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What is FMEA?

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2009-12-28 04:24:44
2009-12-28 04:24:44
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A failure modes and effects analysis (FMEA) pronouced fah-me-ah, is a procedure in operations management for analysis of potential failure modes within a system for classification by severity or determination of the effect of failures on the system. It is widely used in manufacturing industries in various phases of the product life cycle and is now increasingly finding use in the service industry. Failure modes are any errors or defects in a process, design, or item, especially those that affect the customer, and can be potential or actual. Effects analysis refers to studying the consequences of those failures.

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FMEA (Failure Mode and Effect Analysis) is not the primary tool for Risk Assessment. There are other tools as well.


"FMEA training is essential for anaylizing potential failures of any type of system, most commonly a computer system." "Basically, FMEA training will help an engineer plan for potential failures of anything he or she designs, from computers to NASA space shuttles."


I recommend Relia Source, they have really great courses and they are priced reasonably.


Failure mode effects analysis (FMEA) is used to identify the ways in which a system will fail, the likelihood of each failure mode, and what will happen in the event of each failure. It is used in both product design, to improve intrinsic availability and reliability, and in operations management, to improve process design.


The FMEA is a risk assessment tool that helps systematically define where potential points of failure are located, help define the critical nature of the problems and logically layout the plans to resolve them.


FMEA Stands for Failure Mode and Effects Analysis FMEA reviews a process step by step and asks, "What can go wrong?" That's the failure mode. It then asks what happens if it fails? Next, potential root causes of the failure are listed and the frequency of occurrence is determined. The ability to detect (or prevent) the failure is also reviewed for the current process. These three criteria, Severity (S), Occurrence (O), and Detection (D), are rated on scales of 1 to 10, with a 1 representing only a minor incidence and 10 representing a catastrophic event for S, very frequent occurrence for O, or inability to detect the failure for D. The product of the three S*O*D ratings becomes the Risk Priority Number (RPN). Higher RPNs prioritize the need to eliminate the cause, reduce the frequency, or improve detection and prevention of the failure mode. The second part of FMEA is to determine action steps to reduce the RPN for those items selected. Once actions are taken, the S*O*D ratings and the RPN are revised. Most organizations develop rating scales specific to their processes, products, and services.


basically methods department in Engineering is for assisting in manufacturing and assembly.it includes time and motion study,enhancing productivity,process standardisation,training shop floor members frequently,fmea and more.


It's best if you are already a home inspector then apply with Fema see http://www.answerbag.com/articles/How-to-Become-a-FEMA-Home-Inspector/9ba23915-8bee-23e3-894c-47e2e0334f94


* http://www.dbar-innovations.com * Mentorsoftpro, A complete Lean Six Sigma Mentoring, training, statistical analysis and multi project tracking management system. In other words, all you would ever need to do any Six Sigma project, one at a time, twenty at a time or a corporation capable software system. * Starting with understanding the DMAIC method, with out this you are never going to have successful results. I recently discovered this site dedicated to answering all the Lean Six Sigma / process improvement needs and questions. They offer a very complete software system that will walk you through the entire DMAIC methodology. It has a training video at every possible step including example data, video demonstration, voice guided instructions, templates for every step. The goal of Six Sigma is to increase profits by eliminating variability, defects and waste that undermine customer loyalty.A well-documented failure mode and effects analysis (FMEA) with robust action plans and implementation will help an organization avoid rework in software projects, irrespective of the project type (full life cycle development, enhancement or maintenance/production support). In each case, there is an existing process, with a number of process steps/activities. FMEA can unravel the potentially weak steps and show where things may go wrong and where to focus. The FMEA tool - either within a full-fledged Six Sigma DMAIC cycle or without - adds immense value to software projects. The FMEA process begins by identifying the ways in which a product, service or process could fail. A project team examines every element of a process, starting from the inputs and working through to the output delivered to the customer. At each step, the team asks, "What could go wrong here?" The team then figures the probability of each possible failure (known as "occurrence"), the damage it will inflict should it actually fail (termed as "severity"), and the likelihood of finding such failures before final delivery (called "detection"). These three parameters are ranked on a 1-to-10 scale and the product of these three is called the risk priority number, or RPN. The RPN indicates which of the process steps or design components are high-risk items and need to be attended to first for medication and/or control measures. Once this is done, the team has to brainstorm action plans to either reduce occurrence or improve detection. Severity normally remains the same. During the brainstorming, team members need to be clear that the action items should not sound like a wish list or a statement of intent, but should be aimed at adding, deleting or modifying an existing process. If a project team recommends such vague actions as, "Peer reviews should be more effective" or "Problem tickets should be assigned to a team member within 30 minutes of receipt by the team leader," little or no improvement can be expected. Instead, the action points need to be more precise, such as, "If the team leader does not assign a ticket coming to the queue in 30 minutes, a pop-up message will be generated to remind them." The action items vary from introduction of checklist, to mandating reviews before a code release, to planning backup resources, to timely assignment/transfer of problem tickets, etc. Whatever the recommendations, after their implementation, the process flow chart is changed. And once done, the FMEA is executed again in the new process to calculate the reduction in the level of risk exposure. Thus the objective is to first identify the potential risks and then take corrective/preventive action to eliminate or at least reduce those risks. To get the best results, FMEA should be done at the beginning of a software project and every three to six months thereafter. However, it is never too late to do an FMEA. The exercise can be done at anytime during the course of the software project. Besides, if a Six Sigma project is executed to improve performance of an ongoing and long-duration software project (especially one that involves maintenance/production support in addition to development/enhancement), executing a FMEA can add considerable value. Here, FMEA should be part of a "look-ahead meeting," which software project teams normally do to proactively reduce defects/bugs. FMEA is a group activity, normally with six to ten on the team. It may be done in more than one sitting, if necessary. The process owner, or project manager, is normally the leader of the FMEA exercise. However, to get best results, multi-disciplinary representatives from all affected activities should be involved. Team members should include subject matter experts and advisors as appropriate. Each process owner also is responsible for keeping the FMEA updated. The heart of the FMEA is the action points arising out of it and the subsequent process improvement that happens when these actions are implemented. A project team at a large manufacturing company was very enthusiastic using the FMEA through the point of completing the calculation of RPNs for each process step. But once that was done, only a few people participated in the brainstorming session for recommending action points for high-RPN process steps. Needless to say, that organization did not benefit much from using the exercise. FMEA looks simple, but it is an extremely powerful tool when applied in letter and spirit. It helps the team assess stakeholder issues and concerns, identifying and creating a strategy for those that should be moved to a higher level of support. Specifically, FEMA: * Captures the collective knowledge of a team. * Improves the quality, reliability and safety of the process/product. * Is a structured process for identifying areas of concern. * Documents and tracks risk reduction activities. * Helps the team create proactive action plans and thus improve process robustness. Some software project managers argue that they do not really need a separate FMEA tool. Risk analysis and mitigation should be a part of the manager's normal project management job, they say. The point is: If an organization is looking for better results in risk mitigation and improved processes, it needs to use a better tool or technique, such as FMEA. Unless a FMEA is done, improvement activities are likely to remain unclear and unfocused, and may not even get implemented in the pressure of meeting schedules and deadlines. In addition, since FMEA action items are generated by the project team through collective brainstorming, rather than an individual, the buy-in of the actions is much higher, and thus the project manager faces minimum resistance in implementing them. In short, the benefits a software project team will gain from this powerful technique are well worth the time invested in applying it. About the Author: Asoke Das Sarma is a Six Sigma deployment leader in a large multinational computer company. He is based at Bangalore, India, For Help-A complete Six Sigma Mentoring System. This is going to be the industry standard in driving Lean Six Sigma projects. Voice guided with instructions how and where to. Has Continuous training as it walks you through the DMAIC methodology, does statistical analysis, reports and tracks the whole project. No limits to amount of projects, users or capabilities. We will custom tailor to your companies operating applications. This is 1/5 the price of the leading industry software with everything they do not offer in training and analysis. Call 713-436-6941 A demonstration is a must. The goal of Six Sigma is to increase profits by eliminating variability, defects and waste that undermine customer loyalty.A well-documented failure mode and effects analysis (FMEA) with robust action plans and implementation will help an organization avoid rework in software projects, irrespective of the project type (full life cycle development, enhancement or maintenance/production support). In each case, there is an existing process, with a number of process steps/activities. FMEA can unravel the potentially weak steps and show where things may go wrong and where to focus. The FMEA tool - either within a full-fledged Six Sigma DMAIC cycle or without - adds immense value to software projects. The FMEA process begins by identifying the ways in which a product, service or process could fail. A project team examines every element of a process, starting from the inputs and working through to the output delivered to the customer. At each step, the team asks, "What could go wrong here?" The team then figures the probability of each possible failure (known as "occurrence"), the damage it will inflict should it actually fail (termed as "severity"), and the likelihood of finding such failures before final delivery (called "detection"). These three parameters are ranked on a 1-to-10 scale and the product of these three is called the risk priority number, or RPN. The RPN indicates which of the process steps or design components are high-risk items and need to be attended to first for medication and/or control measures. Once this is done, the team has to brainstorm action plans to either reduce occurrence or improve detection. Severity normally remains the same. During the brainstorming, team members need to be clear that the action items should not sound like a wish list or a statement of intent, but should be aimed at adding, deleting or modifying an existing process. If a project team recommends such vague actions as, "Peer reviews should be more effective" or "Problem tickets should be assigned to a team member within 30 minutes of receipt by the team leader," little or no improvement can be expected. Instead, the action points need to be more precise, such as, "If the team leader does not assign a ticket coming to the queue in 30 minutes, a pop-up message will be generated to remind them." The action items vary from introduction of checklist, to mandating reviews before a code release, to planning backup resources, to timely assignment/transfer of problem tickets, etc. Whatever the recommendations, after their implementation, the process flow chart is changed. And once done, the FMEA is executed again in the new process to calculate the reduction in the level of risk exposure. Thus the objective is to first identify the potential risks and then take corrective/preventive action to eliminate or at least reduce those risks. To get the best results, FMEA should be done at the beginning of a software project and every three to six months thereafter. However, it is never too late to do an FMEA. The exercise can be done at anytime during the course of the software project. Besides, if a Six Sigma project is executed to improve performance of an ongoing and long-duration software project (especially one that involves maintenance/production support in addition to development/enhancement), executing a FMEA can add considerable value. Here, FMEA should be part of a "look-ahead meeting," which software project teams normally do to proactively reduce defects/bugs. FMEA is a group activity, normally with six to ten on the team. It may be done in more than one sitting, if necessary. The process owner, or project manager, is normally the leader of the FMEA exercise. However, to get best results, multi-disciplinary representatives from all affected activities should be involved. Team members should include subject matter experts and advisors as appropriate. Each process owner also is responsible for keeping the FMEA updated. The heart of the FMEA is the action points arising out of it and the subsequent process improvement that happens when these actions are implemented. A project team at a large manufacturing company was very enthusiastic using the FMEA through the point of completing the calculation of RPNs for each process step. But once that was done, only a few people participated in the brainstorming session for recommending action points for high-RPN process steps. Needless to say, that organization did not benefit much from using the exercise. FMEA looks simple, but it is an extremely powerful tool when applied in letter and spirit. It helps the team assess stakeholder issues and concerns, identifying and creating a strategy for those that should be moved to a higher level of support. Specifically, FEMA: * Captures the collective knowledge of a team. * Improves the quality, reliability and safety of the process/product. * Is a structured process for identifying areas of concern. * Documents and tracks risk reduction activities. * Helps the team create proactive action plans and thus improve process robustness. Some software project managers argue that they do not really need a separate FMEA tool. Risk analysis and mitigation should be a part of the manager's normal project management job, they say. The point is: If an organization is looking for better results in risk mitigation and improved processes, it needs to use a better tool or technique, such as FMEA. Unless a FMEA is done, improvement activities are likely to remain unclear and unfocused, and may not even get implemented in the pressure of meeting schedules and deadlines. In addition, since FMEA action items are generated by the project team through collective brainstorming, rather than an individual, the buy-in of the actions is much higher, and thus the project manager faces minimum resistance in implementing them. In short, the benefits a software project team will gain from this powerful technique are well worth the time invested in applying it. About the Author: Asoke Das Sarma is a Six Sigma deployment leader in a large multinational computer company. He is based at Bangalore, India, For Help-A complete Six Sigma Mentoring System. This is going to be the industry standard in driving Lean Six Sigma projects. Voice guided with instructions how and where to. Has Continuous training as it walks you through the DMAIC methodology, does statistical analysis, reports and tracks the whole project. No limits to amount of projects, users or capabilities. We will custom tailor to your companies operating applications. This is 1/5 the price of the leading industry software with everything they do not offer in training and analysis. Call 713-436-6941 A demonstration is a must.


Robin E. McDermott has written: 'Employee driven quality' -- subject(s): Industrial efficiency, Suggestion systems, Total quality management 'The basics of FMEA' -- subject(s): Quality control, Reliability (Engineering), Quality assurance, Standards, Failure analysis (Engineering)


Working prototype to be accepted by all in house and final customer for it's look, features, function, produceability and up to serviceability. Design for assembly (DFA) and failure mode effect analysis (FMEA) to be done on the prototype with all contributing and affected group members team. Go a had to be obtained by the in house customer department preferably in writing. After that the actual product design and detailing of the components starts in the real product creation process. The accepted prototype and its test results ,the prformance result will be kept till the market launch and market feed back is obtained. Rahul sharma student of NIIT


A vital feature of engineering and systems design. Often now called FMEA, Failure Mode and Effects Analysis. a) For example, 'what if today's computer backup is not available?'. Should lead you to multiple backups, off-site storage, and so on. b) Many industrial machines, from cooking fryers upwards have heaters on all the time, controlled by a thermostat. Q 'What happens if the thermostat sticks in the ON position?'. Should lead you to a separate thermal measurement, independent of the first, and so on up to automatic cooling/fire suppression systems. The Failure Mode, is a different set of thinking tools, to those of Effects Analysis.


Warren Brussee has written: 'What Tolerance Is Really Required?' -- subject(s): Business, Finance, Nonfiction, OverDrive 'Simplified Linear Transfer Functions' -- subject(s): Business, Finance, Nonfiction, OverDrive 'The great depression' -- subject(s): Depressions, Investments, Portfolio management 'Simplified Process Flow Diagram' -- subject(s): Business, Finance, Nonfiction, OverDrive 'DMAIC' -- subject(s): Business, Finance, Nonfiction, OverDrive 'Six Sigma Methodology and Management's Role in Implementation' -- subject(s): Business, Finance, Nonfiction, OverDrive 'Simplified Gauge Verification' -- subject(s): Business, Finance, Nonfiction, OverDrive 'Correlation Tests' -- subject(s): Business, Finance, Nonfiction, OverDrive 'Simplified FMEA' -- subject(s): Business, Finance, Nonfiction, OverDrive 'Getting Good Samples and Data' -- subject(s): Business, Finance, Nonfiction, OverDrive 'Testing for Statistically Significant Change Using Variables Data' -- subject(s): Business, Finance, Nonfiction, OverDrive 'Testing for Statistically Significant Change Using Proportional Data' -- subject(s): Business, Finance, Nonfiction, OverDrive 'LAOCH (Lay-ock) The Guide Dog Puppy' 'Simplified QFD' -- subject(s): Business, Finance, Nonfiction, OverDrive 'Comparing Six Sigma Data with Quality Department Data' -- subject(s): Business, Finance, Nonfiction, OverDrive


Transfusion of blood saves life. An error in blood transfusion, at the same time, takes life. Blood samples can be autologous, in which the patient's own blood is collected before surgery for possible use during or after surgery or allogenic, in which the blood is collected from donors. The discovery that HIV could be transmitted by blood transfusion in 1982 has given rise to strict regulations on blood donation and screening procedures. Apart from HIV, HBV and HCV risks have also been well addressed in blood transfusion process.1. the fatal acute haemolytic reactions to transfusion caused by ABO incompatibility have been attributed to administrative errors.2. The mismatch of blood units with that of the patient blood as a result of negligence is a serious cause of patient fatality.3. contamination of red cells especially of bacterial origin is a matter of concern. Yersinia enterocolitica is a common organism found to cause contamination of red cells.4. Contamination of platelets is another serious cause whereStaphylococcal infection is very common.5. Klebsiella andSerratia have also been detected in platelet contamination.6. Transfusion related acute lung injury is an acute respiratory distress occurring within hours after transmission, usually characterized by hypoxia due to pulmonary edema.Elimination of errors1. An understanding and knowledge of the pathophysiology of transfusion reactions, symptoms and treatment is essential to safely administer and monitor transfusions.2. A Failure Mode and Effect Analysis (FMEA) on the blood transfusion process to reduce the risk of problems inherent in the procedure has been developed recently to aid nurse decision making in the transfusion process .


There are a number of procedures you may need depending on your industry. Below is a list of some that would be a good idea.1. Manufacturing Operationsa. Schedulingb. Material Review Boardc. Gauge Department Controld. Inspectione. Programming & Planningf. OEE Managementg. Work Center Qualificationh. Tool Crib Management2. Safety Programa. Maintenance Safety Programi. Safety Committeeii. Safety Training Planiii. HazMat Controliv. MSDS Controlb. OSHA Reportingc. Environmental Protectiond. Occupational Safetyi. Hard Hats, Goggles, Ear protection, and Steel toe shoesii. Gloves, Arm protection, and Clothingiii. Eye wash, First Aid, and Emergency Response3. Maintenance Operationsa. Maintenance Assessmentb. Preventive Maintenancec. Maintenance Work Order Managementd. Lockout / Tagoute. Waste Management & Recyclinga. Spares Inventory Managementb. Housekeeping4. Equipment Acquisitiona. Capitalization & Leasingb. New Equipment Launch Planc. Equipment Validationd. Equipment Qualification & Traininge. Facility Layout & Redesignf. Project Management5. Warehouse Operationsa. Receivingb. Binningc. Pickingd. Packinge. Shipping6. Process Improvementa. 5S Organizationb. Dashboardsc. Control Chartsd. Cause & Effect Diagramse. FMEAf. Root Cause Analysisg. Voice of the Customer7. Quality Management (i.e. ISO 9001 QMS)a. PPAPb. Control Plansc. Internal Auditd. Corrective & Preventive Actione. Document Controlf. Record Controlg. Nonconformance Control


The difference between production engineer and manufacturing engineer and industrial engineer varies with both the industry sector and the company's country of origin/ parentage. A UK plant under American ownership uses American-based terminology to keep transparency in high-level management discussions (so large workforces have to use alien terms rather than a few managers/ IT staff learning BOTH jargon sets). Japanese firms and those extensively using their more recent concepts are more likely to include role descriptions such as Kaizen engineer, black belt, etc.We have to dig deep here and fill in the background to the question, as its very easy to say "they are just the same" - but in at least some situations, there are clear differences that allows selection of the most suitable term.In some instances, it will be very clear which is more strictly correct relative to the industry and job description. At other times, a role might sit right in the middle of the overlap between two of the disciplines, in which case the choice of the right description is more arbitrary and indeed a more descriptive title could be picked rather than have someone assume the wrong thing from these wide and varyingly defined jobs. Continuous improvement engineer, production systems engineer and process quality engineer are more succint than any of the 3 more generalised terms, while using language clear to anyone likely to be involved. As company size increases, and width of focus of an individual is constrained, the better the scope to use succinct terms.Paras 1-3 below starts a relatively brief attempt to differentiate between, and show what is most typical among, each of the 3 disciplines.Additional input, comment and revision is fairly likely as this is from direct experience - additional research may well yield further clarity.1 A manufacturing engineer is most likely to be heavily involved in techniques like SPC/ JIT/ Kanbans/ Six Sigma, and a slew of more modern related disciplines which are vying for supremacy and try to be more widely applicable, with varying degrees of success. Reading between the lines, there is a tendency to apply new words to old thinking and muddy the boundaries between the compact and understandable manufacturing methodologies listed above. Six Sigma can have issues with its usefulness depending how it is applied, and what to, but in general, the mid to late 20th-century manufacturing methods have robust and effective implications that are best integrated in any new scheme, rather than sidelined.A manufacturing engineer will be involved in general reporting of good or bad production data to management and liaising with shift supervisors. Whereas a production engineer will have more detailed collaboration with other engineers over specific issues (perhaps identified by a manufacturing engineer) that requires the longer term focus which a manufacturing engineer could not provide with the typical level of routine responsibilities.2 An industrial engineer will more often be associated with continuous processes relating to amorphous product, such as rather than the production of discrete items with a specific shape. If the process is non-continuous, with discrete rather than bulk output product, the term production or manufacturing engineer would be more useful. Note it would be easy to confuse industrial engineer with industrial designer, the latter being about designing the product form and working on elements such as the user interface, requiring more artistic and human factors knowledge.3 A production engineer will more often work earlier in the life of a product, managing the general development process and developing production equipment and product features in close conjunction with the dedicated product development team (eg mechanical, electronics, software developer and industrial design engineers). Product development input, specification of assembly equipment and in-depth analysis (eg FMEA) of manufacturing issues are more likely than a manufacturing engineer, who is there to minimise and handle more routine glitches, to maintain high-volume production. Design ability and more significant knowledge of areas like electro-mechanical integration would be appropriate for a production engineer.


Work System Analysis: The Key to Understanding Health Care SystemsMany articles in the medical literature state that medical errors are the result of systems problems, require systems analyses, and can only be addressed with systems solutions. Within that same body of literature is a growing recognition that human factors engineering methods and design principles are needed to reduce medical errors and, hence, increase patient safety. Work system analysis methods, which are based on industrial and human factors engineering tools, have much to contribute toward patient safety, specifically because of their focus on systems. They offer principles and methods for analyzing systems, which, if followed, should help health care administrators and clinicians properly analyze their units or facilities, and should lead to more robust patient safety interventions. In this paper, steps for executing a work system analysis are provided. To facilitate comprehension of the steps, the medication administration system is used as an example.System analysis has much to contribute to patient safety, specifically through its study of organizational and work systems. In general, a system analysis yields an understanding of how a system works and how different elements in a system interact. This facilitates system design and system redesign, and aims to improve the interface between components of a system in order to enhance the functioning of each individual component in the overall system. Adopting a systems approach to error reduction requires a shift from blaming individuals for errors to analyzing systems to uncover design flaws, thus moving from addressing problems reactively (i.e., after problems occur) to proactively preventing accidents through system analysis and design.Although many different methods have been used to conduct system analysis in industry, few methods have been widely used in health care. System analysis methodologies include, among others, the macroergonomic analysis and design (MEAD), 35, 36 fault tree analysis, 37, 38 failure modes and effects analysis (FMEA), 39, 40 health care failure modes and effects analysis (HFMEA), 41 and probabilistic risk assessment (PRA). 42, 43 Each of these methods uses similar principles to analyze and determine the weaknesses of the system and facilitate its redesign. In the remainder of this paper, the main steps that these methods share are identified and explained in detail.Before presenting the main steps in a system analysis, an understanding of system terms must be developed. To facilitate reader comprehension of the terms and steps in the system analysis, the medication administration system will be used as an example throughout the remainder of the paper.System element: A system element is anything that is part of a particular system. Elements can include people, technologies, policies, lighting, furniture, and jobs. In the case of the medication administration system, elements include the administering nurses, patients, medications, medication administration record (MAR), medication stock room, patient rooms, and identification bands.System attribute: System attributes are the perceived characteristics of the system. The medication administration system attributes could include “error-free,” “time consuming,” “chaotic,” and “high quality.”System boundary: System boundaries are zones between one system and another. These zones can be in time, space, process, or hierarchy.Temporal boundary: A temporal boundary separates systems in time. For the medication administration system, a temporal boundary could be drawn between the first and second shift.Spatial boundary: A spatial boundary separates systems in space. An example could be the medication administration system for one particular unit versus that of another unit.Process boundary: A process boundary separates systems into adjacent component processes, also known as subprocesses. The medication use system contains component processes of ordering, transcribing, verifying, dispensing, administering, and documenting. An example of a process boundary might then be the boundary between the process of dispensing and delivering medications to the unit and the process of administering the medication.Hierarchical boundary: A hierarchical boundary separates systems by their location in a hierarchy of systems. For example, the medication administration system exists within a larger system known as a unit. The unit exists within a larger system of a hospital. A hospital exists within a larger community health system.System input: A system input is anything necessary to energize the system. For medication administration, inputs include nurses who administer drugs, drugs, MARs, physician orders, and pharmacy dispensing. These elements are inputs because they are necessary for medication administration to take place.



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