I Annihilate The Forest (8.3)

hey guys!

I work for a company that remanufactures high voltage battery packs for electric cars. No design and development is done on these production lines.

We got our ISO 9001:2015 certification last year, and we are working on implementing IATF 16949.

IATF is required by some of our customers, and possible future customers. so we HAVE to get this certification.

Outside of remanufacturing we do a lot of design and development. We repurpose the lower capacity batteries for customers that don't require IATF. We are working on a prototype that won't be for automotive at all.

My question is: can we exclude design and development from our quality system?

We are a start up company with shallow pockets, and our overhead has already gone way up because of ISO.

I feel like IATF is designed for large companies who can afford dedicated specialized staff to be in compliance, not a start up company like us. Our Quality department is 3 people. Me, and Internal Auditor, and a document control specialist.

Since certification is by address, could we be IATF certified in 1 building where we do remanufacturing of battery packs, and a 2nd building where we do R&D for non-automotive products that is not IATF certified?

Implementing IATF in parts of our company that has nothing to do with automotive seems like killing trees, and wasting money for zero benefit. Our engineers think IATF is a complete joke for this reason.

Thanks!

 

Hmm, interesting. I want as little paperwork as possible. Every time I see "Shall document" in the standard, I see a piece of paper being filled out.

I am really trying to wrap my head around it.

I have heard that every hard copy of something needs a digital copy. Is that true? is it true the other way around? If it is, I can't see how I can implement IATF without adding piles of paperwork.

I have talked about it with our director of engineering, and he thinks he can fulfill many of the requirements with our website and database.

I am new to the quality world, and have no experience with IATF, and I greatly appreciate the insight.

Oh and the reason why overhead has gone up is that we are paying 3 full time employees to work on quality (myself included) which costs a lot of money, and we make the people who are actually making the company money jump through hoops filling out checklists, and forms which takes away from production. It will pay off in the end when we can get more customers, and bid more aggressively for contracts, but right now it is costing us a lot of money without a noticeable benefit.

 

For IATF, you will limit your scope only to your automotive applicable products. So in your case it sounds like it would be remanufacturing battery packs. Some things may cross over and be applicable to the entire company. Other things will only be applicable to the specific manufacturing product lines.

As for paper work, you'll need to document the required processes indicated in the standard. That's not all that difficult. And use electronic or PDF copies to limit the paper hard copies floating around. As for your manufacturing records, try to keep it simple as possible. You'll find if you keep it to as much as necessary, but as little as possible there isn't a lot of excess paperwork. Good luck.

 

Hey guys!

I think i'm getting this figured out.

These certifications are by the address. having ISO in 2 buildings, and IATF in 1 building is possible, but it would have to be 2 separate quality management systems with 2 separate quality manuals, procedures, etc. It would actually be a lot more work than just having everything IATF certified. Everything should be under 1 quality management system (IATF).

The simple & easy way is to be IATF certified company wide.

Today I deployed an Engineering Change Request (ECR) that is to be used by department managers for changes to their production line that require engineering. This will be our process to document, and approve changes.

There is also a ECR log that I made on Excel that will need to be kept by the Director of Engineering.

I think this is all we need for internal engineering projects, which is great news. Super easy!

We do have a product that we are developing to sell. There are many more requirements to follow for ISO/IATF 8.3 (Design and development). But, these requirements don’t apply to stuff that is for internal use.

For this product we are planning to sell, we will need to document planning, specifications, changes, approvals, control CAD drawings similar to the way we control documents, archiving old drawings, DFMEA’s, Control Plans, etc. This will hopefully all be done by SOLIDWORDS PDM.

From what I understand:

Internal products (testing equipment) not being sold and only used by us: excluded from 8.3 requirements.

Anything that we design and develop to be sold on the market as a product: must meet 8.3 requirements.

What do you guys think? Am I understanding this correctly?

Also, Are you guys familiar with Solidworks PDM?

I talked to Smithers Quality Assessments today (That is who we are planning on using for our IATF certification), and they are familiar with it.

Thanks guys! I really appreciate all the input I've been getting. It helps me out tremendously.

 

I just thought of something that makes this much more complicated.

We have an in house fabrication shop that does a lot of the work for the product we are developing.

http://www.qualityforumonline.com/forum/index.php?threads/in-house-fabrication.1895/

Sorry I have 2 threads now talking about the same thing. Why should I be the only one who is confused? haha.

...I need an adult beverage