Is this a Major AS9100 QMS change - Quality Concerns

[Ian K]

We currently run our Quality concerns through Qpulse and are going to change the structure/flow of the quality concerns process within Qpulse, previously we had a corrective action section within the quality concern process where we could add root cause/corrective and preventative action, we also specified the requirement to attach an 8D if the concern process was serious enough to warrant one. We are now going to alter the concern process within Qpulse to reflect the 8D flow. My question is, is this classed as a major change to the QMS and as such does it need to be recorded and if so how? We have an ECN process for recording engineering changes but my opinion is that this is not the correct format for recording QMS changes.

 

[doctall41]

We currently run our Quality concerns through Qpulse and are going to change the structure/flow of the quality concerns process within Qpulse, previously we had a corrective action section within the quality concern process where we could add root cause/corrective and preventative action, we also specified the requirement to attach an 8D if the concern process was serious enough to warrant one. We are now going to alter the concern process within Qpulse to reflect the 8D flow. My question is, is this classed as a major change to the QMS and as such does it need to be recorded and if so how? We have an ECN process for recording engineering changes but my opinion is that this is not the correct format for recording QMS changes.

Ian,
I assume you have a documented Procedure stating how you handle Corrective Actions. All you need to do is make a revision to that procedure stating what you will now be doing within Qpulse.

 

[Big Jim]

You may be confused with major changes that need to be reported to the certification body. Things that could indicate changes needed in the audits. Things like moving to another facility, adding a facility, adding shifts, significant changes in management, and even that the company was bought out by another company.

As noted above, changes in you documentation need not be reported, but they need to be available for the auditor to review.