Maintaining the required level. Quality management. Ways to lower pH

The text of the document provides links to reference materials containing detailed descriptions of theories, practices and research results related to pollution control. From these materials, the reader, if necessary, will be able to obtain more detailed information. These materials are presented in the Literature section.

Glossary of terms and definitions

Special shoes for the building - a pair of shoes used by personnel in designated areas of the changing room and cleanroom or in auxiliary areas to prevent the entry of contaminants found on outdoor shoes into these areas.

Special clothing for the building - a suit made of 100% polyester or other synthetic fabrics. The shape resembles a two-piece tracksuit, the upper part of which is removed over the head or fastened with a zipper. The suit is worn over your own underwear under cleanroom clothing.

Changing room - a room adjacent to the clean room, designed to control the passage of personnel, as well as for putting on, taking off and storing items of clothing or other accessories.

Class(particle content in the air) - Room cleanliness class in accordance with ISO 14644-1 standard.

Clean room - a room that requires control of airborne particles and includes one or more clean zones.

Second layer clothing (comfort suit) - see “special clothing for the building”.

Pollutant - any substance whose presence on or within a material, or on any surface in a clean room, is undesirable.

Pollution- the result of a contaminant entering a material or onto any surface within a cleanroom.

Controlled Environment - an environment in which compliance with acceptable limits of parameters such as temperature, pressure, humidity and pollution levels is monitored.

Strip- process of removing clothing for clean rooms. The process is strictly controlled to protect clothing from contamination and damage.

Putting on- procedure for donning cleanroom clothing. Clothing is worn in a certain order in a strictly defined manner to prevent its contamination and deterioration of its protective properties.

Gloves to put on - An additional pair of gloves used when donning cleanroom clothing to protect it from direct contact with the hands and prevent contamination by oils or particles on the skin. Gloves can be worn over process gloves when dressing, or used only during changing, and then changed to process gloves.

Electrostatic discharge (ESD) is the transfer of electrostatic charge between two objects that have different electrostatic potential.

Cleanroom clothing - specially designed items of clothing to reduce or prevent the spread of contaminants by personnel. Can be represented by overalls, shoes, shoe covers, gloves, hats, etc.

Set of clothes- A complete set of clothing and consumables used to protect personnel from external influences or protect the environment from pollutants emitted by humans. The kit may include a face mask (beard), hair cap (net), helmet, other items of clothing (overalls, shirts, pants or gowns), cleanroom shoes, safety shoes, shoe covers, boot covers, changing gloves and technological gloves.

HEPA filter(High Efficiency Air Filter) - a dry type filter with increased surface area, housed in a solid frame. The minimum efficiency of such a filter when tested at a fixed airflow rate in accordance with MIL-STD-282 shall be 99.97% for dioctyl phthalate particles with a mass median diameter of 0.3 µm.

Maintenance of clean rooms - maintenance or cleaning of premises carried out to maintain the required level of cleanliness.

Micrometer(µm) - a unit of length equal to one millionth of a meter (approximately 0.00003937 inches).

Air particle counter - A device for continuously counting airborne particles whose size exceeds the permissible limit. The device can be optical, electrical, aerodynamic, etc.

Pre-dressing - Required procedure carried out after entering the building and before entering the changing room.

Garment processing - A process carried out to ensure that clothing and accessories are clean and suitable for use in a controlled environment.

Mechanical shoe shine machine - An electrical device consisting of rotating or moving brushes and a vacuum system for collecting dirt. The shoes are placed inside the device and slowly moved back and forth. At this time, the brushes remove dust and dirt from its surface, which are collected by the vacuum system.

Shoe covers- Disposable covers placed over outdoor shoes in designated areas of the changing room and cleanroom, or in auxiliary areas to reduce the transfer of contaminants on outdoor shoes.

Sticky mat- A disposable or cleanable mat with a sticky surface that, when stepped on, removes particles from the sole of the shoe.

ULPA filter- Disposable dry type filter with increased surface area, housed in a solid frame. The minimum efficiency of such a filter when tested by the methods described in IEST-RP-CC007 shall be 99.999% (i.e. the filter shall pass no more than 0.001% of particles).

Materials cleaning area - An area in the changing room designed to clean the materials used in the cleanroom.


Recommended practices can form the basis for the development of personnel procedures and programs to prepare personnel for work in cleanrooms and contaminant-controlled environments. The presented material does not contain specific information on the performance of operations requiring control of microbiological contamination.
Each application uses individual designs, equipment, protocols and procedures to control contamination, many of which are described below. However, it is entirely up to the consumer to select the most appropriate and compliant contaminant control options.

Most operations carried out in cleanrooms require the presence of personnel. Even a fully automated system requires operator control and maintenance. People and their clothing generate a large amount of contaminants, necessitating an effective contaminant control system to reduce risks to the product, process output and cleanroom environment. In addition, because personnel activity can transfer contaminants from one location to another within a cleanroom, operating protocols must be developed and carefully monitored to ensure adequate levels of control. The basic requirements concerning these aspects are presented in the ISO 14644-5 standard. Compliance with these requirements is the minimum required to establish a cleanroom inspection program.

To select employees who will not cause excessive contamination of the product and who will comply with all dressing procedures and work practices required for a controlled environment, consideration and compliance should be given to determining personnel's cleanroom qualifications, physical and mental characteristics, and professional skills of personnel.

Recruitment
Responsibility for personnel selection

Responsibility for personnel selection should be assigned to a department that has all the necessary information about the physical and intellectual characteristics of employees, as well as their professional skills, without which it is impossible to perform the duties assigned by the cleanroom manager, for example, the human resources department or the personnel management department.

Whenever possible, candidates for cleanroom work should be given a tour of the room as part of the interview to determine the candidate's readiness to perform, qualifications to work in the room, and ability to understand instructions. Additionally, if the candidate does not have experience working in this type of facility, the tour will help the candidate decide whether they are prepared for the inconvenience of wearing building-specific clothing and will also help ensure that appropriate sized clothing is available before the candidate begins work.

Special requirements for the physical and medical characteristics of potential cleanroom personnel

1. Smoking staff . Smoking is prohibited in clean rooms, changing rooms or any other areas where it may have an adverse effect on product quality or the health of other employees due to secondhand smoke. To work in clean rooms of certain cleanliness classes, companies have the right to hire exclusively non-smoking employees. If smoking is allowed on the premises of a production facility, then the smoking employee should be warned that smoking breaks may be shortened, since the process of changing clothes takes some time and, combined with the length of the break, this may adversely affect the quality of the product.

2. Worker dimensions . Although, as a rule, the physical size of employees may not be a barrier to hiring in a clean room, in some cases this aspect must be taken into account. Firstly, special clothing of a non-standard size may be required, secondly, it may be necessary to modify the seating area or bench, and thirdly, the overall body area of ​​​​the employee depends on the dimensions, which can be taken into account when distributing employees among work areas.

3. Facial hair . If present, the employee's facial hair should be covered with cleanroom clothing such as a face mask, hood, or beard mask.

4. Sensitivity to heat . The temperature and humidity levels in a cleanroom are generally maintained within specified limits, however, in some cases the temperature in certain areas of the room may exceed these limits. It is important that personnel working in such areas do not sweat excessively, which releases excess particles and moisture that contaminate the product and environment.

5. Skin condition, allergies, respiratory disorders . Employees with the following skin conditions or upper respiratory tract disorders should not work in cleanrooms:
a. Allergy to synthetic fabrics, solvents or other chemicals used in cleanrooms.
b. Copious nasal discharge.
c. Skin diseases accompanied by increased exfoliation of particles from the scalp, hands or body.
d. Increased acidity of the skin of the hands in a humid environment.
e. Serious nerve disorders that cause itching, scratching, or rubbing of the skin.
f. Emphysema.
g. Sunburn (in this case, the employee may be temporarily suspended from working in the cleanroom).
6. Claustrophobia. Any employee who is or has previously suffered from claustrophobia should not be allowed to work in clean rooms.

Professional skills

1. Personal qualities. In addition to the job skills and abilities required to perform their duties, employees must understand the objectives and practices of cleanroom contamination control. Maximum cooperation and self-discipline are required from them, since most of the airborne contaminants are emitted by the employees themselves or as a result of their activities.

2. Language skills. All employees performing cleanroom operations should be properly trained and aware of contamination control objectives and practices. In this regard, it is very important that they are able to correctly understand the information received during training and the instructions presented in the language used by the supervisory personnel, not only at the beginning of their professional activities, but also in the future. Any misunderstanding between the inspection personnel and the operator may adversely affect the inspection results.
The factors described above may be subject to temporary or permanent changes over time. In this regard, it is recommended to organize continuous monitoring of operators by supervisory personnel.

Compliance Training

Performing a cleanroom entry procedure requires specific skills and knowledge of the specific practices and behaviors required to conduct cleanroom operations. Cleanroom training is important, regardless of frequency of entry or classification, and is provided to all employees entering the cleanroom without exception. When conducting training, the requirements of the ISO14644-5 standard must be observed.

Responsibility

Each organization must appoint those responsible for conducting employee training. Training can be provided by line management, personnel training, quality control, or third-party trainers. Those responsible for training should be knowledgeable about the specific training requirements for cleanroom work and also have the skills necessary to train others.

Employee training programs

The training program will typically consist of several modules covering specific aspects of cleanroom work and should include basic training for personnel with no prior cleanroom experience, more advanced training for new product introductions, and refresher or specialized training. to solve individual problems.

Training modules or courses should cover all aspects of cleanroom operations, including:

a) understanding the nature of pollution and its control;
b) required behavior and discipline;
c) personnel hygiene;
  • dressing procedures;
  • cleaning standards and methods;
d) security measures;
e) specific pollution control procedures for certain types of work;
f) wiping procedure (see Recommended Practice IEST-RP-CC026).

For each module of the training program, special tasks must be established that can be analyzed for implementation.

The content of each program module is determined through research into what the employee being trained needs, conducted through consultation with management and surveys of immediate supervisors. Each of the modules should include monitoring to confirm that the material developed for the training is clearly presented and is being absorbed by staff.

The program should specify the timing of the training, the person(s) responsible for the training, the training methods, and the testing and assessment criteria for each module.

Teaching methods

The training program should include the identification of training methods, such as:

a) standard lectures;
b) remote training using video or audio materials;
c) on-the-job training;
d) courses conducted by specially invited instructors;
e) attending courses provided by other organizations;
f) group discussion;
g) seminars;
h) role-playing games.

To carry out the program, the premises and materials necessary for preparation must be provided, as well as, if necessary, coffee or lunch breaks.

Those involved in the training must clearly understand their roles (lecturer, mentor, consultant or instructor), and also know all the necessary theoretical and practical material before starting the training.

Usually a person remembers:

10% of information presented in the form of oral speech;
50% visual information;
80% of information when participating in a group discussion.

Changing the speed of presentation of information, as well as the use of additional visual aids, can increase the effectiveness of learning. In addition to product samples and on-the-job demonstrations, teaching aids such as flip charts, wall boards, CD-ROMs, electronic projectors and role-playing games may be used.

Knowledge assessment

After completion of training, an assessment of the knowledge acquired by students should be carried out. This assessment may include an oral or written examination or the performance of operations. The progress and results of each assessment must be documented along with a brief description of the examinee's previous work experience.

Training documents

Employee training records should be updated regularly and can be used as part of a cleanroom entry control or for subsequent employee monitoring. Examples of the matrix and individual preparation card are presented in.

Hygiene and health

It is necessary to have and comply with hygiene and health standards for cleanroom personnel. Following these guidelines will help reduce the likelihood of contamination of the cleanroom environment by human particles/fibers. Conducting a risk assessment for each room of different cleanliness classes will allow planning of contamination control in each individual situation, and is also of great importance for ensuring product quality, yield and process efficiency in cleanroom environments.


Personal hygiene

Cleanroom personnel should bathe or shower daily to prevent the accumulation of oils, salts, dirt and bacteria on the skin, which can contaminate the room environment.

Hair also traps and is a source of many particles and should be washed daily; they must be cut to a controlled length, neatly assembled and secured. Cleanroom clothing should completely cover hair.
Personnel's fingernails should be short to prevent them from tearing cleanroom gloves.

Cleanroom personnel should not wear cosmetics, perfumes, hair spray or nail polish as these products contain contaminants.


Diseases

Illnesses associated with recurrent coughing, sneezing, or nasal discharge may interfere with the employee's ability to perform his or her duties and may also result in environmental contamination. If such symptoms appear, the employee should not be allowed to work in a clean room until they completely disappear.

Working indoors may cause fainting or claustrophobia. Such conditions create uncomfortable working conditions for employees and also threaten their safety. The absence of such conditions should be one of the conditions for hiring employees in order to legally protect the employer in the event that the employee concealed the presence or did not know about the existence of such conditions at the time of hiring.

Skin diseases accompanied by peeling can lead to contamination of the cleanroom environment. The absence of such diseases should be one of the conditions for hiring employees in order to legally protect the employer in the event that the employee concealed the presence or did not know about the existence of such diseases at the time of hiring.

If there is a skin allergy to certain items of clothing or materials (for example, latex gloves), employees should be provided with items made from other materials.

Cleanroom employees should notify management if they are coughing or sneezing due to a cold or seasonal allergy. In such cases, it is necessary to determine whether the use of a face mask is sufficient to minimize the risk to the products or processes in the cleanroom, or whether the employee must be temporarily reassigned to another off-site location.

The cleanroom employee must refrain from smoking for 30 minutes before entering the cleanroom to ensure that tobacco smoke particles are completely removed from the lungs and mouth. In addition, employees who smoke should rinse their mouths with water several times and take a few sips of water before entering the premises.

Dressing

Proper dressing procedures prevent clothing from becoming contaminated during dressing, turning it from a particle barrier into a source of contamination. The procedures described include activities conducted in three different locations: home, work (outside the cleanroom), and a controlled environment changing room.


Home preparation

It is necessary to choose clothing that covers as much surface area of ​​the skin as possible. Whenever possible, outdoor clothing should not be made from natural fiber-emitting fabrics. Under cleanroom clothing, it is recommended to wear clothing made from synthetic materials such as polyester, nylon or acrylic.

Procedure for on-the-job training:

  1. All outerwear (coats, hats, gloves, galoshes, etc.) and personal items (bags, umbrellas, food bags, etc.) must be stored in special lockers located as close as possible to the changing room.
  2. Remove all jewelry not permitted by the protocol.
  3. Report any respiratory problems, sunburn, or skin problems to supervisory personnel before entering the changing area.
  4. Remove all makeup from your face.
  5. Cover all your hair with a hair cap, and also, if necessary, cover your facial hair (beard, mustache, sideburns) with a mask.
  6. Put on shoe covers for outdoor shoes (if provided).
  7. Proceed to the cleanroom shoe lockers (if provided).
  8. If special cleanroom shoes are used, remove outdoor shoes from each foot one at a time and put on cleanroom shoes (do not place your bare foot on the floor). Outdoor shoes must be left in the locker.
  9. Proceed to the changing room for men or women, put on a special suit for the building (if provided) and underwear.
  10. Wash and dry your hands before each entry into a clean room. This reduces the amount of contaminants on your hands and can prevent skin irritation.
  11. Apply lotion to your hands (only if provided by the company; using your own lotion is not acceptable).
  12. Wear and secure the disposable face mask behind the ears, if intended for use. Before putting on a corrugated mask, you need to straighten all its folds. After putting on the mask, you should press the mask fabric to the bridge of your nose so that it fits more tightly to your face.
  13. Wear cleanroom gloves. Then put on a second pair of special gloves for changing clothes (if provided). As an alternative, inexpensive polyethylene gloves can be used, discarded after changing clothes and replaced with technological gloves.
  14. Select the required clothing size.
  15. Proceed to the changing room.
Dressing technique

1. Attach the removable face mask (if provided) to the hood so that there are no gaps between the mask and the hood.
2. Put on the helmet so that the identification label is on the outside. Use snaps or ties to adjust the hood so that it fits snugly without causing discomfort.
3. Remove the overalls from the packaging and check for damage. Unzip. With your right hand, take the end of the right sleeve and the right trouser leg, as well as the middle of the torso of the overalls at a distance of approximately 15 cm from the edge of the zipper. In the same way, take the left part of the overalls with your left hand. Insert both legs in turn into the trouser legs so that the overalls do not touch the floor. Raise the helmet and insert your arms into the sleeves.
4. Tuck the helmet into the overalls and make sure that the lower part (bib) of the helmet is evenly distributed over the shoulders, chest and back.
5. Fasten all zippers, the collar of the overalls, and, if any, fasteners on the ankles.
6. Unscrew the top of the changing gloves. Fasten the cuff clasps, if any. Depending on the established procedure, technological gloves are tucked under or pulled over the cuffs.
7. Sit on the bench (if provided), put on your right foot, move it across the bench to a clean area without touching the surface of the bench.
8. Put your other foot on and also move it to a clean area without touching the surface of the bench.
9. Using a full-length mirror installed in the changing room, make sure that clothes are worn correctly and have no defects. Remove and discard changing gloves (if used). Make sure the process gloves are still tucked under or over the cuffs. Enter the clean room.
10. Dispose of all packaging materials in special containers.

Entrance to the clean room

The procedure for entering a cleanroom may vary depending on the design of the room and changing area. The cleanroom entry area is typically equipped with sticky mats to which contaminants remaining on the soles adhere. Mats can be placed anywhere where it is necessary to control the transfer of contaminants on the soles of shoes. A diagram of the recommended placement of mats in a clean room is shown in Figure 1.

Figure 1 - Standard layout of the changing room

The entrance to the clean room from the changing room can be equipped with:

  • air shower,
  • double door with interlocking or single door.
If used, the air shower must meet the following parameters:

A. Description. An air shower is a tunnel or passage leading into a clean room. Passing through it, a person is blown with strong jets of air purified using HEPA and ULPA filters. Additionally, the air shower is equipped with an air ionization system.
b. Task. An air shower acts as an air barrier for the cleanroom and is used to remove large particles from personnel clothing. However, the effectiveness of such a system is ambiguous, and in many cases an air shower is installed to improve employee discipline. The time and effort required to navigate such a system allows personnel to focus and psychologically prepare for entering the cleanroom.
c. Location. An air shower is installed immediately before entering protected areas (i.e. before entering clean rooms or between rooms of different cleanliness classes). Installing an air shower at the entrance to changing areas is ineffective.
d. Operation. Air shower technology is based on the assumption that strong air currents have sufficient speed to blow away large, loosely bound particles from clothing. An air ionization system is used to neutralize the static charge that attracts particles to the surface and prevents them from being blown away. At the same time, to remove small particles, greater force is required, which is achieved by using turbulent air flows. However, after turning off the turbulent flow, particles can re-settle on surfaces. Thus, an air shower does not do a good enough job of removing small particles. To operate effectively, the system requires regular maintenance and monitoring.
e. Design. There are many different designs of air showers, each of which has its own advantages depending on the method of application. To operate most effectively, such a shower should have a ceiling completely covered with HEPA or, preferably, ULPA filters, through which a unidirectional downward air flow is supplied at a high speed (0.45-0.6 m/sec); perforated or slatted floor; as well as at least five adjustable nozzles installed in the walls to supply high-speed air jets.

  1. Air tunnel. A passage that acts as an air barrier and promotes psychological preparation for entering a clean room.
  2. Airlock. The air nozzles are turned on for a certain time (usually 10-15 seconds), during which the employee turns 360° at least three times with his arms raised up. The system must be programmed to turn off the nozzles at least 8 seconds before the airlock exit opens. In this case, the vertical unidirectional air flow is not turned off, because it blows airborne particles down.
  3. Airlock with indirect passage. The employee must walk along a curved corridor to ensure that clothing is processed from all sides.
f. Cleaning. Walls, ceilings, ventilation louvers and floors should be cleaned daily or regularly at regular intervals.
  • 04/08/2019 More than 230 manufacturers and suppliers will present equipment at Russia’s largest exhibition of laboratory equipment and chemical reagents “Analytics Expo 2019”

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    List of participants >>

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    Get a book as a gift for the best question about chromatography

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Dr. Matsko is a retired physician from Pennsylvania. He graduated from Temple University School of Medicine in 2007.

Number of sources used in this article: . You will find a list of them at the bottom of the page.

Fatigue and lack of energy are some of the most common problems faced by people of all ages. Lack of energy negatively affects performance and daily tasks. Luckily, there are a few things you can do to boost your energy levels. Eating healthy, exercising, getting plenty of rest, and managing stress can help increase your energy levels so you can enjoy life and the activities you love.

Steps

Change your diet

    Include more protein in your diet. You may be eating enough food, but the foods you choose may lack nutritional value. One of the most common causes of low energy levels is nutritional deficiency. Protein, in particular, plays an important role in maintaining adequate energy levels.

    Include complex carbohydrates in your diet. Carbohydrate-containing foods are an integral part of a healthy diet. Carbohydrates provide us with energy so we can carry out everyday activities. But there are two types of carbohydrates - good and bad. If you're feeling tired, opt for healthy carbohydrates to help you stay active throughout the day.

    Choose healthy sources of fats. The body, experiencing a carbohydrate deficiency, begins to use fats rather than carbohydrates as the main source of energy. To meet your body's needs, choose the right sources of fat.

    Include raw fruits and vegetables in your diet. Fruits and vegetables provide your body with essential vitamins and minerals that keep you energized throughout the day.

    Drink plenty of water. Not drinking enough water can lead to dehydration, which can include fatigue and low energy levels. To stay hydrated and keep your energy levels up, drink more water.

    Eliminate sugar from your diet. Sugar provides a temporary boost of energy, but it doesn't last long. We feel a short-term surge of strength, which is replaced by severe weakness.

Change your lifestyle

    Exercise. Exercise is the best source of energy. In addition, regular exercise promotes good sleep. If you're feeling tired and low on energy, regular, intense workouts (every day or several times a week) can benefit your energy levels and quality of sleep.

    Do stretching exercises. Even if you spend all day at your desk in the office or on the couch at home, stretching can increase your energy levels.

    Get enough sleep. If you feel tired all the time, you may not be getting enough sleep. Poor quality sleep results in chronic fatigue.

    Reduce your stress levels. Stress aggravates the symptoms of chronic fatigue syndrome and also causes insomnia and other sleep problems.

    Take supplements. If you feel tired all the time, your doctor may recommend taking a supplement. Be sure to consult with your doctor before starting to take supplements.

    Use herbal remedies. Some claim that the herbs help fight fatigue and help increase energy levels. However, please note that herbal remedies interact with medications. So be careful. Do not take herbal medicines without first consulting your doctor.

Product Quality Management– these are actions carried out during the creation and operation or consumption of products in order to establish, ensure and maintain the required level of its quality. The company’s activities in the field of quality are aimed at:

Improving the economic situation of the enterprise;

Expanding and conquering new markets;

Achieving a technical level of products exceeding the level of leading enterprises and firms;

Focus on meeting consumer requirements of certain industries or regions;

Development of products whose functionality is implemented on new principles;

Improving the most important indicators of product quality;

Reducing the level of defects in manufactured products;

Increasing the sales period (warranty) of products;

Service development.

Under product and service quality management understand the constant, systematic, purposeful process of influencing factors and conditions at all levels, ensuring the creation of products of optimal quality and their full use.

Quality management is a process carried out in stages:

Development of a quality improvement plan and measures to create products with the desired (designed) properties;

Assessment of compliance of the properties of manufactured products with the requirements provided for in the plan;

Taking the necessary measures to influence the process if compliance cannot be ensured;

Study of operating conditions in order to determine the direction for further quality improvement.

There are four quality levels:

- compliance with standards(technical conditions, contracts);

- suitability for use(standards and operational requirements);

- correspondence actual market requirements(fulfillment of customer requirements for high quality and low price of goods);

- meeting the hidden needs of buyers.

So, quality management is, first of all: customer orientation; systems approach; covering all phases of the product life cycle.

Product life cycle(LCP) is a set of interconnected processes of changing the state of a product during its creation and use. Stage (stage) of life cycle– this is a conditionally allocated part of it, which is characterized by the specifics of the work performed at this stage and the final results.

Product quality are considered throughout "life cycle": from design, manufacturing and before her implementation.Product life cycle- sequence of stages of product existence.

Life stages of products:

At the stage of marketing research sales markets and consumer requirements for the company's products, the capabilities of suppliers of material resources in relation to quality and delivery discipline are studied.


At the design and product development stage The consumer requirements identified as a result of marketing are transformed into technical requirements, the result of the design is technical documentation (design, technological) and a prototype.

During the procurement process The organization evaluates and selects suppliers based on their ability to supply raw materials, supplies, and products in accordance with the organization's requirements.

During production preparation and support of the manufacturing process is carried out; development and testing of the process, mastering practical skills in manufacturing products.

Product Inspection includes monitoring, measurements and tests (if necessary) carried out at all stages of life cycle. The final stage of verification is acceptance control, the results of which must confirm the finished product’s compliance with the established requirements.

Packaging and storage should contribute to maintaining quality in the areas of production and circulation, transportation, sales and storage.

Distribution and implementation consist in the purchase of goods by wholesale organizations for the purpose of selling to stores and releasing goods to customers by retail organizations.

At the operational stage(use and consumption) the consumer of the product is connected to the management. The service life of the product (product) will, in particular, depend on how competently he uses (operates) the product.

At the recycling stage it is necessary to prevent the harmful effects of used products on the environment.

The recycling stage does not end the organization’s activities. By this time, the organization begins to study the expected needs, clarify current needs and, after marketing activities, begins to design new products. This is how a new round of activities in the field of quality arises - from the marketing stage to the disposal stage.

In addition to managing all stages of the product life cycle, product quality management has the following features:

- duration of the entire cycle from the beginning of quality formation to its implementation can take several years, i.e., the quality management process can be extended over time;

- level of individual quality indicators during the transition from one stage of the life cycle to another tends to decrease– this objective circumstance must be taken into account when forming the goals and criteria for quality management at each stage of the life cycle;

- under the influence of various factors, the quality level decreases, including its physical and moral aging;

- additional effort and costs required to maintain the quality level of products in the field of operation.

The second purpose of risk financing is maintaining an acceptable level of liquidity to pay for retained losses. This goal is closely related to the previous goal of loss coverage.

When an organization retains its losses, it must determine the amount of cash it will need to compensate for such losses and select a temporary payment regime. When deciding how to make its financial resources available to pay for damages, an organization should consider various sources of liquidity—the liquidity of its own assets, the strength of its cash flows, its creditworthiness, and the ability to issue shares (for public organizations).

Liquid asset- an asset that can be converted into cash in the money market. For example, marketable securities are liquid because they can be quickly converted into cash by selling them on the stock exchange or bond market. Some assets, such as machinery, tools, are not liquid because they are difficult to sell quickly.

An organization can increase liquidity by holding more cash than it uses to finance projects or pay dividends. If necessary, an organization can also increase cash holdings and therefore increase liquidity levels by borrowing capital, assuming that it has the financial ability to take out a bank loan or issue securities. Public organizations can create cash by issuing shares.

An organization's liquidity is measured by its working capital And liquidity ratio. These two concepts are explained below.

Working capital and liquidity ratio

Working capital organization is calculated using the following formula:

Working capital = Current assets - Current liabilities.

Current assets provide economic benefit to the organization and consist of cash and other assets that can or will be converted into cash within one year. These include marketable securities, accounts receivable, and company inventory. Current liabilities are obligations of the organization that will be paid in cash within one year. These include bills payable, other expenses and short-term borrowings. For an entity that retains losses, current liabilities also include provisions for expected losses that are paid during the year.

The difference between current assets and current liabilities (working capital) is a measure of an organization's overall liquidity because it is the funds that can be set aside if current assets have been used to finance all required cash expenses for the company's current liabilities.

Working capital is a positive value when an organization actually has available cash to finance damages from unforeseen events that exceed expected payments for retained losses.

The second measure of liquidity is the current ratio, which compares a firm's current assets with its current liabilities. Current ratio calculated using the following formula:

Current ratio = Current assets / Current liabilities.

In general, a current ratio of 2.0 or more means that an organization has a high level of liquidity.

Working capital is an absolute indicator of liquidity because it is measured in monetary units. The liquidity ratio is a relative value; it determines the relationship between the current assets and current liabilities of the organization.

Liquidity and its importance for risk financing is best illustrated using a hypothetical balance sheet of a business.

Assets
Cash 12,0
Liquid securities 78,5
Accounts receivable 279,5
Reserves 222,5
Other current assets 25,0
Current assets 617,5
Non-current assets 1025,9
Total assets 1643,4
Liabilities + share capital
Short-term loans 16.9
Accounts payable 310.5
Reserves for losses retained 4.5
Other current liabilities 38.6
Current liabilities 370.5
Non-current liabilities 601.2
Share capital 671.7
Total liabilities 1643.4

The company's current assets are $617.5 million (cash + marketable securities + accounts receivable + inventories + other current assets), current liabilities are $370.5 million (short-term loans + accounts payable + reserves for losses, left on own deduction + other current liabilities). Therefore, the working capital and current ratio of KYZ Technologies are calculated as follows:

Working capital = $617.5 million - $370.5 million = $247.0 million

Current ratio = $617.5 million/$370.5 million = 1.67.

The KYZ Technologies company has a normal level of liquidity. It has $247.0 million of working capital available to cover unforeseen expenses, including those related to unexpected damages. Its working capital and current assets ($617.5 million) are many times greater than its reserves for retained losses expected to be paid within one year ($4.5 million). Although its current ratio is less than 2.0, as suggested by some of its management, this ratio indicates that the company has a good liquidity ratio.

Instant liquidity ratio

For some firms, inventory and other current assets cannot be easily converted into cash. To take this situation into account, there is another measure of liquidity known as instant liquidity ratio (quick ratio, acid-test ratio). It is stricter than the current ratio. The quick ratio is very similar to the current ratio, except that inventories and other current assets that are difficult to convert into cash are not included in the numerator.

The formula for the instant liquidity ratio is as follows:


= (Cash + Liquid Assets + Accounts Receivable) / Current Liabilities.

For the KZY Technologies company, the instant liquidity ratio is calculated as follows:

Company's instant liquidity ratio =
= ($12.0 million + $78.5 million + $279.5 million)/$370.5 million

Instant liquidity ratio =
= $370.0 million / $370.5 million = 0.999, or approximately 1.0.

A quick ratio of 1.0 is considered acceptable. It is lower than the current ratio because it does not include all current assets, particularly inventories, in the numerator of the quick ratio.

The relationship between the level of an organization's own retention and its liquidity

The higher the organization's own risk retention level, the higher the level of liquidity required. This is determined by the relationship between the level of damage retained and the uncertainty of the costs of such damage. As mentioned earlier, the higher the level of retained damage to an organization, the greater the uncertainty in the extent of retained damage costs. Let's assume that the KYZtechnology corporation does not use insurance or uses some other mechanisms for transferring risk and losses. In the event of a disaster, such as a hurricane, that destroys production facilities, a company will need a large supply of liquid funds to restore damaged facilities.

Quality management

Quality management reviewed in conjunction with quality management, since these are closely related and complementary areas of activity that form company-wide quality management.

Quality management- part of quality management aimed at meeting quality requirements.

Quality management- coordinated activities for the leadership and management of the organization in relation to quality. A footnote to this definition states that these activities typically include the development of quality policies and objectives, quality planning, quality management, quality assurance and quality improvement.

Product Quality Management- actions carried out during the creation and operation or consumption of products in order to establish, ensure and maintain the required level of its quality.

Because quality management And quality management are aspects of general management and management of an enterprise, therefore, before analyzing and comparing these terms, it is necessary to turn to more general concepts control And management.

The essence and relationship of the terms management and management

In the introductory article to the textbook on management, Professor L. I. Evenko defines management in Russian as management, but draws attention to the difference in the interpretation and application of terms management and management. In Russian the term control without clarifying definitions, it is impersonal. In English, the term used for impersonal management activities is administration. In the USA, a popular management training program is called the Master of Business Administration (MBA). In English, when talking about management, they also mean the figure of a manager. In Russian, in such cases the term is used management, which also implies the figure of a leader and is more consistent with the term management. But both management (leadership) and management represent management activities and therefore in practice, depending on the context, the terms management, management and leadership are used as equivalent.

Regarding definitions management and management, in different sources they are interpreted differently. Most often, these definitions come down to listing the functions that must be performed in the process of leadership and management. Among them are planning, organization, command, coordination, control, motivation, personnel selection, communication (information), decision making. Such definitions do not fully reflect the essence of management activities, since they do not reflect subjects and objects management. In reality, management is the process of a subject influencing an object of management by performing management functions, taking into account feedback from the object. . The essence of management can be visually presented as follows.

Management is the influence of a subject on an object by performing management functions with feedback from the object

System driver-car- the most clear illustration of the essence of management. Here the driver (control subject) influences the car (control object), performing the functions of driving the car.

The relationship between the concepts of management and management follows from the interpretation of the term management as management.

Quality Management Process- this is the composition and sequence of performance of quality management functions by managers of all levels of management at the stages of product creation.

As a result, these definitions contain subjects, objects and functions of management and quality management, as well as Russian-language definitions of these terms from the ISO 8402 standard, which makes the meaning, content and relationship of these terms clear.

Using the term quality management The following should be kept in mind.

Unlike the ISO 9000:2005 standard, in the previous terminology standard - ISO 8402:1994, the term quality management was translated as general quality management, administrative quality management. This term is more consistent with the Russian language for naming the activities of senior managers “to guide and manage the organization in relation to quality.” It was more understandable and organic for the Russian language, just as the term quality management is probably organic for the English language. Unlike other acceptable cases of direct use in Russian of the word management, the vague term quality management serves as a clear example of the “mixing of languages: French with Nizhny Novgorod.” But since the term quality management enshrined in the official Russian-language edition of the ISO 9000 series standards, it is also used in the definition formulated above, but for clarity it is supplemented with the variant overall quality management from ISO 8402:1994 standard.

Company-wide quality management

This broad concept includes general management and operational quality management and forms a single continuous quality management process throughout the company. Accordingly, the structure and functions company-wide quality management has the following form.

Quality Management Process

Based on the structure and functions of quality management, process quality management on a company scale, taking into account external factors, is formed as follows.

Senior management, performing its quality functions, carries out general quality management: interacts with the external environment and creates the necessary conditions at the enterprise to ensure product quality.

Middle and lower level managers carry out operational quality management at their level: they influence the process of creating products by consistently performing their functions. Moreover, if, based on the results of quality control and analysis of the information received, all the necessary measures to improve product quality are developed and implemented into production, the next management cycle will be repeated along the “quality loop” at a higher level. Measures taken to improve quality are necessary not only to eliminate shortcomings, but also to constantly improve product quality in order to keep up with competitors. The term "quality loop" for the name of such a cycle was provided in the first and second editions of the ISO 8402 standard.

The presented quality management process shows how the quality management system (quality management system, quality system) functions. The composition of the functions of general management and operational quality management, which are performed in this case, mainly corresponds to the recommendations of the international standard ISO 9001:2008 with requirements for quality management systems.

Comprehensive product quality management

The current state of quality management has a long history. Briefly, in general terms, it can be presented as follows. Until the beginning of the twentieth century, concern for quality was reduced to the implementation of a number of control and support activities that were built into the overall enterprise management process. At the same time, standardization and unification of parts, tools and labor techniques were used, incoming inspection of materials, operational control during the manufacturing process, as well as various types of testing of finished products were used.

As competition intensified and products became more complex, their quality became increasingly important as the basis of competitiveness. “All these phenomena led to the emergence of the concept of transition from individual isolated activities to ensure product quality to a systematic approach, to the need to manage product quality.”

Of particular note is the role of statistical quality control (SQC), which was started by Schuchardt, an employee of Bell (USA), who introduced control charts into practice in the 30s of the twentieth century. Quality management in Japanese companies began with the introduction of statistical methods, after the American statistician Deming conducted courses on their study in Japan in 1950. But already in the 1960s, quality control began to extend beyond the production process and statistical quality control (SQC) began to turn into total quality control at the firm level - English. total quality control(TQC). It provided for the participation of all employees of the company, personnel training, the work of quality circles, and the use of statistical methods. And although the ideas of integrated quality management, quality circles and the use of statistical methods were born in the USA and Europe, Japan actively used and improved them.

As a result of using American, European and Japanese experience in quality management and taking into account an increasing number of factors affecting quality, quality management has acquired a comprehensive, systemic character.

In ISO 8402 - 86 comprehensive quality management mentioned as quality management at company level and in practice it appeared as the coordinated influence of personnel and managers at all levels on all stages of product creation, taking into account all factors that have a significant impact on quality.

An integrated approach to quality management implemented in the form of quality systems (eng. quality systems) within the framework of general enterprise management. Quality systems were formed not only in the USA, Europe and Japan, but also in the former USSR. The first stage was the creation of the Saratov system of defect-free manufacturing (BIP), developed in the mid-1950s. This system took into account the percentage of products handed over to the quality control inspector from the first presentation and, depending on this, the level of moral and material incentives for the employee was established. Subsequently, this system was transformed into a zero-defect labor system (DLT), which, in addition to the BIP system, took into account the rhythm and culture of production. Along with these systems, the KANARSPI system (quality, reliability, service life from the first products) was developed, which was implemented at enterprises in the Gorky (now Nizhny Novgorod) region, as well as the NORM system (scientific organization of work to increase motor resource), which was used at the Yaroslavl Motor Plant. And finally, in the 1970s, a comprehensive product quality management system (KS UKP) was developed and implemented at a number of enterprises in the Lviv region, which incorporated elements of the BIP, SBT, KANARSPI, NORM systems and the experience of other quality management enterprises.

After this, at Soviet enterprises, the introduction of KS UKP began as a directive, with the help of which they hoped to improve the quality of domestic products. Everyone fought for quality, there was a five-year quality plan, the best products were awarded the “Quality Mark”. In 1987, non-departmental quality control was introduced at 1,500 enterprises in the country - state acceptance of products. But all this activity did not, and could not lead to achieving the desired results. It was obvious to most enterprise managers that neither the introduction of the CS UKP nor additional non-departmental control was sufficient to ensure quality without the introduction of modern technologies and taking into account the human factor. But this was not the case at most enterprises. And the economic system itself, with strict control over the implementation of the plan “on the whole,” did not encourage enterprises to produce high-quality products. The exception was the military-industrial complex, where they spared no expense on equipment and paid higher wages, which made it possible to create competitive military equipment. Therefore, at many enterprises, although they implemented the CS UKP under pressure from the State Standard, they still understood that it would not solve the quality problem, and treated it as a purely formal event. Nevertheless, it is impossible not to note the positive role of the KS UKP in documenting quality systems and combining disparate elements of quality management at enterprises into a single system. Subsequently, this significantly facilitated the work of bringing KS PCC systems to the requirements of the ISO 9000 series international standards for quality management, the first edition of which was released in the USSR in Russian translation in 1988.

International standards ISO 9000 series

The ISO 9000 series of standards were developed due to the awareness of enterprises in industrialized countries of the need to implement integrated quality management, which some even then called total quality management. It started with the fact that in the 60-70s of the 20th century they developed national standards with recommendations on what types of work should be implemented at enterprises in order to organize a system in quality work (quality system). It was recommended to introduce quality control of projects, materials, products, management of documentation and measuring instruments, establish a clear procedure for eliminating deficiencies, etc. Then, by 1987, the International Organization for Standardization (ISO) taking into account national standards, mainly based on the British Standard BS 5750, the ISO 9000 series of international standards were developed and published with recommendations for the establishment of quality systems. The benefits of implementing quality management systems were explained by the following considerations. Since the supplier’s warranty cannot serve as a complete guarantee of meeting the customer’s requirements due to possible errors in the design and manufacturing of products, it is important for the customer that the supplier has a clear quality system in place. This gives the customer additional confidence that the supplier’s quality work is not carried out haphazardly, in an emergency manner, but systematically and systematically, which ensures sufficient stability in the quality of the products, and not just individual samples for advertising and exhibitions.

As a result, with the release of ISO 9000 series standards, the experience of an integrated approach to quality management received logical documentation and became widespread in world practice. As experience in applying these standards accumulated, they were refined. The second edition of the standards was published in 1994, and the third in 2000. Currently, the ISO 9000:2005 standard and the ISO 9001 standard are used to create quality systems. Standards have been developed for audits and certification of quality systems, for personnel training, and others. In addition, based on ISO 9000 standards, quality system standards for enterprises were developed, taking into account industry specifics. Unfortunately, the definitions of such terms as product quality, quality assurance, quality management (quality management) given in the standards do not reveal the essence of these concepts and contain a number of erroneous provisions, which was noted when analyzing these terms in the relevant Wikipedia articles. In this regard, in practical work on quality management, to understand these terms, one must be guided by additional authoritative sources on management and terminology indicated in the references.

The further development of quality management did not stop at an integrated approach, which was sufficient in conditions where achieving the required quality was one of the goals of the enterprise, along with the price, volume and delivery time of products under contracts. In the 80s - 90s, due to increased competition in sales markets, product quality came to the fore as the basis of its competitiveness. Complementing the integrated approach with new elements, manufacturers gradually moved to a broader approach to quality management, which in Russian standards was called total quality management (management).

Total Quality Management(English) total quality management, TQM) was introduced in the international standard ISO 8402:1994 as “a quality-oriented approach to managing an organization, based on the participation of all its members, and aimed at achieving long-term success through customer satisfaction and benefit to members of the organization and society.” In a note to the definition of this term, it was noted that “Total Quality Management - TQM” or its components are sometimes called “total quality”, “CWQC” (eng. company-wide quality control) (company-wide quality management), “TQC” (total quality control), etc. In addition to the participation of all personnel, this approach implied strong and persistent quality management from senior management, education and training of all members organizations.

In terms of meaning, the edition of the ISO 9000:2005 standard, which sets out the principles of quality management, is closer to total (total) quality management, although there is no term “total quality management” here. However, this term, using the "total" definition, continues to be used in practice instead of the understandable and natural "total quality management" corresponding to its acronym TQM. In addition, when using the definition of “total” in the phrase “total quality management”, the scope of concepts is violated. A specific concept from a narrow field of knowledge (quality management) is placed next to the all-encompassing word “universal”, which refers to fundamental concepts, such as the universal law of nature. The use of the term “total quality management” can be justified if one wants to emphasize its main feature, when in the activities of the enterprise and all its divisions the priority is to ensure the required quality of products with the wide involvement of personnel.

The emergence of TQM and its further development followed the path of expanding the scope of quality management, involving more and more areas of activity and factors influencing quality. This was documented in the third version of ISO 9000 standards and in the development in the late 1980s and early 1990s of national quality award models that take into account the contribution of various factors to quality assurance and business results.

In the USA, in 1987, the quality award was introduced by the Minister of Commerce M. Baldrige. After this, quality awards were established in a number of European countries, and in 1991 the European Foundation for Quality Management (EFQM) established the European Quality Award, founded by 14 of the largest European companies such as Philips, Volkswagen, Nestlé, Renault, Fiat, British Telecom and others. In Russia, the quality award was established in 1996.

Currently, the following main features of universal (total) quality management can be noted, which can simply be referred to as modern product quality management:

  • Choosing a strategy and policy in the field of quality aimed at constantly improving the quality of products and services;
  • The orientation of the enterprise’s work, based on consumer requests, is to do what sells, and not sell what is being done;
  • Management of all departments of the enterprise by top officials and administration, based on the need to ensure the required quality of products;
  • Involving staff in active work to improve quality by ensuring their satisfaction through proper motivation of work, promoting rationalization work and organizing the work of quality circles;
  • Introduction of flexible production taking into account the individual requirements of consumers in conditions of high-performance mass or large-scale production;
  • Creation of quality systems in accordance with the requirements of international standards ISO 9000 series, taking into account the characteristics of enterprises;
  • Application of process, system, situational and other modern approaches to management accumulated by management practice;
  • Investments in personnel development, continuous improvement of their qualifications, training of workers in related specialties and methods for solving quality problems;
  • Self-assessment of the enterprise’s activities according to the criteria for quality awards and participation in competitions for their award;
  • Product certification, assessment or certification of quality systems, analysis of existing problems and development of necessary measures to ensure and improve quality;

In addition, within the framework of TQM, it is recommended to create environmental management systems in accordance with ISO 14000 standards, as well as occupational safety and health management systems (OHSAS 18000), which complement the quality system, increasing the efficiency and competitiveness of the enterprise.

There is no doubt that quality management will continue to develop, enriched with new approaches and methods of work.

Interaction of quality management with other areas of the enterprise’s activities

Quality management in practical work is closely related to all areas of the enterprise’s activities that provide or participate in the creation of products. The heads of these areas perform their quality functions, and together they form subject of quality management, influencing the process of creating products in order to ensure their quality.

Since quality management is one of the aspects of the general management of a company, it cannot be considered in isolation from the science of management (management), which determines the general patterns of management activities. Therefore, to organize effective quality management, it is necessary to use management provisions and recommendations that can be applied in quality management. This will allow:

  • gain a general understanding of organizations (enterprises) and factors of the internal and external environment, that is, about the conditions in which quality management is carried out;
  • get acquainted with the essence of management and the structure of management activities at the enterprise in order to understand the role and place of quality management in the management of the enterprise as a whole;
  • apply management functions in quality management, as well as approaches and methods for their implementation, accumulated in management practice.

In this case, quality management will have at its disposal a scientific foundation and proven practical management methods, which will provide a solid basis for organizing and conducting professional and effective work on quality management in enterprises.

Notes

  1. International standard ISO 9000:2005 “Quality management systems. Basic provisions and dictionary" M.: Standartinform, 2006
  2. International standard ISO 8402:1994 “Quality management and quality assurance - Dictionary” - M.: VNIIS
  3. GOST 15467-79 Product quality management. Basic concepts. Terms and definitions. - M.: Standards Publishing House, 1979
  4. Kunz G., O'Donnell S. Management. Systemic and situational analysis of management functions. In 2 volumes - M.: Progress, 1981
  5. Merriam-Webster, "organize"
  6. Dictionary of the Russian language in four volumes of the USSR Academy of Sciences, “Russian Language”, vol. 4, third edition. - M.: 1988
  7. International standards “Product quality management ISO 9000 - ISO 9004, ISO 8402”. International standard ISO 8402 - 86 “Quality. Dictionary." - M.: Standards Publishing House, 1988
  8. National standard of the Russian Federation GOST R ISO 9001 −2008 Quality management systems. Requirements. ISO 9001:2008 Quality management systems - Requirement (IDT) M.: Standartinform, 2008
  9. V. G. Versan I. I. Chaika Product quality management systems. - M.: Standards Publishing House, 1988 104 p.