AS9102 C requires a documented process to evaluate changes?



I just notice that AS9102 C requires that (sect 4.6 f.) "The organization shall have a documented process to evaluate any changes to production realization processes or engineering/design requirements that invalidate or are not represented in previous FAI and then perform a full or partial FAI, as determined by the evaluation."

Do we really need a documented procedure for this kind of evaluation? I would think the best approach would be revise our current FAI procedure by adding a section describing a process for changes evaluation, maybe some kind of risk assessment would work with relative values or how would you implement such process?

John Predmore

Trusted Information Resource
When you follow a quality standard and it says "shall have", that is generally makes the requirement mandatory.
[p.s. As a courtesy to and good practice for other readers, FAI means First Article Inspection.]

You say you currently have a documented procedure, so yes, you should be able to add details to be in alignment with AS9102C. I recently did the same. I noticed rev C added language (4.6.b) which makes a stronger call than rev B to form a multi-disciplinary team to make decisions. In that way, your changes evaluation is not limited to any one person's judgement. Also, a group might develop a test plan which is more expedient or economical than one person's idea.

On the question @mig29 asked, I notice the long-used, customary definition of a significant change (potentially affecting fit, form or function) was removed from Rev B to write Rev C. The new standard for repeated FAI is "changes that invalidate or are not represented in the original results". I am not going to interpret the word "invalidate" for someone else, that is why you gather a multi-disciplinary team.

I also noticed Rev C added wording to emphasize that FAI is not a one-time activity, or re-done only after equipment moves or a complete product/process redesign. Instead, FAI could be viewed as a confirmation step of your organization's existing Change Management procedure. If you haven't seen them, you should read guidance documents released within IAQG and SCMH 3.2 the same time as AS9102C, which list FAI common mistakes and best practices.

I always consider FAI to be an important risk reduction measure. The FAI with a sample size of one is NOT redundant to more extensive design, production roll-out, and validation efforts, because FAI provides assurance on a different level. FAI might be your final opportunity to catch those annoying errors that sometimes slip through the cracks in your other quality verification efforts.

In this way, FAI is similar to the dock audits I remember doing, thoroughly inspecting one sample of finished product before a large customer order goes out the door. I almost always found one or more details not right. That is how goofs are uncovered, like the labels threaded in the machine upside down because the wording in the work instruction was not clear, or 3 screws were kitted in the BOM when there were clearly supposed to be 4 but the person who designed the kit was different from the person who designed the assembly, or the mill operator read the hand-written 7 and thought it was a 1. I don't think anyone's "risk assessment" is likely to foresee those errors. As long as your FAI uncovers details which are not right, there is value in doing FAI.
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Thank you John. Do you have any knowledge of standard processes or methodologies on how to evaluate production realization processes or engineering/design requirements that invalidate FAI? Not sure how that process would look like and I want ideas. Thanks.

Bev D

Heretical Statistician
Super Moderator
I implemented such a risk based process in my old organization. We essentially used our FMEA process to asses the risk and then develop a test plan. One big difference to be aware of was that we only used severity and NOT frequency of occurrence or probability for assessing the risk. We used a simple 1-5 scale and required testing for any 3, 4, 5 scores. We used a team approach focusing on FUNCTION. I always stressed that there was no such thing as a small change - only small or large effects. Even smalll changes can have disastrous consequences. We focused mor on unintended consequences than on the intended change…we also had an expert review panel to review and approve all change assessments and test plans. If interested I can provide more details.


Thanks a lot, I actually was thinking about some kind of risk based process as well but wasn't sure if there was something standard already in place. Thanks.
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