Total Quality Management + Quality Management System + ISO

Define quality
the sum total of all characteristics of a product or service that contributes to its superiority and excellence
Define TQM
Total Quality Management
– a management approach of an organization
-centered on quality
-based on the participation of its members and aiming at long-term profitability through customer satisfaction
-thus, benefits to the members of the organization and to society

– if done properly, can reduce cost of compliance activities

Define QM
Quality management
all activities of overall management function that determine quality policy, objectives and responsibilities and implement them by QC, QA, QP, and QI
Define QC
Quality control
operational techniques and activities used to fulfill requirements for quality
Define QA
Quality Assurance
all the planned and systematic actions to be implemented, and demonstrated as needed, necessary to provide adequate confidence that an entity will satisfy given requirements for quality
Define QP
Quality Planning
establishing and developing objectives and requirements for quality and the requirements for the quality system application
Define QS
Quality System
the organizational structure, responsibilities, procedures, processes and resources for implementing quality management
Define QI
Quality Improvements
the actions taken to increase the value to the customer by improving the effectiveness and efficiency of processes and activities throughout the quality loop
Define ISO
International Organization for Standardization
– developed to meet the need for a universally recognized set of quality standards to facilitate the international trade of goods and services
Who are people who have developed a number of philosophies and methodologies for the implementation of TQM system?
What are some gains with employing a TQM system?
reduced: costs of operation (burn rate), scrap and waste

Improved: control of operation, predictability and reliability (meeting milestones), efficiency and productivity, pride and confidence

What are 2 fundamental quality concerns of every organization?
1. Which method should be used to implement, maintain, and continuously improve quality?

2. Having achieved quality, how do companies communicate this information to their customers/clients? (e.g. recognizable logo, ISO registration)

why is it difficult to achieve high quality?
1. usually after the damage is done
2. costly to spend resources (discover, correct, redoing)
3. no guarantee that its error free

Thus must PREVENT rather than APPRAISE.

Who cares about quality for a typical biotech company?
board of directors
senior management
stock option holders
corporate partners
material/serivece providers
regulatory boards (HPB, FDA, EU)
health professionals, patients, public
What is the ISO 9000 system?
A quality management system
What are the main elements of a quality management system?
management responsibilities
policies, plans, systems
procedures and processes
tools and methodologies
What is the 7 step TQM model aka The Puri Approach? (see notes for details)
1. management attitudes (structure/people)
2. suppliers and customers
3. processes within organization
4. plan to improve process (policies, measure statistically)
5. identify parts of system needing improvement
6. standard procedures for identity
7. repeat cycle
what is PONQ?
price of non-quality
– the cost of doing things wrong or of poor quality

e.g. accident, waste of efforts, failure analysis and reporting, fines and penalties, lawsuits, system failures/computer downtime, unplanned maintenance

Traditional vs Modern approach to quality?
– relies on QC, process control, QA of final product and after-sales services

– focus beyond product and services, want quality in any processes related to it (e.g. work environment, employee involvement, pride, reputation, etc.)

What are some restraining forces for implementing a process change?
– lack of training
– pressure to increase output
– poor communication
– lack of management commitment
– affinity for traditional methods (no change)
– apathy/lack of motivation
– lack of creativity/innovation
– intragroup competition/personality conflicts
– skepticism
– lack of time for education/meetings
What are some driving forces for implementing a process change?
– documented procedures
– process flow charts/good planning
– improved technology
– simplified methods
– improved resources (better raw materials)
– team approach/regular meetings
– competition
– management pressure
– personal responsibility
– successful applications of TQM elsewhere
Define QMS
quality management system
– a system that an organization follows (either a self-directed or previously established one) to bring the company under the umbrella of TQM
what are the 10 commendments of TQM that QMS should follow?
1. total management commitment
2. obsession with excellence
3. constancy of purpose
4. customer-driven organization
5. supplier partnering
6. employee involvement/empowerment
7. recognition and incentive
8. disciplined methodology
9. continuous learning
10. continuous improvement
What are other approaches for quality system standards?
Crosby Approach (14 step)
Puri Approach (7 step TQM)
Deming Approach (14 step)
Juran Approach (3 component)
what are the 3 tiers of a quality system?
1. The quality manual – why
2. The quality procedure – what where when who
3. Work instructions and records – how
Define ISO
international organization for standardization
– international, accredited non-government
– develop standards for organizations to follow
– requires that it must be implemented in all areas/processes that can affect quality to products and services of organization (not directly concerned with results)
What is the ISO-9000?
QM and QA standards and guidelines for selection and use (quality management)
– what company does for the management of processes that influence quality
What is the ISO-9001?
QS – design/development, production, installation, servicing (must meet the 20 element standard)

e.g. engineer and construction firms

What is the ISO-14000?
ISO quality standards primarily with environment management
– what company does to minimize harmful effects on the environment cause by its activities
define audit
an official inspection of an organization
– performed for the benefits of the auditee’s customers
define registrar
a private and independent organization that is competent in the audit process and the auditee’s field of activity
define (registration) certification
a certification upon successful completion of an audit that states that the auditee is in compliance to a quality standard
How does registration of a product or service benefit the customers and suppliers?
– product can be sourced from around the world and its quality assured (e.g. recognize a logo indicating registration to ISO
What does generic mean in accordance to ISO?
the same set of standards can be applicable to..
– any organization
– any product/service
– any sector of activity
– any type of organization (business, government..)
Define SAGE
strategic advisory group on the environment
– created by ISO, assess need for international environmental management standards
what are the 8 quality management principles
1. customer focus
2. leadership
3. involvement of people
4. process approach
5. system approach to management
6. continual improvement
7. factual approach to decision making
8. mutually beneficial supplier relationships
What are the aspects of EMS strategies ?
1 Environmental policy
2 Environmental aspects
3 legal and other requirements
4 objectives and targets
5 environmental management program
6 structure and responsibility
7 training, awareness and competence
8 communication
9 EMS documentation
10 document control
11 operational control
12 emergency preparedness and response – contingency planning
13 monitoring and measurement
14 nonconformance and corrective and preventive action
15 records
16 EMS audit
17 management review
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