Update and approved vendor list chatter

It was a rather slow week at the medical device factory, our sterilization load was finished up and was delivered on Friday, management has now moved on to the next crisis- the hardware and software, which I don't directly work on, just test and criticize- so the sterilization load is sitting quietly all weekend until QA finalizes a procedure or form or something. My initial post concerning sterilization was on Aug 2, so it took about 2 months from start to finish, we actually shipped to the sterilizer mid August. Also not news, the company's board did approve moving the company, but someone else picked up the place they were looking at, so that is at least a temporary reprieve.

We did have a contentious meeting regarding the approved vendor list (AVL). My opinion regarding the AVL is that engineers should not have to worry about it. There have been complaints that we're ordering things from vendors not on the list. My thought is the vendor should get approved (or disqualified) before the ECN (or ECO or whatever you call it) with the component or supply on it is finalized. They've actually been waiting until the part has been received in from the vendor before checking if the vendor is on the list and then putting it on the list. Don't ask me what QA/QC is checking on ECNs before signing off on them- it seems as though checking to make sure that what we're planning on doing actually follows quality policy should be high on the list however. I think we have it straightened out now, but its one of many details a startup has to work its way through. Its fine if one of my vendors is disqualified, but telling me about it (or starting the process) after the part is in doesn't help out.

Filling those QA positions

Medical Devices Today reports that QA positions are getting hard to fill:

Finding well-trained, highly skilled professionals to fill a variety of quality assurance (QA) positions is proving increasingly difficult for a large number of medical device manufacturers, leading some to encourage people interested in the quality profession to make more use of specialized education and certification programs.

“It just seems like there aren’t enough people to fill the funnel. There’s a big gap,” says Don Middlebrook, VP of regulatory affairs and quality assurance at Pleasanton, Calif.-based Thoratec.

...

“We have positions – for example, quality engineer [and] quality manager jobs – that sometimes take four or five months or longer to fill.”

We really haven't had good luck hiring full time QA either, for the most part we depend on a couple outside consultants for QA stuff and we hire QC, generally from other industries, and pray that they take to it well enough to be a QA in the future. This QC strategy has pretty much been a total and complete failure to date. We've ended up with people who will sign off on anything and don't do any real checking or questioning of their own. The other thing my company does to make up for this is push QA work off onto design and validation engineers, we have started to wise up to this trick though- a co-engineer wrote a procedure for receiving in some parts, after about seven editing back and forths between various people he got fairly disgruntled for working on something that he felt shouldn't be his job.

Why the QA gap? There are a couple of reasons I can come up with that differ from Thoratec, first off, you need more now, as documentation requirements increase, you need more people to cover it, going from GMP to ISO is a lot of mostly QA work and most every medical device company wants to be ISO now. And second, for a lot of people its not an appealing position, its challenging, and QA can take quite a bit of heat and sometimes it boils down to telling the QA "this is what we're doing, you figure out how to make it work" after they do that, they don't get any credit for their clever regulatory strategy, you need a certain personality type to deal with that well. Also along those lines, some of it is just flat out boring, our QA consultants are pretty gung ho, but things like reviewing software validations make them wild-eyed crazy.

Anyway, I obviously don't have a solution, so until someone figures it out, I guess the engineers will keep getting the work.

QA at work reviewing software documentation.

Medical Device Labeling Control

As I mentioned previously, the hardest part of labeling medical devices is the control of the labels. This really only applies to labels for disposables and packaging labels. Permanent labels for devices are fairly easy, you get them in, you check them out, then use them as you need. Labels for disposables are a whole different animal, the FDA has some guidelines, but mostly its related to the general quality system. Keep in mind these are only my limited experiences, other companies might have brilliantly simple ways to do this.

On a label for disposable products, you want at least the lot number and expiration date (or "use by"- I've spent more hours than I care to debating if the FDA thinks the terms "expiration date" and "use by" are the same thing) - and usually a bar code, mfg date, and whatever else you want- you'll have to print those parts yourself. So the printers print the logos and any warnings on the label and you'll print the rest. This is where the first challenge comes in, the partial label requires its own identification number (id#), then another id# after you print it. You generally like to have the label id# printed on the label so you have to make sure you do that in the second step and tell QA to stuff it if they complain about it not being on the label as received from the vendor (you know who you are). This is all well and good but the first of many challenges. You'll have to keep the label print program under control, the files it prints from and who uses it, not to mention the printer itself along with the ink. You'll also need a procedure and fabrication order for printing and various drawings for label locations on the product. And don't go thinking you can print labels out ahead of time, thats a no no, you want to use those labels right after you (or hopefully someone not you) print them.

So, just keep your received labels, printed labels, printing program, files, printer, ink, how to use them, and who can use them all under control and you're well on your way. The last thing you need is some way to keep track of sterile and unsterile product, usually a tear away label on the box or carton. Once you have all of that in line, I believe you are good to go.

There is still one part of labeling which I haven't covered, the Instructions for Use, Operator's Manual and other such literature. I'll probably leave that alone for now.

Medical Device Labeling Design

The medical device company I work for has a hands off CEO who is also in charge of marketing, because of this I got put in charge of labeling. The text is mostly straightforward, just follow the FDA labeling guidance and requirements. The design is not so much straightforward, other company's labels provide inspiration, but I suspect if things get serious the labels will be redesigned quickly enough. In fact, a couple of the labels we sent out with the validation load for sterilization had the wrong product name, the company decided to rename the product four months before planned 510(k) submittal. This doesn't matter because they were samples and we are testing if the ink runs and do the labels stick through sterilization, things which are independent of the design. Although if push came to shove, the standard label materials have been through sterilization millions of times, so you could probably justify not sterilizing them for validation.

These labels aren't cheap and there are more of them around than you think. Most small medical device companies don't print their own labels and there are plenty of label printers around. I've used three label companies lately, all are fairly similar, the one not in California is a bit cheaper, but really they're all close. Save yourself some money and get a copy of Adobe Illustrator right off the bat, some label companies will do some (usually minimal) work for free, but others will charge you. Chances are if you can draw it in another program, you can draw it just as easy in Illustrator. For each label there is a setup fee that is about $35-$100 and maybe a dye charge of $50-$100. Each color adds cost, so make sure you really want the full color logo with the green and yellow star or whatever in it. Small quantities makes for some goofy pricing. For labels for disposables you'll end up with something like 1,000 labels for $600 or 10,000 labels for $650. Permanent labels for multiple use devices can also add up quickly and start at $20 each and you don't want to order less than ten or you'll pay the setup fee again later on. On the start up project I'm working on I'll probably end up spending more than $10,000 all told on the first batch of labels (not including the printer)- a cost that will probably be the same next year for things like moving and redesigns.

One of the complaints I have about labeling is that I can't get anyone to look at anything before the printing company sends a proof. I'll send around a label eight times and everyone will say its great, then once they get a proof in their hands its can we change that from "Battery Light" to just "Battery" and make everything in all capital letters. This is a style pet peeve of mine and I am in a constant war with the all caps people at my company. In some guidance document that I probably linked above it says one of the ways to make labeling stand out is to have it in all caps, however it is my belief that if EVERYTHING is in caps it negates this and thus only very important information should be all caps, plus I think it just looks bad. Anyway, caps rant aside, the label makers seem to understand, but I can change something in four minutes, waiting for a new proof takes more time.

The most challenging aspect of labeling is labeling control, which I'll save that for another post (now posted here).

Writing skills

Things have been pretty busy for me, but no real notable projects, I eventually want to get around to a medical device labeling post (oooo exciting), but for now I'm thinking about writing skills. Since the medical device industry is regulated, we do a lot more writing than the many other industries. Every procedure must be documented, every form must be properly filled out, etc. The FDA has the right to read whatever documentation you have around and an ambiguous detail can be trouble, not to mention flat out errors. One of my boss's numerous companies had to recall a product years ago because the procedure set a mold temperature to the degree, when in reality it is going to vary a few degrees. There was only one operator who worked that mold and the FDA asked him what temperature he ran at, he told them the range and that was that.

As an engineer I probably spend about half my time writing, although I take on writing assignments more than I probably have to because that is where the real power is. Sort of kidding there, the reports and procedures are important enough that I feel the need to be nit picky and make sure its written like I like. Its harder to request a few spaces here or a rewording there if someone else is doing it, especially the higher up you go in the company.

As I've said before, I work for small company and know everyone pretty well, and we're split about half and half between good writers and bad writers. The bad writers aren't necessarily bad writers per se, just lack attention to detail or computer word processing skills. Not that I'm a great writer, but I'm a formatting ace and I think I can hold my own on the writing- perhaps everyone else does as well and thats the problem. When signing off on things, I'll let some formatting problems slide, but if I find something else that needs fixing, its game on, I'll mark up everything I don't like because it has to be redone anyway. Some suggest resources for coworkers to get help, I just fix things that bother me. Not that I think my company is much worse than anyone else, I have seen contracts and patents that I'm certain dozens of people signed off on and still basic errors get through.

If you're a start up company I think you'll want at least one good writer in every department, QA, manufacturing, and engineering. If you don't have that, you're going to create more work for someone, or its going to slide on through and maybe get you in trouble later.

Moving?

The powers that be have recently started discussing moving the company down the street to a slightly bigger, nicer, cheaper place. If this happens I may have to be restrained from stabbing myself in the eye. While there are certainly good reasons to move a medical device company, the people working on validations never ever want to hear the words "We're moving." To them, this translates into "Everything you've done in the last year is now worthless." Softening the blow with a raise at that point is just good form, if anything a company moves because they're doing well, right?

Moving a medical device manufacturing facility basically means a revalidation of almost everything. Every piece of manufacturing equipment must undergo an installation, operation and performance (or process) qualification (IQ/OQ/PQ- terminology can vary from company to company) when you start to use it. These can range from simple to complex, with most taking less than a day to complete and document. Move a piece of equipment across the room and you are supposed to perform at least the IQ again (which can be very simple) - usually we do all just to be on the safe side. It can become tedious depending on how it is set up, a lefty moving a balance to the other side of the table can give you fits. (Although I don't think I've yet met a QA who kept track of exactly where a piece of equipment was placed, they've relied on Manufacturing to tell them of moves- sounds like something that should be added on the IQ form.) A move to a new building invalidates everything and on top of that you have to show that you can produce product of the same or better quality that you previously produced.

My company and I assume most other companies perform and document these qualifications in house. Engineers generally write them, a tech or engineer will perform them, and then QA will sign off on them and keep them in an equipment log. At my company its a relatively informal process and QA runs the entire show without management involvement.

The silver lining to moving the company is that you don't have revalidate sterility, biocompatibility and maybe some performance testing, but everything else I can think of now is fair game. And of course that raise.

PS: Really nice companies have downloadable sample IQ/OQ/PQs available.

Validating the packaging process

Medical Device Technology has put "How to Validate a Packaging Process" online which contains pretty thorough information. I've discussed packaging a bit before here. Medium sized companies generally have a packaging engineer while small companies get whoever they can to design packaging and hope.

All sorts of design issues can show up unexpectedly in packaging, a small wrinkle in a bag or pouch seal can mean a complete redesign or worse. My boss's blood pressure skyrockets whenever someone mentions the dye penetration test (ASTM F1929) mentioned in the article. We received a bunch of failed test samples back from a testing lab that were solid coated with dye which supposedly showed how we failed the test, except after the test is over dye coats everything so you can't tell. Ever since then he's hated the test with a passion and if you want to avoid a 15 minute rant its better to stay off the subject.

I was part of a PMA that the FDA specifically required the dye penetration test for to move forward, so you'll likely have to get through it (although you can avoid packaging validation in the early stages of a PMA if you hand carry). The dye penetration test basically consists of pouring a dye solution into the packaging and then observing its progression through the package seal in a certain amount of time. The problem is that the test requires judgment calls regarding wrinkles and has a wide time range. A small wrinkle in the seal can allow the dye to penetrate quickly through the seal.

Dye Penetration Test Results

How do you avoid this problem? There are a couple ways to avoid it completely. If you gamma sterilize you don't need Tyvek breathers and the bags won't leak if you seal them properly in the first place. It is slightly harder to seal completely plastic bags, you can end up with ridiculously large amounts of air in the bag if you're not careful. There is also a company that makes Tyvek windows and you seal the plastic bag, since the Tyvek is not on the edge, you're much less likely to have a problem (I forget the name of the company offhand, but I'll update later). The sterilization degassing time may be longer however. The other packaging option is to use a more expensive tray type instead of a bag.

How do you minimize the problem? Don't handle the packaging bags. It makes me cringe when manufacturing or QA handles the bags roughly. The other thing you can do is properly design the box to limit the movement inside- this is difficult with the larger your product is however.