Quality management. Basic principles. (90

in order to survive. In Japan, the land of Kaizen, Carlos Ghosn led a transformational change at Nissan Motor Company which was in a financial and operational crisis. Well organized quality improvement programs take all these factors into account when selecting the quality improvement methods.

Quality standards

The International Organization for Standardization (ISO) created the Quality Management System (QMS) standards in 1987. These were the ISO 9000:1987 series of standards comprising ISO 9001:1987, ISO 9002:1987 and ISO 9003:1987; which were applicable in different types of industries, based on the type of activity or process: designing, production or service delivery. The standards have been regularly reviewed every few years by the International Organization for Standardization. The version in 1994 and was called the ISO 9000:1994 series; comprising of the ISO 9001:1994, 9002:1994 and 9003:1994 versions. The last revision was in the year 2000 and the series was called ISO 9000:2000 series. However the ISO 9002 and 9003 standards were integrated and one single certifiable standard was created under ISO 9001:2000. Since December 2003, ISO 9002 and 9003 standards are not valid, and the organizations previously holding these standards need to do a transition from the old to the new standards. The ISO 9004:2000 document gives guidelines for performance improvement over and above the basic standard (i.e. ISO 9001:2000). This standard provides a measurement framework for improved quality management, similar to and based upon the measurement framework for process assessment.

The Quality Management System standards created by ISO are meant to certify the processes and the system of an organization and not the product or service itself. ISO 9000 standards do not certify the quality of the product or service.

Recently the International Organisation for Standardisation released a new standard, ISO 22000, meant for the food industry. This standard covers the values and principles of ISO 9000 and the HACCP standards. It gives one single integrated standard for the food industry and is expected to become more popular in the coming years in such industry.

ISO has a number of standards that support quality management, one group describes processes (including ISO 12207, ISO 15288)and another describes process assessment and improvement ISO 15504. The Software Engineering Institute has its own process assessment and improvement methods, called CMMi (Capability Maturity Model - integrated) and IDEAL respectively.

Quality management terms

Quality Improvement can be distinguished from Quality Control in that Quality Improvement is the purposeful change of a process to improve the reliability of achieving an outcome.

Quality Control is the ongoing effort to maintain the integrity of a process to maintain the reliability of achieving an outcome.

Quality Assurance is the planned or systematic actions necessary to provide

enough confidence that a product or service will satisfy the given requirements for quality.

QUALITY MANAGEMENT (part II) – SET WORK 2 (Quality improvement – Quality management terms)

I. Read the words and translate them from English into Russian:

to incorporate, drive, guideline, assessment, deployment, robustness, loss, lean, feedback, to embed, to adopt, to be adapted, inventive, reengineering, clean slate, proponent, failure, commitment, scope of, to underestimate, gain, to comprise, valid, framework.

II. Find in the text as many word combinations with the word

“improvement” as you can.

III.State the difference between the following words:

1)prize – award – reward

2)continual – continuous

3)purpose – aim – goal – objective – target

4)enterprise – firm – company – organization

IV. Translate phrases from Russian into English and make up sentences of your own:

1.быть хорошо организованным –

2.находиться в финансовом и рабочем кризисе –

3.принимать во внимание –

4.Международная Организация Стандартизации –

5.система управления качества –

6.быть применимым –

7.оказание услуг –

8.один единственный официально принятый стандарт –

9.придерживаться стандартов –

10.делать изменения (трансформацию) –

11.от старого к новому –

12.в добавление; к тому же –

13.подобно чему-либо –

14.основанный на –

V. Grammar: Passive Voice (to be + V3 (ed)).

a.Find sentences in the text in the Passive voice.

b.Rewrite sentences using verb in Passive voice:

Arrest, wake, knock, check translate, find, drive, make, spend carry.

1.A decision will not _______________ until the next meeting.

2.That old building was dangerous. So it ___________ down.

3.When you go through customs, you luggage ___________ by the customs

officer.

4.In the morning I _____________ by my alarm clock.

5.Next year her new book ______________ into a number of foreign

languages.

6.John kicked a policeman, so he ____________.

7.After a long search the missing boy _____________ in the forest near the

town.

8.Many people think that today too much money ________________ on arms. (arms - зд. оружие.)

9.The injured man couldn't walk, so he _____________ by the hospital

orderlies.

10.I don't mind driving but I like when I _______________ by other people.

VI. Give the main idea of the text (in one sentence) and retell it. VII. Give your opinion upon the following:

1.Nowadays only certified goods should be sold.

2.To gain success enterprises must consider carefully which quality improvement methods to adopt.

3.It is important not to underestimate the people factors, as well as to overestimate.

4.Why are standards regularly reviewed every few years by the International Organization for Standardization?

Text 3. SEVEN RULES FOR MANAGING QUALITY

Read the text, retell it and say w hat rule is the most important for

managing quality.

1.Define what quality means to you and your customers, and how it can help to achieve your business goals and compete more effectively for market share.

2.Develop a strategy that defines a specific aspect of quality designed to provide a competitive advantage. Think outside the box; as you think about quality in your division, look at the bigger picture to address the strategy that will best guide your organization in the marketplace.

3.Focus all functions and levels of your organization on quality and continuous improvement. Build a companywide lasting commitment to the process of continuous improvement. Involve multiple departments in cross-functional quality improvements processes.

4.Use an integrated approach: leverage your service-profit chain; stress attention to details, but incorporate also competitive benchmarking, evaluation and

continuous improvement - all combined in an interactive process with your team members and customers.

5.Build a measurement and benchmarking methodology that will rank you against the competition and provide a mechanism for tracking your progress both independently an in comparison to industrywide best practices. Measure quality improvements both in quality-specific terms and in terms of the impact it has on your shortand long-term business goals. Assess individual contributions to the quality process as part of every employee's periodic review.

6.Top management must be completely involved in the quality improvement process rather than simply supportive of it. Allow for independent assessment of the company's quality management system, and its product and service quality, and act on the findings.

7.Give ownership for quality to your employees, encourage a continuous flow of incremental improvements from the bottom of the organization's hierarchy. Quality is not something that management can mandate or dictate. To gain employee commitment to the quality process, your company's management, control, and reward systems must be modified to give employees greater responsibility and opportunity to become quality and customer oriented and motivate them to strive for continuous improvement.

Text 4. QUALITY MANAGEMENT SYSTEM

Quality Management System

Quality Management System (QMS) can be defined as a set of policies, processes and procedures required for planning and execution (production / development / service) in the core business area of an organization. QMS integrates the various internal processes within the organization and intends to provide a process approach for project execution. QMS enables the organizations to identify, measure, control and improve the various core business processes that will ultimately lead to improved business performance.

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.

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 devices 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. 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 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, 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.

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: Production System; Facilities and Equipment System; Laboratory Controls System; Materials System; Pacheging and Labeling System:

Quality System:

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 CFR: 21 CFR 211. However, FDA has instituted new policies requiring QS for pharmaceuticals.

Quality management organizations and awards

The International Organization for Standardization's ISO 9000:2000 series describes standards for a QMS addressing the principles and processes surrounding the design, development and delivery of a general product or service. Organisations can participate in a continuing certification process to ISO 9001:2000 in order to demonstrate their compliance with the standard, which includes a requirement for continual (i.e. planned) improvement of the QMS.

(ISO 9000:2000 provides guidance on Quality principles and on the common language used by quality professionals. ISO 9004:2000 provides guidance on

improvement methods. It can be seen that 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.

QUALITY MANAGEMENT SYSTEM – SET WORK

I.Read the words and translate them from English into Russian:

procedure, criteria, pioneer, subsequent, vary (varying), emphasize, a

statistician, predominant, status, promulgate, flexibility, traceability, validation, labeling, storage, installation, audit, manufacture, pharmaceutical, compliance, eligible, scheme, grassroots.

II. Find in the text as many word combinations with the word “quality” as you can.

III.State the difference between the following words:

1)policy – politics

2)huge – big – large – immense

IV. Link English and Russian words:

V. Translate phrases from Russian into English and make up sentences of your own:

1.интегрировать –

2.выполнение проекта –

3.концепция качества –

4.от начала до конца –

5.доминировать, преобладать –

6.исправлять ошибки –

7.придавать особое значение чему-либо –

8.найти, увидеть дефекты –

9.назвать в честь кого-то –

10.быть опубликованным –

11.основные элементы –

12.предупредительные действия –

13.производство лекарств –

14.лучшие по качеству –

15.основной уровень –