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60 Cards in this Set
- Front
- Back
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DMAIC
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define (what problem are we addressing), measure (what data is needed and what is the current performance), analyze (what are the root causes of the problem), improve (what is the best solution to remove each root cause), control (how can we insure the gains are maintained).... for products already developed
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DMADV
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define (what problem are we addressing), measure (what are the customer's needs), analyze (what is the high level design concept), design (what is the best design), verify (does the new process/product meet the customers needs)... for new products
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DFSS
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design for six sigma, what I did, during the design of the product
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management infrastructure
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executive team --> champions --> master black belt --> black belt --> green belt
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executive team
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six sigma vision, mandate improvement, identify champions, review all projects
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champions
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communicate the vision, select projects, select candidates for training, review projects weekly, remove barriers and supply resources
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green belts
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lead small six sigma projects, participate as team members, communicate six sigma to organization, carry out technical tasks, analyze data
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black belts
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manage and facilitate six sigma project teams, discover opportunities for new six sigma projects, mentor, train, influence
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master black belts
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lead mega projects, provide statistical expertise, coach, team
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innovation
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meaningful unique... cons: risky, takes awhile
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FMEA
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failure mode and effects analysis
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RPN
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risk priority number... quantifies risk to let company know where they stand, RPN = severity*occurrence*detection (ranges from 1-1000), accepted RPN varies per company
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LSS
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Lean Six Sigma, what prashant did... once in market and manufactured for quality
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lean principles
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value, valuestream, flow, pull, perfection
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rolled throughput yield
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defines waste... multiply percentages of yield for each process
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affinity diagrams
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yellow sticky notes, grouping VOCs into CTQ categories
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kano model
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customer satisfaction in 3 dimensions: delighters, more is better, must be
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confounded
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don't know what factors are more important
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runs
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runs = L^f * replications... where L is levels and f is factors
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factors
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an input is one of the controlled or uncontrolled variables whose influence on a response (output) is being studied in the experiment, either quantitative or qualitative
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Define- DMADV
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establish a project chapter, develop a business case, create a project plan, create a communication plan, determine internal/external requirements, run prototype sample product (D11, D12)
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Measure-DMADV
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gather VOC, translate VOC to technical terms, establish requirements for product, establish critical measures, benchmark competitor product, prioritize CTQ/DFMEA (D13, D14)
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Analyze- DMADV
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analyze process options to meet customer needs, evaluate alternative methods, create DFMEA, define criteria based matrix, customer evaluate sample lot
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Design- DMADV
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design the process, minimize the variability, optimize process for process capability
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Verify - DMADV
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validate the design, establish process controls, run process capability study, close project
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ISO 13485
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medical device standards, allows system to be certified if standards are followed
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registrar
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people paid to help your company get certified
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ANSI
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american national standards institute
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ASQ
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american society for quality
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standard sections
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1) scope
2) narrative reference 3) terms and definitions 4) quality management system 5) management responsibility 6) resource management 7) product realization (largest part) 8) measurement, analysis, and improvement |
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document
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something you go by, living, changes
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record
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history, what you've done, can't change
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lean process
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value, value stream, flow, pull, perfection
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lean
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fundamental change in how the people within an organization think and what they value, thus transforming how they behave... "a philosophy to eliminate waste for people"
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5S
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sort, set in order, shine, standardize, sustain
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value stream mapping
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a simple diagram of every stop involved in the patient and information flows needed to fulfill the requested service
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PDCA
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plan, do, check, act/adjust
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Kaizen
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to break apart and put together in better fashion
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waste
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downtime, non-value added
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4P
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problem solving --> people and partners --> process --> philosophy
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hazard
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a potential source of harm
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risk
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the probability of occurrence of harm multiplied by the severity of that harm
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lapse
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the mental unintended use error when using a device; forgetting
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slip
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the mechanical/physical unintended use error when using a device
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hazardous situation
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user or environment is exposed to multiple hazards
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mistake
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intended use error but making the wrong choice, two types: knowledge based and rule based
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abnormal use
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the intended use of a user to go against how the device is used and disregard manufacturing instructions
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normal use
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the common way to use a device, which could include use errors
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correct use
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normal use without use error
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usability engineering file
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set of records and other documents that are produced by the usability engineering process
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NGOMSL
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natural
goals operators methods selection language |
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working memory
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Working memory includes short-term memory and other processing mechanisms that help to make use of short-term memory.
Some other scientists believe that working memory refers only to the attention-related aspects of short-term memory. |
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validation
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Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.
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verification
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Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
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situation awareness
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perception (working memory) --> comprehension (information processing) --> projection
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workload
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SA + input + output
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HTA
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hierarchal task analysis... goals and tasks
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use scenario
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specified sequence of events defined by the specified user in the specified environment
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usability
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characteristic of the user interface that establishes effectiveness, efficiency, ease of user learning and user satisfaction
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user
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person using, i.e. operating or handling, the medical device
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