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 -

There is clear Top Management Quality Commitment

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.

Statement.

Top executives present annual quality 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 their quality 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 <

Do thing right right the first time >.

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 personnel made aware of the

mission, values, and measurable

objectives of the organization?

How is the effectiveness of training

evaluated?

What happens when training is

Management self

model.

Training and

orientation to

employee.

Leadership role

in problem

solving culture.

Quality circle.

6S.

Quality tools box

trainings.

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.

ineffective?

What training records are maintained?

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 how their

jobs link to the larger mission of the organization. Measurable

objectives be established at relevant functions and levels. All

personnel must 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

promotion are linked to performance results.

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

about your job?

What is a resource that would help you be

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

review.

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?

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 System to

define the authority,

responsibility, execution,

control, monitoring,

maintenance, change, review,

upgrading and improvement of

the QMS.

Execution of procedures.

Functional departments commit

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.

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

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

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.

deviations.

Regular periodical Management Reviews

Managers take the lead to track company and departmental

KPI performance trend, and take actions for under

performance.

General Manager is 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

product quality.

Process owner

product (materials,

WIP, finished goods)

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

use;

Statutory and legal

requirements; and

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

procedure with clear steps and approval gates

Apply Product design tools in product design as appropriated :

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?

What happens when changes are made to

product requirements?

Product development file and record must

Electronic

approval system.

Qualification

system.

knowledge and

quality criteria.

Additional requirements

determined by the

organization.

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. Approval gates

must be signed off and closed based on test data and results.

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/or tools are

in place to facilitate

achievement of objectives and

prevent mistakes. Eliminate the

wastes.

Define Yield Rate (quantity

and/or time) at logical and

financial affordable level.

Process Qualification

Each and all process steps shall be 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;

4. Method – SOE / WI / VA;

5. Measurement System Analysis – G R & R

Production FAI, LAI record.

Improvement actions, projects.

Training records.

Control Plan available.

WI

Control data, graph, chart.

Yield records.

QC records.

Repair records.

IPQA

SPC

6S

Mechanism to stop the

processes at doubtful quality.

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 system to 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.

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.

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.

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 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.

Periodical review materials on

quality, price and

improvement / new versions.

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.

Carry out periodical reliability test to ensure variation is

within control.

Reliability test.

Incoming

material quality

assurance

method -COC

sampling,

supplier test

reports.

In-process Quality Assurance

Have a reliable in-process

quality assurance (IPQA) plant

and team.

Strictly follow process

disciplines.

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.

In-process audit records, data, samples.

Statistics of acceptance and reject records

of finished products.

FA reports and CAR and result records.

IPQA/IPQC

FAI, LAI

WI

SOE

Quality samples.

Updated WI.

Tailor made SPC tools to

monitor and check the

production variations.

Minimize the possibility of

defected products reaching the

customers.

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.

control plan, FAI record, prints, Trained

operators.

SPC

MSA

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. A check 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 Handle nonconforming Ask employee how they to control non- Physical and

Control nonconforming

materials including supplies,

WIP, stocks, customer returns to

prevent pollution to clean

materials.

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

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

conformance.

Ask employee how they can trace the

material with lot number.

Disposition records.

Nonconforming data collection and

analysis records.

Improvement records.

Book quarantine

system.

Monitor quality

costs trend chart.

Logical and

meaningful part

numbering and

lot numbering

system.

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.

Regulatory Compliance There is responsible person and mechanism to ensure legal

requirements, regulatory rules and restrictions, industrial

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.

Verify compliance certificate, approval

documents, test reports.

Specialist

overseeing this

area.

Compliant

reference table

Quality Problem prevention

& Solving

Prevent quality problem

happened rather than discover

quality problem by inspection.

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

Maintenance program and records.

Calibration plan and proof records.

LEAN

6 Sigma

7 QC tools.

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 system and

personnel responsible for

problem solving process.: locate

problem owner and problem

solver, monitoring progresses,

ensure corrective actions are

taken, validate effectiveness of

actions before confirming

problem solved.

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.

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

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 your services and goods

and buy more over time?

Problem solving

training and CI

process training

to employee.

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

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

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.

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

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 personnel and

How are customer perceptions captured on

a proactive basis?

Daily meeting to

follow up

progress on

customer

complaint and

recovery plan

progress and

completion.

After sales services

and technical

supports.

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

orders. Contract review team

should include Sales,

Production, Design, Quality and

legal personnel. Their

confirmation of capability and

on time delivery is essential.

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.

Response Customer feedback

Collect and analyze customer

satisfaction data.

Formulate improvement

strategy.

Communicate actions to

customers.

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 personnel and mechanism

monitors the progresses, actions follow up, validation of

actions effectiveness and closed records.

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?

5D, 8D, CAR

Install sufficient resource for

customer complaint. Take

serious and fast Response to

customer complaint.

Lesson learns are shared broadly. Design teams (product and

process) are compulsory required to review the lesson learns.

Steps to execute the customer complaint process in a way that

meets the customer’s reasonable exceptions and needs, 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 the failure

modes of the product affect the customer. For a given thing

that goes wrong with the process or product, what is the

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. Make requests for data,

samples, etc.

4. Develop a plan for the problem-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 the customer regularly on the status of

the problem-solving efforts. Make sure 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

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?

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?

process proceeds.

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 review the

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

Quality

Scorecard.

Fishbone

LEAN Sigma.

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.

improvement?

Risk Management

How to protect

company and

customer business

from risk of

operations breaking

down.

Recovery Plan

Prepare a recovery plan for

facing disaster or 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 Manager shall 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.