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The Cost of Validation

Written by Jonathan Malkin on . Posted in Articles. 1 Comment on The Cost of Validation

Initial Analysis $100,000
Development and Execution $500,000
Validation Priceless

 

It is amazing, a client pays 100K to 2M or more to develop a system and $0 to make sure the system works. How do we ensure the system meets our needs?

Solution Assessment and Validation

Solution Assessment and Validation is one of six knowledge areas defined in the BABOK (Business Analysis Book of Knowledge). I recently helped a government client document and execute validation under FDA 21 CFR Part 11 rules.

FDA 21 CFR Part 11 Computer Systems Validation outlines validation methods to ensure the system works as expected and meets the business need. All systems must have a Validation Plan, User Requirements, Functional Requirements, and Test Scripts.

User Requirements are general requirements concerning the use of a system.

Functional Requirements break down User Requirements into how users will specifically interact with the chosen system.

Test Scripts are written for each Functional Requirement.

Test scripts are executed, witnessed, and counter-signed. After execution the organization has a fully documented and auditable trail to show the system was properly installed and qualified to meet the business need and technical requirements.

In addition, a validated client documents Standard Operating Procedures for use of the system. This step forces the organization to take a close look at how the system will be used and why it is being implemented. Any time people spend to think through how and why they use a system is a good thing!

Downside?

The downside is less flexibility in making system changes. A COTS system that is highly configurable and easily changed is now subject to a multi-level change control process. A simple configuration change may take days or weeks to propose, authorize, document, and implement.

Conclusion

21 CFR Part 11 Validation is worthwhile where the cost of deviation from process greatly exceeds the cost of change. In the case of manufacturing pharmaceutical drugs or vaccines, minor deviations in process can impact the lives of millions of people with drastic consequences. It’s in these very cases that validation is indeed worthwhile to ensure systems meet the safety and security concerns of all.

Jonathan Malkin is a Business Analyst at Plateau Systems. Jonathan provides configuration, integration, documentation, and deployment support services for a leader in Talent Management Systems. Jonathan’s areas of support include 21 CFR Part 11 Validation and customizations to COTS software for which he has won multiple awards. His experience includes work in the federal government, telecommunications, mortgage and banking, and custom software development industries. Plateau Systems is a leading global provider of adaptable, unified web-based talent management software, content and services to onboard, develop, manage and reward talent.

Will the First CBAPs Be a Credit to the Profession? Well Will You?

Written by Marcos Ferrer on . Posted in Articles. 1 Comment on Will the First CBAPs Be a Credit to the Profession? Well Will You?

Behold the world’s newest shortest BA column (a new record after last month – next month will undoubtedly tend back towards the mean, as do all things).

Obviously, at this moment, this column cannot answer the question it poses – it can only pursue it (no, not because I ran out of time to write, but because there IS NO INFORMATION on how this is going.

I put the question to all 400+ CBAPs – you know who you are, and it is time to lead by sharing.

Be a credit to your profession! Send me your testimonials about observations and experiences since certifying (use [email protected]).

Tell your story in a paragraph or so – no names required – and next month I will “anonymize”, “abstract”, and “analyze” these stories for any patterns or hints at what the future holds.

That’s it for this month – THIS IS IMPORTANT – enquiring minds want to know!

In this Edition: Implementing BA, Managing Requirements, Service Management

Written by Cynthia Low on . Posted in Articles.

sept2_school_fall_150x100.pngSummer tends to become a bit of a habit, doesn’t it? And it’s a habit that’s often hard to kick. But no excuses! We have some articles that we feel sure will provide food for thought and help get you back into the business swing of things. I think you’ll find them a mix of pretty sophisticated business analysis ideas and techniques coupled with some getting the job done in general. Take a read and let us know what you think because that’s what helps us continue to run a website that is for and about you and your profession. And, talking of reading, don’t miss our new Bookstore that we set up just last month. It’s got a wealth of great BA books by leaders in the field.

  • Implementing Business Analysis; Three Distinct Phases. Victor Teplitzky believes that introducing business analysis to an organization is something that has to be carefully planned if it is to be effective. He write about the three phases involved.
  • I Don’t Have Time to Manage Requirements; My Project is Late Already! Part II. In the first article in this series, Elizabeth and Richard Larson looked at the framework for requirements management. Here, they discuss the relationship between the requirements management plan and the project management plan.
  • Random Thoughts on Service Management. Regular blogger Terry Longo gives us his take on service–oriented management and business analysis – and other random BA thoughts.
  • Labor Day is Here. Publisher, Adam Kahn, is sad that Labor Day 2008 has come and gone and the dying days of summer with it. But he’s also looking forward to winding up to take on everything that business can throw at him in the coming months.

And we hope you had a great summer and that you’re ready for and looking forward to new BA challenges and achievements in the busy days ahead.

Random Thoughts on Service Management

Written by Terry Longo on . Posted in Articles. 2 Comments on Random Thoughts on Service Management

  • Google suits my impulsive mind perfectly and is a great first step in discovering whether an idea is “out there” yet. Yesterday I searched for “service-oriented business analysis” and was not disappointed with the results – only seven hits, but this one points to an excellent six-part treatment of SOA and BA.

  • Can a senior BA really be skilled in all aspects of the solution life cycle? As I ponder the scope of BA, I grow more convinced that business requirements elicitation alone could be a fulfilling and challenging career.
  • And speaking of elicitation, if you peel back the first layer of the “agile business analysis” onion, one of the things you would see is agile elicitation. What does that mean in terms of the day-to-day relationship between the BA and the business stakeholders? Would it border on pestering? (Just kidding, kind of….) But what a magnificent way to help drive change management into the core of that relationship.
  • Service modeling in the true SOA sense takes a common concept – refactoring – and applies it to a broader context – the enterprise. There are clearly application refactoring techniques that can be leveraged in an organization’s SOA, service modeling, and BPM initiatives.
  • And speaking of SOA and services, their value arises out of what I have always believed to be the most important and fundamental notion coming out of the Object Oriented fury of the 1990s: that of encapsulation. Inheritance? Polymorphism? Frequently, copy-and-paste is the better technique. But nothing beats encapsulation – it’s the heart of separating the What from the How.
  • SOA and ITIL v3 are a perfect match – BAs involved in business architecture and IT-based solutions would do well to become fluent in both.
  • And speaking of the What vs. the How, it is only a matter of time before nearly every discipline in the enterprise will be modeled as a service, with service level agreements, metrics and measures, reporting and reviewing, and a context of continual service improvement and alignment to targeted business outcomes. Today the focus is on IT via ITIL, because IT really needed to get its house in order ever since the PC and LANs in the 1980s, client/server in the 1990s, security in the 2000s, etc. It will be very interesting to witness the extent to which the practice of ITIL within an enterprise will influence the application of the concept of services in non-IT disciplines.

I Don’t Have Time to Manage Requirements; My Project is Late Already! Part II

Written by Elizabeth Larson on . Posted in Articles.

Now that we have looked at the framework for requirements management, let’s delve deeper into requirements planning.

The Requirements Management Plan 

Planning the business analysis work effort is part of the overall effort to plan the project, and the resulting Requirements Management Plan becomes part of the project management plan. Below is a table with some of the key planning activities, the sub-processes associated with each, and the final deliverables that are produced. As stated earlier, these deliverables are rolled into the requirements management plan, which in turn, is a subsidiary plan within the overall project management plan.

Because of the interrelationship of the project and the product, of the project manager and the business analyst, most of the activities below, while focusing on the product or activities to produce the product, are part of the larger project. The effective project manager, in planning for the whole project, seeks input from a variety of team members to create scope, schedule, and cost baselines. One of these team members is the business analyst, who provides input on the business analysis phase or phases. In other words, the business analyst plans which activities will be needed to define the product requirements completely and correctly. The information from business analysis feeds into the overall project.

Below is a table which expands on the activities in the knowledge area of business analysis planning and monitoring, the processes within the broader tasks, and the key deliverables that are output from these processes.

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Exhibit 3 – Requirements Planning Activities and Deliverables

It is helpful to remember that each of these activities and sub-processes should be considered and performed, although not with the same amount of formality. For example, identifying project roles can take place in a formal, facilitated session with cross-functional representation, or it can occur when the project professional informally touches base with a limited number of stakeholders. Likewise, the deliverables may be permanent and stored in a repository or they can be temporary, a by-product of an informal conversation. In the latter example, the deliverable may be produced on a whiteboard and erased at the end of the discussion, kept in notes until the end of the project, or archived indefinitely. What is important is that these decisions be made purposefully and before the execution of business analysis has occurred.

Clarifying Roles

One of the first tasks in requirements planning is completing stakeholder analysis, during which time it is important to clarify the project professional’s role and associated responsibilities. Because of the interrelationship of the project and product, the roles of project manager and business analyst tend to blur in some organizations and on some projects. Here are several considerations to help clarify these two roles:

  • The difference between the function of managing the project and that of managing both the requirements and the business analysis phase(s). Although the same person can certainly manage both functions, they are different and the associated roles are also different. Skills required and characteristics of effective performance differ for each role, so giving thought to each during stakeholder analysis is important. For example, it is even more important for the project manager than the business analyst to have human resource management skills, and it is even more important for the latter to be an expert facilitator.
  • The consultative nature of the project professional’s role. In establishing roles and responsibilities it is important to view the project professional as a consultant who makes recommendations, rather than either as an owner or as an order-taker. One of the required skills is the ability to influence without authority. A responsibilities assignment matrix, such as a RACI, can help with this clarification. 
  • The importance of distinguishing between requirements management and product ownership is also critical. We need to remember that managing requirements does not mean owning them. When clients are not available, it is rarely in the best interest of the project to continue without executive and business client support. Since it is the sponsor who has a business problem needing a solution, the sponsor needs to assign people who can define what they want in a timely manner. The project professional can have input and can certainly make recommendations, but the final decisions and acceptance of the requirements need to rest with sponsors. Therefore it is necessary to clarify the sponsor’s role as the ultimate owner, even if they have chosen to designate a day-to-day project owner. 
  • Finally, project professionals need to keep asking why the stated business problem is worth solving and to explain why it’s in the sponsor’s best interest to provide available resources who can define the requirements that will solve the business problem.

The next article in the series explores the consultative nature of the project professional and provides tips for negotiating to ensure there is enough project time for requirements management.

Elizabeth Larson, CBAP, PMP and Richard Larson, CBAP, PMP are Principals, Watermark Learning, Inc. Watermark Learning helps improve project success with outstanding project management and business analysis training and mentoring. We foster results through our unique blend of industry best practices, a practical approach, and an engaging delivery. We convey retainable real-world skills, to motivate and enhance staff performance, adding up to enduring results. With our academic partner, Auburn University, Watermark Learning provides Masters Certificate Programs to help organizations be more productive, and assist individuals in their professional growth. Watermark is a PMI Global Registered Education Provider, and an IIBA Endorsed Education Provider. Our CBAP Certification Preparation class has helped several people already pass the CBAP exam. For more information, contact us at 800-646-9362, or visit us at http://www.watermarklearning.com.