ISO software: Valuable during ISO 9001 implementation?

[AndyN]

Definitely do the qms first. This is a bigger fish to fry and isn't, as you know, just about using a number of tools. When you're sure you have most of the wrinkles ironed out, you will have an easier time with the software - you can even claim an improvement 'credit' with your Certification Body......

It will also buy you time to look around at the options, and ultimately, you'll be more informed since you'll be somewhat more experienced in the qms world and more qualified to know what makes a good software 'tick'.

 

[JaneB]

What type of "existing softwares" are you refering to? In-house developed applications?

Yes, I am. I'm not talking of a couple of cobbled-together Access databases/Excel spreadsheets type of thing, but of well-developed systems that essentially underpinned the business and included process workflow. That phrase about workflow is so important. As already pointed out, too many so-called 'ISO' systems do not understand the processes rqeuired, so they're built around functions and they don't actually support process workflow - they way things actually flow. As in the example of the 'Audit' module where no time to audit, because you're too busy filling in fields. Ludicrous & not useful.

I think the idea of having an IT system that supports you as you grow is excellent - but a short timeframe coupled with needing employee buy-in makes the stakes very high.

Bob has done a good job in summarising the pros & cons of homegrown vs purchased:

companies that chose to be software writers instead of manufacturers, and they cobbled together spreadsheets and databases that were neither user friendly nor did they talk to each other. The better software is fully integrated, and the info is cross-linked. That makes data analysis far easier in the long run. Working at a place with the cobbled array of databases and spreadsheets after working with omnibus databases, there is much more time spent duplicating effort, and data analysis across these programs is, well to put it nicely, rustic.

... home brew misses out on best practices and lessons learned from the better programmers (who listen to users), that you will never see.

He's right here - so if someone locally says they can 'just whip up an Access database' I'd be wary. Again, remember the companies I instanced had their own programmers & systems designers - and were way beyond the 'odd spreadsheet & Access' skills level. In each case, the organisation had a very strong and well developed IT capacity, understood software development and thus used it to run & manage themselves. No little homegrown or off the shelf things.

What do you think about my assumption that it would help obtaining employee buy-in?

Unlikely unless they see that it really makes their work easier/better. Often, it doesn't. And if it actually requires more work, they'll resist. I'm with Andy:

To launch both the QMS and a new software product at the same time is, I believe, a train wreck waiting to happen. If you have problems, it'll be difficult to decide if it's the implementation, the software or both......

I strongly urge you to get customer names from any software builder/seller, and talk to them about their experience, and how they use it. Never take the seller's word. (Not having a go at salespeople here, but their job is to sell. There's no substitute for due diligence in checking out other people's experience.)

There's definitely value in having IT system(s) to help you run the business, & support the QMS, manage docs, get data, raise & manage CAs etc. IF you're large enough (or plan to be) and IF you have the support and buy in and IF it is properly implemented. Too many people forget about the time and planning required to realistically implement the software (ie, get it in, get it running, get it populated with data and working, train people, launch it, iron out any teething difficulties, etc). It isn't the same as just popping in a CD and away you go...

But again, if there is good software out there, I'd be happy to reconsider. If any of the systems I've seen operating were commercially available (they aren't, but they would be highly marketable!) it could be a different story. But you still have the 'people change management' aspect to consider in either case: the amount of change that people will have to make, and how best to accomplish that.

 

[JaneB]

If you are still focussed on software, I should mention a suite of software developed here, that might be suitable for your needs.

It comes in 3 basic 'models', each of which is upwardly compatible.

I haven't yet seen it in operation, but have been impressed at demonstrations by the thinking & the experience (including quality management!) behind it, and it would certainly meet the requirements you specify.

http://www.flowbiz.com.au/ Don't let the '.au' put you off - it's operating in the USA.

Note: I have no association or affiliation with this company.

 

[bobdoering]

I still recommend MQ1 http://www.cebos.com I am sure they will be more than happy to demo the software, and provide references. Again, the key is the fully linked capabilities that home brew can't touch. And, no I am not connected to Cebos.

But, buy-in comes from the top management. There has to be no option to shortcut the system. Using a system requires a cultural change of stopping the post it notes and scratch paper and a commitment to using the software. As with any system - ISO or software - shortcuts erode effectiveness. Most people do not see that, and think they are much more efficient with shortcuts. But any of us with more than a week long vision of the future know better. These shortcuts are what make very good programs look very bad. That is where the horror stories begin. It is like the old saying: no time to do it right, but plenty of time to do it again.

Buying and using a couple modules instead of leashing the power of integrated, linked information is also a waste. You are better to do it all, and do it right. If you have never done it that way (correctly) it may be hard to comprehend the benefits. Get a demo and understand the benefits. Do not shortcut yourself. It is not effective.

An example of how the system can work: A new salesman has to visit a customer for the first time. A simple report of all previous phone calls, emails, returns, corrective actions, part numbers and descriptions can be printed out with one command. Punch holes in it, put it in a binder, and he has prep for the trip, shows up with no blind sides. I have done this with a good system. It would take an hour just to get parts of this info (the rest would not even be available) from home brew.

The other beauty is all you need to do is maintain the network. No database IT department to maintain this thing. The vendor does that - and they have experts that know the software inside and out because it is run through the mill at hundreds of other locations. They are not always learning on you alone like your IT department would. That is a waste. Most small-to-medium companies can not afford IT overhead, anyway. The accountant is the IT manager (as if they have a clue).

I have been on implementation teams for several of these software implementations. Some I like, some I do not. I have also worked at companies with home brew database/spreadsheet patchwork. I am giving you advice from living on both sides of that fence.

Use the system, and it will be there for you to use.

 

[IsoClaire]

Hello,

Let me first THANK YOU again for your time and advice, I reallly appreciate your support here at the Cove.

I think the idea of having an IT system that supports you as you grow is excellent - but a short timeframe coupled with needing employee buy-in makes the stakes very high.

I agree 100% and after weighing the pros and cons, I have decided that I am not willing to take the risk, I do not want to jeopardize the QMS implementation by rushing into buying a software package, that we know is not going to build the QMS for us.

However I do believe a software can be valuable (I have not been convinced of its benefits during implementation, but long term I have).
That's why I am going to recommend purchasing a software package at a later time, once our QMS has been developed and implemented. It will also help spread out the costs. Of course, we'll see what my management finally decides...


Claire

 

[IsoClaire]

Happy Holidays to all!

 

[David Smithstein]

Hi Claire,

One of my customers sent me the link to this web site.

I can see by the comments that I really need to market myself better.

The fastest any of my customers has implemented an ISO standard (13485 no less) was 7 weeks. I wasn't there, I just know when he bought the software, and the one call I got 7 weeks later when he had a question during the audit. It was just him, and I think his son was helping him part time.

Basically he used my template documents as a starting point, and the software allowed him to implement all the quality systems he needed to comply with the standard. (Doc control, audits, customer feedback, rejected material, corrective actions, etc, etc) In other words, put the documents in the software and use the software to create the records of performing audits, corrective Actions, etc, and you are basically there.

As with any quality system, paper or electronic, it's up to you to create one that is alive and driving real improvements, or one that is essentially smoke and mirrors to get through your audit.

I'm the developer and CEO, and my design philosophy is that a quality standard, by its very nature, standardizes what people need to do. While it's not prescriptive in how people should do it, people have developed "best practices" in implementing the standard. As a simple example, one of the techniques for controlling documents is by keeping a master list of the latest revision, which can be compared to the actual document.

In fact, having had to be the one to print the correct number of controlled documents, stamp each one and number the copy, get the approval signatures from everyone needed, find out during the review something needed to be changed, print them all over again, stamp them again, sign them again, walk around to all the places they are kept take out the old copies, put in the new ones.....if you did nothing else but get software for document control you will be saving at least a part time employee's worth of time. You can ask any consultant how common it is for a company to hire someone to simply manage document control. (Let’s see, full time with benefits... we are talking about what....at least $40,000 right?)

Of course document control is just one area of your quality system.

And let's not forget that your quality system is supposed to help you use the information to make better decisions. As a big fan of the principles of Lean Manufacturing, I wanted to take the waste out of the quality system and let the time being saved be used for the final product of the quality system...improvements to controlled processes. (Hence the product name, The Lean Machine) You can't press a button on your file cabinet of paper records and display a trending graph of the number of customer complaints last month, or the number of rejects from receiving inspection of a certain part number.

The other thing I like to do is tap into the expertise I find in my customer base and the consultants they are working with as input for my updates and new features. As a one man show the time it takes to make and implement design decisions is pretty fast. It allows me to react to customer needs with updates the next day in many cases. I'm only saying that out loud on this forum because I have been doing this for 8 years now, and I'll be amazed if you come up with something the software needs that someone hasn't already thought of already.

As you progress down the path of wrapping your mind around all the things your quality system needs to have I want you to have the experience of realizing you need something, and then finding that the software already has it, because someone else had that exact same thought, and I figured out a way to do it that gives you enough flexibility to do it in a way that works for your company.

I also don't want you to waste time figuring out how the software works, so I'm making animated tutorials that actually play in the help files (I'm totally enamored with this feature, by the way) You can also watch them on our web site, although I still need to update a few based on our last revision update.

One of the comments I saw, I believe from Jane that said "I can't think of ANY client situation in which they used so called 'ISO software' that actually speeded up the process. In fact, I doubt such software exists."

It does exist. I built it. The only thing it doesn't do is write your procedures for you.

The fastest path to a world class quality system should follow this recipe: (in my opinion)

1. Template quality documents to get started. (Just for the manual and policy level documents, not for work instructions) No reason to re-invent your own way of saying you will do what the standard says you shall do. They will become your own over time as they get revised.

2. Quality Management Software that integrates your quality system. For example you will want to initiate a corrective action from an audit finding, right? (Make sure it's 21 CFR Part 11 compliant so you can save a few trees while you’re at it with electronic signatures)

3. Consulting support to make sure you don't end up with a smoke and mirrors system and everyone (especially management) understands what the system is for, and why it's important to do it right. (Added bonus if the consultant knows the software, but if the software is good, and the consultant is good, it's not that important)

Sorry for the long response, too many energy drinks.

David

 

[Marc]

Per the TOS and the Forum Policies, it should be noted that David Smithstein sells 'Quality' software, however the post content makes that relatively clear.

 

[xavierFR]

Hello everyone,

english 2nd language

First, thank you to share such knowledge forum, It's so important to exchange about our jobs and goals, making our works better day by day, bringing solid argues about it too.

Claire, you look very care already and also you've been strongly adviced on this post by very experimented professionals.

I would like just remind us that we always describe IT sofwares as a strong solution which is usually right but to be enough accurate you will need certainly a IT support behind it (mostly if you share it in many workstations). You will cumulate 70% of the bugs at the beginning, at the same time to engage your QMS. I would attend to say that if you share the pain with many managers, a software will be certainly a good solution to improve your organization, your maintenance. But at the beginning, you will have lots of other issues to solve and deadlines will push you to find it in a desk corner than spend couple of hours trying to find out a solution into it.

Now, I allow me to think that you share our point of view about softwares but you don't know correctly how argue to your supervisor about it?

If it's right, this is what would be my explaination. A software is a great tool but does nothing or usually does wrong if we don't know how manage by ourselves first. a bad drafter using the best drafting softwares will stay bad, worse even. The database generated has to be measurated first. You will need to understand and master it well before to integrate into a software. Also You will have to think of the outcomes, expecting forecasted results that you will need to analyse at the end to measure your gap since the QMS in place. Why not purpose to implement such software solution at a second phase of your project, after the audit. What you were able to do in order to accredit the company will strongly make easier your understand about the good software and how use it. Also it will garantee to you a great training about QMS, then software in order to dispense training to the others users.

Hoping this would give you another point of view, pragmatic and based on solid long term, please keep sharing your very interesting experience.

Regards Xav.

 

[Marc]

I agree 100% and after weighing the pros and cons, I have decided that I am not willing to take the risk, I do not want to jeopardize the QMS implementation by rushing into buying a software package, that we know is not going to build the QMS for us.

However I do believe a software can be valuable (I have not been convinced of its benefits during implementation, but long term I have).
That's why I am going to recommend purchasing a software package at a later time, once our QMS has been developed and implemented. It will also help spread out the costs. Of course, we'll see what my management finally decides...

I think that's a good course. As you go along you can determine what software, if any, is appropriate for your scenario. Many companies, large and small, use 'home grown' things like Access databases for tracking and control of things. Some use very sophisticated, and often very expensive, software (and many times the software is much more than they need, or only part of what the company needs, etc.).

I do take exception to:

One of the comments I saw, I believe from Jane that said "I can't think of ANY client situation in which they used so called 'ISO software' that actually speeded up the process. In fact, I doubt such software exists."

It does exist. I built it. The only thing it doesn't do is write your procedures for you.

Software can help with some chores, but it isn't a substitute for understanding the requirements, and I do not believe that ANY software program is capable of "...The only thing it doesn't do is write your procedures for you....". Every implementation is different and every company has different needs. No one, in my opinion, can write a software package that fits all needs. This is not to mention the differences in company size and complexity.

I've seen so many situations where someone attempted to rely on a software solution ("The sales person told me it would do everything for me...") and had significant problems that I'm simply not a big believer in software solutions, particularly as an implementation tool.