Help with CAPA for an IATF finding regarding inspection documentation


Starting to get Involved
Quality Supervisor for automotive plastic injection molding here. Last week we had an IATF surveillance audit. All in all the audit went well, and we walked away with two minors (one in maintenance and one in quality). I am having a very hard time with trying to come up with a corrective action for the quality hit.

Here is the long story: I have been hounding on my quality team about inspection documentation since I started here in early 2020. I have been asking them to write EVERYTHING down on their in process inspection sheets, including down time, process adjustments, issues, high scrap, visual defects... basically everything. No one was listening. Finally, after I was reviewing the inspection sheets I found that everyone was writing OOT numbers for our coating measurements, not documenting it, not having a supervisor sign off, and not documenting adjustments or additional shots that were checked after adjustments and I lost it. I wrote EVERYONE in the department up. This was about a month ago. They started getting better, but still not doing what I asked, and it came back to bite us.

Jump to last Monday. IATF auditor is here, doing his thing. He was looking over the inspection sheet that was being used at the time, and he pointed out that there were OOT measurements written down. They were signed off by the supervisor, so I know the inspector told the supervisor the numbers were low... but noting else beyond that was documented. No one wrote down that an adjustment was made or that another shot was checked after the adjustment. No notes were written about the adjustment, what was done with the parts to ensure no defects escaped, the timing, how many other parts were checked after, etc. So, we got hit for inadequate inspection documentation and traceability. I 100% agree that we deserved that hit, especially since it has been an ongoing issue for so long.

My problem now is that I can't think of adequate corrective and preventive actions other than retraining and verifying inspection documentation in real time (which I really don't have time for). I don't think it is a systemic issue at all, because we have multiple work instructions on proper procedures and documentation processes for inspection and reaction to non-conforming product, the team has been adequately trained, and they know what they are supposed to be doing, they just don't do it. Can someone, ANYONE, please give me some guidance with this?

Johnny Quality

Quite Involved in Discussions

What is the reaction plan in your control plan when measurements are OOT? Why was that not done?

Could you give us the non-conformance from the auditor?


Quite Involved in Discussions
Without seeing the process sheet, I wonder if it is in need of revision? Just speculation, but I've seen some of these things so complicated no one even tries to fill them out. Maybe you could look at rearranging the sheet to make it flow more smoothly??

Again, this may not be the issue at all, but it is how we corrected an inspection sheet at my place. This particular form was never completed consistently, specially between inspectors. It was extremely overcomplicated and much of the document wasn't even necessary. We streamlined it, provided training, and problem was solved.


Starting to get Involved

What is the reaction plan in your control plan when measurements are OOT? Why was that not done?

Could you give us the non-conformance from the auditor?

I do not have the NC from the auditor yet... waiting on corporate to get it in the system.

The (simple version) reaction plan is to:
1. place product on hold (write it down!)
2. inform the supervisor (write it down!)
3. supervisor makes adjustment and signs off on inspection report
4. inspector documents the adjustment that were made
5. inspector measures parts after adjustment and documents measurement
6. product on hold is given a disposition by me.

I have no idea why this wasn't followed. Everyone in quality has been here for some time, and they all know the process. They know where to find the QMS if they need to reference a work instruction. They know that everything needs to be documented. Like I said, I have been having a problem with all three shift inspectors documenting and following procedures correctly, to the point that I recently wrote the whole department up. I need to do something to change the department's mentality, but I am at a loss as to how.

Mike S.

Happy to be Alive
Trusted Information Resource
I don't know 16949 requirements, but when 3 shifts worth of people are all refusing to do something you have a serious problem. This isn't isolated. There is a "rest of the story" and you need to find it. Usually 3 shifts of people aren't just doing something that they know is outside the procedures because they are hardheaded jerks.

Perhaps someone above them, their boss maybe, is telling them it's okay?

Does following the procedure prevent them from meeting some other quota?


Starting to get Involved
You may want to ask them to answer the Corrective Action. Put the ownership on them for the N/C. You may find the roadblock as to why it isn't being followed correctly.


Starting to get Involved
You may want to ask them to answer the Corrective Action. Put the ownership on them for the N/C. You may find the roadblock as to why it isn't being followed correctly.

I actually thought of doing this!


Forum Moderator
I have two suggestions:
  • Can you make the form electronic with data validation and mandatory fields when an OOT value is entered?
  • Get them together, present the requirements that MUST be met, and ask them to develop the solution that meets those requirements. This will give them a pride of ownership and make them more likely to use the solution


Involved In Discussions
Hello Azaarus. I work in an injection molding environent also, so hopefully I can provide some insight. First, are you using IQMS? IQMS has an SPC data collection module that makes it much easier to record the data. So if you have IQMS, I would start there. We collect ALL of our inspection data electronically, and our calipers, micrometers, indicators, etc are almost all connected directly to the computer. Makes it real easy.

Beyond that, I usually find that if someone is not following a process (in your case, recording the data and subsequent actions) it's usually because it is not convenient to do so. SO if something like IQMS SPC is not an option, find a way to simplify your data collection. Work with your team to solicit their ideas on how to simplify the process and then they will have had a say in the new system. The other obstacle could be a company cultural one, they get away with it because they are not held accountable, but I would start with a team effort to simplify.

It is extra important to have your team and the production supervisor team involved. SO get appropriate members on your 8D team and work the corrective action process.

Best of luck.
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