New requirement from Yandex or mobile control on the line. Linear control as one of the forms of inspection of therapeutic institution linear control car on the road

For 2012

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Memo for the constituent entities of the Russian Federation on the procedure for notifying the Federal Service for Health Supervision on the Beginning of Entrepreneurial Activities of Medical Products

Roszdravnadzor informs that from 12/18/2014 subjects Russian Federation Notification must be notified Federal Service for supervision in the health sector about the beginning business activities in the field of circulation medical devices (except for the conduct of clinical trials of medical devices, their production, installation, commissioning, applications, operation, including maintenanceas well as repair).

In accordance with Article 8 Federal Law dated December 26, 2008 No. 294-FZ "On the protection of the rights of legal entities and individual entrepreneurs in the implementation of state control (supervision) and municipal control»Notification of the start of implementation separate species Entrepreneurial activity is revealed legal entity, individual entrepreneur In the authorized federal organ executive power after state registration and registering in tax authority Prior to the start of the actual performance of work or the provision of services.

The procedure for notification was determined by the Decree of the Government of the Russian Federation of 16.07.2009 No. 584 "On the notification procedure for the implementation of certain types of entrepreneurial activities" (hereinafter - the Decree).

To register notifications about the start of entrepreneurial activities, subjects of medical products are necessary to submit to Roszdravnadzor this document in the form established by Appendix No. 2 to the ruling, directly or to send it by registered mail with the description of the investment with the notification of the presentation or in the form of electronic documentsigned electronic digital signature Applicant.

The list of works and services is determined by clause 5.8 of the Resolution.

Notification is submitted to Roszdravnadzor in 2 copies.

In accordance with clause 10 of the Resolution, legal entities and individual entrepreneurs are obliged to report to the authorized body, which recorded notifications, information on the following changes:

a) change the place of finding a legal entity and (or) the place of actual activities;

b) the change in the place of residence of an individual entrepreneur and (or) the place of actual activities;

c) reorganization of a legal entity.

Information on these changes is submitted to the authorized body within 10 days from the date of making appropriate changes by submitting an application in an arbitrary form with an application of copies of documents confirming the fact that the applicant's electronic digital signature is signed by the electronic digital signature.

On the organization that operated in the field of treatment of medical devices until December 18, 2014, the notification requirement does not apply, but such organizations have the right to submit to Roszdravnadzor the corresponding notice.

In the event that activities in the field of medical deviations were carried out until 18.12.2014 and notifying a legal entity, an individual entrepreneur was not filed in connection with this, then when opening new separate units, a notification should be submitted in accordance with the decision.

Please note that for failure to provide information or the presentation of obviously unreliable information into the federal executive body, performing functions to control and supervision in the field of health, is provided administrative responsibility According to Art. 19.7.8. "Code of the Russian Federation on Administrative Offenses".

canceled / lost strength Editorial 31.12.1981

Order of Maintotrans RSFSR from 31.12.81 N 200 "On approval of the rules for organizing passenger traffic on road transport" (Part 1.)

Linear control

202. Control on the line for the work of passenger vehicles provides for checks:

Quality preparation of cars to work on line (external and internal appearance, equipment);

Execution by drivers, conductor and other linear employees of their official instructions;

Compliance with the schedule of the motion of buses on the routes;

Compliance by drivers of traffic rules;

The correct design of travel documentation;

Fullness of revenue collection;

Status of linear structures;

Availability of passenger taxi in parking lots;

Conditions of taxometer and speedometer equipment of cars;

States and equipment of parking lots of passenger taxi;

Efficiency of the use of radio property;

Passenger execution "Rules for use of urban messages" (Appendix 36), "Rules for use of suburban buses" (Appendix 37) and "Rules for using long-distance communications buses" (Appendix 38).

203. Control over the work of passenger vehicles on the line is carried out by the Audio Service transportation (passenger transportation management), linear dispatchers, administration, public controllers, and in long-distance routes, in addition, the staff of the bus stations and passenger bus service.

204. The Control and Auditor Service of the Transport Management carries out linear control in accordance with the Charter of the RSFSR Automobile Transport and the Regulations on the Control and Revolutionary Service of the Ministry of Automobile Transport of the RSFSR, approved by Resolution of the Council of Ministers of the RSFSR from 03.04.70 N 203.

205. The persons listed in paragraph 203 carry out control on the line if they have a certificate of the control and auditor service of transport management, a certificate of a public controller, and the Administration of Transport Management (Passenger Automobile Transport Management) and motor transport enterprises - in the presence of office certificates.

These individuals monitor control in accordance with the "Methodological Guidelines for the Organization of Padshrunny Control of Fares for City buses" (Appendix 39), as well as in force on road transport by other provisions and instructions.

206. On all the violations identified on the line of violations, the employees of the Audio Service produce marks in travel sheets, the place and time of control are indicated, and the passenger taxi is noted the speedometer and taximeter testimony at the time of control. With gross violations of the rules for the use of cars, abuses with revenue are drawn up acts and reports in forms, approved by the Ministry road transport RSFSR.

In some cases, cars can be removed from the line.

207. Materials about violations of car operating rules identified with linear controls, rules for use of cars, financial disorders, etc. They are sent to motor transport enterprises and organizations to take measures to eliminate them.

The leaders of motor transport enterprises and organizations are obliged to consider the materials presented and the results to report the Control and Audit Service, which sent these materials.

Europeans and Americans achieved, it seems, perfection in the system of linear control of production and services (when an employee controls the quality and compliance with the rules of goods or the service of the previous employee).

Linear control (LC) - Let's start with advantages. What do you see them compared to the traditional control on the part of the head or session?

It is worth noting that the main advantage of linear control is constant current control over the products.

Unfortunately, this will not always be able to achieve traditional control methods with the participation of OTV or the head of the unit. But here it is necessary to immediately make a reservation that for different species Production The most effective is different quality control methods. Otherwise, we would immediately realize that linear control is the best tool, and you should forget about all other control methods. This, of course, is not so.

Linear control is very effective at mass production: the release of beverages and products, electrical products, assembly production, sewing production, etc. When there is a stream technological operations, And to move to the next operation, quality control is required. And, of course, the costs of carrying out linear control with this production are minimal compared to traditional methods for monitoring products.

But there is another type of production - forgotten production. In the case of marked production, unique product requirements are presented, and this is usually a small lot of goods. This requires a certain level of responsibility in assessing the quality, since each batch of goods may differ from the previous one for a number of parameters. It is not necessary to do without control by the head of the unit or the relevant department of OTV.

Why did the linear control do not fit with us?

The main reason is that it is quite difficult to implement and implement linear control. This is due to the fact that it is necessary to describe all technological operations and the requirements for the quality of the products performed. It is necessary to train personnel throughout the technological process, and this time, costs, and considerable costs. It is also the fact that linear control most effectively implements its main advantages on large serial production. Unfortunately, there are no analogues of the production of such a scale in Russia, and, accordingly, there is no demand for such a control system. But there are prerequisites to ensure that such a system is introduced in the future.

"Pest" - how many of them in our production and services?

I believe that now pests are somehow. There is no open sabotage, damage to equipment. First of all, this is due to the fact that, as a rule, there is a motivation of an employee depending on the results of labor.

If you deliberately spoiled the technological line on which you work, then the whole brigade will not be premium, since the premium depends on the volume of products issued. Everything is simple here. But there are features ...

Pests begin to be born and live where there is a conflict. Production conflict, conflicts between employees and management of the company, conflicts between production participants (brigades, shifts), etc. And there is very important monitoring and control of such situations from the leadership. It is worth noting that the main cause of the permit is an emotional component, that is, disagreement of one of the participants with another participant.

Who are they and how do they succeed?

First of all, these are the main participants technological process. And often the crushing concerns the disability of equipment that ensures the implementation of the main technological operations. It is possible to consider this on the example of a sewing production, where there is a cutting shop, a sewing shop and a finish shop. The cutting shop carries out the material cutting and transfers the workpiece into the sewing workshop, the sewing workshop performs operations on the sewing workpieces into the finished product and transmits to the finishing workshop, where the operations on finishing with a color line, the installation of decorative buttons, etc., and so on the sewing workshop appears. The pest, "which does not want to fit into the total technological chain and is not ready to fulfill the requirements for the quality of the octopic seams or check each branch of the cutting shop.

That is, it does not want to carry out the control function of the previous operation. And such an employee always has an excuse that it is not him, this "The sewing machine does not cope, call the setup. Why will I control the cutters and their workpiece? But let them themselves control themselves, they receive a salary for it "... Often, such an attitude leads to an open insertion of technology or damage to the details received from the previous technological operation.

Looking and lazy - how could they take care and exist, "passing our inheritance experience"?

Oh, this is a whole epoch! Looking and lazy there is almost any production in any company. And the nature of such personalities is very often different. There are lazy and loafers who try to be invisible with all their might, and it gives them the opportunity to live in the company very long time. This may continue for years.

And there may be loafers and lazy with charisma. These people really know a lot and know how to scary loyards. Something to entrust them is very difficult, their attitude to work is passive and phlegmatic, but if they are taken for something, then they often fulfill the task above all silence. For this, they appreciate their leadership and for a very long time "does not touch." But it can not continue to continue ...

Both the first and the second category of employees love and know how to communicate, they share their impressions and involve increasingly adherents in their ranks, thereby infecting the atmosphere around themselves in the spirit of laziness and idleness. This, of course, is the worst, and it is necessary to fight.

And how do you imagine the LC system in European companies?

Unfortunately, not many companies, from the point of view of the organization of linear control, I know. But about those about which I know, I can say that there is a LC - this is primarily the Regulations, the Quality Commission, the availability of a quality director and the corresponding certification of management for compliance with certain quality standards.

Of course, in order to implement all this, it is necessary for a long time and great resources. But it brings fruits, and such costs are not in vain.

What do you know about the LC in foreign companies in Russia?

I know that linear control is implemented in such Russian offices western companies Like Coca-Cola, Pepsi-Co, plant Toyota. Implemented in the representative of Castorama. In these companies, the corporate experience of the head company is taken as the basis. The basic quality control is carried out by foreign managers, but in the fields are working Russian specialists in the field of quality and carry out control over work: the main technological and business processes.

What problems are the "tops" of such companies in the implementation of the LC system?

First of all, it regional features labor market. It is not always possible to find specialists of the required profile, competencies and proper motivation, which could solve such issues at the location of the company itself - the place of production, the place of production of raw materials, etc.

It can just look like the company's head office, but when it falls at the level of a particular country or a region of stay, most of the questions arise here.

How would you build an LC system with our staff?

First of all, I would try to form a balanced team of specialists who could support all the functions of linear control on a non-conflict basis. Of course, it depends on the transparency of the management system, from the motivation of specialists and from understanding the contribution of employees to the end result that will be at the output.

Undoubtedly, there will be conflicts and will be, but it is important here that these conflicts lead to a "constructive" in decision-making.

How many warnings can be given an employee when violating the system?

Not too much. I think that a maximum of 3-4. After such a number of violations it is already necessary to make org additions and make decisions.

And if this nuclear power plant? Spaceship?

Here is a combination of linear control and traditional methods.

It is worth noting that these objects to which increased security requirements are imposed. In this regard, as a rule, we will apply multistage control and duplication.

How to synchronize the LK and traditional control systems?

One of the options for such a solution is to divide the control methods. With this approach, linear control can be carried out at the level of certain technological operations for individual parts: grinding, painting, installation of fasteners, etc. And traditional control methods can be used to ensure the quality of the production of entire batches of products: chosen, technical process, equipment downtime.

How to solve the inevitable conflicts of interest?

Communications, motivation. The most important thing is that the conflict acquires the form of a constructive dialogue and led to a positive result, promoted in the direction of improving the business process and did not acquire a devastating form. From the person of the head depends a lot.

How to motivate the participants in the process?

There is nothing unique here: there must be a material and intangible component. It is very important that the motivation involves the involvement of employees in the quality management process: rationalization ideas, proposals that are put forward by employees must be analyzed, and the best of them must be implemented in practice.

* Sergey Polovnikov, cEO Stug Lodzhik.

01.07.2012

Methods of checking linear control of grass

Letter of the Department of Health of the Government of Moscow dated August 10, 1995 N 25 / 09-95 "Methods of verification of linear control of outpatient polyclinic institutions."

1. Sign of institution in form

2. Registration and maintenance of the entrance to the clinic, the work of the wardrobe in the cold season.

3. Sanitary state of adjacent territory, illumination before entering.

4. Availability of a copy of the license in the registration.

5. Availability of linear control log.

6. Availability of the Journal of Operations of San. Transport and the order of its maintenance.

7. The presence of keys from the premises, the availability of all rooms.

8. The presence of the protection of the institution and the order of its work.

9. Mode of operation:

Schedule of the Polyclinic;

Schedule for reception of doctors and subsidiary services all the days of the week;

In the absence of specialists in the establishment, the availability of information on the organization of reception of specialists in other LPUs, including auxiliary services.

10. Availability of information:

About the provision of traumatological assistance in day and night;

On the provision of psychiatric assistance in day and night;

On the provision of ophthalmic assistance in day and night;

On the provision of dental assistance in day and night;

On the provision of leather-venereological assistance in day and night;

On the provision of anti-tuberculous assistance in day and night;

On the provision of drug acquisitions in day and night;

The mode of operation of the medical and physical culture dispensary;

Mode of operation of the clinic of reducing treatment;

Addresses and NN phones of nearby pharmacies;

Mode of operation (VTEK) -Medical and social expert commissions;

Addresses and NN phones of higher organizations (health management, health care, prefectures);

Information about the duty administrator (location, NN phone, last name I.O., the presence of an order or approved schedule of duty administrators);

Reception time of the chief doctor and his deputies on all days of the week;

On the procedure for organizing extraordinary reception of the preferential contingent;

The list of groups of the population eligible for free and preferential vacation of medicines.

11. Check:

The procedure for organizing the issuance of insurance policies, the time of issue, address and telephone of the insurance company;

Presence or absence of paid medical services (in the presence of paid services procedure and organization of payment);

Organization of recording to doctors (preliminary and during the day), especially specialists;

Organization of ICTRATORSHASHRAL REGISTRIST: ConditionsBulatoryCart;

Availability of books for writing proposals, the work of the administration with critical comments and thanks;

organization of reception of calls to the house on weekdays from 14 o'clock. before the completion of the clinic;

Time execution time from the moment of its receipt;

Organization of emergency assistance: the presence of a workshop by a doctor who calls to the house, in procedural Cabinetor in the intensive care room, the presence of instructions and a set of medicines to provide emergency care during cardiogenic shock, anaphylactic reaction, etc. Emergency conditions;

Terms of storage of medicines in the cabinets;

Sanitary state of the cabinets and the implementation of anti-epidemic events medical Personnel, knowledge of the rules of anti-epidemic regime

Availability and availability of instructive material, protective suit, the actions of the staff in case of identifying a patient Ooi;

Availability in the cabinets Antiwid laying, the ability to use it;

The presence and use of disposable syringes;

QualityPostoPostOsumentariaStomatological, Otolaryngological, Ophthalmological, Surgical Cabinets

Firepart premises polyclinic.

Over the past year, the fleet of the police center in Moscow was replenished with 1.5 thousand cars, for this year only "Fords" received more than 200. How to exploit official vehicles in the divisions? To get an answer to this question, the correspondent of the newspaper Petrovka, 38 made a joint raid with the senior inspector-inspector of linear monitoring TsO GUVD in Moscow Major Militia by Alexander Zozulules and duty mechanic of Avtobassa No. 1 Tengiz Margania.

The first checkpoint - ATS in the Babushkin district. At the time of our arrival, 6 cars were located on the territory of the department. We will later go on, and to begin with, we go to the duty part, where documents are stored on the car.

As a rule, each raid begins with availability necessary documentation. The commander of the company PPSM ATS in the district of Babushkin Major Militia Constantine Filatov brings a folder with papers. To our surprise, it does not have an order for the appointment of the responsible for the content and operation of vehicles. When asked, where the order, we could not get a definite answer.

Alas, the cable of violations reached further. So, the deputy cards after work are not returned to the place. Yes, and the storage of documents and keys from cars is not equipped with properly. The duty explains this by the fact that the room attendant is small, so it is not possible to single out the place for storing documents.

In addition, the release of the output-return of service vehicles is not carried out for almost a month. Make sure to fill it should duty. The senior inspector engineer reminds duty that it is his official duty, just like the issuance and reception of the tablet weapon. In general, the tasks of linear control include not only preventive, but also advisory functions. This is done in order for the identified violations to be eliminated and did not occur in the future.

During the test, the commander of the PPP company constantly disappears: then in search of the working list of cars, then behind the way sheets, then behind the keys from cars.

Questions about the state of cars are beginning to arise from the first minutes of inspection. On one of the vehicle testimony machines in the way sheet, they differ greatly from numbers that gives the dashboard. The difference is about 3064 km. In recalculation on gasoline, the amount of more than 7 thousand rubles comes. It is possible that the differences in indications are associated with fuel fraud. If this fact is confirmed, then the money for gasoline drivers will have to return from their funds.

How do you explain such a difference? - We ask the company commander.

Probably B. waybill made erroneous data, - he suggested.

But this, as it turns out, is far from the most interesting. On the "Zhiguli" of the 5th model causes complaints of semidometer equipment. When we removed the dashboard, instead of a standard seal in her place, a lion was discovered. Responsible for the maintenance of vehicles makes a surprised face and in a hurry to check our data to make sure of their authenticity. Unfortunately, we did not hear explanations on this fact.

Thus, just for the hour of work in the Department of Internal Affairs in the district of Babushkin, we revealed a lot of violations. They also pointed out employees of the rear service of the Department of Internal Affairs for SPAO, who recently conducted an inspection. It turns out that the elimination of deficiencies in the Department of Internal Affairs did not even start.

This confirms and responsible for traffic police in Swao Major Militia Vasily Krivtsov. Vasily Viktorovich We caused to verify the results of their district check and our today's raid. Alas, Major Militia Filatov again could not clearly explain why the previously identified violations were not yet eliminated.

Well, problems in this department of internal affairs are more than enough. Whether they will be solved by the time the following check, let's see. In the meantime, our group is sent to the ATS in the Martino area.

At the entrance to the territory of the Department of the Militia, the police requests our driver to open the car trunk to test it for explosives. I confess, it caused me some perplexity, because we arrived at the police car equipped with special signals, and not on simple car. But the order is order. Having inspected the trunk, the watch opens to us the gate and shows where to be parked.

At the entrance to the department we meets the assistant chief of ATS on the rear provision of Major Militia, Leonid Junik. Our group is sent to the duty part.

We check the technique. We have no more than half an hour at this, since there are only two cars on the territory of the department at that time. Their content and operation are organized in accordance with orders.

So, two departments clearly showed their attitude to entrusted them motor vehicles. As they say, the earth and the sky. I wonder how many departments can be attributed to the first category, and how much - to the second one?

Vasily Tremasov