Input data for design and development. Design and Development Design and Development Change Management
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 effect of the purchased product on subsequent production 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 specified purchasing requirements.
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.
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) analysis, verification and validation appropriate to each stage of design and development;
c) responsibility and authority in the field of 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.
The results of planning should be updated, if necessary, during the course of design and development.
7.3.2. Input for design and development
Inputs relating to product requirements shall be defined and records shall be maintained (clause 4.2.4).
The input must include:
a) functional and operational requirements;
b) relevant legislative and other mandatory requirements;
c) where possible, information taken from previous similar projects;
d) other requirements important to design and development. The input data should be analyzed for sufficiency. Requirements must be complete, unambiguous and consistent.
(Changed edition. Rev. No. 1).
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 formally approved prior to their subsequent use.
Design and development outputs should:
a) meet the 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.
(Changed edition. Rev. No. 1).
7.3.4. Design and development analysis
At appropriate stages, a systematic review of the design and development should be carried out in accordance with the planned activities (clause 7.3.1) 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 all necessary actions should be maintained (clause 4.2.4).
(Changed edition. Rev. No. 1).
7.3.5. Design and Development Verification
Verification shall be carried out in accordance with the planned arrangements (clause 7.3.1) to ensure that the design and development outputs meet the input requirements. Records of verification results and all necessary actions should be maintained (clause 4.2.4).
7.3.6. Design and Development Validation
Design and development validation shall be carried out in accordance with planned arrangements (clause 7.3.1) to ensure that the resulting product meets the requirements for the specified or intended use, if known. Where practicable and appropriate, validation should be completed prior to delivery or use of the product. Records of the results of the validation and all necessary actions should be maintained (clause 4.2.4).
(Changed edition. Rev. No. 1).
7.3.7. Project and development change management
Design and development changes must be identified and records maintained. Changes must be reviewed, verified and validated as 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 products already delivered.
Records of the results of the change analysis and any necessary actions should be maintained (clause 4.2.4).
(Changed edition. Rev. No. 1).
7.3.1 Design and development planning
The leadership of Tyumen State University plans and manages the design and development in accordance with the procedures "Preparation educational process» OP 01.02, "Provision of educational and methodological support" PP 01.03.
When assessing the potential, the components of the education system are considered, which have a quantitative characteristic:
Personnel composition;
Material and technical base;
Information base;
Scientific and methodological support;
Financial resources;
Management of the system and its individual elements.
Tyumen State University usually designs and develops the following documents:
4. Accounting for the strategic and medium-term development plan of Tyumen State University.
The development of new cycles of disciplines and the adjustment of existing ones is ensured by the following tasks:
1. Course design. Definition of learning outcomes.
2. Self-analysis of teaching staff and building their own system of pedagogical activity.
3. Attestation and technology of university self-examination.
Planning of design and development is carried out on the basis of the calendar plan contained in the System of program activities for academic year. The work schedule is divided into stages of work, each of which is detailed into separate tasks.
The work schedule establishes the stages of verification, revision and approval of documentation, the stages of verification and validation, the division of responsibility and authority in the field of design and development between the participants in the work.
The head of a specific work analyzes the terms of reference and determines the composition of the design and development executors (including with the involvement of third-party specialists).
Development and design is carried out by Tyumen State University independently or with the involvement of third-party organizations and / or specialists.
The procedure for monitoring the quality of scientific and educational literature consists of an analysis of the results of the activities of the following structural units:
CIT - organization and support of the electronic environment of the university;
ILC - use (acquisition, issuance) of educational, methodological and scientific literature;
Publishing house - publication of educational and methodical and scientific literature;
Faculties and departments - creation and preparation for publication of scientific and educational literature.
Terms of reference for co-executors are developed by the responsible executor with the participation, if necessary, of involved organizations and / or specialists. The content of the terms of reference is determined by Tyumen State University. The terms of reference are approved by the rector.
The agreement (contract) with the co-executor is agreed upon by the following persons (in order of obtaining visas):
· Companion;
· Supervisor structural unit;
· Quality management representative;
Rector and/or vice-rector.
Input data related to the requirements of the educational process at Tyumen State University include:
1. Requirements for educational and organizational documentation;
2. Requirements for information and educational support;
3. Requirements for teaching staff, administrative and managerial and educational support staff;
4. Requirements for material and technical equipment;
5. Requirements for the level of preparation of applicants;
6. Information from the strategic and medium-term development plan of Tyumen State University.
7.3.3 Design and development output
Design and development outputs are:
Educational programs;
Teaching aids;
Dictionaries.
For any design and development, the output should be:
meet the input requirements for design and development;
· provide relevant information on procurement, production and service;
Determine the characteristics of the design and development outputs that are essential for their safe and correct use.
The completeness of the design and development documentation is determined by the terms of reference. As a rule, a set of documents includes a paper version and an electronic version on CD-ROM.
Responsible for the preparation of documents is the responsible executor.
Copies of the developed design and development documentation and their electronic versions are kept by the responsible executor with subsequent transfer to the archive.
Accounting for documentation is carried out by the responsible executor in accordance with the list of documentation specified in the work schedule. Records fixing the account of the developed documentation are reflected in periodic reports on the work done.
Output data of organizational and methodological work:
§ prepared methodological developments,
§ compiled educational and methodological complexes of disciplines,
§ system for calculating the teaching load,
§ organization of the office work system,
§ drawing up plans for departments,
§ preparation of the department for self-certification and accreditation.
7.3.4 Design and development review
In the process of design and development, a systematic analysis is carried out to establish compliance with the requirements for the results of design and development, that is, the quality of development is analyzed (clauses 3.1.1, 3.8.7 GOST R ISO 9000 - 2001).
Tyumen State University uses a multi-level design and development quality analysis system, which provides for analysis at the appropriate design and development stages in accordance with the planned activities. The analysis system includes the following sequential procedures:
· internal analysis carried out by Tyumen State University in the process of preparing preliminary and final versions of design and development documents;
· internal analysis carried out by Tyumen State University in the process of finalizing (correcting) the documentation on the comments and / or suggestions of the Consumer;
external analysis by state expertise bodies (if necessary);
external analysis carried out by the Consumer.
The design and development review system applies to draft and final versions of the documentation. The acceptance system includes design and development review activities at various levels.
The number of levels of analysis depends on the conditions of design and development and may vary.
I level of analysis
The responsible executor carries out the analysis and acceptance of design and development work in accordance with the terms of reference from the full-time employees of Tyumen State University.
In the event that the responsible executor has comments on the submitted documentation, staff members finalize the documentation in the working order.
Confirmation of the analysis and acceptance of work is the signature of the responsible executor.
II level of analysis
The responsible executor of work under the agreement (contract), together with the staff of Tyumen State University, analyzes the documentation and accepts the work in accordance with the terms of reference from subcontractors.
The confirmation of the analysis carried out is the endorsement by the responsible executor of work under the agreement (contract) of the act of acceptance of work from subcontractors.
III level of analysis
The responsible executor of the work, in accordance with the terms of reference, analyzes and accepts the work on individual sections of the documentation from the involved specialists.
In the event that the responsible executor has comments on the submitted documentation, the involved employees finalize the documentation in the working order.
The confirmation of the analysis carried out is the approval by the responsible executor of the act of acceptance of work from subcontractors.
IV level of analysis
Analysis with the involvement of third-party organizations and / or specialists. The decision to involve third-party organizations and/or specialists for the analysis is made by the Quality Management Representative.
The confirmation of the performed analysis is the endorsement by the responsible executor of work under the agreement (contract) of the work acceptance certificate with third-party organizations and / or specialists involved in the analysis.
V level of analysis
Consumer analysis.
In the event that there are comments during such an analysis of the submitted documentation, the employees finalize the documentation in the working order.
The confirmation of the performed analysis is the signing of the work acceptance certificate by the Consumer.
Materials on the analysis of the design and development are stored in the development department and / or with the responsible work executor for 3 years.
7.3.5 Design and development verification
Verification is carried out in accordance with planned activities to ensure that the design and development outputs meet the input requirements. Activities to confirm the fulfillment of the established requirements are carried out in accordance with the planned activities (clause 7.3.1). The following verification steps are provided for various options design and development:
responsible executor;
a designated employee;
With norm control.
The mark of the verification is the signature of the relevant contractor in the places provided for this (on the documents being developed, in the act, etc.). Records of verification results and all necessary actions are maintained.
7.3.6 Design and development validation
Validation activities are carried out in accordance with the planned activities (clause 7.3.1). The following validation steps are provided for various design and development options:
Head of the department;
Dean or head of the institute;
vice-rector;
quality management representative;
Rector.
The mark of the validation is the signature of the relevant performer in the places provided for this (on the documents being developed, in the act, etc.).
In the cases provided for, validation is carried out by the Consumer and / or third-party organizations.
7.3.7 Design and development change control
Changes to the developed documentation may occur:
When errors are found
when improving the developed documentation;
when changing the requirements of Consumers.
Changes to the developed documentation can be carried out at any stage of the work.
Change texts are developed by the change initiator in accordance with the accepted procedure for development and approval. Changes to the developed documentation are carried out by specialists who perform or have performed the relevant work, under the control of the responsible specialist (the form of the change notification is given in the appendix to procedure 01.04.02 / PP 01.04 "Management of Documents and Records").
Changes made to the developed documentation are analyzed in terms of their impact on other developed project documentation, verified, validated and approved in the same manner as the developed documentation (clauses 7.3.3 - 7.3.6 of the Quality Manual ).
The seized documentation is kept for 3 years.
7.3.1 General guidelines
Top management should ensure that the organization has defined, implemented and maintains the necessary design and development processes to respond effectively and efficiently 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 activities and functions, but also all factors contributing to the performance of products and processes to meet 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 development7.3.1 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:
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 determine the inputs to the process that influence the design and development of the product and that contribute to the efficient and effective operation of the process in order 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 on 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 inputInput data relating to product requirements must be defined and records maintained. This data should include:
These inputs should be analyzed for adequacy. Requirements must be complete, unambiguous and consistent. 7.3.3 Design and development outputDesign 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:
|
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 reviews 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;
- output validation software tool 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 reviewAt appropriate stages, a systematic review of the design and development should be carried out in accordance with planned activities in order to:
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 verificationVerification 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 validationDesign 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 controlDesign 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. |
Inputs relating to product requirements should be defined and records maintained (4.2.4). The input must include:
a) functional and performance requirements;
b) relevant legal and other regulatory requirements;
c) where possible, information taken from previous similar projects;
d) other requirements important to design and development.
The input data should be analyzed for sufficiency. Requirements must be complete, unambiguous and consistent.
Design and development output
Design and development outputs must be in a form suitable for verification against design and development input requirements, and must be formally approved prior to their subsequent use.
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.
NOTE Production and service information may include details of product retention.
Design and development analysis
At appropriate stages, a systematic review of the design and development should be carried out in accordance with the planned activities (7.3.1) 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 should be maintained (4.2.4).
Design and Development Verification
Verification shall be carried out in accordance with the planned arrangements (7.3.1) to ensure that the design and development outputs conform to the input requirements. Records of verification results and all necessary actions should be maintained (4.2.4).
Design and Development Validation
Design and development validation shall be carried out in accordance with planned arrangements (7.3.1) to ensure that the resulting product meets the requirements for the stated or intended use, if known. Where practicable, validation should be completed prior to delivery or use of the product. Records of the results of the validation and all necessary actions should be maintained (4.2.4).
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