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Conformity assessment

Содержание

Introduction

Products and services as promises. Business & ndash;customers, consumers, users or government officials have their specific expectations for products and services related to their characteristics such as quality, environmental parameters, safety, cost-effectiveness, reliability, compatibility, utility and efficiency. The process to demonstrate that these properties meet the requirements of standards, regulations, and other documents is called conformity assessment. In other words, conformity assessment helps ensure that products and services deliver on their promises.

Consumers benefit from conformity assessment because its results serve as a basis for their choice of goods or services. The consumer has additional confidence in the product, which is accompanied by an official Declaration from the supplier, has a certificate or a mark of certification, indicating the quality, safety or other desired characteristics[1].

Manufacturers and service providers want to make sure that their products and services meet the specifications and meet customer expectations. Evaluation of products and services in accordance with international standards ISO and IEC allows you to keep up with the current level of technology and knowledge, avoids the losses that are inevitable if a defective product enters the market.

When it comes to health, safety or the environment, conformity assessment very often becomes mandatory at the legislative level. Without proper evaluation and approval, the product can not be allowed to sell, or, for example, the supplier is removed from participation in the bidding for public procurement contracts. International standards and ISO/IEC guidelines also set requirements, provide guidance on the effective implementation and recognition of the results of such assessments.

Regulators are also interested in conformity assessment, as this process is a tool for regulating national health, safety, environmental legislation and achieving public policy objectives[2].

1. Relevance of the topic

Before each enterprise there is a question how to improve methods of the decision of problems on conformity assessment of production. This explains the relevance and practical significance of my thesis.

2. The purpose and objectives of the study, expected results

The Purpose of this work is to study and improve methods for solving problems of conformity assessment of products of industrial enterprises.

Object of research: methods of conformity assessment of products.

Subject of research: identification of methods and methods for conformity assessment of products of industrial enterprises.

Research problem:

  1. To analyze the literature on this issue;
  2. To carry out the analysis of ways and methods on an assessment of economic conformity of production of the industrial enterprise;
  3. To formulate conclusions.

3. Research and development overview

Researches of theoretical, methodological and practical questions of the analysis of methods of conformity assessment of production were carried out by many Russian and foreign scientists in various directions. The writings of W. Deming, D. Juran, K. Ishikawa, F. Crosby, G. Taguchi, A. Feigenbaum, and J. A. Ferguson played an important role. Harrington, W. Shewhart.

Scientific works of the listed authors have important theoretical and practical value. However, the approaches considered in them only partially allow to evaluate the methods of conformity assessment of products[3].

4. Conformity assessment

4.1 Definition of conformity assessment

From the point of view of international standards organizations–ISO and IEC. Through these organizations, compliance professionals and users from around the world have pooled and channeled their knowledge and expertise to create a series of standards and guidelines that are now best practice in this area. These standards and guidelines were developed with the help of the ISO/CASCO conformity assessment Committee, and formed a structure known as theCASCO tools[4].

ISO/IEC 17000 defines conformity assessment as an activity that demonstrates that certain requirements relating to products, processes, systems, persons or structures have been met. Several points should be noted:

  1. In accordance with the terminology of ISO 9000, services are considered a variety of products;
  2. The methods used to verify compliance cover testing, inspection, supplier declarations of conformity and certification;
  3. Certain requirements are contained in the supplier's (buyer's) specifications, national, regional or international standards or technical legislation;
  4. Accreditation of conformity assessment bodies refers to the concept of conformity assessment;
  5. The concept of conformity assessment object includes products, processes, systems, persons or bodies.

Conformity assessment is often seen as a component of quality activities. This emphasizes the importance of conformity assessment within a national or regional quality framework and the interaction between the various elements of that framework.

In addition to testing, inspection and certification, there are other activities that fall within this area that have emerged as a result of serious international work and discussions. Accreditation, production of reference samples, testing of professionalism are essentially conformity assessment activities.

Even within tests, there are differing opinions as to whether certain types of diagnostic tests, such as laboratory tests, will formally be considered a conformity assessment. In practical terms, however, all these different activities are part of daily conformity assessment activities and are important elements of national or regional quality structures.

With regard to accreditation, according to the ISO position, accreditation bodies carry out conformity assessment of conformity assessment bodies, but are not such in themselves.

The definition of conformity assessment and the explanatory text in ISO/IEC 17000 provide sufficient flexibility in the use of this concept for practical purposes, which ensures the effective use of these principles. Introduction to ISO/IEC 17000, conformity assessment activities interact with other areas such as management systems, Metrology, standardization and statistics. This standard does not define the limits of conformity assessment. They remain mutable illustrates this flexibility.

The individual elements of this definition are also divided into smaller components. For example, certification implies certification of management systems, products and personnel. The concept of testing also includes activities related to calibration and measurements.

4.2 Conformity assessment methods

In the field of conformity assessment, as in any other, the competence of the persons carrying out or managing the activities of conformity assessment is of paramount importance. Whether the activity is carried out by a product supplier, a buyer or an independent authority, there should be a clear understanding of the level of knowledge, skills and experience required for persons performing conformity assessment tasks. Each organization, regardless of its role, should use a competency management system that identifies the required levels of competency and can demonstrate the presence of persons who meet these requirements.

Too often, conformity assessment refers to certification and nothing more. In fact, conformity assessment may be conducted by a variety of individuals, including suppliers of goods or services, buyers, or other interested parties, such as insurance companies and regulators. It is advisable, speaking about conformity assessment, to adopt the following division:

  1. The first party–the person or organization that is the subject of the evaluation.
  2. The second party-the person or organization interested in the object.
  3. Third party-a person or body that is independent of the person or organization that is the subject of the assessment or interested in the object.

In General, the conformity assessment methods described in this Chapter can be used by any of these parties.

ISO/IEC 17000 establishes a functional approach to conformity assessment. The functional approach includes the following main processes:

Selection–Definition–Verification (certification) as well as Supervision (inspection control), if necessary.

Each stage includes a specific activity described below, the output of one stage is the input of another.

4.2.1 Choice

Selection involves the planning and preparation of activities to collect and obtain all necessary information and is the input for subsequent functions by definition. The actions taken in the selection vary in composition and complexity. In some cases, the need for such actions may be minimal.

A Little more attention may need to be paid to the selection of the conformity assessment object. Often, the object can be: a large number of identical units are what–either, continuous production; a continuous process or system, or numerous locations.

In such cases, it will be necessary to determine the selection of samples or samples to be used in the determination actions. For example, a river water sampling plan to prove compliance with pollution requirements is an example demonstrating the importance and scope of sampling activities.

There Are cases when the object can be the whole quantity, for example, when one, separate product is the object of conformity assessment. But even in such cases, selection may be necessary to select a part of the whole object (for example, the selection of critical elements of the bridge to determine the degree of fatigue of the material).

In Addition, it may be necessary to define specific requirements. In many cases, there is a standard or other specified set of requirements. However, caution should be exercised when applying existing requirements to a particular conformity assessment object. For example, a special approach will be required when applying the standard developed for metal pipes to plastic pipes. In some cases, there may only be a General set of requirements that need to be extended in relation to the conformity assessment to be meaningful and acceptable to the user.

For Example, government regulation may require that a product does not carry unacceptable safety risks (General requirements) and is expected to, that certification bodies will establish such requirements for specific products or types of products. On the other hand, the requirements for General management systems should be specified, when the management system applies specific requirements to the operational properties.

Selection may also include the selection of the most appropriate procedures (e.g. test methods and control methods) to be used at the determination stage. There is often a need to develop new or modified methods for the determination stage. This may be required to select the right location, the right conditions, or the appropriate personnel to perform this procedure.

Finally, additional information may be needed in order for the determination actions to effectively prove compliance. For example, before making a determination, it should be established whether the accreditation of the laboratory covers all necessary types of tests. Or a description of the services will be required before the relevant definition activities are carried out.

In addition, the activity by definition can be the verification of information in itself, and this information must be collected and identified. For example, a copy of the product instruction manual or a warning label may be required.

4.2.2 Definition

The determination Activity is carried out in order to obtain complete information about the compliance with the specific requirements of the conformity assessment object or the samples selected. Some definition activities are listed below[5].

Terms relating to testing, control, audit and peer review, which are defined as types of activity by definition, can be used with system or scheme to describe conformity assessment systems or its schemes, which include the type of the specified action by definition. Thus, peer review systems are conformity assessment systems that include peer review as a definition activity.

Various definition activities do not have specific names or designations. An example is the study or analysis of a design or other descriptive information relating to certain requirements. Individual areas of conformity assessment (e.g. testing, certification, accreditation) may have separate names that uniquely identify them at the determination stage. But there is no General term describing the activity by definition as a whole. Care must be taken to clearly understand the differences in the nature of testing and verification as an activity by definition[6].

Outputs from the determination stage are presented as information to satisfy all specified requirements. The output is a combination of all the data that appeared at the definition stage, as well as all the inputs to this stage. The output is generally structured to facilitate the verification and attestation process.

Activities undertaken during the determination phase may include:

  1. Tests to determine the specific characteristics of the object of assessment.
  2. Investigation (control) of physical properties of the object of assessment.
  3. Examine (audit) the systems or records associated with the assessment object .
  4. Evaluation of qualitative characteristics of the object of evaluation.
  5. Study of specifications and drawings relating to the object of assessment.

4.2.3 Verification and certification (confirmation of conformity)

Activities carried out in the verification and certification phase may include:[7].

  1. Verification of evidence of compliance of the object with the established requirements collected at the determination stage.
  2. Return to the definition stage to resolve the mismatch.
  3. Preparation and issuance of a document declaring compliance.
  4. Placement of the conformity mark on the relevant product.

4.2.4 Supervision (inspection control)

Activities carried out in the supervision (inspection) phase may include:[8].

  1. Conduct identification activities at the time of production or delivery to the market.
  2. Conduct market definition activities.
  3. Conduct on-site identification activities.
  4. Checking the results of output determination activities.
  5. Return to the definition stage to resolve inconsistencies.
  6. Drawing up and issue of the document confirming constancy of conformity.
  7. Initiation of corrective and preventive measures in case of nonconformity.

Conclusion

The Key to the success of any enterprise lies in the constant improvement of efficiency and effectiveness of production, systematic analysis of production activities, development and implementation of measures aimed at improving the assessment of compliance, product quality, efficiency and effectiveness of production.

In this work the concepts of conformity assessment, functional approach were considered, one of the methods of conformity assessment of products was considered.

The Key to the success of any enterprise lies in the constant improvement of methods for solving problems of conformity assessment of products, systematic analysis of production activities, development and implementation of measures aimed at improving production efficiency.

When writing this essay, the master's work has not yet been completed. Final completion: may 2020. The full text of the work and materials on the topic can be obtained from the author or his supervisor after the specified date.

References

  1. Оcновы оценки соответсвия [Электронный ресурс].–Режим доступа:http://isorf.ru/Novosti/osnovy-oczenki-sootvetstviya.html.
  2. Зачем нужна оценка соответствия? [Электронный ресурс].–Режим доступа:http://www.isoconsulting.ru/osnovy-oczenki-sootvetstviya.html.
  3. Экономический анализ системы менеджмента качества промышленного предприятия / А. Н. Канивец, Б. И. Герасимов, Л. В. Пархоменко; под науч. ред. д-ра экон. наук, проф. Б. И. Герасимова. Тамбов: Изд-во Тамб. гос. техн. ун-та, 2005. 144 с.
  4. Определение оценки соответствия [Электронный ресурс].–Режим доступа: http://www.klubok.net/article2406.html.
  5. Завіновська Г. Т. Економіка праці: Навч. посібник.–К.: КНЕУ, 2000.–200 с.
  6. Курочкин А. С. Организация производства: Учеб. пособие.–К.: МАУП, 2001–216 с.
  7. Аттестация [Электронный ресурс].–Режим доступа: https://www.freepapers.ru/68/ocenka-sootvetstviya/181493.1087388.list3.html.
  8. Как проводится инспекционный контроль [Электронный ресурс].–Режим доступа: https://www.centrattek.ru/info/kak-provoditsya-inspekcionnyy-kontrol/.