NCEES-PE mock - NCEES - PE Civil Engineering Updated: 2023
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Exam Code: NCEES-PE NCEES - PE Civil Engineering mock June 2023 by Killexams.com team|
NCEES-PE NCEES - PE Civil Engineering
The Principles and Practice of Engineering (PE) test tests for a minimum level of competency in a particular engineering discipline. It is designed for engineers who have gained a minimum of four years post-college work experience in their chosen engineering discipline.
The PE Civil test is an 8-hour test with 80 questions. It is administered in pencil-and-paper format twice per year in April and October. See the test schedule for specific dates.
Reviewing the PE test specifications and design standardsReading the reference materials and examinee guideUnderstanding scoring and reportingViewing the most up-to-date PE test pass rates
I. Project Planning
A. Quantity take-off methods
B. Cost estimating
C. Project schedules
D. Activity identification and sequencing
II. Means and Methods
A. Construction loads
B. Construction methods
C. Temporary structures and facilities
III. Soil Mechanics
A. Lateral earth pressure
B. Soil consolidation
C. Effective and total stresses
D. Bearing capacity
E. Foundation settlement
F. Slope stability
Civil Breadth test Specifications Continued
IV. Structural Mechanics
A. Dead and live loads
C. Bending (e.g., moments and stresses)
D. Shear (e.g., forces and stresses)
E. Axial (e.g., forces and stresses)
F. Combined stresses
L. Retaining walls
V. Hydraulics and Hydrology
A. Open-channel flow
B. Stormwater collection and drainage (e.g., culvert, stormwater inlets, gutter flow, street flow, storm sewer pipes)
C. Storm characteristics (e.g., storm frequency, rainfall measurement and distribution)
D. Runoff analysis (e.g., Rational and SCS/NRCS methods, hydrographic application, runoff time of concentration)
E. Detention/retention ponds
F. Pressure conduit (e.g., single pipe, force mains, Hazen-Williams, Darcy-Weisbach, major and minor losses)
G. Energy and/or continuity equation (e.g., Bernoulli)
A. Basic circular curve elements (e.g., middle ordinate, length, chord, radius)
B. Basic vertical curve elements
C. Traffic volume (e.g., vehicle mix, flow, and speed)
A. Soil classification and boring log interpretation
B. Soil properties (e.g., strength, permeability, compressibility, phase relationships)
C. Concrete (e.g., nonreinforced, reinforced)
D. Structural steel
E. Material test methods and specification conformance
VIII. Site Development
A. Excavation and embankment (e.g., cut and fill)
B. Construction site layout and control
C. Temporary and permanent soil erosion and sediment control (e.g., construction erosion control and permits, sediment transport, channel/outlet protection)
D. Impact of construction on adjacent facilities
E. Safety (e.g., construction, roadside, work zone)
CIVILâ€“CONSTRUCTION DEPTH test Specifications
I. Earthwork Construction and Layout
A. Excavation and embankment (e.g., cut and fill)
B. Borrow pit volumes
C. Site layout and control
D. Earthwork mass diagrams and haul distance
E. Site and subsurface investigations
II. Estimating Quantities and Costs
A. Quantity take-off methods
B. Cost estimating
C. Cost analysis for resource selection
D. Work measurement and productivity
III. Construction Operations and Methods
A. Lifting and rigging
B. Crane stability
C. Dewatering and pumping
D. Equipment operations (e.g., selection, production, economics)
E. Deep foundation installation
A. Construction sequencing
B. Activity time analysis
C. Critical path method (CPM) network analysis
D. Resource scheduling and leveling
E. Time-cost trade-off
V. Material Quality Control and Production
A. Material properties and testing (e.g., soils, concrete, asphalt)
B. Weld and bolt installation
C. Quality control process (QA/QC)
D. Concrete proportioning and placement
E. Concrete maturity and early strength evaluation
VI. Temporary Structures
A. Construction loads, codes, and standards
C. Falsework and scaffolding
D. Shoring and reshoring
E. Bracing and anchorage for stability
F. Temporary support of excavation
VII. Health and Safety
A. OSHA regulations and hazard identification/abatement
B. Safety management and statistics
C. Work zone and public safety
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NCEES - PE Civil Engineering
Which of the following assumptions regarding the compression strength of
concrete used in reinforced concrete beam design is valid?
A. The American Concrete Institute (ACI) recommends that all beams be
designed using high strength concrete
B. High strength concrete compression strengths range from 3,000 to 7,000
pounds per square inch
C. Compression strength of normal concrete ranges from 3,000 to 7,000 pounds
per square inch
D. None of the above
The assumption “compression strength of normal concrete ranges from 3,000 to
7,000 pounds per square inch” for the concrete used in reinforced concrete beam
design is valid. ACI does not recommend that high strength concrete be used in
the design of all beams. The compression strength of high strength concrete
ranges from 7,000 - 15,000 pounds per square inch.
What is the velocity (in ft/sec) in a rectangular concrete channel with a width of 3
feet (ft), a hydraulic grade line slope of 0.002 ft/ft, a flow depth of 1.5 ft and an
assumed Manning's coefficient n = 0.014?
A. 0.15 ft/sec
B. 1.50 ft/sec
C. 3.92 ft/sec
D. None of the above
the velocity in a rectangular channel with the given dimensions is 3.92 ft/sec.
Solution: Use Manning's Equation and solve for V V = (K/n) R2/3 Sf1/2 Where:
K = conversion coefficient (1.486 for English units, 1.0 for SI) n = 0.014, the
Manning coefficient d = depth of flow = 1.5 ft w = width of channel = 3.0 ft Sf=
channel slope = 0.002 ft/ft A = Area = d x w = 1.5 ft x 3 ft = 4.5 ft2 P = wetted
perimeter = w + 2d = 3 ft + 3 ft = 6 ft R = hydraulic radius = A/P = (4.5 ft2)/ (6 ft)
= 0.75 ft V = (1.486/0.014) x (0.75 ft)2/3 x (0.002 ft/ft)1/2 = 3.92 ft/sec
The hydraulic radius of a sewer refers to which of the following?
A. The diameter
B. Channel perimeter
C. One-half the diameter
D. The ratio of the cross-sectional area of flow to the wetted perimeter
The hydraulic radius of a sewer refers to the ratio of the cross-sectional area of
flow to the wetted perimeter. (The wetted perimeter is the portion of a cross-
section’s perimeter that is “wet.”) The equation that describes the hydraulic radius
of a channel, Rh, is expressed as follows: Rh = A/P = cross sectional area of flow
/ wetted perimeter
For most proposed land development projects, pre- and post-development
watershed drainage patterns are typically evaluated to determine if substantial
hydrologic alterations are proposed that will result in which of the following?
A. Changes to groundwater recharge
B. Changes to water regime within a given resource area
C. Increase runoff from the area
D. All of the above
For most proposed land development projects, pre- and post-development
watershed drainage patterns are compared to determine if substantial hydrologic
alterations will be made to the watershed’s groundwater recharge, water regime,
and area runoff. The drainage patterns reviewed include the surface and
subsurface paths of water entering, crossing, and leaving the site. Additionally,
areas where water is stored within the project site are also evaluated for pre- and
Euler’s Formula is used to determine which of the following properties related to
a simply-supported column?
A. Maximum bending moment
B. Critical buckling load
C. Shear stress
D. None of the above
Euler’s Formula is used to determine the critical buckling load of a simply-
supported column. Euler’s Formula is expressed as follows: Fcr = [(E x I)(p2)]/L2
Where: - E = Young’s modulus of the material used to construct the column - I =
cross-sectional area moment of inertia - L = column length
What is the composite C value for the following drainage area for a 10-year storm
recurrence interval?Drainage area: 0.25 acres of residential lots with 40%
imperviousness (C = 0.49) 0.25 acres of lawn with 0.95% slope with 0%
imperviousness (C = 0.22) 0.10 acres of impervious pavement (C = 0.95)
D. Not enough information provided
The composite C value for the given drainage area for a 10-year storm recurrence
interval is 0.45. Solution: Calculate composite C by using the following equation:
C = (C1A1 + C2A2 + C3A3) / (A1 + A2 + A3) C = [(0.25 acres x 0.49) + (0.25
acres x 0.22) + (0.10 acres x 0.95)]/ (0.25+0.25+0.10) C = 0.45
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As a licensed Professional Engineer, or PE, you can expect many more benefits when compared to other engineers; most employers offer higher salaries and greater opportunities for advancement to PE's. Only PE's can consult in private practice, and seal company documents to be sent to the government. PEs also have more credibility as expert witnesses in court than most engineers.
Steps in obtaining a PE license:
During your senior year you should take the Fundamentals of Engineering (FE) exam, which is required prior to sitting for the Professional Engineers (PE) Exam. Some requirements vary by state.
The National Council of Examiners Administers Both Exams for Engineering and Surveying
Engineering students at Michigan Tech are encouraged to take and pass the FE examination during their last semester in college, or the first year after graduation. There will never be a time when you are better prepared to pass it than near graduation.
The examination is offered in April and October each year. Students must visit http://ncees.org/exams/ to register for the test and pay the $155.00 fee. The registration deadline is approximately two months before the test.
FE test Waiver
The FE ExamÂ mayÂ be waived for those who have earned a BS in engineering and a PhD in engineering. See the NCEES web site for details.
Professional Engineer Licensure
A professional engineer license is an important professional credential for both civil engineers and environmental engineers. Northwesternâ€™s undergraduate degrees in civil engineering and environmental engineering are both ABET accredited, making them excellent preparation for professional licensure.Â
Professional engineer licenses are granted and maintained by each individual state, which allows for the practice of engineering within that state. For example, the Illinois Department of Financial and Professional Regulation maintains the professional engineer licensure process in the state of Illinois. For more information, please visit the IDFPR website.
Process for Acquiring a Professional Engineer License
Professional practice in the field of structural engineering may require a structural engineering license in certain states (including Illinois). Learn about the structural engineering license procedure at the NCEES website.
Based in the United Kingdom, Ian Linton has been a professional writer since 1990. His articles on marketing, technology and distance running have appeared in magazines such as â€śMarketingâ€ť and â€śRunner's World.â€ť Linton has also authored more than 20 published books and is a copywriter for global companies. He holds a Bachelor of Arts in history and economics from Bristol University.
All facilities are built on, in, or with earth materials. As such, the science and engineering of soil and rock, and of the water and other fluids that permeate them, are critical for addressing national and global issues, including infrastructure construction and reconstruction, mitigation of natural hazards, and frontier exploration and development.
Geotechnical engineering is a branch of civil engineering that generally deals with problems involving soil and rock. Examples include the design of foundations for structures, tunneling, excavations, disposal of waste products by burial, dams, and a variety of similar earth-related topics.
Our goal is to educate graduate students to become leaders in geotechnical engineering practice and academia. We strive to provide a broad and fundamental educational experience. To achieve these goals, we maintain a balance between research and teaching in our program.Â Theory and practice, experimental and analytical techniques, and traditional and cutting-edge ideas are integrated within our research and teaching.
Learn more about research in this department
Learn more about theÂ MS program.
Masterâ€™s and PhD Programs
Because surveys have shown that the greatest challenge often faced by new practicing engineers is in the area of written communication, we require that all graduate students prepare a written report during their graduate studies. The requirement is fulfilled through the preparation of a MS thesis or PhD dissertation.Â Preparation of the document involves extensive individual interaction with the supervising professor, thus developing the student's communication skills, individual thought processes, and problem-solving capabilities.
Request More Information
Download a PDF program guide about your program of interest, and get in contact with our graduate admissions staff.
request info about ms degreeRequest info about phd degree
Our MS program is focused on preparing students for geotechnical engineering practice, while exposing them to geotechnical engineering research. Our PhD program is more research-oriented. The program is tailored to fit the interests and aspirations of the individual student. Some of our PhD graduates go into engineering practice, while others pursue careers in research or teaching.
Developing engineering skills today for a more sustainable tomorrow.
Our departmental mission is to engage in teaching, research, and service to advance environmental resources engineering practices and meet the needs of the world. Our faculty strengths are in ecological engineering, geospatial engineering, water resources engineering, and the broader field of environmental resources engineering.
Teaching includes innovative class, lab, and field exercises in foundational and advanced engineering topics, where our flexible curriculum allows students to focus on traditional or novel engineering practices. Students receive a well-balanced education, including courses that consider the social, economic, and environmental impacts of engineering practice, fundamental engineering and environmental engineering courses, and specialized courses that capture the breadth of their field of study.
The ERE department is internationally recognized for coupling research and service, and many of our courses address community needs. We provide unparalleled mentoring to train students in engineering science and design so they can join our alumni as leaders in professional practice and research.
EREâ€™s home in Baker Laboratory includes:
We are supported by campus staff, wood and machine shops, and ESF's Analytical and Technical Services unit. Research and analysis are facilitated by a powerful range of computing platforms and software. Off-campus facilities include the extensive ESF properties, and numerous field sites supported by an array of field equipment for environmental resource engineering measurements.
Undergraduate Degree Programs
Environmental Resources Engineering
Preparing qualified engineers to operate with professional competence.Learn More
Student Clubs and Organizations
This club familiarizes members with current developments and events in the field of environmental resource engineering. There is an emphasis on professional development and enhancing student-student and student-faculty relationships among those in the ERE curriculum.
Engineering for a Sustainable Society
Engineering for a Sustainable Society (ESS) is a student-initiated university chapter of the national organization. This organization is devoted to implementing low-tech, high-impact, engineering projects as a means of improving the quality of life and environment all over the world.
Engineers Without Borders
The ERE Department maintains a student chapter with the national Engineers without Borders organization, organized by the ESS officers. The ESF EWB club has been coordinating international projects since 2003 and is active with the local professional EWB chapter.
NY Water Environment Association
The New York Water Environment Association Student Chapter engages students in the water resources profession, with an emphasis on water supply and wastewater systems. The student chapter participates in service activities, professional meetings, seminars and conferences to promote sustainable water quality management in order to create an environmentally sound future.
The B.S.E. in Environmental Engineering begins with fundamental courses in college writing, mathematics and science. You will also take an introduction to civil and environmental engineering course that covers computer-aided engineering and design.
During the second year, you will learn additional engineering mathematics, basic engineering mechanics and biology for engineers. Other courses introduce environmental engineering, including an associated laboratory class and environmental engineering chemistry.Â
Junior year coursework addresses energy and sustainability, groundwater hydrogeology and remediation, and biological processes in environmental engineering. In the senior year, you will focus on chemical fate and transport in the environment, air quality and solid waste engineering. You can also take two professional electives, which will count toward a masterâ€™s degree if you are accepted into the combined B.S.E./M.S.E. program.Â
In the final semester, you will complete a capstone design project for the solution of an environmental problem.
UMass Lowell is the only public research university in Massachusetts to offer an undergraduate major in Environmental Engineering.
Visit the Academic Catalog for a complete course listing and to learn more about the minor in Business Administration for Civil and Environmental Engineering.
The B.S. in Civil Engineering at UMass Lowell offers rigorous training in the four main areas of civil engineering:Â
The first year begins with fundamental courses in college writing, mathematics and science. You will also take an introduction to civil and environmental engineering course that covers computer-aided engineering and design.Â
During the second year, you will learn the principles of engineering mechanics, including statics, dynamics and strength of materials. Other courses cover statistics, surveying, geomatics and differential equations. At this point, you can begin the Professional Co-op Program by taking a professional development seminar.Â
Junior and senior year coursework provides a working knowledge of structural, environmental, geotechnical and transportation engineering. You can also take two professional electives, which will count toward a masterâ€™s degree if you are accepted into the combined B.S.E./M.S.E. program. In the senior year, you will participate in a comprehensive capstone design project, which is typically a service-learning project with a community partner.
Visit the Academic Catalog forÂ a complete course listingÂ and to learn more about the minor in Business Administration for Civil and Environmental Engineering.
The first edition of Caroline Whitbeck's Ethics in Engineering Practice and Research focused on the difficult ethical problems engineers encounter in their practice and in research. In many ways, these problems are like design problems: they are complex, often ill defined; resolving them involves an iterative process of analysis and synthesis; and there can be more than one acceptable solution. In the second edition of this text, Dr. Whitbeck goes above and beyond by featuring more real-life problems, stating exact scenarios, and laying the foundation of ethical concepts and reasoning. This book offers a real-world, problem-centered approach to engineering ethics, using a rich collection of open-ended case studies to develop skill in recognizing and addressing ethical issues.
'I am very enthusiastic about Dr Whitbeck's effort to help us think effectively and somewhat pragmatically about professional ethics. Everyone, professionals in particular, must expect ethically-complex situations to arise â€¦ This book will help seasoned professionals clarify their approach to their own behavior, and this book can profoundly affect those who face a messy situation for the first time.' Woodie C. Flowers, from the Foreword for the first edition
'Dr Whitbeck draws the useful analogy between ethical problems and engineering design problems â€¦ a well written book.' Engineering Science Education Journal
'Whitbeck has written a valuable book, regardless of the reader's penchant for general philosophy or cases. Practitioners will find the time invested to get through it well repaid.' ASME International
'This fine textbook in engineering ethics will be useful for courses in engineering ethics, and as a supplementary resource for engineering and science instructors who wish to infuse attention to ethics into their courses. It will also interest students of philosophical ethics who wish to consider a refreshing approach to case-based, 'applied' ethics.' Metaphysics, Epistemology, and Technology
Originally Published MDDI July 2002
Some medical errors can be prevented by incorporating human factors considerations into a product's design and development.
Christine Engelke and Daniel Olivier
Do medical mistakes result from human error or from poor human factors design?
The answer to this controversial question varies depending on who is being asked. Manufacturers have historically identified user error as the cause of many problems that FDA and consumer groups have attributed to poor device design.
Whatever the cause, medical errors are on the rise. This worrisome trend is a result of increasingly complex medicine coupled with a heightened demand for products with greater functionality.
According to FDA, medical errors take the lives of up to 100,000 Americans annually. Such mistakes also injure 1.3 million people, account for more than 3 million hospital admissions, and increase the nation's hospitalization bill by as much as $17 billion each year.1
As a result, human factors engineering is receiving more and more attention from both FDA and the customers who demand products that are easierâ€”and saferâ€”to use.
In fact, medical device problems attributed to inadequate human factors considerations have been growing for many years. Table I provides a listing of some of these device problems.2 Although some may seem trivial, the consequences in many of these cases have been catastrophic.
HUMAN ERROR VERSUS DESIGN ERROR
The popular six-sigma management strategy argues that processes, not people, fail; therefore, poor design is the culprit when use errors occur.3 Many manufacturers are now beginning to accept the responsibility for creating designs less prone to user error in conjunction with their efforts to increase customer satisfaction.
The means for assigning root causes to medical errors is changing as a result of legal precedents, evolving industry practices, and changing regulatory standards. Although the distinction between user error and design error is not well established, it is clear that the demand for more-robust and error-resistant designs is increasing.
This is not to say that all user errors are the fault of the manufacturer; clearly, the manufacturer must make certain assumptions about the expertise of the user, the user's observance of the labeling (and advertising) claims for the intended use of the product, and his or her adherence to the instructions. Table II presents examples of design changes made by manufacturers to reduce the likelihood of user error. Nevertheless, society is increasingly expecting the manufacturer to produce designs that minimize the risk of operator-related problems even further.
SPECIFIC ISSUES AND SOLUTIONS
In designing a device to minimize user error, it is helpful for manufacturers to refer to specific principles that make the device easier to use and understand. One example is creating a simple user interface that includes a well-organized layout of controls for easy system operation. Others include incorporating easy-to-understand reference documentation and considering such environmental factors as lighting, ambient noise, and space availability.
Data Overload. A common mistake made by many manufacturers is to present too much data on displays. This information overload can lead the operator to overlook important data, or to make mistakes due to the complexity of operating the device. (Many people have felt a similar feeling of information overload when trying to program their VCRs).
The greater the capability of the display, the greater the manufacturer's tendency to fill it up with more data, graphics, menus, buttons, and so on. The benefits of white space so often discussed with respect to printed materials should also be applied to displays. Too much text or too many graphics on a display decrease the reader's comprehension, just as they do for printed reports.
Designers of devices and displays must exercise restraint to include only essential information. Simpler is better. For example, consider an indicator for an electrical stimulator that displays "Stimulation ON" or "Stimulation OFF." This design could be simplified by having an indicator turn red when the device is on and disappearing altogether when the device is off.
Chunking by Sevens. George Miller wrote a paper titled "The Magic Number Seven, Plus or Minus Two."4 His idea is that the human mind is limited in its ability to process information. Miller's studies concluded that most humans are unable to retain more than seven "chunks" of information at one time. This philosophy can help manufacturers understand the limits of the amount of information users can readily process and understand.
The rule of sevens has implications for the amount of information presented on displays as well as within software program menus. In designing information displays and menus, engineers should first determine what information is essential, then decide how to best structure secondary information that may be of interest to the user.
A Word about Warnings. Although warnings and cautions printed on labels can be used to prevent errors, these are the least effective methods. A design should take into account that errors will occur, and then permit the user to recover from a mistake. Error-tolerant designs include such techniques as error trappingâ€”which identifies data entries or event sequences that could cause problemsâ€”and confirming commands that initiate critical event sequences.
Warnings and cautions sometimes appear on a device even when they are clearly ineffective. For example, a card provided for passengers seated in the exit row of a commercial aircraft reads, "If you are seated in an exit row and you cannot understand this card or cannot see well enough to follow these instructions, please tell a crew member."
In certain cases, however, warning or caution labels might be the only feasible way to reduce risk. The need for these types of labels is recognized by users, and studies have shown that a product with a warning label is perceived by users as safer than the same product without the label.5 In other words, warning and caution labels can't hurt, but they are not particularly effective, either.
Designing Home-Care Products. Robust designs become more critical in inverse proportion to the expertise of the user. Devices targeted to home use must be especially easy to operate, as this population includes users who are potentially ill, medicated, handicapped, elderly, and generally less knowledgeable about the specific operation of the device. The wide variety of home users requires device designers to target the lowest level of education and skill across this population. Manufacturers should avoid relying on training and product labeling alone as preventive measures against user error.
BUILDING HUMAN FACTORS INTO EXISTING DESIGN PROCESSES
Human factors engineering is a user-centered design process. When devising a product, designers should research how different individuals use or might use the device in both a clinical setting and its various associated environments. Their research should determine the following characteristics:
Ease of use is difficult to incorporate into a device after the initial design has been rendered. Human factors engineering activities must be integrated into a prospective design process; this minimizes additional overhead and helps realize significant benefits. Successful companies have learned that new product development activities must include assessment and evaluation of the product's ease of use and other human factors issues as essential ingredients for success.
New-product success is also based on the integration of design principles and the allocation of resources to ensure that human factors issues are addressed in existing design activities. Table III provides a list of specific practices associated with requirements definition, including design, implementation, testing, and user labeling, all of which can be applied to design and development activities.
The identification of potential errors is best accomplished by conducting an analysis of events and sequences in the user environment that can contribute to errors. This must be performed early in the requirements definition phase.
In the effort to Strengthen human factors processes, it is also useful to learn the reasons why bad designs are sometimes created. Bad designs are never created intentionally; problems arise when the designers are unfamiliar with the genuine use environment, are unaware of the expertise of the user population (or lack thereof), do not consider the unique situations that can face the user, or fail to identify and account for the physical limitations of the user population.
Why are designers not aware of these issues as prerequisites for any design project? One explanation may be the intense pressure to get new products to market has made knowledge of the user population a low priority. Yet one way to ensure good design is for the engineers to talk directly with the users and visit them in their operational environments. This simple assignment often sheds light on innovative ways to better serve the real needs of the users.
TESTING FOR HUMAN FACTORS DESIGN FLAWS
It is important to ensure not only that new products are properly designed, but that they are adequately tested. It is essential that optimal test practices be enforced (i.e., test practices that are effective in identifying potential errors).
Traditional test practices focus on testing derived from established requirements and conducted by internal test resource personnel. One problem with this approach to testing, however, is that these individuals might not be totally familiar with the operational use environment and might not know the common problems that can occur during device use. Identifying human factors problems requires exposure to the scenarios that occur during genuine use. Questioning individuals through user focus groups, asking users to conduct beta tests, issuing surveys of user perceptions of device performance, and monitoring genuine use scenarios are all effective ways to pinpoint such problems.
To ensure good design, the testing program must also be comprehensive. The testing program should address the following potential operator error conditions: entry of out-of-range or unexpected values or nonstandard command sequences, the use of improper configurations, operation with failed hardware components, a loss of power, operation under maximum loading conditions, and so on. The tester should introduce test sequences that are likely to present realistic error situations. This is best accomplished through testing in an genuine use environment and using testers who are experienced in that environment.
EFFICIENCY VERSUS EFFORT
The extent and scope of any human factors effort can be scaled according to specific project needs, such that safety, effectiveness, and usability are optimized at a reasonable cost. The AAMI HE74 standard recommends exerting more-intensive efforts in the following circumstances:
These recommendations complement FDA's guidelines for increasing the rigor of formal design controls and documentation for devices that present higher levels of concern for users.7 The greater the potential risk associated with a user error, the more effort is warranted for its prevention.
To quantify this, designers can perform a task-and-hazard analysis, with an emphasis on human factors issues. An example, shown in Table IV, assigns a severity ranking to each item. These rankings can be used collectively to evaluate the overall risk.
CONTINUAL IMPROVEMENT OF HUMAN FACTORS DESIGN
Because no design is ever perfect, it is essential to have a program in place for continual improvement. Manufacturers receive information from customers concerning product ease of use and complaints of product errors. This feedback provides opportunities to confirm the robustness of a design and to identify potential enhancements.
Some manufacturers report a reluctance among medical personnel to report user errors; this results in minimal feedback to the manufacturer and therefore an underestimation of the significance of certain design elements. To counteract this tendency, manufacturers should make problem-reporting easy for medical staff, and provide training to service personnel, field sales agents, and customer service operators on effective techniques for soliciting this type of information. Such technologies as downloadable event logs and Web-enabled reporting can also increase the volume of useful feedback.
Once data are collected, techniques such as Pareto analysis can be applied to identify the most common errorsâ€”which would provide the greatest benefits if corrected. (Pareto analysis involves identifying the few crucial factors that contribute the most to an overall effect.) It is appropriate to add a caution here: there is a tendency on the manufacturer's part to blame all problems on the user. A more detailed analysis of the problems can uncover methods at the design level that can reduce the occurrence of the errors.
Cause-and-effect diagrams or matrices can be helpful in identifying alternative design techniques to reduce the occurrence of problems experienced by users. Added investment in these types of analyses can prove valuable. It not only can reduce the number of complaints received from customers, but also may result in the creation of a product that is easier to use, which contributes to higher customer satisfaction. Manufacturers must also consider the benefits of reducing the liability risk that might be attributed to the so-called user errors.
Poor human factors design is being increasingly identified as a significant cause of medical errors. Those errors result from both failures in the design of medical products and changes in society's expectations for product design. As a result, it is becoming increasingly important for medical product manufacturers to emphasize human factors engineering.
Designers and manufacturers can apply specific design and testing techniques to reduce the initial risk of human error, and they can implement continual improvement programs to reduce risk after new-product introduction. The advantages of participating in a human factors engineering program have traditionally been stressed from a customer-satisfaction perspective; however, the reduced liability risk is potentially a much greater benefit to manufacturers.
1. "FY 2003 Justification of Estimates for Appropriations Committees," in FY 2003 Budget Summary, Food and Drug Administration, Department of Health and Human Services, (Rockville, MD: FDA, 2002), 2.
2. Do It By Design FDA, (Rockville, MD: 1996), 9.
3. M Harry and R Schroeder, Six Sigma: The Breakthrough Management Strategy Revolutionizing the World's Top Corporations (New York: Doubleday, 2000), 225.
4. GA Miller, "The Magic Number Seven, Plus or Minus Two: Some Limits on Our Capacity for Processing Information," The Psychological Review 63 (1956): 81â€“97.
5. M Sanders and E McCormick, Human Factors in Engineering and Design (New York: McGraw-Hill 1993), 680.
6. "Human Factors Design Process for Medical Devices," ANSI/AAMI HE74:2001 (AAMI, 2001), 13.
7. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Rockville, MD: FDA, May 29, 1998), 12.
Christine Engelke is a software quality engineer at Certified Software Solutions Inc. (San Diego). Daniel Olivier is president of Certified Software Solutions Inc.
Copyright Â©2002 Medical Device & Diagnostic Industry
The department of Electrical and Microelectronic Engineering (EME) offers bachelorâ€™s, masterâ€™s and doctoral degrees that combine the rigor of theory with the flexibility of engineering practice. From technology development to technology application, the innovations of electrical and microelectronic engineers are shaping our future.
The departmentâ€™s mission is to establish its electrical and microelectronic engineering programs among the top programs in the world by providing high quality, inclusive education that cultivates intellectual curiosity. Our curricula apply mathematical and scientific foundations to the varied electrical and microelectronic disciplines in order to train high quality, independent thinking engineers and researchers that make measurable impacts on the world.Â
Electrical engineering is a discipline concerned with the study, design, and application of equipment, devices, and systems that use electricity, magnetism, and electromagnetism. The discipline is divided into multiple focus areas, including:Â Analog and Mixed-Signal Electronics, Electronic Devices and Components, Digital and Computer Systems, Electromagnetics and Waves, Mechatronics, Electrical Power Systems, Telecommunications, Signal Processing, Machine Learning, Artificial Intelligence, Robotics. As a result, electrical engineers work in a wide variety of industries and are required to possess skills such as device modeling, circuit design, system architecture, algorithm development, and project management. Electrical engineers intensively use computer assisted design tools and methods, and test equipment.
Microelectronic engineering focuses on the study, design, and fabrication of very small electronic devices and components (micrometer scale or below). These are semiconductor and photonic devices that impact virtually every aspect of human life, from communication, entertainment, and transportation, to health, solid-state lighting, and solar cells. There is an ever-increasing need for talented engineers that not only understand the design of these devices but can direct and optimize their fabrication. Integrated nanoelectronic and microelectronic circuits and sensors drive our global economy, increase our productivity, and help Strengthen our quality of life.Â
The BS degrees in electrical engineering and microelectronic engineering are accredited by the Engineering Accreditation Commission of ABET, www.abet.org, which certifies that they meet the highest quality standards of the corresponding professions and that the graduates are well prepared to enter a global workforce.
For Enrollment and Graduation Data, Program Educational Objectives, and Student Outcomes, please visit the collegeâ€™s Accreditation page.
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