Input data relating to product requirements must be defined and records maintained. This data should include:

a) functional and operational requirements;
b) relevant statutory and regulatory requirements;
c) where applicable, information taken from previous similar projects;
d) other requirements important to design and development.

These inputs should be analyzed for adequacy. Requirements must be complete, unambiguous and consistent.

Design and development output

Design and development outputs must be in a form that can be verified against the design and development inputs and must be validated prior to release.

Design and development outputs should:

a) meet the design and development input requirements;
b) provide relevant information on procurement, production and service;
c) contain or reference product acceptance criteria;
d) determine the characteristics of the product that are essential to its safety and proper use.

Design and development analysis

At appropriate stages, a systematic review of the design and development should be carried out in accordance with planned activities in order to:

a) evaluating the ability of design and development results to meet requirements;
b) identifying any problems and making suggestions for necessary actions.

Participants in such a review should include representatives from departments relevant to the design and development stage(s) under review. Records of the results of the analysis and any necessary actions must be maintained.

Design and Development Verification

Verification shall be carried out in accordance with planned activities to ensure that the design and development outputs meet the design and development input requirements. Records of verification results and all necessary actions should be maintained.

Design and Development Validation

Design and development validation shall be carried out in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the intended use or intended use, where known. Where practicable, validation should be completed prior to delivery or sale of the product. Records of the results of the validation and all necessary actions should be maintained.

Project and development change management

Design and development changes must be identified and records maintained. Changes should be reviewed, verified and approved, if appropriate, and approved prior to implementation. The analysis of design and development changes shall include an assessment of the impact of the changes on the constituent parts and delivered products.

Records of the results of the change analysis and any necessary action shall be maintained.

Purchasing process

The organization shall ensure that purchased product conforms to the purchase requirements. The type and extent of control applied to the supplier and the purchased product should depend on the impact of the purchased product on subsequent production of the product or the finished product.

The organization shall evaluate and select suppliers based on their ability to supply products in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation should be developed. Records of the results of the assessment and any necessary actions arising from the assessment must be maintained.

Purchasing Information

Purchasing information should describe the products ordered, including, where appropriate:

a) approval requirements for products, procedures, processes and equipment;
b) personnel qualification requirements;
c) requirements for the quality management system.

The organization shall ensure that specified purchasing requirements are adequate before they are communicated to the supplier.

Verification of purchased products

The organization shall establish and implement controls or other activities necessary to ensure that purchased product conforms to established requirements to purchases.

If the organization or its customer intends to carry out verification activities at the supplier's facility, the organization shall state in the purchasing information the intended verification measures and method of release from the supplier.

The input data must be identified in order to provide a basis for the formulation of the requirements that are used to verify and validate the output data. Input data can be external and internal.

In order to ensure that the needs and expectations of all interested parties in relation to a process and/or service, process or system are met, design and/or development inputs must be accurate and complete. The resolution of ambiguous or conflicting inputs should be done with the involvement of affected external and internal parties.

External inputs may include customer or market needs and expectations, stakeholder specifications, contract requirements, regulatory requirements, international or national standards, industry codes and regulations.

Internal inputs may include policies, standards and specifications, qualification requirements, documentation and data for existing products and/or services, and outputs from other processes.

In the case of designing and/or developing software or services, inputs derived from end user requirements (as well as direct customer requirements) can be particularly important. Such inputs should be formulated in such a way that they can be effectively controlled for subsequent verification and validation. Such inputs should be formulated in such a way that they can be effectively controlled for subsequent verification and validation.

Input data may also occur during the development phase in activities that are not even fully evaluated. Also, the input data should be the subject of evaluation for subsequent reviews and verification and validation activities.

Other inputs identify those design and/or development characteristics that are critical to the safety and proper functioning of the product and/or service, or identify processes such as workflow, storage, handling, operation, and storage requirements.

Typical examples of development-related activities include:

modified materials

modified product components,

new technologies for providing services,

market analysis results.

Inputs that are critical to the product and/or service or process must be identified in order to assign appropriate responsibilities and resources.

ISO 9001:2000 - Quality management systems - Requirements 7.3.2 Design and development inputs. The requirements for the product and/or service should be defined and recorded (see 5.6.7). These requirements should include: performance requirements from the customer or the market; applicable regulatory and legal requirements; applicable requirements for environment requirements arising from previous similar projects; any other requirements essential to design and development. These inputs must be reviewed for adequacy or inconsistency with respect to the requirements to be met.

"GOST R 57189-2016 / ISO / TS 9002: 2016. National standard of the Russian Federation. Quality management systems. Guidelines for the application of ISO 9001: 2015 (ISO / TS 9002: 2016, IDT)" (approved by Order of Rosstandart dated October 25, 2016 N 1499-st)

8.3.3 Design and development input

Determining the inputs for a particular design and development project is one of the activities that should be included in the design and development plan. These inputs must be unambiguous, complete, and consistent with the requirements that define the characteristics of the product or service. They should include:

a) functional and performance requirements defined by customers, market needs or the organization;

b) information from previous similar design and development activities (which may improve performance and enable the organization to develop good practices or avoid errors);

c) statutory and regulatory requirements that relate directly to the product or service (e.g. safety regulations, food hygiene laws) or to the production of that product or service (e.g. practices within the manufacturing process, transportation or other delivery techniques);

d) voluntary standards or codes of practice that the organization has adopted (eg industry codes, health and safety codes);

e) the potential consequences of failure due to the nature of the products and services; such failures can range from potentially fatal (e.g., poor security planning traffic can occasionally lead to accidents) to factors that lead to a loss of customer satisfaction (for example, unstable ink on fabric leads to discoloration or staining).

Input for design and development

Inputs relating to product requirements should be defined and records maintained (4.2.4). This data should include:

a) functional and performance requirements;

b) relevant legislative and mandatory requirements;

c) where appropriate, information taken from previous similar projects;

d) other requirements important to design and development. These inputs should be analyzed for adequacy. Requirements must be complete, unambiguous and consistent.

Design and development output

Design and development outputs must be in a form that can be verified against the design and development inputs and must be validated prior to release.

Design and development outputs should:

a) meet design and development input requirements;

b) provide relevant information on procurement, production and service;

d) determine the characteristics of the product that are essential for its safe and correct use.

History of work in the field of quality in Russia.

Speaking of best practices in the field of quality management, one cannot but recall the domestic practice of quality improvement.

What concepts of quality improvement existed in our country?

1. BIP concept(Defect-Free Manufacturing of Products) The basis of this system was the mechanism of activation of participants production process, stimulating them to identify and eliminate not product defects, but their causes. After the repeated presentation of the product, the worker was deprived of the bonus.

2. The concept of CANARSPI(Quality, Reliability, Resource from the First Products) It was introduced at the Gorky Aviation Plant. Recognized as the best in the country, the system was based on the following principles:

versatility (can be used in other industries)

Comprehensive product quality assurance

conducting research aimed at improving the quality of products and the development of experimental design services of the enterprise

organization of a comprehensive accounting of the quality of products

Concentration on product quality at the stage of its development

Involvement of consumers in the improvement of products

1. NORM concept In the mid 1960s. in Yaroslavl engine plant"Avtodiesel" introduced the NORM system, in which one of the most important technical parameters- resource to the first overhaul. Particular attention was paid to the development of design and technology to improve the technical level and quality of the engine. In the NORM system, the main elements of the Saratov and Gorky production quality management systems were used and developed.

2. The concept of KSUKP(Comprehensive Product Quality Management System)

In the first half of the 1970s. as a result of a joint scientific and production experiment of the enterprises of the Lviv region, the All-Russian Research Institute of Standardization of the State Standard of the USSR and the Sistema scientific and production association, an integrated product quality management system was developed and tested.

the main objective of the system was to ensure high and sustainable growth rates of the quality of products manufactured by the enterprise, due to:

· creation and development of new high-quality products;

timely launch of new products;

removal from production of obsolete products;

· improvement of indicators of quality of let out production by means of its improvement and modernization.

What was the specific Russian experience quality management?

The specificity of quality management in Russia was that effective quality management systems were created at the enterprises of the military-industrial complex (MIC). It was in the military-industrial complex that methods of quality assurance were widespread at the stages of research and design of new products, statistical quality control using control charts, and special standards. In the bowels of the military-industrial complex, the KSUKP was born ( complex systems product quality management, including automated ones).

QMS: Management of nonconforming products.

Methodology for managing nonconforming products.

1) determine the products included in the scope of the QMS, 2) determine what the relevant products are, 3) determine which control mechanisms are applicable to which products (may be in the form of a table), 4) describe these mechanisms in detail as applied to specific products: who is responsible for what, what powers he has, what he does.

While we have products.

What can we do to ensure product conformity when a nonconformity is found?

The first is obvious: fix. those. in terms of ISO 9000 to carry out the correction. But this is not always possible.

Then the second is to assess how the nonconformity interferes with the intended use of the product, and if acceptable, then resolve the deviation. If possible, permission to deviate is also requested from the consumer, whether he agrees. The customer, after analyzing which features will be missing, may consider this quite acceptable and give permission.

If neither the first nor the second is possible, then a third option remains: change the original application or refuse to use the product altogether.

It is obvious that the procedure for managing nonconforming products cannot be fully developed if

 the products themselves are not defined, the quality of which is controlled within the framework of the QMS,

 it is not defined what the conforming product is, because this is equivalent to the fact that the nonconforming product is not defined.

From the experience of auditing: if I cannot understand from the quality manual which specific products are included in the scope of the QMS, then I can not even look at the procedure for managing nonconforming products, ensuring in advance that it is formal.

Control mechanisms in each of the three cases:

Change products (correction)

 indicate the method of identifying nonconforming products and the person responsible for this identification,

 indicate the person responsible for preventing the release and supply of identified nonconforming products and his authority,

 indicate the person responsible for the correction,

 Establish a re-control procedure and a person responsible for its implementation,

 establish the form in which the record of the nature of the nonconformity and the decision to correct is made.

Change Requirements

 identify the authorized waiver and its powers, and establish the procedure for such waiver, including the identification of the person authorized by the consumer to give waiver,

 Determine the form in which the nature of the nonconformity and the concession are to be recorded.

Change Application

 establish a person responsible for preventing the initial use of nonconforming products by the consumer and his authority, as well as a procedure for such prevention,

 establish the form in which the record of the nature of the nonconformity and actions taken to prevent initial application is recorded.

The consumer's product.

Obviously, in this situation, none of the mechanisms described above is applicable: the product is out of our control. All we can do in this case is to take actions that reduce the negative consequences or the risk of such consequences for the consumer. As an example, here you can give everyone famous companies for vehicle recalls.

7.3.1 General guidelines

Top management should ensure that the organization has defined, implemented and maintained necessary processes design and develop to effectively and efficiently respond to the needs and expectations of its customers and other interested parties.

When designing and developing products or processes, management needs to ensure that the organization is able to take into account not only its core business and its functions, but also all factors contributing to the performance of products and processes meeting the expectations of customers and other interested parties. For example, an organization must consider product life cycle, health and safety, testability, suitability, ease of use, reliability, durability, ergonomics, environment, product disposal, and certain risks.

Management is also responsible for taking action to identify and mitigate potential risk to users of the organization's products and processes. Risk assessment should be carried out to assess the possibility of their occurrence and the consequences of possible failures or deficiencies in products or processes. The results of the assessment should be used to determine and implement preventive actions to mitigate the identified risks. Examples of design and development risk assessment tools include:

Analysis of the causes and consequences of project failures;
- fault tree analysis;
- reliability forecast;
- dependence diagrams;
- methods of classification;
- modeling methods.

7.3 Design and development 7.3.1 Design and development planning The organization shall plan and manage the design and development of products. During design and development planning, the organization shall determine: a) design and development stages; b) carrying out the analysis, verification and validation appropriate to each stage of design and development; c) responsibility and authority for design and development. The organization shall manage the interaction of the various groups involved in design and development in order to ensure effective communication and a clear division of responsibility. Escape planning should be updated, as appropriate, as design and development progress.

7.3.2 Inputs and outputs for design and development

The organization needs to identify the inputs to the process that affect the design and development of the product and contribute to the effective and effective work process to meet the needs and expectations of customers and other interested parties. These external needs and expectations, combined with the internal demands of the organization, must be suitable for translation into input requirements for the design and development processes.

Examples are:

a) external inputs such as:

The needs and expectations of consumers or the market;
— the needs and expectations of other interested parties;
- the contribution of suppliers;
- user input aimed at creating a stable project and development;
— changes to relevant statutory and regulatory requirements;
- international or national standards;
- industrial codes of practice;

b) internal inputs such as:

Policy and goals;
— the needs and expectations of people in the organization, including those receiving process outputs;
- technological developments;
- requirements for the competence of designers and developers;
- feedback on past experience;
- records and data about existing processes and products;
- outputs of other processes;

c) inputs that define those characteristics of processes or products that are critical to their safety, proper functioning and maintenance, such as data on:

Work, installation and application;
- storage, loading and unloading operations and delivery;
- physical parameters and external environment;
- requirements for the disposal of products.

Product-related inputs based on an assessment of the needs and expectations of end users as well as direct consumers can be essential. These inputs need to be formulated so that the product can be effectively and efficiently verified and validated.

The output includes information that allows verification and validation against planned requirements. Examples of design and development output include:

Data confirming the comparison of the inputs to the process with the outputs of the process;
— product specifications, including acceptance criteria;
- specifications for the process;
- specifications for materials;
- test specifications;
- requirements for personnel training;
- information about the user and consumer;
- procurement requirements;
- protocols for checking compliance with specifications.

Design and development outputs should be analyzed against inputs to provide objective evidence that the outputs effectively and efficiently meet process and product requirements.

ISO 9001:2000. Quality management systems. Requirements 7.3.2 Design and development input Input data relating to product requirements must be defined and records maintained. This data should include: a) functional and operational requirements; b) relevant statutory and regulatory requirements; c) where applicable, information taken from previous similar projects; d) other requirements important to design and development. These inputs should be analyzed for adequacy. Requirements must be complete, unambiguous and consistent. 7.3.3 Design and development output Design and development outputs must be in a form that can be verified against the design and development inputs and must be validated prior to release. Design and development outputs should: a) meet the design and development input requirements; b) provide relevant information on procurement, production and service; c) contain or reference product acceptance criteria; d) determine the characteristics of the product that are essential to its safety and proper use.

7.3.3 Design and development review

Top management needs to ensure that appropriate people are assigned to manage and conduct systematic reviews to establish that design and development goals are being achieved.

Such reviews may be carried out at selected points in the design and development process, as well as after it has been completed.

The objects of such analyzes are:

Adequacy of inputs to complete design and development tasks;
— the progress of the planned design and development process;
— compliance with the objectives of verification and validation;
- assessment of potential risks or causes of failures in the use of products;
- data life cycle relating to product characteristics;
— managing change and its consequences during design and development;
- identification and correction of problems;
— opportunities to improve the design and development process;
- the potential impact of the product on the environment.

At appropriate stages, the organization should also conduct analyzes of design and development outputs and processes to meet the needs and expectations of customers and those of the organization receiving process outputs. Consideration must also be given to the needs and expectations of other stakeholders.

Examples of activities to verify the outputs of the design and development process are:

Comparing input requirements with respect to process output;
- application of comparative methods, such as alternative calculations in design and development;
- assessment in relation to analogues;
- verification, simulation and testing to control compliance with specific requirements for input data;
— evaluation of lessons learned from past experience, such as inconsistencies and process deficiencies.

The validation of the outputs of the design and development processes is important for their successful acquisition and use by customers, suppliers, employees of the organization and other interested parties.

Party participation allows actual users to evaluate outputs through means such as:

Technical design validation prior to construction, installation or application;
— validation of software outputs prior to installation or use;
- Validation of services before they are widely introduced.

Partial validation of design and development outputs may be required to provide confidence in their future application.

Verification and validation should collect sufficient data to enable analysis of design and development methods and decisions made. Method analysis includes:

Improvement of processes and products;
- output data on applicability;
— adequacy of process records and analysis;
— failure investigation activities;
- future needs of the design and development process.

ISO 9001:2000. Quality management systems. Requirements 7.3.4 Design and development review At appropriate stages, a systematic review of the design and development should be carried out in accordance with planned activities in order to: a) evaluating the ability of design and development results to meet requirements; b) identifying any problems and making suggestions for necessary actions. Participants in such a review should include representatives from departments relevant to the design and development stage(s) under review. Records of the results of the analysis and any necessary actions must be maintained. 7.3.5 Design and development verification Verification shall be carried out in accordance with planned activities to ensure that the design and development outputs meet the design and development input requirements. Records of verification results and all necessary actions should be maintained. 7.3.6 Design and development validation Design and development validation shall be carried out in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the intended use or intended use, where known. Where practicable, validation should be completed prior to delivery or sale of the product. Records of the results of the validation and all necessary actions should be maintained. 7.3.7 Design and development change control Design and development changes must be identified and records maintained. Changes should be reviewed, verified and approved, if appropriate, and approved prior to implementation. The analysis of design and development changes shall include an assessment of the impact of the changes on the constituent parts and delivered products. Records of the results of the change analysis and any necessary action shall be maintained.