Thursday 23 December 2010

Quality management

Quality

Quality is difficult to define, it's an abstract term, it requires continuous and dynamic adaptation of products and services to fulfill or exceed the requirements or expectations of all parties in the organization and the community as a whole.

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'Quality means conformance to requirements' (Philip Crosby, 'Quality Is Free'). It does not matter whether or not the requirements are articulated or specified; if a product does not fully satisfy, it lacks quality in some respect. ('Quality is binary -- you've either got it, or you haven't' -- ibid. Note that both these quotes are 'top-of-the-head' and therefore approximate.)

The starting-point for a 'quality product', therefore, is precise determination of the requirements of its users. This may not be possible in practice, but should still be attempted as best possible (see *Acceptable Quality Level*).

Note that the 'quality' of a product is the sum of multiple separate *Quality Attributes*.

Quality

A refined process in which products are assessed, improved, ensured, and confirmed.

Quality

Achieving excellence in a product/service by meeting/exceeding the requirements of the
customer.

Quality

Quality is a function of loss. The better the quality, the lesser is the loss it causes to society. – Taguchi

Quality

The essential and distinguishing trait why product X may not be replaced by a similar product Y

QUALITY - DEFINITION

Reduction of variation around the "Mean".

Quality Assurance

A planned and systematic set of activities to ensure that variances in processes are clearly identified, assessed and improving defined processes for fullfilling the requirements of customers and product or service makers.

A planned and systematic pattern of all actions necessary to provide adequate confidence that the product optimally fulfils customer's expectations.

A planned and systematic set of activities to ensure that requirements are clearly established and the defined process complies to these requirements.

"Work done to ensure that Quality is built into work products, rather than Defects." This is by (a) identifying what "quality" means in context; (b) specifying methods by which its presence can be ensured; and (c) specifying ways in which it can be measured to ensure conformance (see *Quality Control*, also *Quality*).

Quality Attribute

A property of a work product or goods by which its *Quality* will be judged by some *Stakeholder* or stakeholders. (Also "Quality Factor" or [Gilb] "Quality".) Quality attributes are and should be quantifiable in specifications by the definition of some appropriate and practical

Quality Control

Also called statistical quality control. The managerial process during which actual process performance is evaluated and actions are taken on unusual performance.
It is a process to ensure whether a product meets predefined standards and requisite action taken if the standards are not met.

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Quality Control measures both products and processes for conformance to quality requirements (including both the specific requirements prescribed by the product specification, and the more general requirements prescribed by *Quality Assurance*); identifies acceptable limits for significant *Quality Attributes*; identifies whether products and processes fall within those limits (conform to requirements) or fall outside them (exhibit defects); and reports accordingly. Correction of product failures generally lies outside the ambit of Quality Control; correction of process failures may or may not be included.

Quality Dictionary

Dictionary of quality terms. You are reading a quality dictionary.

Quality Function Deployment

Quality function deployment (QFD) is a structured methodology and mathematical tool used to identify and quantify customers' requirements and translate them into key critical parameters. In Six Sigma, QFD helps you to prioritize actions to improve your process or product to meet customers' expectations

Quality Gap

It is the difference between the approved standards, criteria or expectations in any process or activity and the real results in such process or activity in accordance with the adopted national and or international standards by any country.

Quality Improvement

A systematic and continuous activity to improve all processes and systems in the organization to achieve optimal level of performance.

The organized creation of beneficial changes in process performance levels.

Quality Management

A systematic set of activities to ensure that processes create products with maximum *Quality* at minimum *Cost of Quality*. The activities include *Quality Assurance*, *Quality Control*, and *Quality Improvement*.

Quality Procrastination

Postponing quality improvement decisions and programs to the last moment, putting the organization under time pressure.

Quality Record

Quality record indicates that a control has been made or an observation has been been done

Quality Target

Each operation in the manufacturing process, which has an effect on the conformance of the end product to the customer's specifications, is assigned a Quality Target value. This value represents the maximum allowable discrepancies per 1,000 opportunities. (See also Opportunity)

Quantifiers

Quantifiers are the means by which the performance of measurables is tracked. The values of the quantifiers are typically plotted over time in trend charts. Quantifiers associated with result measurables are called result quantifiers and quantifiers associated with process measurables are called process quantifiers.

Quantitative data

Continuous data.

Quantitative data will be different depending on the types of questions you ask and the data you gather.
 Quantitative Variable

A variable that consists of a count or numerical measurement of the characteristics of objects, people or events.

variable that measures a numerical characteristic; also called a measurement variable For example, since the response to how many brothers and/or sisters a person has is a number, this variable is a quantitative variable.

count variable - a type of quantitative variable; answers the question, "How many?"




Quality management
can be considered to have four main components: quality planning, quality control, quality assurance and quality improvement. Quality management is focused not only on product/service quality, but also the means to achieve it. Quality management therefore uses quality assurance and control of processes as well as products to achieve more consistent quality..

Quality terms:

  • Quality Improvement can be distinguished from Quality Control in that Quality Improvement is the purposeful change of a process to improve the reliability of achieving an outcome.
  • Quality Control is the ongoing effort to maintain the integrity of a process to maintain the reliability of achieving an outcome.
  • Quality Assurance is the planned or systematic actions necessary to provide enough confidence that a product or service will satisfy the given requirements.
interdiction about quality.  5S:


5S is the Japanese concept for House Keeping.

1.) Sort (Seiri)
2.) Straighten (Seiton)
3.) Shine (Seiso)
4.) Standardize (Seiketsu)
5.) Sustain (Shitsuke)
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I think the concept of 5S has been twisted and its real meaning and intention has been lost due to attempts to keep each element in English word to start with letter 'S', like the real Nippongo words (seiri, seiton, seiso, seiketsu, and shitsuke). Well, whoever deviced those equivalent English words did a good job, they’re close, but the real interpretation is not exactly the correct one. For the benefit of the readers who would like to develop and establish their own understanding and applications, the following are the real meaning of each element in English:

Japanese - English Translations
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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 (Actually this is not a part of '4S', but a typical teaching and attitude towards any undertaking to inspire pride and adherence to standards established for the four components)
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Reference: The Improvement Book
By: Tomo Sugiyama
Productivity Press, Cambridge, MA / Norwalk, CT

FIRST S-SORTING(GOOD AND BAD, USEABLE AND NON USEABLE)
SECOND S- SYSTEMIC ARRANGEMENT(ONCE SORTED KEEP SYSTEMATICALLY TO HAVE TRACEABILITY)
THIRD S-SPIC AND SPAN(KEEP ARRANGED THINGS ALWAYS READY TO USE AND IN DIRT FREE AND TIDY STATUS)
FOURTH S-STANDARDIZE(MAKE A PROCESS FOR ABOVE THREE STAGES AND MAKE STANDARDS AND ALSO KEEP ON REVIEWING THESE.)
FIFTH S- SELF DISCIPLINE (INDIVIDUAL HAS TO COMMIT)

5 Why's

The 5 why's typically refers to the practice of asking, five times, why the failure has occurred in order to get to the root cause/causes of the problem. There can be more than one cause to a problem as well. In an organizational context, generally root cause analysis is carried out by a team of persons related to the problem. No special technique is required.

An example is in order:
You are on your way home from work and your car stops:
·  Why did your car stop? Because it ran out of gas.
·  Why did it run out of gas? Because I didn't buy any gas on my way to work.
·  Why didn't you buy any gas this morning? Because I didn't have any money.
·  Why didn't you have any money? Because I lost it all last night in a poker game.

I hope you don't mind the silly example but it should illustrate the importance of digging down beneath the most proximate cause of the problem. Failure to determine the root cause assures that you will be treating the symptoms of the problem instead of its cause, in which case, the disease will return, that is, you will continue to have the same problems over and over again.

Also note that the actual numbers of why's is not important as long as you get to the root cause. One might well ask why did you lose all your money in the poker game last night?

Here's another example. I learned the example using the Washington Monument used when demonstrating the use of the 5 Whys.

The Washington Monument was disintegrating
Why? Use of harsh chemicals
Why? To clean pigeon poop
Why so many pigeons? They eat spiders and there are a lot of spiders at monument
Why so many spiders? They eat gnats and lots of gnats at monument
Why so many gnats? They are attracted to the light at dusk.
Solution: Turn on the lights at a later time.

                                                  
5Z

This standard defines the procedure of “5Z Accreditation” which is the scheme to promote, evaluate, maintain and improve process control using the Genba Kanri principles.
“5Z” is a general term for the following five actions ending with “ZU”…meaning “Don’t” in Japanese.

-UKETORAZU (Don’t accept defects)
-TSUKURAZU (Don’t make defects)
-BARATSUKASAZU (Don’t create variation)
-KURIKAESAZU (Don’t repeat mistakes)
-NAGASAZU (Don’t supply defects)



                                                  6 Ms

The traditional 6Ms are:

* Machines

* Methods

* Materials

* Measurements

* Mother Nature (Environment)

* Manpower (People)


Other definitions:

Machines
Methods
Materials
Measurements
Milieu (Mother Nature, surroundings, environment)
Manpower (People/mainly physical work)
Mindpower (Also people/mainly brain work)
Management (separate from Manpower/People because it considers Tampering)
Money
Miscellaneous
(the) Moon (so far unknown cause)
                                                6W

Your project planning should answer following question:

WHAT : What will you make/do this?
WHY: Why will you make/do this?
WHERE: Where will you make/do this?
WHO: Who will make/do this?
WHEN: When will you start/stop this (time scheduling)?
WHICH: Which will you make/do this (process, tooling, material sources etc…)?
7 QC Tools
1) Histograms
2) Cause and Effect Diagram
3) Check Sheets
4) Pareto Diagrams
5) Graphs
6) Control Charts
7)Scatter Diagrams
                                            Wastes of Lean

The 7 wastes are at the root of all unprofitable activity within your organization.

The 7 wastes consist of:

1. Defects
2. Overproduction
3. Transportation
4. Waiting
5. Inventory
6. Motion
7. Processing

Use the acronym 'DOTWIMP' to remember the 7 Wastes of Lean.

The worst of all the 7 wastes is overproduction because it includes in essence all others and was the main driving force for the Toyota JIT system, they were smart enough to tackle this one to eliminate the rest.
                          8 D Process

The 8D Process is a problem solving method for product and process improvement. It is structured in to 8 steps (the D's) and emphasizes team. This is often required in automotive industries. The 8 basic steps are: Define the problem and prepare for process improvement, establish a team, describe the problem, develop interim containment, define & verify root cause, choose permanent corrective action, implement corrective action, prevent recurrence, recognize and reward the contributors.

Of course, different companies have their different twists on what they call the steps, etc...but that is the basics.

8 D is short for Eight Disciplines which oOriginated from the Ford TOPS (Team Oriented Problem Solving) program. (First published approximately 1987)
D#1 - Establish the Team
D#2 - Describe the problem.
D#3 - Develop an Interim Containment Action
D#4 - Define / Verify Root Cause
D#5 - Choose / Verify Permanent Corrective Action
D#6 - Implement / Validate Permanent Corrective Action
D#7 - Prevent Recurrence
D#8 - Recognize the Team


                                           8 Wastes of Lean

An easy way I learned at a seminar to remember the wastes, they spell TIM WOODS
T - Transport - Moving people, products & information
I - Inventory - Storing parts, pieces, documentation ahead of requirements
M - Motion - Bending, turning, reaching, lifting
W - Waiting - For parts, information, instructions, equipment
O - Over production - Making more than is IMMEDIATELY required
O - Over processing - Tighter tolerances or higher grade materials than are necessary
D - Defects - Rework, scrap, incorrect documentation
S - Skills - Under utilizing capabilities, delegating tasks with inadequate training.
                                         Accuracy

1) Accuracy refers to clustering of data about a known target. It is the difference between a physical quantity's average measurements and that of a known standard, accepted 'truth,' vs. 'benchmark.' Envision a target with many arrows circling the bullseye, however, none of them are near each other.

2) Precision refers to the tightness of the cluster of data. Envision a target with a cluster of arrows all touching one another but located slightly up and to the right of the bullseye.

In practice it is easier to correct a process which has good precision than it is to correct a process which is accurate. This is due to the increased amount of variation associated with accurate but not precise process.
                                           Affinity Diagram


A tool used to organize and present large amounts of data (ideas, issues, solutions, problems) into logical categories based on user perceived relationships and conceptual frameworking.

Often used in form of "sticky notes" send up to front of room in brainstorming exercises, then grouped by facilitator and workers. Final diagram shows relationship between the issue and the category. Then categories are ranked, and duplicate issues are combined to make a simpler overview.
                                                 APQP

Advanced Product Quality Planning

Phase 1 -
Plan & Define Programme - determining customer needs, requirements & expectations using tools such as QFD
review the entire quality planning process to enable the implementation of a quality programme 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 programmes.

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.
                             Acceptable Quality Level - AQL

Acceptable Quality Level. Also referred to as Assured Quality Level. The largest quantity of defectives in a certain sample size that can make the lot definitely acceptable; Customer will definitely prefer the zero defect products or services and will ultimately establish the acceptable level of quality. Competition however, will 'educate' the customer and establish the customer's values. There is only one ideal acceptable quality level - zero defects - all others are compromises based upon acceptable business, financial and safety levels.

Acceptance Number

The highest number of nonconforming units or defects found in the sample that permits the acceptanc

Accessory Planning

The planned utilization of remnant material for value-added purposes.e of the lot.

Accountability

Conditional personal or professional liability “after” the fact, determined by action or responsibility. Accountability to action assumes the willingness to be held accountable for adequate expertise and capability. (see responsibility)
Arrow Diagrams

A tool used for working out optimal schedules and controlling them effectively. It shows relationships among tasks needed to implement a plan using nodes for events and arrows for activities. Arrow diagrams are used in PERT (Program Evaluation and Review Technique) and CPM (Critical path method).
Assurance

Providing an optimal degree of confidence to Internal and External Customers regarding establishing and maintaining in the organization, practices, processes, functions and systems for accomplishing organizational effectiveness.

Establishing and maintaining an optimal degree of confidence in the organizational practices, processes, functions and systems for accomplishing organizational effectiveness.

Alternate definition:
Establishing and maintaining the commitments made to Internal and External Customers.
Attribute Data

Attribute data is the lowest level of data. It is purely binary in nature. Good or Bad, Yes or No. No analysis can be performed on attribute data.

Attribute data must be converted to a form of Variable data called discrete data in order to be counted or useful.

It is commonly misnamed discrete data.

Attributes data are qualitative data that can be counted for recording and analysis.

Examples include the presence or absence of a required label, the installation of all required fasteners.

Attributes data are not acceptable for production part submissions unless variables data cannot be obtained.

The control charts based on attribute data are percent chart, number of affected units chart, count chart, count-per-unit chart, quality score chart, and demerit chart.
Audit

A timely process or system, inspection to ensure that specifications conform to documented quality standards. An Audit also brings out discrepencies between the documented standards and the standards followed and also might show how well or how badly the documented standards support the processes currently followed.

Corrective, Preventive & Improvement Actions should be undertaken to mitigate the gap(s) between what is said (documented), what is done and what is required to comply with the appropriate quality standard. Audit is not only be used in accounting or something that relates to mathematics but also used in Information Technology.
Average Incoming Quality

AIQ - Average Incoming Quality: This is the average quality level going into the inspection point.

Average Outgoing Quality

AOQ - Average Outgoing Quality: The average quality level leaving the inspection point after rejection and acceptance of a number of lots. If rejected lots are not checked 100% and defective units removed or replaced with good units, the AOQ will be the same as the AIQ.
Bias

Bias in a sample is the presence or influence of any factor that causes the population or process being sampled to appear different from what it actually is. Bias is introduced into a sample when data is collected without regard to key factors that may influence it. A one line description of bias might be: "It is the difference between the observed mean reading and reference value."

Linearity

Linearity is the variation between a known standard, or "truth," across the low and high end of the gage. It is the difference between an individual's measurements and that of a known standard or truth over the full range of expected values.
Bimodal Distribution

Bimodal Distribution is one in which 2 values occur more frequently in data set than rest of the values.

Binomial Distribution

In a situation where there are exactly two mutually exclusive outcomes (Ex: Success or Failure) of a trial, to find the x success in N trials with p as the probability of success on a single trial.

Ex:
Team A has won 15 Cricket Matches out of 50 played. What is the probability of winning atmost 5 matches in the next 10 matches?

x = 5, N = 10 and p = 15/50 = 0.3
Mean = N * p = 10 * 0.3 = 3
Bimodal Distribution

Bimodal Distribution is one in which 2 values occur more frequently in data set than rest of the values.
Calibration

Calibration is simply the comparison of instrument performance to a standard of known accuracy. It may simply involve this determination of deviation from nominal or include correction (adjustment) to minimize the errors. Properly calibrated equipment provides confidence that your products/services meet their specifications. Calibration:

increases production yields,
optimizes resources,
assures consistency and
ensures measurements (and perhaps products) are compatible with those made elsewhere.
CAPA

Acronym for Corrective and Preventive Action.

Corrective action:
Action taken to eliminate the cause of the existing non-conformity to prevent its recurrence.

Preventive action:
Action taken to eliminate the cause of potential non-conformity.

Both of these are prevention oriented.

The quick fix type actions are called as corrections.
Capability

The capability of a product, process, practicing person or organization is the ability to perform its specified purpose based on tested, qualified or historical performance, to achieve measurable results that satisfy established requirements or specifications.

Capability Analysis

Capability analysis is a graphical or statistical tool that visually or mathematically compares actual process performance to the performance standards established by the customer.

To analyze (plot or calculate) capability you need the mean and standard deviation associated with the required attribute in a sample of product (usually n=30), and customer requirements associated with that product.

See the tool Capability Analysis.

Capacity

The maximum amount of parts that may be processed in a given time period.

Is constrained by the bottleneck of the line--that is, the capacity of a production system depends on what is usually the slowest operation.

Capacity = 1 / Cycle Time

Typically the above formula is used when cycle time is expressed in shifts/part, thus measuring capacity as parts/shift.
CAR (Corrective Action Report)

Procedure used in response to a defect. This implies that you are reporting on a detected Non Conformance (NCR or NCMR) and have determined root cause to correct this from reoccuring.

Cause

A cause is anything that affects a result. But in root cause analysis we generally think of causes as bad. Therefore we need a different term to include both adverse influences and beneficial influences. Therefore, see "Factor."

Cause

A factor (X) that has an impact on a response variable (Y); a source of variation in a process or a product or a system.

Anything that adversely affects the nature, timing, or magnitude of an adverse effect.
Cause and Effect Diagram

A cause and effect diagram is a visual tool used to logically organize possible causes for a specific problem or effect by graphically displaying them in increasing detail. It helps to identify root causes and ensures common understanding of the causes. It is also called an Ishikawa diagram.

Cause and Effect relationships govern everything that happens and as such are the path to effective problem solving. By knowing the causes, we can find some that are within our control and then change or modify them to meet our goals and objectives. By understanding the nature of the cause and effect principle, we can build a diagram to help us solve everyday problems every time.
Cause and Effect Diagram

A cause and effect diagram is a visual tool used to logically organize possible causes for a specific problem or effect by graphically displaying them in increasing detail. It helps to identify root causes and ensures common understanding of the causes. It is also called an Ishikawa diagram.

Cause and Effect relationships govern everything that happens and as such are the path to effective problem solving. By knowing the causes, we can find some that are within our control and then change or modify them to meet our goals and objectives. By understanding the nature of the cause and effect principle, we can build a diagram to help us solve everyday problems every time.
Convert DPMO/Sigma To Cpk

Cpk = Z(short-term) which is sigma level / 3

However, if you are starting with DPMO, convert it to a decimal value(divide by 1,000,000), look this decimal value up in a standard normal curve(z table) and find the corresponding z. Minitab can do this as well. Anyway this is long term z. To convert to short term z which is sigma level:

z(short term) which is sigma level = Z(long term) + 1.5

then you can plug into the equation above to get Cpk

COQ

Cost of Quality. See Cost of Poor Quality.

COPQ

COPQ stands for Cost of Poor Quality. See Cost of Poor Quality for definition


Common Cause

A source of *Quality* failure that is always present as part of the random *Variation* inherent in the *Process* itself.

Its origin can usually be traced to an element of the process which only management can correct.

The less well-defined a process is, the more it is subject to random variation, resulting in a higher level of quality failures (bugs).

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In general, and very approximately, Common Causes outweigh *Special Causes* as origins of quality failures by four to 1 (*Pareto* distribution).

Common Cause Variation

Common cause variation is fluctuation caused by unknown factors resulting in a steady but random distribution of output around the average of the data. It is a measure of the process potential, or how well the process can perform when special cause variation removed.

Common cause variability is a source of variation caused by unknown factors that result in a steady but random distribution of output around the average of the data. Common cause variation is a measure of the process's potential, or how well the process can perform when special cause variation is removed. Therefore, it is a measure of the process technology. Common cause variation is also called random variation, noise, noncontrollable variation, within-group variation, or inherent variation. Example: Many X's with a small impact.

Common cause variation is the remaining variation after removing the special causes (non-normal causes) due to one or more of the 5Ms and an "E" causes (Manpower, Material, Method, Measurement, Machine, and Environment), also known as 6Ms (Man power, Mother nature, Materials, Method, Measurements or Machine).


Continuous Improvement (CI)

Continuous Improvement (CI): Adopting new activities and eliminating those which are found to add little or no value. The goal is to increase effectiveness by reducing inefficiencies, frustrations, and waste (rework, time, effort, material, etc). The Japanese term is Kaizen, which is taken from the words "Kai" means change and "zen" means good.

Continuous Data

Continuous data is information that can be measured on a continuum or scale. Continuous data can have almost any numeric value and can be meaningfully subdivided into finer and finer increments, depending upon the precision of the measurement system.

As opposed to discrete data like good or bad, off or on, etc., continuous data can be recorded at many different points (length, size, width, time, temperature, cost, etc.).

Continuous data is data that can be measured and broken down into smaller parts and still have meaning. Money, temperature and time are continous.Volume (like volume of water or air) and size are continuous data.

Let's say you are measuring the size of a marble. To be within specification, the marble must be at least 25mm but no bigger than 27mm. If you measure and simply count the number of marbles that are out of spec (good vs bad) you are collecting attribute data. However, if you are actually measuring each marble and recording the size (i.e 25.2mm, 26.1mm, 27.5mm, etc) that's continuous data, and you actually get more information about what you're measuring from continuous data than from attribute data.

Data can be continuous in the geometry or continuous in the range of values. The range of values for a particular data item has a minimum and a maximum value. Continuous data can be any value in between.

It is the data that can be measured on a scale.
Control Chart

A graphical tool for monitoring changes that occur within a process, by distinguishing variation that is inherent in the process(common cause) from variation that yield a change to the process(special cause). This change may be a single point or a series of points in time - each is a signal that something is different from what was previously observed and measured.

Control Limits

Control limits define the area three standard deviations on either side of the centerline, or mean, of data plotted on a control chart. Do not confuse control limits with specification limits. Control limits reflect the expected variation in the data. Bi latral specification/tolerances have two limits on both side of the tolerances which is not appreciated in the Unilatral tolerances.
Control Plan

The intent of a process control plan is to control the product characteristics and the associated process variables to ensure capability (around the identified target or nominal) and stability of the product over time.

The process Failure Modes and Effects Analysis (FMEA) is a document to identify the risks associated with something potentially going wrong (creating a defect - out of specification) in the production of the product. The FMEA identifies what controls are placed in the production process to catch any defects at various stages on the processing.

Every completed Six Sigma project should have not only a control chart (if applicable), but a control plan. This ensures that the process doesn't revert to the way it previously operated.
Correction versus Corrective Action

Correction is taken to rectify a known nonconformance; Corrective Action is taken to prevent recurrence of said nonconformance.

Corrective Action

Action to eliminate the cause of a detected nonconformity. There can be more than one nonconformity. Corrective action is taken to prevent recurrence. Correction relates to containment whereas corrective action relates to the root cause. See Preventive Action.

Corrective Action versus Preventive Action

Preventive Action is action to prevent the occurrence of a potential nonconformance; Corrective Action is taken to prevent recurrence of a known nonconformance. Examples of Preventive Action include (but are not limited to): Reviews (contracts, purchasing, processes, designs), Statistical Process Control (SPC) Analysis, Software Validation and Verification, Supplier Surveillance, Preventive Maintenance & Calibration Controls, Management Review of Quality Management System, Capability Studies, FMEA, Capability Maturity Model (CMM)/Capability Maturity Model Integration (CMMI) Processes, Employee Training Programs that train employees prior to commencing work, Suggestion Boxes, Disaster Recovery Planning, Trend Analysis, Benchmarking

Correlation

Correlation is a technique for investigating the relationship between two quantitative, continuous variables.

Correlation is the degree or extent of the relationship between two variables. If the value of one variable increases when the value of the other increases, they are said to be positively correlated. If the value of one variable decreases when the value other variable is increasing it is said to be negatively correlated. If one variable does not affect the other they are considered to not be correlated.

Cost Of Conformance

(COC) A component of the *Cost Of Quality* for a work product. Cost of conformance is the total cost of ensuring that a product is of good *Quality*. It includes costs of *Quality Assurance* activities such as standards, training, and processes; and costs of *Quality Control* activities such as reviews, audits, inspections, and testing.

COC represents an organisation's investment in the quality of its products.

Contrast *Cost Of Non-Conformance*.

Cost Of Non-Conformance

(CONC.) The element of the *Cost Of Quality* representing the total cost to the organisation of failure to achieve a good *Quality* product.

CONC includes both in-process costs generated by quality failures, particularly the cost of *Rework*; and post-delivery costs including further *Rework*, re-performance of lost work (for products used internally), possible loss of business, possible legal redress, and other potential costs.

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See also *Cost of Poor Quality - COPQ*

Cost of Poor Quality - COPQ

COPQ consists of those costs which are generated as a result of producing defective material.

This cost includes the cost involved in fulfilling the gap between the desired and actual product/service quality. It also includes the cost of lost opportunity due to the loss of resources used in rectifying the defect. This cost includes all the labor cost, rework cost, disposition costs, and material costs that have been added to the unit up to the point of rejection. COPQ does not include detection and prevention cost.

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See also *Cost Of Non-Conformance*.

COPQ should contain the material and labor costs of producing and repairing defective goods, you can include a portion of the appraisal cost if you have an inspection point, but never should you include prevention costs.
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COPQ – Suppliers
Cost of Poor Quality from Suppliers

Suppliers can generally affect our cost due to:
a) Producing defective material.
b) Damaging material during delivery.

Our COPQ will generally cover the followings:
1) Cost of labor to fix the problem.
2) Cost of extra material used.
3) Cost of extra utilities .
4) Cost of lost opportunity
a) Loss of sales/revenue (profit margin)
b) Potential loss of market share
c) Lower service level to cus

Cost Of Quality

The cost associated with the quality of a work product.

As defined by Crosby ("Quality Is Free"), Cost Of Quality (COQ) has two main components: *Cost Of Conformance* and *Cost Of Non-Conformance* (see respective definitions).

Cost of quality is the amount of money a business loses because its product or service was not done right in the first place. From fixing a warped piece on the assembly line to having to deal with a lawsuit because of a malfunctioning machine or a badly performed service, businesses lose money every day due to poor quality. For most businesses, this can run from 15 to 30 percent of their total costs.
                                                   Cp

Process Capability index: a measure of the ability of a process to produce consistent results - the ratio between the permissible spread and the actual spread of a process. Permissible spread is the difference between the upper and lower specific limits of acceptibility (a.k.a. total tolerance); actual spread is defined, arbitrarily, as the difference between upper and lower 3 x sigma deviations from the mean value (representing 99.7% of the normal distribution). As a formula, Cp = (USL-LSL)/(6 x sigma). Note this takes no account of how well the output is centered on the target (nominal) value. For that see Cpk.

You can think of the process capability index Cp in 3 ways:

1. Cp measures the capability of a process to meet its specification limits. It is the ratio between the required and actual variability.

2. More mathematically, the Cp is the ratio of the Spec difference (upper - lower) divided by 6-sigma, which is the spread of a normal curve. Minitab gives the following explanation: 'Capability statistics are basically a ratio between the allowable process spread (the width of the specification limits) and the actual process spread (6s)'

3. Graphically, think of positioning a normal curve centered between the specs. Now look at the tail areas that exceeds the specs. The smaller the area, the larger the Cp. In this sense it is equivalent to looking at the popular PPM measure (parts-per-million) which gives the area of the normal curve that exceeds the specs.


Posted By: Peter Wooding
Modified By: David Ortega
Last Modified: Mar. 8, 2003

Cpk

Process Capability index ('equivalent') taking account of off-centredness: effectively the Cp for a centered process producing a similar level of defects - the ratio between permissible deviation, measured from the mean value to the nearest specific limit of acceptability, and the actual one-sided 3 x sigma spread of the process. As a formula, Cpk = either (USL-Mean)/(3 x sigma) or (Mean-LSL)/(3 x sigma) whichever is the smaller (i.e. depending on whether the shift is up or down). Note this ignores the vanishingly small probability of defects at the opposite end of the tolerance range. Cpk of at least 1.33 is desired.


Critical Element

A critical element is an X that does not necessarily have different levels of a specific scale but can be configured according to a variety of independent alternatives. For example, a critical element may be the routing path for an incoming call or an item.


Critical To Quality - CTQ

CTQs (Critical to Quality) are the key measurable characteristics of a product or process whose performance standards or specification limits must be met in order to satisfy the customer. They align improvement or design efforts with customer requirements.

CTQs represent the product or service characteristics that are defined by the customer (internal or external). They may include the upper and lower specification limits or any other factors related to the product or service. A CTQ usually must be interpreted from a qualitative customer statement to an actionable, quantitative business specification.

To put it in layman's terms, CTQs are what the customer expects of a product... the spoken needs of the customer. The customer may often express this in plain English, but it is up to us to convert them to measurable terms using tools such as DFMEA, etc.
CRM

Customer Relationship Management (CRM) is a philosophy that puts the customer at the design point, it is being customer-centric. It should be viewed as a strategy rather than a process. It is designed to understand and anticipate the needs of current and potential customers. There is a plethora of technology out there that helps capture customer data and external sources, and consolidate it in a central warehouse to add intelligence to the overall CRM strategy. "We are in business because of our customers. So it only makes sense to build and intimate relationship with the customer." Now that's CRM!

CSM

Characteristic Selection Matrix

CTC

CTC or Critical To Customer.

This is the input to the Quality Function Deployment activity, for the customer requirements side of the analysis. Not same as CTQ.

CTQ's are the internal critical quality parameters that RELATE to these customer-critical parameters. QFD relates the two, and leads to the DFMEA efforts which quantify the severity and frequency of occurance of failure to meet the CTQ's and thus the CTC's by relationship. Car door sound when closing might be a CTC, while the dimensional tolerances and cushioning that produce those conditions are CTQ's for the auto maker.
Customer

Customer:
A person who receives the product or service of a process.

In a laymans language:
A customer is one who buys or rates our process/product (In terms of requirements), and gives the final verdict on the same. This in turn acts as a hidden feedback which can be implemented leading to improvement to all the parameters of the Process Management

Customer Focus

The concept that the customer is the only person qualified to specify what Quality means. This leads to detailed analyses of who are the customers, what are their needs, what features (or new) are required of our products/services, how do customers rate our products/services versus our competitors and why, how can we keep our customers satisfied?

Customer Requirements

The wants or voice-of-customer in Stated or ImpliedTerms.

Most of the times the customer is enabled to state the requirements precisely. (Like please bring me a glass of luke warm water to drink). However customer may not always be able to precisely state or equipped to realize the basic attributes of his requirements. It is therefore the responsibility of the supplier to reconsider the attributes of desired/ supplied product in terms of the 'implied or real' requirements. For example the hygiene of the environment in which food is cooked in a resturant.

Cycle Time

Cycle time is the total time from the beginning to the end of your process, as defined by you and your customer. Cycle time includes process time, during which a unit is acted upon to bring it closer to an output, and delay time, during which a unit of work is spent waiting to take the next action.

In a nutshell - Cycle Time is the total elapsed time to move a unit of work from the beginning to the end of a physical process. (Note, Cycle Time is not the same as Lead Time).

 
Error (Type I)

Error that concludes that someone is guilty, when in fact, they really are not. (Ho true, but I rejected it--concluded Ha). Also known as ALPHA error. Also known as Producer's risk.

Error (Type II)

Error that concludes that someone is not guilty, when in fact, they really are. (Ha true, but I concluded Ho). BETA

Accept an hypothesis or statement as true when it is false: Ho is false, but I conclude Ho is true. Error that concludes that someone is not guilty, when in fact, he or she really is. (accept Ho as true, beeing false, when Ha is true).

A failed alarm is a Type II error

BETA is the probabilty of error type II

Also known as consumer's risk.

Error Cause Removal

This is one of the steps in 14 steps advocated by Philip B crosby in his methodology of Quality Improvement.

Error Mode Effects Analysis

Error Modes and Effects Analysis (EMEA)

A procedure in which each potential error made in every sub-process of a process is analyzed to determine its effect on other sub-processes and on the required accuracy of the process.

An EMEA is also used to prioritize & rank potential causes of process or human failures as well as create, launch and evaluate preventative actions.

ESER

Engineering Sample Evaluation Report

EWMA

Exponentially Weighted Moving Average

The exponentially weighted moving average (or EWMA) control chart is good for detecting small process shifts

Exit Criteria

A predefined set of conditions used as a *Process Control* mechanism, to verify that a *Process* or sub-process has been completed and that its products are of acceptable *Quality*.

Exit Criteria prevent the delivery of "Garbage Out" to downstream users of the products.


FIFO

First In, First Out. A method of inventory rotation to ensure that the oldest inventory (first in) is used first (first out).
Fishbone

A tool used to solve quality problems by brainstorming causes and logically organizing them by branches. Also called the Cause & Effect diagram and Ishikawa diagram. For more information, view the fishbone section
Failure Modes and Effects Analysis (FMEA)

A procedure and tools that help to identify every possible failure mode of a process or product, to determine its effect on other sub-items and on the required function of the product or process. The FMEA is also used to rank & prioritize the possible causes of failures as well as develop and implement preventative actions, with responsible persons assigned to carry out these actions.

Failure modes and effects analysis (FMEA) is a disciplined approach used to identify possible failures of a product or service and then determine the frequency and impact of the failure.

Factor (of a Consequence)

In root cause analysis we seek to construct an evidence based, logically complete, tightly linked tree of chains of factors affecting a specific consequence. (Most of the time we first select the most unacceptable consequence, be it actual, expected, or potential.)

{Consequence}<-- {Factors}
{Direct, Immediate, proximate Factors}<-- {Intermediate Factors}
{Intermediate Factors}<-- {Deeper Intermediate Factors}
{Deeper Intermediate Factors}<-- {Even Deeper Intermediate Factors}
Etc.
{Deepest Intermediate Factors}= {"Root" Factors}
Form / Format

Form is a pre-defined template required to be used in a Process / instruction for information / data collection.
Gantt Chart

A Gantt chart is a powerful and preferred visual reporting device used for conveying a project's schedule. A typical Gantt chart graphically displays the work breakdown, total duration needed to complete tasks, as well as %completion. The Gantt chart itself will not display level of effort, and is not an effective planning tool on its own. Today, Gantt Charts may be integrated with other spreadsheet-type reporting devices that convey additional information related to project planning. Furthermore, Gantt Charts are often enhanced with functionality that includes the identification of relationships between tasks, and the ability to dynamically change task attributes.
Gage R&R

Gage R&R, which stands for gage repeatability and reproducibility, is a statistical tool that measures the amount of variation in the measurement system arising from the measurement device and the people taking the measurement. See Gage R&R tools.

There's an excellent post on the discussion forum by Stephen Curtis describing Gage R&R:

"Gage R&R is intended to be a study to measure the measurement error in measurement systems."
http://www.isixsigma.com/forum/showmessage.asp?messageID=6070

Characterizing the Measurement Process
http://www.isixsigma.com/library/content/c020527a.asp

----------------------
AIAG Automotive Industry Action Group publishes a booklet called Measurement Systems Analysis which answer your questions. Their website is http://www.aiag.org.

When measuring the product of any process, there are two sources of variation: the variation of the process itself and the variation of the measurement system. The purpose of conducting the GR&R is to be able to distinguish the former from the latter, and to reduce the measurement system variation if it is excessive.

Typically, a gage R&R is performed prior to using it. We repeat the gage R&R anytime we have a new operator or inspector, it is part of our training and certification process. We also repeat it annually to make sure we aren't experiencing any erosion of skills. It is used as part of the Six Sigma DMAIC process for any variation project.
                                             Histogram

A bar graph of a frequency distribution in which the widths of the bars are proportional to the classes into which the variable has been divided and the heights of the bars are proportional to the class frequencies.

A histogram is a basic graphing tool that displays the relative frequency or occurrence of continuous data values showing which values occur most and least frequently. A histogram illustrates the shape, centering, and spread of data distribution and indicates whether there are any outliers.

A graphic way to summarize data. Size is shown on the horizontal axis (in cells) and the frequency of each size is shown on the vertical axis as a bar graph. The length of the bars is proportional to the relative frequencies of the data falling into each cell and the width is the range of the cell. Data is variable measurements from a process.

 
Incoming Goods Inspection

Incoming Goods Inspection (IGI)

A verification check if the product arrived in good condition at your warehouse before accepting them into your stock. In some cases additional measurements are required to verify if the product is according to the desired specification, but in general it means checking if the boxes are OK, the labels are there in the right place, the quantity is OK, etc., etc. The functionality is, or should be, guaranteed and proved with a measurement report from the vendor.
Inspection Plan

What is an inspection plan:
a. check machine tool for accuracy
b. select the critical and important dimensions to inspect
c. select the measuring insturments
d. construct SPC charts for all dimensions

This is part of NIMS certification for H.S. machine shop teachers and I could use some help! Thanks Jim
----------------------

The general purposes of a Plan are these: To identify the goal(s) to be achieved; to specify the best route (methods, processes ...) for arriving at the goal(s); to catalogue resources (tools, time ...) needed to pursue the chosen route; to assign responsibilities for controlling and consuming those resources; and to secure agreement by relevant stakeholders. (This is *not* an exclusive list!)

See further under Software Inspection Plan.
Ishikawa, Ichiro

Japanese Quality professional widely known for the Ishikawa diagram also known as the fishbone or cause and effect diagram. He is also known as Ishikawa, Kaoru.
Just In Time (JIT) Manufacturing

A planning system for manufacturing processes that optimizes availability of material inventories at the manufacturing site to only what, when & how much is necessary.

Typically a JIT Mfg. avoids the conventional Conveyor Systems. JIT is a pull system where the product is pulled along to its finish, rather than the conventional mass production which is a push system. It is possible using various tools like KANBAN, ANDON & CELL LAYOUT.
Others tools include: shojinka, smed, jidoka, poka-yoka, and kaizen.
Kaikaku

Kaikaku is a rapid change event as opposed to Kaizen which is smaller incremental changes. Kaikaku is revolutionary while Kaizen is evalutionary

Kaizen

Japanese term that means continuous improvement, taken from words 'Kai' means continuous and 'zen' means improvement.

Some translate 'Kai' to mean change and 'zen' to mean good, or for the better.

The same japanese words Kaizen that pronounce as 'Gai San' in chinese mean:

Gai= The action to correct.

San= This word is more related to the Taoism or Buddhism Philosophy in which give the definition as the action that 'benefit' the society but not to one particular individual. The quality of benefit that involve here should be sustain forever, in other words the 'san' is and act that truely benefit the others.

Kaizen Blitz

Kaizen definition has been Americanized to mean "Continual Improvement." A closer definition of the Japanese meaning of Kaizen is "to take apart and put back together in a better way." According to Webster - blitz is short for blitzkrieg. And blitzkrieg is (b) -"Any sudden overpowering attack." Therefore, a Kaizen Blitz could be defined as 'a sudden overpowering effort to take something apart and put it back together in a better way." What is taken apart is usually a process, system, product, or service. Read "Goldratt", who wrote the book called "The Goal"

Kaizen Event

Any action whose output is intended to be an improvement to an existing process.

Kaizen Events are commonly refered to as a tool that:

1) Gathers operators, managers, and owners of a process in one place
2) Maps the existing process (using a deployment flowchart, in most cases)
3) Improves on the existing process
4) Solicits buy-in from all parties related to the process

Kaizen Events are an extremely efficient to quickly improve a process with a low Sigma score. Kaizen Events are also useful for convincing organizations new to Six Sigma of the methodology's value.

The true intent of a kaizen event is to hold small events attended by the owners and operators of a process to make improvements to that process which are within the scope of the process participants.

Kaizen Event

Could also be a one shot improvement in a process or place due to which there will long term benefits. For example, cleaning up and re-organizing the warehouse to have better account of materials in locations, remove all dead inventory, organize slow moving inventory etc.

The process improvement here would be - accurate material issue, accurate storage of material in specified locations easy traceability of material due to re organizing etc.

Kaizen events, whether big or small, would benefit immediately once event is completed.

Kanban

Kanban: A Japanese term. The actual term means "signal". It is one of the primary tools of a Just in Time (JIT) manufacturing system. It signals a cycle of replenishment for production and materials. This can be considered as a “demand” for product from on step in the manufacturing or delivery process to the next. It maintains an orderly and efficient flow of materials throughout the entire manufacturing process with low inventory and work in process. It is usually a printed card that contains specific information such as part name, description, quantity, etc.

In a Kanban manufacturing environment, nothing is manufactured unless there is a “signal” to manufacture. This is in contrast to a push-manufacturing environment where production is continuous.

Kano Analysis

Kano analysis is a quality measurement tool used to prioritize customer requirements based on their impact to customer satisfaction.

Kano analysis is a quality measurement tool which is used to determine which requirements are important. All identified requirements may not be of equal importance to all customers. Kano analysis can help you rank requirements for different customers to determine which have the highest priority.

Kano analysis is a tool which can be used to classify and prioritize customer needs. This is useful because customer needs are not all of the same kind, not all have the same importance, and are different for different populations. The results can be used to prioritize your effort in satisfying different customers.

Note that the Kano model can be used to help identify customer segments, based on the relative prioity of each segment's requirements. Once segments have been defined, using both needs analysis and more tradition criteria such as gender, company size, etc., the Kano model can be re-applied to each segment to further defined the segment's priorities.

Briefly, Kano (a Japanese researcher), stated that there are four types of customer needs, or reactions to product characteristics / attributes:

1. The 'Surprise & Delight' factors. These really make your product stand out from the others. Example, a passenger jet that could take off vertically.
2. The 'More is Better'. E.g. a jet airliner that uses a little less fuel than the competition.
3. The 'must be' things. Without this, you'll never sell the product. E.g. A jet airliner that cannot meet airport noise regulations.
4. Finally, there are the 'dissatisfiers', the things that cause your customers not to like your product. E.g. a jet airliner that is uncomfortable to ride in.
Kaizen

Japanese term that means continuous improvement, taken from words 'Kai' means continuous and 'zen' means improvement.

Some translate 'Kai' to mean change and 'zen' to mean good, or for the better.

The same japanese words Kaizen that pronounce as 'Gai San' in chinese mean:

Gai= The action to correct.

San= This word is more related to the Taoism or Buddhism Philosophy in which give the definition as the action that 'benefit' the society but not to one particular individual. The quality of benefit that involve here should be sustain forever, in other words the 'san' is and act that truely benefit the others.
Laws of Lean Six Sigma

5 Laws of Lean Six Sigma have been formulated to provide direction to improvement efforts. The laws are a conglomeration of Key Ideas of Six Sigma and Lean.

Law 0: The Law of the Market - Customer Critical to Quality defines quality and is the highest priority for improvement, followed by ROIC (Return On Invested Capital) and Net Present value. It is called the Zeroth law as it is the base on which others are built.

Law 1: The Law of Flexibility - The velocity of any process is proportional to the flexibility of the process.

Law 2: The Law of Focus - 20% of the activities in a process cause 80% of the delay. (Related to Pareto Principle)

Law 3:The Law of Velocity - The velocity of any process is inversely proportional to the amount of WIP. This is also called "Little's Law".

Law 4: The complexity of the service or product offering adds more non-value, costs and WIP than either poor quality (low Sigma) or slow speed (un-Lean) process problems.
Cmk

Machine Capability index, should be 2.00 or higher. See also Cpk.

Calculated using continuous / Uninterupted samples. Also known as short term capability. Cmk > 1.67 is the preferable situation. Usually, The long term capability studies shall be done in a machine / Process after achieving the required Cmk value.
Machine Capability Index


Often Known as Cmk. This is a short term machine capability index derived from the observations from uninterrupted production run. Even though the formulae are as same as Cp&Cpk calculation,the standard deviation used here is sample standard deviation (RMS). The preferred Cmk value is >1.67.Usually, The long term process capability to be planned and studied after achieving the targeted Cmk Value

Lead Time

The amount of time, defined by the supplier, that is required to meet a customer request or demand. (Note, Lead Time is not the same as Cycle Time).


Measurement System Analysis - MSA

Measurement system analysis (MSA) is an experimental and mathematical method of determining how much the variation within the measurement process contributes to overall process variability.

There are five parameters to investigate in an MSA: bias, linearity, stability, repeatability and reproducibility.

According to AIAG (2002), a general rule of thumb for measurement system acceptability is:
·  Under 10 percent error is acceptable.
·  10 percent to 30 percent error suggests that the system is acceptable depending on the importance of application, cost of measurement device, cost of repair, and other factors.
·  Over 30 percent error is considered unacceptable, and you should improve the measurement system.

AIAG also states that the number of distinct categories the measurement systems divides a process into should be greater than or equal to 5.

In addition to percent error and the number of distinct categories, you should also review graphical analyses over time to decide on the acceptability of a measurement system.

Reference:
Automotive Industry Action Group (AIAG) (2002). Measurement Systems Analysis Reference Manual. Chrysler, Ford, General Motors Supplier Quality Requirements Task Force.

Median

Relating to or constituting the middle value in a distribution.

The median is the middle point of a data set; 50% of the values are below this point, and 50% are above this point.

Median is the middle value, when all possible values are listed in order. Median is not the same as Average (or Mean).

Mode

The value or item occurring most frequently in a series of observations or statistical data.

The most often occurring value in the data set.

A data set may contain more than one mode, e.g., if there are exactly 2 values or items that appear in the data the same number of times, we say the data set is bi-modal

Moods Median

Mood’s median test can be used to test the equality of medians from two or more populations and, like the Kruskal-Wallis Test, provides an nonparametric alternative to the one-way analysis of variance. Mood’s median test is sometimes called a median tests
Mazume

Mazume is a Japanese word meaning "Gap Shrinking". This is used while doing a innovation in process lay out by shrinking the gap between equipment, thus saving the floor space and movement of operator / material.

Mean

The mean is the average data point value within a data set. To calculate the mean, add all of the individual data points then divide that figure by the total number of data points.
Muda

The Japanese term for waste.

MURA

The Japanese term for inconsistency

MURI

The Japanese term for strain
O.E.M.

Original Equipment Manufacturer

O.E.E.

O.E.E. means overall equipment effectiveness.It is a method to find out overall effectiveness of equipment. It is obtained by multiplication of three ratios.
1. Availability ratio - Time for which equipment was available for operation divided by total calender period for which O.E.E. is being calculated.
2. Quality Ratio - Quantity of "A" grade/Prime grade material produced divided by total production (Off grade+Prime grade)
3.Performance Ratio - Rate of production divided by Capacity of machine to produced.

Normaly O.E.E. is presented in terms of percentage

OEE

OEE = Availbility * Performance Rate * Quality rate

where

Availbilty =(Calender Hours - Planned losses -Unplanned lossed)/ Calender hours

Performance rate = Operatig Efficiency * Rate Efficiency

where ,
Operating Efficiency=(Available hours -Losses beyond equipment/plant's
control
                            OSHA

Occupational Safety and Health Administration
                                                    Pareto

The Pareto principle states that 80% of the impact of the problem will show up in 20% of the causes. (Originally stated: 80% of the wealth is owned by 20% of the people.) A bar chart that displays by frequency, in descending order, the most important defects. Proper use of this chart will have the cumulative percentage on a second y-axis (to the right of the chart). This chart-type is used to identify if the Pareto principle is evident in the data. If the Pareto principle is evident, about 20% of the categories on the far left will have about 80% of the impact on the problem.
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 occurance, (c) document the process.(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.

In safety terminology in chemical industry, PFMEA can directly be related to HAZOP Analysis. HAZOP is an acronym for Hazard and Operability. It is a process to find out the potential failures of equipment, piping, pumps and utilities and their effects on plant and human safety. This study helps in introducing extra safety features beforehand on equipment and piping to avoid the potential failures and consequent disasters.
                                                 Poka Yoke

Japanese term which means mistake proofing.
A poka yoke device is one that prevents incorrect parts from being made or assembled, or easily identifies a flaw or error.

poka-yoke - 'mistake-proofing', a means of providing a visual or other signal to indicate a characteristic state. Often referred to as 'error-proofing', poke-yoke is actually the first step in truly error-proofing a system. Error-proofing is a manufacturing technique of preventing errors by designing the manufacturing process, equipment, and tools so that an operation literally cannot be performed incorrectly.

To avoid (yokeru) inadvertent errors (poka).
PPAP

Production Part Approval Process:
The Production Part Approval Process (PPAP) outlines the methods used for approval of production and service commodities, including bulk materials, up to and including part submission warrant in the Advanced Quality Planning process. The purpose of the PPAP process is to ensure that suppliers of components comply with the design specification and can run consistently without affecting the customer line and improving the quality systems. PPAP ensures that you will achieve the first time quality and will lower down the cost of quality.

Ppk

Ppk represents the long-term capability of the process.

Process Acceptance Certificate

A certificate or other document that is completed immediately prior to a new or modified process being accepted into the live environment for business use.  It provides a degree of confidence that all required activities have been undertaken to ensure that the service is capable of being delivered to the process owner's satisfaction. 

Incomplete tasks should be recorded here as should the degree of risk to which these shortcomings are now exposing the business.  Based upon that information, the decision can be taken as to whether the new or changed process should be released into the live environment.
PPM

Parts Per Million. Typically used in the context of defect Parts Per Million opportunities. Synonymous with DPMO.

Defects Per Million Opportunities - DPMO

Defects per million opportunities (DPMO) is the average number of defects per unit observed during an average production run divided by the number of opportunities to make a defect on the product under study during that run normalized to one million.

Defects Per Million Opportunities. Synonymous with PPM.

To convert DPU to DPMO, the calculation step is actually DPU/(opportunities/unit) * 1,000,000.
Process Capability

Process capability refers to the ability of a process to produce a defect-free product or service in a controlled manner of production or service environment. Various indicators are used-some address overall performance, some address potential performance.
Process Capability Index

Process Capability Index is used to find out how well the process is centered within the specification limits.It is denoted by Cpk.

Cpk = Cp(1-K)

Where,

Cp = Process Capability

K = 2(Design Target - Process Average) / (USL - LSL)

Design target is the actual specification targetted without +/- allowance.
Process Control

1. The features or mechanisms that control the execution of a *Process*, including process initiation, selection of process steps, selection of alternative steps, iteration of steps within a loop, and process termination.

2. Controlling mechanisms that ensure that a *Process* is conducted to maximum cost-effectiveness, including *Entry Criteria*, formal procedure specifications, and *Exit Criteria*.

----------
In development or manufacturing processes, the rate of *Variations* that reveal themselves as work product *Defects* is in general inversely proportional to the degree in which the process is formalised and followed. Or, poor processes produce bugs ...

See *Common Cause*, *Special Cause*.


Process Design Requirements

What the organization needs and expects of the process to meet customer requirements.

Process Indicator

See also Process Measurables.

These are indicators which directly measure the performance of key processes that affect customer expectations. Specific actions can be taken to improve the performance of these indicators, which in turn should improve the performance of the result measurables.

Originally Posted By: "Mark" defined as Process Measurables.
Process Entitlement

It is the best short-term performance of an output characteristic when the input variables are running in a constrained fashion.

Process entitlement helps us set realistic goals.
Repeatability

Repeatability is the variation in measurements obtained when one person measures the same unit with the same measuring equipment.

-----

Repeatability is the variation in measurements obtained when one person takes multiple measurements using the same instrument and techniques on the same parts or items.
Replicates

Number of times you ran each corner. Ex. 2 replicates means you ran one corner twice.

Replicate is the number of applications applied to a treatment level.

Reproducibility

Reproducibility is the variation in average measurements obtained when two or more people measure the same parts or items using the same measuring technique.
Responsibility

Defined or assumed conditional liability “before” the fact, limited to overt practices. Capacity to be responsible assumes the use of adequate expertise and capability

Result Measurables

These are indicators which are tied directly to customer expectations. There is usually little direct control over result measurables.
Root Cause

An identified reason for the presence of a defect or problem.

The most basic reason, which if eliminated, would prevent recurrence.

The source or origin of an event.

----------
A root cause of a consequence is any basic underlying cause that was not in turn caused by more important underlying causes. (If the cause being considered was caused by more important underlying causes, those are candidates for being root causes.)

Root Cause Analysis

Study of original reason for nonconformance with a process. When the root cause is removed or corrected, the nonconformance will be eliminated.

RPN
Risk Priority Number

RQL

RQL - Rejectable Quality Level: generic term for the incoming quality level for which there is a low probability of accepting the lot. The quality level is substandard.

R-Square

A mathematical term describing how much variation is being explained by the X.

Rsq = 1 - SS(regression)/SS(total), Assuming "SS" = Sum Squared error, and that "SS(total)" means the variance in the data. This should be obvious, as R-squared approaches unity as a regression approaches a perfect fit.(i.e., Rsq = 1 - sum((data - regression)^2))/sum((data - datamean).^2))

The R-squared value is the fraction of the variance (not 'variation') in the data that is explained by a regression.

Run Chart

A performance measure of a process over a specified period of time used to identify trends or patterns.
Runs Test

Use Runs Test to see if a data order is random. Runs Test is a nonparametric test because no assumption is made about population distribution parameters. Use this test when you want to determine if the order of responses above or below a specified value is random. A run is a set of consecutive observations that are all either less than or greater than a specified value.

Suppose an interviewer selects 30 people at random and asks them each a question for which there are four possible answers. Their responses are coded 0, 1, 2, 3. You wish to perform a runs test in order to check the randomness of answers. Answers that are not in random order may indicate that a gradual bias exists in the phrasing of the questions or that subjects are not being selected at random.
                                        Total Quality Management

A short label for the list of prerequisites for achieving world-class quality. Use began in the last half of the twentieth century. Although there is no agreement on what were the essential elements of TQM, many use the criteria of the Malcolm Baldrige National Quality Award.

A conceptual and a philosophical context which requires management and human resources commitment to adopt a perpetual improvement philosophy, through succinct management of all processes, practices and systems throughout the organization to achieve effectiveness in the organizational performance and fulfilling or exceeding the community expectations.

                                                   TPM

Japanese management philosphy. Stands for Total Productive Maintenanace. Used to increase time between failure (MTBF) or life of machinery.

                                                    TQM

Total Quality Management

                                            Time Value Map

A Time Value Map is generated by tracking a work item through the process and tracking where it spends its time. Only work that is seen as Value added by the customer is plotted above the middle line; everything else is waste in their eyes.

The concept of a Time Value Map is simple: We can track any work item into one of the 3 categories. 1) Value added work 2) Waste that is unavoidable due to business reasons (the work or functions for which the customer does not pay for e.g., payroll, legal, regulatory) and 3) delays/waste.

Then a time line is drawn and the time segments is marked off for each category. The idle queuing time is represented by the blank space.

                                             Total Quality

Holistic sufficiency, efficiency, efficacy and effectiveness in all organization functions to accomplish continuous excellence in business outcomes.
                                       Tree Diagram

Breaks down or stratifies ideas in progressively greater detail. The objective is to partition a big idea or problem into its smaller components, making the idea easier to understand, or the problem easier to solve
Zero Defects

A practice that aims to reduce defects as a way to directly increase profits. The concept of zero defects lead to the development of Six Sigma in the 1980s.
Zadj

The probability of a defect when defects are correlated. For example, when linewidths are printed too wide the process can cause thousands of 'bridging' defects, so although the number of defects is extremely high, there is only one opportunity. Unless of course there are say four sensitive areas on the circuit so that a slight 'under exposure' condition would only cause say four sensitive areas to bridge, in which case Zadj would then have four opportunties.
Z st

ZST represents the process capability when special factors are removed and the process is properly centered. ZST is the metric by which processes are compared.
Z Shift

Z shift is the difference between ZST and ZLT. The larger the Z shift, the more you are able to improve the control of the special factors identified in the subgroups.

Z shift is usually assumed to be 1.5 (ZST = ZLT+1.5). However it can be computed precisely for any given process by calculating its "Between sub-group variation" using Process Capability Analysis
Z Score

A measure of the distance in standard deviations of a sample from the mean. Calculated as (X - X bar) / sigma















































 

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