CRP 112 Lecture 2 Flashcards
Lean six sigma
lean - redue waste by streamlining process
six sigma - reduce defects by effectively solving problems
Lean accelerates six sigma
-focus on preventing defects rather than defect detection
sigma definition
-measure of spread of data, or varition within a given population of products
-there is common cause variation = normal and expected
-special cause variation = abnormal to the process. Requires investigation for root cause
six sigma definition
-level of quality
-level 6 = no more than 3.4 defects per million oppertunities
lean six sigma problem solving methodology
DMAIC
Define
Measure(quantify)
Analyze (find cause)
Improve (implement and verify solution)
Control (maintain solution)
quality by design and six sigma
DMADV
-Define goals
-mesure metrics
-analyze options
-design new product/process/service
-verify design effectiveness in real world
-key feature: perpectual feedback
Define stage
-input from internal (QA, product development, manufacturing, regulatory) and external roles (suppliers, contractors)
-define project charter (direction and scope)
-prioritize measurable, validated, contributing variable that can be improved
-communication plan,project plan (documented)
-create agreement to move to meausrement stage
-prioritize variables, six sigma sources of variation (which ones to prioritize)
-SIPOC to create process map
Six Sigma 6Ms sources of variation
-methods
-materials
-machines
-measurements
-mother nature
-man
SIPOC model
-for creating process map
-Supplier (who supplies process input?)
-Input (what inputs are required? machinery, tools, materials etc)
-Process (what does process look like? start to finish, product design to shipping)
-Output (what are the outputs? final product, waste, etc)
-Customer (who are the customers? public, businesses, internal employees)
Measure stage
-focus on data collection (inputs, outputs)
-goal is to make a snapshot of the process
-data should be unbiased, random, representative, reliable and consistent, holisitc to process, accurate, precise
-plan for data collection (type of data, sample size, source and location, forms for collection, who is collecting, training)
Accuracy (calibrations, maintentane)
-collect data and convert to tables
Analysis stage
-determine which input variables have predominate effects on output variables
-correlation does not equal causation
-six sigma uses descriptive statistics
-must have evidence to suggest correlation is valid
Design stage
-have a problem and its root cause
-how to design for improvement
-likely solutions and their benfits
verify stage
-goal: sustain improvements made
-measure and document the solution
-training is key to ensure improvements remain
5s
lean six sigma tool
-keep working space in order
-sort, straighten, shine/sweep, standardize, sustain
Kaizen
lean six sigma tool
-Japanese philosophy on continuous improvement in life
-makeing small improvement from bottom up
-
Gemba
-lean six sigma tool
-Go and See, japanese for the place where value is created
-real-time observations of process aimed at pinpointing process defects
-oppertunity to listen to employees, not to find fault or quickly implement changes
-i.e. undercover boss
value stream mapping (VSM)
lean six sigma tool
-identifies process waste and cause of waste
Jidoka/autonomation
-lean six sigma tool
-stops production when defect occurs
-automatic detection at early stage
-like a traffic light
Kanban
-lean six sigma tool
-Viual board
-manages inventory levels and highlights low or high inventory
-process of continious movement -prioritized backlog (to do) to work in progress to validate to complete
Lean six sigma belts
-white: no formal training, overview, understands value
-yellow: basic, participates in project teams
-Green: starts and manages projects, provides training, assists in data collection and analysis
-black: leads projects, advaced expertise, acts as mentor
-master black: works with leaders to identify gaps and select projects, trains, develops metrics and strategic direction, reponsible for lean six sigma implementation and company culture changes
-champion: exectutive leader, selects projects, removes barriers, supports change and lean six sigma culture (not a belt)
lean six sigma and pharma
-needs of pharma R&D:
-new highthroughput technology
-streamline existing processes
-detect high failure candidates early on
-maximize output of R&D
-shorten development cycles (time to market)
-drive innovation
change control definition
-any potential change required to project DURING execution
-one change at a time
human resources
-change control: turnover of staff
-internal movement of staff to new positions
-process to identify people with potential for needed positions
-idenitfy future service needs, identify positions, select high potential candiates, select training, implement training, monitor and evaluate
-have training materials ready and a transition plan
Out of scope
Change control
-new directions requested by upper management or sponsor
-identify impact on triple constraint (time, cost/budget, quality)
-out of scope log
-change proposals require documentation
-directives log: all guidances provided by stakeholders
Change management
-this and change control are part of quality by design (change management encompasses change control)
-management is oversight of entire portfolio of changes and the change process
-systematic approach to changes (proposing, evaluating, approving, implementing, reviewing)
-plan for change, risked based approach
-therefore you are ready to make changes when needed/anticipate change
