AS9100 Facility Relocation

[QCBOB]

Good afternoon,

I am starting a new job as Quality Manager for a Laser Machining company in the next couple weeks and over the course of some conversations with the General Manager, I asked for some of my first tasks/issues that I will be faced when I start so I can start getting a game plan. The company has a new building and are relocating their 2 sites to this one facility. The facility is almost complete and the have moved one of the sites to the new location, but it is not up in running.

One of my first tasks will be for the re-qualification of machines at the new site, I believe this will require of a IQ, OQ, and PQ, but unfortunately I have never faced this before.
My second task will be dealing with the AS9100D recertification. I have gone through the whole certification process at my current employer, so I am not as concerned about that task.

But for the IQ, OQ, and PQ, does anyone have any tips or suggestions for dealing with a facility relocation? Also, does anyone have any examples of IQ, OQ, PQ forms I could reference?I tend to be more a visual learner and find it easier to visualize the process.

Thanks in advance

QCBOB

 

[Sidney Vianna]

Go to the IAQG SCMH website and get all the guidance material on “WORK TRANSFER” and apply to the relocation. Notify your aerospace customers and your CB of the change.

Good luck.

 

[QCBOB]

Go to the IAQG SCMH website and get all the guidance material on “WORK TRANSFER” and apply to the relocation. Notify your aerospace customers and your CB of the change.

Hi Sidney, Thank for the reference to the guidance material, the company has already notified their customers and the CB of the change. I guess I was looking for more information on the documentation process for IQ, OQ, and PQs. I apologize if I did not make that clear.

But again thank you for the reference.

QCBOB

 

[Sidney Vianna]

guess I was looking for more information on the documentation process for IQ, OQ, and PQs.

That’s Medical Device protocol. In Aviation, Space & Defense, you will be doing something akin to First Article Inspections and, if special processes are involved, revalidation.

 

[Cari Spears]

That’s Medical Device protocol. In ASD, you will be doing something akin to First Article Inspections and, if special processes are involved, revalidation.

I had to google IQ, OQ and PQ.

 

[John Predmore]

IQ, OQ, PQ are a great outline for a thorough process validation, and that formality may serve your company well, but that sequence is not well-known outside the medical device industry. In AS9100, the section to refer to is 8.5.1.3 Production Process Verification, but nearly everyone calls it First Article Inspection (FAI or sometimes FAIR for the report). I spent a lot of time in automotive industry and FAI is something like a level 3 PPAP, but without the capability study and control plan which are but a footnote in 8.5.1.3. There is a separate AS standard describing industry standards for FAI, and that is AS9102. Your customer may require you to use the AS9102 forms, and have contract language on their expectations. If you want to prepare a control plan and more along the lines of Advanced Product Quality Planning, aerospace has a separate standard outlining APQP, and that is AS9145. I don't think AS9145 is as widely used as FAI. As Sidney mentioned, there is a lot of free resources on the IAQG.org website under SCMH.

 

[rubbimeister]

Has the organization completed LAI's as part of the work transition?

When completing similar work we completed Last Article Inspection reports along with an assessment of 9 samples from last/first which was used to 'prove the process' out as a Belt and Braces approach.

I'd be pushing for LAI's to be completed ASAP as when you're in the new facilities and every things changed you've nothing to fall back on to demonstrate that the process your moving is good/repeatable/robust, you'll be left with the any issues that exsist in the 'New' facilities to own.

Our work transition LAI's flagged up a number of production/test issues that were being 'Managed' at a working level that would never have come to light if not checked.

 

[ChrisM]

I'm not too sure about IQ, OQ and PQ in respect of AS9100 but having worked for a medical device company that relocated, in addition to what has been said above, we also did some testing and (dimensional) inspection of some finished product at the old site, then re-did everything after the move and compared results. With almost zero variation we concluded this was good supporting evidence that test and measurement equipment and use had "survived" the move without any deterioration.