FMEA is a systematic analysis of potential failure modes aimed at preventing failures.

This is
intended to be a preventative action process carried out before implementing new or changes in
products or processes. An effective FMEA identifies corrective actions required to prevent failures
Handling & Process (pdf) from reaching the customer and to assure the highest possible yield, quality and reliability.
DEPARTMENT
PROFILES In semiconductor device design and manufacturing, it is common to perform different types of
Reliability Test FMEA. These can be divided into two primary categories: product related and process related.
Services These are often called Design FMEA and Process FMEA and they are often further subdivided to
focus on specific areas of product or process development. The main purpose of an FMEA is: To
QUALITY WHITE identify possible failure modes that could occur in the design or manufacturing of a product.
PAPERS
Defects in
DMOS To identify corrective actions that could reduce or eliminate the potential for failures to
Antenna Ratio occur.
Violation To provide documentation of the process.
To quantify the risk level associated with each potential failure mode.
ADDITIONAL
INFORMATION
FAQ An FMEA is a two-phase process. First the potential failure modes and corrective actions are
identified. Then after the corrective actions are implemented, the product or process is re-evaluated
EOS/ESD
to determine if the result is acceptable. This is best accomplished with a cross-functional team with
Information members from all affected work groups (e.g. Marketing, Engineering, Manufacturing, Test, QRA,
Obsolete etc.)
Product Listings
Environmental
Benefits of FMEA
Safety
Glossary:
Quality Terms An FMEA provides benefits to both the manufacturer and the customer. Some of these benefits
include:
CONTACT US
Comments &
Assists in determining the best possible design and development options to provide high
Questions
National reliability and manufacturability potential.
Locations Assists in considering the possible failure modes and their effect on the reliability and
manufacturability of the product.
Provides a well-documented record of improvements from corrective actions implemented.
 
Provides information useful in developing test programs and in-line monitoring criteria.
Provides historical information useful in analyzing potential product failures during the
manufacturing process.
Provide new ideas for improvements in similar designs or processes.

Documenting an FMEA

This preventative action process provides a methodical approach to study the cause and effect of
potential failures. The form below (Fig. 1) is used to document the process.

Product or Process: FMEA Type: FMEA Date:

FMEA Team Members:   Rev __ / Rev Date:

Process/Product Description or P

 or Process: FMEA Type: FMEA Date:

FMEA Team Members:   Rev __ / Rev Date:

Process/Prod Potential Potential S C Potential O Current D R Recommended Who Actions S O D R

uct Failure Effect(s) Causes/
Description or Modes of Failure E L C Design/ E P Actions When Taken E C E P
Purpose Mechanisms
V A C Process T N V C T N
Of Failures
S Control
 S Prevention

Detection

Fig. 1:  Typical FMEA Form

Fig. 1:  Typical FMEA Form

The Process/Product Description or Purpose should be clearly defined. This may be broken down into sub-processes with each
being considered separately. Potential Failure Modes lists the different ways the process might fail to meet the process requirements
or design intent. The Potential Effect(s) of Failure is how the customer perceives the failure. The "customer" includes subsequent
design or manufacturing operations and/or the end customer. Each of the Failure Modes and Effects is assigned a Severity (SEV)
value and Classification (CLASS). How a failure could occur should be described in terms of something that can be corrected or
controlled and listed under Potential Causes/Mechanisms of Failures. The probability that a given cause or mechanism that might
occur is assigned a numeric value in OCC. Current Design/Process Control Prevention/Detection describes any controls that can
prevent or detect each of the failure mechanisms. The probability that each control will effectively detect the failure is assigned a
numeric value in DET.

The Risk Priority Number (RPN) is the product of Severity, Occurrence and Detection. These are assessed and engineering
judgment is used to determine if the risk is acceptable. Recommended Actions are developed to reduce the RPN with priority given to
the highest RPN values and customer defined specific characteristics. Once the actions are implemented, the Severity, Occurrence
and Detection values are reassessed, and a new RPN is calculated. This process continues until the risk level is acceptable.

An FMEA is a living document that should be reviewed and updated periodically. Any change in design, process or use of the product
should be updated in the FMEA.

Quality System Certifications - ISO/TS 16949,

ISO9001 & Stack
National Semiconductor Product Groups and Manufacturing Sites have successfully completed & ISO/TS16949 based (including
Det Norske Veritas (DNV) Certification Incorporated and are currently certified.

The following DNV certifications certify conformance of National Semiconductor's Quality Systems:

Corporate Sites Certification Corporate Sites Certification

STACK Certification
ISO / TS16949 ISO 9001:2000
All Sites Click to View Certificate
Santa Clara, CA
Arlington, TX
So. Portland, Maine
Greenock, UK
Malacca, Malaysia Click to Expand

Suzhou, China

DNV is one of the leading international certification bodies. For more information about the Det Norske Veritas, visit their web site
Local units have been awarded accreditation for their certification services by the respective National Authorities, in the following
 Australia Holland
Belgium Italy
Denmark Sweden
Finland Switzerland
Germany United Kingdom

National Semiconductor has been audited and meets the requirements of the STACK International, StackTrack - Supplier Certific

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Site Map | About "Cookies" | National is ISO/TS16949 Certified | Privacy/Security Statement | Contact Us/Feedback | RSS F

Copyright © 2011 National Semiconductor Corporation

Reliability

National Semiconductor Corporation strives to achieve best-in-class quality and reliability performance on all their products through a
systematic approach that emphasizes quality at every phase of product development through manufacturing. From initial design
conception to fabrication, test, and assembly; quality is built-in and assured through stringent SPC monitoring of fabrication and
assembly processes, materials inspections, wafer level reliability (WLR), new product qualifications, reliability monitoring of finished
product and strict change control management.

What is Reliability?

Reliability is the characteristic expressed by the probability that the part will perform its intended function for a specific period of time
under defined usage conditions.

Reliability Failures

There are 2 basic types of failures, Early Failures and Wear Out Failures. These are reflected in the curve known as the Bathtub
curve.
 National Semiconductor uses Reliability Testing to ensure all its products are below targets set for Early Failure Rates in PPM and
Wear Out Failures in FITs.

Qualification

New Processes and New Packages

New Processes and New Packages are qualified using a minimum 3 lot (77 units per lot) testing for:

 Early Failure Testing (915 samples)

 Operating Life Test
 Temp and Humidity Biased Test
 Temperature Cycling
 Auto-Clave
 ESD/Latch-Up
 Board Level Temp Cycle (for packages)

Power Cycling and Data Retention Testing is also done when applicable.

Smart Quals

Products designed to Process and Package Design Rules and using Qualified Processes and Packages are released using 168hr
Rel Data.
This approach supports Time to Market needs without compromising Reliability.
To ensure there is no customer risk, National has continuous reliability monitoring in place.

Reliability Monitor Program

An Ongoing Reliability Monitor is in place to ensure that products manufactured to Qualified Processes under Qualified Reliability
Standards, has not drifted.

Results of the Rel Monitor Program are published on National’s Quality Web Page; Test Frequency is as
posted below.

TEST FREQUENCY

EFR Every week

(All major processes)

OPL (1000 hr) Every 8 weeks

THBT (1000 hr) Every 8 weeks

ACLV (96 hr) Every 8 weeks

TMCL (1000 cycles) Every 8 weeks

Fix Reliability Testing Capabilities Reliability Test Services and ESD and Latch-Up Testing Labs are fully
equipped to support the Reliability Qualification Testing. Details of the Lab Equipment are listed in the
following two tables. Reliability Testing Services Equipment Inventory

Dynamic Operating Life (Op Life) Comments:

13 ADEC burn-in ovens 65 to 160°C Vector driven
3 Wakefields 65 to 160°C Driver board dr.
1 AMT 65 to 160°C Driver board dr.

Static Operating Life  

4 Jarvis ovens 65 to 160°C
9 Marin 65 to 160°C
 Temp & Humidity (T&H) Can do:
12 BLUM M ovens 85 C at 85% humidity (normal) 20 to 90 C at 30 to 90%
humidity

Temp Cycles
2 Blue M Systems -40 to 125°C 200lbs. Each
4 Ransco systems (batch loaded) -65 to 150°C 1 - 200lbs, 2 – 40lbs
-40 to  60°C 1 - 151lbs
  0  to 125°C

Auto-Clave (ACLV)  
5 Dispatch systems (batch loaded) 121 C at 15 PSI

High Accelerated Stress Test  (HAST)

2 Hirayama 135C at 85% RH/PSI
1 Express 135C at 85% RH/PSI Board loaded voltage applied
1 Dispatch 135C at 85% RH/PSI

Power Temp Cycle

1 Thermo Dynamic system 40 to 125°C (Ambient) Board loaded voltage applied
3 ICA1 systems 40 to 125°C (Ambient) Board loaded voltage applied

Air Power Cycle

2 Approval systems 25 to 150°C (Ambient) Board loaded voltage applied

Water Power Cycle

-   1 Approval systems 25 to 150°C (Ambient) Board loaded voltage applied

Thermo Shock  (Liquid to Liquid)    

-   1 Approval systems

Electromigration
-   1 Micro-instrument 210C, 175C, 150C Forcing current

Highly Accelerated Life Test

(HALT) Vibration and thermal3 axis, BSBO – Ethernet cards
-   1 Qualmark System plus 65C to 150°C Plexis/Tigris

Equipment in the ESD/Latch-Up Lab

MM IEC 1000 On Board Vectored

  Max Pins HBM Voltage
Voltage Capable Clock Latch-up

Keytek
Zap 256 25 - 12000 25 - 2000 Yes No No
Master

RCDM N/A 50 - 4000 N/A No No No

MK-2 768 50 - 8000 50 - 2000 No Yes Yes

Failure Mechanisms/Failure Models

Various failure mechanisms are tested during Rel Testing. Major ones are listed below.

Failure Mechanism and Model

Failure Mechanism Failure Model

Electromigration Blacks Model

Excessive Intermetallics Kidsons Model

Reverse Bias Breakdown Tasca

Stress Dependent Okabayashi Model n NE 1, Okabayashi Model n EQ 1

Diffusive Voiding
 Time Dependent Dielectric Fowler Nordhiem Tunnel Model
Breakdown

Slow Trapping Positive Gate Voltage Model, Negative Gate Voltage Model

Metallization Corrosion Plastic Metal Corrosion, Hermetic Metal Corrosion

Die fracture Westergaard Bolger Model Die, Suhirs Vert Crack Model Die, Suhirs Horz
Crack Model Die, Westergaard Model Power, Suhirs Horz Crack Power

Modular Case Fatigue Shear Fatigue Model Case

Modular Case Fracture Shear Fatigue Model Case

Substrate Fracture Westergaard Bolger Model Sub, Suhirs Vert Crack Model Sub, Suhirs Horz
Crack Crack Model Sub

Die Attach Fatigue Attach Fracture Model Brittle, Attach Fatigue Model Brittle, Tensile Fatigue
Model Ductile, Shear Fatigue Model ductile, Raja Die Attach Fatigue

BGA Solder Fatigue Time to fail by Creep,  Coffin Manson BGA Solder Fat

Discrete Solder Fatigue Dis Solder Jnt Cap 90pb10sn, Dis Soldr Jnt Fat Cap 63sn37pb

Flip Chip Solder Fatigue Inner Flip Chip Revised, Hybrid Flip Chip Revised

Lead Seal Fracture Principal Stress Model

Lead Solder Joint Fatigue Thermal Cycle Fatigue Model

Lid Seal Fracture Tensile Strength Model

Substrate Attach Fatigue Substrate Attach Fracture Model, Substrate Attach Fatigue Model

Wire Bond Fatigue Hu Pecht Dasgupta Model, Wirebond Pad Shear Failure, Bond Pad Fatigue
Revised

Wire Fatigue Hu Pecht Dasgupta Model

Electro Static Discharge Wunsch and Bell Model, Wunsch and Bell Model, Wunsch and Bell Model

Determination of Failure Rate (Point Estimate)

Failure rate can be determined by using actual test results. Determine "demonstrated" failure rate from actual test data as follows:

Failure Rate=No. rejects/sample size x no. hours

Example 1. Assume a sample size of 13500, 2 failures and test duration of 500 hours. To calculate FR:

FR = 2 rejects/13500 devices x 500 hours

FR = 2/6750000 device-hours=0.000000296 rejects per device-hour
          296 FITS
          or 3375,000hours MTBF (reciprocal of 0.000000296)

In expressing Failure Rate, the equivalent values below may be helpful.

No. Failure
% Per 1000
Per Device- Failure Rate PPM (Hours) FITS MTBF (Hour)
Hours
Hours

1/1 x 109 0.000000001 0.0001 0.001 1 1 x 109

1/1 x 108 0.00000001 0.001 0.01 10 1 x 108

1/1 x 107 0.0000001 0.01 0.1 100 1 x 107

1/1 x 106 0.000001 0.1 1 1000 1 x 106

1/100,000 0.00001 1.0 10 10,000 1 x 105

 1/10,000 0.0001 10.0 100 100,000 1 x 104

1/1,000 0.001 100 1000 1,000,000 1 x 103

Determination of Failure Rate (Statistical Estimates)

In addition to point estimates, FR and MTBF may be estimated by using the chi-square statistic at 2 (r + 1) degrees of freedom. The
50% probability statistic would give the "best estimate", the 60% or 90% probability statistic would give the upper confidence limit.

Acceleration Factors

In order to express accelerated test results in terms of expected failure rate at actual use conditions, semiconductor manufacturers
commonly use the Arrhenius model.

The Arrhenius model assumes that degradation of a performance parameter is linear with time, with the rate of degradation
depending on the temperature stress. To put it another way, the Arrhenius equation relates the time rate of change of a process to
the temperature at which the process is taking place.

If appropriate, the calculated acceleration factors listed in the following table may be used.

Acceleration Factors for Common Junction Temperatures

and Common Activation Energies

Est.
Estimated TJ9 Activation
RJAccel.
Normal Use Application Energies
Tests

  25°C 35°C 40°C 45°C 50°C 55°C 60°C 70°C 85°C eV

125°C 49 31 23 18 15 12 9.6 6.4 3.7  

130°C 58 35 27.5 22 17.4 14 11.3 7.5 4.3 0.4

150°C 89 60 47 37.4 29.8 24 19.4 12.9 7.3  

125°C 134 71 52.7 39.4 29.7 22.6 17.3 10.4 5.1  

130°C 160 85 63.1 47 35.5 27.1 20.7 12.4 6.1 0.5

150°C 317 169 124 92.6 69.9 53.4 40.8 24.5 12  

125°C 942 388 255 171 114 77.6 54 26 9.7  

130°C 1,218 500 330 219 148 101 69 34 12.6 0.7

150°C 3,159 1,300 855 569 383 259.1 180 88 32.7  

125°C 2,540 914 567 358 226 145 95.6 43.4 13.6  

130°C 3,377 1,221 754 476 300 193 127 57.7 18.1 0.8

150°C 10,041 3,632 2,240 1,414 893 575 378 171 53.8  

125°C 6,691 2,140 1,250 735 449 272 168 67 18.8  

130°C 9,174 2,964 1,710 1,006 616 370 229 92.2 26 0.9
 150°C 31,256 10,100 5,825 3,429 2,101 1,261 781 314 88.2  

Calculation of Applicable Junction Temperature

Failure rates and MTBFs obtained from Operating Life Tests pertain when the junction temperature is the same as the ambient test
temperature. Temperatures used during OPL tests are usually TA=125°C or TA=150°C. In most cases, these ambient temperatures
are very close to the junction temperature TJ  . However, when a significant difference between TA and TJ exists, respective TJ must
be considered. This would be the case with parts that dissipate significant amounts of power, such as certain linear and MOS
devices.

Confidence Factors

The failure rate resulting from a High Temperature Bias test is an average, or estimate, of the typical expected failure rate for a
product or process; but has no statistical boundaries established.

National Semiconductor generally states the upper 60% confidence limit for failure rate estimate using the chi-squares statistic, per
the following formula.
Values of chi square are found in a number of statistical tables. A few more typical values are shown as follows:

Percentiles of the Chi2 Distribution

(Values of Chi2 corresponding to certain selected probabilities)

LTPD or 90%
Typical Use AQL Best Estimate 60% Confidence
Confidence

Probability in % 5.0 50.0 60.0 90.0

0.05 0.50 0.60 0.90

df Total Failures        

2 0 0.103 1.390 1.830 4.61

4 1 0.711 3.360 4.040 7.78

6 2 1.640 5.350 6.210 10.60

8 3 2.730 7.340 8.350 13.40

10 4 3.940 9.340 10.500 16.00

12 5 5.230 11.300 12.600 18.50

14 6 6.570 13.300 14.700 21.10

16 7 7.960 15.300 16.800 23.50

18 8 9.390 17.300 18.900 26.00

20 9 10.900 19.300 21.000 28.40

22 10 12.800 21.300 23.000 30.80

26 12 15.400 25.300 27.200 35.60

32 15 20.100 31.300 33.400 42.60

42 20 28.200 41.300 43.700 54.10

With regards to the role of a QAM, that is dependent on the nature of the company and the size of your
facility and whether or not you are wearing multiple hats or just one...

Our facility has approximately 250 employees and some of the roles of our Quality System Manager
(comparable to a QAM I believe) are as follows:
* Management Representative for our ISO Audits
* Manage and oversee our Internal Audit Process, including the responsibility for overseeing the training
and development of our Internal Auditors
* Manage and oversee our Corrective Action Process
* Assist in the effective resolution of our Customer Complaints
* Manage and oversee our Quality System Documentation
* Organize and schedule our Management Reviews
* Help support our Supplier Management Program (in conjunction with our Purchasing and Maintenance
functions)
* Assist in the Quality Planning portion of Product Realization
* etc.
PS: Our Quality System Manager currently wears one hat.

Just our slant on things...

__________________
~ ERL ~ :)

There went the easy answer. Here is a list of the non-contract specific things I normally handle.

Ensures documentation of quality procedures and work instructions

Develop and maintain a quality system in accordance with ANSI/ISO/ASQC Q 9001:2000 Quality
Management Systems-Requirements (2000-12-15: Third Edition) and ANSI/ISO/ASQC Q 9001:2000.
Enforces adherence to the Quality Manual, procedures, work instructions, and ANSI/ISO/ASQC Q
9001:2000 Quality Management Systems-Requirements (2000-12-15: Third Edition).
Train auditors
Schedules and communicates information on external audits
Prepare and implement the audit schedule
Interface with project managers and site manager
Interface with team leads
Interface with purchasing, system engineer, and quality control
Retain or monitor the retaining of quality records and their anaylsis
Participates Monthly Management Reviews and Corprorate Program Reviews
Chair any ISO 9000-based/Process meetings
May attend department product quality meetings
Take notes at the Management Review meetings with the site manager
Perform, schedule, create process awareness training for staff
Acts as mediator or impartial chair in meetings as ask by management
Interfaces directly with management on process manament resourse needs
Informs management of any negitive trends
Manage and validate the corrective and preventive action system
Manage on the job training database
Cordinate process activities between teams
Process Cheerleader- rewards for good process and quality related activities & tours to the customer

Quality Manager Responsibilities

Posted on November 16, 2009 by At-PQC™
The Quality Manager is responsible for the administration of the Quality Plan and has the authority
to manage all work affecting quality. The Quality Manager will provide leadership for the
development, implementation, communication and maintenance of quality systems policies and
procedures for the Company according to the approved quality system. A primary goal is to achieve
a high degree of joint ownership of quality and compliance strategies with all of the major
operational stakeholders in the Company while addressing regulatory requirements in an effective,
timely and responsible manner.

Responsibilities

 Formulate and manage the development and implementation of goals, objectives, policies,
procedures and systems pertaining to the quality assurance and regulatory functions.
 Develop, implement, communicate and maintain a quality plan to bring the Company’s
Quality Systems and Policies into compliance with quality system requirements.

 Manage documentation related to Quality System guidelines.

 Quality Assurance project lead for cross-functional projects including determining QA

timelines, plans and position strategies.

 Manage and maintain the quality aspects of the Design Control Program including but not
limited to design input and output documentation, applicable risk analyses, verification and
validation activities and formal design reviews.

 Provide leadership for developing and directing Quality Assurance and Quality improvement
initiatives (Cost-of-Quality reductions, Audit system, CAPA system, etc.) for all products,
processes and services.

 Manage and maintain the Company’s internal quality audit program and assess improvement
initiatives resulting from all Quality Audits – internal and external.

 Effectively interact with Production and Development teams to maintain product supply and
help introduce new products.

 Manage training of all company personnel in the requirements, documentation and

maintenance of the corporate Quality System.

 Manage and maintain the Company’s quality inspection and product release programs for
incoming and in-process materials and components, processes and finished goods.

 Establish an auditing program and lead compliance audits of third party suppliers,
manufacturers and distributors.

 Report on timely basis to executive management on the performance of the quality system,
any non-compliance issues and recommended actions.

Qualifications
 Minimum of 5 years of Quality Systems supervisory/management experience within a related
industry.

 Experience interacting with regulatory authorities.

 Experience in quality management systems.

 Experience in quality system audits.

 Working knowledge of design control processes.

 Experience with statistical sampling plans and trending analyses.

 Knowledgeable about electronic data management.

 Professional certifications (e.g. American Society for Quality (ASQ), Certified Quality Auditor
(CQA) desirable).

Skills

 Ability to lead projects and programs with a positive “Get It Done” attitude.

 Organized, attentive to detail and able to prioritize and handle multiple projects with
competing deadlines.

 Works efficiently both on independent basis and as part of a team.

 Ability to deal effectively with all levels within the organization as well as with external
parties, including regulatory bodies.

 Proven strong problem solving ability with attention to root cause.

 Maintains a personal and professional “continuous improvement” philosophy.

 Excellent written and verbal communication skills, strong interpersonal skills.

The quality manager should be familiar with management tools for problem solving, process
management and various metrics. Quality managers use problem solving tools to determine root
causes and suggest solutions from various perspectives using data to make decisions.

Problem solving tools include:

1. The Seven Quality Tools using Pareto charts, cause and effect diagrams, flowcharts, control
charts, check sheets, scatter diagrams and histograms.
2. Basic management and planning tools using Affinity diagrams, tree diagrams, process
decision program charts, matrix diagrams, interrelationship digraphs, prioritization matrices
and activity network diagrams.
3. Process improvement tools using root cause analysis, PDCA, six sigma DMAIC model, failure
mode and effects analysis and statistical process control.
4. Innovation and creativity tools using creative decision making and problem solving
techniques that include brainstorming, mind mapping, lateral thinking, critical thinking and
design for six sigma.
5. Cost of Quality using prevention, appraisal, internal and external failure costs to suggest ways
and means to improve the bottom line.
Process Management Tools include:

1. Planning and setting goals

2. Establishing controls
3. Monitoring and measuring performance
4. Documentation
5. Cycle-time reduction
6. Waste elimination
7. Theory of constraints for local vs system optimization and physical vs policy constraints that
affect throughput
8. Elimination of special causes of variation
9. Maintaining improvements
10. Continuous improvement
11. Process mapping
12. Flowcharting
13. 5 S’s
14. Just in time
15. Kanban
16. Value streams
Measurement, Assessment and Metric Tools include:
1. Goal-question-metric modeling to identify when, what and how to measure projects and
processes
2. Sampling techniques when appropriate
3. Statistical analysis to measure central tendency, dispersion and types of distributions to
monitor processes and make data oriented decisions
4. Trend and pattern analysis to assess data-sets, graphs and charts for various cyclic, seasonal
and environment trends and pattern shifts
5. Theory of variation to identify common and special causes of variation
6. Process capability using Cp and Cpk indices
7. Reliability and validity measurement theories using content, construct and criterion types of
measures
8. Qualitative assessments using anecdotal feedback, observations and focus group output
instead of objective measurements
9. Survey analysis interpretation
Additional quality manager skills include:

1. Customer relationship management to ensure partnerships and alliances

2. Energizing internal Customers to improve products, processes and services
3. Identification and prioritization of Customer needs and expectations using tools such as
Voice of the Customer, House of Quality, Quality Function Deployment, focus groups and
Customer surveys
4. Measurement of Customer satisfaction and loyalty using complaints, surveys, interviews,
warranty data, value analysis and corrective actions
5. Conflicting requirement resolution and management of resources
How-To Achieve the Goal

Cheat – that’s right – cheat; well, another way to put it is to re-design the process to control the
sheet music. Remember the movie clip from “Dune” – “He who controls the spice controls the
universe”? Well, if you control the sheet music then you control the orchestra. That’s the tail
wagging the dog but the technique works. Everybody in the orchestra needs sheet music so all you
have to do is implement Efficient QMS™ in your business process to truly orchestrate (manage) an
efficient quality management system.

This entry was posted in Efficient QMS™ and tagged . Bookmark the permalink.

What is PPM?
 (Parts per million)
Click here for print version

PPM (Parts per million) is a measurement used today by many customers to

measure quality performance.

Definition: One PPM means one (defect or event) in a million or 1/1,000,000

There was a time when you were considered a pretty good supplier when your
defect rate was less than 1%, (10,000 PPM), then the expectation was increased to
0.1% or 1,000 PPM. Now the rate for most automotive components is targeted at
25 PPM or 0.0025%

To calculate: For example, let's say you had 25 pieces defective in a shipment of
1,000 pieces. 25/1000= .025 or 2.5% defective. .025 X 1,000,000 = 25,000 PPM.

Use the PPM Calculator:

Let's put it in perspective. Let's say, you produce 10,000,000 parts per year for
your customer. If you're like most companies, your plant operates around 5 days a
week, 50 weeks per year or 250 days a year. Let's assume your customers
requirements are 25 PPM. That means that you would be allowed 25 pieces for
every 1,000,000 pieces or 250 defective parts per year. Or to put it another way,
one bad part per day! Notice I did not say one bad part per day per person or job,
or shift or machine. One bad part for the entire plant for 24 hours!

Impossible? Yes if you are still using the same manufacturing methods which
were responsible for the 5 or 10% scrap you used to accept.

A friend of mine had the following quotation on his wall:

Insanity is doing things the same way we've always done them and expecting
different results. 

The monitoring and measurement systems we have today have paved the way for
improved quality. We can now control the process in order to control the quality.
Quality can not be inspected in after the fact. It is the result of careful planning,
design, and execution.

If you don't measure it you can not control it.

If you would like to learn how to reduce your PPM while increasing profits I can
help.
First by demonstrating a systematic and scientific approach to design and
manufacturing in your facility.

Second, by training your personnel in the use of the tools and methodology.

For a more detailed article on PPM visit the following

page.http://www.drdiecast.com/PPM_is_it_possible.htm

Click the following for information on consulting and training services offered by

McClintic & Associates.

Process capability index

From Wikipedia, the free encyclopedia

In process improvement efforts, the process capability index or process capability ratio is a statistical measure of process
capability: The ability of a process to produce output within specification limits.[1] The concept of process capability only holds
meaning for processes that are in a state of statistical control. Process capability indices measure how much "natural
variation" a process experiences relative to its specification limits and allows different processes to be compared with respect
to how well an organization controls them.

If the upper and lower specification limits of the process are USL and LSL, the target process mean is T, the estimated mean
of the process is   and the estimated variability of the process (expressed as a standard deviation) is  , then commonly-
accepted process capability indices include:

Index Description

Estimates what the process would be capable of producing if the process could
be centered. Assumes process output is approximately normally distributed.

Estimates process capability for specifications that consist of a lower limit only
(for example, strength). Assumes process output is approximately normally
distributed.

Estimates process capability for specifications that consist of an upper limit only
(for example, concentration). Assumes process output is approximately
normally distributed.

Estimates what the process is capable of producing if the process target is

centered between the specification limits. If the process mean is not

centered,  overestimates process capability.   if the process mean

 falls outside of the specification limits. Assumes process output is
approximately normally distributed.

Estimates process capability around a target, T.   is always greater than

zero. Assumes process output is approximately normally distributed.   is

also known as the Taguchi capability index.[2]

Estimates process capability around a target, T, and accounts for an off-center

process mean. Assumes process output is approximately normally distributed.

 is estimated using the sample standard deviation.

Contents
 [hide]

1 Recommended values

2 Relationship to measures of process fallout

3 Example

4 References

5 See also

[edit]Recommended values

Process capability indices are constructed to express more desirable capability with increasingly higher values. Values near or
below zero indicate processes operating off target (  far from T) or with high variation.

Fixing values for minimum "acceptable" process capability targets is a matter of personal opinion, and what consensus exists
varies by industry, facility, and the process under consideration. For example, in the automotive industry, the AIAG sets forth
guidelines in theProduction Part Approval Process, 4th edition for recommended Cpk minimum values for critical-to-quality
process characteristics. However, these criteria are debatable and several processes may not be evaluated for capability just
because they have not properly been assessed.

Since the process capability is a function of the specification, the Process Capability Index is only as good as the
specification . For instance, if the specification came from an engineering guideline without considering the function and
criticality of the part, a discussion around process capability is useless, and would have more benefits if focused on what are
the real risks of having a part borderline out of specification. The loss function of Taguchi better illustrates this concept.

At least one academic expert recommends[3] the following:

Recommended minimum process capability Recommended minimum process capability

Situation
for two-sided specifications for one-sided specification
Existing process 1.33 1.25

New process 1.50 1.45

Safety or critical parameter for

1.50 1.45
existing process

Safety or critical parameter for

1.67 1.60
new process

Six Sigma quality process 2.00 2.00

It should be noted though that where a process produces a characteristic with a capability index greater than 2.5, the
unnecessary precision may be expensive[4].

[edit]Relationship to measures of process fallout

The mapping from process capability indices, such as Cpk, to measures of process fallout is straightforward. Process fallout
quantifies how many defects a process produces and is measured by DPMO or PPM. Process yield is, of course, the
complement of process fallout and is approximately equal to the area under the probability density

function   if the process output is approximately normally distributed.

In the short term ("short sigma"), the relationships are:

Area under the probability density

Cpk Sigma level (σ) Process yield Process fallout (in terms of DPMO/PPM)
functionΦ(σ)

0.33 1 0.6826894921 68.27% 317311

0.67 2 0.9544997361 95.45% 45500

1.00 3 0.9973002039 99.73% 2700

1.33 4 0.9999366575 99.99% 63

1.67 5 0.9999994267 99.9999% 1

2.00 6 0.9999999980 99.9999998% 0.002

In the long term, processes can shift or drift significantly (most control charts are only sensitive to changes of 1.5σ or greater
in process output), so process capability indices are not applicable as they require statistical control.

[edit]Example

Consider a quality characteristic with target of 100.00 μm and upper and lower specification limits of 106.00 μm and 94.00 μm
respectively. If, after carefully monitoring the process for a while, it appears that the process is in control and producing output
predictably (as depicted in the run chart below), we can meaningfully estimate its mean and standard

deviation. 

If   and   are estimated to be 98.94 μm and 1.03 μm, respectively, then

Index
 The fact that the process is running about 1σ below its target is reflected in the markedly different values for C p, Cpk, Cpm, and
Cpkm.

[edit]References

1. ^ "What is Process Capability?". NIST/Sematech Engineering Statistics Handbook. National Institute of Standards

and Technology. Retrieved 2008-06-22.

2. ^ Boyles, Russell (1991). "The Taguchi Capability Index". Journal of Quality Technology (Milwaukee,

Wisconsin: American Society for Quality Control) 23 (1): pp. 17 – 26. ISSN 0022-4065. OCLC 1800135

3. ^ Montgomery, Douglas (2004). Introduction to Statistical Quality Control. New York, New York: John Wiley &

Sons, Inc.. p. 776.ISBN 9780471656319. OCLC 56729567.

4. ^ Booker, J. M.; Raines, M.; Swift, K. G. (2001). Designing Capable and Reliable Products. Oxford: Butterworth-

Heinemann.ISBN 9780750650762. OCLC 47030836.

[edit]See also

 Process performance index

Categories: Index numbers | Process management | Quality control

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The Seven new Management and Planning Tools have their roots in Operations Research work done after World
War II and theJapanese Total Quality Control (TQC) research. In 1979 the book Seven New Quality Tools for Managers
and Staff was published and in 1983 was translated into English.

The seven new tools include:

1. Affinity Diagram (KJ Method)

2. Interrelationship Diagraph (ID)
3. Tree Diagram
4. Prioritization Matrix
5. Matrix Diagram
6. Process Decision Program Chart (PDPC)
7. Activity Network Diagram
 Contents
 [hide]

1 The seven new tools

o 1.1 Affinity Diagram

o 1.2 Interrelationship Diagraph

o 1.3 Tree Diagram

o 1.4 Prioritization Matrix

o 1.5 Matrix Diagram

o 1.6 Process Decision Program Chart (PDPC)

o 1.7 Activity Network Diagram

2 References

3 Further reading

4 External links

[edit]The seven new tools

[edit]Affinity Diagram

This tool takes large amounts of disorganized data and information and enables one to organize it into groupings based
on natural relationships. It was created in the 1960s by Japanese anthropologist Jiro Kawakita. Its also known as KJ
diagram,after Jiro Kawakita. Affinity diagram is a special kind of brainstorming tool.

[edit]Interrelationship Diagraph

This tool displays all the interrelated cause-and-effect relationships and factors involved in a complex problem and
describes desired outcomes. The process of creating an interrelationship diagraph helps a group analyze the natural
links between different aspects of a complex situation.
[edit]Tree Diagram

This tool is used to break down broad categories into finer and finer levels of detail. It can map levels of details of tasks
that are required to accomplish a goal or task. It can be used to break down broad general subjects into finer and finer
levels of detail. Developing the tree diagram helps one move their thinking from generalities to specifics.

[edit]Prioritization Matrix

This tool is used to prioritize items and describe them in terms of weighted criteria. It uses a combination of tree and
matrix diagramming techniques to do a pair-wise evaluation of items and to narrow down options to the most desired or
most effective.

[edit]Matrix Diagram

This tool shows the relationship between items. At each intersection a relationship is either absent or present. It then
gives information about the relationship, such as its strength, the roles played by various individuals or measurements.
Six differently shaped matrices are possible: L, T, Y, X, C, R and roof-shaped, depending on how many groups must be
compared.

[edit]Process Decision Program Chart (PDPC)

A useful way of planning is to break down tasks into a hierarchy, using a Tree Diagram. The PDPC extends the tree
diagram a couple of levels to identify risks and countermeasures for the bottom level tasks. Different shaped boxes are
used to highlight risks and identify possible countermeasures (often shown as 'clouds' to indicate their uncertain nature).
The PDPC is similar to the Failure Modes and Effects Analysis (FMEA) in that both identify risks, consequences of
failure, and contingency actions; the FMEA also rates relative risk levels for each potential failure point.

[edit]Activity Network Diagram

This tool is used to plan the appropriate sequence or schedule for a set of tasks and related subtasks. It is used when
subtasks must occur in parallel. The diagram enables one to determine the critical path (longest sequence of tasks).
(See also PERT diagram.)

[edit]References
This article does not cite any references or sources.
Please help improve this article by adding citations to reliable sources. Unsourced material may be challenged andremoved. (October
2008)

[edit]Further reading

 Brassard, M. (1996) The Memory Jogger Plus+. ISBN 1-879364-83-2.

 Seven New Management and Planning Tools
 Seven Basic Tools of Quality.

QS-9000

QS-9000 is the name for the Quality System Requirements used to increase customer

confidence in the quality of its suppliers.

The idea of QS-9000 is quite similar to ISO-9000, International Quality System Standard, but QS-
9000 applies particularly to the automotive industry for Chrysler Corporation, Ford Motor
Company, General Motors Corporation, and truck manufacturers. QS-9000 is made up of three
sections: an ISO-9000 based requirement, a sector-specific requirement, and a customer-specific
requirement. These requirements guarantee a supplier procures a good quality product.
Furthermore, by developing QS-9000, we will be able to improve our product, customer
satisfaction, and supplier relations as well.
 Standards for ISO-9001 and QS-9000
____________________________________________________________________
ISO QS
Quality System Requirements 9001 9000
--------------------------------------------------------------------
Management Responsibility X X
Quality System X X
Contract Review X X
Design Control X X
Document and Data Control X X
Purchasing X X
Control of Customer-Supplied Product X X
Product Identification and Tractability X X
Process Control X X
Inspection and Testing X X
Control of Inspection, Measuring, and Test Equipment X X
Inspection and Test Status X X
Control of Non-Conforming Product X X
Corrective and Preventive Action X X
Handling, Storage, Packaging, Preservation and Delivery X X
Control of Quality Audits X X
Training X X
Servicing X X
Statistical Techniques X X
--------------------------------------------------------------------
Production Parts Approval Process X
Continuous Improvement X
Manufacturing Capability X
--------------------------------------------------------------------
Customer-Specific Requirement X
____________________________________________________________________

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Quality

Quality means a totality of characteristics of an entity that bear on its ability to satisfy stated and
implied needs. In some references, Quality is referred to as "fitness for use", "fitness for
purpose", "customer satisfaction", or "conformance to the requirements."

To achieve satisfactory quality we must concern all stages of the product or service cycle. In the
first stage quality is due to a definition of needs. In the second stage it is due to product design
and conformance. In the last stage quality is due to product support throughout its lifetime.

There are two major aspects of quality: quality of design and quality of conformance. Quality of
design involves the variations of a product or services in grades or levels of quality. This includes
the types of materials used in construction, tolerance in manufacturing, reliability, etc. Quality of
conformance concerns how well the product conforms to the specifications and tolerances
required by the design. Quality of conformance is influenced by the choices of manufacturing
processes, training and supervision of the workforce, the type of quality-assurance system used,
and the motivation of the workforce to achieve quality.

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Quality at Source (Source Inspection)

Source inspection is a technique used to prevent product defects by controlling the conditions that
influence quality at their source. It is the performance of the supplier's facilities to increase
customer confidence with the supplier's product quality. The following elements are essential
parts of source inspection.

 The quality history of suppliers.

 Any possible effects that occur during purchasing, based on the performance, safety, and
reliability of the final product.
 Product complexity.
 The ability to measure the product quality from buyer data.
 The availability of special measuring equipment at the buyer's plant to perform the required
inspection.
 The product's nature and its quality.

It is important to have either external or internal company inspectors to assure adequate product
control. A sources inspection is performed to insure that the decision making is correct and
unbiased. Furthermore, source inspection can be devised into two categories as follows;

1. Vertical source inspection inspects the process flow to identify and control external
conditions that affect quality.
2. Horizontal source inspection inspects an operation to identify and control interval
conditions that affect quality.

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SOP - Standard Operating Procedures

Standard Operating Procedures (SOP) are the instructions that cover operational parts. Initially,
an SOP is based on Armywide publications and then modified to use local operating conditions
and command policies as a guideline. The scope of SOP is extensive and varies. It provides the
major instructions for all division elements of operational features.

In general, there are two formats for an SOP to follow:

 A format that publishes all comprising documents which details of the function and the
responsibilities of subordinate units.
 A format that is published as a basic document which includes general instructions to all
units. This kind of format has specific instructions for each individual unit. It is more
detailed and easier to use.

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SMED - Single Minute Exchange of Die

SMED, often called "Quick Changeover", is an process that can help us to reduce downtime due
to set-ups and changeovers. Quick Changeover means we reduce time to set up a machine or
process. We use SMED as a guideline to eliminate our waste changeover time in our production
process, especially while changing a machine from one product to another.

There are six major steps that we should be concerned with :

1. Ensure that everything needed for setup is already organized and on hand to save time
finding something in the process setup.
2. It is good to move your arms but not your legs to avoid spending too much time during
adjustment or set-ups.
3. Do not remove bolts completely to save time during removing bolts and setting up the
process.
4. Regard bolts as enemies; do what ever you can to get rid of them to save time by using
some equipment that is better than bolts when changing the process.
5. Do not allow any deviation from die and jig standards to save time by using the same
standards. For example, use the same size of nut and bolts for each die and jig.
6. Adjustment is waste to make the jig or figure simple to setup and avoid wasting time to
adjust the positions.

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SPC - Statistical Process Control

Statistical Process Control (SPC) is an collection of statistical techniques that are used to monitor
critical parameters and reduce variations. We used SPC to achieve process stability and improve
the capability through reduction of variability. Often the term "Statistical Quality Control" is
used interchangeably with "Statistical Process Control."

The objective of SPC is to get a process under control. This is done by identifying and eliminating
any specific causes of variation not associated with the process itself. A process that is in control
will constantly perform within its own natural limits.

SPC can be broken into two components: process control and acceptance sampling. In process

control, SPC involves these seven tools: Histogram, Check Sheet, Parato Chart, Cause and Effect
Diagram, Defect Concentration Diagram, Scatter Diagram, and Control Chart These tools often
called "The Seven QC tools." Most of the tools help us to identify a problem in the process.
Acceptance sampling is used to reduce variation in the process by using statistical sampling
techniques to select the proper sampling size and to interpret whether our whole product should
be accepted or rejected.

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Sampling

Sampling is the process of obtaining samples from a large group of data (or called population).
There are numerous data, so it is difficult or impossible to examine the whole group. Examining
all data will expend a lot of time, so doing only a small part of entire data, a sample, is more
appropriate. Additionally, sampling theory is a study of the relationship between the whole data
and the samples. It is useful to understand whether there are differences between two samples.

All possible samples of size n can be drawn from a given population. For each sample, we can
calculate a statistic; for example, the mean and the standard deviation of the data will vary from
sample to sample. So a sampling distribution is useful to explain the data characteristics.

There are three types of sampling processes:

1. Single sampling is composed of selecting a specifically random sample of n items from

each group of items presented, and then condemning each group depends up on the results.
For example, chose n items from each group for inspection. We will accept the group if the
number of defects is less than or equal to d, a specific value. Otherwise, we will reject
them.
2. Double sampling is composed of selecting two specifically random samples
of n1 and n2 from data. By a technique of this type, the results of selecting a first
sample (n1) are accepting the group, rejecting, or talking another sample of n2 items. The
decision making depends on the associated results.
3. Multiple sampling is a technique of sampling that is similar to the double sampling, but
there are more than two sampling items used in decision making.

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Scatter Diagram

A scatter diagram is a graphical diagram to show the relationship between two data variables. It

is used to display the change of one variable when another changes. From a scatter diagram, we
can find a mathematical equation that relates to the variables. To create a scatter diagram, these
steps are followed:

 Collect data. This is the most essential step.

 Build a data sheet to show the information from the data.
 Define the variable axis of the graph.
1. The horizontal axis (X axis) displays the variable's measurement values; most are
cause variables.
2. The vertical axis (Y axis) shows the measurement values of another variable; most
are effect variables.
 Plot data on the graph.
 Construct a mathematical equation.
From a scatter diagram, curves are tentatively devised for linear and non-linear curves. With this,
we can call two relationships between variables to linear and non-linear relationships.

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Self Inspection

Self inspection is a technique of inspection in which workers check their own work. Self
inspection provides the most immediate feedback. With this technique, the worker may accept
products that ought to be rejected. Furthermore, the worker may not notice all the errors.

On the other hand, if the errors in decision and careless mistakes are eliminated, self inspection
would be the efficient technique. However, it could be improved by developing tools or using
devices that could automatically detect defects or mistakes. Providing new knowledge of quality
processes to workers is an efficient method to improve the self inspection technique.

Generally, the results from inspections are reported in terms of the total percentage of defects.
With this method, inspectors will check the final products. They may find some mistakes or
product errors, but they will not know the actual error source. As mentioned, self inspection is a
method to solve this problem.

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Sensory Inspection

Inspections involve distinguishing acceptable from unacceptable goods and comparing them with
a standard. Sensory inspection is a kind of inspection, conducted by the human senses, such as
inspections of paint saturation or judgments of plating adequacy. They are different from physical
inspection, which involves the use of devices, like calipers, micrometers or gauges, to measure.

For inspection of this kind, it is difficult to set criteria because it depends on the physical
condition of human workers, the period of work, and the skills acquired from experience.
Naturally, different people have different senses and even the same person may make different
judgments at different times. It is laborious to judge an object with a complex form or a not-well-
defined shape.

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Seven Steps or Seven QC Steps

The 7 QC Steps process is a structured problem solving approach for improving weak processes.
This approach is known as reactive improvement. The 7 QC Steps is easy to understand and learn,
easy to use, and easy to monitor.

The 7 QC steps process is structured as follows:

Step 1: Select a Theme. In this step, the weakness in the process or the problem to be solved is
clarified in a theme statement. A Flowchart, a Theme Selection Matrix, or a Cause & Effect
Diagram is used as a tool in this step.

Step 2: Collect and Analyze Data. This step focuses facts about the problem and discovers what
types of problems occur frequently. When collecting data, you must think of all possible causes.
Checksheets and Pareto Diagrams are the tools most often used.

Step 3: Analyze Causes.With sufficient data from step 2, the root cause, or fundamental cause, is
found by constructing a Cause & Effect Diagram.

Step 4: Plan and Implement Solution. In this step, you brainstorm for ideas that are causing the
problem and develop a solution that prevents the root cause from recurring. Then, you implement
an adjustment to the process. The 4W's and 1H Matrix (What, When, Where, Who, and How
Matrix) is used to develop a plan.

Step 5: Evaluate Effects.You evaluate the effects of implemented solution to make sure the
solution worked and does not have unacceptable results from the comparison of data, before and
after the implementation of the solution. In this step, comparative Pareto Charts and Graphs are
frequently used to identify the results.

Step 6: Standardize Solution. A standardized solution is confirms that the old process is
replaced with an improved process and indicates that the solution is workable. A flowchart is
most often used.

Step 7: Reflect on Process and the Next Problem. In this step, you consider what the team's
accomplishment was in the first 6 steps and recommend a weakness to work on next.
Back to Original Page

7QC Tools

Seven QC tools are fundamental instruments to improve the quality of the product. They are used
to analyze the production process, identify the major problems, control fluctuations of product
quality, and provide solutions to avoid future defects. Statistical literacy is necessary to
effectively use the seven QC tools. These tools use statistical techniques and knowledge to
accumulate data and analyze them.

Seven QC tools are utilized to organize the collected data in a way that is easy to understand and
analyze. Moreover, from using the seven QC tools, any specific problems in a process are
identified.

7QC tools always include :

 Check Sheet is used to easily collect data. Decision-making and actions are taken from the
data.
 Pareto Chart is used to define problems, to set their priority, to illustrate the problems
detected, and determine their frequency in the process.
 Cause-and-Effect Diagram (Fishbone Diagram) is used to figure out any possible causes
of a problem. After the major causes are known, we can solve the problem accurately.
 Histogram shows a bar chart of accumulated data and provides the easiest way to evaluate
the distribution of data.
 Scatter Diagram is a graphical tool that plots many data points and shows a pattern of
correlation between two variables.
 Flow Chart shows the process step by step and can sometimes identify an unnecessary
procedure.
 Control Chart provides control limits which are generally three standard deviations above
and below average, whether or not our process is in control.

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