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ISO 9001-Compliant Document Control?
SmoothBreaker writes "Coming into a new company, I have been tasked with sourcing Document Control software to meet ISO 9001 standards. From everything I can find, ISO places no requirements on the software itself, aside from maintaining control of documentation and process. This was discussed eleven years ago. I'd like software that allows intuitive use for our less savvy users, and in a perfect world, graphical access to previous revisions of a document. I've used Microsoft's SharePoint, which the higher-ups like simply because it's Microsoft, but thankfully they trust their Tech Department to find the cream of the crop. What experience do you have with this kind of software, what would you recommend using, and what should I avoid?"
Did I meet you yesterday? When you transferred to this company from India? If you need help, just walk over and ask.
You might look into KnowledgeTree. It's open source.
I've had enough abrasive sigs. Kittens are cute and fuzzy.
You might try checking out Alfresco which is an open-source Java based content management system with an excellent document module. In addition to ISO, it also meets many of the FDA requirements for medical product documentation. The link is http://www.alfresco.com
but I'm actually a fan of Sharepoint. Have used it for years and never found it lacking for documentation management in my line of work (engineering software development field). The price is an issue for some, but it requires very little maintenance and is fairly intuitive in it's workings, even to a newer user. Most of our co-ops figure out how to use it with little or no instruction, and our senior developers (myself included) haven't complained about lack of features or expressed frustration with not being able to get something done.
just my 2 cents.
In Soviet Russia jokes are formulaic and decidedly non-humorous.
We use alfresco it runs like a champ....setup can be a bit tough but its worth it.
# chattr -R +a /home
C-x C-s C-x k
I have had good success with Design Data Manager.
This tools is primarily for managing CAD documents, but can also deal with other kinds of data.
http://www.designdatamanager.com/
A work that expires before its copyright never enters the public domain and thus enjoys eternal copyright protection.
"I've used Microsoft's SharePoint, which the higher-ups like simply because it's Microsoft, but thankfully they trust their Tech Department to find the cream of the crop.
It sounds like you don't like SharePoint "simply because it's Microsoft". I've seen SharePoint used for this exact business requirement many times and it is actually quite simple to implement. Some 3rd party tools might be needed for more advanced functionality (i.e. storing content external from the SharePoint database), but even then, the solutions are relatively simple.
Or basically any other wiki product could be used to fill this need. We use MediaWiki among a lot of other products in document control and it works fairly well.
Say what you do, and do what you say. I don't think you need software for that. What my company did was have a central document repository and a documentation standard, and everything boiled down to saying what we did, and doing what we said.
Towards the Singularity.
Some of the ISO-9001 knowledge becomes very long-lived. Stick to things that will work for a very long time. It is not uncommon to see ISO, software, CAD, and project documentation files from 25 years ago. Having to support DOS PCs for legacy projects sucks.
Think about whatever software you use, and make sure it is formed around standards that will persist. For instance, does SharePoint depend on Microsoft Internet Explorer? Is Microsoft Internet Explorer V9 compatible with Internet Explorer V6? Take a look at all the other legacy software inside your organization dependent on Microsoft IE V6. Don't do it again.
In the end, there is a strong argument for keeping PDF, DOC, and XLS files around, and placing a version control system on them. Some systems, try to integrate the entire quality control system into a document management system, and the results cannot be maintained long-term. One expensive system that I deployed, didn't survive the 24-month rollout process. You need to stick to standards, and keep your options open, both short and long term.
Good organization is hard to put in place and even harder to keep in place over the long term unless you exclusively employ anal-retentive OCD types. Luckily, lots of companies make programs whose purpose is to help you with organizing things and keeping them organized, which is basically what's being asked for here. For the type of people who love organizing stuff all day, this software is not needed. For the rest of us, any kind of document organization simply wouldn't get done without them.
The problem with that logic is that expensive solutions can be abandoned on a whim. The supplier can make a simple business decision, they can go out of business, or taken over by a competitor. Depending on the contract, is it a term license or a perpetual license? Is the software dependent on other peoples code? With proprietary software, you can be locked out at any moment.
Additionally, have you ever actually tried to get a software company to pay out on a law suit for defective code? It is almost impossible. Check the disclaimers in the contracts.
just make sure your QMS says this other wise you will fail your Audit
"what should I avoid?" You should avoid taking on politically dangerous and thankless tasks that make no contribution to the bottom line as your first assignment at a new company. Seriously, the tech issues here are secondary. First, figure out the politics. Next, make sure your second assignment contributes to the company's bottom line. Sorry to sound like a grumpy old fart here, but hey, I'm a grumpy gray-beard that has seen this movie before and I don't like the ending.
Since 9001 doesn't really define anything in terms of requirements you'll probably want to spend some time putting together what it is your organization wants to do with this content. Does your organization need/want a content management system? You're referencing revisioning on documents, so I'm guessing yes. Is this going to be a one off for the engineering/manufacturing folks? You could so something like this in subversion and have reasonably simple versioning of your documents. A wiki model works if you're just trying to do knowledge capture but I'm guessing you've got structured documents you need to manage. If you've got people who are fairly technical and can handle the caveats that come with something like that it's cheap and easy. However, these types of implementations frequently turn into folks in marketing or somewhere else saying "well we have FOO over in engineering we can probably use it too", next thing you know you've got the whole company using something that was kind of cobbled together for one group. Sounds like you've already got SharePoint, it's usable but I'm not a big fan of it as a content management system. Works decently as a collaboration platform. I haven't seen their latest stuff and I know they're trying to make moves in that direction so it might be better, but at last view I was underwhelmed. It's very platform specific, the search functionality was poor, it was difficult or impossible to get a good metadata model together and security was goofy.
Try and look towards the future and see if your organization is going to need to take it up a notch in their content management needs. How complex is your security model going to be? How much content are you expecting to manage? Are you going to want a full text search capable system or would a metadata search be good enough? Think about a metadata model for your organization, then research the topic and rethink it. A good or bad metadata model can completely change the fate of a content management system implementation.
What I've seen of Alfresco I like, it's free software so if you're budget constrained or just value that type of thing you've got that going for you. Someone else mentioned Knowledge Tree for a FOSS product, I haven't touched that so I can't comment. If you're going to go commercial I really think Oracle has a great product with their UCM platform (used to work there), but it's gotten god awful expensive and they suck as a company to deal with. Documentum seems like a massive resource hog and maintenance intensive from what I've discussed with people who've done work with it. I had an install of TRIM under my care at a previous gig, HP owns them now, and that had some quirks but was generally good. If you're focusing on records management capabilities this probably deserves a closer look as that's what they kinda specialize in. OpenText is pretty highly regarded, but I haven't touched it or known anyone directly who has.
(shoves paper off keyboard)
I dun need no stinkin' organizin!
FOX NEWS.com should be BANNED from television and internet. Have the Congress take it over and give us Truespeak.
I looked at the 3 big ones, alfresco, KM and Nuxeo, and like the latter best. For one, their full version == their GPL version. So if you want to do it all yourself, you will get all the features.
Secondly, I found the interface nice and simple.
Thirdly, they have this option where you can open a document from your browser, edit it and save it back into the DM system directly. (That requires a plugin for your browser & office). They used to have an openoffice version of that plugin too. Very sweet.
The best software will be useless without QA and/or RM/DC personnel that can enforce its use. This is because 9001 is a matter of quality processes, and the software can only implement those processes and policies that are already in place. An auditor wants to see that you can do what you say you'll do, whether that's one person with a key to a filing cabinet of contracts, or electronic file access tracking (knowing who has even looked at a document). There are businesses that can do that without software at all, I've worked with several. It really depends on the size of the employee base and their acceptance of a new tool. I don't believe it's possible for software to be certified for something that it can't accomplish, and it can't without complete buy-in from all employees. Good luck with that.
And just so you know, don't let your boss think you can get this done in six months, even if you pour your entire work week into it. The average mid-large corporation spends tens of thousands in hard and soft costs testing and implementing a new Content Management System in phases over years, which doesn't even include the vendor costs of licensing and supporting the thing. Unless you have categorical authority to pick a program and implement it, you will run in to a LOT of roadblocks, and even picking what to buy may not be something that you can put on your "completed tasks" list a year from now.
Lastly, if you are in fact part of your IT department, do check with your organization's org chart to find out if there are Quality/Document/Records people your choice will be impacting. The fact that you are asking Slashdot for software help instead of ARMA or a Quality organization for records procedure help, belies the possibility that your company is not mature enough to separate Information Science from Information Technology.
I personally have found the practice of heap sorting my belongings to be very effective.
In our 8-man Document Management department, we use Documentum. Yes, that's 8 people just to support Documentum, and our users. It's been very effective for years, but there are a number of problems with it.
First, it is expensive. In fact, it is so expensive that we are seriously looking at Alfresco as an alternative due to how much ECM wants to charge us for extra seats.
Second, the official ECM support techs and consultants don't know the product very well. We have paid ECM twice to have them send a tech to look at our system and help us troubleshoot it. After we sent the second one back because we knew more than both of them about Documentum and how it runs, we haven't thought about calling them for any support since then. This is a common theme among Documentum shops.
Third, unofficial (community) support is scarce. Finding good information is very difficult, and when you do, it disappears quickly. Nobody wants to host the stuff for some reason.
If you do decide to use Documentum, check out dm_cram for training info, and this excellent book for understanding Documentum.
Mod parent up.
They care that it works with the corporate standard which is IE.
You got it backwards. IE is the corporate browser because they've heavily invested financially and politically in crappy, brittle enterprise systems that break when you move away from IE6. Nobody picked enterprise software because of the browser it ran on.
I deal a lot with corporate IT management types. Seriously IE--in particular IE6 which is the standard that is the issue--has NO redeeming qualities WHATSOEVER. IE6 does not conform to standards. IE6 is insecure. IE6 is slow. IE6 is obsolete. In places where IE is mandated it has NOTHING to do with it being superior. Hell, it doesn't even have anything to do with it being welded to the MSFT OS--when you already have to create a corporate image with things like Citrix, 3270 emulation, notes client, VPN, in-house apps, etc etc. what is the big deal adding Firefox? You have to slipstream in service packs and countless security updates to make IE even marginally acceptable anyways.
Corporate types make IE the standard because some pointy-haired boss 10+ years ago made the decision to invest millions into SAP or similar big gigantic ERP mess that included web portal functionality that was built against IE6. Some of these ERP abominations even involved the deployment of ActriveX controls and other toxic, proprietary IE only garbage. Back then they didn't care--Netscape was dying, Firefox didn't exist and the new Gecko engine was not even halfway finished baking. IE was indeed the "best" (and being built in rather convenient) option and arguments from IT people were considered academic to PHBs and thus fell on deaf ears. If the business software was really kick-ass and it required Netscape they sure as heck would've went to the effort to deploy netscape, but there was no such software out there for the enterprise.
Now IE6 is widely recognised as being the garbage it is, there are real, honestly superior alternatives out there and even MSFT has moved on with IE7 and IE8 barely supporting IE6 style behaviour because it is saddled with the IE6 legacy it shot itself in the foot with in its other products..
IT managers who are not idiots realise what IE is, and know IE is not a standard. XHTML 1.x and HTML5 ad CSS2.x and so on are standards. If they pick Sharepoint it has nothing to do with it working with IE--it is becasue they are a MSFT house and they just cannot bother to fight lock-in (or they are contend being locked into their guilded cages). Of you use MS Windows for your client AND server OSes, MS Exchange for communication, MS Office for document creation, MS SQL for your database, IIS for your intranet, MS Forefront for security/antivirus......why stop there? Certainly Sharepoint would be easiest to integrate, easiest to use, etc. At least from an end-user perspective.
The thing is Sharepoint works GOOD ENOUGH with non-IE/standards-based browsers, but the coolest stuff about it isn't the web portal anyways it is how it integrates with Office and Visual Studio/Team Foundation Server and so on. If it had seious standards-compliant issues that made it rely heavily on IE, I seiously doubt ANY competent IT manager would go near it--they'd remember the hell they've had to go through because of th IE6 lock-in the've had to deal with the last couple of years.