by Mary Beth Nilles
It's no secret that successful
organizations share best practices internally and then improve upon them. In fact, this is one of the primary reasons that standards such as ISO 9000:2000, ISO 14000 and QS-9000 emphasize a
process approach to achieve improvement. Complying with these standards means implementing a philosophy of ongoing process evaluation, improvement and measurement. Like most things worth
achieving, it's easy to say that you agree, but it's sometimes hard to do.
Of course, this is made all the more challenging by the standards' flexibility. They state what needs to be
accomplished but don't dictate how to do it. In addition, the 20-clause format of the ISO 9000:1994 series is out; ISO 9000:2000's eight management principles are in. This flexibility is somewhat
of a mixed blessing because some organizations are confused about how to organize and manage their quality or environmental management system processes. Those companies that do successfully
comply with ISO 9001, QS-9000 or ISO 14001 have found a way to organize their business processes to follow the new standards' management principles. Many have found that the most effective tool
for doing so is the right software.
The million-dollar question, sometimes literally, is, "What's the right software?"
Let's start with what software is not: a customized packaged program. After years of trying to organize quality
management systems on paper, quality managers were delighted when software providers started offering "complete QMS packages" to automate the system.
managers discovered that most packages don't work without modification. Remember, programmers, not quality managers, design these software packages. They know code; they know platforms; they
don't know quality management. Even if the programs do have QMS input, they are created to serve customers in a wide variety of industries. Users notice this and complain that the packages just
don't fit the way their company does things. Sometimes entire applications are missing.
To get around these obvious shortcomings, quality managers buy add-on packages to supplement the
original package or get information technology staff to modify the program. Both fixes add considerably to the company's implementation costs and sometimes create friction between quality staff
and IT staff.
The fact is that most companies end up customizing their software. In the report "Conquering Customization" by Forrester Research Inc., in which researchers asked
41 IT executives who are responsible for 68 major packaged-software programs about the software they use, it was discovered that fewer than 10 percent of the programs were implemented without
customization. Yet the overwhelming majority (95%) of those companies didn't make the purchase intending to customize; it just became necessary once the program was implemented.
Customization is expensive. The authors of the Forrester report created a model company showing that 10-percent customization of an operational program increased support costs by 20 percent
of the original customization expense per year. Another study, "Systems Development," prepared by Heather
Tinkham of the University of Minnesota's Carlson School of Management, shows
that the cost of changing program lines increases exponentially. For example, changing 5 percent of a program's code costs five times more than changing just 3 percent of the code. In either
case, because these are unplanned modifications, the costs are rarely budgeted and therefore must be absorbed.
There are plenty of firms that specialize in customizing software. Some, of
course, don't modify packages but create completely specialized programs. However, others have created a niche by taking on the IT staff's overflow. Quality managers who are forced to turn to
outside help face even higher costs.
What's worse, the modifications usually increase upgrade cycle time and expense, sometimes making upgrades impossible, as 20 percent of the companies
in the Forrester report found. Some software package vendors, of course, frown on customization.
This scenario is obviously not an example of applying best practices and achieving
continuous improvement. So, what's a quality manager to do? It's not an option to go back to the "stack of paper and three-ring binder" sort of quality manual. It's usually more
cost-efficient to use a powerful tool like software to create a quality manual. So what program is right for you? The following outlines what to look for when searching for the right QMS or EMS
Look for flexibility
If you're looking for solutions to meet ISO 9001, QS-9000, ISO 14001
or similar standards' requirements, consider ISO 9001:2000's eight management principles while looking at customized software:
Involvement of people
System approach to management
Factual approach to decision making
Mutually beneficial supplier relationships
Keep these in the back of your mind while we look at the following suggested program
features. Some characteristics fit the management principles better than others, but they all apply.
The primary characteristic quality managers should look for in a software package is
flexibility. Because we've already established that there's no such thing as a truly complete package, look for one that can be easily modified to what you need. This kind
of program will allow a designated user, usually the quality manager or the system administrator, to customize the forms and worksheets to your company's needs. Let's
call this a self-customizable program. This type of program functions when the administrator sets up a few profiles that define everything about a form, from field prompts to routing.
Glenn McCarty, CEO of EtQ Inc., a software company that offers EtQ Solutions, knows about self-customizable software. "EtQ's business model recognizes that every
company meets compliance according to its own practices," he says. "So providing a software tool with maximum flexibility to match the customer's individual process,
without programming, is the first consideration. Closely behind that is the recognition that maintaining documentation and distributing it to those who need it is a laborious and
expensive process that requires process workflow automation to further save companies time and money, and to speed decision making."
The software should allow customers to configure existing, pre-built applications for such processes as document control, corrective action, audits, surveys and more,
without programming. It should also allow customers to develop new applications, again without programming.
For example, with EtQ Solutions, the self-customization process begins when the administrator sets up the first profile, the database profile. This is the collection of fields
that will be displayed in the main document. Depending on the organization's processes, the administrator can add or delete fields, determine the sequence of which data are
input, set up keyword lists, change field prompts and set up data links to other databases.
Next, each form gets a workflow profile. This establishes, among other things, the
steps in the process that forms go through; whether forms should be editable, read-only or hidden in a particular step; whether the program auto-assigns personnel and due dates
based on business rules; automatic revision control; document security; and archiving.
Remembering that the whole idea behind a good software program is to facilitate
ongoing improvement, ensure that the software package allows for changes as your processes change and for new applications without programming. This kind of
scalability is crucial for keeping costs down and minimizing interruptions in production. You want to add and maintain new applications through the system administrator without
being totally dependent on your IT staff.
Save on the cost of ownership
Having the right software will result in savings. To begin with, there are the obvious financial savings during the implementation phase. Basically, there should be no
unwelcome surprises, such as add-ons or IT modifications like the Forrester report companies and many others experienced. "To ensure a successful project, statistics
show all companies avoid putting users through too many 'changes' by customizing software," adds McCarty. "But customizing software typically means production delays
and a 25-percent increase in upfront cost, with a 5-percent increase in support cost and a 7.5-percent increase in upgrade cost." Most companies don't plan for these costs and
get blindsided when the need to customize applications pops up.
The right kind of software program reduces the IT staff's modification and maintenance
time to zero. IT staff can spend its time on other, more profitable, projects for the company. And the quality staff won't have to wait for changes to be made. It's hard to
say whom this will please more--IT staff, upper management, or you, the quality manager.
The software program should allow you to set the notifications and approvals of each form so that the forms are automatically routed the proper way through the company
without the user needing to remember what step is next. The "proper way" refers to how your organization manages the process, not how the software company thinks you
should do it or even the way another industry does it.
Look for a program that offers automatic e-mail notification which integrates with your
system. E-mail is a powerful tool for connecting users, both on a large scale for organizations with multiple work sites in diverse and distant areas around the country
and world, and for small firms with only a few users. Automatic e-mail notification is probably the easiest way to notify assigned users, remind users of due dates and keep
affected users in the communication loop. It's fast, free and efficient.
Once the forms are completed and routed, the data contained within them often need to
be merged or rolled up into a report. You'll want an application that allows for easy reporting in a program your company already uses, such as Microsoft Excel or Lotus 1-2-3.
Companies of all sizes, but larger ones especially, will probably want to look for a program that works with Web browsers. Programs that run via the Web can reduce
costs dramatically. Users already have the browsers on their computers, which are already connected to an intranet, an extranet or the Internet. Any expenses related to that
have already been incurred. Software programs that are run via the Web don't require multiple licenses. Even better, users train faster with familiar systems, so a program run
through a familiar Web browser will save time and training costs.
There's a lot to look for in a new QMS or EMS software program, and quality managers
have been burned before. So carefully assess programs by applying ISO 9000:2000's eight management principles when evaluating the many options on the market. Don't be
surprised if they lead you to a flexible, self-customizable program that doesn't involve IT work. You'll be on your way to meeting ISO 9001 or 14001 and beyond.
About the author
Mary Beth Nilles is a freelance writer and editor who frequently writes about quality-related issues. E-mail her at