1. Total Quality Management System Framework
By: Leo Yip Kingwah
2009.9.9
Quality Elements System Elements Procedures Report / Review / Record / Analysis
Results
Tools
Quality Culture
Require behavior and
responsibilities.
Quality Policy.
Quality Concept.
Quality conscious.
Common sense.
Quality Policy
Focus on customer expectations
and satisfaction.
Strike for quality excellence.
Set zero quality failure targets.
Company quality policy is recommended to be written up in
simple and easy understanding words,and is posted up and
promoted on public locations. Employee is required to say out
the policy when asked. Print the policy on the company batch
carried by each employee.
Management team must be self model in pursuing quality
excellence.
Measure quality costs - Define and track quality Appraisal,
Prevention and Failure cost.Use data for improvement.
Quality growth plan - Management formulate and steer the
company Quality Growth Plan, track progress records and
review results,make adjustments in time.
Management Commitment in quality -
Do all employees know what the quality
policy is?
Quality Commitment statement, Quality
Growth plan and review records.
Quality cost data, analysis report, charts,
graph; comments and recommendations
and actions completed.
Resources to quality plan and actual
commitment.
Communication Channels
Policy Poster.
Training.
Bench Marking.
Audits.
Quality
performance
dash board.
Achievement
and failure
lesson learn.

2. There is clear Top Management Quality Commitment
Statement.
Top executives present annualquality performance KI to
company board, and communicate to whole company.
Formulate yearly quality direction statement and objectives.
Plan and approve resources support quality functions.
Quality Mindset
Customer first. Meet and
exceed customer requirements.
Quality Owner of process
owner.
Do it right right the first time.
Zero defect target.
Problem owner.
Build Quality Mindset amongst all employees
Concept of internal and external customers and employee is
liable to understand theirquality requirements and
expectations.
Process owner is responsible for the quality. Employee for
producing right quality requirement in their process.
Job Skills and Knowledge are well defined and identified
for each position
Trainings to employee with right skills, knowledge, use of
tools and judgment of accept / reject quality.
Qualify operators before allow them to engage a task. Ensure <
How do employee contribute to the
achievement of their organization’s
objectives?
How are training needs
determined?
What kind of orientation training is
provided when employees are hired?
How are personnelmade aware of the
mission, values, and measurable
objectives of the organization?
How is the effectiveness of training
evaluated?
Management self
model.
Training and
orientation to
employee.
Leadership role
in problem
solving culture.
Quality circle.
6S.
Quality tools box

3. Do thing right right the first time >.
Define problem owner and problem solver
Problem owners are those supervisors,managers, and
executive leaders who own problems happened in their areas
of responsibility. They are responsible for leading their team to
solve the problems happened in their area. Problem owners
play a significant role in reinforcing the cultural change.
What happens when training is
ineffective?
What training records are maintained?
trainings.
Feedback,
reward right
behavior system.
Mission
Achieve objectives as integral
part of job responsibility.
Department and Employee
understand specifically what
they can do to improve the
organization. This kind of
knowledge creates strategic
focus throughout the
organization.
Clear Role
Define Quality responsibility in job description. Employee are
communicated what matters most to the company's success.
They know the significance of their roles and are prepared to
carry them out.
Clear objectives
Set clear objectives. Instead of just having a micro view of
activities and tasks,personnel begin to understand howtheir
jobs link to the larger mission of the organization. Measurable
objectives be established at relevant functions and levels. All
personnelmust be able to communicate, in their own words,
how they help move objectives in the right direction.
Clear desirable behavior
Practice immediately feedback. Economics award and
How is progress against objectives
communicated to the organization? Is
there evidence of achieving objectives?
How do employees contribute to the
achievement of organization’s objectives?
Dash Board showing performance trend to
all employee.
What’s the most important thing
about your job?
What’s the hardest thing about your job?
What are some things you’d like to change
QFD (Quality
function
deployment)
Dash board
management
Set quality target
achievement as
one of base
employee
performance
review.
Set quality care
as one of core
behavior in
performance

4. promotion are linked to performance results. about your job?
What is a resource that would help you be
more effective?
What should your manager know that he
or she currently doesn’t know?
If you were the manager here,
what would you do differently?
review.
Management
Commitment
Financial support.
Power authorization.
Action quality, no lip
quality.
A Quality Management
System.
Top management committed to
finance and execute :
A Quality Organization to
implement, manage, maintain,
monitor and lead to improve the
QMS.
A Documentation Systemto
define the authority,
responsibility, execution,
control, monitoring,
maintenance, change, review,
upgrading and improvement of
the QMS.
Build and well define an infrastructure of QMS.
Have a detailed total quality control blue print.
Quality Management System Organization
Build up Quality Management Team, define responsibility and
authority, appoint Quality Management Representative.All
Managers are member of Quality Management Team,
Department / Functional manager is quality representative of
department.
Quality Management System Documentation
Build up Comprehensive processes procedure to provide well
defined guidelines and steps to operations.There is a
Document Control System to define document creation,
authorization of use, maintain, change,obsolete, retain.
QMS Organization Chart.
QMS Product Realization Flow Chart
CI project and CAR records. CI project,
CA follows up review, completion and
effectiveness.
Tools training, Customer feedback review
and action plan, QMS effectiveness
assessment and recommendations.
Company/Department have updated
document list, training record of all
employee.
MRM records, Improvement Plan.
Regular audits
and reviews on
documented
procedure and
processes.
CI on area of
weakness.
LEAN

5. Execution of procedures.
Functional departments commit
to follow 100% process
procedures,set and achieve
departmental targets align with
company goals.
Have detailed action plan and
resources to pursue the
targets.
Targets be achievable and
measurable.
Product Quality Control Flow Chart
A clear processes flow chart to show clear control steps of
product realization. Strict rules are set to govern sideways and
deviations.
Regular periodical Management Reviews
Managers take the lead to track company and departmental
KPI performance trend, and take actions for under
performance.
General Manageris owner of annual quality MRM.
Product Quality
Company does not
allow existence of
quality-in-doubt
products,in house or
on field.
Before sales,sales,
and after sales
services to customers
are integral parts of
Quality by Design
Written requirements, criteria
and standards must be part of
design inputs.
Requirements stated by
the customer;
Requirements not stated
by the customer but
necessary for intended
Professional Sales Services
See customer satisfaction section below.
Contract Review
There is specific contract review procedures and forms to
complete before starting formal product development.
Customer Services, Sales, Quality, Engineering, legal and
Operation are required to review and sign confirmation in
respect to their control and responsible area.
There is standardize product design and development
Are product requirements completed?
How does the organization ensure that
correct versions are available?
How do requirements get reviewed prior
to acceptance?
How to ensure that product meets the
stated requirements?
Electronic
approval system.
Qualification
system.

6. product quality.
Process owner
product (materials,
WIP, finished goods)
knowledge and
quality criteria.
use;
Statutory and legal
requirements; and
Additional requirements
determined by the
organization.
procedure with clear steps and approval gates
Apply Product design tools in product design as appropriated :
APQP, DFSS, QFD, MSA, FMEA, PPAP
Product Qualification
There is procedure of product qualification plan for every new
product to qualify for mass production.Qualification criteria
approval gates are well defined and must meet. Approvalgates
must be signed off and closed based on test data and results.
What happens when changes are made to
product requirements?
Product development file and record must
be completed and well maintained with
FAI report and samples.
Product qualification record shows
approval date and signature.
Quality by Process
All processes is defined with
SIPOC.
LEAN the flow.
Necessary aids and/ortools are
in place to facilitate
achievement of objectives and
prevent mistakes. Eliminate the
wastes.
Define Yield Rate (quantity
Process Qualification
Each and all process steps shallbe well defined the objective
matrix : criteria and standard of SIPOC (Supplier, Input,
Process-steps,Output,Customer)
Qualify the processes with 5 M 1 E Qualification (Man,
Materials, Machine, Method, and Environment) – Each needs
specific qualification procedure and criteria of acceptance.
1. Man – Skill and training;
2. Material – Specification and sample;
3. Machine – Setting and maintenance;
Production FAI, LAI record.
Improvement actions, projects.
Training records.
Control Plan available.
WI
Control data, graph, chart.
Yield records.
IPQA
SPC
6S

7. and/ortime) at logical and
financial affordable level.
Mechanism to stop the
processes at doubtfulquality.
4. Method – SOE / WI / VA;
5. Measurement SystemAnalysis – G R & R
6. Environment – temperature, humidity, lighting, noise,
dust etc.
7. Control Plan.
8. Ensure Yield rates.
9. 6S
FAI and LAI
There is First Article Approval systemto govern production
take place. Last Article to verify variation to indicate Sigma
[σ] level within specification.
WIP quality control
Have in-process sampling plan for each product and execute
seriously.
Verify process SOE and disciplines are followed exactly.
To minimize the Rolled Throughput Yield (RTY) by applying
self check, Poke-yoke in each process station.
QC records.
Repair records.

8. Define stop line criteria and trigger points.
Prevent materials damages from handling , transferring
and storage
1. Find the best fit container / packaging for materials,
protect them from damaging, deterioration during
transits,storage.Specify container / packaging used
for each material, WIP and finished goods in material
specification.
2. Consider material environmental requirements
always.
3. Always be cautious of human direct contact that could
cause later defect (example – Oxidization).
4. Clear Identification of materials.

9. Quality Assurance
Quality Knowledge
and skills.
Trained personnel.
Quality supplies.
Strict process
disciplines.
Supplies Quality Assurance
Build up supplier and supplies
Selection systems,including
performance monitoring
method.
Impose incoming material
quality control to prevent
source of problem from
incoming materials.
Periodical review materials on
quality, price and improvement
/ new versions.
Supplier Qualification procedure
There is Suppliers selection process and criteria to ensure
supplier capacity and capability of meeting quantity and
quality requirements. Develop comprehensive supplier
assessment quality feedback forms.
There is purchase order review and confirmation processes
with suppliers to secure right quality requirements are
understood and confirmed achievable by suppliers.
Regular Supplier communication.
Supplier support:training in technology and industrial
standards,legal requirements.
Material qualification procedure
There is materials selection and approval process to ensure
materials are met with specification. Develop qualification
form and approval gates.
Incoming material quality assurance
There is incoming inspection plan and approved reference
sample for each material. The plan shall have specific
acceptance criteria, such as sampling plan and accepting level,
COC or supplier inspection report in lieu of tests.
Supplier approval records and
performance data.
Material approval records,samples.
Incoming material control records.
How incoming non-conformance is
handled and record or rectification.
Supplier performance evaluation and
improvement action taken.
Supplier
evaluation audit.
Sample approval
system.
Approval sample
regular review.
Supplier
performance
system.
Reliability test.
Incoming
material quality
assurance
method -COC
sampling,
supplier test
reports.

10. Carry out periodical reliability test to ensure variation is
within control.
In-process Quality Assurance
Have a reliable in-process
quality assurance (IPQA) plant
and team.
Strictly follow process
disciplines.
Updated WI.
Tailor made SPC tools to
monitor and check the
production variations.
Minimize the possibility of
defected products reaching the
customers.
In-process quality control
See quality by process.
Outgoing quality assurance
There is either in-process sampling plan or outgoing sampling
plan procedure or both to ensure product quality, before
shipping to customer are conformed to defined quality
requirements.
There is clear guidelines and authority to trigger production
line / shipment stop when quality is diversified from control
point(s).
Collect and analyze performance data to ensure process is
stable or need to take action to reinstall.
In-process audit records, data, samples.
Statistics of acceptance and reject records
of finished products.
FA reports and CAR and result records.
control plan, FAI record, prints,
IPQA/IPQC
FAI, LAI
WI
SOE
Quality samples.
Trained
operators.
SPC
MSA

11. Engineering Change
Management
Make strict written procedure
and detailed processes to guide
all kinds of changes.
Engineering Change Control
For all changes,first study the impacts to customers. No
Changes are allowed if they affect customers form and fit, and
agreed quality, unless obtained their approval.
Follow strictly change procedure and processes.Acheck sheet
to monitor completion of change process activities. A change
center shall monitor the flow and task to guarantee 100%
completed and correct. There are actions to verify no multiple
systems/formats,missing information, wait
time/responsiveness,manual re-keying of information,
translation/interpretation, conflicting changes.
It is recommended a to see the final authorized signal before a
change is taken place.
Change records, customer approval
records. Trace back to
specifications, FMEA, control
plan, FAI, prints.
Paper or
electronic
process and
approval gate
system.
Engineering
Change
completion and
effectiveness
verification log
book.
Control nonconforming
Control nonconforming
materials including supplies,
WIP, stocks,customer returns to
prevent pollution to clean
materials.
Handle nonconforming
There are detailed instructions of how to handle
nonconforming.
There are specific locations to quarantine nonconforming.
Find Root causes of nonconforming and eliminate them.
Preventive and improvement actions are formulated and their
Ask employee how they to control non-
conformance.
Ask employee how they can trace the
material with lot number.
Disposition records.
Nonconforming data collection and
Physical and
Book quarantine
system.
Monitor quality
costs trend chart.
Logical and
meaningful part

12. results are verified. Update process flow.
Nonconforming cases are needed to close and nonconforming
materials are required to dispose within specific time limit.
Nonconforming quantity and values are collected for
management review and identify area of improvement.
Traceability
Structure the lot number of material, WIP, finished goods so
that they can be traced back to origination at any time. The lot
number shall be able to tell where, when, which. A material
lot number can trace to which WIP, finished goods lots; a
finished goods lot number can trace to which materials lots.
Materials, WIP, finished good always travel with ID.
Structure the part number of material to maximize information
to detect there is a material problem. (Categories, model/class,
size, color, distinct characteristics (hardness,thickness,
voltage, watt, etc), maker.
Every employee is trained to know how to trace materials with
part numbers and lot numbers.
analysis records.
Improvement records.
numbering and
lot numbering
system.
Regulatory Compliance There is responsible person and mechanism to ensure legal
requirements, regulatory rules and restrictions, industrial
Verify compliance certificate, approval Specialist
overseeing this

13. standards,environmental regulations, technical approval etc
are compliant.
Maintain a table of compliance requirements for all categories
of materials.
Ensure material compliant from beginning of product
development.
Ensure compliance of supplies.COC must be supported by
qualified lab test result. Might need to reconfirm by 3rd party
lab test irregularly.
documents,test reports. area.
Compliant
reference table
Quality Problem prevention
& Solving
Prevent quality problem
happened rather than discover
quality problem by inspection.
Openly shares data and
encourages its analysis on a
broad scale, employees are
made known the problems so as
to make preventive action
becomes easy.
Have specific systemand
personnelresponsible for
Problem prevention
Apply quality tools such as Poke-yoke, auto counting,sensors
to prevent quality problem from happening. Detect potential
problem by collecting and analyzing data. Generate
preventive action through data analysis indicators rather than
seeing actual problem happened. Data analysis is a primary
job of identify quality problems.
Regular maintenance program, calibration plan are fixed for
Machine, equipment, measurement tools,software.
SPC detect process variation.
MSA ensure precise and precision of measurement system.
Maintenance program and records.
Calibration plan and proof records.
FMEA records.
Problem solving tools training.
Ask employee how they handle a problem.
What does your organization do to solve
customer problems better than competitors
so that customers old and new will pay
good money for yourservices and goods
LEAN
6 Sigma
7 QC tools.

14. problem solving process.: locate
problem owner and problem
solver, monitoring progresses,
ensure corrective actions are
taken, validate effectiveness of
actions before confirming
problem solved.
Poke-yoke to prevent human error.
Problem Solving
There is procedure to set up problem solving team and select
members for the team for each problem. Quality personnel
shall always take the lead for the problem solving process –
1. Locate problem area, problem owner and problem
solver.
2. Monitor, follow up progress,and verify solution and
validate effectiveness.
The team shall use cause and effect tool (5M1E : Man,
Machine, Material, Method,Measurement and Environment -
Fishbone and 5 why )
Problem owners are those supervisors,managers,and
executive leaders who own problems happened in their areas
of responsibility. They are responsible for leading the problem
solvers to get the problems solved.The members of problem
solving team from other functional departments shall support
as needed to solve the problem. All employees within the
organization, no matter what their levels, find themselves in
the role of problem solver from time to time.
1. Set expectations for your employees, at a local level,
to use effective problem solving method and tools as part of
and buy more over time?
Problem solving
training and CI
process training
to employee.

15. their jobs.
1. Know how to expose and clearly define problems.
2. Actively coach employees on effective problem
solving process.
3. Take responsibility to standardize the process once a
problem has been solved.
4. Recognize and reward employees for successfully
solving problems.
Problem solvers are our employee who are given
appropriated trainings in skill and knowledge. They will act as
change agent, be a power force in the workplace by both
adopting and promoting new behaviors to others across and up
the organizational structure.The management shall :
1. Employees are trained with skills and knowledge so
that they can see problems. They are trained to be capable of
recognizing that a current situation may be a problem and to
define the problem clearly in measurable terms.
2. Build up quality mindset that it is the responsibility of
employee to take up and solve problems as culture. Problem
solvers must be willing and able to accept ownership for
solving the problems in their area of responsibility, to
communicate the existence of a problem to leadership if it’s

16. too large for the problem solver to solve, and to point out
problems to others if they are outside the problem solver’s area
of responsibility. Problem solvers must take immediate actions
to contain and solve problems in their area of responsibility.
3. Apply structured,data-driven problem solving
process to solve problems.
Customer
Satisfaction
Contract review:
Changes
(Engineering,
specifications,
delivery schedule)
communication.
After sales services
and technical
supports.
Meet and exceed Customer
expectations.
Sales and Customer Services
are well verse of product
knowledge, common legal
sense. Product knowledge shall
include their quality
specifications and standards,
and regulatory requirements
(name of specification and
standard such as Industrial
standards,IEC, UL, VDE,
RoHS, FCC, legal restrictions
etc, but not the detailed
content).They should conclude
the quality requirements with
the customers at selling point
and take the lead to review the
contract before processing the
There is process to verify and take care of customer
requirements.
Sales, customer services are responsible for obtaining and
confirming specific quality requirements, including criteria
and standard,from customers. Company provides trainings to
them.
There is confirmed formal and written quality requirements
document for each business/sales contract / order. The
document is communicated to all relevant personneland
implemented in a Control Plan.
Quality personnel are responsible for conforming the products
that are shipped to customers are conformed to customer
requirements, industrial standards,and legal specifications.
Sales and customer services carry out detailed customer
satisfaction survey activities (visit, telephone,letter, email).
Publish and communicate to all employees.
How are customer perceptions captured on
a proactive basis?
Daily meeting to
follow up
progress on
customer
complaint and
recovery plan
progress and
completion.

17. orders. Contract review team
should include Sales,
Production, Design, Quality and
legal personnel. Their
confirmation of capability and
on time delivery is essential.
Response Customer feedback
Collect and analyze customer
satisfaction data.
Formulate improvement
strategy.
Communicate actions to
customers.
Install sufficient resource for
customer complaint. Take
serious and fast Response to
customer complaint.
There is strict customer complaint procedure with specific
response times, response format (such as 5D, 8D, CAR), and
response personnel.Customer quality services team
responsibilities are strictly defined.
The Quality Department shall organize the response to
customer complaint. There are personneland mechanism
monitors the progresses,actions follow up, validation of
actions effectiveness and closed records.
Lesson learns are shared broadly. Design teams (product and
process)are compulsory required to review the lesson learns.
Steps to execute the customercomplaint process in a way that
meets the customer’s reasonable exceptions andneeds, but does
not compromise the true resolution of the problem.
1. Know the details of how the product works in the
customer’s process and product. Know how thefailure
modes of the product affect thecustomer. For a given thing
that goes wrong with the process or product, what is the
How are customer perceptions captured on
a proactive basis?
How is data on customer satisfaction
analyzed?
How are opportunities identified and
prioritized?
What is the connection to the corrective
and preventive action system?
What are the organization’s long term
trends in customer satisfaction?
How are resources for customer
satisfaction identified and provided?
What connections exist between customer
satisfaction and the organization’s
objectives?
5D, 8D, CAR

18. exact effect on the customer?
2. React quickly to a customer notification. CQE should take a
customer notification of a problem as an alarm for the
organization. Containment should be a priority, with all
investigation started after containment is achieved.
3. Be sure to obtain as much detail from the customer as
possible. Make sure you listen to the customer for the
details of what is occurring. Makerequests for data,
samples, etc.
4. Develop a plan for theproblem-solving efforts and stick to
it. Be realistic with the customer on the time-frame that is
needed for a thorough investigation and resolution of the
problem. Once a plan is developed and agreed to, the timing
must be considered sacred.
5. Communicate with thecustomer regularly on thestatus of
the problem-solving efforts. Makesure the customer knows
exactly where you are in the problem-solving process.
Ensure that the customer understands all that is being done,
including verification of containment measures as the
process proceeds.
How are customer complaints
handled?
What is the largest complaint category?
What is being done about it?
How has the number of complaints changed
over time?
How are personnel trained to prevent
complaints?
How customers are made aware of actions on
their complaints?
What tools are used to identify the
causes of complaints?

19. Continuous
Improvement
LEAN approach to
eliminate wastes.
Re-engineering to
add values.
Improve sigma of
defectives.
Keep competitiveness
Keep in space with customer's
expectation growth by
upgrading products and
technology.
Product improvement -
1. Improve failed product to
prevent repeat failure.
2. Improve product to exceed
customer requirements.
Process improvement -
1. Improve process to prevent
producing poor quality.
2. Improve process to increase
profit margin.
Strengthen competitiveness by improving total quality.
Benchmarking with competitors all the time to keep an eye on
competitiveness. Publish and communicate strength and
weakness to all employees to make them know what are
needed to improve.
Regular periodical review on quality performance report and
identify improvement needs.Lesson learns are shared broadly.
Design teams (product and process)are compulsory required
to review the lesson learns.
Organize process owners into improvement team, equip them
with CI skills.
Improve product quality in two folds
1. Products failed to meet quality in field and in house
shall be examined and provide failure analysis, hence take
improvement action to prevent repeat problem.
2. Products are reviewed after launch to seek
opportunity of adding more values both to customer and the
company.
Improve process in two folds
1. Processes that identified to create quality problem
How do data trends get analyzed?
How do employees communicate their
improvement ideas?
How do preventive actions get recorded?
Are statistical techniques being used?
How are customer perceptions captured on
a proactive basis?
How does top management reviewthe
organization’s performance?
Who is involved in reviewing the
organization’s performance?
What actions have resulted from these
reviews?
How are records of the reviews generated?
Are all required inputs and outputs
addressed by records?
How does the rest of the organization
learn of actions and decisions that are
determined during reviews?
What evidence are seen to show continual
improvement?
Quality
Scorecard.
Fishbone
LEAN Sigma.

20. shall be re-engineered to prevent repeat problem.
2. Processes are reviewed after launch to look for room
to improve in yield and eliminate variations. Challenge but not
exceed process limits.

21. Risk Management
How to protect
company and
customer business
from risk of
operations breaking
down.
Recovery Plan
Prepare a recovery plan for
facing disasteror serious
accident that forces the
production down.
Back Up System
Prepare an emergency plan to include:
1. An emergency team list with full name and
emergency contact number. The General Managershall be
team leader. Functional managers are compulsory members.
Each member has kept a copy an emergency recovery
procedure.
2. Keep a back up copy of important documents outside
the site. The backup copy is updated every day if possible.
3. Prepare a back up production facilities list that an
alternative production location can be easily located.
4. There is employee evacuation plan for fire, power
failure, poison gas etc possible accident. Practice the plan
regularly.
5. There is trained emergency outbreak handling
volunteer team, such as fire fighting, first aid.
Ask to describe how to act upon an
accident happened in the plant.
Ask how many emergency evacuation
practices a year.
Verify documents backup and recovery
team information.
Photos and records of practices.
Periodical
practices plan.