AS9100 - QA Intern Help!!

[jennyd]

Getting employees to follow the procedure will work best if they are involved in setting it up. Without their input, you could be creating a process that doesn't fit in their normal workflow, or worse, that they can't even follow.

Your Quality Manual should stay at a pretty high level; i.e., this is "what" we do, not "how" we do it. That should keep it from churning often.

You're eating an elephant, sounds like, so realize you can't eat it all at once. You say you were already audited and are awaiting certification - presumably the foundation is in place so look for where your biggest risks are and begin incremental updates. You may not be able to "finish" by the time your internship is over so maybe lay out a long-term plan.

Hello,

Thank you so much for the thoughtful response. That was really helpful to read. I completely agree that involving employees in developing or revising procedures makes a big difference. That’s something I’ve been trying to figure out here, especially since there’s a language barrier and not everyone is as engaged with documentation. Do you have any suggestions for how to involve shop employees in reviewing or updating procedures when communication can be difficult?

I also appreciate your point about keeping the Quality Manual at a high level. That makes a lot of sense, and it’s a good reminder that it should focus on what we do rather than how we do it. I’ve been trying to strike that balance while revising some sections, so hearing that confirmed is reassuring.

And you’re absolutely right about “eating the elephant.” I’ve been feeling that lately — it’s a lot to take on at once. Would you recommend starting with simplifying processes first, or cleaning up and organizing the documentation structure as a foundation before diving deeper into process improvements?

Thank you again for taking the time to respond. I really appreciate your insight and perspective.

— Jenny

 

[jennyd]

As far as document nomenclature, we use QPs for high level quality procedures, WI for detailed work instructions, and QM for the quality manual. The first two numbers after the letters is the applicable ISO 13485 clause (we manufacture medical devices). So design control would be QP73-XXX, where the last three numbers are sequential documents relating to ISO 13485:2016 clause 7.3. It works very well and makes it super easy to trace procedures to the ISO clause that requires them. I don't know how well this would work for AS9100 as I have never worked with that standard before.

Our Quality Manual outlines all of the processes we maintain and any applicable references to an ISO clause or MDR requirement. We don't go in detail about how we comply but rather have references to the applicable QP document.

As for revision management, going as paperless as possible will help immensely as Golfman stated. Make sure for network folders that archived documents are limited access to only those who really would need access to the historical revisions. We generally put "Uncontrolled if Printed" in the footer of every controlled document. It is a good reminder for everyone to make sure they are using the current revision. Part of the change control process for revision changes of documents is updating them everywhere they might be located. Maybe this is just moving the old revision to the "obsolete" folder on a network or maybe this involves printing current revision copies and replacing physical copies of the previous revision. I know some spaces in the manufacturing environment it is very difficult to access an electronic work instruction or procedure.

Hello Nichole,

Thank you for sharing all of that. This was incredibly helpful.

I really like your point about going as paperless as possible. We've been trying to move in that direction too, but we still have a few areas where printed copies get used on the shop floor. I love your "Uncontrolled if Printed" footer idea and will look to use that. Do you use any kind of notification or checklist when a revision is issued to make sure older printed copies are swapped out, or is that just part of your change control process?

Thanks again for taking the time to explain your setup. This really gives me some good ideas for tightening up our own document control system.

—Jenny

 

[Golfman25]

Hello!

Thank you so much for sharing that. I really like your plain-language approach. It makes a lot of sense and seems much easier for employees to navigate.

Out of curiosity, I had a few questions for you:

1. If you use plain-language names, how do you avoid duplicate titles or confusion when two forms are similar (e.g., 'Inspection Report' vs. 'Final Inspection Report')?

You just did. Although we used "In Process Inspection Report" and "Final Inspection Report.

1. When you make a revision and replace the PDF, how do you ensure employees know it changed? Do you send a notice or do you rely on the version control built into the file name?

So it depends. In many cases, it doesn't matter -- if we are just fixing errors, wordsmithing, etc. All they needed was access to the most recent version. In other cases, the employees who used the document where part of the change, so they knew it was coming thru. And in some cases we used our Sneaker Net -- we walked over to the affected employee(s) and told them about the change.

Right now, I organize our quality folders and files based on what something is rather than which process it belongs to. For example, my current structure is numbered and looks like this:

1 Quality Policy, Objectives, & Risks
2 Quality Manual
3 Procedures & Documents
4 Forms
5 Records
6 Obsolete
7 AS9100 2025 Audit Documents
8 Checklists

Would you recommend continuing to organize things by document type like this, or would it be better to move toward a process-based layout (for example, Purchasing, Production, Inspection, etc.) like you described? I can see how your structure keeps things simpler and more intuitive, but I’m curious how it scales over time.

Thank you again for taking the time to explain your setup — it really helps me understand how to simplify ours without losing control or traceability.

— Jenny

The problem with that method is you have to "know" what you're looking for. Am I looking for a form, a record, a procedure? And then go thru dozens of unrelated files to find it. If I am looking for something related to purchasing I can just go to the purchasing file and see all the related procedures, forms, etc. If manufacturing, I go to the manufacturing file and find the same. We do have a file for the Quality Manual and Obsolete documents, audit stuff, etc.

 

[jennyd]

Do you design your own product or are you a build to print shop? What kind of audit did you have? Are you trying to be ISO certified or Aerospace, Automotive....need to know so I may be able to help.

Hello Steve,

Thank you for offering to help! We’re a build-to-print shop primarily doing CNC machining for the oil and gas industry, and we’re hoping to expand into aerospace work once our AS9100 certification is finalized and listed in OASIS.

We don't design our own products. We manufacture strictly to customer drawings and requirements, but we do handle documentation such as first articles, material certs, inspection reports, and calibration records internally.

I'd really appreciate any advice you have on how to organize or streamline documentation and records for a small build-to-print operation like ours.

Thank you again for your time and guidance.

— Jenny

 

[jennyd]

When we rewrote a lot here it was just using a letter prefix so Q for quality P for production, created a key and slowly worked through. Most of it was just copying the document and giving it a name. Then we went through the actual documents and as mentioned earlier consulted and sought advice from the process owners before up reving as required. Went from probably 300 documents of varying use to 200 that actually meant something eradicated duplicates or processes that when looked at were able to be combined. Numbers now creeping back up but its controlled and new documents only released when we are happy they are needed not just written up for the sake of their being a document. The frame work must be pretty strong already if you are recieving certification otherwise you wouldnt have been able show your controls in the audit.

Hello,

Thank you for sharing that. I really like your approach of using simple letter prefixes by process. That seems like an easy way to stay organized without overcomplicating things.

We've been struggling with a lot of duplicate or outdated documents, so hearing how you consolidated and cleaned up your system really helps put things in perspective. I agree that keeping the framework lean makes it much easier to manage in the long run.

Out of curiosity, when you consulted your process owners during the rewrite, did you do that through meetings or more informal reviews? I'm trying to find a good way to involve our shop employees without overwhelming or frustrating them.

Thanks again for the insight.

— Jenny

 

[yodon]

Do you have any suggestions for how to involve shop employees in reviewing or updating procedures when communication can be difficult?

That's a tricky one. Suggest maybe you just sit with them and observe. If you have someone that can translate, have them explain that you're just there to observe and learn, not to critique. See what their workflow is like and what records they capture (keeping in mind what they're supposed to capture). If possible (possibly through the translator), ask where they have difficulties.

Would you recommend starting with simplifying processes first, or cleaning up and organizing the documentation structure as a foundation before diving deeper into process improvements?

Since you said you've already been audited and are awaiting certification, it sounds to me like the systems in place right now are at least sufficient to comply with the standard. Cleaning up and organizing is a good first step. You probably need to get better awareness of the processes before making changes.

 

[Nichole F]

Hello Nichole,

Thank you for sharing all of that. This was incredibly helpful.

I really like your point about going as paperless as possible. We've been trying to move in that direction too, but we still have a few areas where printed copies get used on the shop floor. I love your "Uncontrolled if Printed" footer idea and will look to use that. Do you use any kind of notification or checklist when a revision is issued to make sure older printed copies are swapped out, or is that just part of your change control process?

Thanks again for taking the time to explain your setup. This really gives me some good ideas for tightening up our own document control system.

—Jenny

To communicate changes, it really depends on what the change was. At a previous company, we used minor and major changes. A minor change was something like correcting a typo or formatting error. These were processes as a decimal revision change. So if Document XXX was at revision 8 and had a minor change, the new revision would be 8.1. This means no one has to train on it.

For major changes, we communicated based on our training matrices. We mostly had people do read and sign training to make sure they understood that a revision had occurred, and what the newest document states. For more complicated change, we did in person trainings with effectiveness verifications via quizzes.

For documents that did not require training (such as forms) we would send out a notice that a new document had been released.

Part of your release processes could be collecting paper copies of the old revision and replacing them with a new revision. Historically, every company I've worked at had a lists of tasks associated with document changes. Replacements of old revisions was a step in the document release process. This does require some work to establish a "map" of where these documents are. This "map" may also include links to other documents that may also be impacted by the change.

Again, my experience is coming from the medical device work (ISO 13485) so it may be different than what you are working with.

 

[mattador78]

Hello,

Thank you for sharing that. I really like your approach of using simple letter prefixes by process. That seems like an easy way to stay organized without overcomplicating things.

We've been struggling with a lot of duplicate or outdated documents, so hearing how you consolidated and cleaned up your system really helps put things in perspective. I agree that keeping the framework lean makes it much easier to manage in the long run.

Out of curiosity, when you consulted your process owners during the rewrite, did you do that through meetings or more informal reviews? I'm trying to find a good way to involve our shop employees without overwhelming or frustrating them.

Thanks again for the insight.

— Jenny

I was lucky i was once a process holder for most things here ive done 30 years shop floor to management. Informal to start is always the best take your procedure and go ask them to talk you through the job they are doing. They will probably forget tell you a few steps and show you new ones. But it will be as close to honest as the job is being done, which is what you need. That works for the production and the office side, main rule if you have never done the job dont tell somebody they are doing it wrong from a mangement level without finding out what and why they are doing it.

 

[Steve Weber]

Hello Steve,

Thank you for offering to help! We’re a build-to-print shop primarily doing CNC machining for the oil and gas industry, and we’re hoping to expand into aerospace work once our AS9100 certification is finalized and listed in OASIS.

We don't design our own products. We manufacture strictly to customer drawings and requirements, but we do handle documentation such as first articles, material certs, inspection reports, and calibration records internally.

I'd really appreciate any advice you have on how to organize or streamline documentation and records for a small build-to-print operation like ours.

Thank you again for your time and guidance.

— Jenny

Jenny, The advise you get from this forum will be top notch. There are a lot of intelligent folks that have great input to whatever subject gets posted. The nice thing about this is that once a person responds, it usually prompts someone else to chime in and expand on the response. Eventually you will have enough information to pick and choose what ever may work for you.