Selecting, Implementing,and Using QMS SoftwareSolutions

Getting on the Quality Management SoftwareSoapboxIs The Quality Management Software market Evolving to beEasier, or more Complex?As the world market evolves, product lifecycles are speeding up to accommodate market demand and keep up with competing products. As a result, Quality benchmarks need to evolve as well. Risk is fast becoming the benchmark for assessing Quality throughout an organization. This is because organizations need a systematic and objective way of looking at incoming information and making decisions on how best to manage Quality. Risk Management provides this benchmark—it allows for a quantitative method to review the data and come up with decision criteria to help make better decisions leading to better Quality.

Risk has evolved over the years to be more quantitative in nature and is incorporated into traditional Quality models in order to keep up with the pace of the new markets. This evolution is seen in adopting risk matrices incorporated into multiple facets of the Quality dynamic; Complaints, Audits, Non conformances, Corrective Actions, and similar functions all use Risk in some form or another. This is growing in interest to the point in which risk activities often govern the processes and are fully integrated in the traditional work flows

What You Didn’t Know, or Were Afraid to Ask?

The main obstacle to truly being risk-based is the shift in changingyour understanding of Quality and risk. It’s sometimes difficult tounderstand what is “critical” in a business, and therefore overuseCorrective Actions. Many feel it’s better to just initiate the CorrectiveAction and deal with the process than truly assess whether you evenneed it. Not every adverse events needs to be a Corrective Action; thisdilutes the purpose of the process. Corrective Actions are designedto correct critical and/or systemic issues. Risk Assessment and RiskManagement are designed to help discern which is critical and whichis not critical. Non-critical events can be immediately corrected;however, many businesses do not see the value of correct

Why Companies are Still Reluctant to Purchasea QMS ?

Software is a key component in today’s industries. Again, industries are moving faster and much like the automated assembly line, so too must the business processes that govern manufacturing be automated. So why are people so hesitant to implement software?

Here are a few potential reasons:

1. The Fallacy of the Custom Solution:

Most people remember the days of the custom-developed solution, where in order to get the software to work the way you want it to, you need a team of developers over the period of a year or more to code the system into your company’s “mold.” While the stigma remains, the software has evolved beyond this. Especially in business process automation (such as Quality), the custom solution is gone, giving way to the “configured” solution. Adaptations and changes to the system are all encased in settings and drag and drop interfaces, making the configuration of the system as easy as changing your Facebook settings. Now the business user, not a developer, is adapting the system to meet the business need; this is extremely powerful and time-saving on resources, but is also putting the software design in the hands of the people who actually use the tools. Very powerful, and organizations are slowly warming up to this

concept.

2. The Fallacy that Software is too Expensive:

Much like the advent of standardize parts in the automotive industry, having a configured system that has all the components developed out of the box has driven the price point down considerably. One solution can satisfy many different organization’s needs, and so companies can now get into a decent enterprise software product for a fraction of the cost 10.

3. The Fallacy of the In-House Maintenance:

Another issue that comes up with many smaller businesses is a small IT foot-print. They cannot manage yet another system, and IT will not administer the system for them. Thanks to the advent of cloud computing, we are seeing this paradigm slowly fade. Software as a Service (SaaS) is growing in exponential fashion, and it enables a small organization to get into the game with little to no administrative IT footprint. Much like we use Facebook, Pandora, and LinkedIn in our personal lives, so too are professional software solutions coming into the fray. Applications that are delivered in the cloud and are paid as a subscription are enabling smaller businesses to enjoy the benefits of enterprise Quality Management solutions, without having to dedicate specific resources or significant cash flow to a single tool. Pay as you go—it’s the way of the future.

What are the Obvious and Not-so Obvious Benefits to a QMS Solution?

The obvious benefits are:

4. Time-savings:

6. Rapid Application Development:

5. Return on Investment:

7. Enterprise Risk Management:

Simple Rules for Selecting a Quality Management Software System

1. Flexibility to Adapt to Business Processes:

Probably the most important consideration is the ability of the system to adapt to your existing business processes, and be flexible enough to change and improve as your processes change and improve. This may seem like a simple statement, but many times software vendors build their systems around a generic, best-practice approach that cannot be changed without substantial time and cost. These vendors want you to adapt your processes to their software, not the other way around. If your company has spent years developing and fine-tuning business processes, and upon purchasing a software system, you find yourself re-engineering your proven processes to fit within the software system’s limitations, you have compromised your efficiency.

2. Web-based versus Web-enabled:

The Internet has made the world much smaller. Organizations are building intranets and extranets into their global network, and the need to have systems in place that not only utilize the Internet but also thrive on it is key to success. Following this lead, enterprise software vendors are building tools that move away from the old client-server models to a thin-client interface, allowing for more flexibility in a global environment. There are software vendors that are Web-based and some that are “Web-enabled.” Knowing the difference between the two can provide a key differentiator in your selection of the system.

3. Look and Feel—Making the System Your Own:

One of the more overlooked issues when selecting the software is the ability to “brand” the system with your organization’s look and feel. While many ask whether the system can be configured to meet their changing needs, the ability to change the colors, logos fonts, and general layout of the navigators, forms and reports is usually an afterthought. Many systems will offer some level of configurability, but this will usually not extend to the layouts themselves. End users must contend with the vendor’s look and-feel, which will be foreign to them. The ability to control all aspects of the software’s user interface helps user-acceptance of the software, and user buy-in is one of the major contributors to a software implementation’s success.

4. Making Sense of the Data Reporting and Searching:

When you automate using QMS, there is an enormous amount of data created. Without some means of easily accessing the data, the QMS makes it extremely difficult to derive trends and insights on the Quality system. Users are left to their own devices to manually filter out the data, or even export the results into an external system for reporting. This is a time-consuming effort, and can lead to time management issues in finding the data, filtering the data and reporting on the data. Software systems will often offer some means of search capabilities, but this comes in many ways and may require administrative intervention.

5. Taking Quality to the Enterprise—Scalability Matters:

Ultimately, your QMS may not serve a single site, especially if yourorganization has multiple facilities. As more and more companies scale their systems to span the enterprise, it will become necessary for the QMS to follow suit. When selecting a software system, think about the long-term goals on how you plan to scale. It may not be an immediate need, but having the ability toexpand your QMS beyond your four walls to include other facilities, or even suppliers and customers, can make a difference in the system’s long-term value. Watch out for false scalability promises—some systems will claim scalability, but have no real experience in the matter. A scalable system must obviously betechnically capable of handling the load of additional users, but that is only half of the picture. The scalability of administration is equally important and can be much more expensive to fix later if not considered up-front.

6. Tying Systems Together through Integration:

areas no longer live in silos when it comes to business systems.Whether they are Production, Financial, or Quality systems, theability to interact, collaborate, and coordinate across the business is key to uncovering any gaps in processes, and creates visibility from one operational area to the next. It is of paramount importance to be able to integrate your systems.

7. Know Your Audience—End User Acceptance: Typically, the team selecting a software system is made up of multiple areas—IT, Quality, Operations, Purchasing, and more. More often than not, the participants are manager-level, and are making the decision on behalf of themselves and the end users. The end users, while most likely the highest volume user, are more than likely not involved in the ultimate decision. Many software systems will have the technology and process management needed, but once implemented, the end users are lost.8. Time to Value—Implementation and Deployment:

You've covered your needs in terms of the solution and it has all the bells and whistles your company needs—now what? The solution needs to be implemented.

Look Under the Surface:4 Things to Ask a Compliance Software Vendor

Web-based research will give you some of the key areas to rate a vendor on, such as:

Market expertise Features and utilities Broad company

overview Pricing and support

structure Breadth of

applications offered

All these things can be commonly found after some basic research,and a few discovery demonstrations. However, we still see caseswhere a company has selected a vendor, and that vendor continuesto fail on their delivery of the solution. You would think that thesefailures would be picked up on during their extensive, informedresearch, but there is more to a company than the above bulletpoints. Below are some additional considerations to be aware ofwhen selecting an enterprise vendor—those that go beyond pricing,features, and tools.

1.Implementation Track Record 2. Customer Satisfaction

3. Financial Well-Being

4. Proof of Concepts and Workshops

Build vs. Buy: Best Practice QMS Solution overCustom Development

When determining the strategy for automating a mission criticalbusiness process like those in QMSs, a “Build versus Buy” choiceremains a key decision. Overwhelmingly, organizations have proventhe decision to “Buy” provides much greater value and success thanthe decision to “Build.” Here is a “Top Five” list of things to watch outfor in a build versus buy scenario.

1. Predictable and Transparent Costs: Developing an enterprise application is no small task, especially when it comes to estimating the cost of development. When you buy a best-practice enterprise solution, you evaluate in advance the features, functions, and capabilities in an existing enterprise environment. A known cost is attached to a best-practice solution. If you build a new system with alternative development resources, projectcosts and time to deploy may range widely, affecting the successof the project.

A best practice configured application is a production ready application that can be customized for a unique environment within a relatively short time frame

2. Flexibility and the Ability to Adapt to Change:

When determining an enterprise solution, it is important to consider the focus of the organization. How well do the vendors know the business challenges your organization faces? How well versed in best practices is the vendor, and what is their experience in theindustry?

3. Best Practices Experience and Core Business Focus:

4. Consider the Project Scope—Proven Implementation versus New Application Development:

Software vendors with best practices built-in draw on a history of implementation of similar processes, and have implemented hundreds of projects of similar focus and scope. These implementations follow a proven process, and follow a pattern of project management that delivers the product on-time and within scope.

5. Return on Investment—Look for the Hidden Cost of Development

Comparison: Build Versus Buy

Consider the breakdown on build versus buy conducted in a Standish Group Report, illustrated in the tables

Avoid Scope Creep in Enterprise Software Implementation

The responsibility of a software implementation project is shared between the vendor and the customer. While the vendor needs to deliver on all those promises they made in the RFP, the customer needs to make sure that their processes are well defined, and that all the requirements of the solution are outlined in detail

1. Get the Requirements Up Front

2. Get a Design Specification

3. UAT—User Acceptance Testing

ROI: Assessing Value in a Quality and EHSManagement System

Everyone seeks out value. Whether you’re a coupon clipper, a sale shopper, or a garage sale stalker, people look to get some sort of value out of their buying experience. And if the product is purchased at retail, you look for ways to get the most out of the product you purchased. In this market, ROI needs to happen quickly. We have entered a time when IT departments are cutting budgets and looking for ways to consolidate and integrate business systems. As such, IT is looking for ways to cut systems that are draining resources, protect budgets for larger-scale implementations, and seek out solutions that are low-cost alternatives. The Chief Information Officer (CIO) is looking for ways to demonstrate immediate ROI on projects, to the tune of seeing returns within a Quarter. This need has had an effect on the “Software Middle-Class”—those systems that are high-cost with long time-lines to ROI. You have three real scenarios in this IT solution model:

1. The “Too Big To Fail”: These are the long-term, high budget projects that are simply too big to abandon or too critical to the business to scale back. SAP is a prime example—the solution touches so many parts of the business, and has so much stake in the success of IT, that it will never be scaled or abandoned.

2. The “Software Middle-Class”: These are specialized solutions that serve a singular need (or the needs of a few), but come at a high-price of entry, and no definable ROI in the near future. These are solutions that end up on the chopping block with people looking for lower cost alternatives. 3. The “Low Entry, High Return”: These are specialized

solutions that have carved out their niche in a particular function, and have certain “out-of-the-box” qualities that make the product have a low entry cost, but due to the configurable nature and flexibility, can yield a faster ROI than their middle class cousins.

The CIO will look at their infrastructure and say, “can my too-big-to-fail systems handle the processes we need, and if not, what systems can we put in place that will integrate with these systems and provide me with quick ROI?” QMS and EHS are prime examples of systems to accomplish this goal. Here’s what these systems offer:

1. Work flow and Business Process Automation: 2. Integration Capabilities:

3. Provide Immediate Value: 4. Demonstrate Definable

ROI:

Three Keys to Global Harmonization in Quality:Learning to Share

1. Ask, “How can we all be Common, but Keep our Processesand Data Unique?”

2. The Technology Platform Needs to Support Harmonization:

3. Get a Strong Project Team to Work Out the Details:

A strong team builds innovation and the technology drives it. Thecombination of these two elements will then answer the question,“how can we all be common, but keep our processes and dataunique?”

Thank YouQuestions???