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

M

mattador78

Quite Involved in Discussions
#21
#21
thumphrey03 said:
I completely understand what you're saying, but unfortunately auditors don't think that way. We would get a minor nonconformance.
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We have a monitored spreadsheet with colour coded warnings of calibration expiry dates, controlled by myself and the production manager no written procedure of what to do just when it needs calibrating, contact our approved supplier who 999/1000 has calibrated it prior and post it off with a PO for the required task. Been in place for at least 12 years never got a minor for it on ISO or AS audits it works for us an Auditors all happy we are mitigating the risk
 
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T

Tyler

Starting to get Involved
#22
#22
Peter Fraser said:
So a "process" is different from a "process description", and it was a "process" that the standard was asking for (even if it got the concept wrong!)
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Thanks. That makes sense.

Part of the reason we think of processes the way we do at my company is to try and eliminate confusion and ambiguity. "Process", "procedure", "program", "task", etc. are sometimes used interchangeably. We came up with this scheme so that people know precisely what we are talking about when we use these terms. It works for us and as far as I can tell it does not conflict with the standard, but it certainly is not prescribed by the standard.
 
Peter Fraser

Peter Fraser

Trusted Information Resource
#23
#23
Tyler said:
Thanks. That makes sense.

Part of the reason we think of processes the way we do at my company is to try and eliminate confusion and ambiguity. "Process", "procedure", "program", "task", etc. are sometimes used interchangeably. We came up with this scheme so that people know precisely what we are talking about when we use these terms. It works for us and as far as I can tell it does not conflict with the standard, but it certainly is not prescribed by the standard.
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Deming talked of "operational definitions" - so long as everyone understands what a term means in your own context then you are OK.
 
B

Big Jim

Super Moderator
#24
#24
Until TC-176 provides a better definition of the meaning of "process" there will continue to be confusion. It is widely interpreted the "process" in 4.4 is your business processes. It is also easy to see that a business process is not what they have in mind when talking about "special processes" (8.5.1f & 8.5.1.2). The definition given in ISO 9000:2015 doesn't help in the least.

This ship will remain adrift until someone in TC-176 wakes up.
 
B

Big Jim

Super Moderator
#25
#25
Back to the the OPs original question. Remember that it doesn't say document, only define. It is up to you to document if you find it useful but it is not a requirement. There are several ways to accomplish this positive recall when calibration is due. A couple of simple ones is to have it on your outlook calendar or to have a spreadsheet that is check at the beginning of each month that the items due that month display in red. You have to keep a register anyway so it would be easy to add that feature.

An NO, you do not need to include that process on your interaction of process (IOP) description.
 
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