AS9100Dbag
Registered
First some context:
I have no quality management experience. I'm a lowly inspector who has been charged with significant responsibility for the last 8 or so months:, assisting our quality manager with assessing our QMS after our prior manager retired last year.
I'm a smart dude and my boss trusts me to take it seriously and become capable, and he needs the help, but I am UTTERLY unqualified. My boss has no previous experience in his role, but he's been working in manufacturing for a long time and has a pretty good general idea about QMSs, but I don't believe he's been responsible for building/assessing/maintaining one. We're figuring it out largely on our own and I'm so grateful for the guidance you guys have been giving me for some time now.
I work in a small manufacturing company of about 30 employees. The QMS is obviously a mess to anyone that uses it or looks at it, even myself, but our manufacturing processes are mature and stable and well controlled. As such, our customer issues very few C.A.s, but we could probably make inroads in efficiency and cost, I think. There are significant holes in the way we meet some requirements, more importantly there's a tremendous opportunity to improve the things we don't do well. I've already consumed the 'process over requirements' Kool-Aid.
Even as a small company with one product line and one customer, we have more than 1800 controlled documents in our QMS. This does not include any drawings or spec documentation, merely guidelines, procedures, forms, work instructions etc. It is a straight-up fucking nightmare. We consistently do good work, but it's not in any way a result of an effective QMS.
We're not going to be bringing in consultants and the argument that we need implementation guidance for a certification we already have is moot. I have gone through a 5-day AS9100D lead auditor certification course, and I've read much AIQG and ISO guidance documentation, the ASQ ISO9001:2015 Explained book, and Craig Cochran's ISO in Plain English book. The two of us ARE going to be doing this on our own. That's great for me, personally, but it's a daunting task.
We began by defining processes and interactions. Now that we've properly conceptualized our company's processes I have to assess them and the way in which we support them with documentation. We have to figure out what our own process requirements are, then develop an audit program, audit, and then start cleaning up the mess.
I have gone through the standard and color-code highlighted all "shall" statements categorizing them into 4 types: things we need to think about, things we need to do, management specific responsibilities, and documentation requirements. Thereafter, I've begun to look at a process, Product Design for instance, and then go through the standard, requirement by requirement and see if it applies. I then note the clause and verbiage in a correspondingly color-coded process assessment (proto-audit) document. Effectively, I'm creating documents for myself that mimic the AS9101 Form 2: QMS Process Matrix Report from our last audit, but instead of a "C" or "NC" bubble, I transcribe the detail of the clause verbiage and notes specific to our process in order to define which standard requirements are applicable to that process. I'm going to do this for all of our core processes. I'll then repeat this exercise with regard to NADCAP, our customer's Supplier Quality Manual, and any regulatory standards by which we're bound. Then we'll begin looking at our onerous pile of documentation, probably having to do a half-assed internal audit in there before our CB audit in October, because the getting our arms around our documentation (I told you there are 1800 controlled QMS docs?) and then developing a legit audit program is a long haul type of project.
Now onto the questions:
Is there a better way for me to be identifying the requirements of our processes while maintaining a holistic yet granular approach to assessing this bloated and inefficient monstrosity of ours, and also accommodating my own baseline experience and knowledge deficits? Is there a better way for me to discern what applies to which process, and to not miss anything?
How would I go about determining if there's some regulation by which we're bound that we haven't identified? How one could possibly ever determine if they're compliant with the whole of federal, military, and international aerospace regulations I have no idea. Like the massive tax code, that you can't possibly comply is probably at least part of the point.
What am I not thinking about in tearing our QMS down to the frame and rebuilding it?
I have no quality management experience. I'm a lowly inspector who has been charged with significant responsibility for the last 8 or so months:, assisting our quality manager with assessing our QMS after our prior manager retired last year.
it sucks
I work in a small manufacturing company of about 30 employees. The QMS is obviously a mess to anyone that uses it or looks at it, even myself, but our manufacturing processes are mature and stable and well controlled. As such, our customer issues very few C.A.s, but we could probably make inroads in efficiency and cost, I think. There are significant holes in the way we meet some requirements, more importantly there's a tremendous opportunity to improve the things we don't do well. I've already consumed the 'process over requirements' Kool-Aid.
Even as a small company with one product line and one customer, we have more than 1800 controlled documents in our QMS. This does not include any drawings or spec documentation, merely guidelines, procedures, forms, work instructions etc. It is a straight-up fucking nightmare. We consistently do good work, but it's not in any way a result of an effective QMS.
We're not going to be bringing in consultants and the argument that we need implementation guidance for a certification we already have is moot. I have gone through a 5-day AS9100D lead auditor certification course, and I've read much AIQG and ISO guidance documentation, the ASQ ISO9001:2015 Explained book, and Craig Cochran's ISO in Plain English book. The two of us ARE going to be doing this on our own. That's great for me, personally, but it's a daunting task.
We began by defining processes and interactions. Now that we've properly conceptualized our company's processes I have to assess them and the way in which we support them with documentation. We have to figure out what our own process requirements are, then develop an audit program, audit, and then start cleaning up the mess.
I have gone through the standard and color-code highlighted all "shall" statements categorizing them into 4 types: things we need to think about, things we need to do, management specific responsibilities, and documentation requirements. Thereafter, I've begun to look at a process, Product Design for instance, and then go through the standard, requirement by requirement and see if it applies. I then note the clause and verbiage in a correspondingly color-coded process assessment (proto-audit) document. Effectively, I'm creating documents for myself that mimic the AS9101 Form 2: QMS Process Matrix Report from our last audit, but instead of a "C" or "NC" bubble, I transcribe the detail of the clause verbiage and notes specific to our process in order to define which standard requirements are applicable to that process. I'm going to do this for all of our core processes. I'll then repeat this exercise with regard to NADCAP, our customer's Supplier Quality Manual, and any regulatory standards by which we're bound. Then we'll begin looking at our onerous pile of documentation, probably having to do a half-assed internal audit in there before our CB audit in October, because the getting our arms around our documentation (I told you there are 1800 controlled QMS docs?) and then developing a legit audit program is a long haul type of project.
Now onto the questions:
Is there a better way for me to be identifying the requirements of our processes while maintaining a holistic yet granular approach to assessing this bloated and inefficient monstrosity of ours, and also accommodating my own baseline experience and knowledge deficits? Is there a better way for me to discern what applies to which process, and to not miss anything?
How would I go about determining if there's some regulation by which we're bound that we haven't identified? How one could possibly ever determine if they're compliant with the whole of federal, military, and international aerospace regulations I have no idea. Like the massive tax code, that you can't possibly comply is probably at least part of the point.
What am I not thinking about in tearing our QMS down to the frame and rebuilding it?