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Quality Tools and Methodologies Compiled by Larry Nyman

Quality Improvement Techniques

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Page 1: Quality Improvement Techniques

Quality Tools and Methodologies

Compiled by Larry Nyman

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Index• List of Key Quality Standards• Six Sigma Methodologies• KAIZEN• Lean Production• TQM• Hoshin• SWOT• Balanced Scorecard• 8 disciplines (8D)• 5S (Housekeeping)• Good to Great• Deming’s 14 points• PDCA cycle• Sampling• Seven Classical Quality Improveme

nt Tools– Checksheet (tally sheet)– Control Chart (SPC)– Process Flow Chart– Histogram (frequency distribution)– Pareto Analysis (80-20 rule)– Scatter Diagram (variable relationsh

ip)– Cause and Effect Analysis (fishbon

e)

• Brainstorming • Root Cause Analysis• Malcolm Baldrige• TRIZ• Kepner-Tregoe's

Five-Phase Strategy Model• “Zero Defects” Approach• Cost of Quality• FMEA• PFMEA• TOC (Theory of Contraints)• Process Capability• QFD• APQP• CMM• HACCP

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List of Key Quality StandardsISO 9001 Quality Management Standard

ISO 14001 Environmental Management Standard

OHSAS 18001 Occupational Health and Safety Management Standard

ISO 17025 Laboratory Management Standard

HACCP-9000 encompasses all of ISO 9001 plus food and beverage (inc. water) specific requirements.

ISO/TS 16949 encompasses all of ISO 9001 plus Automotive specific requirements. Replaces QS 9000.

ISO 13485/13488 encompasses all of ISO 9001 plus Medical Device specific requirements.

AS 9100 encompasses all of ISO 9001 plus Aerospace specific requirements.

TL 9000 encompasses all of ISO 9001 plus Telecommunication specific requirements

ISO 9000 Fundamentals and Vocabulary for using ISO 9001 and ISO 9004

ISO 9004 Guidelines on implementing ISO 9001 and continuous improvement

ISO 10005 Guidelines for Quality Plans

ISO 19011 Guidelines for Auditing

ISO 10012 Guidelines for Calibration

Malcolm Baldrige Business Excellence Standard

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Six Sigma Methodologies

The DMAIC methodology breaks down as follows:– Define the project goals and customer (internal and

external) requirements.– Measure the process to determine current

performance.– Analyze and determine the root cause(s) of the

defects.– Improve the process by eliminating defect root causes.– Control future process performance.

DFSS is the acronym for Design For Six Sigma

The five phases of DMADV are defined as: – Define the project goals and customer (internal and

external) requirements.– Measure and determine customer needs and

specifications; benchmark competitors and industry.– Analyze the process options to meet the customer

needs.– Design (detailed) the process to meet the customer

needs.– Verify the design performance and ability to meet

customer needs.

DCCDI methodology breaks down as follows : – Define the project goals.– Customer analysis is completed.– Concept ideas are developed, reviewed and selected.– Design is performed to meet the customer and

business specifications.– Implementation is completed to develop and

commercialize the product/service.

DMEDI is being taught by PricewaterhouseCoopers and stands for Define, Measure, Explore, Develop and Implement.

IDOV is a well known design methodology, especially in the manufacturing world.

– Identify the customer and specifications (Critical To Quality: CTQs ).

– Design translates the customer CTQs into functional requirements and into solution alternatives. A selection process whittles down the list of solutions to the "best" solution.

– Optimize uses advanced statistical tools and modeling to predict and optimize the design and performance.

– Validate makes sure that the design you've developed will meet the customer CTQs.

Six Sigma methodology is a proven tool set for driving and achieving transformational change within an organization. It is a business improvement process that focuses an organization on customer requirements, process alignment, analytical rigor, and timely execution. Six Sigma is a measure of quality that strives for near perfection. The Six Sigma process uses data and rigorous statistical analysis to identify "defects" in a process or product by reducing variability and achieve as close to zero defects as possible.

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3 3.5 4 4.5 5 5.5 6

66,803 22,800 6,200 1,350 233 32 3.4

Quality Level v defects per million

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KAIZENThe Japanese word "KAIZEN" means improvement, improvements without spending

much money, involving everyone from managers to workers, and using much common sense. The Japanese way encourages small improvements day after day, continuously. The key aspect of KAIZEN is that it is an on-going, never-ending improvement process. It's a soft and gradual method opposed to more usual western habits to scrap everything and start with new.

Kaizen activities can be conducted in several ways. First and most common is to change worker's operations to make his/her job more productive, less tiring, more efficient or safer. To get worker buy-in as well as significant improvement, worker is invited to cooperate, to reengineer by himself and with help of team mates. The second way is to improve equipment, like installing foolproof devices (poke yoke) and/or changing the machine layout. Third way is to improve procedures. All these alternatives can be combined in a broad improvement plan.

The first stage is reviewing the current work standards to check the current performance and than estimate how and how much performance can still be improved. When new leap is done, upgrade the standards.

Kaizen is controlled; It is not acceptable to let anybody change designs, layouts or standards for some pretended "improvement". Most often Kaizen is controlled by improvement groups and everybody, regardless to rank or position, is encouraged to suggest through suggestion submitting system (TEIAN in Japanese). Suggestions will be discussed by authoritative committee. Suggestions likely to be turned into application are usually rewarded according to the global gain. Improvement idea can be a response to a problem exposed by KAIZEN committee or come out spontaneously.

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Lean ProductionLean production is aimed at the elimination of waste in every area of production including customer

relations, product design, supplier networks and factory management. Its goal is to incorporate less human effort, less inventory, less time to develop products, and less space to become highly responsive to customer demand while producing top quality products in the most efficient and economical manner possible.

Seven types of waste:– Overproduction: to produce more than demanded or produce it before it is needed (JIT). It

is visible as storage of material. It is the result of producing to speculative demand; – Inventory or Work In Process (WIP): is material between operations due to large lot

production or processes with long cycle times (kanban); – Transportation: does not add any value to the product. Instead of improving the

transportation, it should be minimized or eliminated (e.g. forming cells); – Processing waste: should be minimized by asking why a specific processing step is

needed and why a specific product is produced. All unnecessary processing steps should be eliminated;

– Motion: of the workers, machines, and transport (e.g. due to the inappropriate location of tools and parts) is waste. Instead of automating wasted motion, the operation itself should be improved;

– Waiting: for a machine to process should be eliminated. The principle is to maximize the utilization/efficiency of the worker instead of maximizing the utilization of the machines;

– Making defective products: is pure waste. Prevent the occurrence of defects instead of finding and repairing defects (poke yoke).

Muda = Any wasteful activity or any obstruction to smooth flow of an activity. Activity = Work + Muda Mura = Inconsistencies in the system Muri = Physical Strain

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TQMUnderstand customer needs. Develop processes that continuously

collect, analyze, and act on customer information. Activities are often extended to understanding competitor's customers. Developing an intimate understanding of customer needs allows TQM organizations to predict future customer behavior.

Integrate customer knowledge with other information and use the planning process to orchestrate action throughout the organization to manage day to day activities and achieve future goals. Plans are reviewed at periodic intervals and adjusted as necessary. The planning process is the glue that holds together all TQM activity.

Understand that customers will only be satisfied if they consistently receive products and services that meet their needs, are delivered when expected, and are priced for value. Use the techniques of process management to develop cost-controlled processes that are stable and capable of meeting customer expectations.

Understand that exceptional performance today may be unacceptable performance in the future so use the concepts of process improvement to achieve both breakthrough gains and incremental continuous improvement. Process improvement is even applied to the TQM system itself!

The final element of the TQM model is total participation. Understand that all work is performed through people. This begins with leadership. Top management must take personal responsibility for implementing, nurturing, and refining all TQM activities. They make sure people are properly trained, capable, and actively participate in achieving organizational success. Management and employees work together to create an empowered environment where people are valued.

All of the TQM model's elements work together to achieve results.

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When all of its elements are implemented properly, TQM is like a well-built house.  It's solid, strong, and cohesive.  If TQM is not planned for and implemented correctly, it will be structurally weak and will probably fail.

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HoshinThe hoshin process is, first of all, a systematic planning methodology for defining long-

range key entity objectives. These are breakthrough objectives that typically extend two to five years with little change. Second, the hoshin process does not lose sight of the day-to-day "business fundamental" measures required to run the business successfully. This two-pronged approach provides an extended period of time for the organization to focus its breakthrough effort while continuously improving key business processes day to day.

The hoshin methodology provides:–  Breakthrough objective focus;–  Development of plans that adequately support the objective;–  Review of progress of these plans;–  Changes to plans as required;–  Continuous improvement of key business processes; and–  A vehicle for organizational learning.

 Hoshin ensures that everyone in the organization is working toward the same end. The

plan is hierarchical, cascading down through the organization and to key business-process owners. Ownership of the supporting strategies is clearly identified with measures at the appropriate level or process owner within the organization.

The hoshin process fits under the umbrella management philosophy of total quality management (TQM).

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SWOT Analysis• SWOT is an acronym for Strengths,

Weaknesses, Opportunities, Threats.• Assists in decision making.• Here are some examples of what a SWOT

analysis can be used to assess:– a company (its position in the market,

commercial viability, etc) – a method of sales distribution – a product or brand – a business idea – a strategic option, such as entering a

new market or launching a new product

– a opportunity to make an acquisition – a potential partnership – changing a supplier – outsourcing a service, activity or

resource – an investment opportunity

Subject of SWOT analysis Strengths

Advantages of proposition? Capabilities? Competitive advantages? USP's (unique selling points)? Resources, Assets, People? Experience, knowledge, data? Financial reserves, likely returns? Marketing - reach, distribution,

awareness? Innovative aspects? Location and geographical? Price, value, quality? Accreditations, qualifications,

certifications? Processes, systems, IT,

communications? Cultural, attitudinal, behavioural? Management cover, succession?

Weaknesses

Disadvantages of proposition? Gaps in capabilities? Lack of competitive strength? Reputation, presence and reach? Financials? Own known vulnerabilities? Timescales, deadlines and pressures? Cashflow, start-up cash-drain? Continuity, supply chain robustness? Effects on core activities, distraction? Reliability of data, plan predictability? Morale, commitment, leadership? Accreditations, etc? Processes and systems, etc? Management cover, succession?

Opportunities

Market developments? Competitors' vulnerabilities? Industry or lifestyle trends? Technology development and

innovation? Global influences? New markets, vertical, horizontal? Niche target markets? Geographical, export, import? Tactics - surprise, major contracts, etc? Business and product development? Information and research? Partnerships, agencies, distribution? Volumes, production, economies? Seasonal, weather, fashion influences?

Threats

Political effects? Legislative effects? Environmental effects? IT developments? Competitor intentions - various? Market demand? New technologies, services, ideas? Vital contracts and partners? Sustaining internal capabilities? Obstacles faced? Insurmountable weaknesses? Loss of key staff?

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Balanced Scorecard• The balanced scorecard forces managers to

look at the business from four important interconnected perspectives.

• Reference: ‘The Balanced Scorecard’ by Kaplan & Norton. IBSN:0-87584-651-3

• The balanced scorecard method seems to be more of a one-way street -- the executive team creates the strategy, and it cascades down from there.

• The balanced scorecard has strong similarities to Hoshin Planning. Hoshin Planning or hoshin kanri is widely used by Japanese companies.

• One thing that the Japanese emphasize is "catchball", the process of give and take between levels/functions/divisions that helps to define strategy.

Customer

“To achieve ourvision, howshould weappear to ourcustomers?”

Ob

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Me

asu

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Ta

rge

ts

Initi

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Internal BusinessProcesses“To satisfy ourshareholdersand customers,what businessprocesses mustwe excel at?”

Ob

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Me

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Employees

“To achieve ourvision, howwill we sustainour ability tochange andimprove?”

Ob

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Financial

“To succeedfinancially, howshould weappear to ourshareholders?”

Ob

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Visionand Strategy

Satisfied Employees needeffective & efficient Processes

to delight the Customersso Financials will increase; thus,

increasing Employee satisfaction…

“Start the flywheel spinningand people will jump on”

-Jim Collins

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8 D (8 disciplines)A Process Improvement approach

1. Use Team ApproachEstablish a small group of people with the knowledge, time, authority and skill to solve

the problem and implement corrective actions. The group must select a team leader.

2. Describe the ProblemDescribe the problem in measurable terms. Specify the internal or external customer

problem by describing it in specific terms.

3. Implement and Verify Short-Term Corrective ActionsDefine and implement those intermediate actions that will protect the customer from the

problem until permanent corrective action is implemented. Verify with data the effectiveness of these actions.

4. Define end Verify Root CausesIdentify all potential causes which could explain why the problem occurred. Test each

potential cause against the problem description and data. Identify alternative corrective actions to eliminate root cause.

5. Verify Corrective ActionsConfirm that the selected corrective actions will resolve the problem for the customer

and will not cause undesirable side effects. Define other actions, if necessary, based on potential severity of problem.

6. Implement Permanent Corrective ActionsDefine and implement the permanent corrective actions needed. Choose on-going

controls to insure the root cause is eliminated. Once in production, monitor the long-term effects and implement additional controls as necessary.

7. Prevent RecurrenceModify specifications, update training, review work flow, improve practices and

procedures to prevent recurrence of this and all similar problems.

8. Congratulate Your TeamRecognize the collective efforts of your team. Publicize your achievement. Share your

knowledge and learning.

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5S’s

5S is the Japanese concept for House Keeping.

1.) Sort (Seiri) 2.) Straighten (Seiton) 3.) Shine (Seiso) 4.) Standardize (Seiketsu) 5.) Sustain (Shitsuke)

The following are the real meaning of each element in English:

Japanese - English Translations Seiri - Put things in order

(remove what is not needed and keep what is needed) Seiton - Proper Arrangement

(Place things in such a way that they can be easily reached whenever they are needed) Seiso - Clean

(Keep things clean and polished; no trash or dirt in the workplace) Seiketsu - Purity

(Maintain cleanliness after cleaning - perpetual cleaning) Shitsuke – Commitment

(Conduct a Gemba Walk – where management walks around the workplace to inspect and ask non-judgemental productivity questions)

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Good to Greatby Jim Collins (IBSN 0-06-662099-6)

1. Level 5 LeadershipLevel 5 leaders channel their ego needs away from themselves and into a larger goal of building a great company. Put these people in leadership roles.

2. First Who, Then WhatBefore strategizing, get the right people on the bus. … They will be self-motivated.

3. Confront the Brutal FactsAcknowledge the realistic facts of the current status. … Confront reality with open and honest communication.

4. Hedgehog ConceptDefine what you can be ‘best in the world’ at; define what you can make money doing; define what your passion is. This is the Company’s long-term Vision. Don’t let go of it… Persevere!

5. Develop a Disciplined CultureAfter the right people are in place, take planned actions within the framework of the Hedgehog Concept. Create a “Stop Doing” list.

Once people see how improvements and positive results fit into the Vision (Hedgehog Concept), they will be motivated to jump on board. This is called the Flywheel Effect. As momentum of the flywheel increases, a breakthrough will occur – resulting in Greatness.

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Deming’s 14 points(reference: ‘Out of the Crisis’ by W.Edwards Deming IBSN: 0-911379-01-0)

1. Create constancy of purpose toward improvement of product and service, with the aim to become competitive and to stay in business, and to provide jobs.

2. Adopt the new philosophy. We are in a new economic age. Western management must awaken to the challenge, must learn their responsibilities, and take on leadership for change.

3. Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place.

4. End the practice of awarding business on the basis of price tag. Instead, minimize total cost. Move toward a single supplier for any one item, on a long-term relationship of loyalty and trust.

5. Improve constantly and forever the system of production and service, to improve quality and productivity, and thus constantly decrease costs.

6. Institute training on the job.

7. Institute leadership (see Point 12 and Ch. 8). The aim of supervision should be to help people and machines and gadgets to do a better job. Supervision of management is in need of overhaul, as well as supervision of production workers.

8. Drive out fear, so that everyone may work effectively for the company (see Ch. 3).

9. Break down barriers between departments. People in research, design, sales, and production must work as a team, to foresee problems of production and in use that may be encountered with the product or service.

10. Eliminate slogans, exhortations, and targets for the work force asking for zero defects and new levels of productivity. Such exhortations only create adversarial relationships, as the bulk of the causes of low quality and low productivity belong to the system and thus lie beyond the power of the work force.

– Eliminate work standards (quotas) on the factory floor. Substitute leadership.

– Eliminate management by objective. Eliminate management by numbers, numerical goals. Substitute leadership.

11. Remove barriers that rob the hourly worker of his right to pride of workmanship. The responsibility of supervisors must be changed from sheer numbers to quality.

12. Remove barriers that rob people in management and in engineering of their right to pride of workmanship. This means, inter alia, abolishment of the annual or merit rating and of management by objective (see Ch. 3).

13. Institute a vigorous program of education and self-improvement.

14. Put everybody in the company to work to accomplish the transformation. The transformation is everybody's job.

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PDCA cyclePlan - a change or a test, aimed at improvement.In this phase, analyze what you inted to improve, looking for areas that hold

opportunities for change. The first step is to choose areas that offer the most return for the effort you put in-the biggest bang for your buck. To identify these areas for change consider using a Flow chart or Pareto chart .

Do - Carry out the change or test (preferably on a small scale).Implement the change you decided on in the plan phase. Check or Study - the results. What was learned? What went wrong?This is a crucial step in the PDCA cycle. After you have implemented the

change for a short time, you must determine how well it is working. Is it really leading to improvement in the way you had hoped? You must decide on several measures with which you can monitor the level of improvement. Run Charts can be helpful with this measurement.

Act - Adopt the change, abandon it, or run through the cycle again.After planning a change, implementing and then monitoring it, you must

decide whether it is worth continuing that particular change. If it consumed too much of your time, was difficult to adhere to, or even led to no improvement, you may consider aborting the change and planning a new one. However, if the change led to a desirable improvement or outcome, you may consider expanding the trial to a different area, or slightly increasing your complexity. This sends you back into the Plan phase and can be the beginning of the ramp of improvement.

The Ramp of Improvement:This is a schematic representation of the use of the PDCA cycle in the improvement

process. As each full PDCA cycle comes to completion, a new and slightly more complex project can be undertaken. This rolling over feature is integral to the continual improvement process.

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Sampling• Sampling Plans originate from MIL-STD-105E and are now within

spec: ASQ Z1.4. get a free copy here: old MIL STDs

• Here’s how to use 105E (simplistically):– On Page 13 – find the lot size range (the number of units in the lot). Go to General

Inspection Level II (normal) column and find the corresponding Letter code.– On Page 14 – find the Letter code and find the sample size (this is the number of

units that will be randomly chosen from the lot). Go to the corresponding AQL (Acceptable Quality Level) column and determine the Ac and Re numbers.

• If ≤ Ac are not acceptable, the entire lot is accepted. • If ≥ Re are not acceptable, the entire lot is rejected.• All rejected units are repaired or replaced.

Switching rules:– If 2 of 5 consecutive lots are rejected, use the General Inspection Level III

(tightened) column (page 13).– If 5 consecutive lots are accepted at Level III, return back to Level II.– If 10 consecutive lots are rejected at Level III, perform 100% inspection.– If 10 consecutive lots are accepted at Level II, go to Level I (Reduced).– If 1 lot is rejected at Level I, return back to Level II.

• Also see http://iew3.technion.ac.il/sqconline/milstd105.html

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When to Sample?General Rule of Thumb

Let p = nonconforming product (NCP) per lot.Let C1 = cost of inspection and removal of NCP.Let C2 = cost of rework if NCP went to the next step.

Use 100% inspection if:p > C1 / C2

Use NO inspection if:p < C1 / C2

Use Sampling if:p ≈ C1 / C2

Also based on supplier quality history and criticality of the material. One needs to ask: “what would be the result of allowing a nonconforming item to continue through production and/or on to the consumer?”

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Seven Classical Quality Improvement Tools

1. Checksheet (tally sheet)

2. Control Chart (SPC)

3. Process Flow Chart

4. Histogram (frequency distribution)

5. Pareto Analysis (80-20 rule)

6. Scatter Diagram (variable relationship)

7. Cause and Effect Analysis (fishbone)

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1. Checksheet• Also known as a “tally sheet”• Used for simple data collection.• Used to measure the frequency of events or defects

over short time intervals.• It illustrates, at a glance, what the most occurring

problems are.

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2. Statistical Process Control (SPC)Every process varies.

– unusual variations are due to "special causes“ – Process is ‘Out-of-Control’

– consistent variations are called “common causes“ – Process is ‘In Control’

All control charts have three basic components:

– a centerline, usually the mathematical average of all the samples plotted.

– upper and lower statistical control limits that define the constraints of common cause variations. (±3σ)

– performance data plotted over time

Things to look for:The point of making control charts is

to look at variation, seeking special causes and tracking common causes. Special causes can be spotted using several tests:

– 1 data point falling outside the control limits

– 6 or more points in a row steadily increasing or decreasing

– 8 or more points in a row on one side of the centerline

– 14 or more points alternating up and down

Reducing common cause variation saves money and time.

Types of control charts:•X bar R charts •XmR charts •C charts •p charts •np charts •u charts

calculating limits

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3. Process Flow Chart• A pictorial representation describing a process

being studied.

• Used to plan stages of a project or steps in a process.

• Provides people with a common language or reference point when dealing with a project or process.

The shapes

Supplier Customer

Requirements

Inputs Outputs

Requirements

Feedback Feedback

Controls

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Resources

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4. Histogram

• Sometimes called the “Bell Curve”.

• Lets you see the shape of a set of data - where its center it, how far it spreads out on either side, and location of outliers.

• As the shape gets thinner, the variation is less.

• Used to determine process capability.

Normal Distribution

Bimodal Distribution

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5. Pareto Analysis

• Used to graphically summarize and display the relative importance of the differences between groups of data.

• Used to focus on critical issues by ranking them in terms of importance and frequency.

• 80/20 Rule: About 80% of the problems are from 20% of the causes.

97%93%

89%82%

63%

35%

0

10

20

30

40

50

60

70

0%

25%

50%

75%

100%

freq 25 20 13 5 3 3 2

% 35% 63% 82% 89% 93% 97% 100%

Doc NeT IeT LoT HE Tec Clsns

Code Root Cause CADoc Lack of clear documentation/information Create/update documentation and distributeNeT Not enough time to do the job right Define Priorities based on corporate initiatives

IeT Ineffective Training1. Improve training technique and provide retraining. 2. Reassign employee 3. Review HR recruiting techniques

LoT Lack of Training Make training availableHE Human Error Apply mistake-proofing techniquesTec Technology will not allow improvement Upgrade technologyClsns Carelessness 1. Define Consequences for actions 2. Apply mistake-proofing techniques

Focus on these three

items (80%)

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6. Scatter Diagram • Used to interpret data by graphically displaying

the relationship between two variables.

• Validating "hunches" about a cause-and-effect relationship between types of variables (ex: is there a relationship between the production speed of an operator and the number of defective parts made?)

• Displaying the direction of the relationship (positive, negative, etc.) (ex: will increasing assembly line speed increase or decrease the number of defective parts made?)

• Displaying the strength of the relationship (ex: how strong is the relationship between assembly line speed and the number of defective parts produced?)

Rules:•If the points cluster in a band running from lower left to upper right, there is a positive correlation (if x increases, y increases). •If the points cluster in a band from upper left to lower right, there is a negative correlation (if x increases, y decreases). •Imagine drawing a straight line or curve through the data so that it "fits" as well as possible. The more the points cluster closely around the imaginary line of best fit, the stronger the relationship that exists between the two variables. •If it is hard to see where you would draw a line, and if the points show no significant clustering, there is probably no correlation.

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7. Cause and Effect Analysis

• Brainstorm and write down all the potential reasons why.

• Continue asking “why” at least 5 times or until there are no other (practical) reasons.

• To visualize the discussion, construct a “Fishbone” (aka Ishikawa or Cause-and-Effect) diagram.

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Brainstorming• Brainstorming is simply listing all ideas put forth by a

group in response to a given problem or question. – To conduct a successful brainstorming session:

• Make sure everyone understands and is satisfied with the central question before you open up for ideas.

• You may want to give everyone a few seconds to jot down a few ideas before getting started.

• Begin by going around the table or room, giving everyone a chance to voice their ideas or pass. After a few rounds, open the floor.

• More ideas are better. Encourage radical ideas and piggybacking. • Suspend judgment of all ideas. • Record exactly what is said. Clarify only after everyone is out of

ideas. • Don't stop until ideas become sparse. Allow for late-coming ideas. • Eliminate duplicates and ideas that aren't relevant to the topic.

– Rapidly group ideas that seem to belong together (called an Affinity Diagram). These groups can be used as the Fishbone’s categories.

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Root Cause Analysis• Will determine “why” the root cause occurred in the first place.• Asks difficult and sometimes embarrassing questions about how the

organization is managed. It may even be ignored for internal political reasons.

• Stops when you’ve exhausted all “practical” causes.• The best candidates for root cause analysis are those situations which are

recurring the most and use up the greatest amount of resource to correct. • Extremely important because if done correctly, it will prevent the problem

from happening again.

10 Steps:1. Develop a problem statement2. Understand how the affected process works3. In a team setting (preferably) or individually, ask “why” the problem occurred (5x)4. Determine the Solution (Corrective Action) to each Root Cause5. Score and prioritize the causes by their frequency, likelihood and ease to correct6. Select the Root Cause(s) and attempt to validate them7. Develop a Plan to Implement the Solution8. Execute the Corrective Action Plan9. Verify that the Corrective Action was effective10. Monitor Process

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Team DynamicsCharter : What is the purpose of the team?

Set a clear Objective and Target.

Leader : Facilitates the team’s actions.

Champion/Angel : motivates and provides management support to remove obstacles and provide funding/resources.

The Team maturity progression is:– Creating: Cross functional; include suppliers, process, customers.– Forming: High dependence on leader for guidance and direction. – Storming: Conflict occurs in interpersonal relationships. – Norming: Agreement and consensus is reached among team, who

respond well to facilitation by the leader.– Performing: The team has a shared vision and is able to stand on its

own feet with no interference or participation from the leader.

– Adjourning: the break-up of the team, hopefully when the task is

completed successfully, its purpose fulfilled.

Adjourn Create

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Malcolm Baldrigesee http://baldrige.nist.gov/

Applying for the Baldrige Award is an opportunity to examine your organization critically and identify strengths and opportunities to improve.

An organization will accelerate improvement efforts; energize their employees; gain an outside perspective; learn from feedback; and focus on results.

The Core Values and Concepts are embodied in seven Categories, as follows:1. Leadership2. Strategic Planning3. Customer and Market Focus4. Measurement, Analysis, and Knowledge Management5. Human Resource Focus6. Process Management7. Business Results

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Malcolm BaldrigeCore Values and ConceptsThe Criteria are built upon the following set of interrelated Core Values and Concepts:

• visionary leadership• customer-driven excellence• organizational and personal learning• valuing employees and partners• agility• focus on the future• managing for innovation• management by fact• social responsibility• focus on results and creating value• systems perspective

These values and concepts are embedded beliefs and behaviors found in high-performing organizations. They are the foundation for integrating key business requirements within a results-oriented framework that creates a basis for action and feedback.

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TRIZ(see: http://www.triz-journal.com)

• A problem solving tool based on logic and data rather than intuition.

• Eliminates contradictions (e.g., Training should be thorough but not take any time)

• Uses 40 Principals (see website)

• TRIZ doctrine:– Somebody, someplace, has already solved

any problem – or one similar to it– Creativity means finding that solution and

adapting it to a current problem.

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Kepner-Tregoe'sFive-Phase Strategy Model

Phase I: Strategic Intelligence Gathering and AnalysisA rigorous process is undertaken to gather, organize, and analyze data on markets, competitors, technology, and past performance to ensure that the right information is used to facilitate good strategic decision making. Phase One provides an information base for strategic decision making and an agreed-upon set of assumptions about the internal and external environments in which an organization will operate during its strategic time frame.

Phase II: Formulating StrategyA strategic profile of the organization is developed for guiding day-to-day decision making. This profile defines key strategic elements including:

– The basis for competitive advantage – The scope of the products and services that will and

will not be offered, and the markets that will and will not be served

– The relative emphasis and financial mix of the future product/market scope

– The source of new business and growth – The capabilities needed to implement the strategy – The business results to be achieved – The critical issues (barriers to implementation) to be

resolved

Phase III: Implementation PlanningAs a result of formulating a clear strategy, many projects emerge, the execution of which leads to successful implementation of the strategy. The creation of a strategic Master Project Plan is the key output of this phase, providing a detailed definition of each project, sequencing projects, developing a schedule, and indicating the required resource levels for each project. The training of key staff in Project Management techniques ensures successful implementation.

Phase IV: Implementing StrategyEven the most elegant and robust strategic visions are worthless without effective implementation. It is the implementation phase of the process that yields the tangible results sought by all organizations. During this phase, planned actions are taken, implementation is monitored, and the plan is modified as circumstances change and the strategy is revised. Also during this phase, employees are given the necessary skills to play their role effectively in implementation, with a particular emphasis on project management and decision making. Effective communication is at the heart of flawless strategy implementation. Every employee and external stakeholder is briefed on the strategy with the intent of creating understanding, commitment, and answers to the question, "What's in it for me?"

Phase V: Strategy Monitoring and UpdatingOngoing review of the strategy is essential for keeping the strategy vibrant and relevant as a key tool in the continuous quest for success. Typically, executive leaders are adept at reviewing the operations and financial dimensions of the business. The strategic review process is equally important. Activities include: determining if the assumptions upon which the strategy rests remain valid; assessing if the strategic direction continues to make business sense; and keeping abreast of progress toward implementation.

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Philip Crosby’s“Zero Defects” Approach

1. Obtain Management Commitment: Make it clear where management stands on quality.

2. Form a Quality Improvement Team: Manages the quality improvement program.

3. Measure Performance: Bring problems into the light.

4. Determine Cost of Quality: Compare with overall sales $.

5. Provide Quality Awareness: Let employees know what you intent to do and what you expect from them.

6. Corrective Action: Identify/prioritize improvement opportunities and fix them so they don’t recur.

7. Zero Defects Planning: Develop plan to launch Zero Defects Program.

8. Supervisor Training: Get buy-in and prepare them to train their workers.

9. Zero Defects Day: Let employees know that Mgmt is serious about the Zero Defects program.

10. Goal Setting: Every division will set stretch goals.

11. Error Cause Removal: employees will identify problems throughout the business.

12. Recognition: Reward those who exceed goals or perform outstanding acts.

13. Quality Councils: Form teams to discuss improvements and lessons learned.

14. Do it over again: After 12-18 months, form a new QI Team.

“Why would a target be anything other than ZERO Defects?”

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Cost of (poor) QualityThe costs associated with quality are divided into two categories:

– costs due to poor quality and – costs associated with improving quality.

Prevention costs and appraisal costs are costs associated with improving quality, while

failure costs result from poor quality.

Cost of quality comprises of four parts: – External Failure Costs: associated with product failure after the completion of the production

process. (e.g., customer complaints, returns, recalls, penalties)– Internal Failure Costs: expenses incurred before the product or service is provided to the

customer. (e.g., repair, rework, scrap, data corrections)– Appraisal Costs: direct costs of measuring quality. (e.g., inspection, test, calibration and

maintenance)– Prevention Costs: associated with preventing defects and imperfections from occurring.

(e.g., process monitoring, SPC, audits, planning)

Phillip Crosby states that “quality is free”. The costs related to achieving quality are traded off between the prevention/appraisal costs and the failure costs. Therefore, the prevention/appraisal costs resulting from improved quality, allow an organization to minimize or be free of the failure costs resulting from poor quality. “Do it right the first time”. The total Cost of Quality should not be > 2.5% of your total Sales dollar. (reference “Quality is Free” IBSN: 0-451-62585-4)

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FMEA(see steps at http://www.npd-solutions.com/fmea.html)

Failure Modes and Effects Analysis (FMEA)a methodology for analyzing potentialreliability problems early in the developmentcycle where it is easier to take actions to overcome these issues,thereby enhancing reliability through design.

FMEA is used to identify potential failure modes, determine their effect on the operation of the product, and identify actions to mitigate the failures. A crucial step is anticipating what might go wrong with a product. While anticipating every failure mode is not possible, the development team should formulate as extensive a list of potential failure modes as possible.

The early and consistent use of FMEAs in the design process allows the engineer to design out failures and produce reliable, safe, and customer pleasing products. FMEAs also capture historical information for use in future product improvement.

MIL-STD-1629

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PFMEA

Process Failure Modes Effects Analysis.

Is a systemized group of activities intended to: (a) recognize and evaluate the potential failure of a

product/process and its effect,(b) identify actions which could eliminate or reduce the occurrence,(c) document the process, and(d) track changes to process- incorporated to avoid potential

failures.

Is a living document. Is better to take actions addressed to eliminate or reduce the potential causes than implement controls in process. Is a process which before hand tells you the potential failure modes and their effects.

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TOC (Theory of Contraints)Ref: ‘The Goal’ by Goldratt IBSN: 0-88427-061-0

The Five focusing steps:

1. Identify the System's constraints.A process is analyzed so that a task or activity that limits the productivity of an entire system can be identified. A system constraint may be identified by a long queue of work or long processing times.

2. Decide how to exploit the system's constraints.Decisions must be made on how to modify or redesign the task or activity so that work can be performed more effectively and efficiently.

3. Subordinate everything else to the above decision. (step 2)Management directs all its efforts to improving the performance of the constraining task or activity and any other task or activity and any other task or activity that directly affects the constraining task or activity.

4. Elevate the system's constraint.Additional capacity is obtained that will increase (elevate) the overall output of the constraining task or activity. This differs from step 2 in that the added output comes from additional purchased capacity, such as buying a second machine tool or implementing a new information technology.

5. If, in the previous step, a constraint has been broken, go back to step 1 but do not allow inertia to cause a new constraintSets up a process of ongoing improvement. As a result of the focusing process, the improvement of the original constraining task or activity may cause a different task to become a constraining task or activity. Inertia could blind management from taking steps to improve the system's output now limited by a new constraint.(1)

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• Process Capability (Cpk)– Relationship between the natural variation of

the process and the design specifications.

– A Cpk of greater than one indicates that the process spread is less than the width of the specification. Potentially, this means that the process can fit inside the specification limits.

– Cpk > 1.33 (capable)

– 1.00 > Cpk < 1.33 (capable with tight control)

– Cpk < 1.00 (not capable)

Process Capability• Measures the ability of a process to

produce a product that will consistently meet design specifications.

6

LTLUTLC p

σ CPk Defects/million

opportunities

% Yield

1.5 0.50 500,000 50

3.0 1.00 66,800 93.32

3.5 1.17 22,800 97.73

4.0 1.33 6,200 99.379

4.5 1.50 1,350 99.865

5.0 1.67 233 99.977

6.0 2.00 3.4 99.9997

3

,3

minLTLUTL

C pk

Process Capability Index Process Capability Ratio

UTL = Upper spec limitLTL = Lower spec limitσ = std deviation of processμ = process meanmin = which ever is smaller

Calculations

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QFD(also see http://sern.ucalgary.ca/courses/seng/613/F97/grp2/report.htm)

Quality Function Deployment (QFD) is a method of listening to customers to learn exactly what they want, and then using a logical system to determine how best to fulfill those needs with available resources. It is a product-development tool that can systematically deploy customer requirements into production requirements. QFD is a team builder approach; it ensures that everyone works together to give customers what they want. It gives everyone in the organization a road map showing how every step, from design through delivery, interacts to fulfill customer requirements.

QFD’s primary goal is to overcome three major problems in traditional methods:

• disregard for the voice of the customer• loss of information, and• different individuals and functions working to different requirements.

In QFD, these issues are addressed by effectively answering the following questions:

• What are the qualities the customer desires? • What functions must the product serve and what functions must we use to

provide the product or service? • Based upon the resources we have available, how can we best provide what

our customer wants?

House of Quality

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APQPAdvanced Product Quality Planning (used mostly in automotive industry)

Phase 1 - Plan & Define Program - determining customer needs, requirements & expectations using tools such as QFD review the entire quality planning process to enable the implementation of a quality program how to define & set the inputs & the outputs.

Phase 2 - Product Design & Development - review the inputs & execute the outputs, which include FMEA, DFMA, design verification, design reviews, material & engineering specifications.

Phase 3 - Process Design & Development - addressing features for developing manufacturing systems & related control plans, these tasks are dependent on the successful completion of phases 1 & 2 execute the outputs.

Phase 4 - Product & Process Validation - validation of the selected manufacturing process & its control mechanisms through production run evaluation outlining mandatory production conditions & requirements identifying the required outputs.

Phase 5 - Launch, Feedback, Assessment & Corrective Action - focuses on reduced variation & continuous improvement identifying outputs & links to customer expectations & future product programs.

Control Plan Methodology - Discusses use of control plan & relevant data required to construct & determine control plan parameters stresses the importance of the control plan in the continuous improvement cycle.

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CMMThe Capability Maturity Model for Software

(also known as the CMM and SW-CMM) has been a model for judging the maturity of the software processes of an organization. This model helps organizations identify the key practices required to help them increase the maturity of these processes.

Predictability, effectiveness, and control of an organization's software processes are believed to improve as the organization moves up these five levels. While not rigorous, the empirical evidence to date supports this belief.

1) Initial. The software process is characterized as ad hoc, and occasionally even chaotic. Few processes are defined, and success depends on individual effort and heroics. 2) Repeatable. Basic project management processes are established to track cost, schedule, and functionality. The necessary process discipline is in place to repeat earlier successes on projects with similar applications. 3) Defined. The software process for both management and engineering activities is documented, standardized, and integrated into a standard software process for the organization. All projects use an approved, tailored version of the organization's standard software process for developing and maintaining software. 4) Managed. Detailed measures of the software process and product quality are collected. Both the software process and products are quantitatively understood and controlled. 5) Optimizing. Continuous process improvement is enabled by quantitative feedback from the process and from piloting innovative ideas and technologies.

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HACCPHazard Analysis and Critical Control Point

HACCP is a scientific system for process control that has long been used in food/beverage production to prevent problems by applying controls at points in a production process where hazards could be controlled, reduced, or eliminated.

The program reduces risks to the customers. A plant must have an effective HACCP system to comply with regulatory requirements and prevent adulteration of product. See: 9 CFR Part 417.

Steps to meet HACCP are defined on the right.

Assemble amultifunctional

team

Validate the flowdiagram

Construct a flowdiagram

Identify theIntended Uses

Describe theProduct

Conduct HazardAnalysis

Identify CriticalControl Points

(CCP)

Establish CriticalLimits

Identify monitoringprocedures

EstablishCorrective Action

Procedures

Validate & VerifyHACCP Plan

Establishdocumentation

and recordkeeping

Plan, develop, verify, andimplement the HACCP

program.

Define the source,treatment, storage, anddistribution of the water.

Define the applicableregulations/standards

Define how the water isused (e.g., drinking,

irrigation, firefighting, etc)and its major users (e.g.,residential, commercial,industrial, municipal).

Document a schematicshowing water sources,

treatment, storage,pumping, & distribution to

end users.

Confirm that the flowdiagram is accurate.

Using the flow diagram,identify hazards, their

likelihood of occurrence,potential consequences, &

control measures.

Using the Hazards List,select the most significanthazards to control (where

the consequences offailure are irreversible).

Determine performancemeasures for the CCPs

that will trigger a correctiveaction.

Establish Monitoringpoints, frequency, and

responsibilities.

Develop plans for followup activity when

performance measures forCCPs are exceeded.

Check (audit) the plan foraccuracy, ability to

implement, and potentialeffectiveness.

Develop a recordkeepingsystem to track systemperformance at CCPs.

Decide to developHACCP Program

Decide if 3rd partycertification has

value