CRP 112 Lecture 2

Question 1

Lean six sigma

Answer 1

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

Question 2

sigma definition

Answer 2

-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

Question 3

six sigma definition

Answer 3

-level of quality
-level 6 = no more than 3.4 defects per million oppertunities

Question 4

lean six sigma problem solving methodology

Answer 4

DMAIC
Define
Measure(quantify)
Analyze (find cause)
Improve (implement and verify solution)
Control (maintain solution)

Question 5

quality by design and six sigma

Answer 5

DMADV
-Define goals
-mesure metrics
-analyze options
-design new product/process/service
-verify design effectiveness in real world
-key feature: perpectual feedback

Question 6

Define stage

Answer 6

-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

Question 7

Six Sigma 6Ms sources of variation

Answer 7

-methods
-materials
-machines
-measurements
-mother nature
-man

Question 8

SIPOC model

Answer 8

-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)

Question 9

Measure stage

Answer 9

-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

Question 10

Analysis stage

Answer 10

-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

Question 11

Design stage

Answer 11

-have a problem and its root cause
-how to design for improvement
-likely solutions and their benfits

Question 12

verify stage

Answer 12

-goal: sustain improvements made
-measure and document the solution
-training is key to ensure improvements remain

Question 13

5s

Answer 13

lean six sigma tool
-keep working space in order
-sort, straighten, shine/sweep, standardize, sustain

Question 14

Kaizen

Answer 14

lean six sigma tool
-Japanese philosophy on continuous improvement in life
-makeing small improvement from bottom up
-

Question 15

Gemba

Answer 15

-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

Question 16

value stream mapping (VSM)

Answer 16

lean six sigma tool
-identifies process waste and cause of waste

Question 17

Jidoka/autonomation

Answer 17

-lean six sigma tool
-stops production when defect occurs
-automatic detection at early stage
-like a traffic light

Question 18

Kanban

Answer 18

-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

Question 19

Lean six sigma belts

Answer 19

-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)

Question 20

lean six sigma and pharma

Answer 20

-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

Question 21

change control definition

Answer 21

-any potential change required to project DURING execution
-one change at a time

Question 22

human resources

Answer 22

-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

Question 23

Out of scope

Answer 23

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

Question 24

Change management

Answer 24

-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