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Elements of QMS

Organizational structure
Responsibilities
Procedures
Processes
Resources

Concept of quality - historical background

The concept of quality as we think of it now first emerged out of the Industrial Revolution. Previously goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet 'quality criteria'. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. In the late 1800s pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor established Quality Departments to oversee the quality of poof production and rectifying of errors, and Ford emphasized standardization of design and component standards to ensure a standard product was produced. Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to 'catch' defects.

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. Over this period, few other disciplines have 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.

Quality system for medical devices

Quality System requirements for medical have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983, and were instituted as requirements in a final rule published on October 7, 1996. The U.S. Food and Drug Administration (FDA) had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if Quality Systems had been in place. The rule is promulgated at 21 CFR 820.

According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in Part 820 of the QS regulation. As with GMP, 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.

The 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. These elements include:

personnel training and qualification;
controlling the product design;
controlling documentation;
controlling purchasing;
product identification and traceability at all stages of production;
controlling and defining production and process;
defining and controlling inspection, measuring and test equipment;
validating processes;
product acceptance;
controlling nonconforming product;
instituting corrective and preventive action when errors occur;
labeling and packaging controls;
handling, storage, distribution and installation;
records;
servicing;
statistical techniques;

all overseen by Management Responsibility and Quality Audits.

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 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 Code of Federal Regulations: 21 CFR 211. However, the FDA has instituted new policies requiring QS for pharmaceuticals.

Quality management organizations and awards

The International Organization for Standardization's ISO 9001:2008 series describes standards for a QMS addressing the principles and processes surrounding the design, development and delivery of a general product or service. Organizations can participate in a continuing certification process to ISO 9001:2000 to demonstrate their compliance with the standard, which includes a requirement for continual (i.e. planned) improvement of the QMS.

(ISO 9000:2005 provides information the fundamentals and vocabulary used in quality management systems. ISO 9004:2000 provides guidance on improvement methods. Neither of these standards can be used for certification purposes as they provide guidance, not requirements).

The Malcolm Baldrige National Quality Award is a competition to identify and recognize top-quality U.S. companies. This model addresses a broadly based range of quality criteria, including commercial success and corporate leadership. Once an organization 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 Malcolm 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.

References

ICH1 Guidance E6: Good Clinical Practice: Consolidated guideline
Pyzdek, T, "Quality Engineering Handbook", 2003, ISBN 0824746147
Godfrey, A. B., "Juran's Quality Handbook", 1999, ISBN 007034003

External links

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 ==Concept of quality - historical background==
-The concept of quality as we think of it now first emerged out of the [[Industrial Revolution]]. Previously goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet 'quality criteria'. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. In the late 1800s pioneers such as [[Frederick Winslow Taylor]] and [[Henry Ford]] recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor established Quality Departments to oversee the quality of production and rectifying of errors, and Ford emphasized standardization of design and component standards to ensure a standard product was produced. Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to 'catch' defects.
+The concept of quality as we think of it now first emerged out of the [[Industrial Revolution]]. Previously goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet 'quality criteria'. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. In the late 1800s pioneers such as [[Frederick Winslow Taylor]] and [[Henry Ford]] recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor established Quality Departments to oversee the quality of poof production and rectifying of errors, and Ford emphasized standardization of design and component standards to ensure a standard product was produced. Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to 'catch' defects.
 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 (business)|quality]] is named.