What does AS9100 mean when it says you must establish a process to do X?

Tyler

Starting to get Involved
#1
There are several places in the standard where AS9100 states that a process is required for some specific purpose. The following excerpt from clause 7.1.5.2 is one such example.

"The organization shall establish, implement, and maintain a process for the recall of monitoring and measuring equipment requiring calibration or verification."

Is AS9100 suggesting that a standalone process is required for this purpose? That is, do we need to define a process with inputs, outputs, KPIs, procedures, etc. for this one specific purpose? I have always believed that this is not the case. My interpretation has been that so long as some other process includes procedures and/or controls that cover the requirements then you are compliant.
 
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Castaway99

Involved In Discussions
#3
There are several places in the standard where AS9100 states that a process is required for some specific purpose. The following excerpt from clause 7.1.5.2 is one such example.

"The organization shall establish, implement, and maintain a process for the recall of monitoring and measuring equipment requiring calibration or verification."

Is AS9100 suggesting that a standalone process is required for this purpose? That is, do we need to define a process with inputs, outputs, KPIs, procedures, etc. for this one specific purpose? I have always believed that this is not the case. My interpretation has been that so long as some other process includes procedures and/or controls that cover the requirements then you are compliant.
I think you are in compliance, the standard is not asking for a stand alone process.
As per ISO 9000
1601425167689.png

And here is some simple stuff that I made on excel which is my process for ' recall of monitoring and measuring equipment '.
Only that the process should be effective.
Thas my take.
 

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Tyler

Starting to get Involved
#4
I think you are in compliance, the standard is not asking for a stand alone process.
Thanks for the response.

I guess the reason why I get confused is because section 4.4 of the standard implies that the term "process" has a very specific meaning. Section 4.4 suggests that a process is a well defined, fundamental element of a QMS; it is an essential building block of a QMS. Indeed, we get audited against the processes we identify. It is because of this that the term "process" should never be used in a general sense within the context of AS9100.

The phrase "...a process must be established to..." suggests that...
  • there is a single process, and...
  • the purpose of this process is whatever follows the "to".
Like you, I believe that you should be able to cover whatever follows the "to" in one or more existing processes; however, that is not what the phrase says. If it means what both you and I think it should mean, then the authors of AS9100 are using the term "process" in a general way.

What is interesting is that it appears that it is only in the AS9100 additions to ISO9001 that these statements are found. Perhaps the authors of ISO9001 know not to throw around the term "process" lightly.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#5
There are several places in the standard where AS9100 states that a process is required for some specific purpose. The following excerpt from clause 7.1.5.2 is one such example.

"The organization shall establish, implement, and maintain a process for the recall of monitoring and measuring equipment requiring calibration or verification."

Is AS9100 suggesting that a standalone process is required for this purpose? That is, do we need to define a process with inputs, outputs, KPIs, procedures, etc. for this one specific purpose? I have always believed that this is not the case. My interpretation has been that so long as some other process includes procedures and/or controls that cover the requirements then you are compliant.
Every process by definition has an input and output. Not every process has/needs a KPI. Every process has a procedure associated with it, but not every procedure needs to be documented.

If you have a process for the recall of something else that would also work for M&M equipment I see no reason the same process cannot be used.
 

Tyler

Starting to get Involved
#6
Every process by definition has an input and output. Not every process has/needs a KPI. Every process has a procedure associated with it, but not every procedure needs to be documented.
But section 4.4.1 says that the following requirements must be addressed for your organization's processes...

"The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:
a. determine the inputs required and the outputs expected from these processes;
b. determine the sequence and interaction of these processes;
c. determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
d. determine the resources needed for these processes and ensure their availability;
e. assign the responsibilities and authorities for these processes;
f. address the risks and opportunities as determined in accordance with the requirements of 6.1;
g. evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h. improve the processes and the quality management system."


That is why I am confused. It sounds like we all agree that a standalone, documented process is unnecessary (or should be unnecessary); but the language & requirements of the standard suggests otherwise.
 

Kronos147

Trusted Information Resource
#7
There are several places in the standard where AS9100 states that a process is required for some specific purpose. The following excerpt from clause 7.1.5.2 is one such example.

"The organization shall establish, implement, and maintain a process for the recall of monitoring and measuring equipment requiring calibration or verification."
"The organization shall determine the processes needed for the quality management system'
I might answer:
'While we do have a process, it is not one of the processes we define per 4.4. We manage it as a sub-process of our QA process. We have a work instruction, and a log of devices, and we retain the calibration certs.'

It's YOUR system, not the auditors.
 

John Broomfield

Staff member
Super Moderator
#8
Study your system for converting customer needs into cash in the bank and you’ll find that it already comprises processes that satisfy entirely or mostly the requirements specified in 4.4.1.

Do this first, then the standard makes more sense.

Unfortunately these system standards attempt to justify their existence by implying that we do not already have a system that is our organization at work.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#9
But section 4.4.1 says that the following requirements must be addressed for your organization's processes...

"The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:
a. determine the inputs required and the outputs expected from these processes;
b. determine the sequence and interaction of these processes;
c. determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
d. determine the resources needed for these processes and ensure their availability;
e. assign the responsibilities and authorities for these processes;
f. address the risks and opportunities as determined in accordance with the requirements of 6.1;
g. evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h. improve the processes and the quality management system."


That is why I am confused. It sounds like we all agree that a standalone, documented process is unnecessary (or should be unnecessary); but the language & requirements of the standard suggests otherwise.
I think you are imagining requirements that are not there, as even many 3rd party auditors do. Look carefully: where specifically does 4.4.1 say something different than the quote of mine you posted?

4.4.1 largely says to you that you need to "determine what is needed".
 

Peter Fraser

Trusted Information Resource
#10
There are several places in the standard where AS9100 states that a process is required for some specific purpose. The following excerpt from clause 7.1.5.2 is one such example.
"The organization shall establish, implement, and maintain a process for the recall of monitoring and measuring equipment requiring calibration or verification."
Is AS9100 suggesting that a standalone process is required for this purpose? That is, do we need to define a process with inputs, outputs, KPIs, procedures, etc. for this one specific purpose? I have always believed that this is not the case. My interpretation has been that so long as some other process includes procedures and/or controls that cover the requirements then you are compliant.
Tyler
You are right to be confused, and it is the wording of the standard that is the cause. 9001 does the same - it implies that you don't have existing processes (as John Broomfield points out above) which may need to be refined. "Recall" is likely to be a single task or step in another process. ISO has been carried away with the concept of "processes" since they discovered it back in 2000 - all they mean is that you must "do" it. Even if they had said "recall and take action" it might have made more sense - just "recalling" ain't a process in most folks eyes.
 
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