Essential Elements of a Quality Management System

A good quality management system in a pharmaceutical company can significantly improve the net profit status, high quality medicines for patients, less rework and recall which save more money, good work environment and compliance with local and international regulations.

Quality management is a philosophy. It takes management understanding, commitment and responsibility before introducing and implementing the concept. Once practiced a good quality management system slowly develop or reshape a sustainable organization culture that pays off rapidly.

The initial step of introducing a good quality management into a system is to know the essential elements of the quality system and clear study from where to start. Company objectives should be clearly understood. Policies should be prepared. Then comes the design of the process flow, validating the process, material flow and organization chart. When a good integration between people, process and material is achieved the next step is to putting the integrated system in a state of control. Any deviation from the controlled system must be analysed and corrected.

Essential Elements of a Quality Management System

Some basic but essential elements of Quality Assurance as depicted in GMP guidelines and ISO 9001 guideline for pharmaceutical industry can be listed as: the Preparation of standard operating procedures of a complete system maintaining cGMP principles; Preparation and maintenance of effective change control of quality and master file documentation; Recording and management of manufacturing change control; Recording and reporting procedure of Deviations of your systems; Quality concern investigation process; Customer complaint investigation procedure; Quality audit procedures; Vendor assessment, evaluation and certification procedure; Quality control laboratory procedure, Rework procedures for the defective manufactured products; Procedures on training for manufacturing staffs and recall procedure.

Standard operating procedures and manuals should be written in details and referenced to relevant other documents, so a new starter within the organization should be trained easily and expected to perform as per procedure. The result will be a common standard of activities across the organization, good tractability of work flow, deviations and ease of corrective actions as necessary.

Standard Operating Procedure

You should prepare SOPs, forms, templates and manuals, which can be used immediately as the system runs. Forms and templates should be used for record keeping which your people can follow routinely.

Documentations - Classification, Definition and Approval

Quality and Technical/Master file documents to be created to build up a good quality management system for your manufacturing sites. Definition of documents, their classification, approval requirements and retention requirements should be understood.

Quality Documentation Management and Change Control

Procedures to be created on how to generate new quality documents or change control of existing documents, review of quality documents, satellite file management, role of document author, approver, document control officer and satellite file administrator. In this procedures you will also define the numbering systems of different quality documents like audit files, SOPs, forms, templates, manuals, training files, QA agreements, project files etc and their effective archiving system.

Preparation, Maintenance and Change Control of Master Documents

Procedures to be created which will particularly focus on the management of master file documents like specifications, control methods, raw materials, finished goods and packaging specification and test reports, formulation, stability files etc required to generate during the product registration in the market.

Deviation Report System

It is a regulatory requirement to capture all sorts of deviations evolves in your systems in order to maintain the continuous improvement of your processes and systems. Procedures should be created that describes how to categorize the deviations between production, audit, quality improvements, technical deviations, customer complaints and environmental, health and safety deviations. It should also describes the management responsibilities of initiating deviation, capturing data, analysis, investigation, determination of assignable cause/s, generation of management report and initiatives to be taken on corrective and preventative actions.

Vendor Selection and Evaluation

Procedures to be followed during the vendor assessment and vendor evaluation for purchasing of raw materials, critical and non critical packaging components, laboratory supplies, engineering supplies and imported finished goods from the vendor. These instructions are essential for approving prospective vendor.

Vendor Certification

This procedure aims to describe the process by which a vendor may be certified to supply materials or services. This procedure applies to vendors that supply a material or service to be used at any stage of manufacture by operations. Here you will describe the roles of each department in the process to certify an approved vendor.

Product Complaint Procedure

You should have strong procedure to cover the receipt, logging, evaluation, investigation and reporting system of all complaints received from customers for the marketed products. This procedure should contain step by step instruction to be followed during the customer complaint management like numbering of complaint, registering the complaint, evaluation, determination of assignable cause for the complaint deviation, implementation of corrective and preventative actions, trending of complaints and handling of counterfeit products.

Annual Product Review

Some countries require reports as Annual Product Review to sell your products into their market. So you have to create instructions on how to do annual product review, to evaluate data, trends and to identify any preventative or corrective action that would lead to product quality improvements and report them to management.

Rework Procedure

Procedure should contain the step by step instructions to be followed when the rework of an in-process or completed finished good is required. Product Identification and Traceability The purpose of this procedure is to define the method used for the identification of all contributing materials that could affect product quality and to ensure their full traceability.

GMP Audits

Procedure should be created to describe the process of planning, performing, reporting and follow-up of different audits for your systems like Internal Quality audit, Vendor audit, Environmental Health and Safety (EHS) audit, EHS workplace inspection, Housekeeping audit.

Evaluation of Batch Documentation and Release for Sale

This procedure should describe the process of collection, evaluation and record of batch related document generated during the production of a batch before an authorized person can release the batch for sale.

GMP Training

Effective GMP related training modules to be created for your manufacturing staffs. Training records and reports have to produce on each employee as justified.

Management and Control of Contract Work

There should have procedure to describe the management and control of contract work provided by the contractors for packaging and finished products for your company as well as control of contract works done by your company on behalf of others.

Quality Concern Investigation Process

Procedure should be made that contains instructions to follow when conducting Investigations collection of data and information, analysis, assigning root cause, determine corrective and preventive actions.

Essential Elements of a Quality Management System
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Essential elements of a good quality management system are described in this article for pharmaceutical industry. Check more in Pharmaceutical Quality Procedures

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What Is the Importance of Time Management

Many people who are aware of the fact that work has to be done on time. In fact, if you can't finish the tasks that require to be accomplished in a day, you presumably require a time management solution. It's not unusual. Many people don't have a satisfactory time management solution, but they should. Having a goal is quite critical.

Anyway, having a goal-oriented strategy that makes an effective use of your time will bring you success no matter how you look at it. There isn't anything we can do about time itself. It keeps ticking the same as ordinary. We can change how we deal with events though.

It is hard to overestimate the importance of time management. Firstly, we cannot change the amount of time there is in a day. No matter how we juggle things around, there is still only twenty-four hours in a day.

What Is the Importance of Time Management

This gives us a limited amount of time to work on during the year - in fact one might say that despite differing opportunities in life everyone has the exact amount of time, so the only thing we can do in our lives when it comes to time is altering the way we use it.

Once you realize this, you know that wasting time leads to a wasted job, project or even life itself. In this article, we look closely at the importance of time management in our lives.

Your important time starts now

Everybody knows that we have more than twenty different things that need to be done in a day. We don't really know how we are going to fit all of this into our busy schedule.

The time management importance is this next statement: Those twenty things you need to do have to be prioritized. What does this mean? This means you need to put the things you want to do into a list and then decide which ones are more important, and which ones can wait.

The things that can be done later are still put on the list, but we know there are other areas to take care of first. We now have to decide how long we are giving ourselves to do each of those different tasks.

We need to be realistic. If it is an event that requires travel, the actual traveling needs to be put in the plan as well. If you know you have to stop for gas when on the road, you will need to add that into the plan as well.

This is to show you where all of the time is being used up. This can also help you with a time wasting strategy.

Put some priority into your daily activities

If you have followed your list and you still don't have enough time in a day to do anything, look at your information to see where time is wasted. Wasted time is not good in any body's life.

To be able to fit everything into your day you need to eliminate those time wasting activities. By doing, so you will be able to get more work done and still have time left to enjoy with yourself and your family.

The importance of time management can be gauge from the truth that by following its simple principles we can go from breathing day to day to living a full, successful live in which we work actively towards our life goals. No other skill or information set lets us achieve that.

Thanks a lot for taking your time to read this article. Go up before and look around to discover other helpful tips and information.

Even though, you may now know the importance of proper time management, but all words no actions is simply does not make your goals come true.

Take action now is the most right thing to do if you want you goals realized.
Without an effective and proper time management system, there will not be much goal-oriented lifestyle to hope for.

Understanding the fact that an effective program for time management habit may be easy to follow and implement and now allowing you to side-track is really allowing you to enjoy your life once again. So, please don't wait any longer before giving another excuse to realize your goals again.

What Is the Importance of Time Management
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Eddy K Elgin is the author of the 17 Minutes Time Management Secrets. Drop by at importance of time management for more details.

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What is the Importance of Change Management in Your Organisation?

Change management is one of the most important disciplines of Information Technology Infrastructure management. The Wikipedia defines change management as "The objective of Change Management in this context is to ensure that standardized methods and procedures are used for efficient and prompt handling of all changes to controlled IT infrastructure, in order to minimise the number and impact of any related incidents upon service."

Change management was always an integral part of business management, but with emergence of Information technology it gathered seriousness. Information Technology Infrastructure management is one broad term which encompasses all the elements necessary to ensure smooth functioning of business processes which may be threatened due to technological problems or other incidents. It's the "change is rule" attitude (as coined by some experts) that forced these businessmen to change their attitude towards change management. Good change management techniques always help the businessmen to adapt and adopt new ways of doing business. Change management is not merely implementation of new techniques to cope up with a change within the organisation; rather it is a discipline of Information technology infrastructure managementwhere changes are managed with a more systematic, reliable, rigorous and disciplined approach. Changes are brought into system when the integrity of business organisation is challenged due to some incidents or customer requests or technological updates.

Process of change management unfolds through following steps

What is the Importance of Change Management in Your Organisation?

1. Identifying the need for change in organisation.
2. Designing need specific changes to curb with the requirement of the organisation.
3. Making others understand why change is necessary for the proper functioning of the organisation.
4. Altering the organisational process like processes, technology and performance meters to incorporate the changes.
5. Managing the production and changes to ensure that customer and the stakeholder continues to be bonded with each other over the long run.

According to Wikipedia Change management involves management of process related to Hardware, communications equipment and software, system software, and all documentation and procedures associated with the running, support and maintenance of live systems.

Project management is another aspect of change management, which needs to incorporate its values for proper functioning. There are some touch points between project management and change management. Project management is all about handling change with elance. It is defined as the discipline of planning, organising and managing resources in order to ensure the successful completion of projects. Aim of any project management endeavour is to attain the successful results despite of constraints like space, time, changes, quality, time and budget. Every project is developed around some permutation and combination methodology. Changes are made to the existing methodology in order to avoid potential failures. Identifying, managing and controlling changes become important for the smooth functioning of the Project. According to some experts "project is change and change is project". So it becomes difficult to differentiate or draw a line between the inter reliability of project management and change management.

So change management holds utmost importance in the world of business where things are assessed on the basis of their perfection and capability to address the needs of customers and clients.

What is the Importance of Change Management in Your Organisation?
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What is the Purpose of Dr. Deming's Theory of Management?

After World War II American industry returned to the peacetime production of consumer goods, for which there was unparalleled demand and no competition. Untouched by war, the industrial heartland produced cars, washing machines, vacuum cleaners, mixers, lawnmowers, refrigerators, furniture, carpet, and all the goods for the growing postwar suburbs inhabited by a generation of prosperous Americans.

The American corporation had fulfilled the promise of 'scientific management,' formulated by an influential industrial engineer named Frederick Winslow Taylor more than three decades earlier. Taylor had held that human performance could be defined and controlled through work standards and rules. He advocated the use of time and motion studies to break jobs down into simple, separate steps to be performed repeatedly without deviation by different workers. Minimizing complexity would maximize efficiency, although it was as bad to overperform as it was to underperform on a Taylor-style system.

Scientific management evolved during a period of mass immigration, when the workplace was being flooded with unskilled, uneducated workers, and it was an efficient way to employ them in large numbers. This was also a period of labor strife, and Taylor believed that his system would reduce conflict and eliminate arbitrary uses of power because so little discretion would be left to either workers or supervisors. Hence the evolution of the rule-bound, top-heavy American corporate management structure.

What is the Purpose of Dr. Deming's Theory of Management?

Quality in these postwar years took a backseat to production. Quality control came to mean end-of-the-line inspection. If there were defects and rework, there would be profit enough to cover them. Although some quality control lingered for a time, particularly in defense industries, for the most part the techniques taught by Dr. Deming were regarded as time consuming and unnecessary, and they faded from use. By 1949, Dr. Deming says mournfully, "there was nothing not even smoke." This setback only served to strengthen Dr. Deming's conviction, as he considered what had gone awry.

Purpose of Dr. Deming's Theory of Management

As a statistician, Dr. Deming's lifelong mission had been to seek sources of improvement. World War II had quickened the pace of quality technology, but as World War II ended, progress in quality control began to wane. Many companies saw it as a wartime effort and felt that it was no longer needed in a booming market. Given the failure of statistical methods for quality control to endure, he figured out what might have caused the failure and how to avoid it in the future. He gradually concluded that what was needed was a bedrock philosophy of management, with which statistical methods were consistent. He was ready with new principles to teach when the Japanese called him in 1950 to aid in the reconstruction of their country.

The aim of Dr. Deming's theory of management also known as, 'System of Profound Knowledge,' challenges leaders to embrace a new paradigm based on the following three major points:

The purpose of the new paradigm transformation is to 'unleash the power of human resource contained in intrinsic motivation,' and to foster an environment of full cooperation between people, departments, companies, governments, and countries to achieve win-win scenarios through process improvement, team work, and innovation.

The system of profound knowledge is a fitting theory for leadership in any culture or business. In some circles people think incorrectly of Total Quality Management with industrial connotations. For example, in the health care arena the customer is the patient, and production could be equated to the quality of patient care. Indeed many of the concepts which are espoused by TQM relate to interpersonal interaction as much as they do to other more production oriented criteria.

Therefore the key dimensions of TQM can be identified as: team development, statistical quality control, process management, assessment of customer's needs, fact-based decision making, continuous quality improvement, and benchmarking. Applying this management theory requires a focus to the new kind of world of interdependence that we are in now. The prevailing paradigm in the Western world is not based on any holistic or comprehensive theory; it is just the cumulative result of assorted reactive experiences and methods:

Managers basing their leadership in the above listed paradigms will be lost in the new economic age. Such leaders need to open their minds and change to be able to learn the new paradigms of Total Quality Management (TQM).

Assumptions of Dr. Deming's Theory of Management

Dr. Deming's theory of management is based on four assumptions:

1. Management's function is to optimize the whole system, not just your components

E.g., Western-style management: Reward-punishment performance appraisal systems optimize components of the system.

E.g., Deming-style management: A better way is to evaluate an individual long-term virtue, to know if they are in the system or out of the system, and to understand the performance issues as special or common cause. According to statistical research by Deming, Ishikawa, and Juran over 80% of problems are related to common cause or system problems of the organization.

2. Cooperation works better that competition

E.g., Western-style management: Internal competition to recognize the top 10% sales people in an organization creates a system where 90% of the population is labeled substandard performers or worse yet losers for those on the bottom half.

E.g., Deming-style management: In any distribution curve, 50% of the population is going to be below average, and only 10% are going to be top performers. It does not make sense to grow an organization of malcontents because nobody wants to labeled a loser. If the system is stable and has good hiring policies in place, a better way to manage is to have a goal to shift the distribution curve to the right by continuous improvement and removing common causes of variation. All employees in the system should be recognized for the accomplishments of the enterprise, rather than just the top 10%.

3. Manage using both a process and results orientation, not only a results orientation

E.g., Western-style management: Asking to sell 30% more (by a MBO goal) without understanding the process that allows that goal to be attained, or providing a process for goal attainment, creates a fail syndrome (demanding unreasonable greater results has the opposite effect that contradict the Pygmalion effect).

E.g., Deming-style management: A better way is to analyze historical performance using statistics. Then basing sales growth goals within +/- 3 standard deviations from the mean, where 99% of the sample population is predicted to attain the goal, and shifting the curve to the right by improving the sales process. If a stable system is pushed beyond its limits, the system typically breaks down.

4. People are motivated by a mix of intrinsic and extrinsic motivation

E.g., Western-style management: Recognizing people solely through extrinsic motivation by giving plaques, letters of commendation, bonuses, and pats in the back to motivate employees.
E.g., Deming-style management: A better way is for management to combine extrinsic and intrinsic motivation to increase quality and pride in the work. Intrinsic motivation is the enthusiasm and positive stimulation an individual experiences from the sheer joy of an endeavor. Management can release intrinsic motivation by creating a culture that encourages employee involvement in using process improvement tools such as the Deming wheel (SDSA and PDSA) to innovate and improve quality.

Each of these assumptions are directly associated with the interrelationships between people. They all revolve around a key concept, receptivity of the management style by those who are not only managing but those who are being managed. The implementation of management philosophies obviously revolves around employee motivation, and not all employees are either easily motivated or receptive to management styles that differ from those to which they have been accustomed.

What motivates an individual, therefore, is at the center of Total Quality Management philosophy. Motivational theory in itself has a long history of both direct and indirect applicability to many aspects of management in general and to Total Quality Management in particular. Indeed, the importance of teamwork in the organizational atmosphere cannot be underestimated. Before employees can effectively interact as a team, however, they must be able to function independently in an efficient and productive manner.

Such independence revolves around numerous factors, some of which were learned in childhood and some of which can be instilled in the professional environment. An important part of this independence is being able to relate to one's peers and to turn criticism and resistance, which exists from some peers, into a positive factor in influencing team performance.

Leaders applying the Deming-style management need to be experts at molding independent workers and teams. A high performing team is to some degree the product of the individual player's personalities, personalities that had roots as far back as childhood. Deming's teachings recognize that an individual's qualities or lack of them could be refined in the professional workplace. Lastly, Deming has influenced my thinking in a variety of ways. What stands out is the wisdom behind the value of teamwork, process improvement, individual versus systemic issues, and the pervasive power of continuous improvement.

What is the Purpose of Dr. Deming's Theory of Management?
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Professional experience traverses key business disciplines including entrepreneurship, leadership, and strategic management. From a 15 year stint with a start-up developer of software and equipment for the automation and controls industry, which led to several promotions including VP of Sales; to the acquisition of this firm by a Blue Chip company; to managing businesses with P&L accountability for Fortune 100 firms, I have enjoyed a productive career accented by sales/marketing, management, and leadership talents. Recent educational achievements include an MBA from the University of Miami, Six Sigma Green Belt Certification, and ISO 9001 QMS Certification.

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Organizational Management - Management Structure

In this installment of our guide to organizational management we look at management structure...

The process of planning, organizing, and controlling human and other resources in order to meet an organizations goals, is known as management.

Typically, a company will be set up to include different types of managers, which can include managers with responsibility for a specific department or division of the entity, as well as regional managers who supervise activities in a particular geographic region. The types of management positions will vary in accordance with the size of the business.

Organizational Management - Management Structure

Management structure (also known as organizational structure) is the method by which staff, departments, divisions and regions work and interact with one another. There are two main types of such structures, known as flat and hierarchal.

Whats known as a flat management structure promotes a decentralized decision-making process, which increases staff involvement and is achieved by very few or no management layers between front-line workers and the company's leadership.

By elevating the level of responsibility of baseline employees, and by eliminating layers of middle management, comments and feedback reach all personnel involved in decisions more quickly. Since the interaction between workers is more frequent, this management structure generally depends upon a much more personal relationship between workers and managers.

The hierarchal management structure has a set chain-of-command - that is each unit in the organization (except that at the very top) is subordinate to another unit or division. That means that each individual communicates directly with an immediate supervisor or subordinate and does not jump over layers of management to get to the top leader.

The benefit of a hierarchal structure is also its primary limitation in that it will reduce the level of communication that goes directly to the top. The hierarchal configuration, however, is the most prevalent for large corporations, governments, and even organized religions.

Flat management structures will typically only work well in smaller companies, or within smaller defined units of a large organization. Once an entity reaches a certain size, this type of structure will not work as well and could end up having a negative impact on productivity. An organizations complexity can be related to its size and how widely distributed it is geographically, and it is this complexity that governs which management structure is most beneficial to the company.

Organizational Management - Management Structure
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