Quality Control Datasheets

abublitz

Registered
Hi all,

I work for a contract manufacturer that produces both medical and non-medical devices. In our Electronics department, we manufacture PCBAs which are 100% inspected. With the exception of a few non-medical devices, all our PCBAs are serialized. Some are just visually inspected (either human or AOI) and others are visually and functionally inspected.

Unfortunately, most of our processes are stuck in the '90s and are very paper reliant, it is also not possible to reduce inspections to an AQL sample size, as opposed to 100% inspection due to customer requirements. I am working on ways to improve our current system (without totally redoing it) and hopefully reduce paperwork. Our current system is a QC sheet that is generated with the every serial number assigned to the job/batch (50 serial numbers on each sheet) along with a rework sheet printed on the back.

Our current process works ok.... until we put on large jobs for devices that we are expected to ship quarterly volumes worth at a time. An example is for one device, we generally put on a job for 2,000 PCBAs. That turns into 40 pages of QC sheets and if no failures are found that generate rework, our QC techs are having to go and cross out, N/A and date/initial every single back page.

I was wondering if anyone had any examples they would be willing to share on how they do QC sheets for something like this? I've attached a sample of what we are using currently.
 

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  • QC sheet example.pdf
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Terry He

Registered
1)is this 100% inspection required for QC based on the history ?on-line inspection? you can undertand what's the concern from customer and regulation ? from quality concept an additional inspection is not required .2) is this reord need show the inspection record or "A"/"R" judgement on each unit ? is this mandatory requirement from customer or others , if not you can generate a lot to include all the units , and release by Lot , a lot can include quality 50,100,200,1000......, and make a final judegment as "A" or "R" for the lot 3) the S/N information in this lot in inspection sheet can generated by system automatically 4)for defect you have no more choice for paperwork on each unit , hope this can be helpful.
 

Mike S.

Happy to be Alive
Trusted Information Resource
That turns into 40 pages of QC sheets and if no failures are found that generate rework, our QC techs are having to go and cross out, N/A and date/initial every single back page.

One option would be to say in your procedure that governs this process and references this form that if rework is done it will be noted on the back of the form. If no rework is done, the back will be empty and it is not required to N/A and date/initial every single back page.
 
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