Hi! First Post - New to AS9100 QMS Implementation

[SpaceCase]

So I have been saddled with the task of whipping my company's Quality System into line to get us AS 9100 certified. We have always been As 9100/ISO 9001 compliant, but this is our first stab at getting the certification (with the hopes of winning back a big customer we lost a few months ago!) We are a small company (less than 15 people) we have a class 10,000 clean room and about 95% of our business is precision cleaning for aerospace, we also do some fabrication, but it is all build-to-print per our customers' drawings, we have no engineering/design department and have noted that as an exclusion in our manual. I have downloaded the Quickstart Kit from the AS9100Store.com to help get us going in the right direction because our current manual and etc are a disaster.
One of my problems is that our "Quality Manager" (in quotations because she is such by title, but neither manages anything nor has Quality in the forefront of her mind) does not want to make any decisions in regards to any of this stuff. So far I've just been giving her the procedures on a flash drive and asking her to fill them out, but if there's anything that isn't already covered by our current books, she asks me what should go there.
Another problem is have is that there are no consequences for anything around here, no accountability, etc. a good example is the QM, she hardly ever leaves her lab to witness things like hyrdostat tests, she just trusts the guys out in pre-clean.... I keep telling ownership that we need to start implementing these things, but it just seems to go right over their heads.
Anyhow, I could keep writing for days about stuff like that...

Do you all have any advice for me on where to begin straightening this all out?
Thanks in advance!

 

[Michael_M]

It sounds like you do not have support from top management, or top management is not flowing this down. In a small company, many people wear many hats and your procedures should reflect this.

When you say:

she hardly ever leaves her lab to witness things like hyrdostat tests, she just trusts the guys out in pre-clean....

is this a requirement of the clean room or is this a requirement of your procedures. If it is part of your procedures, is it necessary? If it is part of the requirements of having a clean room, why and what can you do to reflect what is actually happening (and still follow the requirements)?

One of the big issues I ran into when converting a ISO9001 compliant system into a AS9100 certified system was our procedures. They had to be changed/upgraded to what we actually do. Since we were only compliant, we did not truly perform internal audits and verify what the procedures said.

 

[SpaceCase]

It is a requirement for the Quality procedure that she witness ALL testing in order to buy off our certs and other quality documentation.
IMHO, anything bought off by her that wasn't actively witnessed by her is invalid.

 

[Michael_M]

Can you change the procedure and still follow all requirements from your customers and the standard?

Can someone else sign-off on the witnessing, what if the only person who can sign-off goes on vacation for 2 weeks, can you still ship product/service?

Try not to write the procedures to paint the company into a corner.

 

[SpaceCase]

We do have a total of 3 employees who have Quality stamps who can buy off these tests(one is our Production Manager and the third is the other person trained for the Lab, but she isn't one to sit still, she gets whatever needs done done), our QM is just being lazy.

 

[Sidney Vianna]

We do have a total of 3 employees who have Quality stamps who can buy off these tests(one is our Production Manager and the third is the other person trained for the Lab, but she isn't one to sit still, she gets whatever needs done done), our QM is just being lazy.

One of the (broken link removed) that is not really translated into requirements in ISO 9001 nor AS9100 is Involvement of People (working for the organization). If an organization allows for a system where people can not be trusted and QA folks have to police the rest of the workforce, you have an archaic, untenable situation. Modern quality management requires employees to be accountable for their work.

If they can't be trusted to run a test, which needs to be witnessed by QA, why would we trust them to fabricate a part or assemble a product.

Cultural affinity to modern quality management is paramount, for a cost-effective, business-supportive, trustworthy QMS, in my experience.

 

[SpaceCase]

They can be trusted to do their work correctly, its part of her job to witness these tests. It's not that QA is policing the Pre-Clean Techs, it's just that its her job as Quality to bear witness to it since she is the one claiming parts are passing tests.

 

[SpaceCase]

For clarification, our "product" is actually a service. A typical job goes like this:
Customer says they have a 1/4" x 50' flex hose they need cleaned to a particular spec, we quote them, they send us a PO and they ship us the part, or we go pick it up if they are local.
The first stop after receiving inspection and work order and traveler write-up is the hydrostat test table where the guys use water to bring the hose up to pressure and hold the hose to 1.5 times the normal operating pressure for 5 minutes, which is supposed to be witnessed by quality so they can draw up the hydrostat certificate.
After that it is cleaned and sampled per spec. The sample is run through a filter pad and the pad is read on a microscope in the lab and the particles are counted to assure cleanliness.
As long as the particle counts do not exceed levels set by the spec the part is then packaged as the spec outlines and is returned to the customer along with the accompanying Quality Documents.

I hope this helps!

 

[Michael_M]

the hydrostat test table where the guys use water to bring the hose up to pressure and hold the hose to 1.5 times the normal operating pressure for 5 minutes, which is supposed to be witnessed by quality so they can draw up the hydrostat certificate.

Can the person performing the test sign the certification or sign an 'inspection' document that is then used by QC to sign the certification?

This would seem to be a better process than having 2x individuals watch the same test. I think this is what Sidney was eluding to: The person performing the test should be responsible for the recording of the results of the tests.

I do not know what type of customer requirements you are following, they may require QC to witness, but the AS9100 specification does not.

 

[SpaceCase]

Thank you, I never thought of it that way, I will have to see what we can do about changing this!