Eagle library editor

from. Not

That's what Atomic Energy of Canada thought, too. Until their Therac-25 therapy system severely hurt lots of people and killed three of them. This is one of the reasons why agencies have stepped up the requirements placed on medical device companies.

But if your stuff can't hurt or kill people it may be ok not to follow such procedures.

These rules are not nonsense at all. They are very similar to numerous other fields such as aerospace, and they save lives. Since I grew up in med devices I have no problem getting used to strict rules in other markets, it's not much different from being transferred to another job in the military. When I did my first aerospace electronics design and submitted it I didn't hear feedback. So I asked whether the documentation was ok. "Yeah, it's all in there. We never see that with new consultants, where did you learn that?"

called 1234567AA (the

and the second 1234567AB,

Gerbers, and everything in

for 1234567AB will just be

board #1234567A.

different one versus

different BOM (a

documenting the board. If

represents may or may not

document the bare

is it

set and the CAD

typically do) have a

isn't a requirement.

schematic file

themselves are the

footprints, all

schematic that

and the

original design.

same

none of those

if needed.

separate P/N and

a new rev B

boards

board. It's a BOM

document for an

working in

values in

the latest

integrity of the

are

those

The first

documentation

issued.

service wants

because

not be

next

use and

Now

many

they're the

that's

They can read schematics, alright. Calculate what voltage should be, not so much. At least one had an associates. Not sure about other but he'd have a better chance of figuring out such things (and old-school tech).

another

Nope. They look for process problems and "are all the parts on there". They wouldn't know a schematic from flypaper.

For QC? What a *boring* waste of an EE.

look in

like a

P/Ns

No, they made mistakes and your process wasn't there to help. The changes we made did.

build the

to

You did say "Painstakingly enter all changes into the old schematic". That doesn't happen, *intentionally* on a BOM-only ECO.

Along with a few so called 'engineers' I've met.(

of a

Then they would not be able to use a scheamtic to any useful potential, at least not often.

another

Impossible in medical devices. A QC department that does understand how our products work would have been no good to us.

I could not have done that job for too long either. Once a QC EE and I had to drive to the Bay Area to audit a company (yes, sometimes I am Inspecteur Clousieau ...). Meaning almost 6h in the car, lots of time to talk. He actually liked his job a lot. It also paid quite well because it comes with a lot of responsibility.

look in

like a

P/Ns

Sorry, I disagree. If they had really followed the process the mistakes would have been caught. But you pointed out one major problem yourself: You guys have no EEs in QC. So I guess nobody is double-cheking what your EEs do. Not good at all, IMHO.

build the

enough to

We just issue a new schematic, new rev level, _correct_ and _actual_ values in there. That's the proper way to do it. BOM-only ECOs are horrid.

Where does the BOM come from?

Why not edit the schematic and derive the BOM automatically from the schematic? That gets you an accurate schematic.

of a

Of course they can. Even with *no* values shown schematics show the circuit topology very well. In fact, when we sent schematics to UL, et. al., all values were stripped from them. They were happy with that.

another

Why? Is QC's job to check your work?

...and no other sucker would take the crap job. What a waste.

look in

like a

the P/Ns

You disagree that they helped? Fortunately, management trumps Usenet peanut gallery opinions. ;-) Of course there is no one looking over the shoulder of EEs. While they haven't exactly treated as adults, recently, they were responsible for the design. No dope that couldn't find any other job was looking over their shoulder.

never

build the

enough to

...in your royal opinion.

first

documentation

^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

Well Keith, that is part of what is broken in your system.

...and I was just thinking that this thread was troll free. Oh, well.

The only documents that can be trusted are the ones that are formally released. Even if they are wrong, the things that are wrong can be formally corrected. Anything else is chaos.

If you only make a couple of products, and are personally, intimately familiar with each one, you can get by with informal documentation... for a while. But that doesn't scale. Once you have hundreds and thousands of schematics and assemblies and revs and BOMs and datasheets and manuals and test sets and test procedures and firmware versions and FPGA versions, you need formal control.

John

of a

help.

Don't try that with a primary switcher on a med device, or with a unit for RTCA/DO-160 aircraft approval, they'll throw it right back at ya. It's sorta important whether the resistor across the barrier is 50M or

another

Yes, in med it most certainly is. That is why one of their EEs sat in our design reviews, always. And they did ask questions.

So you also think that aerospace engineers whose sole job is checking aircraft structural integrity and design, engineers who do crash tests on cars for a living, engineers who check the integrity of bridges and so on are "a waste"? Maybe some folks thought so in Minnesota, and people died. Or on the Therac-25 therapy units, and people died.

Sorry, I fully disagree with you on this one.

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like a

the P/Ns

Read again. I said I disagree that the change away from a system like I described was unnecessary, an IMHO a mistake. But I do not care what your management or you think about it, it is not my company. As long as you don't build medical stuff, aircraft or anything that can hurt or kill people.

never

as

build the

enough to

And that of regulators. Which is what really counts for me.

functioning of a

help.

I have *no* interest in living with the crap you have to put up with. I'd rather design stuff than jump through government hoops for a living.

computer

another

They

That's *not* QC's job. They're a manufacturing department.

I don't much care about other people's crappy jobs. I'll stay on this side of suicide by administrivia, thanks.

Amazing! We agree! ;-)

look in

like a

the P/Ns

we

We don't, thank the Lord. I'd rather flip burgers than dance to some government droid's drum.

never

as

build the

enough to

In case you hadn't noticed...

functioning of a

help.

so

As I said before, then I wish you guys good luck that there will never be a situation where something burns down a big building or someone gets hurt. Because then chances are that the DA, the jury and the judge see it the same way I see it, which is the same way government agencies see it.

computer

reference

another

They

That assertion is IMHO wrong. Unfortunately they design houses that way in some countries and we've all seen the grief that has caused.

Take a look at your ECOs. Does QC sign off on those or not? If they don't, then you guys are really flying seat of the pants. Probably nothing wrong with that in your opinion. As long as nothing bad happens, that is ...

functioning of a

help.

so

Second that. Somebody has to design and build life-critical stuff, but I don't want to. I can probably design five times as many new things per year if I don't have to conform to *anybody's* standards. And since designing new things is what I like to do, I avoid standards.

A lot of our products are risky and speculative. We push parts, push performance, make a couple, and put them on the web site, or loan protos to customers, and see what happens. We don't need no stinkin' marketing department! We couldn't do that in a regulated environment.

A couple of our OEM customers do take our stuff through CE and UL as part of their systems, and we make any changes they require, but the hasslefactor is low there.

computer

reference

another

They

Ditto here. QC makes sure the products are built to the drawings and are assembled and soldered to high quality levels. We do invite our test manager to design reviews, where she comments on testability issues and often helps in the overall review. Our production manager is also our primary mechanical designer, so he's invited to any design sessions and reviews if there are any new packaging or cooling or assembly issues. The Brat has a checklist that she makes sure is run through before we release anything. A PCB will get at least two group reviews, one when the first schematic is sort of roughly done (lots of debate in that one!) and one just before release, after the board is laid out, the BOMs done, all that.

John

functioning of a

help.

so

have a

I've had no problems with CE/UL/CSA. As long as the product is well designed there's usually little to nothing that needs changing.

Once you start to deal extensively with a heavily regulated field it pretty much seems to make you uncompetitive in fast-moving commercial or speculative R&D products. Salaries are usually much higher, schedules can be an order of magnitude longer, nothing happens without firm specifications, and all that sort of thing. Unless you're big enough to hive off a division that can be hermetically sealed off from your other business it's a one-way street. It may be fine for a consultant, but it can easily be fatal for a smaller company that has to finance themselves over the very long lead times before revenue starts to appear.

Best regards, Spehro Pefhany

functioning of a

help.

not so

have a

circuit

I've had very few problems with these either but Joerg is talking about a

No thanks! ...and I sure didn't notice any higher salaries for those jobs. Rather the opposite, really.

functioning of a

help.

not so

have a

circuit

Actually, it can be done by a smaller company. We've done it. This stuff would not exist otherwise and many people would die if it didn't:

Very strictly controlled by agencies because the ultrasound catheter that connects to it goes _into_ the heart of people. I personally brought the original system through safety cert for the patient side when it was still under our name (EndoSonics), mainly because I had designed the patient interface. This company was later successfully sold. The company that bought us messed it up. It seems not everyone is able to run a medical electronics manufacturer. Now it's all back in good hands again.

Fussing about onerous rules and regs is easy to do but somebody has to design and build this kind of stuff. Because most of us will becomes seriously ill at some point and then we need it to be there.

There is a corollary to this -

A company that does *not* deal with a heavily regulated field would be crazy to voluntarily burden themselves with all the processes used in those fields.

... and if they take everything too loosey goosey would therewith increase their exposure to lawsuits in the event something happens. Like this:

Building bridges is not a "regulated field"? Perhaps it should be.

I am not at all arguing for a free-for-all in all situations. But I see no reason either to pick the field with the most regulations, and blindly apply all its processes on the principle "more is better".