Quality Management System

A Quality System (QMS) is a system that outlines the policies and procedures necessary to improve and control the various processes that will ultimately lead to improved business performance. One of their purposes is quality control in manufacturing.

Although it may seem obvious that quality systems are necessary, many small or start-up companies function, or attempt to function, with only some areas covered. A survey performed in 1988 indicates the breadth of the systems established within the biopharmaceutical industry. The table below summarizes the systems and the percentages of the respondent companies that had established these systems. The age of the company and the industry had some effect on the extensiveness of the quality function activities. It is clear that testing is the primary emphasis. This supports the observation that testing or QC is perceived, at least in the beginning, as the emphasis of the quality function.

In manufacturing industries, statistical process control is a vitally important methodology used to control quality. This is important in the Six Sigma quality management scheme, pioneered by Motorola.

Concept of Quality - A Historical Background
The concept of quality evolved from inspection, measurement, and testing, which had been in practice for many, many years. Long ago, an artist or a sculptor took pride in his work and as a result always tried to excel in what was created. Mass production systems brought the concept of inspection by someone other than the craftsman in the first half of the 20th century.

Application of statistical control came later as a result of World War production methods. Quality Management Systems are the outgrowth of work done by W. Edwards Deming, a statistician, after whom the Deming Prize for quality is named.

Quality, as a profession and the managerial process associated with the quality function, was introduced during the second-half of the 20th century, and has evolved since then. No other profession has seen as many changes as the quality profession.

The quality profession grew from simple control, to engineering, to systems engineering. Quality control activities were predominant in the 1940s, 1950s, and 1960s. The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field. Like medicine, accounting, and engineering, quality has achieved status as a recognized profession.

Current Good Manufacturing Practice
According to Current Good Manufacturing Practice (cGMP) medical device manufacturers should use good judgment when developing their quality system and apply those sections of the Food and Drug Administration (FDA) Quality System (QS) Regulation that are applicable to their specific products and operations, 21 CFR 820.5 of the QS regulation. Operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.

FDA has identified in the QS regulation the essential elements that a quality system shall embody for design, production and distribution, without prescribing specific ways to establish these elements. Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement specific procedures tailored to their particular processes and devices. For example, if it is impossible to mix up labels at a manufacturer because there is only one label to each product, then there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling.

Drug manufactures are regulated under a different section of the CFR: 21 CFR 211.

Quality Management Organizations and Awards
The International Organization for Standardization's ISO 9000 series describes standards for a QMS addressing the processes surrounding the design, development and delivery of a general product or service. Organisations can participate in a continuing certification process to demonstrate their compliance with the standard.

The Malcolm Baldrige National Quality Award is a competition to identify and recognise top-quality U.S. companies. This model addresses a broadly based range of quality criteria, including commercial success and corporate leadership. Once an organisation has won the award it has to wait several years before being eligible to apply again.

The European Foundation for Quality Management's EFQM Excellence Model supports an award scheme similar to the Malcom Baldrige Award for European companies.

In Canada, the National Quality Institute presents the 'Canada Awards for Excellence' on an annual basis to organisations that have displayed outstanding performance in the areas of Quality and Workplace Wellness, and have met the Institute's criteria with documented overall achievements and results.

The Alliance for Performance Excellence is a network of state, local, and international organizations that use the Malcolm Baldrige National Quality Award criteria and model at the grassroots level to improve the performance of local organizations and economies. NetworkforExcellence.org is the Alliance web site; browsers can find Alliance members in their state and get the latest news and events from the Baldrige community.

Reference
ICH1 Guidance E6: Good Clinical Practice: Consolidated guideline