Hazard Analysis in Engineering Design
|
|
|
- Chrystal Thomas
- 10 years ago
- Views:
Transcription
1 Hazard Analysis in Engineering Design Introduction The National Society of Professional Engineers (NSPE) is the society for registered professional engineers which was founded in 1934 and has approximately 60,000 members. NSPE has articulated a Code of Ethics for Engineers that spans the entire range of engineering and is widely accepted by professional engineers. In the preamble to the code, the following statement is made: the services provided by engineers require honesty, impartiality, fairness and equity, and must be dedicated to the protection of the public health, safety, and welfare. (emphasis added) The NSPE code of ethics lists six fundamental canons. The FIRST of those canons is stated as follows: Engineers, in the fulfillment of their professional duties, shall hold paramount the safety, health and welfare of the public. (emphasis added) Associated with the first fundamental canon are five rules of practice, two of which are stated as follows: a. If engineers' judgment is overruled under circumstances that endanger life or property, they shall notify their employer or client and such other authority as may be appropriate. (emphasis added) e. Engineers having knowledge of any alleged violation of this Code shall report thereon to appropriate professional bodies and, when relevant, also to public authorities, and cooperate with the proper authorities in furnishing such information or assistance as may be required. (emphasis added) It is significant that the first duty of an engineer, according to the NSPE, is to be dedicated to the protection of the public health, safety, and welfare. This obligates a design engineer to assess potential failure modes and the resulting hazards to people for every design as part of the engineering design process. The Accreditation Board for Engineering and Technology (ABET) accredits university engineering and technology programs of all varieties across the United States. ABET [1997] has published a Code of Ethics for Engineers. The FIRST TWO of the four Fundamental Principles are -- Engineers uphold and advance the integrity, honor and dignity of the engineering profession by: using their knowledge and skill for the enhancement of human welfare; (emphasis added) being honest and impartial, and serving with fidelity the public, their employers and clients; (emphasis added) The FIRST Fundamental Canon is stated as follows: 1. Engineers shall hold paramount the safety, health and welfare of the public in the performance of their professional duties. (emphasis added) Obviously ABET agees with NSPE that the first duty of an engineer is to protect public health, safety, and welfare. ASME International (formerly the American Society of Mechanical Engineers) is the principal professional society for mechanical engineers which was founded in 1880 and has a membership of approximately 125,000 worldwide. ASME International has published a Code of Ethics for Engineers which contains three fundamental principles. The FIRST of those fundamental principles is stated as follows: 2001, Dale O. Anderson, Ph.D. 1 Louisiana Tech University
2 Engineers uphold and advance the integrity, honor and dignity of the engineering profession by using their knowledge and skill for the enhancement of human welfare. (emphasis added) The ASME code also lists eight fundamental canons, the FIRST of which is stated as follows: Engineers shall hold paramount the safety, health and welfare of the public in the performance of their professional duties. (emphasis added) The ASME code presents the following statements of interpretation for the first fundamental canon: a. Engineers shall recognize that the lives, safety, health and welfare of the general public are dependent upon engineering judgments, decisions and practices incorporated into structures, machines, products, processes and devices. (emphasis added) b. Engineers shall not approve or seal plans and/or specifications that are not of a design safe to the public health and welfare and in conformity with accepted engineering standards. (emphasis added) c. Whenever the Engineers' professional judgments are over ruled under circumstances where the safety, health, and welfare of the public are endangered, the Engineers shall inform their clients and/or employers of the possible consequences. (emphasis added) (1) Engineers shall endeavor to provide data such as published standards, test codes, and quality control procedures that will enable the users to understand safe use during life expectancy associated with the designs, products, or systems for which they are responsible. (2) Engineers shall conduct reviews of the safety and reliability of the designs, products, or systems for which they are responsible before giving their approval to the plans for the design. (emphasis added) (3) Whenever Engineers observe conditions, directly related to their employment, which they believe will endanger public safety or health, they shall inform the proper authority of the situation. (emphasis added) d. If engineers have knowledge of or reason to believe that another person or firm may be in violation of any of the provisions of these Canons, they shall present such information to the proper authority in writing and shall cooperate with the proper authority in furnishing such further information or assistance as may be required. (emphasis added) Obviously ASME International agees with the NSPE and ABET that the first duty of an engineer is to protect public health, safety, and welfare. The ASME Code of Ethics for Engineers First Fundamental Canon, statements b and c.2 specifically advise engineers to conduct an analysis of the safety of a design, product or system before approving the plans. In the chemical industry, US government regulations require a process hazard analysis -- OSHA's Process Safety Management standard 29CFR , and EPA's Risk Management Program Rule 40 CFR Part 68. Most hazard analysis methodologies presented herein may be used either for product or process design or redesign. The Engineering Design Process The engineering design process is part of the overall product or process realization process which takes an idea from conception through implementation to obsolescence. It involves a very detailed cradle to grave analysis. Once a decision has been made to develop a new product or process, the engineering design process to achieve it may be described as follows: 2001, Dale O. Anderson, Ph.D. 2 Louisiana Tech University
3 1. Conceptual design/taguchi systems design [Taguchi et al, 1989] generate multiple potential solutions. Perform quick and dirty initial analyses of each potential solution. Benchmark the potential solutions against a common set of requirements and select the most promising. 2. Detailed design/taguchi parameter and tolerance design [Taguchi et al, 1989] perform detailed analyses on the selected solution to determine functionality, geometry, size, fit, finish, tolerances, human interface, safety, etc. Develop all of the models, specifications, drawings and plans necessary for production, distribution, use and disposal. The conceptual design step is characterized by the generation of multiple potential product or process ideas. These ideas may come from the natural evolution of existing products or processes, benchmarking competing products or processes, market surveys, new knowledge, or the generation of new and different ideas (brainstorming). Each of these ideas undergoes preliminary analysis to create a common basis for comparison. The ideas are then compared against each other (a benchmarking process) and the idea judged to have the highest probability of success is selected for further development. The detailed design process then fleshes out the idea into a workable design and produces all of the information necessary to implement the selected design. Problems that are solved very early in the design process incur insignificant development cost and provide very large potential revenue gains through simplified production, increased consumer satisfaction, increased market share, and reduced product liability. Problems that are solved late in the design process or after production has begun usually incur substantial development cost and implementation delay. Design for Safety Design for Safety [Bralla, 1996, pp ] is a design methodology that protects the health, safety and welfare of the customer, the public, and the workers who manufacture and distribute the product. It requires that the potential hazards inherent in the manufacture, distribution, use, and disposal of a product be identified in the design phase and mitigated as much as possible. While it may not be possible to remove all hazards from a product (eg. the sharp kitchen knife), the number and severity of the hazards should be minimized and the customer warned about the hazards that remain. The first step in identifying the hazards associated with any system is to identify all possible ways the system might fail through internal faults, customer use and abuse, and use in challenging environments. Potential failure modes for mechanical components and systems may be listed as follows [after Dieter, 2000, p. 559]: 1. Elastic deformation 2. Brittle fracture 3. Plastic deformation, creep, yielding 4. Ductile failure, buckling, ductile fracture, stress rupture, yielding 5. Fatigue failure: corrosion induced, fretting induced, high-cycle, impact induced, low-cycle, surface, thermal induced, vibration induced 6. Impact/shock induced failure: deformation, fatigue, fracture, fretting, wear 7. Wear: adhesive, abrasive, cavitation, corrosive, deformation induced, erosion, fretting, galling, impact induced, scoring, surface fatigue, surface pitting 8. Thermally induced failure: change of material properties, deformation, thermal shock 9. Bonding failure, delamination 10. Corrosion/chemical attack: galvanic, crevice, hydrogen, intergranular, leaching, oxidation, pitting 11. Combined failure: creep induced buckling and fatigue, thermally induced deformation, etc. 12. Mechanical interface failure: decoupling, interference, seizing, slipping, 13. Biological/environmental attack: animals, decay, insects, people, plants, weather 14. Radiation damage: infrared, microwave, nuclear, ultraviolet (UV) 2001, Dale O. Anderson, Ph.D. 3 Louisiana Tech University
4 Potential failure modes for electrical components and systems may be listed as follows: 1. Overvoltage conditions 2. Undervoltage conditions 3. Open circuit failures: what leads to loss of output? 4. Short circuit failures: what happens with the system output is shorted out? 5. Thermal problems: change in material properties, operating temperature, thermal expansion, thermal runaway 6. Mechanical problems: component insertion/removal, vibration 7. Component burnout: how does one failed component affect the system? 8. Supply power problems: fundamental frequency, high frequency noise, RMS and P-P voltage, waveform 9. Time domain signal anomalies: noise, spurious signals, waveform 10. Frequency domain signal anomalies: aliasing, distortion, spectral content MIL-STD-1629A requires that the following minimum set of system failure modes be considered: 1. Premature operation. 2. Intermittent operation. 3. Failure to operate at a prescribed time. 4. Failure to cease operation at a prescribed time. 5. Loss of output or failure during operation. 6. Degraded output or operational capability. Once the potential failure modes have been identified, then the hazards associated with them can be determined. The failure modes should be examined from the greatest hazard to the least in an effort to eliminate the failure mode or mitigate the hazard caused by it. The goal of design for safety is to produce a product or process with the minimum potential hazard exposure. Design for Safety is discussed by the following authors: Atila & Jones [1993, pp ], Bralla [1996, pp ], Dieter [2000, pp ], Lindbeck [1995, pp ] and Voland [1999, pp ]. Historical Failure and Hazard Information Historical information on the performance and problems of existing products and processes is useful to the design engineer. Such information is available in customer service departments and repair facilities as part of their normal activities. It need only be collected and archived for future reference. It may also be collected as part of a market survey. In addition, litigation filed for personal injury and product liability can be scanned for cases involving similar products or processes and the allegations can be examined. A significant number of similar complaints about a product or process may indicate a problem that should be addressed in the next redesign cycle. By systematically removing potential hazards from a product or process it is made safer and therefore more desirable to the customer, assuming the price does not increase significantly beyond inflation. In addition, the exposure to litigation is reduced, thereby saving additional costs. Intelligent Fast Failure Intelligent fast failure [Matson, 1991] is a conceptual design methodology in which potential solutions which are known to be unsuitable or unworkable are compiled by an idea generation process such as brainstorming. These unsuitable potential solutions may be used in conjunction with a list of potentially suitable solutions to define the limits of the design space within which the engineer must work. The intelligent fast failure process may easily incorporate a qualitative analysis of potential failure modes and hazards of the ideas generated. This information may then be used to guide the benchmarking process used to select the design idea that will be developed and implemented. Using this methodology, a design engineer is aware from the outset of potential failure modes and 2001, Dale O. Anderson, Ph.D. 4 Louisiana Tech University
5 hazards of each new design and may take steps to minimize the hazards during the design process at little additional cost. Failure Modes and Effects Analysis (FMEA) Failure Modes and Effects Analysis is a formal methodology for identifying potential failure modes and their associated hazards which is suitable for detailed engineering design of a product or process. Middendorf [1998, p. 46] [1990, pp. 40-1] describes the steps as follows: 1. Describe the system or process whose failure modes are sought. 2. Identify the ways in which the system or process might fail. These failure modes may be identified by historical data, personal experience, or a process similar to brainstorming. 3. Identify the symptoms of each failure mode that might aid in detection. 4. Determine the effects of each failure mode should it occur look at property damage and hazard to people. 5. Assess the probability of each failure mode occurring. A qualitative ranking may be used if statistical data is not available a low ranking means a low probability of occurrence. 6. Assess the risk (probability) of personal injury and property damage for each failure mode. Again, a qualitative ranking may be used in the absence of statistical data. 7. Compute a danger index from the numbers assigned in steps 5 & 6 multiply the probabilities or rankings together. The FMEA is normally presented as a table. The danger index is a ranking of the risks associated with each design. The failure modes should be examined for possible mitigation through design changes starting with the highest danger index and proceeding to the lowest. It is usually not possible to completely eliminate all failure modes from a consumer product but the hazard to people should be minimized as much as possible. This process should also minimize the exposure of the manufacturer to product liability litigation. McDermott, et. al, [1996, pp ] and Dieter [2000, pp ] propose rating scales for failure severity, probability of occurrence, and probability of detection as shown in tables 1-3. Given ratings in all three categories for each failue mode, a risk priority number (RPN) is computed as follows: RPN = (failure severity) X (probability of occurrence) X (probability of detection) (1) The failure modes should be ranked in descending order by RPN and those at the top of the list should be addressed first. A high RPN indicates a significant risk of system failure and hazard that should be mitigated if possible by redesigning the system to reduce effect severity, reduce the probability of occurrence, and increase the probability of detection. Once changes have been made to the design, the severity, occurrence, detection, and RPN values are recomputed for the affected failure modes. All potential failure modes cannot be eliminated from all systems, but the goal of the design process should be to minimize RPNs of the system. A minimum RPN should correspond to maximum public safety and minimum exposure to litigation. 2001, Dale O. Anderson, Ph.D. 5 Louisiana Tech University
6 Table 1. Rating Scale for Failure Effect Severity Rating Description Effect on System or Customer Potential for Property Damage Potential Hazard 1 Not noticeable almost none almost none almost none 2 Very minor noticeable almost none almost none 3 Minor customer annoyed almost none almost none 4 Slight customer annoyed almost none almost none system needs service 5 Moderate customer complains minor slight system needs service 6 Significant customer complains moderate slight partial system malfunction 7 Major customer dissatisfied significant minor injury major system malfunction 8 Extreme system inoperable or unfit for use major injury 9 Critical system inoperable or unfit for use extreme serious injury 10 Hazardous system inoperable or unfit for use extreme life threatening injury Table 2. Rating Scale for Probability of Occurrence Dieter [2000, p. 552] McDermott [1996, p. 37] Rating Description One Occurrence per _?_ Events One Occurrence per _?_ Events One Occurrence 1 Extremely remote 1,000, ,000,000 in 5+ years 2 Highly unlikely 100, ,000,000 in 3-5 years 3 Very slight chance 25,000 1,666,667 in 1-3 years 4 Slight chance 2,500 16,667 per year 5 Occasional ,000 in 6 months 6 Moderate in 3 months 7 Fairly frequent per month 8 High 5 20 per week 9 Very high 3 3 every few days 10 Extremely high 2 3 per day Table 3. Rating Scale for Probability of Failure Detection Rating In Service Manufacturing QC 1 Almost certain 100% automatic inspection (SPC) + routine calibration & maintenance 2 Very high 100% automatic inspection (SPC) 3 High 100% SPC (C pk 1.33) 4 Moderately high 100% SPC 5 Moderate some SPC plus 100% final inspection 6 Low 100% manual inspection using go/no-go gauges 7 Slight 100% manual inspection in the process 8 Remote samples inspected, 100% no defects 9 Very remote samples inspected by acceptable quality level 10 Almost none no inspection 2001, Dale O. Anderson, Ph.D. 6 Louisiana Tech University
7 Failure Modes and Effects Analysis (FMEA) is discussed by the following authors: Christianson & Rohrbach [1986, pp ], Dieter [2000, pp ] [1991, pp ], McDermott, et. al, [1996], Middendorf [1990, pp. 40-2], Middendorf & Englemann [1998, pp. 46], Pugh [1990, pp ] and Voland [1999, pp ]. Failure Modes, Effects And Criticality Analysis (FMECA) The US Department of Defense has published MIL-STD-1629A [1980] which defines the standard procedures for performing a Failure Modes, Effects and Criticality Analysis (FMECA). FMECA is essentially FMEA with the additional step of evaluating the criticality of each failure mode (a process similar to computing the RPN for each failure mode). The DOD recommends that the FMECA be initiated early in the conceptual design process and updated as the design evolves. In FMECA, each a failure mode is assigned a probability of occurrence. In the absence of probability data, the following levels may be used: Level A Level B Level C Level D Level E Frequent the highest probability of occurrence. Reasonably probable Occasional Remote Extremely unlikely the lowest probability of occurrence Each effect is assigned a severity index (ranking) based on MIL-STD-882, which are listed as follows: Category I Category II Category III Category IV Catastrophic a failure which may cause death or whole system loss. Critical a failure which may cause severe injury, major property damage, or major system damage which results in mission loss. Marginal -- a failure which may cause minor injury, minor property damage, or minor system damage which will result in delay or loss of system availability or mission degradation. Minor -- a failure not serious enough to cause injury, property damage, or system damage, but which will result in unscheduled maintenance or repair. At each design review, the failure modes leading to category I and II severities are discussed. The criticality analysis ranks each potential failure mode identified according to the combined influence of the probability of occurrence and the severity index. The failure modes with the highest criticality rankings should be addressed first to reduce both the probability of occurrence and the severity of the effect. Fault Tree Analysis (FTA) Fault Tree Analysis is a graphical flow charting method that connects potential system faults (failures) to expected outcomes (hazards) using a logic diagram. It was originally developed for analyzing electrical systems. Given fault probabilities, the probability of potential outcomes may be determined. A fault tree is essentially a graphical presentation of a Failure Modes and Effects Analysis. Middendorf [1998, pp ] [1990, pp ] states that FTA starts with the identification of potential hazards in the design. Both hazard to people and property damage are considered. Each potential hazard is depicted as the output block in a logic diagram. Next the combination of faults necessary to produce each hazard are determined. This combination of faults is depicted as a logic circuit ending in the potential hazard. Probabilities for the occurrence of each fault may be assigned and the probability of occurrence of the hazard may be determined by combining the fault probabilities according to the logic diagram. 2001, Dale O. Anderson, Ph.D. 7 Louisiana Tech University
8 Fault Tree Analysis (FTA) is discussed by the following authors: Christianson & Rohrbach [1986, p. 176], Dieter [2000, pp ] [1991, pp ], Middendorf [1990, pp ], Middendorf & Englemann [1998, pp ], Pugh [1990, pp ] and Voland [1999, pp ]. Hazard Analysis and Critical Control Points (HACCP) Hazard Analysis and Critical Control Points (HACCP) [USFDA, 2001] was developed by the Pillsbury Company in 1960 to provide quality control for foods produced for the US space program. It was adopted by the US Food and Drug Administration in 1973 and has since been mandated for many types of food processing industries and medical device manufacturers. There are seven principles of HACCP: 1. Conduct hazard analysis. Prepare a list of steps in the manufacturing process where significant hazards occur and identify preventive measures. Data from risk management tools such as Fault Tree Analysis (FTA), Failure Modes Effects Analysis (FMEA), and Failure Modes Effects Criticality Analysis (FMECA) should be used, if available, to identify the hazards in a HACCP system. 2. Identify the critical control points (CCP). A CCP is a step or procedure at which control can be applied and a safety hazard can be prevented, eliminated, or reduced to acceptable levels. 3. Establish critical limits for preventive measures associated with each CCP identified. 4. Establish CCP monitoring requirements. Establish procedures for using monitoring results to adjust the process and maintain control. 5. Establish corrective actions to be taken when a critical limit deviation occurs. 6. Establish procedures for verification that the HACCP system is working correctly. 7. Establish effective record-keeping procedures that document the HACCP system. HACCP appears to be an extension to FMEA for processes that identifies specific control points in the process where monitoring and corrective action can be done. It is designed to facilitate government regulatory efforts and therefore requires substantial record keeping. Hazard and Operability Study (HAZOP) Hazard and Operability Study (HAZOP) [Voland, 1999, pp ], developed in the UK for chemical plants, is a team-based, systematic, qualitative method for identifying the hazards involved in process industries. The study begins by considering deviations from the desired performance of the process using guide words such as more, less, none, part of, other than, etc. The team then considers the consequences of each deviation by asking questions such as: Will someone be harmed? Who? In which way? How severely? Will the processes performance be reduced? In which way? How severely? What will be the impact? Will costs increase? By how much? Will there be any cascading effects where this deviation leads to other deviations? What are they? Finally, the team develops an action plan to eliminate or minimize the deviations and their consequences. Hazard and Operability Study (HAZOP) is discussed by the following authors: Kletz [1991] and Voland [1999, pp ]. 2001, Dale O. Anderson, Ph.D. 8 Louisiana Tech University
9 Hazards Analysis (HAZAN) Hazards Analysis (HAZAN) [Voland, 1999, pp ], developed in the UK for chemical plants, is a systematic probabilistic analysis method for quantifying the importance of hazards involved in process industries that is usually done by one or two people. HAZAN can be summarized in three basic questions: How often? (How often will the hazard occur?) How big? (What are the consequences of occurrence?) So what? (How important is this hazard compared to all the others?) Once the hazards are identified, efforts are made to eliminate them or at least to reduce the frequency of occurrence beginning with the most important and continuing to the least important. For those hazards that cannot be completely eliminated, efforts are made to minimize the consequences and warn those potentially affected. HAZAN appears to be very similar to FMEA. The question How often? identifies the probability of occurrence. The question How big? identifies the severity of the hazard. The probability of detection is not used in HAZAN. The question So what? identifies an overall hazard rating, similar to an RPN, that allows the hazards to be ranked and considered in order of importance. 323]. Hazards Analysis (HAZAN) is discussed by the following authors: Kletz [1991] and Voland [1999, pp Root Cause Analysis Root Cause Analysis [Lumsdaine, 1995, p. 16] was developed by the Ford Motor Company to handle problems that arose in their business processes. Ford calls it the 8-D Method because they have defined eight steps as follows: 1. Form a team. 2. Define the problem. 3. Handle the current emergency. 4. Find the root causes of the problem/emergency. 5. Test potential corrective actions and devise the best plan of action. 6. Implement the plan of action. 7. Prevent recurrence of the problem/emergency. 8. Congratulate the team for a job well done. Obviously the task of finding the root cause of a problem is at the heart of this method. Frequently, checklists are developed and used to assist in this task. Management Oversight and Risk Tree (MORT) is a commonly used checklist for evaluating management involvement in a problem. When appropriate checklists are not available, the team must devise their own using idea generation techniques such as brainstorming. Root Cause Analysis has become a widely accepted tool in quality control circles. It is evident that it can be used to facilitate the process of finding failure modes in the FMEA and FTA methods. Root Cause Analysis is discussed by the following authors: Lumsdaine [1995, p. 16] Cause and Effect Diagram A Cause and Effect Diagram [Ishikawa, 1982], also knows as fishbone or Ishikawa diagram, is a directed graph connecting potential causes (faults) to an effect (hazard or outcome). It is hierarchical and usually end up 2001, Dale O. Anderson, Ph.D. 9 Louisiana Tech University
10 looking like the skeleton of a fish (hence the name fishbone diagram). It is a convenient and useful way to graphically represent a Failure Modes and Effects Analysis, although it is not as quantitative as a fault tree. Focus on work Work Habits Study Skills Read other texts in library Work example Review for exams problems Condense notes Start homework early Review with friends Work comes Ask questions before parties Schedule Take good notes study time Read well Assignments Participate in class Turn in completed reports Turn in completed homework Take exams Eat regularly Punctual Good night's sleep Have text & notebook Aerobic & toning exercise Awake No alcohol or illegal drugs Ask questions Easy on the tobacco Prepared Easy on the caffine Read assignment Easy on the junk food Work examples Annual checkup Look at homework Personal Health In Class Fig. 2 A Sample Cause and Effect Diagram Final Grade Cause and Effect Diagrams are discussed by the following authors: Dieter [2000, pp ], Ishikawa [1982], Voland [1999, p. 328]. Discussion and Recommendations James G. Bralla, a manufacturing consultant, has stated [1996, p. 195] Safety is a vital issue. From a human standpoint and probably from a cost standpoint as well, it may be the most important consideration of all in product design. Safety during the manufacture, safety during use, and safety after the disposal of the product are all important. George Dieter, Dean of Engineering and Professor of Mechanical Engineering at University of Maryland, recommends [1983] that industry engage in more defensive research to minimize exposure to litigation. This means that the potential hazards of each product must be identified and an effort made to minimize the risk of injury to the consumer. Every design can be improved and the risk of injury reduced, however, in most cases some hazards cannot be completely eliminated. For those hazards that remain in the product, clearly and simply written warning labels and owner manuals must be written and provided to the consumer. Juvinall & Marchek recommend [1991] that design engineers make safety an integral part of the product design. As potential hazards are identified, incorporate appropriate safety features into the design. Sometimes this means using an entirely new approach in the product. Provide warning labels and warnings in the user documentation about significant unavoidable hazards that remain in the product. Shigeo Shingo developed and championed the poke-yoke system [1986] of mistake-proofing the assembly process. It improves safety during manufacturing and product quality by designing the product and assembly process to avoid potential errors, problems and hazards during assembly. W. Edwards Deming, considered by many to be the father of the modern quality revolution, has stated [1986, p. 396] I would not participate in any attempt to use cost/benefit analysis for design of product where possible 2001, Dale O. Anderson, Ph.D. 10 Louisiana Tech University
11 injury or loss of life is at risk. Hazards to people should be eliminated where ever possible. Attempting to quantify the cost of injury or death and balance it against potential profits from a consumer product clearly does NOT satisfy the first fundamental canon of the NSPE Code of Ethics for Engineers to hold paramount the safety, health and welfare of the public. Design decisions that affect safety should be made before decisions based on economics. References: Accreditation Board for Engineering and Technology (ABET), 1997, Code of Ethics for Engineers, Baltimore, MD, ASME International (American Society of Mechanical Engineers), 1998, Code of Ethics for Engineers, New York, NY, ( Bralla, James G., 1996, Design for Excellence, McGraw-Hill, New York. (ISBN ) Christianson, L. L. and R. P. Rohrbach, 1986, Design in Agricultural Engineering, American Society of Agricultural Engineers, St. Joseph, MI. (ISBN ) Deming, W. Edwards, 1986, Out of The Crisis, MIT Center for Advanced Engineering Studies, Cambridge, MA. (ISBN ) Dieter, George E., 2000, Engineering Design, 3 rd ed., McGraw-Hill, New York. (ISBN ) Dieter, George E., 1991, Engineering Design, 2 nd ed., McGraw-Hill, New York. (ISBN ) Dieter, George E., 1983, Engineering Design, McGraw-Hill, New York. (ISBN ) Ertas, Atila and Jesse C. Jones, 1993, The Engineering Design Process, Wiley, New York. (ISBN ) Ishikawa, K., 1982, Guide to Quality Control, Quality Resources, White Plains, NY. Juvinall, R. C. & K. M. Marchek, 1991, Fundamentals of Machine Component Design, 2 nd ed., Wiley, New York. (ISBN ) Kletz, T. A., 1991, HAZOP and HAZAN: Identifying and Assessing Process Industry Hazzards, 3 rd ed., Institution of Chemcial Engineers, Rugby, Warwickshire, UK. Lindbeck, John R., 1995, Product Design and Manufacture, Prentice Hall, Upper SaddleRiver, NJ. (ISBN ) Lumsdaine, Edward & Monika Lumsdaine, 1995, Creative Problem Solving, McGraw-Hill, New York. (ISBN ) Matson, J. V., 1991, The Art of Innovation: Using Intelligent Fast Failure, Penn State University, University Park, PA. McDermott, R. E., R. J. Mikulak and M. R. Beauregard, 1996, The Basics of FMEA, Productivity, Portland, OR. (ISBN ) Middendorf, W. H. and R. H. Englemann, 1998, Design of Devices and Systems, 3 rd ed., Marcel Dekker, New York. (ISBN ) Middendorf, W. H., 1990, Design of Devices and Systems, 2 nd ed., Marcel Dekker, New York. (ISBN ) MIL-STD-1629A, 1980, Military Standard Procedures For Performing A Failure Mode, Effects And Criticality Analysis, Department of Defense, Washington, DC. ( National Society of Professional Engineers (NSPE), Code of Ethics for Engineers, Alexandria, VA, ( Pugh, Stuart, 1990, Total Design: Integrated Methods for Successful Product Engineering, Addison-Wesley, Reading, MA. (ISBN ) Shingo, Shigeo, 1986, Zero Quality Control: Source Inspection and the Poka-Yoke System, Productivity Press, Stamford, CT. [ISBN ] Taguchi, Genichi, Elsayed A. Elsayed & Thomas Hsaing, 1989, Quality Engineering In Production Systems, McGraw-Hill, New York. (ISBN ) US Food and Drug Administration, Center for Devices and Radiological Health, 2001, Hazard Analysis and Critical Control Points (HACCP) Inspections, ( Voland, Gerald, 1999, Engineering by Design, Addison Wesley, Reading, MA. [ISBN ] 2001, Dale O. Anderson, Ph.D. 11 Louisiana Tech University
Risk Assessment for Medical Devices. Linda Braddon, Ph.D. Bring your medical device to market faster 1
Risk Assessment for Medical Devices Linda Braddon, Ph.D. Bring your medical device to market faster 1 My Perspective Work with start up medical device companies Goal: Making great ideas into profitable
Risk Assessment and Management. Allen L. Burgenson Manager, Regulatory Affairs Lonza Walkersville Inc.
Risk Assessment and Management Allen L. Burgenson Manager, Regulatory Affairs Lonza Walkersville Inc. Standard Disclaimer Standard Disclaimer: This presentation is the opinion of the presenter, and does
Failure Modes & Effects Analysis
The Failure Modes and Effects Analysis (FMEA), also known as Failure Modes, Effects, and Criticality Analysis (FMECA), is a systematic method by which potential failures of a product or process design
Occupational safety risk management in Australian mining
IN-DEPTH REVIEW Occupational Medicine 2004;54:311 315 doi:10.1093/occmed/kqh074 Occupational safety risk management in Australian mining J. Joy Abstract Key words In the past 15 years, there has been a
Title: Basic Principles of Risk Management for Medical Device Design
Title: Basic Principles of Risk Management for Medical Device Design WHITE PAPER Author: Ganeshkumar Palanichamy Abstract Medical devices developed for human application are used for diagnostic or treatment
Software-based medical devices from defibrillators
C O V E R F E A T U R E Coping with Defective Software in Medical Devices Steven R. Rakitin Software Quality Consulting Inc. Embedding defective software in medical devices increases safety risks. Given
University of Paderborn Software Engineering Group II-25. Dr. Holger Giese. University of Paderborn Software Engineering Group. External facilities
II.2 Life Cycle and Safety Safety Life Cycle: The necessary activities involving safety-related systems, occurring during a period of time that starts at the concept phase of a project and finishes when
Reliability Analysis A Tool Set for. Aron Brall
Reliability Analysis A Tool Set for Improving Business Processes Aron Brall ManTech International 1 Introduction Outline Defining Business Process Reliability Quantifying Business Process Reliability Business
Risk Assessment Tools for Identifying Hazards and Evaluating Risks Associated with IVD Assays
Risk Assessment Tools for Identifying Hazards and Evaluating Risks Associated with IVD Assays Robert C. Menson, PhD AACC Annual Meeting Philadelphia, PA 22 July 2003 What Risks Must Be Managed? Risk to
Introduction to HACCP Principles in Meat Plants1
Introduction to HACCP Principles in Meat Plants1 Jeff W. Savell Professor and E.M. Rosenthal Chairholder Department of Animal Science Institute of Food Science and Engineering Texas A&M University College
OPERATIONAL RISK MANAGEMENT B130786 STUDENT HANDOUT
UNITED STATES MARINE CORPS THE BASIC SCHOOL MARINE CORPS TRAINING COMMAND CAMP BARRETT, VIRGINIA 22134-5019 OPERATIONAL RISK MANAGEMENT B130786 STUDENT HANDOUT Basic Officer Course (ORM) Introduction Importance
3.0 Risk Assessment and Analysis Techniques and Tools
3.0 Risk Assessment and Analysis Techniques and Tools Risks are determined in terms of the likelihood that an uncontrolled event will occur and the consequences of that event occurring. Risk = Likelihood
3.4.4 Description of risk management plan Unofficial Translation Only the Thai version of the text is legally binding.
- 1 - Regulation of Department of Industrial Works Re: Criteria for hazard identification, risk assessment, and establishment of risk management plan B.E. 2543 (2000) ---------------------------- Pursuant
Designing an Effective Risk Matrix
Designing an Effective Risk Matrix HENRY OZOG INTRODUCTION Risk assessment is an effective means of identifying process safety risks and determining the most cost-effective means to reduce risk. Many organizations
Failure Analysis Methods What, Why and How. MEEG 466 Special Topics in Design Jim Glancey Spring, 2006
Failure Analysis Methods What, Why and How MEEG 466 Special Topics in Design Jim Glancey Spring, 2006 Failure Analysis Methods Every product or process has modes of failure. An analysis of potential failures
QUALITY RISK MANAGEMENT (QRM): A REVIEW
Lotlikar et al Journal of Drug Delivery & Therapeutics; 2013, 3(2), 149-154 149 Available online at http://jddtonline.info REVIEW ARTICLE QUALITY RISK MANAGEMENT (QRM): A REVIEW Lotlikar MV Head Corporate
Hazard/Risk Identification and Control Procedure
Hazard/Risk Identification and Control Procedure Introduction Hazard identification and the steps taken to minimize the risks associated with identified hazards are a critical component of working safely.
Improved Utilization of Self-Inspection Programs within the GMP Environment A Quality Risk Management Approach
Improved Utilization of Self-Inspection Programs within the GMP Environment A Quality Risk Management Approach Barbara Jeroncic Self-inspection is a well-established and vital part of the pharmaceutical
Guidance for Industry
Guidance for Industry Q9 Quality Risk Management U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation
Quality Risk Management ICH Q9 & ISO 14971. Presented by Michael Kerr 11 th November 2011
Quality Risk Management ICH Q9 & ISO 14971 Presented by Michael Kerr 11 th November 2011 Agenda Risk Concept QRM Fundamentals Regulatory Expectations Warning Letters / Observations Application of QRM Introduction:
Software Quality. Unit 2. Advanced techniques
Software Quality Unit 2. Advanced techniques Index 1. Statistical techniques: Statistical process control, variable control charts and control chart for attributes. 2. Advanced techniques: Quality function
RISK ASSESMENT: FAULT TREE ANALYSIS
RISK ASSESMENT: FAULT TREE ANALYSIS Afzal Ahmed +, Saghir Mehdi Rizvi*Zeshan Anwer Rana* Faheem Abbas* + COMSAT Institute of Information and Technology, Sahiwal, Pakistan *Navy Engineering College National
Controlling Risks Risk Assessment
Controlling Risks Risk Assessment Hazard/Risk Assessment Having identified the hazards, one must assess the risks by considering the severity and likelihood of bad outcomes. If the risks are not sufficiently
Quality Risk Management Understanding and Control the Risk in Pharmaceutical Manufacturing Industry
International Journal of Pharmaceutical Science Invention ISSN (Online): 2319 6718, ISSN (Print): 2319 670X Volume 4 Issue 1 January 2015 PP.29-41 Quality Risk Management Understanding and Control the
Power plant safety: a wise business move
Power plant safety: a wise business move Power plant safety: a wise business move Going to work in a controlled and safe environment is not an unreasonable expectation for any worker. In many occupations,
RISK MANAGEMENT FOR INFRASTRUCTURE
RISK MANAGEMENT FOR INFRASTRUCTURE CONTENTS 1.0 PURPOSE & SCOPE 2.0 DEFINITIONS 3.0 FLOWCHART 4.0 PROCEDURAL TEXT 5.0 REFERENCES 6.0 ATTACHMENTS This document is the property of Thiess Infraco and all
FINAL DOCUMENT. Global Harmonization Task Force
FINAL DOCUMENT Global Harmonization Task Force Title: Quality management system Medical Devices Guidance on corrective action and preventive action and related QMS processes Authoring Group: Study Group
LSST Hazard Analysis Plan
LSST Hazard Analysis Plan Large Synoptic Survey Telescope 950 N. Cherry Avenue Tucson, AZ 85719 www.lsst.org 1. REVISION SUMMARY: Contents 1 Introduction... 5 2 Definition of Terms... 5 2.1 System... 5
QUALITY RISK MANAGEMENT
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE QUALITY RISK MANAGEMENT Q9 Current Step 4 version
Total Quality Management TQM Dr.-Ing. George Power. The Evolution of Quality Management
Total Management TQM Dr.-Ing. George Power The Evolution of Management The Evolution of Management Assurance Total Control Companywide Control Mass Inspection Control (Acceptance Sampling) 2 Evolution
Quality Risk Management Tools Quality Risk Management Tool Selection When to Select FMEA: QRM Tool Selection Matrix
Quality Risk Management Tools Quality Risk Management Tool Selection When to Select FMEA: QRM Tool Selection Matrix 26 Quality Risk Management Tools The ICH Q9 guideline, Quality Risk Management, provides
Accident Investigation
Accident Investigation ACCIDENT INVESTIGATION/adentcvr.cdr/1-95 ThisdiscussionistakenfromtheU.S.Department oflabor,minesafetyandhealthadministration Safety Manual No. 10, Accident Investigation, Revised
Using a Failure Modes, Effects and Diagnostic Analysis (FMEDA) to Measure Diagnostic Coverage in Programmable Electronic Systems.
Using a Failure Modes, Effects and Diagnostic Analysis (FMEDA) to Measure Diagnostic Coverage in Programmable Electronic Systems. Dr. William M. Goble exida.com, 42 Short Rd., Perkasie, PA 18944 Eindhoven
Nuclear Power Plant Electrical Power Supply System Requirements
1 Nuclear Power Plant Electrical Power Supply System Requirements Željko Jurković, Krško NPP, [email protected] Abstract Various regulations and standards require from electrical power system of the
University of Ljubljana. Faculty of Computer and Information Science
University of Ljubljana Faculty of Computer and Information Science Failure Mode and Effects (and Criticality) Analysis Fault Tree Analysis Report Computer Reliability and Diagnostics Ľuboš Slovák Assoc.
The Original Quality Gurus
The Original Gurus What is a quality guru? A guru, by definition, is a good person, a wise person and a teacher. A quality guru should be all of these, plus have a concept and approach quality within business
CONCEPTS OF FOOD SAFETY QUALITY MANAGEMENT SYSTEMS. Mrs. Malini Rajendran
CONCEPTS OF FOOD SAFETY AND QUALITY MANAGEMENT SYSTEMS Mrs. Malini Rajendran Brief background 1963 - The Codex Alimentarius Commission was created by FAO and WHO to develop food standards, guidelines and
CAPA - the importance of data analysis
CAPA - the importance of data analysis Presented by: Sue Jacobs QMS Consulting, Inc. 1 847 359 4456 [email protected] QMS Consulting, Inc. 2007 1 Topics Regulatory Requirements Design Controls and
Failure Mode and Effect Analysis. Software Development is Different
Failure Mode and Effect Analysis Lecture 4-3 Software Failure Mode and Effects Analysis in Software Software Development, Pries, SAE Technical Paper 982816 Software Development is Different Process variation
FMEA and FTA Analysis
FMEA and FTA Analysis Why it is Coming to Your Hospital and Your Laboratory Tina A. Krenc Director, R&D Phase Systems Abbott Laboratories 1 Agenda Background on requirements for risk management Tools to
Fuzzy Knowledge Base System for Fault Tracing of Marine Diesel Engine
Fuzzy Knowledge Base System for Fault Tracing of Marine Diesel Engine 99 Fuzzy Knowledge Base System for Fault Tracing of Marine Diesel Engine Faculty of Computers and Information Menufiya University-Shabin
ISO 22000 Food Safety Management System
This is an ideal package for Food Manufacturers looking to meet International Food Safety Standards. This system meets the requirements of International Standard ISO 22000:2005 for Food Safety Management
A Risk Management Standard
A Risk Management Standard Introduction This Risk Management Standard is the result of work by a team drawn from the major risk management organisations in the UK, including the Institute of Risk management
FAILURE MODES AND EFFECTS ANALYSIS (FMEA)
FAILURE MODES AND EFFECTS ANALYSIS (FMEA) ABSTRACT Category: Analysis-Design Tools KEYWORDS Failure Modes and Effects Analysis (FMEA) (G) is a procedure that is performed after a failure mode effects analysis
Risk Management in IEC 60601-1 3 rd Edition. Presented by Alberto Paduanelli Medical Devices Lead Auditor, MHS-UK, TÜV SÜD Product Service
Risk Management in IEC 60601-1 3 rd Edition Presented by Alberto Paduanelli Medical Devices Lead Auditor, MHS-UK, TÜV SÜD Product Service General Information Time of presentation: 50-60 min. Questions
Quality Risk Management Principles and Industry Case Studies
Final Draft Rev. December 28, 2008 Quality Risk Management Principles and Industry Case Studies T. Frank 1, S. Brooks 2, R. Creekmore 3, B. Hasselbalch 4, K. Murray 5, K. Obeng 6, S. Reich 5, E. Sanchez
USING INSTRUMENTED SYSTEMS FOR OVERPRESSURE PROTECTION. Dr. Angela E. Summers, PE. SIS-TECH Solutions, LLC Houston, TX
USING INSTRUMENTED SYSTEMS FOR OVERPRESSURE PROTECTION By Dr. Angela E. Summers, PE SIS-TECH Solutions, LLC Houston, TX Prepared for Presentation at the 34 th Annual Loss Prevention Symposium, March 6-8,
employed to ensure the continuing reliability of critical systems.
4 Regulations 1989, Regulation 4, places a duty on employers to provide safe systems for their workers: Regulation 4 of the Electricity at Work Regulations 1989 Systems, work activities and protective
DRAWING NUMBER REVISION TITLE PAGE 90-2000-7.1 C Planning of Product Realization 1 of 5
90-2000-7.1 C Planning of Product Realization 1 of 5 WRITTEN BY: DATE: APPROVED BY: DATE: J. Caruso J. Porter PRODUCT RESOURCES NEWBURYPORT, MA USA NOTICE: THIS DOCUMENT IS PROPRIETARY AND ITS CONTENTS
PROJECT RISK MANAGEMENT
PROJECT RISK MANAGEMENT DEFINITION OF A RISK OR RISK EVENT: A discrete occurrence that may affect the project for good or bad. DEFINITION OF A PROBLEM OR UNCERTAINTY: An uncommon state of nature, characterized
TAGUCHI APPROACH TO DESIGN OPTIMIZATION FOR QUALITY AND COST: AN OVERVIEW. Resit Unal. Edwin B. Dean
TAGUCHI APPROACH TO DESIGN OPTIMIZATION FOR QUALITY AND COST: AN OVERVIEW Resit Unal Edwin B. Dean INTRODUCTION Calibrations to existing cost of doing business in space indicate that to establish human
The Philosophy of TQM An Overview
The Philosophy of TQM An Overview TQM = Customer-Driven Quality Management References for Lecture: Background Reference Material on Web: The Philosophy of TQM by Pat Customer Quality Measures Customers
Hazard Identification and Risk Assessment for the Use of Booster Fans in Underground Coal Mines
Hazard Identification and Risk Assessment for the Use of Booster Fans in Underground Coal Mines Felipe Calizaya Michael G. Nelson Mahesh Shriwas Feb 26, 2013 Outline Introduction Booster Fans in U/G Coal
Criteria for Flight Project Critical Milestone Reviews
Criteria for Flight Project Critical Milestone Reviews GSFC-STD-1001 Baseline Release February 2005 Approved By: Original signed by Date: 2/19/05 Richard M. Day Director, Independent Technical Authority
The Body of Quality Knowledge
Introduction According to Dr. Juran every profession needs a body of knowledge as one of the foundations that defines the profession and provides the basis for regulation of the profession. The Body of
The use of statistical problem solving methods for Risk Assessment
The use of statistical problem solving methods for Risk Assessment Citti P., Delogu M., Giorgetti A. University of Florence. DMTI, Department of Mechanics and Industrial Technology Via Santa Marta, 3 50121
Corrective and Preventive Action Background & Examples Presented by:
Corrective and Preventive Action Background & Examples Presented by: Kimberly Lewandowski-Walker Food and Drug Administration Division of Domestic Field Investigations Office of Regulatory Affairs Overview
ENGINEERING COMPETENCIES ENTRY LEVEL ENGINEER. Occupation Specific Technical Requirements
ENGINEERING COMPETENCIES ENTRY LEVEL ENGINEER Responsible for performing entry level engineering analysis, design, plan, review and inspection for small to medium projects and/or designated segments of
Systems Assurance Management in Railway through the Project Life Cycle
Systems Assurance Management in Railway through the Project Life Cycle Vivian Papen Ronald Harvey Hamid Qaasim Peregrin Spielholz ABSTRACT Systems assurance management is essential for transit agencies
Overview of Medical Device Design Controls in the US. By Nandini Murthy, MS, RAC
Overview of Medical Device Controls in the US By Nandini Murthy, MS, RAC 18 controls are a regulatory requirement for medical devices. In the US, compliance with the design controls section of 21 Code
SAFETY LIFE-CYCLE HOW TO IMPLEMENT A
AS SEEN IN THE SUMMER 2007 ISSUE OF... HOW TO IMPLEMENT A SAFETY LIFE-CYCLE A SAFER PLANT, DECREASED ENGINEERING, OPERATION AND MAINTENANCE COSTS, AND INCREASED PROCESS UP-TIME ARE ALL ACHIEVABLE WITH
Hazard Analysis and Critical Control Points (HACCP) 1 Overview
Manufacturing Technology Committee Risk Management Working Group Risk Management Training Guides Hazard Analysis and Critical Control Points (HACCP) 1 Overview Hazard Analysis and Critical Control Point
Quality Risk Management
PS/INF 1/2010 * * Quality Risk Management Quality Risk Management Implementation of ICH Q9 in the pharmaceutical field an example of methodology from PIC/S Document > Authors: L. Viornery (AFSSAPS) Ph.
Selecting Sensors for Safety Instrumented Systems per IEC 61511 (ISA 84.00.01 2004)
Selecting Sensors for Safety Instrumented Systems per IEC 61511 (ISA 84.00.01 2004) Dale Perry Worldwide Pressure Marketing Manager Emerson Process Management Rosemount Division Chanhassen, MN 55317 USA
A Short Guide to The Safety, Health and Welfare at Work Act, 2005
A Short Guide to The Safety, Health and Welfare at Work Act, 2005 3 A Short Guide to the Safety, Health and Welfare at Work Act, 2005 Published in August 2005 by the Health and Safety Authority, 10 Hogan
Mechanical Design/Product Design Process
Mechanical Design/Product Design Process Several Major Steps: Define project and its planning Identify customers (users) and their needs Evaluate existing similar products (benchmarking) Generate engineering
QA GLP audits. Alain Piton. Antipolis,, France. [email protected]
Risk based assessment applied to QA GLP audits Alain Piton Galderma R&D, Sophia-Antipolis Antipolis,, France [email protected] RISK BASED ASSESSMENT FOR GLP AUDITS INTRODUCTION Since the origin
Media fills Periodic performance qualification (Re-Validation)
Media fills Periodic performance qualification (Re-Validation) Minimum number of Simulations Number of units Contaminated Units Action a Two per Year (Retrospective & Prospective Validation) < 5000 5000
Upon completion of this activity, the participant should be able to:
The Utility of Root Cause Analysis and Failure Mode and Effects Analysis in the Hospital Setting Learning objectives: Upon completion of this activity, the participant should be able to: 1. Discuss the
ISO 14971: Overview of the standard
FDA Medical Device Industry Coalition ISO 14971: Overview of the standard Risk Management Through Product Life Cycle: An Educational Forum William A. Hyman Department of Biomedical Engineering Texas A&M
Guidance for Industry: Quality Risk Management
Guidance for Industry: Quality Risk Management Version 1.0 Drug Office Department of Health Contents 1. Introduction... 3 2. Purpose of this document... 3 3. Scope... 3 4. What is risk?... 4 5. Integrating
Title: OHS Risk Management Procedure
Issue Date: July 2011 Review Date: July 2013 Page Number: 1 of 9 1. Purpose: To outline the methodology by which Department of Education and Early Childhood Development (DEECD) identifies, assesses, controls
Introduction. Chapter 1
Chapter 1 Introduction The area of fault detection and diagnosis is one of the most important aspects in process engineering. This area has received considerable attention from industry and academia because
Common Tools for Displaying and Communicating Data for Process Improvement
Common Tools for Displaying and Communicating Data for Process Improvement Packet includes: Tool Use Page # Box and Whisker Plot Check Sheet Control Chart Histogram Pareto Diagram Run Chart Scatter Plot
HACCP: Hazard Analysis Critical Control Points. Dr. Angela Shaw Department of Food Science and Human Nutrition Extension and Outreach
HACCP: Hazard Analysis Critical Control Points Dr. Angela Shaw Department of Food Science and Human Nutrition Extension and Outreach Information Adapted from: Hazard Analysis and Critical Control Point
Introduction. Background
Predictive Operational Analytics (POA): Customized Solutions for Improving Efficiency and Productivity for Manufacturers using a Predictive Analytics Approach Introduction Preserving assets and improving
Government Degree on the Safety of Nuclear Power Plants 717/2013
Translation from Finnish. Legally binding only in Finnish and Swedish. Ministry of Employment and the Economy, Finland Government Degree on the Safety of Nuclear Power Plants 717/2013 Chapter 1 Scope and
Compliance Management Framework. Managing Compliance at the University
Compliance Management Framework Managing Compliance at the University Risk and Compliance Office Effective from 07-10-2014 Contents 1 Compliance Management Framework... 2 1.1 Purpose of the Compliance
FMEA and HACCP: A comparison. Steve Murphy Marc Schaeffers
FMEA and HACCP: A comparison Steve Murphy Marc Schaeffers FMEA and HACCP: A comparison Introduction FMEA and Control planning is being used more and more in industry. In the food industry companies use
Injury and Illness Prevention Plan (IIPP) University of Nebraska-Lincoln
Environmental Health and Safety Injury and Illness Prevention Plan (IIPP) University of Nebraska-Lincoln Revised March 2011 UNL Environmental Health and Safety 3630 East Campus Loop Lincoln, Nebraska 68583-0824
Process Quality. BIZ2121-04 Production & Operations Management. Sung Joo Bae, Assistant Professor. Yonsei University School of Business
BIZ2121-04 Production & Operations Management Process Quality Sung Joo Bae, Assistant Professor Yonsei University School of Business Disclaimer: Many slides in this presentation file are from the copyrighted
Managing Clinical Trial Risk: It's a Tough Job, But One Person Has To Do It
Managing Clinical Trial Risk: It's a Tough Job, But One Person Has To Do It Michael Macri, Director, Strategic Services, inventiv Health Clinical Sherry Merrifield, Director, Clinical Monitoring, inventiv
INTRODUCTION TO OSHA PRESENTATION
Introduction to OSHA 2-hour Lesson Directorate of Training and Education OSHA Training Institute Lesson Overview Purpose: To provide workers with introductory information about OSHA Topics: 1. Why is OSHA
Design Verification The Case for Verification, Not Validation
Overview: The FDA requires medical device companies to verify that all the design outputs meet the design inputs. The FDA also requires that the final medical device must be validated to the user needs.
Hazard Identification and Risk Assessment in Foundry
Hazard Identification and Risk Assessment in Foundry M.SaravanaKumar 1, Dr.P.SenthilKumar 2 1 (Industrial Safety Engineering, K.S.R, College of Engineering / Anna University, Chennai, India) 2 (Department
A Six Sigma Approach for Software Process Improvements and its Implementation
A Six Sigma Approach for Software Process Improvements and its Implementation Punitha Jayaraman, Kamalanathan Kannabiran, and S.A.Vasantha Kumar. Abstract Six Sigma is a data-driven leadership approach
Occupational Electrical Accidents in the U.S., 2003-2009 James C. Cawley, P.E.
An ESFI White Paper Occupational Electrical Accidents in the U.S., 2003-2009 James C. Cawley, P.E. INTRODUCTION The Electrical Safety Foundation International (ESFI) is a non-profit organization dedicated
Installation and safety instructions for AC/DC built-in devices
The device type and date of manufacture (week/year) can be found on the device rating plate. In the event of any queries about the device, please quote all the details given on the rating plate. For further
Lecture 1: Introduction to Software Quality Assurance
Lecture 1: Introduction to Software Quality Assurance Software Quality Assurance (INSE 6260/4-UU) Winter 2009 Thanks to Rachida Dssouli for some slides Course Outline Software Quality Overview Software
BAE 402: Biosystems Engineering Design I Biosystems and Agricultural Engineering College of Engineering Fall 2013
Instructor: BAE 402: Biosystems Engineering Design I Biosystems and Agricultural Engineering College of Engineering Fall 2013 Dr. Czarena Crofcheck Rm 212 CE Barnhart Building - 257-3000 ext. 212 - [email protected]
Declaration of Practices and Procedures
Peggy S. Arcement, MS, MA, LDN, LPC, NCC Licensed Professional Counselor Baton Rouge Christian Counseling Center 763 North Boulevard, Baton Rouge, Louisiana 70802 Phone: 225-387-2287 Fax: 225-383-2722
Annex 2. WHO guidelines on quality risk management. 1. Introduction 62. 2. Glossary 67 3. Quality risk management process 70
Annex 2 WHO guidelines on quality risk management 1. Introduction 62 1.1 Background and scope 62 1.2 Principles of quality risk management 64 2. Glossary 67 3. Quality risk management process 70 3.1 Initiating
Understanding Safety Integrity Levels (SIL) and its Effects for Field Instruments
Understanding Safety Integrity Levels (SIL) and its Effects for Field Instruments Introduction The Industrial process industry is experiencing a dynamic growth in Functional Process Safety applications.
Design Failure Modes and Effects Analysis DFMEA with Suppliers
Design Failure Modes and Effects Analysis DFMEA with Suppliers Copyright 2003-2007 Raytheon Company. All rights reserved. R6σ is a Raytheon trademark registered in the United States and Europe. Raytheon
SKF Asset Management Services. Your trusted resource for life cycle support and sustainability of physical assets
SKF Asset Management Services Your trusted resource for life cycle support and sustainability of physical assets SKF Asset Management Services People, processes and technology to optimize asset efficiency
ISO/IEC 17025 QUALITY MANUAL
1800 NW 169 th Pl, Beaverton, OR 97006 Revision F Date: 9/18/06 PAGE 1 OF 18 TABLE OF CONTENTS Quality Manual Section Applicable ISO/IEC 17025:2005 clause(s) Page Quality Policy 4.2.2 3 Introduction 4
Reflective Summary Project Risk Management. Anthony Bowen. Northcentral University
Northcentral University Spring 2010 - BowenAPM7004-7 1 Reflective Summary Project Risk Management Anthony Bowen Northcentral University March 20, 2010 Northcentral University Spring 2010 - BowenAPM7004-7
Nova Scotia EMO. Hazard Risk Vulnerability Assessment (HRVA) Model. Guidelines for Use. October, 2010
Nova Scotia EMO Hazard Risk Vulnerability Assessment (HRVA) Model Guidelines for Use October, 2010 EMO NS Hazard Risk Vulnerability Assessment Model Page 1 of 10 Table of Contents 1. Background 2. Definitions
