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Proceedings of the 8 Annual symposium of the INCOSE, 1998 Page 1

Converting Your Systems Engineering Organization

To ISO 9001 Compliance
Joseph E. Kasser Victoria R. Williams
University of Maryland University College Keane Federal Systems, Inc.
University Boulevard at Adelphi Rd. 1375 Piccard Drive, Suite 200
College Park, MD 20742-1614 Rockville, MD 20850
Phone 301-985-4616, fax 301-985-4611 Phone 301-548-4450, fax 301-548-1047
E-mail: jkasser@polaris.umuc.edu E-mail: vwilliam@keane.com

Abstract. Quality control is evolving from only being Be assured, if you don't go for standardization, the
present during final inspection, into becoming an integral day will come when your customer will state "if you don't
part of the systems engineering process. This evolution is understand your systems engineering processes, I can't
being helped by the International Organization of trust you to develop my product in a cost effective
Standards (ISO) 9000 series of standards that provides a manner" (Kasser, 1995).
checklist for documenting processes and assessing their
performance. The standards do not apply to systems System engineering organizations can choose from
engineering at this time. They are however taking the several process standardization approaches, including:
place of similar Department of Defense (DoD) standards,
so there is an excellent probability that they or an C The International Council on Systems Engineering
equivalent standard will apply to systems engineering in (INCOSE) System Engineering Capability Maturity
the future. This paper describes one proposed way to Model (CMM) and other CMM=s (Sheard, 1997).
transform an organization toward compliance with the C The ISO 9001 Standard.
ISO 9001 Standard, and make an organization’s systems
engineering process more cost effective. This paper focuses on achieving certification as being
compliant with the ISO 9001 Standard. Such compliance
INTRODUCTION requires:
In today’s economic climate, the drive is toward cost
effectiveness and the focus is on reduction of waste. One C A documented process.
way of reducing waste is to perform tasks the same way C Proof that the process is performed as documented.
each time the task is implemented (Taylor, 1911). This
principle has since evolved into the concept of a The transition usually takes at least two years to
>standardized process=. Since systems engineering has complete (Hockman, Grenville, Jackson, 1994). This is
been defined as "an iterative process of top down because:
synthesis, development and operation of a real world
system that satisfies in a near optimal manner, the full C It takes time to plan and implement the changes.
range of requirements for the system@ (Eisner, 1988), the C The organization has to function in accordance with
concepts of standardized processes apply to organizations the new process for several months so that data can be
providing systems engineering services or performing collected to demonstrate compliance to the ISO 9001
systems engineering as part of a System Development Life Standard.
Cycle (SDLC). Thus, the underlying reasons for a systems
engineering organization to take the road to process In-house personnel headed by someone with authority
standardization are as follows: and credibility must implement transition. However, a
consultant is often brought in to assist with reengineering
C Reduce waste by standardizing processes within the the organization into an ISO 9001 Standard compliant
organization. mode. If such an external consultant is employed for this
C Develop and communicate an understanding of the function, the consultant must be used as a guide and
processes within the organization. mentor, not as the implementor.
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Proceedings of the 8 Annual symposium of the INCOSE, 1998 Page 2

THE ISO 9000 SERIES OF STANDARDS provides guidance on quality management and quality
The ISO first published the 9000 Series Quality system elements.
System Standards in 1987 and subsequently published Each standard in the ISO 9000 series deals with
revised versions in 1994. These standards have been defining and documenting a product or service process.
adopted in the United States and issued as the American ISO 9001 and ISO 9002 are very similar; being
National Standards Institute/American Society for Quality contractual standards for use in a buyer-supplier
Control (ANSI/ASQC) Q9000 series standards. As the relationship.
ISO 9000 Standard states, the standards were developed
because: Advantages of ISO compliance. The advantages of
meeting the ISO 9000 Standards include (ISO 9000
ACustomer requirements are often incorporated Group, 1998) :
in >specifications=. However, specifications may
not in themselves guarantee that a customer's C Optimized company structure and operational
requirements will be met consistently, if there are integration.
any deficiencies in the organizational system to C Improved awareness of company objectives.
supply and support the product”. C Improved communications and quality of information.
C Responsibilities and authorities clearly defined.
There are five basic standards: C Improved traceability to 'root causes' of quality
problems.
C ISO 9000 (ANSI/ASQC Q9000-1-1994). Quality C Improved utilization of time and materials.
Management and Quality Assurance Standards C Formalized systems ensure consistent quality and
Guidelines. ISO 9000 explains the philosophy behind punctual delivery.
the standards and provides a road map for their C Documented systems provide useful references and
application. training tools.
C Fewer rejects, therefore, less repeated work and
C ISO 9001 (ANSI/ASQC Q9001-1994). Model for warranty costs.
Quality Assurance in Design and Development, C Errors rectified at the earliest stage and not repeated.
Production, Installation, and Servicing. ISO 9001 is C Improved relationships with customers and suppliers.
applicable when the contract specifically requires C Improved control during periods of change or growth.
design efforts and the product requirements are C Use of a recognized logo on stationery and
stated principally in performance terms or they advertisements.
need to be established. C Improved corporate quality image.
C Ability to bid for 'ISO 9000' contracts at home and
C ISO 9002 (ANSI/ASQC Q9002-1994). Model for abroad.
Quality Assurance in Production and Installation. ISO C Continuous quality assessment by experienced
9002 is applicable when the specified requirements professionals.
for a product are stated in terms of an established C Reduced number of customer audits.
design or specification. C Improved records in case of litigation.

C ISO 9003 (ANSI/ASQC Q9003-1994). Model for A study commissioned by Lloyd's Register Quality
Quality Assurance in Final Inspection and Test. ISO Assurance, a United Kingdom-based certification body
9003 is applicable in situations when the conformance that assesses quality management systems, indicated that
of the product to specifications can be shown with the benefits increase over time (Brecka, 1994). However,
adequate confidence providing that certain suppliers' the standards do not deal with the effectiveness of the
capabilities for inspection and tests conducted on process. The hope seems to be that when the process is
finished products can be satisfactorily demonstrated. documented, it will also be analyzed and improved.
C ISO 9004 (ANSI/ASQC Q9004-1-1994). Quality
Management and Quality System Elements. ISO 9004 THE ELEMENTS OF THE ISO 9001 STANDARD
presents the philosophy behind the quality program Section 4 of the ISO 9001 Standard contains 20
elements and provides guidance on how to implement Quality System Elements, which provide a checklist or
a quality program within an organization. ISO 9004 guide in the following areas:
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Proceedings of the 8 Annual symposium of the INCOSE, 1998 Page 3

C the records that must be made and how they are

C Process definition. then to be made use of.
C Process control.
C Process measurement. Quality System. To meet the requirements of this section,
C Process improvement. the supplier must show that procedures are documented,
C Administrative support. and more important, are implemented to ensure the
product is produced to specifications. This is the standard
Consider each element of Section 4 of the ISO 9001 SDLC methodology in which the:
Standard in turn and a suggested way to comply with it
(Kasser, 1995). The term product refers to the: C System Requirements Review (SRR) validates and
provides consensus for the system level requirements.
C System under development, to distinguish it from any C Preliminary Design Review (PDR) and Critical
systems used in the SDLC process. Design Review (CDR) verify the configuration items.
C Service provided under the terms of a systems
engineering support services contract. Demonstration of compliance to this section of the
standard may be by means of:
Management Responsibility. The standard recognizes
that the commitment to quality starts at the top of the C Procedures or methodology manuals. These
organization and cannot be delegated. The documentation manuals must describe the systems engineering
requirements of this section may be met by producing a methodologies used. They must also contain
Management Plan in the form of a System Engineering descriptions of the processes used within the
Management Plan (SEMP) for the quality program. The methodology, such as the documentation preparation
contents of this document must cover: process, and the methodology for optimizing the
effectiveness of a meeting.
C Quality Policy. A statement of the objectives and C Quality planning. A written description of how the
commitment to Quality. The policy has to be requirements for quality shall be met.
understood and implemented at all levels in the
organization. This is the basic element for developing Contract Review. To meet the requirements of this
and communicating the vision of quality within the section, the supplier must maintain procedures for
organization. contract review and for the coordination of these
C Organization. A description of the charter, activities. In systems engineering, this section covers the
organization, and interrelation of all personnel who parts of the SDLC methodology for:
manage, perform, and verify work affecting the
quality of the product. This includes a description of C Change control. The change control process must be
their roles and responsibilities. documented and shown to be followed.
C Verification Resources and Personnel. A C The supplier's capability to perform. The degree of
description of in-house activities to verify compliance expertise of the personnel performing the work. For
to requirements, the resources allocated to those example, the contractor must:
activities, and training. C demonstrate there are sufficient senior personnel
C Management Representative. The name of the to guide the junior personnel in performing the
person who has the authority and responsibility for systems engineering activities with a minimal
ensuring that the requirements of the standard are amount of wasted effort.
implemented and maintained. The road to ISO 9001 C show how skills needed on a part time basis by
certification is a brand new path, so that person must the project are made available.
be an effective person and must be given an adequate • Documentation of milestone reviews. The
budget to do the job. documentation must include:
C Management Reviews. A description of when, and • a description of the procedures to prepare and
under what circumstances: present each review.
C the quality program undergoes internal reviews at • the products to be produced and signed off at
appropriate intervals to ensure the process is in each review.
control.
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• the process for resolving the review item C Select sub-contractors on their basis to meet the
discrepancies and other outstanding issues. requirements of the sub-contract, and on their history
of past performance.
Design Control. To meet the requirements of this section, C Establish and maintain a list of acceptable sub-
the supplier must establish and maintain procedures to contractors.
control and verify the design of the product to ensure that C Ensure that every sub-contractor has a quality system.
the specified requirements are met. This section may be C Select Commercial-off-the-Shelf (COTS) component
met by developing a SEMP for the project that must suppliers on their basis to meet the need in a timely
describe: manner, and on their past performance.
C Ensure that the purchasing documentation is clear,
C Procedures to control and verify designs. concise, correct, and communicates the need in an
C The orderly transfer between stages in the SDLC. effective manner.
C Plans that identify the responsibility for the design C Ensure that the purchasing process contains a
and development activity. feedback mechanism so that purchase orders and sub-
C Activities and the resources allocated to them. contracts are reviewed before being placed.
C An Interface Control Document (ICD) between the C Verify the deliverables from a sub-contractor at
different departments in the company defining their source, namely an on-site acceptance test, prior to
organizational and technical interfaces. shipment.
C The methodology for verifying the system
requirements. Control of customer supplied product. To meet this
C The methodology for validating that the system meets section of the standard, the systems engineering contractor
the requirements. must have and follow procedures to verify, store, and
C The procedure for identification, and appropriate maintain customer supplied products for incorporation
review and approval of all changes and modifications. into the product. In government contracts, this section
deals with handling Government Furbished Equipment.
Document and Data Control. To meet the requirements These procedures must apply to software and hardware
of this section, the supplier must establish, document and elements (i.e., integrated circuits, sub-assemblies and
maintain procedures to control all documents and data that workstations).
relate to the requirements of the standard. Complying with
this section means having a documented process to: Product Identification and Traceability. To meet this
section of the standard, the systems engineering contractor
C Ensure up-to-date SDLC documents are accessible as must where appropriate, have and follow procedures to:
needed and where needed.
C Destroy obsolete SDLC documents and replace them C Identify and trace requirements from applicable
by current versions, and notify all personnel of that authorized sources.
fact. C Set up and use a configuration control system.
C Review and approve SDLC documents. C Retain manufacturing and test records.
C Incorporate the reason for changes in the SDLC
documents. These capabilities allow speedy assessment of the:
C Circulate a master list of SDLC documents, with
current revision status. C Effect of proposed changes to requirements.
C Reissue SDLC documents after a number of changes C Scope of rework or other damage control techniques
have been made, as appropriate, instead of attaching in the event of problems occurring down schedule.
change pages to the original.
Process Control. To meet this section of the standard, the
Purchasing. To meet this section of the standard, the systems engineering contractor must where appropriate,
systems engineering contractor must establish, maintain, have and follow procedures to deliver the product in a
and follow documented procedures to: cost-effective manner, under controlled conditions,
including:
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C Monitoring and controlling to ensure the performance C Issue a Discrepancy Report (DR) when a problem is
and appropriate tailoring of the SDLC methodology. noted at a checkpoint in the SDLC.
C Minimizing latent defects in the system. Latent C Maintain records to identify the person who approved
defects in systems engineering tend to show up as a product at a checkpoint in the SDLC.
bugs in the software, interface problems, and
performance gaps after the system has been accepted Control of Nonconforming Products. To meet this
and placed into operation. section of the standard, the systems engineering contractor
must have and follow configuration control procedures to:
Inspection and Testing. To meet this section of the
standard, the systems engineering contractor must have C Separate nonconforming products from conforming
and follow procedures to: products.
C Track DRs and their resolution.
C Inspect purchased COTS products prior to integration
in the system. This applies to software as well as Corrective and Preventative Action. To meet this
microcomputers, disk drives and other hardware section of the standard, the systems engineering contractor
elements. must have and follow procedures to:
C Be able to process a waiver of receipt inspection in
the event of urgent need. C Investigate the root cause of a DR and determine the
C Develop a test plan for the product under corrective action to be taken to prevent recurrence.
development. C Detect and eliminate potential causes of non-
C Perform in-process inspection and testing at various conformance in the process and product.
checkpoints in the SDLC. C Review the effectiveness of the proposed corrective
C Perform final acceptance test prior to handover to the action.
customer. C Maintain records of DRs and corrective actions.
C Determine the disposition in the event of non-
conformance to a test. Handling, Storage, Packaging, Preservation and
C Maintain and make use of inspection and test records. Delivery. To meet this section of the standard, the
systems engineering contractor must have and follow (as
Inspection, Measuring and Test equipment. To meet appropriate) procedures to:
this section of the standard, the systems engineering
contractor must have and follow procedures to: C Handle, store and ship the system to the customer's
location.
C Verify all hardware test equipment have the C Maintain the quality of the product after on-site
appropriate resolution to make the necessary inspection through the delivery and installation
measurements. process at the customer's location.
C Calibrate all test equipment used in measuring the C Restrict access to the product to authorized personnel
performance of the system. during the SDLC.
C Periodically check the calibration of the test
equipment. Control of Quality Records. To meet this section of the
C Test software tools to verify they have the capability standard, the systems engineering contractor must have
to make the measurement. and follow procedures to collect, maintain, and provide
C Place the software tools used to test the system under access to quality records. This requirement may be met by
configuration control. a configuration control system database.
C Maintain and make use of inspection and test records.
Internal Quality Audits. To meet this section of the
Inspection and Test Status. To meet this section of the standard, the systems engineering contractor must have
standard, the systems engineering contractor must have and follow procedures to verify the quality process,
and follow procedures to: namely:

C Maintain configuration control over the product in C A methodology for the conduction of internal audits
each stage in the SDLC. to verify conformance to the ISO 9001 Standard.
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C An independent evaluation of the audit results. C Appoint a project manager who is an experienced
C A review of the audit results with the personnel systems engineer with knowledge of the ISO
responsible for the activity audited. standards and certification process.
C Verification that the recommendations of the audit are C Allocate suitable resources in terms of knowledgeable
carried out. The recommendations of one audit personnel and equipment.
become additional metrics for a subsequent audit. C Ensure the project personnel have a stake in the
successful outcome of the project.
Training. To meet this section of the standard, the
systems engineering contractor must have and follow The ISO project implementation team will probably
procedures to: be working part time on this effort. This is not as bad as it
seems, because the expanded time factor will assist in
C Identify training needs. overcoming any potential resistance to the change.
C Provide appropriate training.
C Identify appropriate qualifications for the personnel This road contains a number of phases leading to
who will perform the training. intermediate milestones. The discussion that follows is a
C Maintain records of which personnel received which simplified description of one process an organization can
training courses, and when the training took place. follow to become ISO 9001 compliant.

Servicing. To meet this section of the standard, the In the spirit of applying lessons learned, statistics
systems engineering contractor must have (as appropriate) show (Hodlin, 1993):
and follow procedures to:
C Seventy percent of all companies fail the assessment
C Resolve post-delivery problems including latent the first time around.
defects. C Sixty percent of the problems are associated with the
C Maintain records of post-delivery activities. following five clauses of the standard:
C Document control.
Statistical Techniques. To meet this section of the C Design control.
standard, the systems engineering contractor must have C Purchasing.
and follow procedures to: C Inspection and test.
C Process control.
C Identify adequate statistical techniques for verifying
the acceptability of the process and product. Thus, the areas listed above represent the areas to
C Use statistical techniques for verifying the concentrate on during the performance of the ISO 9001
acceptability of the process and product. Compliance Transition Project.

The terminology chosen for describing the project

THE ISO 9001 COMPLIANCE TRANSITION milestones is based on engineering language. This is
PROJECT because transforming an organization is a non-trivial
The ISO 9001 Compliance Transition Project begins project, and must be treated as such. This approach
when upper management makes and demonstrates their applies the project methodology for transitioning a legacy
commitment to travel the road. This commitment is (computer based) system to the process of transforming an
essential because of the resources that they will have to organization. The legacy system is non-ISO 9001
commit toward the effort. The decision must be an compliant, while the future system after the transition is
informed one, so, in systems engineering terminology, ISO 9001 compliant.
management must:
The concept development phase. Once the project has
C Authorize the ISO 9001 Compliance Transition been approved, the first phase is the preparation of an
Project. Operations Concept Review (OCR) for the process. This
C Authorize a realistic budget. review must cover the road map, namely:

C The ISO 9001 Standard.

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C The reason for making the commitment.

C The vision of how the organization will function once The unit development phase. The next phase along the
compliance with the ISO 9001 Standard is achieved. road maps into the unit development phase of the SDLC.
C An initial assessment of the status of the organization During this phase:
C An estimate of the resources that will be needed.
C The ISO 9001 Compliance Transition Project C The Quality Manual is written.
organization chart (authority and responsibilities). C Each process in the system engineering methodology
C Which consultants will be brought in, why they are to (or methodologies) is upgraded to conform to the
be brought in, and what expertise they will supply. requirements of the standard and documented
C The initial transition plan (including any alternatives) accordingly. This is also a good time to make use of
showing in very broad terms how the changeover suggestions for process improvement by the
from the current way of doing business to the ISO employees who perform the process.
9001 Standard compliant way will be made. C Training takes place to make the new process known.
C A preliminary schedule for the transition, which by C The test team performs an audit to verify the change
the way started when the project was first authorized. has taken place.
C Periodic management progress reviews take place and
The review must be attended by all the managers in reports are published so that everybody involved can
the organization including the Chief Executive Officer see the progress being made outside of the area in
and their staff to demonstrate their commitment to the which they are working in. Certificates of
change (Hockman, et al., 1994). The review handout may Appreciation for any outstanding efforts should be
serve as the System Operations Concept Document presented at these review meetings.
(SOCD) and initial version of the SEMP for the project. C The third party registrar is chosen.
The decision to continue made at the end of the OCR must
be visible throughout the organization. The pre-assessment review. The CDR must not take
place until at least 90% of the processes have been
The requirements development phase. This is the phase upgraded and have been in operation for at least two
in which: months. In this instance, the CDR is a readiness review
prior to performing the pre-assessment (quality language)
C The ISO 9001 Standard is dissected. or Integration Test (systems engineering language). The
C A requirement is developed for each process and review covers:
product to be documented.
C The Requirements Traceability Matrix (RTM) is C The status of the project.
developed. C Customer feedback, what the customer thinks of the
C Alternative ways of meeting the requirements may be effort.
proposed and analyzed. C Lessons learned during the process.
C Internal audits take place to determine the exact C An estimate of the cost savings due to process
current situation. improvements already implemented.
C The existing processes are documented. The people C Internal audit results.
who perform each process must be involved in the C Trend data collected by the test team (internal audit
documentation of their process. team) showing the rate of improvement.
C The documents are tested by auditing the processes.
C The Transition Plan is developed in more detail to The pre-assessment test. The remaining processes are
show which elements will be firmed up in which order upgraded and the upgraded system allowed to operate for
and by when. This plan is based on the resources that at least two months. At the end of that time, the pre-
will be available. assessment test is performed. This test is a dress rehearsal
C The Test Plan is also developed for demonstrating for the assessment (Acceptance Test). An outside auditor:
progress.
C Audits the processes, to ensure the procedures are
This phase terminates with a SRR. As before, the followed.
decision to continue made at the end of the SRR, must be
visible throughout the organization.
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C Compares the processes to the requirements in the more than just the systems engineering and test
Quality Manual to ensure that the system itself departments because of the procurement and materials
complies with its requirements. management aspects. This paper has suggested one
approach to transitioning an organization to compliance
The format of this test typically is: with the ISO 9001 Standard.

C An opening meeting. REFERENCES

C The interview and investigation period. ISO-9000 (ANSI/ASQC Q9000), 1994.
C A closing meeting. ISO-9001, ANSI/ASQC Q9001-1994, Section 1.
ISO-9002, ANSI/ASQC Q9002-1994, Section 1.
The result of the test is presented at the closing ISO-9003, ANSI/ASQC Q9003-1994, Section 1.
meeting. This pre-assessment may identify missing ISO-9004, ANSI/ASQC Q9004-1-1994, Section 1.
elements in the quality system that must be corrected Brecka, J., "Standards", Quality Progress, May 1994.
before the assessment takes place. These are documented Eisner H., Computer Aided Systems Engineering, Prentice
as DRs. Hall, 1988, p 17.
Hockman, K.K., Grenville, R., Jackson, S., "Road Map to
The operations phase. Any changes recommended as a ISO 9000 Registration", Quality Progress, May 1994.
result of the pre-assessment review are then made and the Hodlin, S.F., Certification Process, ISO 9000: An
system allowed to operate for at least six months to collect Introduction to Assessment and Certification, Prince
data. By doing so, objective evidence (data) that the George's Community College, Largo, MD., October
organization is in compliance with the requirements of the 27, 1993.
ISO standard will be available to the assessor. Kasser, J.E., Applying Total Quality Management to
Systems Engineering, Boston, Artech House, 1995.
The Assessment and its aftermath. The assessment is Taylor, F.W., The Principles of Scientific Management,
performed by the third party registrar and follows the Harper & Brothers Publishers, 1911.
same format as the pre-assessment. If the outcome of the Sheard, S.A., AThe Frameworks Quagmire, A Brief
assessment is a recommendation for registration, a Look@, The 7th INCOSE Symposium, Los Angeles,
certificate will be received within two months. If minor CA., 1997.
discrepancies are found, the organization will have two The ISO 9000 Group, http://www.commerce-
months or so to correct them. associates.com/iso/iso_adv.html, last accessed April
7, 1998.
Registration is just the beginning. The initial
registration serves as a baseline for further process BIOGRAPHY
improvement. The system is now in its operational phase Dr. Kasser has more than 25 years of award winning
and changes (improvements) will occur. Each experience in management and engineering. He teaches
improvement lowers the cost of doing business increasing software design, software validation and verification, and
the competitive edge. Internal audits must continue to software maintenance in the Graduate School of
ensure the process and the documentation are Management and Technology at the University of
synchronized. These audits will probably generate DRs Maryland University College. He is a recipient of
which must be handled according to due process in a NASA=s Manned Space Flight Awareness (Silver
timely manner under configuration control. This process Snoopy) Award for quality and technical excellence. He is
of improvement is a continuous loop without an exit. a Certified Manager and a recipient of the Institute of
Certified Professional Manager's 1993 Distinguished
SUMMARY Service Award. He is the author of Applying Total Quality
While the ISO 9000 series of standards have not yet Management to Systems Engineering published by Artech
been adopted in the systems engineering field, it is House and more than 30 journal articles and conference
probable that the time will come when the standard or an papers. His current interests lie in the areas of applying
equivalent will apply. ISO 9001 compliance provides an systems engineering to organizations and using
excellent starting point for institutionalizing quality when technology to improve the practice of management.
an organization begins the long trek down the road to cost
effective systems engineering. It does however organize
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Victoria R. Williams is a Senior Consultant at Keane

Federal Systems, Inc. in Rockville, MD. She has 18 years
of award winning experience in various aspects of systems
engineering. She has received many awards and
commendations from employers and customers including
Computer Data Systems Inc., the Department of the Navy,
Naval Air Systems Command, and the Department of the
Army. She has written software in HTML, PowerBuilder,
Java, FoxPro and Visual Basic. She has performed object-
oriented analysis and design in an effort to reengineer an
operational legacy system. Her previous experience
includes project management support for the Department
of the Navy, systems and software engineering for the
U.S. Navy, the Royal Australian Navy, and the U.S.
Military Sealift Command. She is also trained at CMM
Level 2 and is currently working on her Master of Science
Degree in Computer Systems Management in the
Graduate School of Management and Technology at the
University of Maryland University College in College
Park, Maryland.