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Medical or Aerospace Certification worth it?

Houdini16

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Nov 28, 2017
Quick question since I haven't worked at a shop in this field.
With the increasing number of small garage shops set out to increasingly ruin standard job shop demographics.
I am looking to where I want to direct my current investment as a small shop forward, but also possibly diversify those efforts and funds in the future.

For reference I do have a background as a tooling engineer/machinist, and have managed an injection molding shop also.
I also do have a background from the dental medical field, manufacturing titanium implant components and ceramic substructures.

The question, should I look to start buying higher end, tighter tolerance capable, expensive $$$ machines, CMM's, get certifications ISO9001, AS9100...and try to switch over to the high end machining markets and separate our business from the guy in his garage..
but also with that which Aerospace or medical? or both?

Would you more recommend instead the diversification of adding tooling manufacturing to our list, and start buying injection molding machines,sinker edm, wire edm... and have a more diversified investment over the aerospace/medical machining market.

I would like to get some experienced opinions on this from actual business owners.
 
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Do you have any nearby aerospace or medical companies whose business you would be hoping to earn? If not, what will differentiate you from all the other faceless, certified shops that aren't in their neighborhood?

With aero / defense: would you be offering straight machining of parts or are you a specialist that does complex assemblies, weldments, etc?

The sourcing of parts smaller than a breadbox aren't usually a problem to source. The 'specialty' stuff enters the equation when you have larger machines that can work in tough materials. And then you have to certify in those larger, tougher materials. So larger metrology requirements, etc.
 
Do you have any nearby aerospace or medical companies whose business you would be hoping to earn? If not, what will differentiate you from all the other faceless, certified shops that aren't in their neighborhood?

With aero / defense: would you be offering straight machining of parts or are you a specialist that does complex assemblies, weldments, etc?

The sourcing of parts smaller than a breadbox aren't usually a problem to source. The 'specialty' stuff enters the equation when you have larger machines that can work in tough materials. And then you have to certify in those larger, tougher materials. So larger metrology requirements, etc.
This is definitely applicable, we have a local Boeing, I have been told that I could get contracts if I had capability. What part types, I have no idea yet, would need to ask.
But I hate making large parts, I despise it, I hated using forklifts and cranes to make injection molds.
I do like making small highly detailed intricate small parts though, as I did in the dental field, we currently do all the machining for one of the (unnamed NDA) pistol sight companies, I like making these parts.
I did research our area (Utah)for the 2 different demographics of customer base and aero and medical were equal.

This also puts the question, do you start to go after the work then buy the machines, or buy the machines and go after the work.
I would hate to buy a $800k+ machine to find there isn't work for it, when your current work could get by with a $200k machine.
 
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You can do aero / defense all day long on a Haas. You'll probably need a climate controlled inspection room to certify your parts. Automated CMM, manual CMM or a good surface plate and a lot of patience / labor?

Start sending out your measurement tools for calibration. Hire an ISO consultant. They'll come in and tell you how to do it, or you can read up on it and do it yourself. You basically have to have processes and controls in place, that show how everything happens in your shop. It's not a set of standards you must meet. It's showing that a person can pick up a binder, look inside and see that you have two sets of calibrated measurement tools, one is out being calibrated at a time. You have an inspection process and it involves Bob, measuring the parts in the inspection room, after 24 hours of thermal normalizing of the parts. Etc, etc.

After that, you need to contact their global supply chain people and get on their preferred supplier list. They'll send out 'inspectors' (clueless people who won't understand a damned thing but will pretend like they do) to check out your shop. Give them a tour. Show them your ISO process binder. Show them your shadow-boxed Lean, 5S processes in front of each machine, show them how you handle parts to ensure there are no chips or other debris introduced into the holes and cavities. Show them how you package to ensure they stay that way.

Then sit by your phone and wait for them to call.
 
I had a bunch of contacts at the local aerospace company. I usually did prototype stuff for the engineers to test. I asked about getting audited to become an approved supplier for production stuff

They sent out a guy and he was more interested in the paperwork side of things. No big deal everything was in order.

Turns out I was denied because they didn’t think we could keep up with the paperwork they required. Had nothing to do with our machining capabilities.
 
I had a bunch of contacts at the local aerospace company. I usually did prototype stuff for the engineers to test. I asked about getting audited to become an approved supplier for production stuff

They sent out a guy and he was more interested in the paperwork side of things. No big deal everything was in order.

Turns out I was denied because they didn’t think we could keep up with the paperwork they required. Had nothing to do with our machining capabilities.
Yeah the whole thing reminds me of manufacturing/production engineering, Its just ensuring the tracking of systems implemented to more ensure a specific outcome.
Truth is I'm extremely OCD anyway, and I like having systems implemented on everything anyway, increases our efficiency, lessens errors, and lessens skills needed for each individual to get the same job done, and the same every time.
Actually we already have systems that can be documented for pretty much everything we do already.
 
We did too. I had a lady working for me who used to be a quality manager and had gotten her previous employer ISO certified. She wrote our quality manual to be ISO “compliant”. Even gave them a copy of our quality manual. They still didn’t feel we could keep up with the paperwork end of things.

Oh well. I moved on.
 
I did have a medical customer for many years. No quality systems required, but per their certifications sub contractors could not “substantially manufacture “ their parts. So we’d get long Swiss turned parts to mill details on. Very lucrative.
 
We did too. I had a lady working for me who used to be a quality manager and had gotten her previous employer ISO certified. She wrote our quality manual to be ISO “compliant”. Even gave them a copy of our quality manual. They still didn’t feel we could keep up with the paperwork end of things.

Oh well. I moved on.
Strange scenario, some minority report action, It's like, why don't you wait and see if I can keep up with the paperwork. Nope we got a minority report, you cant, done!
 
Turns out I was denied because they didn’t think we could keep up with the paperwork they required. Had nothing to do with our machining capabilities.
This surprises me. What kind of paperwork were they expecting? Usually, they need the material batch lots that the parts were made from, sources of any other purchased parts (often must be certified domestic) and maybe some internal checklists showing the parts passed all your quality checks (per your own manual). That smells of them wanting to steer work somewhere else. Not much you could do to prove it though.
 
I get an upcoming auction email from an Injection Molding or "Aerospace Shop" going under every week if not twice a week, and there's gotta be many more than this as I'm only signed up with a couple auction sites.
Maybe buy one of those, seemed to work out great for them...
Don't worry, there will be many more buying opportunities over the next few years.
 
Sometimes I have seen some strange things related, I once made an injection mold for a single use spinal implant insertion tool, we had no clean room, certifications.....
mold wasnt made of stainless, not even P20, Aluminum 7075.
We even ran the thing for them in a dirty nasty standard injection mold shop, with dirty greasy machines with who knows what was in the barrel from the shots prior.
No ionized air blowers, no clean room or suites, nothing.
No one checked our polymers, lubrication for FDA compliant, or food safe....No one checked our injector pin lube, or our mold release agent...NOTHING!
And somewhere they were inserting spinal components with this single use implant tool.
 
I get an upcoming auction email from an Injection Molding or "Aerospace Shop" going under every week if not twice a week, and there's gotta be many more than this as I'm only signed up with a couple auction sites.
Maybe buy one of those, seemed to work out great for them...
Don't worry, there will be many more buying opportunities over the next few years.
I know 3 other larger shops that are job shops, and tooling shops, but more so injection mold shops, they all make more money running injection molds than running a machine shop they have said.
 
You saw my cautions elsewhere about companies that call their buyers "Global supply chain." I personally wouldn't do business with them but I'm not a job shop. If I were in your shoes and adding ISO certification is a simple add-on to your existing business, maybe it will open some doors for you to add some customers. I wouldn't hang my future on it, buy machines to capture bigger contracts, etc. If anything throttles your customer's funding, they cut off all parts purchases instantly. You'll be left with giant machine payments and nothing to pay for them.
 
I’m the Director of Quality for a large Swiss shop. We have ISO9001 (without design) certification but no AS9100 or 13485. We have looked at getting one or the other over the years but have stuck with 9001, and not suffered any great loss of work. In reality, any legit company makes its subcontractor decisions based on capacity and capabilities, instead of a piece of paper. Nobody in their right mind will place important work in a garage shop without some tangible evidence that the shop can perform and has the capacity to do so. Most parts are now made on CNC machines so showing off a row of Hardinge HLV-H lathes won’t impress most SQE’s unless you have some type of niche process(s) or specialize in one-off parts (which will still be difficult without CNC). That being said, it will likely be difficult to land work unless the right type of machines are already on the floor.
 
You saw my cautions elsewhere about companies that call their buyers "Global supply chain." I personally wouldn't do business with them but I'm not a job shop. If I were in your shoes and adding ISO certification is a simple add-on to your existing business, maybe it will open some doors for you to add some customers. I wouldn't hang my future on it, buy machines to capture bigger contracts, etc. If anything throttles your customer's funding, they cut off all parts purchases instantly. You'll be left with giant machine payments and nothing to pay for them.
You talkin about the guy with the $800k Robodrill, YUK! With a economy that is going into a forced recession, interest rates sky rocketed, Cali taxes, and after the historical bond yield curve inversion , we should be knee deep in the shit by mid to end next year.
and dude buys a $800k Robodrill ouch!
 
Turns out I was denied because they didn’t think we could keep up with the paperwork they required. Had nothing to do with our machining capabilities
That's interesting that you had that happen. Whenever customers or supplier quality guys come to tour my shop I always play up my paperwork skills. I tell them about all the years I spent doing paperwork and how I'm actually a paperwork expert and this machining stuff is just window dressing for the paperwork. "The job's not done until the paperwork is done", "the plane isn't ready to fly until the weight of the paperwork exceeds the weight of the jet" etc etc.
 
You talkin about the guy with the $800k Robodrill, YUK! With a economy that is going into a forced recession, interest rates sky rocketed, Cali taxes, and after the historical bond yield curve inversion , we should be knee deep in the shit by mid to end next year.
and dude buys a $800k Robodrill ouch!
No, I was thinking more of that million dollar Haas bridge mill or one of the Taiwan versions that others were touting. The robodrill would be easy to move out of a shop if you closed down. Some big-ass bridge mill is going to take ongoing customers, who want and need big parts. Orbital ATK is there in your neighborhood. I'm pretty sure they (or whoever bought them this week) won the contract for the ICBM replacement.

They walk in your door, ask if you want to make some of the big bulkheads or longerons in the structure. You buy a big-ass machine, pour custom slabs in your building for it, move it in, get it all commissioned and then the government "rephases" the contract, stretching it to double the length. Existing parts will do for the next five years. You're sitting on all that debt, hoping they remember your name when production resumes. I don't know why shops take the risk, unless it's backed up by other industries and customers.
 
ISO 9001 and all derivative standards are poorly written. Many of the requirements are unclear, repeated more than once in the document or are just irrelevant hoops to jump through. The document is written to be overly broad, but at the same time includes some pretty cryptic passages that only really apply to the aerospace electronics industry. I first read it and thought that I understood it, then I worked in aerospace electronics and my understanding completely changed. If I ever have enough free time, I'm going to lobby congress to revise it so that it is easier to understand and apply and less of a crooked cash grab from shady consultants. All this effort to create a cottage industry of consultants and auditors doing the most boring job on earth.

Don't get these certifications and think it will open any doors. All that will happen is the people saying "No" will come up with a new excuse. What equipment you buy is up to you. I buy equipment speculatively to win new business. Sometimes it works out and sometimes not.
 
No, I was thinking more of that million dollar Haas bridge mill or one of the Taiwan versions that others were touting. The robodrill would be easy to move out of a shop if you closed down. Some big-ass bridge mill is going to take ongoing customers, who want and need big parts. Orbital ATK is there in your neighborhood. I'm pretty sure they (or whoever bought them this week) won the contract for the ICBM replacement.

They walk in your door, ask if you want to make some of the big bulkheads or longerons in the structure. You buy a big-ass machine, pour custom slabs in your building for it, move it in, get it all commissioned and then the government "rephases" the contract, stretching it to double the length. Existing parts will do for the next five years. You're sitting on all that debt, hoping they remember your name when production resumes. I don't know why shops take the risk, unless it's backed up by other industries and customers.
I would do something similar, but not as $$$ or large scale, If current customers profits pay for the machine.
 








 
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