.5.2. And with all due respect I have not seen a point to make waiver on this.

1. Special processes, regardless of the source, must be validated in accordance with 7.5.2. This is not in question, I hope.
2. You say that the requirements of 7.5.2 are satisfied.
3. Based on #2 you want to exclude the requirement in #1.

Do you see how this makes no sense? Do you understand that in excluding 7.5.2, you are also attempting to abdicate responsibility for validation of special processes in all cases? This is what comes of trying to match activities to clauses in the standard. Somewhere in your system you're obliged to describe how you handle validation of special processes. If you've done that, and you do indeed validate special processes according to the requirements, you've satisfied 7.5.2 no matter what you call it or how you classify it.

 

[QE-Bob in Wisc]

This subject came about during a discussion I am having with a colleague for another company. So I would just point out that we do not have any processes where the results cannot be verified prior to use or installation. I think this would work.

 

[QE-Bob in Wisc]

Thanks Jim, I think I am seeing the light. Your sentance of " If you've done that, and you do indeed validate special processes according to the requirements, you've satisfied 7.5.2 no matter what you call it or how you classify it.".

I will accept the fact that I was over thinking the standard and go with that.

 

[kekoukele]

首先外包过程放在4.1.1 总要求中：确保对外包过程的控制。 请问怎么“确保”？
见7.4.1，举个例子， 关键工序外包可能对外包方的体系、过程及能力、产品均可能提出很多要求，这些要求在7.4.1中提出来。
而7.5.2 适用于所有特殊过程，可以作为7.4.1对供方要求的指南。
但是审核此条款，不作为对外包的要求。
the first outsourse should be included 4.1.1 general requirements-- supplermental: ensuring control of outsoursed processes. now i will ask ' how to ensure?' so the standand give us a tip,see 7.4.1 ,for eg, crital process outsourse,sometimes we should qualified supples quality system\process capability\product and so on. these request were shown from 7.4.1 .
but i think 7.5.2 suit for all special process, not only inhouse, it can be a gulidline for how to management our outsourse special process.
in 3rd audit process, it couldn't be a require for outsoursed.