QM-c2 - Models and Framework in Quality Management - Handout

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QUALITY MANAGEMENT:

Dr Le Thai Phong

Foreign Trade University

T: 0975.055.299

E:[email protected]

Chapter 1: Quality Management:

Foundation

QUALITY MANAGEMENT

AND PRODUCTIVITY

Dr Lê Thái Phong

Vice Dean

Faculty of Business Administration

T: 0975.055.299

E: [email protected]

QUALITY MANAGEMENT:

Dr Le Thai Phong

Foreign Trade University

T: 0975.055.299

E:[email protected]

Chapter 1: Quality Management:

Foundation

Chapter 2:

Quality: Models and

frameworks

Dr Lê Thái Phong

Vice Dean

Faculty of Business Administration

T: 0975.055.299

E: [email protected]

Contents

• 1. Early quality management framework

• 2. Deming Prize

• 3. Malcolm Badridge

• 4. Eupean Union Prize

• Cost of quality

• 2. Waste

• 3. Q – Base system

• 4. GMP

• 5. HACCP

• Others

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Early quality management framework


• 1 Create constancy of purpose towards improvement of product and service.

• 2 Adopt the new philosophy. We can no longer live with commonly accepted levels of delays, mistakes, defective workmanship.

• 3 Cease dependence on mass inspection. Require instead statistical evidence that quality is built in.

• 4 End the practice of awarding business on the basis of price tag.

• 5 Find problems. It is management’s job to work continually on the system.


• 6 Institute modern methods of training on the job.

• 7 Institute modern methods of supervision of production workers. The responsibility of foremen must be changed from numbers to quality.

• 8 Drive out fear, so that everyone may work effectively for the company.

• 9 Break down barriers between departments.

• 10 Eliminate numerical goals, posters, and slogans for the workforce asking for new levels of productivity without providing methods.

• 11 Eliminate work standards that prescribe numerical quotas.

• 12 Remove barriers that stand between the hourly worker and his right to pride of workmanship.

• 13 Institute a vigorous program of education and retraining.

• 14 Create a structure in top management that will push every day on the above 13 points.

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Juran

1904-2008


• 1 Build awareness of the need and opportunity for improvement.

• 2 Set goals for improvement.

• 3 Organize to reach the goals (establish a quality council, identify problems, select projects, appoint teams, designate facilitators).

• 4 Provide training.

• 5 Carry out projects to solve problems.

• 6 Report progress.

• 7 Give recognition.

• 8 Communicate results.

• 9 Keep score.

• 10 Maintain momentum by making annual improvement part of the regular systems and processes of the company.


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• Four absolutes:

• Definition – conformance to requirements.

• System – prevention.

• Performance standard – zero defects.

• Measurement – price of non-conformance


• 1 Make it clear that management is committed to quality.

• 2 Form quality improvement teams with representatives from each department.

• 3 Determine where current and potential quality problems lie.

• 4 Evaluate the cost of quality and explain its use as a management tool.

• 5 Raise the quality awareness and personal concern of all employees.

• 6 Take actions to correct problems identified through previous steps.


• 7 Establish a committee for the zero defects program.

• 8 Train supervisors to actively carry out their part of the quality

• improvement program.

• 9 Hold a ‘zero defects day’ to let all employees realize that there has been a change.

• 10 Encourage individuals to establish improvement goals for them-selves and their groups.

• 11 Encourage employees to communicate to management the obstacles they face in attaining their improvement goals.

• 12 Recognize and appreciate those who participate.

• 13 Establish quality councils to communicate on a regular basis.

• 14 Do it all over again to emphasize that the quality improvement program never ends.

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Quality award models: Deming Prize

• 1950: the Union of Japanese Scientists and

Engineers (JUSE) instituted the prize for

‘contributions to quality and dependability of

product’.

Quality award models: Deming prize


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Quality award models: the Malcolm

Baldrige National Quality Award

• 1980s in USA, aiming at:

• Help improve organizational performance

practices, capabilities and results;

• Facilitate communication and sharing of best

practices information;

• Serve as a working tool for understanding and

managing performance and for guiding,

planning and opportunities for learning

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Quality award models: the Malcolm

Baldrige National Quality Award

Quality award models: European

• Early 1990s: the launch of the European

Quality Award by the European Foundation

for Quality Management (EFQM)

Quality Award Models: European

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Quality Award Models: European

Quality model: 4Ps + 3Cs


• Planning– the development and deployment of policies and strategies; setting up appropriate partnerships and resources; and designing in quality.

• Performance– establishing a performance measure framework – a ‘balanced scorecard’ for the organization; carrying out self-assessment, audits, reviews and benchmarking.

• Processes– understanding, management, design and redesign; quality management systems; continuous improvement.

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• These four Ps: ‘hard management necessities’

Three Cs of Culture, Communication, and

Commitment: ‘soft outcomes’ of the model

Cost of quality

• Cost of quality = cost of control (cost of

conformance) + cost of failure of control (cost

of non-conformance)

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Cost of quality

Cost of quality

Failure cost

• 5R

• Reject

• Rework

• Recall

• Return

• Regret

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Waste

• Wasting:

PDCA cycle

• It is 4 step methodology for business process improvement

• It is an iterative process – so repeat to continue achieving improvement

Plan Establish objectives and how they will be achieve

Do Put the plan into effect

Check Verify that the process achieved the desired results

Action Analyse any differences and their causes

Take action to improve things

PDCA cycle

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Planning stage

• Set up

Planning stage

• Set up

Document system

(Procedure, regulations…)

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Q-Base system

• For SME with lack of resources to implement

fully ISO 9001, Telarc Q-Base provides an

excellent alternative.

Q-Base Code is based upon the ISO 9001.

• It enables you to implement basic

management disciplines to assure quality of

products and services.

Q-Base system

• < 10 employees

• Rarely employ staff who are quality management professionals.

• Are managed by the owner who has a strong hands-on role and spends after-hours on paperwork.

• Work on low profit margins

• Rarely have a documented system and procedures manual.

Q-Base system: clauses

1. Management of the quality system

2. Control of documents and records

3. Customers' needs

4. Purchasing

5. Training and work instructions

6. Inspecting and control of substandard work

7. Continual Improvements

8. Association, Industry or other criteria

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GMP:

Good Manufacturing Practice

• GMP ensures that quality is built into the organization & processes involved in manufacture

• GMP covers all aspects of manufacture including collection, transportation, processing, storage, QC & delivery of the finished product

GMPGMPGMPGMP

• Part of QA which ensures that products are consistently produced & controlled to the quality standards appropriate to their use.

• GMP is an integral part of QA.

GMP

• GMP in solid dosage forms

• GMP in semisolid dosage forms

• GMP in Liquid orals

• GMP in Parenterals Production

• GMP in Ayurvedic medicines

• GMP in Biotechnological products

• GMP in Nutraceuticals & cosmeceuticals

• GMP in Homeopathic medicines

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GMP

• Good Manufacturing Practice

• Good Management Practice

• Get More Profit

• Give more Production

• GMP Training with out tears

Ten Principles of GMP

1. Design & construct the facilities & equipments properly

2. Follow written procedures & Instructions

3. Document work

4. Validate work

5. Monitor facilities & equipment

6. Write step by step operating procedures & work on instructions

7. Design, develop & demonstrate job competence

8. Protect against contamination

9. Control components & product related processes

10. Conduct planned & periodic audits

Beyond GMP

• Reduce pollution -� Zero discharge

• Adaptation of environment friendly methods

• Consideration for better & healthier life

tomorrow

• Consideration of ethics in life

• One should begin with end in mind otherwise it

will be the beginning of the end

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PERSONNEL

• Adequate staff with relevant knowledge, experience and capabilities in assigned task

a. Production and QC are headed by different persons, neither of whom shall be responsible to the other

b. Responsibilities and authority of key personnel are clearly defined

c. Training on the understanding of procedures, work instruction, GMP principles, etc.

3 Key Personnel

• The head of production

• The head of QC

• The head of QM (QA)

The head of QM (QA)

• The head of QM (QA) should be a qualified

pharmacist, have adequate training & practical

experiences which enable him/her to perform

him/her function personally.

• The head of QM (QA) should given full authority &

responsibility in all quality system/assurance duties.

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PREMISES

Specify the requirements of location, design , constructions and maintenance of manufacturing premises with respect to the following:

a. prevention of contamination from surrounding environment and pests

b. prevention of mix up of materials and products

c. facilities such as toilet, changing rooms, sampling areas and QC lab

d. defined areas for certain activities

e. wall, ceiling, drains , air intake and exhaust, lighting and ventilation, pipe work and light fitting

f. storage areas

• Suitable location, design , constructions and

maintenance for manufacturing premises :

– defined areas for certain activities (e.g material

sampling & dispensing)

– wall, ceiling, drains , air intake and exhaust,

lighting and ventilation, pipe work and light fitting

– storage areas of adequate space

– Physical separation of toilets and QC lab from

production

PREMISES

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Building & facilities

1. Design and construction features.2. Lighting.3. Ventilation, air filtration, air heating and cooling.4. Plumbing.5. Sewage and refuse. 6. Washing and toilet facilities. 7. Sanitation.8. Maintenance.

Paint Finish…

• Not only building

paintwork must be

considered but also

equipment

Building Finishes

Not Acceptable AcceptablePVA Paint � Epoxy or Enamel paint ☺

Window sills � Flush glazed windows ☺

Exposed pipes � Smooth surfaces ☺

Horizontal pipes & services � Concealed services ☺

Open floor drains � Hygienic drains ☺

Floor cracks, flaking floor surfaces �

Homogonous sealed floors –epoxy finish or welded vinyl ☺

Ceiling cracks & joints � Smooth sealed ceilings ☺

Exposed, open light fittings � Flush light fittings ☺

Wooden furniture � S/Steel or Melamine furniture ☺

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Poor & Good Windows

HACCP

• In the early 1960s, food scientists at Pillsbury, in

collaboration with NASA scientists realized that

traditional food safety methods – testing and analysis

- would be inadequate to guarantee food quality in

space.

• Taking strategy from munitions makers, they were

asked to identify certain “critical failure areas” and

eliminate them from the system.

What is HACCP?

• NASA had already mandated the use of “Critical

Control Points” in their engineering management, so

Pillsbury adopted it for food.

• In 1971 and 1972 there were numerous incidents of

botulism poisoning from commercially canned foods

in the US.

– The US Government asked Pillsbury to train its inspectors

and help with a new food safety program based on

Pillsbury’s NASA experience, which eventually became

HACCP.

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What is HACCP?

• “Hazard Analysis and Critical Control Points”.

• This program is often cited as a very successful

collaboration between industry and

government.

• The initial HACCP system was based on three

principles:

– 1. Conduct a hazard analysis.

– 2. Determine critical control points.

– 3. Establish monitoring procedures.

• Based on its experience, Pillsbury quickly

adopted two additional principles:

– Establish corrective actions to take when

deviations occur at a CCP.

– Establish critical limits to be enforced at CCPs.

The first HACCP foods

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HACCP Today

1. Conduct a hazard analysis.

2. Determine the CCPs.

3. Establish critical limit(s).

4. Establish a system to monitor control of the CCPs.

5. Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.

6. Establish procedures for verification to confirm that the HACCP system is working effectively.

7. Establish documentation concerning all procedures and records appropriate to these principles and their application.

HACCP Today

• Used in all types of manufacturing, not simply food or beverages.

• Adopted by brewers in the early 1990s.

Other models

• 6 sigma

• JIT – Just in Time

• Benchmarking

• SA 8000

• TQM

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6 sigma

6 sigma

6 sigma

• 68.26% of the population within 1 standard

deviation around the mean


deviations around the mean


deviations around the mean

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6 sigma in different industries

0,01

0,1

1

10

100

1000

10000

100000

1000000DPMO(defectspermillionopportunities)

2σ 3σ 4σ 5σ 6σ 7σ

Best-in-class

Airlines baggagecheck in

Restaurant bills

Lufthansa (6,6σ)

Quantas, SAS

Air India(5,8)Egypt Air (5,8σ)

Source: Motorola, Air Safety Online

6 sigma in different industries

0,01

0,1

1

10

100

1000

10000

100000

1000000DPMO(defectspermillionopportunities)

2σ 3σ 4σ 5σ 6σ 7σ

Best-in-class

Airlines baggagecheck in

Restaurant bills

Lufthansa (6,6σ)

Quantas, SAS

Air India(5,8)Egypt Air (5,8σ)

Source: Motorola, Air Safety Online

The quality mantra

“Quality can not be tested into

products; it has to be built in by

design”

Documents

QM-c2 - Models and Framework in Quality Management - Handout