GMP Quality Management Systems: System That Needs Management Commitments!!
Over two decades “quality” and “quality management systems” (QMS) have been leading buzzwords in the business world. Numerous consultants have built their careers around these topics, and quality issues in business have been responsible for the development of new organizations and even industries, for instance, the American Society for Quality and Six Sigma consulting. A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization. (i.e. areas that can impact the organization’s ability to meet customer requirements.) ISO 9001:2008 is an example of a Quality Management System.
The story of QMS is not recent either, it all began as early as 1950’s in Japan. Statistical process control (SPC) and problem solving techniques that were very effective in gaining the necessary momentum to change the mentality of organizations needing to produce high quality products and services. W. Edwards Deming was one of the best statisticians, who was considered as the guru of SPC during those days. He was a strong believer of that 85% of all quality problems were at the fault of management. In order to improve, management had to take the lead and put in place the necessary resources and systems. For example, consistent quality in incoming materials could not be expected when buyers were not given the necessary tools to understand quality requirements of those products and services. Another influential person in the area QMS was Joseph Juran who had also played a key role in quality improvements for many Japanese organizations. Juran’s “Fitness for Use” was a famous model of QMS during that time. Quality got its dime right only after 1980’s when an American Automotive manufacturer “FORD” started implementation of Deming’s models to produce higher quality products and maintain the standards forever.
Since the early 1980s and on into the twenty-first century, quality issues have surfaced in every industry and almost every organization in the United States including the at most regulated industries like Pharmaceutical. The quality movement started in manufacturing and then moved to service industries. Initially service organizations did not feel quality systems would transfer very easily from manufacturing, but today service companies are reaping substantial rewards from implementing quality programs.
Any organization will benefit from establishing an effective QMS. The basis of a quality organization is the concept of the customer and supplier working together for their mutual benefit. For this to become effective, the customer- supplier interfaces must extend into, and outside of, the organization, beyond the immediate customers and suppliers. By definition QMS is “A set of coordinated activities to direct and control an organization in order to continually improve the effectiveness and efficiency of its performance”. These activities interact and are affected by being in the system, so the isolation and study of each one in detail will not necessarily lead to an understanding of the system as a whole. The main thrust of a QMS is defining the processes, which will result in the production of quality products and services, rather than in detecting defective products or services after they have been produced.
The QMS has its own benefits, a fully documented QMS will ensure that two important requirements are met:
The customers’ requirements – confidence in the ability of the organization to deliver the desired product and service consistently meeting their needs and expectations.
The organization’s requirements – both internally and externally, and at an optimum cost with efficient use of the available resources – materials, human, technology and information.
These requirements can only be truly met if objective evidence is provided, in the form of information and data, to support the system activities, from the ultimate supplier to the ultimate customer.
A QMS enables an organization to achieve the goals and objectives set out in its policy and strategy. It provides consistency and satisfaction in terms of methods, materials, equipment, etc. and interacts with all activities of the organization, beginning with the identification of customer requirements and ending with their satisfaction, at every transaction interface.
Management systems are needed in all areas of activity, whether large or small businesses, manufacturing, service or public sector.
A good QMS will have:
Set direction and meet customers’ expectations
Improve process control
Increase market share
These days there are standardized systems available to have better controls over QMS, which are governed by the International standards organization (ISO). The ISO9000 series are very well known to every segment and sector of the industries. There are about 132 national standards bodies which governs the implementation, usage and management of proper QMS across.
An organization that would like to have ISO certification needs to meet all the criteria stated in the ISO standards and pass a detailed audit performed by an ISO auditor. In some industries ISO certification has become necessary; for example, some large manufacturers require all suppliers to be ISO certified. While ISO certification is highly respected, if it is not a trend in your specific industry, the additional cost of certification is a deterrent to most managers. It is very possible to reach the desired quality level within an organization with a well-planned quality system and without going through all the additional steps for ISO certification.
The concept of quality in business emphases on the savings and additional revenue that organizations can realize if they eliminate errors throughout their operations and produce products and services at the optimal level of quality desired by their customers. The errors are very common, and the costs incurred seem minimal. But over time when mistakes are repeated the costs add up to a significant amount, so eliminating errors can result in significant increases to the bottom line of a business.
Prasad Panzade, Ph.D.
Director Analytical R&D , Product Development Solid dosage
- Waterloo, Iowa Area