Head of Standardization and Quality Control Department. Job description of the head of the quality control department. II. Job responsibilities

06.12.2023

I CONFIRM:

[Job title]

_______________________________

[Name of company]

_______________________________

_______________________/[FULL NAME.]/

"_____" _______________ 20___

JOB DESCRIPTION

Head of Quality Control Department

1. General Provisions

1.1. This job description defines and regulates the powers, functional and job responsibilities, rights and responsibilities of the head of the quality control department [Name of the organization in the genitive case] (hereinafter referred to as the Company).

1.2. The head of the quality control department is appointed and dismissed in accordance with the procedure established by the current labor legislation by order of the head of the Company.

1.3. The head of the quality control department reports directly to [name of the immediate manager's position in the dative case] of the Company.

1.4. The head of the quality control department belongs to the category of managers and has quality engineers subordinate to him.

1.5. A person with a higher professional (technical) education and professional experience in engineering, technical and management positions in the relevant industry profile of the enterprise is appointed to the position of head of the quality control department.

1.6. The head of the quality control department is responsible for:

effective performance of the work assigned to him;
compliance with the requirements of performance, labor and technological discipline;
the safety of documents (information) in his custody (that have become known to him) containing (constituting) a trade secret of the organization.

1.7. The head of the quality control department must know:

legislative and regulatory legal acts, methodological materials on product quality management;
a system of state supervision, interdepartmental and departmental control over product quality;
systems, methods and means of technical control;
production technology of the enterprise's products;
current industry and enterprise standards and technical conditions;
procedure for certification of products (works, services);
procedure for certification of the quality of industrial products;
the procedure for submitting and considering complaints regarding the quality of raw materials, materials, semi-finished products, components and finished products;
rules for testing and acceptance of products;
organization of accounting, procedure and timing for reporting on product quality;
experience of leading domestic and foreign enterprises in achieving high levels of product quality and organizing its control;
fundamentals of economics, organization of production, labor and management;
basics of labor legislation;
rules and regulations of labor protection.

1.8. The head of the quality control department is guided in his activities by:

state and industry production standards;
local acts and organizational and administrative documents of the Company;
internal labor regulations;
rules of labor protection and safety, ensuring industrial sanitation and fire protection;
instructions, orders, decisions and instructions from the immediate supervisor;
this job description.

1.9. During the period of temporary absence of the head of the quality control department, his duties are assigned to [name of the deputy position].

2. Job responsibilities

The head of the quality control department is required to perform the following labor functions:

2.1. Organizes work to control the quality of products manufactured by the enterprise, perform work (services) in accordance with the requirements of standards and technical specifications, approved samples (standards) and technical documentation, terms of delivery and contracts, as well as to strengthen production discipline, ensure high-quality and competitive production products.

2.2. Organizes the development of measures to improve the quality of products (works, services), ensuring their compliance with the modern level of development of science and technology, the needs of the domestic market, export requirements, etc.

2.3. Ensures verification of material resources supplied to the enterprise (raw materials, materials, semi-finished products, components), preparation of conclusions on the compliance of their quality with standards and technical conditions; operational control at all stages of the production process, control of the quality and completeness of finished products, the quality of tools and technological equipment manufactured at the enterprise, as well as the correct storage in the departments of the enterprise and in warehouses of raw materials, materials, semi-finished products, components, and finished products.

2.4. Manages the implementation of measures to improve the quality of products (works, services), prepare them for state certification and certification, develop and implement a quality management system, standards and regulations, indicators regulating the quality of products (works, services), the most advanced control methods involving automation and mechanization of control operations, systems for defect-free delivery of products, non-destructive testing, etc., and the creation of special means for these purposes.

2.5. Participates in the work of determining the range of measured parameters and optimal standards of measurement accuracy, selecting the necessary means for their implementation, monitoring compliance with regulatory deadlines for updating products and preparing them for certification and certification.

2.6. Organizes spot checks of the quality of finished products, raw materials, materials, semi-finished products, components, quality and condition of technological equipment and tools, conditions of production, storage and transportation of products not provided for by the technological process.

2.7. Provides control over the testing of finished products and the preparation of documents certifying the quality of products (works, services), the preparation of complaints in case of violations of supply quality requirements by suppliers, as well as the timely preparation of methods and technological instructions for the ongoing monitoring of the product manufacturing process, the condition of control and measuring equipment at the enterprise and the timeliness of their submission for state verification, ensuring that quality control services provide the necessary technical documentation.

2.8. Heads the work of analyzing complaints, studying the causes of defects and violations of production technology, deterioration in the quality of work, production of defective products and products of lower grades, developing proposals for their elimination, as well as monitoring the implementation of the necessary measures to increase the responsibility of all levels of production for product output, meeting established requirements, to stop accepting and shipping low-quality products.

2.9. Organizes work on recording the results of control operations, maintaining records of product quality indicators, defects and their causes, drawing up periodic reports on the quality of products and work (services) performed.

2.10. Manages department employees.

In case of official necessity, the head of the quality control department may be involved in the performance of his official duties overtime, in the manner prescribed by the provisions of federal labor legislation.

3. Rights

The head of the quality control department has the right:

3.1. Give instructions and tasks to his subordinate employees and services on a range of issues included in his functional responsibilities.

3.2. Monitor the implementation of production tasks, timely execution of individual orders by subordinate services and divisions.

3.3. Request and receive the necessary materials and documents related to the activities of the head of the quality control department, subordinate services and divisions.

3.4. Interact with other enterprises, organizations and institutions on production and other issues within the competence of the head of the quality control department.

4. Responsibility and performance evaluation

4.1. The head of the quality control department bears administrative, disciplinary and material (and in some cases provided for by the legislation of the Russian Federation, criminal) responsibility for:

4.1.1. Failure to carry out or improperly carry out official instructions from the immediate supervisor.

4.1.2. Failure to perform or improper performance of one's job functions and assigned tasks.

4.1.3. Illegal use of granted official powers, as well as their use for personal purposes.

4.1.4. Inaccurate information about the status of the work assigned to him.

4.1.5. Failure to take measures to suppress identified violations of safety regulations, fire safety and other rules that pose a threat to the activities of the enterprise and its employees.

4.1.6. Failure to ensure compliance with labor discipline.

4.2. The performance assessment of the head of the quality control department is carried out:

4.2.1. By the immediate supervisor - regularly, in the course of the employee’s daily performance of his labor functions.

4.2.2. The certification commission of the enterprise - periodically, but at least once every two years, based on documented results of work for the evaluation period.

4.3. The main criterion for assessing the work of the head of the quality control department is the quality, completeness and timeliness of his performance of the tasks provided for in these instructions.

5. Working conditions

5.1. The work schedule of the head of the quality control department is determined in accordance with the internal labor regulations established in the Company.

5.2. Due to production needs, the head of the quality control department is required to go on business trips (including local ones).

5.3. Due to production needs, the head of the quality control department may be provided with official vehicles to carry out his work functions.

6. Signature right

6.1. To ensure his activities, the head of the quality control department is given the right to sign organizational and administrative documents on issues included in his functional responsibilities.

I have read the instructions ___________/___________/ “____” _______ 20__

ECSD 2018. Revision dated April 9, 2018 (including those with changes that entered into force on July 1, 2018)
To search for approved professional standards of the Ministry of Labor of the Russian Federation, use directory of professional standards

Head of Quality Control Department

Job responsibilities. Organizes work to control the quality of products manufactured by the enterprise, perform work (services) in accordance with the requirements of standards and technical specifications, approved samples (standards) and technical documentation, terms of delivery and contracts, as well as to strengthen production discipline, ensure high-quality and competitive production products. Organizes the development of measures to improve the quality of products (works, services), ensuring their compliance with the modern level of development of science and technology, the needs of the domestic market, export requirements, etc. Provides verification of material resources supplied to the enterprise (raw materials, materials, semi-finished products, components), preparation of conclusions on the compliance of their quality with standards and technical conditions, operational control at all stages of the production process, quality control and completeness of finished products, quality of tools manufactured at the enterprise and technological equipment, as well as the correct storage in the departments of the enterprise and in warehouses of raw materials, materials, semi-finished products, components, and finished products. Manages the implementation of measures to improve the quality of products (works, services), prepare them for state certification and certification, develop and implement a quality management system, standards and regulations, indicators regulating the quality of products (works, services), the most advanced control methods involving automation and mechanization of control operations, systems for defect-free delivery of products, non-destructive testing, etc., and the creation of special means for these purposes. Participates in the work of determining the range of measured parameters and optimal standards of measurement accuracy, selecting the necessary means for their implementation, monitoring compliance with regulatory deadlines for updating products and preparing them for certification and certification. Organizes spot checks of the quality of finished products, raw materials, materials, semi-finished products, components, quality and condition of technological equipment and tools, conditions of production, storage and transportation of products not provided for by the technological process. Provides control over the testing of finished products and the preparation of documents certifying the quality of products (works, services), the preparation of complaints in case of violations of supply quality requirements by suppliers, as well as the timely preparation of methods and technological instructions for the ongoing monitoring of the product manufacturing process, the condition of control and measuring equipment at the enterprise and the timeliness of their submission for state verification, ensuring that quality control services provide the necessary technical documentation. Heads the work of analyzing complaints, studying the causes of defects and violations of production technology, deterioration in the quality of work, production of defective products and products of lower grades, developing proposals for their elimination, as well as monitoring the implementation of the necessary measures to increase the responsibility of all levels of production for product output, meeting established requirements, to stop accepting and shipping low-quality products. Organizes work on recording the results of control operations, maintaining records of product quality indicators, defects and their causes, drawing up periodic reports on the quality of products and work (services) performed. Manages department employees.

Must know: legislative and regulatory legal acts, methodological materials on product quality management, a system of state supervision, interdepartmental and departmental control over product quality, systems, methods and means of technical control, production technology of enterprise products, standards and technical conditions in force in the industry and at the enterprise, procedure carrying out certification of products (works, services), the procedure for certifying the quality of industrial products, the procedure for submitting and considering complaints about the quality of raw materials, materials, semi-finished products, components and finished products, rules for testing and acceptance of products, organization of accounting, procedure and deadlines for compiling reports on product quality, the experience of leading domestic and foreign enterprises in achieving high levels of product quality and organizing its control, the basics of economics, the organization of production, labor and management, the basics of labor legislation, rules and regulations of labor protection.

Qualification requirements. Higher professional (technical) education and work experience in the specialty in managerial positions for at least 5 years.

Vacancies for the position of Head of Quality Control Department on the all-Russian vacancy database

The responsibilities of the head of the QC are determined regulations on the department And job description. In accordance with these documents, he must:

Ensure that all necessary tests are carried out on raw materials, intermediate products and finished products;

Provide all necessary information and documents on quality control to the head of the quality assurance department and upon his instructions (recommendations) To an authorized person;

Ensure the preparation and approval of selection SOPs samples, testing of raw materials, materials, intermediates and finished products, as well as other quality control SOPs;

Monitor the condition of the department’s premises, analytical and testing equipment and instruments, their technical maintenance and metrological support, documentation, storage conditions for reagents, drawing up requests for logistics support;

Carry out investigations into cases of non-compliance of raw materials, materials, semi-finished products and finished products with specifications;

Ensure that validation analytical techniques and control equipment used by the department;

To approve or reject, as he deems necessary, raw materials, packaging and labeling materials, as well as intermediate and finished products;

Ensure control of sanitary processing of production premises, cleaning of technological equipment and control production process;

Ensure microbial control contamination of technological clothing, hands of staff, clean rooms, equipment, sterility and pyrogenicity water for injections, finished product;

Ensure product stability control;

Approve specifications for raw materials, materials, semi-products and finished products;

Manage the department’s personnel training program, take part in the preparation of the enterprise’s personnel training program.

Training of QC personnel

Based on the special requirements imposed by the rules of organization and quality control of medicinal products (GMP) for personnel, employees involved in quality control must undergo training in accordance with the program approved by the enterprise. The purpose of the training is to maintain and improve the knowledge of department personnel in the field of quality control at level that ensures the proper performance of their duties, monitoring the degree of understanding and assimilation of GMP rules in relation to control procedures, as well as the adaptation of quality control service employees to the GMP philosophy and the company’s quality policy.

The organization of personnel training, advanced training, as well as the preparation of appropriate plans, is entrusted to the head of the QC.

Personnel training plans are agreed upon with the head of the training facility and approved by the director of the enterprise.

Organization of training. All employees of the quality control department, without exception, participate in the training program. Training of the head of the QC and the head of the quality control department is carried out according to the training program management enterprises.

The following forms of training are practiced:

Without interruption from production;

With a break from production;

Extramural studies;

Externship (independent study of ND with passing an exam; the exam is accepted by a commission created at the enterprise or an examination committee of a training organization).

The form of training is determined by the head of the QC, if necessary, in agreement with the employee.

The frequency of training is determined by the form and specific training plan in accordance with the position held, the quality and degree of mastery of the material at the previous stages of training, as well as labor indicators. The final decision on the frequency of training for a specific employee, as well as the need for early (unscheduled) completion of the course (cycle), is made by the head of the QC, if necessary, in agreement with the HR manager and the specific employee.

The head of the QC has the right to control, verify and evaluate the employee’s knowledge of GMP rules, as well as other regulatory documentation in the field of quality. An employee’s knowledge is assessed through an exam, interview, questionnaire or other form of control (for example, by analyzing performance indicators, the quality of maintaining registration records, etc.), at the discretion of the head of the QC.

The fact of employee participation in the training program is certified by the following documents:

Certificate, identification, reference and other documents issued by training organizations after completion of training;

An entry in the employee’s personal card in the personnel department (personnel department) of the enterprise;

An entry in the QC personnel training log.

Upon completion of training, the employee can undergo certification by the certification commission of the enterprise, which has the right to submit to management a petition to assign the employee a higher (or lowering to a lower) certification category (or another form of identification of professional suitability), giving the right to an increase in wages or other form material or moral incentives (or reduction in wages in case of downgrading).

Training schedules and plans. Training schedules and plans are determined by position, qualifications, length of service and quality of work (performance indicators). In general, the training plan for QC personnel should correspond to that for other departments of the enterprise and include the following forms of training:

- primary, mandatory for all newly hired employees at OKC;

- periodic, mandatory for all employees;

- emergency, for individual employees or groups of employees in case of detection of defects in their work that led to the adoption of erroneous decisions;

- special, intended for training employees under a special program (for example, when working with toxic or potent substances or pathogenic microorganisms, when training to test for the presence of bacterial endotoxins using the LAL test, etc.).

In QC, there may be three schedules and plans for employee training, depending on the position and professional training:

Schedule and training plan for supervisors;

Schedule and training plan for analytical chemists;

Schedule and plan for training microbiologists.

The training schedule for supervisory foremen may include on-the-job training, for example, once a quarter by conducting classes on their own (the head of the QC) or with the invitation of relevant specialists. Lesson duration – 2 academic hours; Classes are held outside working hours with subsequent compensation for hours spent.

It is also possible to train by inviting specialists once a year to conduct a series of classes at the enterprise lasting 1 - 2 weeks.

For off-the-job training, employee(s) are sent once a year to a seminar or training cycle according to the relevant program.

Correspondence studies are carried out in agreement with the relevant educational institution or scientific institute (center).

Esternatura – involves independent study of the relevant material followed by passing an exam (or passing an interview or testing) by a commission at an enterprise or at a relevant educational institution (or research center).

The training plan for inspection supervisors may include the study of RD on procedures for incoming inspection, operational control, control of finished products, environmental control of production premises, personnel, selection samples, personnel hygiene, implementation of SOPs. The study of changes to the RD, control of these changes (change control), control of the maintenance of registration documentation taking into account the requirements of GMP and the changes made may be provided.

The training schedule for analytical chemists may include on-the-job training once every six months by conducting classes on their own (the head of the quality control department) or with the invitation of relevant specialists. Lesson duration – 2 academic hours; Classes are held outside working hours with subsequent compensation for hours spent. It is also possible to train by inviting specialists once a year to conduct a series of classes at the enterprise lasting 1 - 2 weeks.

The training plan for analytical chemists may include the study of methods and techniques for physical and chemical instrumental analysis of drugs, substances, impurities, raw materials and materials, intermediates, express methods for stability analysis (accelerated storage), maintaining registration records, registration, processing and archiving of the results obtained using information technology.

The training of microbiologists can be structured in a similar way. The senior microbiologist may be responsible for drawing up the training schedule and plan.

Incoming control

General provisions

Incoming control means quality control of raw materials, materials, and intermediate products received from the supplier to the enterprise for use in production. The purpose of incoming control procedures is to establish a uniform procedure for monitoring their quality so that non-conforming initial components do not enter production. Incoming control determines the relationship between the divisions of the enterprise regarding control procedures, as well as the relationship between the enterprise and suppliers on quality issues.

Raw materials– medicinal substances, medicinal plants, their parts or processed products, intermediate products received from external suppliers, excipients used in the production and manufacture of medicinal products (except for packaging and labeling materials).

Materials are divided into packaging materials And auxiliary materials. In its turn packaging materials may represent primary packaging materials And secondary packaging materials(except for transport packaging) . Primary packaging materials are in direct contact with dosage forms: these are ampoules, vials, bottles, jars, stoppers, caps, tubes, contour packaging (blisters) for solid dosed non-sterile dosage forms (tablets, dragees, capsules), etc. Secondary packaging materials are used to house primary packaging: these are mainly boxes, cardboard, plastic bags and films, foil, etc. Materials include various types of labels: individual, group, identification, and critical.

Auxiliary materials are mainly represented by excipients or, as they are now called, pharmaceutical excipients– components of a medicinal product (dosage form), giving it certain properties or forming its mass, but not intended for separate use as a medicinal product. These include: water for injections, a large group of excipients in the production of solid dosed medicinal products (diluents, disintegrants, adhesives and glidants, dyes, coating substances, etc.), soft dosage forms - ointments, creams, pastes and suppositories (petroleum jelly, lanolin, hydrogenated oils, emulsifiers , surfactants, etc.).

Intermediate product– partially processed raw materials that must go through further stages technological process before it becomes a finished product.

Raw materials, materials and intermediate products to be checked are included in the specification for incoming control, developed by the production department and agreed with the quality control department, and, if necessary, with other departments and services, and approved by the production director. The specification is developed for the same period for which the technological regulations of the enterprise are approved. If necessary, changes and additions are made to the specification in accordance with the established procedure. In relation to raw materials, the name of quality indicators is established, according to which an inspection must be carried out. The list of mandatory raw material quality indicators is established taking into account the provision technological process in accordance with the requirements of the current technological regulations, as well as the production of products that meet the requirements of regulatory documentation (ND). The approved specification is transferred to the departments performing incoming control.

To organize incoming quality control, an incoming quality control group is usually created within the quality control department.

Main goals

The main tasks solved during incoming inspection include:

Monitoring the compliance of the quality of raw materials, materials, semi-products received by enterprises from the supplier(s) with the requirements of specifications;

Preventing the occurrence of defects due to the receipt of initial components of medicinal products of inadequate quality at the enterprise;

Timely preparation of data for filing complaints about incoming raw materials in cases where their quality does not meet specification requirements;

Monitoring and accumulation of statistical data on the actual level of quality of raw materials supplied to the enterprise and development on this basis of recommendations for evaluating suppliers, including approved ones, in the temporary aspect of their work;

Periodic monitoring of compliance with the rules and shelf life of suppliers’ products;

Deciding on the feasibility of transferring incoming quality control of raw materials to the supplier’s enterprise.

Procedures

Incoming quality control can be continuous or selective. Complete control is carried out in the following cases:

When there is a risk of releasing products that do not meet specifications due to the low quality of raw materials supplied to the enterprise in the absence of an alternative supplier;

If the supplier has made changes in technology that he did not notify the consumer in advance and which raise concerns about a possible deterioration in the quality of his products;

When increased demands are placed on the manufactured product, and controlled raw materials are used in its production (for example, in the production of sterile medicinal products intended for administration into the cerebrospinal fluid);

If multiple defects are detected during sampling.

In a number of EU countries, regulatory authorities often require pharmaceutical companies to conduct continuous incoming inspection of active pharmaceutical ingredients (substances). Such requirements are imposed, for example, by the Irish regulatory authorities in relation to enterprises located in the free economic zones of Dublin and Shannon. Continuous incoming control is also applied to raw materials intended for the production of sterile products.

Selective control is carried out under the condition of stable functioning production in the aspect of constant and guaranteed compliance with both the quality of our own production and the supplier’s products. When conducting random inspection, inspection plans and acceptance rules must comply with ND and product specifications.

Sample selection

In selective inspection, the most important thing is sample representativeness during selection samples. The formula 0.4 (n) 0.5 recommended by the Global Fund XI is outdated. In addition, based on the requirements of the pharmacopoeia, it should only be used in the selection samples finished products. The practice of its widespread use in other cases of selection samples does not guarantee during random control sample representativeness and, consequently, obtaining reliable and objective information about the quality of products in the studied series.

Consider a procedure that guarantees sample representativeness.

Let from a supply of raw materials containing n one package of raw materials series, selected randomly m packages from which selection must be made samples. How to determine the number of packages for selection samples so that the sample is representative? What is the degree of confidence in the results obtained from testing the selected samples? How to test selected ones samples?

An analysis of the various approaches currently used to obtain answers to the questions posed shows that the most acceptable is the approach based on the MIL-STD-105D (USA) standard. table 16, table 17 data is provided to allow you to select the required number m packages and evaluate the quality of the delivered batch based on testing results samples taken from these packages.

To illustrate, let's look at a specific example. Let us assume that the supply consists of n=160 packs. It is required to select and evaluate the quality of the delivered batch of raw materials based on testing results samples.

From the data presented in table. 16 it follows that the number of packages from which must be selected samples, is equal to 32, i.e. m=32. If a positive result is obtained after testing all 32 samples, then an acceptable level of quality is ensured (acceptable quality level (AQL) means the percentage of packages with defective raw materials) equal to 0.4% (see Table 17). If a positive result is obtained during testing 31 samples out of 32 selected, the quality level will be 1.5%. If test results are positive 29 samples out of 32, a quality level of 4% is ensured.

Consequently, the formation of the average samples from all selected samples and its testing makes it possible to assess the actual level of quality provided only in the case of a positive result of its testing. At the same time, assessing the actual level of quality provided is often important in practice, especially when testing packaging materials with text printed on them, as well as labels.

Table 16

Relationship between n And m

Let's consider another case. Let, under the influence of the environment, a property of an object, for example, m s М M, transforms into another property, for example, m p s М M p. It is obvious that the degree of difference between the properties m s and m p s, characterized by the distance between points m s and m p s, depends, in the general case, on the level of environmental influence on part of the object ( sample). With a low level of environmental impact on part of the object ( sample) the distance between points m s and m p s can be so small that the decision made regarding the property m p s will coincide with the property m s. If there is a large level of environmental impact on part of the object ( sample) the distance between points m s and m p s can be so great that the decision made regarding the property m p s will be fundamentally different from the property m s.

Therefore, it is necessary to ensure such conditions for selecting part of the object under study ( samples), in which the impact of the environment on some properties in the process of selecting part of the object under study ( samples) would be minimal or non-existent.

These conditions, in general, can be ensured if the selection samples of the studied object (raw materials, intermediate products, finished products, water for injection, ambient air, etc.) will be carried out according to written instructions (standard operating procedure) in a room (box) with cleanliness class, higher or equal cleanliness class a room in which the environment directly affects the object, and the sequence of actions described in the instructions (standard operating procedure) has been successfully completed validation. In addition, the delivery procedures themselves samples to the quality control laboratory premises where testing is carried out samples, the design of these premises, as well as the procedure and testing conditions must also eliminate or at least significantly reduce the impact of the environment on samples.

Of course, in special cases, the stated requirements can be specified.

Table 17

Data for assessing the delivered batch of raw materials

PUK, %

0,010

0,015

0,025

0,040

0,065

0,10

0,15

0,25

0,40

0,65

1,0

1,5

2,5

4,0

0 1

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Head of Quality Control Department(.doc, 76KB)

I. General provisions

The head of the quality control department belongs to the category of managers.
A person with a higher professional (technical) education and work experience in the specialty of at least 5 years is appointed to the position of head of the quality control department.
Appointment to the position of head of the quality control department and dismissal from it is made by order of the director of the enterprise.
The head of the quality control department must know:
1. 4.1. Legislative and regulatory legal acts, methodological materials on product quality management.
2. 4.2. A system of state supervision, interdepartmental and departmental control over product quality.
3. 4.3. Systems, methods and means of technical control over product quality.
4. 4.4. Systems, methods and means of technical control.
5. 4.5. Technology of production of the enterprise's products.
6. 4.6. Current industry and enterprise standards and technical conditions.
7. 4.7. The procedure for certification of products (works, services).
8. 4.8. The procedure for certification of the quality of industrial products.
9. 4.9. The procedure for submitting and considering complaints regarding the quality of raw materials, materials, semi-finished products, components and finished products.
10. 4.10. Rules for testing and acceptance of products.
11. 4.11. Organization of accounting, procedure and timing of reporting on product quality.
12. 4.12. Experience of leading domestic and foreign enterprises in achieving high levels of product quality and organizing its control.
13. 4.13. Fundamentals of economics, organization of production, labor and management.
14. 4.14. Fundamentals of labor legislation.
15. 4.15. Labor protection rules and regulations.
During the absence of the head of the quality control department (vacation, illness, etc.), his duties are performed by a deputy (in his absence, a person appointed in the prescribed manner), who acquires the corresponding rights and is responsible for the proper performance of the duties assigned to him.

II. Job responsibilities

Head of Quality Control Department:

Organizes work to control the quality of products manufactured by the enterprise, perform work (services) in accordance with the requirements of standards and technical specifications, approved samples (standards) and technical documentation, terms of delivery and contracts, as well as to strengthen production discipline, ensure high-quality and competitive production capable products.
Organizes the development of measures to improve the quality of products (works, services), ensuring their compliance with the modern level of development of science and technology, the needs of the domestic market, export requirements, etc.
Ensures verification of material resources supplied to the enterprise (raw materials, materials, semi-finished products, components), preparation of conclusions on the compliance of their quality with standards and technical conditions.
Operational control at all stages of the production process, control of the quality and completeness of finished products, the quality of tools and technological equipment manufactured at the enterprise, as well as the correct storage in the departments of the enterprise and in warehouses of raw materials, materials, semi-finished products, components, finished products.
Manages the implementation of measures to improve the quality of products (works, services), prepare them for state certification and certification, develop and implement quality management systems, standards and regulations, indicators regulating the quality of products (works, services), the most advanced control methods involving automation and mechanization of control operations, systems for defect-free delivery of products, non-destructive testing, etc., and the creation of special means for these purposes.
Participates in the work of determining the range of measured parameters and optimal standards of measurement accuracy, selecting the necessary means for their implementation, monitoring compliance with regulatory deadlines for updating products and preparing them for certification and certification.
Organizes spot checks of the quality of finished products, raw materials, materials, semi-finished products, components, quality and condition of technological equipment and tools, conditions of production, storage and transportation of products not provided for by the technological process.
Ensures control over testing of finished products and execution of documents certifying the quality of products (works, services), preparation of complaints in case of violation of supply quality requirements by suppliers, as well as timely preparation of methods and technological instructions for ongoing monitoring of the product manufacturing process, the condition of control and measuring equipment at the enterprise and the timeliness of their submission for state verification, ensuring that quality control services provide the necessary technical documentation.
Heads the work of analyzing complaints, studying the causes of defects and violations of production technology, deterioration in the quality of work, production of defective products and products of lower grades, developing proposals for their elimination, as well as monitoring the implementation of the necessary measures to increase the responsibility of all levels of production for product output, meeting established requirements, to stop accepting and shipping low-quality products.
Organizes work on recording the results of control operations, maintaining records of product quality indicators, defects and their causes, drawing up periodic reports on the quality of products and work (services) performed.
Manages department employees.

III. Rights

The head of the quality control department has the right:

Act on behalf of the department, represent the interests of the enterprise in relations with other structural divisions of the enterprise, organizations on issues of management and product quality control.
Request and receive necessary information from heads of structural divisions of the enterprise and specialists.
Check the activities of the structural divisions of the enterprise for compliance with the requirements of standards and technical specifications when producing the enterprise's products.
Interact with the heads of all structural divisions on management and quality control issues.
Independently conduct correspondence with structural divisions of the enterprise as well as other organizations on issues within its competence.

IV. Responsibility

The head of the equipment procurement department is responsible for:

For improper performance or failure to fulfill one’s job duties as provided for in this job description - within the limits determined by the current labor legislation of the Russian Federation.
For offenses committed in the course of carrying out their activities - within the limits determined by the current administrative, criminal and civil legislation of the Russian Federation.
For causing material damage - within the limits determined by the current labor and civil legislation of the Russian Federation.

I approve

_____________________________ (Last name, initials)

(name of organization, its ________________________________

organizational and legal form) (director; other person authorized

approve job description)

JOB DESCRIPTION FOR THE HEAD OF QUALITY CONTROL DEPARTMENT

——————————————————————-

(name of institution)

00.00.201_g. №00

I. General provisions

1.1. This job description establishes the rights, responsibilities and job responsibilities of the head of the quality control department ________________________________________ (hereinafter referred to as the “enterprise”). Name of institution

1.2. The head of the quality control department belongs to the category of managers.

1.3. A person appointed to the position of head of the quality control department must have a higher professional (technical) education and work experience in his specialty in managerial positions for at least 5 years.

1.4. Appointment to the position of head of the quality control department and dismissal from it is carried out on the basis of an order.

1.5. The head of the quality control department reports directly to _________________________________________________________________________________.

1.6. If the head of the quality control department is absent, then his duties are temporarily performed by a person appointed in accordance with the established procedure, who is responsible for the proper performance of his official duties.

1.7. In his activities, the head of the quality control department is guided by:

the charter of the enterprise and this job description;
labor regulations;
legislative and regulatory documents on the work performed;
methodological materials relating to relevant issues;
orders and instructions of the director of the enterprise (direct manager).

1.8. The head of the quality control department must know:

production technology of the enterprise's products;
current industry and enterprise standards and technical conditions;
procedure for certification of products (works, services);
procedure for certification of the quality of industrial products;
the procedure for submitting and considering complaints regarding the quality of raw materials, materials, semi-finished products, components and finished products;
rules for testing and acceptance of products;
legislative and regulatory legal acts, methodological materials on product quality management;
a system of state supervision, interdepartmental and departmental control over product quality;
systems, methods and means of technical control;
organization of accounting, procedure and timing for reporting on product quality;
basics of labor legislation;
labor safety rules and regulations;
experience of leading domestic and foreign enterprises in achieving high levels of product quality and organizing its control;
fundamentals of economics, organization of production, labor and management.

II. Functions

The head of the quality control department is assigned the following functions:

2.1. Preparation of relevant documentation.

2.2. Maintaining records of product quality indicators.

2.3. Submission of established reports.

2.4. Ensuring healthy and safe working conditions for subordinate performers.

2.5.Organization of work to control the quality of products manufactured by the enterprise, performance of work (services).

2.6. Methodological support for issues within his competence.

III. Job responsibilities

The head of the quality control department performs the following job responsibilities:

3.1. Provides verification of material resources supplied to the enterprise (raw materials, materials, semi-finished products, components), as well as preparation of conclusions on the compliance of their quality with standards and technical conditions.

3.2. Conducts activities to improve the quality of products (works, services), manages their preparation for state certification and certification.

3.3. Manages the development and implementation of a quality management system, standards and regulations, indicators regulating the quality of products (works, services), the most advanced control methods, providing for automation and mechanization of control operations, systems for defect-free delivery of products, non-destructive testing, etc., the creation for these purposes of special means.

3.4. Organizes the work:

— to control the quality of products manufactured by the enterprise, the performance of work (services) in accordance with the requirements of standards and technical conditions, approved samples (standards) and technical documentation, terms of delivery and contracts;

— to strengthen production discipline;

— to ensure the production of high-quality and competitive products.

3.5. Organizes the development of measures to improve the quality of products (works, services), ensure their compliance with the current level of development of science and technology, the needs of the domestic market, export requirements, etc.

3.6. Provides:

— operational control at all stages of the production process;

— quality control and completeness of finished products, quality of tools and technological equipment manufactured at the enterprise;

— correct storage in departments of the enterprise and in warehouses of raw materials, materials, semi-finished products, components, finished products.

3.8. Heads the work aimed at ensuring control over the implementation of the necessary measures to increase the responsibility of all levels of production for the production of products that meet established requirements, to stop accepting and shipping low-quality products.

3.9. Takes part in the work to determine the range of measured parameters and optimal standards of measurement accuracy, and to select the necessary means for their implementation.

3.10. Manages department employees.

3.11. Provides control:

— testing of finished products and preparation of documents certifying the quality of products (works, services);

— for the timely preparation of methods and technological instructions for ongoing monitoring of the product manufacturing process;

Over the condition of control and measuring equipment at the enterprise and the timeliness of their submission for state verification;

— providing quality control services with the necessary technical documentation.

3.12. Organizes spot checks of the quality of finished products, raw materials, materials, semi-finished products, components, quality and condition of technological equipment and tools, production conditions, storage and transportation of products not provided for by the technological process.

3.13. Organizes work on recording the results of control operations, maintaining records of product quality indicators, defects and their causes, drawing up periodic reports on the quality of products and work (services) performed.

3.14. Takes part in work aimed at monitoring compliance with regulatory deadlines for updating products and preparing them for certification and certification.

IV. Rights

The head of the quality control department has the right:

4.1. Contact the company management:

— with proposals for improving the activities of the enterprise on relevant issues;

- with demands to provide assistance in the performance of their official duties and rights.

4.2. Get acquainted with the draft decisions of the enterprise management related to its activities.

4.3. Monitor compliance with standards and technical specifications when releasing products in the structural divisions of the enterprise.

4.4. Represent the interests of the enterprise in relations with other organizations and government bodies on issues of product quality management.

4.5. Interact with heads of structural divisions of the enterprise.

4.6. Receive information and documents necessary to perform your job duties.

4.7. Conduct correspondence with structural divisions of the enterprise and other organizations on issues of product quality management.

4.8. Sign and endorse documents within your competence.

V. Responsibility

The head of the quality control department is responsible for:

5.1. In case of causing material damage, within the limits determined by the criminal, civil, and labor legislation of the Russian Federation.

5.2. If an offense is committed in the course of carrying out its activities, within the limits determined by the criminal, civil, administrative legislation of the Russian Federation.

5.3. In case of failure to perform or improper performance of their official duties, which are provided for in this job description, within the limits determined by the labor legislation of the Russian Federation.

Head of structural
divisions:

(signature) surname, initials

00.00.00
(signature) surname, initials

I have read the instructions:

00.00.00
(signature) surname, initials

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