Document Hierarchy Importance?

#1
Hi there,
I recently switched industries as a QA Systems Admin.
I was liable for ISO 9001:2015 in a laboratory setting and I am trying to spread my wings in the manufacturing industry.

I am currently having trouble in my new QA department with Document Hierarchy.

It seems the current Quality team does not employ such documentation. They were certified for both IATF16949 and AS9100D recently so I am assuming it is not a requirement.

I come from bigger companies and I am struggling to grasp the concept of the documentation here as well as grasp manufacturing a product vs a service (acronyms have become the bane of my existence).

I have been here only a few months; unfortunately I am the youngest and I'm not trying to make waves but my questions are being taken as assaults on their Quality System (no matter how I word/bow/play the stupid card). The more people I encounter that came from outside companies are just as lost as I am; I want to help and I want to improve the communication barrier between QA and everyone else here (how else am I ever going to get my CARs closed? :frust:)

With that being said - is there any solid reads that I can get that would be a good "Manufacturing QA for Dummies?"

Please advise.
Thank you ahead of time.
 
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Marc

Hunkered Down for the Duration
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#2
Put the "Document Hierarchy" aside for a moment. Have you mapped out the documentation structure in the company, and their interactions?

If you are trying to adhere to the old Document Pyramid, you can (if you feel you have a need to) assign each document a place after you have the existing system mapped.

If you have questions specific to closing out corrective action request(s) we'll need a bit more specific information.

:2cents:
 

Golfman25

Trusted Information Resource
#3
Hi there,
I recently switched industries as a QA Systems Admin.
I was liable for ISO 9001:2015 in a laboratory setting and I am trying to spread my wings in the manufacturing industry.

I am currently having trouble in my new QA department with Document Hierarchy.

It seems the current Quality team does not employ such documentation. They were certified for both IATF16949 and AS9100D recently so I am assuming it is not a requirement.

I come from bigger companies and I am struggling to grasp the concept of the documentation here as well as grasp manufacturing a product vs a service (acronyms have become the bane of my existence).

I have been here only a few months; unfortunately I am the youngest and I'm not trying to make waves but my questions are being taken as assaults on their Quality System (no matter how I word/bow/play the stupid card). The more people I encounter that came from outside companies are just as lost as I am; I want to help and I want to improve the communication barrier between QA and everyone else here (how else am I ever going to get my CARs closed? :frust:)

With that being said - is there any solid reads that I can get that would be a good "Manufacturing QA for Dummies?"

Please advise.
Thank you ahead of time.
It sounds to me like you viewed as coming in to make a bunch of changes. Worse, it sounds like you are looking for documents which manufacturers generally hate. If they are recently certified, you can assume they at least have the basics down. What don't they have that you are looking for?
 
#4
"If you are trying to adhere to the old Document Pyramid, you can (if you feel you have a need to) assign each document a place after you have the existing system mapped."
-- They have a process interaction diagram for production documentation only (which the numbering is very confusing but the diagram is there).
-- Supporting or what I am used to as "Policies" or overarching documents for "This is how we number our documents" "this is our document template" "this is our responsibility matrix" "this is risk management" "this is how we validate" "This is IQOQPQ" are not found here and I have no idea what to reference when I am I trying to review documentation (I am learning PPAP and APQP).

"It sounds to me like you viewed as coming in to make a bunch of changes. Worse, it sounds like you are looking for documents which manufacturers generally hate. If they are recently certified, you can assume they at least have the basics down. What don't they have that you are looking for?"
I am not trying to make changes; I don't make enough or have the title to. They have to have whatever they need because they are certified; this much I know.
As for "documents which manufacturers generally hate" -- lets be honest -- everyone hates documentation except QA; so I am not sure what those documents could be.

I am looking for possible manufacturing documentation sites to help me muddle through the difference between science and manufacturing.

I sit for my CQA exam next month -- maybe I will find out then if I am actually cut out to be an Auditor. If I would audit this system I would be lost (which is inevitable as an internal auditor).
The reason I need outside sources is because they are "too busy to train" me.
Maybe this is just a bad situation for me.

But thank you for trying to help.
 

Golfman25

Trusted Information Resource
#5
Well it sounds like you're asking for documents they don't have or that the deem are not needed. Remember they are manufacturers, not scientists. They will probably be more "fly by the seat of their pants" than a scientist.

To have a written numbering scheme, document template, or other overarching documents are probably not high on their list of priorities. If your doing audits, I would start with your standards for training -- figure out what actually needs to be (not should be) documented and go from there. Don't get caught in what you used to do, and look at what they do. It's probably not rocket science, so you should be able to walk yourself thru most of it.
 
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