Good evening, SF. Today's question from vthoky deals with lot/component traceability.

My company has started a project manufacturing a couple of items for an automotive supplier. I've worked in automotive before (previous job), but it's a relatively new venture for my current employer.

As the new project is an automotive application, lot/component traceability is an absolute must. We're in the process of assembling specifications for an automated system, but I've been asked to explore the idea of building our own traceability system.

In a previous job, we had to keep lot records and such, but it was all paper-based. The obvious problems there were: bad penmanship, paper records (hard to search if necessary), a dirty environment (got the paperwork filthy all the time), and so on. My current environment is far cleaner, and we'd like to do as much with bar-coded data as possible. I'm thinking this could be done with LabVIEW, a couple of WYSE terminals, and a handful of bar code scanners.

To be honest, I'm a little thin on specifics (what all has to be recorded, for instance), but I know at least one SF member has mentioned being involved with automotive plant startups. (Embarrassingly, I can't remember who that was. I think I know, but....)

Anyway... I'd like to talk with someone who's got experience in this area. I have some ideas, but I'm sure I'm only scratching the surface of what needs to be explored. Is it reasonable to think of building a system ourselves? Is there commercial software on the market for this sort of thing already? (Seems unlikely.) Am I opening up a really ugly can of worms even thinking of doing this on our own?

What do you know, SF? Thank you.

Have you checked out practicalmachinist.com? There are a lot of guys over there that could answer your questions.

As a gun tie-in the owner of Seekin's Precision used to post a lot.

I work at a small volume fabricated, machined product manufacturer. We do offer full traceability on materials. We utilize Microsoft Access for databases for our manufacturing documentation, scheduling, purchasing. On all raw materials we get mill test reports or certifications. We scan as pdf files and all reports are tied into the heat/lot number, a inventory number, purchase order and our internal job number. No bar coding yet, but some of our customers require shipping docs and tagging to be bar coded, which we do, not sure what software does that. We developed our databases internally with the continuing help of a local tech service. Access is pretty powerful, but we’re relatively small in size and volume.

I was a machinist for 10+ years (before becoming an engineer). We did a lot of space flight hardware which required material tracibility. We had a work planning system that our estimators used that generated travelers for every job we did. This allowed us to also upload our material certification information and attach it to the traveler and was then associated to the part number and serial numbers of the parts that we made. I don't remember what software it was as it was a couple of years ago. I would say that you should look into what commercial software is already out there as you guys are not the first company to need this kind of record keeping. I can't imagine that it would be more cost effective to have you come up with you own thing.
I did a google search and found this page that looks like it has some useful software you might want to check out: https://www.softwareadvice.com...software-comparison/

At my current company they recently decided to purchase an inventory control software as our inventory excel sheet started getting out of hand, and it seems like it has some modules that could also do what you want, but I heard it was a bit expensive.
https://softwareconnect.com/erp/edata-viper/

We are going to use it for tractability purposes as we recently became a manufacturer of products to be used on small airplanes and need to be able to handle all the record keeping associated with FAA approval.

I would look at shoptech.com E2 cloud. They have lot traceability module. miSys is another but my client in the mfg business went with E2. They do not do lot tracing but it is available should they need to.

Growing your own may work but why do that when there are already solutions out there like E2

Good luck

We built ours in house but we are a high volume medical device manufacturer so having a customized system that follows our process is worth the cost. Having the team that developed the software on staff in our IT dept makes support and updates pretty smooth. But that translates into A LOT of money.

Depending on what you need to track you could probably make do with a simple batch record.
Design a cover sheet that lists each record you need to track and identify each cover sheet by a unique lot number.
Assemble each of the records required by the cover sheet and then convert the entire file into a PDF type file. You can even digitally sign each record if you feel the need to.

One of our companies (low volume) does this, the physical record actually accompanies the device through the manufacturing process as quality checks are documented throughout the process. The finished record is scanned in and associated by the device's serial number.

Is it impossible to ask an unanswerable question on SigForum?
At least where one is looking for people who have experience in X, where X is whatever the hell you can imagine, I believe the answer is "yes".

I have worked with traceability being that my work has been in the medical / pharmaceutical industry.

If you have an ERP / MRP system, there's probably a module or a switch to flip to enable traceability.

My email is in my profile and we can chat over the phone.

Biggest thing upfront is getting the requirements of your company's customers: Do they want lot traceability (a batch of parts manufactured with the same components and with the same processes for a defined time usually a day) or device traceability (each part you send to your buyer has its own unique serial number).

Format of the lot/serial number. Where it will be placed, whether people readable or machine readable.

Each of the components and variables going into the product you send to your supplier must have their own traceability. Components coming from your suppliers will need to have your traceability number when it gets to your door. You'll have to ask whether your customer requires your suppliers to have their own traceability records.

Variables that should be captured in any batch or device record are dates of processes, operator names, which machinery or line it was processed from.

The basic idea is you should be able to identify the different component batches went into a finished product you sent to your customer and which other finished product lots did any one of those component batches went into. This is to enable identifying the root cause of any out of spec condition and developing a CAPA (Corrective Action and Preventive Action).

For example, you sell several lots of product ABC to your customers consisting of lot 1, 2, 3, 4, and so on.

Your customer comes back to you and say that lot no. 13 of product ABC does not meet specifications and they identified component B of the product as what is driving the out of spec condition.

They would then require you to concurrently 1) figure out if there are any other lots of component B in your inventory similarly affected, 2) determine which lot of component B went into lot 13 of product ABC, and 3) determine what other lots of product ABC or any other product used that particular lot of component B and 4) determine to which of your customer plants did you send those products that used that particular lot of component B and what are the finished product's lot numbers. If it's a SHTF situation and component B is a part you buy from a supplier and accept on a certificate of assurance then you should be able to turn to your supplier and with their records, they can tell you what went into making that particular lot of part B.

If you're a big company with the resources and the right personnel, I suppose you can come up with your own system. But I've worked for very big corporations and the cheaper way was to buy the lot traceability module of whatever system they're using and pay to customize the software. It's a big enough job to get everything else internally changed to work with lot traceability.

You would need to tie in whoever does your Quality Assurance / Quality Control, Documentation, Supply, Production, Warehousing/Shipping, and IT.

There are some rabbit holes that people like to fall into like unique vs non-unique lot numbers meaning once a lot number is assigned it can't be assigned to any other part even if it's a different part. But from my experience, this just tie your hands needlessly. It should be sufficient that each lot of a particular part number should be unique but two different part numbers can have the same lot number (useful for parent/child part relationship where it's a 1:1 relationship. In the very unique lot number system, just a lot number identifies that batch and part number; in the standard lot number system, a part number - lot number combination identifies a specific batch of that particular part number. A handy use for the second form is that if you have a critical component of an assembly, sometimes it makes it efficient to apply the lot number of the critical component as the lot number of the assembly as well.

As you can imagine, you'll need a whole set of procedures revised to account for the serial number/lot numbers. Two I mentioned above: you'll need a Material Review Board process to identify, review, and address any out-of spec parts and a CAPA process to correct and prevent root causes of out of spec parts. If you have those, then you'll also need a Quality Review Board/Quality System where Senior Management reviews the metrics of the MRB and CAPA processes. It's an ugly can of worms but it's the cost of doing business. Good luck.

Edited to add: If your company is supposed to be ISO qualified, your systems have to be validated including your IT system housing the traceability records to make sure the records are controlled and cannot be altered without authorization, etc. I don't know how much it cost to validate IT systems. You're going to have to ask someone. If your company doesn't want to spend the resources to validate your system, you can still use an IT system to keep your traceability records but your official stand is you use your paper documents as the official controlling records and only use the IT system as an aid.

If you're going to use automated lot/tracing system to avoid manual paper entries, there are systems that scan and generate the lot number stickers. You could ask your customer what they use in terms of formats and systems. That would make it so that your output is uniform with theirs and you should be able to ask for help/guidance/direction from them.

I think that's about it. As I said, this is coming from a medical device background and it might be too stringent for your environment but I can't imagine it being too far off. Once you talk about traceability, the above is what's entailed. It's the cost of doing business just in case SHTF.

This message has been edited. Last edited by: Rey HRH,

Take a look at this. It might get you started in the direction to where you want to go. As mentioned, medical devices/pharmaceuticals have been in this mode for decades.

https://www.capterra.com/manuf...-execution-software/

Good morning, all, and thank you for your responses.
What you've given me so far is great, and matches up with some that's been discussed already. I'll be in a meeting about it again this morning and have more details afterward.

Rey, I'll be in touch. Thank you!

And Dr. T, you're right! I can't get to SF from work, so all afternoon yesterday I was looking forward to getting home and asking this, so I could get on with the task!