7.3.1 Design and development planning
The management of Tyumen State University plans and manages design and development in accordance with the procedures “Preparation of the educational process” OP 01.02, “Providing educational and methodological support” PP 01.03.
When assessing potential, the components of the education system that have quantitative characteristics are considered:
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 carries out the design and development of the following documents:
4. Taking into account the strategic and medium-term development plan of Tyumen State University.
The development of new cycles of disciplines and adjustment of existing ones is ensured by the implementation of the following tasks:
1. Course design. Definition of learning outcomes.
2. Self-analysis of teaching staff and construction of their own system of teaching activities.
3. Certification and technology of self-examination of the university.
Design and development planning is carried out on the basis of the calendar plan contained in the System of Program Activities for the academic year. The work schedule is divided into stages of work, each of which is detailed into individual tasks.
The work schedule establishes the stages of verification, revision and approval of documentation, the stages of verification and validation, the division of responsibilities and powers in the field of design and development between the participants in the work.
The manager of a specific work analyzes the technical specifications 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 divisions:
CIT – organization and support of the university’s electronic environment;
ILC – use (acquisition, issuance) of educational, methodological and scientific literature;
Publishing house – publication of educational, methodological and scientific literature;
Faculties and departments – creation and preparation for publication of scientific and educational literature.
Technical specifications for co-executors are developed by the responsible contractor with the participation, if necessary, of involved organizations and/or specialists. Content terms of reference 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 the order of obtaining visas):
· Co-executor;
· 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 includes:
1. Requirements for educational and organizational documentation;
2. Requirements for information and educational support;
3. Requirements for teaching staff, administrative, managerial and educational support personnel;
4. Requirements for material and technical equipment;
5. Requirements for the level of training of applicants;
6. Information from the strategic and medium-term development plan of Tyumen State University.
7.3.3 Design and development output
The design and development outputs are:
Educational programs;
Teaching aids;
Dictionaries.
For all design and development, the output must:
· meet input requirements for design and development;
· provide relevant information on procurement, production and service;
· determine the characteristics of the design and development results that are essential for their safe and correct use.
The completeness of the design and development documentation is determined by the technical specifications. Typically, a set of documents includes a paper version and an electronic version on CD-ROM.
The responsible executor is responsible for the preparation of documents.
Copies of the developed design and development documentation and their electronic versions stored by the responsible executor with subsequent transfer to the archive.
Documentation is kept by the responsible person in accordance with the list of documentation specified in the work schedule. Records recording the documentation developed 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,
§ payment system study load,
§ exam schedule,
§ organization of an office management system,
§ drawing up department plans,
§ preparation of the department for self-certification and accreditation.
7.3.4 Design and development analysis
During the design and development process, a systematic analysis is carried out to establish compliance with the requirements for the design and development results, that is, the quality of the development is analyzed (clauses 3.1.1, 3.8.7 GOST R ISO 9000 - 2001).
Tyumen State University uses a multi-level system for analyzing the quality of design and development, which provides for the analysis to be performed at the appropriate stages of design and development in accordance with 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 (adjusting) documentation based on the comments and/or suggestions of the Consumer;
· external analysis by state examination bodies (if necessary);
· external analysis carried out by the Consumer.
The design and development review system applies to preliminary and final versions of documentation. The acceptance system includes activities to analyze design and development at various levels.
The number of levels of analysis depends on the design and development conditions 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 technical specifications from Tyumen State University staff.
If the responsible person has any comments on the submitted documentation, staff members finalize the documentation in a routine manner.
Confirmation of the analysis and acceptance of the work is the signature of the responsible executor.
II level of analysis
The responsible executor of the work under the agreement (contract), together with Tyumen State University staff, analyzes documentation and accepts work in accordance with the technical specifications from subcontractors.
Confirmation of the analysis is the endorsement by the responsible contractor of the work under the agreement (contract) of the work acceptance certificate from subcontractors.
III level of analysis
The responsible executor of the work, in accordance with the terms of the technical specifications, analyzes and accepts the work on individual sections of the documentation from the involved specialists.
If the responsible person has any comments on the submitted documentation, the involved employees finalize the documentation in a routine manner.
Confirmation of the analysis carried out is the endorsement by the responsible executor of the work acceptance certificate from subcontractors.
IV level of analysis
Analysis with the involvement of third-party organizations and/or specialists. The decision to engage third-party organizations and/or specialists for analysis is made by the Quality Management Representative.
Confirmation of the analysis carried out is the endorsement by the responsible contractor of the 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
Analysis from the Consumer side.
If there are any comments during such an analysis on the submitted documentation, employees finalize the documentation in a routine manner.
Confirmation of the analysis carried out is the signature of the work acceptance certificate on the part of the Consumer.
Materials on the analysis of the project and development are stored in the development department and/or with the responsible contractor for 3 years.
7.3.5 Design and development verification
Verification is carried out according to planned activities to ensure that the design and development outputs meet the input requirements. Activities to confirm compliance with established requirements are carried out in accordance with planned activities (clause 7.3.1). The following verification steps are provided for various design and development options:
Responsible executor;
A specially appointed employee;
Under standard control.
A mark on verification is the signature of the relevant executor in the places provided for this (on 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 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.
A confirmation of the validation is the signature of the relevant executor in the places provided for this (on documents being developed, in the act, etc.).
In appropriate cases, validation is carried out by the Consumer and/or third parties.
7.3.7 Design and development change management
Changes to the developed documentation may occur:
· when errors are detected;
· when improving the developed documentation;
· when Customer requirements change.
Changes to the developed documentation can be made at any stage of the work.
The texts of changes are developed by the initiator of the change 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 notification of changes is given in the appendix to procedure 01.04.02/PP 01.04 “Documentation and Records Management”).
Changes made to the developed documentation are analyzed from the point of view of their impact on other developed documentation for the project, verified, validated and agreed upon in the same manner as the documentation being developed (clauses 7.3.3 - 7.3.6 of the Quality Guide ).
The seized documentation is kept for 3 years.
7.3.1. Design and development planning
The organization must plan and manage the design and development of products.
During design and development planning, the organization should determine:
a) design and development stages;
b) carrying out 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 must manage the interaction various groups involved in design and development, to ensure effective communication and clear distribution of responsibilities.
Planning results should be updated, if necessary, as design and development progress.
7.3.2. Design and Development Inputs
Input data related to product requirements must be defined and records maintained (4.2.4).
Inputs should include:
a) functional and operational requirements;
b) relevant legal and other mandatory requirements;
c) where possible, information taken from previous similar projects;
d) other requirements important for design and development. Input data must be analyzed for sufficiency. Requirements must be complete, unambiguous and consistent.
(Changed edition. Amendment No. 1).
7.3.3. Design and development output
The outputs of design and development shall be presented in a form that allows verification against the design and development input requirements, and shall 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. Amendment No. 1).
7.3.4. Design and development analysis
At appropriate stages, a systematic analysis of the design and development should be carried out in accordance with the planned activities (clause 7.3.1) in order to:
a) assessing the ability of the design and development results to satisfy the 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) being analyzed. Records of the analysis results and all necessary actions must be maintained in working order (clause 4.2.4).
(Changed edition. Amendment No. 1).
7.3.5. Design and development verification
Verification shall be carried out in accordance with planned activities (clause 7.3.1) to ensure that the design and development outputs meet the input requirements. Records of verification results and all necessary actions must be maintained in working order (clause 4.2.4).
7.3.6. Design and development validation
Validation of the design and development shall be carried out in accordance with the planned activities (clause 7.3.1) to ensure that the resulting product meets the requirements for its specified or intended use, if known. Where practicable and appropriate, validation should be completed prior to delivery or use of the product. Records of validation results and all necessary actions must be maintained (clause 4.2.4).
(Changed edition. Amendment 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 before implementation. Review of design and development changes should include an assessment of the impact of the changes on components and products already delivered.
Records of the results of the change analysis and any necessary actions must be maintained (clause 4.2.4).
(Changed edition. Amendment No. 1).
Input data related to product requirements shall be defined and records shall be 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
The design and development outputs shall be in a form suitable for verification against the design and development input requirements and shall 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 maintenance information may include details of product preservation.
Design and development analysis
At appropriate stages, a systematic review of the design and development shall be carried out in accordance with the planned activities (7.3.1) in order to:
a) assessing the ability of the design and development results to satisfy 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) being analyzed. Records of the results of the analysis and all necessary actions shall be maintained (4.2.4).
Design and development verification
Verification shall be carried out in accordance with planned activities (7.3.1) to ensure that the design and development outputs meet the input requirements. Records of the results of verification and all necessary actions shall be maintained (4.2.4).
Design and development validation
Validation of the design and development shall be carried out in accordance with the planned activities (7.3.1) to ensure that the resulting product meets the requirements for its specified or intended use, if known. Where practicable, validation should be completed prior to delivery or use of the product. Records of the results of validation and all necessary actions shall be maintained (4.2.4).
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 before implementation. Review of design and development changes must include an assessment of the impact of the changes on components and products already delivered. Records of the results of the change analysis and any necessary actions shall be maintained (4.2.4).
Procurement
Procurement process
The organization shall ensure that purchased products comply with established purchasing requirements. The type and degree of control applied to the supplier and purchased product should depend on its impact on subsequent stages life cycle products or finished products.
The organization shall evaluate and select suppliers based on their ability to provide 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 resulting from the assessment shall be maintained (4.2.4).
Purchasing information
The purchasing information must describe the products ordered, including, where appropriate, the requirements:
a) to the official approval of products, procedures, processes and equipment;
b) personnel qualifications;
c) the quality management system.
The organization shall ensure that specified purchasing requirements are sufficient before they are communicated to the supplier.
Input data must be identified in order to provide the basis for the formulation of requirements that are used to verify and validate the output data. Input data can be external and internal.
To ensure that the needs and expectations of all interested parties for a process and/or service, process or system are met, design and/or development inputs must be accurate and complete. Resolution of ambiguous or contradictory inputs should be done with input from affected external and internal parties.
External inputs may include customer or market needs and expectations, stakeholder specifications, contractual requirements, regulatory requirements, international or national standards, and 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 design and/or development of software or services, inputs arising from end user requirements (as well as direct customer requirements) may be particularly important. Such inputs must be formulated in such a way that they can be effectively controlled during subsequent verification and approval. Such inputs must be formulated in such a way that they can be effectively controlled during subsequent verification and approval.
Inputs may also arise during the development phase from activities that are not even fully evaluated. Also, input data should be the subject of evaluation of subsequent review and verification and approval 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 work operations, storage, handling, operation and disposition requirements.
Typical examples of development activities include:
modified materials,
changed 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.
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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 market; applicable regulatory and legislative requirements; applicable requirements for environment requirements arising from previous similar projects; any other requirements essential to the design and development. These inputs must be reviewed for adequacy or inconsistency with respect to the requirements to be met. |
Input data related to product requirements must be defined and records maintained. This data should include:
a) functional and operational requirements;
b) applicable legal and regulatory requirements;
c) where applicable, information taken from previous similar projects;
d) other requirements important for design and development.
These input data must be analyzed for adequacy. Requirements must be complete, unambiguous and consistent.
Design and development output
The design and development outputs must be in a form that can be verified against the design and development input requirements and must be approved prior to release.
Design and development outputs should:
a) meet the input requirements for design and development;
b) provide relevant information on procurement, production and service;
c) contain product acceptance criteria or references to them;
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 the planned activities in order to:
a) assessing the ability of the design and development results to meet the 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) being analyzed. Records of the results of the analysis and all 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 must 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 actions should be maintained.
Procurement process
The organization shall ensure that purchased products comply with purchasing requirements. The type and degree of control applied to the supplier and purchased products should depend on the impact of the purchased product on subsequent production of the product or finished product.
The organization shall evaluate and select suppliers based on their ability to provide 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 resulting from the assessment must be maintained.
Purchasing information
Purchasing information must 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 products comply with specified purchasing requirements.
If the organization or its customer intends to carry out verification activities at the supplier's facility, the organization shall establish in the purchasing information the intended verification activities and method of release from the supplier.
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