QAguygoqa

Starting to get Involved
#1
Hello QA Pros,
AS9100D requirement 4.4 requires an org to "shall" determine the processes needed for the quality management system and their application throughout the organization....etc..

We identified our company process needed for our QMS as follows : Engineering, Purchasing, Sales, Shipping, Receiving, Quality, Production.

We have supporting processes such as Mgmt Review, CAR, Maintenance, Audits, etc.

The auditor issued to us an NCR claiming that we don't have metrics for maintenance. We stated that maintenance is a supporting process. The auditor states that the IAQG standard clause 4.4.1C requires this info. We stated that we are responsible to meet AS9100D requirements and not IAQG clause requirements.
Let me know what is your point of view. Who is correct?

NOTE: I am submitting our IOP for your kind review. Thank you.
 

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AndyN

A problem shared...
Staff member
Super Moderator
#2
Hello QA Pros,
AS9100D requirement 4.4 requires an org to "shall" determine the processes needed for the quality management system and their application throughout the organization....etc..

We identified our company process needed for our QMS as follows : Engineering, Purchasing, Sales, Shipping, Receiving, Quality, Production.

We have supporting processes such as Mgmt Review, CAR, Maintenance, Audits, etc.

The auditor issued to us an NCR claiming that we don't have metrics for maintenance. We stated that maintenance is a supporting process. The auditor states that the IAQG standard clause 4.4.1C requires this info. We stated that we are responsible to meet AS9100D requirements and not IAQG clause requirements.
Let me know what is your point of view. Who is correct?

NOTE: I am submitting our IOP for your kind review. Thank you.
Which IAQG document? Check your CB agreement, but unless you signed up for something other than AS9100D, your auditor is off scope...
 

QAguygoqa

Starting to get Involved
#3
Hello Andy,
I have never seen this IAQG document, nor have I ever signed it. The registrar's home office states it is and IAQG document with a requirement 4.4.1c. I have never seen or been informed, and my company committed to follow AS9100D requirements. Look, I wouldn't mind addressing a corrective action if the finding was something we can reference to begin containment and corrective action. However, without a requirement to follow, my argument is how do I start a corrective action? I resent my registrar not being open to admit their incorrect.
 

AndyN

A problem shared...
Staff member
Super Moderator
#4
Hello Andy,
I have never seen this IAQG document, nor have I ever signed it. The registrar's home office states it is and IAQG document with a requirement 4.4.1c. I have never seen or been informed, and my company committed to follow AS9100D requirements. Look, I wouldn't mind addressing a corrective action if the finding was something we can reference to begin containment and corrective action. However, without a requirement to follow, my argument is how do I start a corrective action? I resent my registrar not being open to admit their incorrect.
All I see is the ISO 9001:2015 based requirements for the things listed in (c). I see no need for metrics, just to ensure the process is effective and controlled. Maintenance - if you draw a parallel with your car maintenance - is required to be performed at certain intervals. I see zero (stated) need for metrics. The oil & filter (for example) are either changed (close to) the stated interval or not. Records will show that. The performance of the equipment will show that (eventually). Sounds like auditor "mission creep"...
 

RCW

Quite Involved in Discussions
#5
QAguygoqa:

If this was an AS9100 audit, the information from the audit is loaded into the IAQG OASIS database which you should have access to. (If you don't then you need to get access to this immediately!) Once you log in, pull up your audit form under Manage Audits. When you open up the audit form, click on the form 4 and open up the NCR you received from this finding. Right at the top of Section 1 - Nonconformity Details it should state which AQMS the NCR is being written against and the applicable clause.

Just curious what this NCR was actually written against.

(If you need help finding the above, send me a private message.)
 
Last edited:

QAguygoqa

Starting to get Involved
#6
RCW, thank you for your kind reply. I'll check form 4 in the IAQG OASIS database. I'll get in touch with you, really appreciated.
 
#7
All I see is the ISO 9001:2015 based requirements for the things listed in (c). I see no need for metrics, just to ensure the process is effective and controlled. Maintenance - if you draw a parallel with your car maintenance - is required to be performed at certain intervals. I see zero (stated) need for metrics. The oil & filter (for example) are either changed (close to) the stated interval or not. Records will show that. The performance of the equipment will show that (eventually). Sounds like auditor "mission creep"...
Well, I have to disagree a bit, the clause calls for

"shall determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and controll of these processes;"

So, we have to have criteria (goals), and a method (defined way to consistently do it), to ensure effective (how can this be determined without a goal/criteria?) control (we know if our outputs are stable and meet requirements).

The "control" portion compels us to have some way of knowing how well we're doing, we can't just file the oil change records and only go evaluate them if there's a crisis, or after the car breaks down.
  • Even if all that matters is if the oil change is close to the interval or not, how close is close enough, how often are we close enough, why does it matter if we're close enough?

Even if it's a "support" process, it's important enough to need to "establish, implement, maintain, and continually improve" it per 4.4.1, as it will affect the outcome of your core processes. Whether or not it's called a "metric" in your firm, think of the way that Maintenance affects your operations, look for measures which are already in place and make business sense, track them and take action if things go south, and track whether planned investments/ improvements deliver as planned!

:2cents:
 

AndyN

A problem shared...
Staff member
Super Moderator
#8
Well, I have to disagree a bit, the clause calls for

"shall determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and controll of these processes;"

So, we have to have criteria (goals), and a method (defined way to consistently do it), to ensure effective (how can this be determined without a goal/criteria?) control (we know if our outputs are stable and meet requirements).

The "control" portion compels us to have some way of knowing how well we're doing, we can't just file the oil change records and only go evaluate them if there's a crisis, or after the car breaks down.
  • Even if all that matters is if the oil change is close to the interval or not, how close is close enough, how often are we close enough, why does it matter if we're close enough?

Even if it's a "support" process, it's important enough to need to "establish, implement, maintain, and continually improve" it per 4.4.1, as it will affect the outcome of your core processes. Whether or not it's called a "metric" in your firm, think of the way that Maintenance affects your operations, look for measures which are already in place and make business sense, track them and take action if things go south, and track whether planned investments/ improvements deliver as planned!

:2cents:
Criteria are not goals. If they meant goals, the TC would have used that word! Criteria are related to what's acceptable/unacceptable. In the example, the goal is to have a reliable/available vehicle. The criteria are things like the weight of the oil (10W40) and the specification of filter etc. Feel free to disagree, however, when you overload a business with objectives and measurements which aren't required to be effective, is when management decide that doing "ISO" is a waste of time...

Trust me, the auditor is reading too much into this requirement.
 
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