Total Quality Management : A Promising Fixation To Accomplish Zero Defects

When developing and implementing new quality systems, reviews should take place more frequently rather than when the system has matured. Outside of scheduled reviews, the quality system should typically be included as a standing agenda item in general management meetings. In addition, a periodic review performed by a qualified source, external to the organization, may also be useful in assessing the suitability and effectiveness of the system.

Review outcomes typically include:--

• Improvements to the quality system and related quality processes
• Improvements to manufacturing processes and products
• Realignment of resources

 

Under a quality system, the results of a management review would typically be recorded. Planned actions should be implemented using effective corrective and preventive action and change control procedures.

Quality Management in Pharmaceutical Industry:-

Quality management plays a key role in the pharmaceutical industry. To ensure that products are safe and effective, manufacturing processes are subject to strict legal conditions. National and international authorities constantly monitor the manufacturers' adherence to regulations. The directives and procedural instructions for validation require companies in the industry to document the entire logistics chain in full - from goods inwards to delivery, and from the development of new preparations to the maintenance of mixers and packaging lines. Because the pharmaceutical industry has traditionally focused upon the application of Good Manufacturing Practice (GMP), it has been slow to consider the potential benefits to be gained by implementing an EN ISO 9001 Quality Management System (QMS).

Over the last few years the global pharmaceutical market has undergone significant change, forcing pharmaceutical companies, more than ever before, to focus on customer needs and upon their own internal efficiency in order to continue to compete effectively.
Keeping this in mind CEFIC commissioned, a working group of experts drawn from several major Active Pharmaceutical Ingredients (API) producers to prepare a practical, user-friendly guidance document integrating current GMP requirements into the EN-ISO 9001 QMS framework. To achieve this the working group have taken relevant features from the August 1996 CEFIC/EFPIA publication “Good Manufacturing Practice for Active Ingredients Manufacturers“ and combined these with the relevant complementary requirements of EN-ISO 9001 “Quality Systems: Model for quality assurance in design, development, production, Installation and servicing“. It is intended that these Guidelines are applicable to all APIs. However, in the case of a sterile API, the Guidelines should be applied at least to the point at which the API enters a sterilizing process. To facilitate understanding of this composite guidance document it is important for the reader to be aware of the following points:

EN-ISO 9001 is a generic, business focused, standard which supports the effective management of quality to an internationally recognized level of best practice. It is flexible in that it specifies what is to be achieved, but allows each company freedom to determine, and justify, how these requirements are achieved. In contrast, GMP is an industry-specific standard prescribing what must be done to ensure product safety and efficacy. Thus, EN-ISO 9001 benefits the business by ensuring the quality of the management system, while GMP ensures that regulatory requirements are met.

Although there is inevitably some overlap between the requirements of a QMS and GMP they are, in fact, highly complementary. This view is supported by a statement in the introduction to the PIC (International Inspection Convention) GMP Guideline which refers to “....... a correctly implemented system of Quality Assurance incorporating GMP .......“, and by the wording of the introduction in ISO itself which points out that “....... this international standard is complementary - not alternative - to the technical (product) specified requirements“.

The interrelationship between EN-ISO 9001 and API GMP was described as the main QMS elements and GMP requirements.

Quality Management System - integrating GMP into ISO

To be effective the QMS should have the visible and ongoing support of top management.

To take full benefit for company the QMS should involve all staff whose activities influence quality, have a clear and unambiguous continuous improvement focus, and incorporate relevant, realistic performance measures with emphasis on reducing failure costs, and satisfying (internal and external) customer needs.

The quality manual occupies the highest level in the document hierarchy. It overviews and acts as a directory to the QMS, capturing the unique character of the company.

An effective QMS has a minimum of paperwork, and should constantly question the need for the existing documents. In contrast, a bureaucratic and inefficient QMS will arise if the Standard is misinterpreted, and incorrectly applied.

Principle

The Quality system - in the form of organizational structure, procedures, processes and resources needed to implement the quality policy - should be described in a quality manual. The quality manual should cover relevant EN ISO 9001 and GMP requirements describe the documentation hierarchy and indicate how the quality system is managed.

The need for quality planning is an important feature of the QMS. It requires that adequate consideration is given to an activity before implementation, thereby reducing the risk and cost of failure.

Quality manual

The quality manual is the master quality document and, as such, should provide an Outline of, and directory to, the quality system. It should cover relevant ISO 9001 and GMP quality management requirements
The quality manual should be positioned at the head of the documentation hierarchy, and be supported by other document groups such as policies, Guidelines, procedures (such as Standard Operating Procedures) etc.
The quality manual should be used as a basis for auditing the performance of the QMS.
The quality manual should be written in a clear, concise and user-friendly style since it will be read, and needs to be understood, by all grades of staff. It should also be open to inspection by external auditors and (possibly) by customers.
Quality system procedures
The quality system should ensure that all quality related activities are documented and carried out in a systematic and approved manner.
Duplication of content between documented procedures (e.g. operating procedures versus training modules) should be avoided in order to minimize the risk of documentation overload.
Procedures should, where appropriate, address control of the horizontal (cross functional) communication interfaces as well as vertical communication in the Organization. Quality planning
Activities related to quality should be systematically planned, and the plan should be well documented. This will help to ensure consistency of performance and provide greater confidence that the outcome will be satisfactory. The quality manual is the overall plan for the QMS. Each policy, procedure etc. within the QMS is a form of quality plan supporting the achievement of short and long term objectives. Some examples of activities whose implementation should be preceded by a quality plan are as follows:

 

Problems to adopt Total Quality Management

 

In order to facilitate decision making about adoption of TQM and to access the organizational position along the preparedness continuum there are some factors which can come in the boulevard of implementation.
Bellow mentioning are the some points which may create hindrance while adopting Total Quality Management. It is hypnotized here that the decision to adopt TQM for the ultimate objective of customer satisfaction is influenced by the following variables:-

A. Organizational factors:-

1. Structure of organization
2. Centralization
3. Formalization.
4. Integration.
5. Strategic planning.
6. Implementation planning.
7. Infrastructure.

B. Policy factors:-

a. Environmental policy.
i. Firm’s technology policy.
ii. Customer interaction.
iii. Competitor scanning.
b. Organization orientation.
i. Goals and Strategy of functional department.
ii. Management risk position.

C. Environment factors:-

a. Technical environment.
b. Social environment.
c. Economic environment.
d. Legal/Political environment.

D. Support factors:-

a. Individual employee support.
b. Top management support.

Barricade in execute TQM

1) Lack of understanding of the TQM concept.
2) Absence of visible support from senior and top management.
3) Fear of change. scepticism in the minds of management that TQM will reveal their deficiencies and dilute their authority & importance.
4) Many layers of existing organization structure.
5) Poor internal communication.
6) Heavy workloads.
7) Nature of organization .
8) Lack of adequate education and training:
9) Limited resources
10) Irregularity of the meetings
11) Delay in implementation of the recommendation of QIT’s.
12) Measurement difficulties.

1. Lack of understanding of the TQM concept:

? The top and senior executives should develop full understanding, conviction and faith in the concept and should be committed to extend whole hearted support.
? The training programs at the beginning and also periodically, as well as continuous stress on benefits to the organization and individual help developing loyal and committed work force to the cause of TQM.

2. Absence of visible support from senior and top management:-

? The management should make sincere efforts to let know their commitment by way of frequent visits to quality improvement team’s meeting and story sessions.
? They should have informal talks with the members of QIT’s. Providing facilities, resources, finance for TQM activities and attending presentation and participating in steering committee meeting will make the commitment visible.

3. Fear of change. Scepticism in the minds of management that TQM will reveal their deficiencies and dilute their authority & importance-

? These misconceptions need to the eradicated by being advised by the top management suitably.
? In fact, successful implementation of TQM would result in better opportunities and harmonious relations.
? More exposures to the concept of TQM would help people to appreciate the gain of TQM.

4. Many layers of existing organization structure –

? TQM requires a flat organizational structure with large span control. A change in organizational structure to meet this is required.

5. Poor internal communication –

? Exchange of ideas, by participation of members of different departments in QIT’s.
? Periodic visit of one department employees to another.
? Seminars, group discussions, news letters expressing the view.
? Breaking the barriers to communications.

6. Heavy workloads-

? TQM does not require any extra time and effort on the part of management. A conscious expression of interest in day to day work is sufficient.

7. Nature of organization

? TQM is a philosophy and suits any organization. Committed, continuous, conscious efforts towards customer’s satisfaction need to be the way of life.

8. Lack of adequate education and training:-

? Provide education about TQM.
? Organize regular training programs.
? Emphasize on “Learning to learn”

9. Limited resources:-

? Get experts from outside to train and educate senior and top management.
? Develop internal training mechanisiom
? Develop commitment, bring about a cultural change, resources will follow suit.

10. Irregularity of the meetings:-

? Holding of steering committee and QIT’s meeting on specified time and day should be ensured by the management.
? Use committed work leaders.

11. Delay in implementation of the recommendation of QIT’s.

? Implements suggestion immediately
? If not possible, communicate.

12. Measurement difficulties:-

? Set objectives and standards in verifiable mode.
? Use standard questionnaire.
? Carry out periodic survey,

Total Quality Management

Total Quality Management is a management approach that originated in the 1950's and has steadily become more popular since the early 1980's. Total Quality is a description of the culture, attitude and organization of a company that strives to provide customers with products and services that satisfy their needs. The culture requires quality in all aspects of the company's operations, with processes being done right the first time and defects and waste eradicated from operations
TQM (Total Quality Management) is the management of total quality. We know that management consists of planning, organizing, directing, control, and assurance. Then, one has to define "total quality". Total quality is called total because it consists of 3 qualities:
? Quality of return to satisfy the needs of the shareholders,
? Quality of products and services to satisfy some specific needs of the consumer (end customer)
? Quality of life - at work and outside work - to satisfy the needs of the people in the organization.
This is achieved with the help of upstream and downstream partners of the enterprise. To this, we have to add the corporate citizenship, i.e. the social, technological, economical, political, and ecological (STEPE) responsibility of the enterprise concerning its internal (its people) and external (upstream and downstream) partners, and community. Therefore, Total quality management goes well beyond satisfying the customer, or merely offering quality products (goods and/or services). Note that we use the term consumer or end customer.
The reason is that in a Supply Chain Management approach, we don't have to satisfy our customers' needs but the needs of our customers' all the way to the end customer, the consumer of a product and/or service. By applying this definition an enterprise achieves Business Excellence, as suggested by the Malcolm Baldrige (American) and the EFQM (European) Performance Excellence Models. To do that, one has to go well beyond ISO 9000 Standards series as suggested by these standards (ISO 9001, then ISO 9004, then Total Quality).
Total Quality Management, TQM, is a method by which management and employees can become involved in the continuous improvement of the production of goods and services.

A model for organization management

It is a combination of quality and management tools aimed at increasing business and reducing losses due to wasteful practices.

Some of the companies who have implemented TQM include Ford Motor Company, Phillips Semiconductor, SGL Carbon, Motorola and Toyota Motor Company.

Frame work for improving service quality

TQM is a management philosophy that seeks to integrate all organizational functions (marketing, finance, design, engineering, and production, customer service, etc.) to focus on meeting customer needs and organizational objectives.

TQM views an organization as a collection of processes. It maintains that organizations must strive to continuously improve these processes by incorporating the knowledge and experiences of workers. The simple objective of TQM is "Do the right things, right the first time, every time".

TQM is infinitely variable and adaptable. Although originally applied to manufacturing operations, and for a number of years only used in that area, TQM is now becoming recognized as a generic management tool, just as applicable in service and public sector organizations. There are a number of evolutionary strands, with different sectors creating their own versions from the common ancestor. TQM is the foundation for activities, which include:

ü Commitment by senior management and all employees

ü Meeting customer requirements

ü Reducing development cycle times

ü Just In Time/Demand Flow Manufacturing

ü Improvement teams

ü Reducing product and service costs

ü Systems to facilitate improvement

ü Line Management ownership

ü Employee involvement and empowerment

ü Recognition and celebration

ü Challenging quantified goals and benchmarking

ü Focus on processes / improvement plans

ü Specific incorporation in strategic planning

This shows that TQM must be practiced in all activities, by all personnel, in Manufacturing, Marketing, Engineering, R&D, Sales, Purchasing, HR, etc.

Objective of TQM:-

The classic observation of quality is the position of a product attribute on a good-bad scale.

From the TQM standpoint, quality is the whole thing that an organization does in the eyes of its customers, which will give confidence them to look upon that organization as one of the preeminent in its meticulous field of operation.

The Four Pillars of TQM

Principles of TQM

The key principles of TQM are as following:-

Ø Management Commitment

v Plan (drive, direct)

v Do (deploy, support, participate)

v Check (review)

v Act (recognize, communicate, revise)

Ø Employee Empowerment

v Training

v Suggestion scheme

v Measurement and recognition

v Excellence teams

Ø Fact Based Decision Making

v SPC (statistical process control)

v DOE, FMEA

v The 7 statistical tools

Ø ``Continuous Improvement

v Systematic measurement and focus on CONQ

v Excellence teams

v Cross-functional process management

v Attain, maintain, improve standards

Ø Customer Focus

v Supplier partnership

v Service relationship with internal customers

v Never compromise quality

v Customer driven standards

The Concept of Continuous Improvement by TQM

TQM is mainly concerned with continuous improvement in all work, from high level strategic planning and decision-making, to detailed execution of work elements on the shop floor. It stems from the belief that mistakes can be avoided and defects can be prevented. It leads to continuously improving results, in all aspects of work, as a result of continuously improving capabilities, people, processes, and technology and machine capabilities.

Continuous improvement must deal not only with improving results, but more importantly with improving capabilities to produce better results in the future. The five major areas of focus for capability improvement are demand generation, supply generation, technology, operations and people capability.

A central principle of TQM is that mistakes may be made by people, but most of them are caused, or at least permitted, by faulty systems and processes. This means that the root cause of such mistakes can be identified and eliminated, and repetition can be prevented by changing the process.

There are three major mechanisms of prevention:

1. Preventing mistakes (defects) from occurring (Mistake - proofing or Poka-Yoke).
2. Where mistakes can't be absolutely prevented, detecting them early to prevent them being passed down the value added chain (Inspection at source or by the next operation).
3. Where mistakes reoccur, stopping production until the process can be corrected, to prevent the production of more defects. (Stop in time).

Implementation Principles and Processes

A preliminary step in TQM implementation is to assess the organization's current reality. Relevant preconditions have to do with the organization's history, its current needs, precipitating events leading to TQM, and the existing employee quality of working life. If the current reality does not include important preconditions, TQM implementation should be delayed until the organization is in a state in which TQM is likely to succeed.

If an organization has a track record of effective responsiveness to the environment, and if it has been able to successfully change the way it operates when needed, TQM will be easier to implement. If an organization has been historically reactive and has no skill at improving its operating systems, there will be both employee skepticism and a lack of skilled change agents. If this condition prevails, a comprehensive program of management and leadership development may be instituted. A management audit is a good assessment tool to identify current levels of organizational functioning and areas in need of change. An organization should be basically healthy before beginning TQM. If it has significant problems such as a very unstable funding base, weak administrative systems, lack of managerial skill, or poor employee morale, TQM would not be appropriate.

Constructs of TQM implementation framework

However, a certain level of stress is probably desirable to initiate TQM. People need to feel a need for a change. Kanter (1983) addresses this phenomenon be describing building blocks which are present in effective organizational change. These forces include departures from tradition, a crisis or galvanizing event, strategic decisions, individual "prime movers," and action vehicles. Departures from tradition are activities, usually at lower levels of the organization, which occur when entrepreneurs move outside the normal ways of operating to solve a problem.

A crisis, if it is not too disabling, can also help create a sense of urgency which can mobilize people to act. In the case of TQM, this may be a funding cut or threat, or demands from consumers or other stakeholders for improved quality of service. After a crisis, a leader may intervene strategically by articulating a new vision of the future to help the organization deal with it. A plan to implement TQM may be such a strategic decision. Such a leader may then become a prime mover, who takes charge in championing the new idea and showing others how it will help them get where they want to go. Finally, action vehicles are needed and mechanisms or structures to enable the change to occur and become institutionalized.

Steps in Managing the Transition

Beckhard and Pritchard (1992) have outlined the basic steps in managing a transition to a new system such as TQM: identifying tasks to be done, creating necessary management structures, developing strategies for building commitment, designing mechanisms to communicate the change, and assigning resources.

Task identification would include a study of present conditions (assessing current reality, as described above); assessing readiness, such as through a force field analysis; creating a model of the desired state, in this case, implementation of TQM; announcing the change goals to the organization; and assigning responsibilities and resources. This final step would include securing outside consultation and training and assigning someone within the organization to oversee the effort. This should be a responsibility of top management. In fact, the next step, designing transition management structures, is also a responsibility of top management. In fact, Cohen and Brand (1993) and Hyde (1992) assert that management must be heavily involved as leaders rather than relying on a separate staff person or function to shepherd the effort. An organization wide steering committee to oversee the effort may be appropriate.

Developing commitment strategies was discussed above in the sections on resistance and on visionary leadership. To communicate the change, mechanisms beyond existing processes will need to be developed. Special all-staff meetings attended by executives, sometimes designed as input or dialog sessions, may be used to kick off the process, and TQM newsletters may be an effective ongoing communication tool to keep employees aware of activities and accomplishments.

Management of resources for the change effort is important with TQM because outside consultants will almost always be required. Choose consultants based on their prior relevant experience and their commitment to adapting the process to fit unique organizational needs. While consultants will be invaluable with initial training of staff and TQM system design, employees (management and others) should be actively involved in TQM implementation, perhaps after receiving training in change management which they can then pass on to other employees. A collaborative relationship with consultants and clear role definitions and specification of activities must be established.

In summary, first assess preconditions and the current state of the organization to make sure the need for change is clear and that TQM is an appropriate strategy. Leadership styles and organizational culture must be congruent with TQM. If they are not, this should be worked on or TQM implementation should be avoided or delayed until favorable conditions exist.

Remember that this will be a difficult, comprehensive, and long-term process. Leaders will need to maintain their commitment, keep the process visible, provide necessary support, and hold people accountable for results. Use input from stakeholder (clients, referring agencies, funding sources, etc.) as possible; and, of course, maximize employee involvement in design of the system.

Always keep in mind that TQM should be purpose driven. Be clear on the organization's vision for the future and stay focused on it. TQM can be a powerful technique for unleashing employee creativity and potential, reducing bureaucracy and costs, and improving service to clients and the community.

TQM tools are well-established techniques that can be applied equally well to process improvement as to the development of strategic business planning. The application of a variety of TQM tools used to develop a strategic business plan that is more often used for process improvement or product concept development.

To be successful implementing TQM, an organization must concentrate on the eight key elements:

Ø Ethics

Ø Integrity

Ø Trust

Ø Training

Ø Teamwork

Ø Leadership

Ø Recognition

Ø Communication

Key Elements

TQM has been coined to describe a philosophy that makes quality the driving force behind leadership, design, planning, and improvement initiatives. For this, TQM requires the help of those eight key elements. These elements can be divided into four groups according to their function. The groups are:

Ø Foundation – It includes: Ethics, Integrity and Trust

Ø Building Bricks –It includes: Training, Teamwork and Leadership.

Ø Binding Mortar –It includes: Communication.

Ø Roof –It includes: Recognition.

Total Quality Management is a term first coined by the U.S. Naval Air Systems Command to describe its Japanese-style management approach to quality improvement. Since then TQM has taken on many meanings, but at its core perception, it is a management approach to long-term success through customer satisfaction.

In a TQM effort, all members of an organization participate in improving processes, products, services and the culture in which they work. The methods for implementing this approach come from the teachings of such quality leaders as Philip B. Crosby, W. Edwards Deming, Armand V. Feigenbaum, Kaoru Ishikawa and Joseph M. Juran.

A core concept in implementing TQM is through Deming’s 14 points, a set of management practices to help companies increase their quality and productivity:

Ø Create constancy of purpose for improving products and services.

Ø Adopt the new philosophy.

Ø Cease dependence on inspection to achieve quality.

Ø End the practice of awarding business on price alone; instead, minimize total cost by working with a single supplier.

Ø Improve constantly and forever every process for planning, production and service.

Ø Institute training on the job.

Ø Adopt and institute leadership.

Ø Drive out fear.

Ø Break down barriers between staff areas.

Ø Eliminate slogans, exhortations and targets for the workforce.

Ø Eliminate numerical quotas for the workforce and numerical goals for management.

Ø Remove barriers that rob people of pride of workmanship, and eliminate the annual rating or merit system.

Ø Institute a vigorous program of education and self-improvement for everyone.

Ø Put everybody in the company to work accomplishing the transformation.

The term “Total Quality Management” has lost favor in the United States in recent years but it has been commonly substituted with “Quality management”. Total Quality Management however, is still used extensively in Europe .

Total Quality Management is an approach to the art of management that originated in Japanese industry in the 1950's and has become steadily more popular in the West since the early 1980’s.

Total Quality is a description of the culture, attitude and organization of a company that aims to provide, and continue to provide, its customers with products and services that satisfy their needs. The culture requires quality in all aspects of the company's operations, with things being done right first time, and defects and waste eradicated from operations.

Some useful messages from results of TQM implementations:

¨ If you want to be a first-rate company, don't focus on the second-rate companies who can't handle TQM, look at the world-class companies that have adopted it.

¨ The most effective way to spend TQM introduction funds is by training top management, people involved in new product development, and people involved with customers.

¨ It’s much easier to introduce EDM/PDM in a company with a TQM culture than in one without TQM. People in companies that have implemented TQM are more likely to have the basic understanding necessary for implementing EDM/PDM. For example, they are more likely to view EDM/PDM as an information and workflow management system supporting the entire product life cycle then as a departmental solution for the management of CAD data.

Important aspects of TQM include customer-driven quality, top management leadership and commitment, continuous improvement, fast response, actions based on facts, employee participation, and a TQM culture.

Models of TQM

The Oakland Model Of “Total Quality Management”

Sohal, Tay, Wirth’s Integrated Model Of “Total Quality Management”

Foundations

Total Quality Management: The Building Blocks (Zaire 1991)

Price, Gaskill’s 3-Dimensional Quality Model

“Japanese Tqm Models”

The House Of “Total Quality Management”

Calculation of Quality Achievement:

To know whether Total Quality Management can implement or not in proper way in an organization we need to ask some question to that organization people and of course to the management too.

As because, implementation of Total Quality Management is not the mere responsible of the management only, each and every person of the organization have to work accordingly as per the rules and regulation of TQM, which has decided by the management.

If the organization can give answer for the entire above question, then the organization can sketch for implementing Total Quality Management.

After reviewing of their own specified answer against the question, it will be clear to adopt the meticulous strategy for TQM which will give benefits to reduce the time and cost during implementation.

Data collection

Customer-driven quality

TQM has a customer-first orientation. The customer, not internal activities and constraints, comes first. Customer satisfaction is seen as the company's highest priority. The company believes it will only be successful if customers are satisfied. The TQM Company is sensitive to customer requirements and responds rapidly to them. In the TQM context, `being sensitive to customer requirements' goes beyond defect and error reduction, and merely meeting specifications or reducing customer complaints. The concept of requirements is expanded to take in not only product and service attributes that meet basic requirements, but also those that enhance and differentiate them for competitive advantage.

Each part of the company is involved in Total Quality, operating as a customer to some functions and as a supplier to others. The Engineering Department is a supplier to downstream functions such as Manufacturing and Field Service, and has to treat these internal customers with the same sensitivity and responsiveness as it would external customers.

TQM leadership from top management

TQM is a way of life for a company. It has to be introduced and led by top management. This is a key point. Attempts to implement TQM often fail because top management doesn't lead and get committed - instead it delegates and pays lip service. Commitment and personal involvement is required from top management in creating and deploying clear quality values and goals consistent with the objectives of the company, and in creating and deploying well defined systems, methods and performance measures for achieving those goals. These systems and methods guide all quality activities and encourage participation by all employees. The development and use of performance indicators is linked, directly or indirectly, to customer requirements and satisfaction, and to management and employee remuneration.

Continuous improvement

Continuous improvement of all operations and activities is at the heart of TQM. Once it is recognized that customer satisfaction can only be obtained by providing a high-quality product, continuous improvement of the quality of the product is seen as the only way to maintain a high level of customer satisfaction. As well as recognizing the link between product quality and customer satisfaction, TQM also recognizes that product quality is the result of process quality. As a result, there is a focus on continuous improvement of the company's processes. This will lead to an improvement in process quality. In turn this will lead to an improvement in product quality, and to an increase in customer satisfaction. Improvement cycles are encouraged for all the company's activities such as product development, use of EDM/PDM, and the way customer relationships are managed. This implies that all activities include measurement and monitoring of cycle time and responsiveness as a basis for seeking opportunities for improvement.
Elimination of waste is a major component of the continuous improvement approach. There is also a strong emphasis on prevention rather than detection, and an emphasis on quality at the design stage. The customer-driven approach helps to prevent errors and achieve defect-free production. When problems do occur within the product development process, they are generally discovered and resolved before they can get to the next internal customer.

Fast response

To achieve customer satisfaction, the company has to respond rapidly to customer needs. This implies short product and service introduction cycles. These can be achieved with customer-driven and process-oriented product development because the resulting simplicity and efficiency greatly reduce the time involved. Simplicity is gained through concurrent product and process development. Efficiencies are realized from the elimination of non-value-adding effort such as re-design. The result is a dramatic improvement in the elapsed time from product concept to first shipment.

Actions based on facts

The statistical analysis of engineering and manufacturing facts is an important part of TQM. Facts and analysis provide the basis for planning, review and performance tracking, improvement of operations, and comparison of performance with competitors. The TQM approach is based on the use of objective data, and provides a rational rather than an emotional basis for decision making. The statistical approach to process management in both engineering and manufacturing recognizes that most problems are system-related, and are not caused by particular employees. In practice, data is collected and put in the hands of the people who are in the best position to analyze it and then take the appropriate action to reduce costs and prevent non-conformance. Usually these people are not managers but workers in the process. If the right information is not available, then the analysis, whether it be of shop floor data, or engineering test results, can't take place, errors can't be identified, and so errors can't be corrected.

Employee participation

A successful TQM environment requires a committed and well-trained work force that participates fully in quality improvement activities. Such participation is reinforced by reward and recognition systems which emphasize the achievement of quality objectives. On-going education and training of all employees supports the drive for quality. Employees are encouraged to take more responsibility, communicate more effectively, act creatively, and innovate. As people behave the way they are measured and remunerated, TQM links remuneration to customer satisfaction metrics.

A TQM culture

It's not easy to introduce TQM. An open, cooperative culture has to be created by management. Employees have to be made to feel that they are responsible for customer satisfaction. They are not going to feel this if they are excluded from the development of visions, strategies, and plans. It's important they participate in these activities. They are unlikely to behave in a responsible way if they see management behaving irresponsibly - saying one thing and doing the opposite.

Product development in a TQM environment

Product development in a TQM environment is very different to product development in a non-TQM environment. Without a TQM approach, product development is usually carried on in a conflictual atmosphere where each department acts independently. Short-term results drive behavior so scrap, changes, work-arounds, waste, and rework are normal practice. Management focuses on supervising individuals, and fire-fighting is necessary and rewarded.

Product development in a TQM environment is customer-driven and focused on quality. Teams are process-oriented, and interact with their internal customers to deliver the required results. Management's focus is on controlling the overall process, and rewarding teamwork. Process Analytical Technology (PAT) is a perfect example of a system where products used to developed through Total Quality Management (TQM)

Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing processes based on

1) An understanding of the scientific and engineering principals involved, and

2) Identification of the variables which affect product quality. The PAT initiative is consistent with the current FDA belief that quality cannot be tested into products, but should be built-in or by design.

According to the FDA draft guidance, the desired state of pharmaceutical manufacturing is that:

Ø product quality and performance are ensured through the design of effective and efficient manufacturing processes

Ø product and process specifications are based on a mechanistic understanding of how formulation and process factors affect product performance

Ø quality assurance is continuous and real time

Ø relevant regulatory policies and procedures are tailored to accommodate the most current level of scientific knowledge

Ø risk-based regulatory approaches recognize both the level of scientific understanding and the capability of process control related to product quality and performance

Ø The primary goal of PAT is to provide processes which consistently generate products of predetermined quality. In so doing, improved quality and efficiency are expected from:

Ø reduction of cycle times using on-, in-, or at-line measurements and controls

Ø prevention of reject product and waste

Ø real time product release

Ø increased use of automation

Ø facilitation of continuous processing using small-scale equipment, resulting in improved energy and material use and increased capacity

Building Quality into Products

Effective PAT implementation is founded on detailed, science-based understanding of the chemical and mechanical properties of all elements of the proposed drug product. In order to design a process that provides consistent product, the chemical, physical, and biopharmaceutical characteristics of the drug and other components of the drug product must be determined. Although the science of analyzing for chemical attributes such as identity and purity is mature, certain physical attributes such as solid form, particle size, and particle shape are more difficult to analyze and control.

SSCI is uniquely experienced to address this aspect of PAT. Given a compound of interest, our scientists routinely:

SSCI scientists have extensive experience solving solid-state problems in drug products. Process Control once the properties of the drug product components are understood, the processing variables that control the relevant properties must be identified. Identification of these variables necessarily requires a multivariate approach. From a solid-state point of view, PAT implementation involves the design of manufacturing processes based on a thorough scientific understanding of the solid-state properties and stability of the components of the drug product at critical points throughout manufacturing. Then, measurement and control of the critical parameters integrates a broad spectrum of analytical technologies interfaced to production plant control networks and incorporated into standard procedures.

SSCI works with clients to establish specific process understanding and design process analytical control strategies. Building upon the current SSCI reputation for meticulous cGMP pharmaceutical research and analysis, SSCI can assist clients in all aspects of PAT implementation, including:

• process understanding through advanced solid-state research
• identification of critical control variables using multivariate techniques
• development and validation of appropriate analytical methods for measuring critical control variables
• transfer of analytical methods to on-, in-, or at-line use
• consultation and assistance in method validation and use after transfer

Potential Regulatory Impact FDA presentations indicate their anticipation that PAT implementation will eventually change the regulatory process. Documentation of quality by design during the pre-IND meeting, the end of phase II meeting, and in regulatory submissions will allow early review and analysis of the CMC section of an NDA by the FDA. Addressing issues of concern and further quality by design can result in classification of the drug substance and drug process manufacturing process as low-risk. In some cases, this approach is expected to result in a less comprehensive or eliminated pre approval inspection. While these procedural changes will not happen overnight, they present a possibility for more rapid regulatory approval and reduced time to market.

The pharmaceutical industry is moving in its industrial practice towards a more in depth comprehension of its processes.

This is caused by different factors:

1.  
   1. Experience gained by some leaders,
   2. Technology with new probes able to be located on/in line,
   3. Development of statistics,
   4. A challenge opened by the FDA to this community.

As there are a lot of safety reasons attached to the pharmaceutical production, the quality concept is evolving: instead of a final and binary control of a desired quality, new tools allow to develop a process designed to get the desired quality. And in the best world, it would make useless any final quality control. This implies to become familiar with multivariate analysis, to be able, for instance, to identify critical parameters of a process.

Pharmaceutical Quality Assessment System:

Ø The Current State of Pharmaceutical Manufacturing

ü Not state-of-art compared to other industries

ü Achieve reasonable quality –but at great effort and cost

ü Manufacturing is 25% of expenses –equal to R&D investment

ü Factory/equipment utilization rate about 15%

ü Product waste up to 50% for some products

ü Inability to predict effects of scale-up

ü Lack of agility –usually takes years to bring up a new production site

ü Operations fragmented around globe

ü Inability to understand reasons for manufacturing failures

Ø Consequences of State

ü High cost and low efficiency of manufacturing

ü Drug shortages due to inability to manufacture

ü Slowed development/access for investigational drugs

ü Partly due to lack of clarity about IND stage regulatory requirements

ü Need for intensive regulatory oversight

Ø Characteristics of Desired State

ü Manufacturers have extensive knowledge about critical product and process parameters and quality attributes

ü Manufacturers strive for continuous improvement

ü FDA role: Initial verification, subsequent audit

ü No manufacturing supplements needed

Ø Barriers to Desired State

ü Lack of trust

ü Lack of scientific knowledge

ü Upfront investment requirements

ü Legacy products

ü Bureaucratic resistance (in firms)

Ø How do we operationally the Desired State? Two Key Concepts

[A] Quality by design and the design space concept: adoption by industry and FDA

§ Develop scientific understanding of critical process and product attributes

§Design controls and testing based on the limits of scientific understanding at development stage

§ Utilize knowledge gained over the product’s lifecycle to operate in an environment of continuous improvement

§Pre-market:

v Assess level of product and process understanding to determine design space: the extent to which critical quality attributes and process parameters are scientifically supported as suitable quality surrogates for clinical performance

vAgree with sponsor on manufacturing design space

§Post-market:

v Evaluate changes based on risk, science and design space

vPost-market: Confirm successful design implementation

[B] Quality system approach: adoption by industry and FDA

§Modern quality system implements adequate change control process

§Design, controls, and validation are refined over lifecycle

§Industry, not government, charged with maintaining quality, including during process changes

§Establish minimum (e.g., “floor”) parameters for quality management system

§Inspections are audit of quality system implementation

§Ensure that adequate quality system is in place

Ø Managing the Transition

§Traditional regulatory processes will run in parallel with new approach

§Product manufacturers will need to select participation in a pilot

§FDA will need to seamlessly manage each system

§Clarity of procedures and objectives

§Clarity of roles and responsibilities

§Led via Council on Pharmaceutical Quality

§“Early adopters” will be pioneers-engaged in CMC pilots with FDA

§Some products/firms –will stay in current paradigm

§Middle ground –moderate changes –will be the most difficult to manage

Ø FDA: Roles and Responsibilities

§Review side (lead)

§Scientific assessment of product and manufacturing process design

§Evaluate and approve product quality specifications in light of established FDA standards (e.g., impurities, stability, etc.)

§Set and maintain product quality standards

§Field (lead)

§Evaluate implementation and effectiveness of process design (CMC agreement)

§Evaluate quality system

§Implement enforcement actions

§Set policies

§Compliance Offices (lead)

§Establish and maintain quality system standards for cGMPs and related guidance

§Establish and maintain risk management system for inspections

§Determine conformance with application and quality standards

§Facilitate conformance with quality standards

Ø Integration

ü Industry

§R&D and Production need to be integrated

§Modern quality systems are needed domestically and internationally

ü FDA

§CMC and cGMP Programs need to be integrated

§Will lead to Industry and Regulator synergy to advance to the desire state

To augment the up to date scenario of pharmaceutical practice we necessitate doing the hard work such as product Quality Initiative poised to take next steps into 21stcentury, will require movement onto unfamiliar ground for all of us, Tremendous benefits to public, industry, regulators await and We must be guided, as always, by rigorous science.

Ø Vision for the Future

Janet Woodcock, FDA (Oct 2005) on the Desired State:

“A maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight”

Ø Foundation for Future

· Establish framework for a modern approach to pharmaceutical quality and manufacturing

·Emphasize manufacturing science, risk-based assessment, robust Quality Systems

·Encourage thorough understanding of process and product

·Emphasize what is critical

·Endorse continuous improvement over a product’s lifecycle

v Challenges

§Changing FDA/Sponsor interactions

§More frequent, different interactions

§Adequate expertise, time, and resources

§Submission content will be different

§Conveying Quality-by-Design knowledge

§Driving and embracing significant change

§Moving to very different paradigm impacting pharmaceutical development, review and assessment, submission content, post-approval environment

§Strategic vision ensuring alignment of all the moving parts

§Assessment process, focus, and approval will be different

§Readiness of reviewers

§Impact of sharing more knowledge

§Achieving Quality by Design

§Role of the Regulatory Agreement

§Changes in FDA organizational structure and review process

§Concepts will change

§Quality by Design and Design Space

§Specifications and Validation

§Regulatory commitments

§Integrate non-QbD activity

§Role of inspectors

§Defining and achieving regulatory flexibility

§Handling of post-approval changes

§Evolving Quality Systems

§Ensuring continuous improvement

§Clear roles of Center and Field

v Progress

·Certain areas have forward momentum

·Other areas are still in conceptual phase

·More CMC-only meetings

·Interactions have increased for Pilot Program experiences

·Several Conferences and Workshops

·Pilot Program experiences

·Continued implementation of review process changes

·Future ICH opportunities –Q8B, QOS

v Opportunities

·Many –some defined, some yet to be defined

·Continue progress beyond Pilot Program

·Determine the right venue, frequency, and participants

·Continued public discussion

·Elimination of non-value added information, redundancy

·Global acceptance

·Continued discussion and clear alignment on all of the above

·Global acceptance where feasible

·Move concept of Regulatory Agreement into practice

·Determine specifics of new post-approval environment

To achieve success, we will need to begin or continue progress on defining:

üEffective communication between FDA/sponsor

üUnderstanding Quality by Design

üImpact on submission content and assessment

üRegulatory Agreement

üPost-approval regulatory environment

üRoles of Center and Field

We have made some progress pharmaceutical innovation field, we still have worked to do to accomplish the desired state and with a strategic vision, focus, and progress on the details we can achieve.

Quality By Design for Total Quality management:-

The United States Food and Drug Administration (FDA) has challenged the pharmaceutical industry to achieve a level of process understanding consistent with controlling process variability and assuring product quality in “real-time” while a batch is being manufactured (RTQA). Ideally, the appropriate level of quality must be assured by the process in real-time despite variations in materials and processing. In the past, such variations would have resulted in unacceptable product batches that were prevented from entering the market only by laboratory testing of the finished product.  In other words, the ability to achieve the appropriate quality outcome must be designed into the process itself rather than relying on final product testing.

This increased emphasis on “Quality by Design” (QbD) requires pharmaceutical manufacturers to make larger investments earlier in the product life cycle during process development in advance of approved commercial operations. The goal is to develop a sound scientific basis for a “Control Space” that accommodates a range of defined variability in the commercial process materials and operations and still produces the right product quality outcomes. 

It is expected that companies who adopt QbD, together with a quality system as described in the draft International Conference on Harmonization (ICH) Q10 document, “Pharmaceutical Quality Systems,” will achieve this “desired state” of pharmaceutical manufacturing. 

The new regulatory environment has highlighted innovative ideas regarding process development and manufacturing and forced us to think about the practicalities of implementing them. It has also focused renewed attention on two very important areas of the process sciences that have been somewhat neglected in the pharmaceutical industry:

1) Design Space Development

2) Design for Manufacturing.

Design Space Development in QbD

Process development results in the definition and approval of a “Control Space” within the universe of possibilities about a process called a “Knowledge Space.”  The approved manufacturing process can be operated within the Control Space to produce material that meets the required specifications for identity, potency, quality, etc.

As the product matures in its life cycle, scale-up, economic and/or other factors can require changes in the control scheme for the process, moving it from Control Space 1 to a new Control Space 2. The scientific basis for Control Space 2 is usually developed out of necessity to cope with process shortcomings long after the original process development work was done.

It needed to be reviewed and approved by the regulatory authorities before the process could be operated commercially in the new Control Space. This could be a costly and inefficient process because it could trigger the need for new clinical studies. Furthermore, many of the expert resources that developed and gained approval for Control Space 1 could have moved on by the time Control Space 2 was needed. (Shown in Figure 1)

Figure 1

With the publication of ICH Q8, the opportunity now exists to develop an approvable Design Space in advance of commercial launch that anticipates and accommodates more than one Control Space. This allows manufacturers to make changes that move the process from Control Space 1 to Control Space 2 as necessary without the need for regulatory approval, provided that both Control Spaces remain within the approved Design Space.  (Shown in Figure 2)

Figure 2

To realize the benefits of such a Design Space approach, the process development and manufacturing teams must develop and document in the Chemistry Manufacturing and Controls (CMC) section of the regulatory submission the scientific basis for approval of the Design Space. The information used for this work comes in part from appropriately designed experiments that define and test the outer limits of the intended Design Space to understand the effects on the Critical Quality Attributes (CQAs) and define and characterize any new Critical Process Parameters (CPPs) that might arise in a new Control Space. At the time of process start-up and tech transfer, data and information about the Control Spaces – as well as the Design Space within which the Control Spaces – operate must be readily available so that it can be transferred to the manufacturing operation.

Design for Manufacturing in QbD

Developing and gaining approval for a Control Space and/or a Design Space depends on fully utilizing the prior knowledge and experience of the process development and manufacturing teams. Data about the way previous processes behaved when subjected to the constraints of full-scale commercial operations is a vital source of guidance for designing the next process to operate successfully within those constraints. The FDA has coined the term “Design for Manufacturing” to describe the utilization of this process information to consistently achieve an acceptable quality standard.

This type of information is derived from accessing and analyzing the actual data about prior manufacturing processes operating under the same or similar conditions as the process currently under development. These analyses monitor, identify and correlate the relationships between CPPs and CQAs under the well controlled, full-scale operating conditions used during commercial manufacturing.

Other sources of valuable information used in Design for Manufacturing are data about the relationships between CPPs and CQAs collected during process upsets. Such upsets are the practical equivalent of full-scale experiments that can also reveal previously unrecognized CPPs, the control of which also needs to be built into the next process. Failure to utilize these valuable sources of information to design the next process appropriately for full-scale manufacturing conditions is generally due to 1) databeing not collected and/or not made available for analysis, 2) the fact that CPP information is too deeply buried in the oceans of in-house data or 3) the fact that  a culture of collaboration and continuous process improvement is absent or lacks the proper supporting technologies.

Achieving QbD through Process Understanding and Technology

Successful approaches to real-time quality assurance require that the CPPs driving variability in the CQAs be identified and understood during process development so that they can be measured and controlled in real-time during the manufacturing process. This is what the FDA means by “Process Understanding.” It requires a culture of continuous improvement without the need for regulatory intervention to approve changes, and close collaboration between the process development and manufacturing teams along with deployment of appropriate enabling technologies. As an added benefit, this collaboration has the potential to drive the adoption of better practices and sustain the business benefits of higher process predictability and quality compliance across the entire global manufacturing network.

Many pharmaceutical companies have been standardizing the desktop and back office environments in order to gain better systems control and consistency. As the industry moves towards collecting and analyzing more process data (including continuous or on-line data), new challenges to these standards are requiring new thinking.

One trend of note is data warehouses. Typically, these are not real time and do not contain continuous data. However, they can contain significant elements of data useful for identifying trends or causes of process variability. Process improvement initiatives must be able to take advantage of the information content of this warehoused data together with the data from newer (PAT) instruments and other on-line measurements.

Process improvement and PAT need a framework for managing the manufacturing process and enabling collaborative investigational analysis of the resulting data to improve the predictability and quality of operations and products.  The key is to provide on-demand access to not only the summary production data, but also to the individual underlying data elements in a context that is natural to users who are (non-IT) process experts. This improves the speed and depth with which they can identify and understand underlying cause-and-effect relationships.

Three important technology aspects to consider for successful QbD include PAT, on-demand data access and collaborative analytics.

Ø Process Analytical Technology (PAT):--

Achieving QbD may involve the use of instruments more sophisticated than those currently used in pharmaceutical manufacturing processes. Some of these instruments have been used for decades in other industries, but have not yet been applied to pharmaceutical production processes. Some of the newer instruments available to life science manufacturers make relatively simple measurements like effusivity. Other instruments make much more complex measurements like Near Infrared (NIR) absorption. In many cases, these instruments are capable of measuring the CPPs and CQAs in real-time. Such instruments generate large amounts of data that must be understood if the measurements are to be useful.

The usefulness of any PAT or other process improvement initiative in QbD depends on all the data (discrete, replicate, continuous and paper-based) and the right process trending, reporting, descriptive analysis, univariate and multivariate cause-and-effect analysis, and parameter relationship modeling capabilities all being easily available on-demand to users in the same integrated environment. Users must be able to work with continuous, discrete and replicate data together for quantitative analysis. 

Ø On-demand Data Access

A critical success factor for process improvement is easy, on-demand access to all the data and data types in the infrastructure systems, including Supervisory Control and Data Acquisition (SCADA), Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), and Electronic Batch Record (EBR) systems and other manufacturing control and data acquisition infrastructure systems. On-demand access allows a multi-disciplinary team of users can extract the information in context and use it to understand cause-and-effect relationships. Thus, the technology platform needed for QbD and its associated process improvement initiatives must allow immediate user-centric access to all the process development and manufacturing data sources and data types so that their value can be leveraged together with data from newer (PAT) instruments.

The data must be available on-demand to end users in the same working environment with the analytics, visualization and reporting capabilities that allow exploration of cause-and-effect relationships in collaborative multi-disciplinary teams of process development, manufacturing and quality users that work across geographic locations.

The different types of data must be easily accessible in a way that automatically accounts for their different formats and naming conventions, as well as their intra- and inter-batch genealogies. The data access method must let users move directly into identifying and understanding cause-and-effect relationships between CPPs and CQAs without spending excessive amounts of time on manual programming tasks or manually collecting and reconciling data. This is the modern replacement for what is so often the “spreadsheet madness” that occurs today when things go wrong and the process needs to get back on track under crisis conditions.

Ø Collaborative Analytics

Collaboration between individual participants in the process development, manufacturing and quality teams requires that the technology platform they use to access data and share ideas must be useful to the diverse group of users found on these teams - production engineers, statisticians and quality professionals -who are typically not programmers.

Practically speaking, it is not sufficient to provide capabilities that only those comfortable with writing their own SQL queries or thinking in n-dimensional space can use.  Basic as well as advanced analysis capabilities must be available in the same environment where the data is accessible on-demand directly by end users. This collaborative environment must also allow users to share their results easily and build on each other’s findings regardless of where in the world they are each located. In this way, the best thinking can be harnessed to the work of QbD and the results can be more easily institutionalized so that “the wheel does not need to be re-invented.”

The Bottom Line Benefits of QbD and Process Understanding

When fully implemented, QbD means that all the critical sources of process variability have been identified, measured and understood so that they can be controlled by the manufacturing process itself. The resulting business benefits are significant:

§Reduced batch failure rates, reduced final product testing and lower batch release costs

§Lower operating costs from fewer failures and deviation investigations

§Increased predictability of manufacturing output and quality

§Reduced raw material, WIP and finished product inventory costs

§Faster tech transfer between development and manufacturing

§Faster regulatory approval of new product applications and process changes

§Fewer and shorter regulatory inspections of manufacturing sites

These benefits translate into significant reductions in working capital requirements, resource costs and time to value. The bottom line gains, in turn, pave the way for additional top line growth.

The last few years has seen the FDA steer industry further in the direction of a quality–by–design (QbD) approach, and away from the quality–by–testing (QbT) approach traditionally taken by the pharmaceuticals sector. This move has largely been lauded by business as a sensible move likely to ensure consistent quality of the end product. Crucially, it hopes to encourage far more innovation in the industry, which has traditionally lagged behind other manufacturing sectors such as semiconductors in its understanding of the science and engineering behind quality manufacturing. Furthermore, the approach ties in well with the PAT initiative; a regulatory framework backed by the FDA, which many forecast will have a big impact on the sector.

Quality by Design (QbD) Verses Quality by Testing (QbT):-

Both QbD and QbT are fundamentally different to one another, and there are good reasons for the emerging focus on QbD. The traditional QbT approach is wasteful and inefficient, and some have been critical of the approach for failing to evaluate the quality of the product until it has already been produced. “The basis of quality by testing is that the finished product is tested for quality. Quality is assessed by testing and rejecting lots that fail to meet its stated specification. “This approach therefore results in a great deal of waste and thus is costly to the manufacturer and in turn the consumer.”

Astonishingly, the wastage cause by the quality by testing approach can inflate production costs by as much as 10 percent. FDA regulations that require approval of every change to manufacturing process have been a hindrance in encouraging an alternative approach to manufacturing. However, the tide has turned and the FDA has now reconsidered its traditional approvals procedures to rectify the concerns that overly restricting regulations may in fact have a detrimental effect on manufacturing innovation. One of the big restrictions was the regulatory framework in which pharma production has been embedded, with rule–based process specifications (sop-back-bone-pharmaceutical-industries" class="alinks-link" title="SOPs (standard operating procedures)">SOPs) that cannot be changed after the submission to FDA, etc. Regulations have now been lowered to allow for improved progress.

“Within QbD, processes are understood at a mechanistic level, design reflects this knowledge and quality is inherent in the product. This design incorporates knowledge of the product and the process to ensure all critical quality parameters are adequately controlled.”

A change for the better

The shift in focus is expected to bring about a well-needed modernization to the sector and allow new ideas the breeding ground needed to flourish. “As pharmaceutical manufacturing evolves from an art to a science and engineering based activity, application of this enhanced science and engineering knowledge in regulatory decision–making, establishment of specifications, and evaluation of manufacturing processes should improve the efficiency and effectiveness of both manufacturing and regulatory decision–making.”

Delivering an effective framework to ensure that risk is mitigated whilst encouraging the continuous improvement and innovation is a key public health objective according to the FDA. The Administration has recently changed its review system from the CMC system to a new risk–based pharmaceutical quality assessment system within their Center for Drug Evaluation and Research’s Office of New Drug Quality Assessment. This new switch will “encourage the implementation of process analytical technology (PAT), Quality by Design and facilitate continuous manufacturing improvements via implementation of an effective quality system

There are numerous benefits the initiative can bring to the industry and help achieve the desired future state of pharmaceutical manufacturing.

These include:

• Product quality and performance achieved and assured by design of effective and efficient manufacturing processes.
• Product specifications based on mechanistic understanding of how formulation and process factors impact product performance.
• Continuous “real time” assurance of quality

Regulatory policies and procedures tailored to recognize the level of scientific knowledge supporting product applications, process validation, and process capability.

Risk-based regulatory scrutiny that relates to the level of understanding of how formulation and manufacturing process factors affect product quality and performance and the capability of process control strategies to prevent or mitigate risk of producing a poor quality product.

Any firm that sees innovation as one of its priorities will find the initiative beneficial and applying the guidelines can lower production and monitoring costs and while mistakes cannot be ruled out entirely by following the PAT guidelines, they will be spotted far sooner rather than at a much later stage nearer the completion of the product. This way it will avoid any catastrophic problems that fail regulatory requirements.

Providing the catalyst

Manufacturing quality analysis is one area that the pharmaceutical industry has some serious catching up to do. The PAT initiative is likely to provide the catalyst so urgently needed by the industry. Prior to the introduction of the initiative, regulations already in place made the industry very reluctant to change to new technologies and process in case they defied them. Now though moving towards following the PAT–based manufacturing process might be the way forward.

Certain concerns have made some companies reluctant to embrace the PAT initiative. For instance, one of the biggest worries is that adapting processes may reveal new problems that will then have to be reported to the FDA. Rectifying this new problem can be a time consuming and costly business. Rising costs resulting from updating processes is especially off putting for many companies. Through identifying key processes parameters theses imagined costs can however be avoided.

Data overload is also a major concern for many companies who assume that the amount of data analytical technology will generate will be unmanageable. According to the FDA “real-time or near real-time measurement tools typically generate large volumes of data”. This can be combated by only targeting the most essentially important data.

Overall, although initially apprehensive, the industry does appear to moving closer to embracing the initiative, and recognizing the beneficial impact that it can have. Indeed, uptake seems to be spreading throughout the sector – the initiative has been embraced by many ranging from non-application products (Over-the-counter products), generic products, new products, and biopharmaceuticals. Encouragingly, it appears the initiative has interested most firms that the FDA has dealt with. With a renewed focus now on quality, the industry is looking to leave its testing times well and truly behind.

Essentials of TQM should focus on:

ØCustomer satisfaction

ØLeadership

ØQuality policy

ØOrganizational structure

ØEmployee involvement

ØQuality cost

ØSupplier selection and development

ØRecognition and reward

After studying poles apart surroundings of Total Quality Management in scrutiny of customer diverse findings may move toward. Some of elucidation as well as analysis are as under:-

Customer satisfaction has several dimensions such as:-

ØFitness for use

ØReliability, the life aspect of quality

ØValue for money

ØAfter sales service and support

ØPackaging

ØCustomer information and transit

Ø Maintain ability

ØVariety

ØSpeed of service

ØCivility of service at all labels

ØImage of the company and customer confidence in the organization

It is the essential to emphasize on the minds of every one in the organization that customers are:

üThe most important people in the business

üNot dependant on the organization.

üThe organization depends on them.

üNot an interruption to work but are the purpose of it.

üDoing a favor when they seek business and not vice versa

üA part of business, not outsiders.

üNot just a statistic, they are flesh and blood human beings with feelings and emotions.

üPeople who come with their needs and jobs. The organization fulfills them.

üDeserve the most courteous and attentive treatment.

üLife blood of the business.

Effect Of Interactive Environment On Business System With “Total Quality Management”

Designing the organization as customer-centered culture:-

ØIdentify the customers and characterize them accordingly

ØEstablish and define the customer’s requirements

ØEstablish the main objective and aim of the organization

ØDesign customer centered cultural process plan

ØDesign action diplomacy to operate the goals

ØIdentify key issues and constraints on implementation

ØBuild momentum for change

ØPut into practice (Implement)

ØCategorize performance measures

ØEstimate customers’ satisfaction

ØIntermittent assessment and monitors

Top management commitment and involvement.

vMiddle managers and employee commitment and involvement.

vCommunication.

vTraining and education.

vQuality infrastructure.

vFormal documented quality management system.

Frame Work Of Organisational Structure

The TQMEX Model

Diagramming the Home Court Advantage

 

Interpretation, findings & recommendations

Even though the perception of quality is very older, today it is possibly the foremost anxiety of organizations wide-reaching. However in the up to date year, Total Quality Management (TQM) has captured the world-wide awareness and is being adopted in many organizations. TQM is being acknowledged as a management philosophy. Many organizations in the region of the globs are conducting organizational development (OD) programmes to augment quality awareness and to revolutionize the attitudes of their human resources. These hard works towards understanding, adopting and promoting TQM are first and foremost because of the changes captivating place in the global economy, changing market circumstances and customer’s expectations and increasing bloodthirsty pressures. Many large organizations have recognized the important assistance that TQM can make in big business with these challenges.

Many companies have difficulties in implementing TQM. Surveys by consulting firms have found that only 20-36% of companies that have undertaken TQM have achieved either significant or even tangible improvements in quality, productivity, competitiveness or financial return. As a result many people are sceptical about TQM. However, when you look at successful companies you find a much higher percentage of successful TQM implementation.
TQM is a collaborative system. It can be conceptualize as an arrangement of processes and activities through which various people in the organization can make out different characteristic of a predicament and can constructively walk around their differences and search for continuous improvements that go to the front of their own limited vision of what is possible. TQM, consequently, is an interdepartmental and inter organizational endeavor to address tribulations of improvements. TQM provides a groundwork designed for heartrending towards answering the questions of why, how and with what consequences people participates in manifold dimensional problem solving. TQM does not rely exclusively on the chain of command; it develops multi-channel interactive networks all the way through the organization. Therefore, TQM is essentional to set up cooperative links with in the organization that can span the various gaps among people to unable coordinate the action. TQM can be viewed to play transformational role within the organization. Transformational changes occurs only when hard issues like budget, manufacturing, marketing, distribution and so on are blended with soft issues like values, cultures, vision, leadership style, innovative behavior and so on.

Every nation has its own self-governing historical and cultural background. The quality scenarios, consequently, differs from one national setting to the supplementary. The nations are orienting their quality management strategies and systems to congregate the requirements of the operating environment though the primary center of attention remains the same, that is, Total Costumer Satisfaction. Many of the present techniques of quality management were developed in Japan. How ever, USA, European nation and developing nations have also contributed significantly to this development. The studies carried out by researchers in different national settings revels that the concepts and philosophies of TQM are not unspoken by the managers and others. And all out efforts, therefore, is mandatory to endorse the understanding by launching massive educational and management development programs at all levels so as to create a cultural consciousness towards quality.

TQM is not a uni-dimensional approach but is multifaceted in natures. Understanding these facets is essential to promote a flourishing quality improvement program. Focusing only on a few measurements and over looking others would create problems leading to the failure of the program. An integrated mutual supportive approach from all parts of the organization, focusing on all vital components of TQM is obligatory to achieve the desired goal.

The development of quality management philosophy, in its present state, is the result of experimentation and analysis of various researchers. This has also resulted in ideas, methods and systems which will suit the untrustworthy objectives and cultural requirements of the organization. The organizations, therefore, can decide on the philosophy to ensemble their objectives and needs. Although, there is lot of different in approaches, anticipated programs and emphasis, all leads to improve quality culture and creates a satisfied customer based.

Productivity and quality contribute to a strong synergistic relationship. As against the traditional deep rooted belief that quality has a cost and reduces productivity, TQM emphasizes on quality improvement as a major strategy for productivity enhancement. Reduction in waste, promotion of commitment, motivation for envelopment, cross-functional management, establishing communication lines and so on are promoted through TQM which consequences in establishing strong human bounds leading to productivity and profitability improvement. Recognition of linkage between quality and productivity and the causes affecting this helps management organize and integrate the systems in a track which encourage both quality and productivity.

The significance of a proper service philosophy and strategy is vital to establish high quality and continual improvement in services. However, producing consistently high quality services has not received as much attention as in manufacturing. This is primarily because of the belief, amongst in the managers of service organization, that quality improvement methods used successfully in manufacturing are not applicable to service organization. However, with growing dominance of services and increased rivalry in service business, many service firms are realizing that quality is the major determinant of accomplishment and with proper service philosophy and strategy continual improvement in services is possible. A firm can develop a proper service philosophy and program to promote quality by following TQM approach involving the following steps:-

üDevelop service quality strategy.

üAnalyze service process and define the service quality measures.

üEstablish process control systems.

üInvestigate the process to identify opportunities.

üImprove process quality.

Attention to the application of quality improvement program in the service industry has not acknowledged much consideration until recently, but efforts aimed at spreading it, are increasing swiftly. Understanding the basic services philosophy and developing a strategy for continual growth are the necessary requirements for future services quality goals.

Put into practice Total Quality Management is not at all a bed of roses. It can not be left to its own providence subsequent to the launch and requires constant development and follow up by the management. Management must remain its figures on the rhythm of TQM efforts as bringing an alteration in culture, attitudes and beliefs is a perceptive and insubstantial matter. Problems in implementation are, therefore, to be anticipated and universal in temperament. However, patience, perseverance, sincere and loyal efforts on the part of management will help to overcome many of the problems.

Abbreviation

FDA- Food and Drug Administration

QS- Quality System

CGMP- Current Good Manufacturing Practice

QMS- Quality Management System

ANSI -American National Standards Institute

ASAC - Administrative Sciences Association of Canada

CEFIC- The European Federation of Chemical Industry Council

EFPIA- The European Federation of Pharmaceutical Industries Associations

PAT- Process Analytical Technology

ECVAM- The European Center for the Validation of Alternative Methods

ISO- International Organization of Standardization

QIT- Quality Improvement Team

DOE- Design of Experiment

FMEA- Failure Mode Effect Analysis

CONQ- Cost Of Non Quality

EDM- Engineering Document Management

PDM- Product Data Management

CAD- Computer-aided design

QFD- Quality Function Deployment

SSCI- Social Sciences Citation Index

OPS- Office of Pharmaceutical Science

PC-Principle Component

PCA-Principle Component Analysis

CMC- Chemistry, Manufacturing & Control

Computer-mediated communication (CMC)

Bibliography:-

1) “Hand book of Total Quality Management”, by R.P.Mohanty and R.R. Lakhe, Jaiko Publication House, Eighth edition 2007

2) “Achieving Quality by Design, Part I: Best Practices and Industry Challenges”, by Ed Adams, http://www.ibm.com/developerworks/rational/library/content/RationalEdge/...

3) “Implementation of a Pharmaceutical Quality Assessment System: Challenges, progress and Opportunities”, by Diane J. Zezza, Ph D http://www.fda.gov/ohrms/dockets/AC/06/briefing/2006-4241B1-02-13-FDA-Qb...

4) “Process Analytical Technology: a tool for quality by design in pharmaceutical industry”, by Y.M. Ginot, France, Rencontres HélioSPIR - 27 October 2006 http://www.heliospir.free.fr/file/5eme_rencontre/abstract_confHelioSPIR_...

5)“Pharmaceutical Quality in the 21stCentury –An Integrated Systems Approach”, by Janet Woodcock, M.D. http://www.fda.gov/oc/cgmp/report0507.html

6)“Quality by Design: A Challenge to the Pharma Industry”, http://www.fda.gov/ohrms/dockets/ac/02/briefing/3869B1_07_Camp.pdf

7) “What is Total Quality Control” The Japanese Way, by Ishikawa K, Prentice-Hall, Engle-Wood Cliffs, N. J., 1985.

8) “10 Percepts of Quality”, by Motiska, P.J. and Shillif, K.A., Quality Progress, Feb, 1990

9)“A Quality by Design Qbd Approach for Pharmaceutical Capsule Filling Unit Operation: Identifying Critical Process Variables and Detecting Possible Interactions”, by Huiquan Wu , Lin Xie , Meiyu Shen , Mansoor A. Khan, Larry Augsburger and Stephen W. Hoa g http://aiche.confex.com/aiche/2007/preliminaryprogram/abstract_97025.htm

10)  “ Pharma Meets Juran: Quality by Design, at Wyeth and Beyond—It’s Not Just for Automobiles and Widgets ”, On Pharma ,September 7, 2006

11)  “Quality by Design is Essential in the New U.S. Regulatory Environment” By Justin O. Neway , Ph.D. http://www.ngpharma.com/pastissue/article.asp?art=271746&issue=225

12)  “Quality counts”, by Ali M. Afnan, http://www.ngpharma.com