Due to non-compliance with the established warehouse requirements.

The organization shall ensure that products that do not conform to requirements are identified and controlled to prevent their unintended use or supply. Controls, associated responsibilities and authorities for handling nonconforming product shall be defined in a documented procedure.

The organization shall resolve nonconforming product in one or more of the following ways:

a) take action to eliminate the detected nonconformity;

b) authorize its use, release or acceptance if there is permission to deviate from specified requirements from the appropriate authority or body and, where applicable, the consumer;

c) take action to prevent its original intended use or application.

Records of the nature of nonconformities and any subsequent actions taken, including acceptance of product for approval, must be maintained.

If nonconforming products are brought into compliance, they must be re-verified to demonstrate that compliance.

If nonconforming product is identified after delivery or use, the organization shall take action appropriate to the consequences (or potential consequences) of the nonconformity.

Non-conformity management

General provisions

The organization's top management needs to give people within the organization the authority and responsibility to report nonconformities at any stage of any process to ensure timely detection and resolution of nonconformities, and to define the authority associated with responding to nonconformities to maintain product and process conformity with specified requirements. The organization should effectively and efficiently manage the identification of nonconforming products, their separation from conforming products and their disposal to prevent their misuse.

Where possible and appropriate, nonconformities should be recorded at the same time as their location to facilitate their investigation and provide data for analysis and improvement of the organization's performance. The organization may also decide to record and manage nonconformities related to both product life cycle processes and supporting processes.

The organization may also review records of nonconformities that have been corrected during use of the product. Such data can provide valuable information to improve the efficiency and effectiveness of processes.

Notes

1 The health care facility should attempt to resolve any nonconformities found. Examples of non-conforming product purchases include receiving mislabeled or contaminated medications and other products. Inappropriate services (see 3.1.18) may include incorrectly prescribed procedures or incorrect dosages of medications, delayed telephone connections, missing prescribed medications, poor quality of food, unfriendly or rude staff, and slow response to patient/client complaints.

2 Non-compliance with the management protocol on the part of the patient/client is not an example of a non-conforming product (service). Moreover, the problem is outside the scope of the health care facility's quality system and has a negative impact on intended treatment outcomes, which should be documented in the patient/client record. Patient/client education may be required to resolve the problem and minimize deterioration of the patient/client's condition.

NOTE 3 The terms “disagreement” and “nonconformity” are sometimes used interchangeably to describe situations where a product or service does not meet intended results. The term "nonconformity" is defined in ISO 9000 as "failure to comply with a requirement" (see 3.6.2). The terms used in the quality management system should be consistent with those commonly used by personnel working with the system; terms should be familiar and understandable to healthcare facility personnel.

8.3.1.1 Handling of nonconforming products

Nonconforming products (services) (see 3.1.14) shall be separated from conforming products, if practicable, to prevent their unintended use. The health care facility must quantify, analyze, and minimize nonconforming products/services through the development of a corrective action plan. The implementation of this plan must be monitored.

8.3.2 Nonconformity analysis And their elimination

The organization's senior management must ensure that an effective and efficient review process is developed and any nonconformities identified are resolved. It is necessary that nonconformity analysis be carried out by authorized individuals to determine whether any trends or patterns of occurrence require attention. Negative trends should be considered in order to change them for the better, and also as input for management analysis when discussing tasks to reduce these trends and attract the necessary resources for this,

Reviewers must have the competency to assess the overall impact of nonconformities and the authority and resources to resolve nonconformities and determine appropriate corrective actions. Confirmation that nonconformities have been resolved may be a contractual requirement of customers or other interested parties.

Important questions

Has a procedure been developed for identifying and handling non-conforming products (services)? How are non-conforming products/supplies handled to ensure they are not used until at least further processing? Is non-compliance data, including data on erroneous dispensing of medicinal products, collected and promptly analyzed with a view to taking corrective or preventive action?

1. PURPOSE AND SCOPE

1.1. This documented procedure for the quality management system was developed in accordance with the requirements of section 8.3 of ISO 9001:2000 and regulates the procedure for dealing with products recognized as non-conforming to the requirements established in the regulatory documentation (hereinafter referred to as ND) in departments ___________.
1.2. The requirements of this D 00.06 apply to descriptions of processes dealing with products and their nonconformities.
Procurement process P 01.00.
Sales planning process P 02.00.
Production process P 03.00.
Product quality control process P 04.00.
Process of transportation, storage and release of products P 05.00.

When developing this documented procedure, the following regulatory documents were used:

ISO 9000:2000 Quality management systems - Fundamental principles and vocabulary.
ISO 9001:2000 Quality management systems - Requirements.
RK 00.00 Quality Manual ___________.
D 00.03 Procedure for managing quality records.
D 00.04 The procedure for developing and implementing corrective actions.

3. DEFINITIONS OF TERMS, SYMBOLS AND ABBREVIATIONS

3.1. Terms and Definitions
This documented procedure uses terms and their definitions from ISO 9000:2000 and the following:
Products . result of the process. In this documented procedure, products should be understood as incoming raw materials and supplies, containers and packaging materials, semi-finished products at intermediate stages of manufacturing and finished products.
Non-conforming products - products that do not meet the requirements of the ND (products that have deviations or are produced under conditions that do not meet the standards specified in the ND).
Identification -
1. Assigning to an object a symbol (identifier) established in the RD in order to distinguish it in a homogeneous mass or homogeneous array and eliminate the possibility of confusion.
2. Recognition of an object according to criteria, features (identifiers) established in the RD.

Identification of nonconforming products - assignment of an index to non-conforming products (tags, markings, placement in a designated, indexed place) in order to prevent its unintentional use.
Disposal of non-conforming products - action taken on nonconforming products to prevent their original intended use (reprocessing, destruction).
Permission to Reject -permission to use or release products that do not meet established requirements.
Note: Permission to deviate generally applies to the supply of products that do not meet specifications for the agreed upon time or quantity limits for that product.
Release - permission to proceed to the next stage of the process.
3.2 Abbreviations
ND - normative documentation;
TU - technical conditions;
OTK. Technical control department
SI - measuring instruments.
GP. finished products.

4. DESCRIPTION OF THE PROCESS

4.1. This description of the procedure for dealing with non-conforming products regulates the requirements for the content of section 8.3 “Process description...”.
4.2. The description of actions with nonconforming products is intended for:
a) to ensure that during the production and delivery process materials, raw materials, and products that do not meet the established requirements cannot be unintentionally used;
b) analyzing nonconformities and obtaining quality data to develop corrective and preventive actions;
c) development and implementation of procedures for refinement, restoration and downgrading of non-conforming products;
d) disposal of products recognized as non-conforming and not suitable for modification, restoration and downgrading;
e) material accounting of non-conforming products.
The procedure for dealing with non-conforming products includes:
Registration of deviations of product quality from the requirements of ND;
identification of nonconforming products;
separation of such products from corresponding ones;
conducting an analysis of the causes and possible consequences of nonconformity;
making decisions on further use of products;
actions in case of detection of non-conformity after shipment of products to the customer;
recycling and accounting of rejected products.
4.2.1 Deviation registration. Deviations of product quality from the requirements of RD occur during the production process and are discovered during control operations or at the customer’s site.
All established cases of deviation of products from the requirements of the RD must be registered.
Note: Not all cases of detection of deviations in product quality require a decision to recognize the product as non-compliant with ND standards. For example, production control standards are ________ significantly stricter. than the standards of technical specifications and are used for ongoing adjustment of the process without stopping production and rejecting part of the product in cases of compliance with the standards of technical specifications.
Deviations of product quality or conditions of its production, control, storage, transportation and delivery from the standards established in the RD (including in the description of the process) are subject to registration.
The method and place of registration of deviations is established in the “Description of the process...” for each type of deviation.
4.2.2. Identification of nonconforming products. All products recognized as non-conforming to specification standards (TU) must be identified. The identification method is selected based on the type of product and should exclude the possibility of unintentional use of non-conforming products. For identification, as a rule, inscriptions, stickers, tags, marks in accompanying documentation, etc. are used.
The identification method must provide a clear picture of the status of the product. Product status can have the following types:
Products are in the process of control (for example: incoming control of materials is not carried out during the night shift, a sample of material is left until the morning and is controlled by the head of the quality control department or a senior laboratory assistant).
Status identification method:
containers with the inscription “For GP control” and indicating the hours of sampling for GP control;
an unfilled material identification sheet before completion of all incoming inspection procedures for incoming materials inspection;
or another way;

The product has been found non-conforming and is awaiting a decision.
Status identification method:
a label glued to a bag with samples of products recognized as non-conforming by the consumer - a decision on such products (for the entire supply or part of it) is made after analyzing the consumer’s complaint.
designation of products (materials) that have been in storage for longer than the period established by the RD. a decision on the further use of such products or materials may be made after further testing.
or another way;

The product is considered defective and must be disposed of. (for example: samples of caps on which laboratory or production controls are carried out).
Status identification method:
container for used samples with the inscription “Reject”.
or another way.

4.2.3. Separation of non-conforming products. Products recognized as non-conforming to the specification standards (TS) must be separated from the corresponding ones to exclude the possibility of their unintentional use.
Note: Separation of nonconforming products is inherently one of the identification methods and consists of placing nonconforming products in a specially designated area. In cases where the labor intensity of separating non-conforming products is too high, it is permissible to make do only with the identification of such products.
4.2.4. Conducting an analysis of the causes and possible consequences of non-conformity and making a decision on further use of the product.
To make a decision on measures to eliminate the causes of detected product nonconformity, see Section 8.3 “Process Description.” Typical types of nonconformity and those responsible for carrying out the analysis for each of them are indicated.
For example: misgrading of products, deviations in technical parameters of products, incomplete supply of materials, etc.
The results of the analysis and the decision made on the further use of the product are formalized by the person responsible for the analysis with the “Deviation Analysis Protocol” F 00.04.01
Appendix A "Procedure for the development and implementation of corrective actions" (D 00.04).
Decisions regarding future use of products may include:

carrying out sorting;
carrying out additional tests;
obtaining consumer consent for the supply of products deviating from the technical specifications;
decision on disposal due to the impossibility of further use;
decision to return to the supplier material whose non-compliance was detected during incoming inspection or during production;
permission to produce (use) products (materials) with minor deviations from technical specifications, authorized by the general director and deputy. General Director for Quality. For example: shipment of products to the consumer in containers without a logo;
other.
4.2.5. Actions in case of detection of non-conformity after delivery of products to the customer.

If a nonconformity is detected after delivery of the product to the customer (starting to use non-conforming incoming materials), actions must be described to immediately identify such products, notify the customer about the incident, conduct an analysis of the causes and consequences of the deviation and, if necessary, replace the product with the appropriate one.
Note: These actions are described for all cases of production of products of inadequate quality, including those tested using measuring instruments (MI) that have lost metrological accuracy.
If the customer discovers a non-conformity of the product during use and makes quality claims, the actions to immediately obtain the necessary information from the customer must be described, an analysis of the non-conformity must be carried out, the result of the analysis and the decision made must be communicated to the customer and, if necessary, the product must be replaced with an appropriate one ( or other actions agreed with the customer).
4.2.6. Disposal and accounting of rejected products. Where appropriate, a system for recording quantities and/or types of nonconforming products shall be described. The number of cases of nonconformity, volumes of nonconforming and rejected products should be included in the process performance indicators and participate in the work of section 8.4 “Data Analysis” “Process Description.”

5. DOCUMENTATION AND ARCHIVING

5.1. The original of the documented procedure after expiration, cancellation or replacement is kept in production for 3 years.

5.2. Quality records generated by this documented procedure include:

5.3. Quality records are maintained in accordance with the requirements of documented procedure D 00.03 “Procedure for managing quality records.”

6. PROCEDURE FOR MAKING CHANGES

6.1. GT reviews this D 00.06 once every two years for compliance with the requirements of the quality management system.

6.2. Based on the results of the consideration, the GT may decide to extend the validity of D 00.06 without changes. In this case, the validity of procedure D 00.06 is extended for the next two years, for which the GT makes an entry in the Change Registration Sheet. control copy: .Validity period extended to ............ year., signed and dated. Otherwise, the GT makes a note: Requires revision. The validity period has been extended to ............ a year (the extension period in this case should not exceed 1 month), signed and dated. Such an entry initiates the start of a review of this procedure D 00.06.

The decision to change procedure D 00.06 is made by the GT based on proposals from other divisions of the enterprise, the results of an analysis of established and foreseeable inconsistencies, as well as recommendations from internal or external audits.

Prepared for publication by Andrey Garin

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The organization shall ensure that products that do not conform to requirements are identified and controlled to prevent unintended use or supply. Controls, associated responsibilities and authorities for handling nonconforming product shall be defined in a documented procedure.

The organization shall resolve nonconforming product in one or more of the following ways:

a) take actions to eliminate the detected nonconformity;

b) authorize its use, release or acceptance if there is permission to deviate from the appropriate authority and the consumer, where applicable;

c) take action to prevent its original intended use or application,

Records of the nature of nonconformities and any subsequent actions taken, including approvals for deviations obtained, shall be maintained.

When nonconforming products are corrected, they must be re-verified to confirm compliance.

If nonconforming product is identified after delivery or use, the organization shall take action appropriate to the consequences (or potential consequences) of the nonconformity.

Data analysis

The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system, and to assess where continuous improvement in the effectiveness of the quality management system can be made. Data should include information obtained from monitoring and measurement and other relevant sources.

Data analysis should provide information on:

a) customer satisfaction;

b) compliance with product requirements;

c) characteristics and trends of processes and products, including the possibility of taking preventive actions;

d) suppliers.
9. Improvement

Continuous improvement

The organization shall continually improve the effectiveness of the quality management system through the use of quality policies and objectives, audit results, data analysis, corrective and preventive actions, and management review.

Corrective actions.

The organization shall take corrective action to eliminate the causes of nonconformities to prevent their reoccurrence. Corrective actions must be adequate to the consequences of identified nonconformities.

a) analysis of inconsistencies (including consumer complaints);

b) establishing the causes of nonconformities;

c) assessing the need for action to avoid recurrence of nonconformities;

d) determining and implementing necessary actions;

e) records of the results of actions taken;

f) analysis of corrective actions taken.
Preventive Actions

The organization shall determine actions to eliminate the causes of potential nonconformities to prevent their occurrence. Preventive actions must be appropriate to the possible consequences of potential problems.

A documented procedure shall be developed to determine the requirements for:

a) identifying potential nonconformities and their causes;

b) assessing the need for action to prevent the occurrence of nonconformities;

c) determining and implementing the necessary actions;

d) records of the results of actions taken;

e) analysis of the preventive actions taken.

In the current modification of the ISO 9000 series standards, the set of elements of development, creation and consumption of products is called the product life cycle. But in previous modifications of ISO 9000-88 and ISO 9000-94, and in many works on quality management, starting with K. Ishikawa, this set was called the “quality loop” and the stages of product creation were revealed somewhat differently. In the next paragraph we will describe the stages of the product life cycle in terms corresponding to the “quality loop” and the reader will be able to compare their content.

Open questions

1. Explain the processes related to consumers.

2. What is included in design and development?

3. What is procurement?

4. Tell us about the production and service stage.

5. Explain monitoring and measurement.

6. What is nonconforming product management?

7. What does data analysis involve?

Closed questions

1. Consider the proposition:

1. Quality planning should be carried out by planning and economic departments that are part of the company’s economic service.

2. Quality planning includes the development of new product designs.

c) both are correct;

d) both are incorrect.

2. Quality assurance includes:

a) ensuring the supply of materials that meet technology requirements;

b) compliance with technological instructions;

c) development of projects that meet consumption conditions;

d) metrological support.

Please indicate the wrong answer.

3. Consider the judgment

1. For any enterprise producing household appliances, quality systems are needed that include all elements of the quality loop.

2. For enterprises manufacturing food products, it is enough to have quality loop elements from the first to the eighth in the system.

a) the first is true, the second is false;

b) the first is false, the second is true;

c) both are correct;

d) both are incorrect.

Indicate the correct combination of assessments of the given judgments.

Elements of the Quality Loop

The quality loop includes the following elements:

1. Marketing, searches and market research;

2. Product design and development;

3. Planning and development of the production process;

4. Procurement;

5. Production or provision of services;

6. Checks;

7. Packaging and storage;

8. Sales and distribution of products;

9. Installation and commissioning;

10. Technical assistance and maintenance;

11. After-sales activities;

12. Disposal after use.

Figure 6 schematically shows the sequence of all stages of the quality system over time. This schematic image is called “quality loop” or “quality spiral”. This name reflects the idea that cycles repeat endlessly, like the links of a spiral.

If we look at the quality spiral, it becomes obvious that its right side, that is, stages two to seven, relates to intra-company activities, and the left side, that is, stages eight to one, concerns non-company activities.

Fig.6 Quality loop

Previously created quality systems in our country included mainly stages related to intra-company activities, and very rarely they included stages related to the life of products outside the enterprise gates. This was due to the planned distribution system, which did not sufficiently force the enterprise to take care of the buyer, and the lack of effective competition, and to some extent, the insufficient competence of management. Therefore, the main task when reworking quality systems in order to bring them into compliance with the international standards of the ISO 9000 series is to develop those activities that are aimed at the environment, and, first of all, to develop the marketing stage.

Anyone who wants to certify a product must begin by transforming the quality system into one that has all the necessary elements of the quality loop. Of course, this does not mean that all elements are necessary for every product. If a company produces confectionery products, then it will not need such stages as installation and adjustment, technical assistance and disposal. But if a company produces freezers for trade, then its quality system must include all stages.

Now let us characterize the stages themselves, that is, the content of activities for each of them.

1. Marketing

The marketing function should play a leading role in determining the requirements for product quality. It is no coincidence that K. Ishikawa, the founder of Japanese management methods, repeatedly drew attention to the fact that quality management and marketing are half-overlapping activities. You can't talk about quality management without doing marketing, and you can't talk about marketing without doing quality management. In this context, K. Ishikawa, when he said “quality management,” meant what is now called total quality management.

Marketing function in the quality system:

· identify needs for products or services;

· give a quantitative and qualitative definition of market demand and sales area;

· predict future needs;

· study the conditions of consumption and thereby create conditions for the company to stay ahead of consumer requirements;

· study the consumer’s assessment of the quality of manufactured products, collect and analyze his proposals to eliminate shortcomings and improve the quality of the project;

· identify areas for quality improvement.

2. Product design and development

The function of developing technical specifications is to translate into technical language the requirements for materials, processes and products, consumer needs, expressed in the form of a brief description of the product. Design allows you to transform the concept of a product into technically clearly understood documentation, according to which the product can be manufactured.

The design and technical conditions must ensure the possibility of product production, testing and control in the conditions of production, installation, sale and use. The project must contain clear and specific data necessary for logistics, execution of work, and verification of product compliance with established technical requirements.

The ISO 9004-94 standard describes the content of this function in great detail, and those who will develop an enterprise design standard can be advised to refer to clause 8 of the said standard.

3. Process planning and development

Preparation of production processes consists primarily of developing technology and documenting it in the form of technological instructions. At the same time, work is being carried out to provide production with the necessary equipment, tooling, tools, instruments, computer software, and personnel trained in the new technology. The technical capabilities of the process and its statistical controllability are also being studied; places for operational control of product quality, methods of control and places for checking technological parameters are determined; the organization of product traceability is thought through and prepared.

4. Procurement (materials and technical supply)

Logistics functions include:

· development of requirements for the supply of materials and components;

· selection of qualified suppliers;

· coordination with suppliers of technical specifications;

· coordination of methods for checking the quality of supplies;

· agreement on provisions for resolving controversial issues related to the quality of supplies;

· reaching an agreement on plans for acceptance inspection and incoming inspection;

· organization of registration and analysis of quality data during incoming control;

· organizing interaction with the supplier on preventive work aimed at reducing defects;

· organizing interaction to improve the quality of supplies.

The modern understanding of procurement includes the opportunity for the buyer to ensure that the supplier’s quality system meets any of the listed standards, which is reflected in supply contracts.

5. Production or provision of services

Production management functions in the quality system include:

· organization of storage, separation, transportation and protection of materials and components to maintain their functional suitability at the proper level;

· organizing the identification and traceability of products when necessary to ensure their quality;

· organizing the proper condition of equipment and its timely repair;

· organizing control over compliance with technology and operational control, including self-control;

· organization of metrological support of the technological process;

· registration of data on certification of personnel, processes and equipment;

· management of changes in technological processes, including determining the circle of persons who have the right to change processes and establishing procedures.

6. Product inspection

Includes inspection of purchased materials and components, inspection of product quality during production (operational control), inspection of finished products, as well as control of instrumentation and testing equipment, management of non-conforming products.

Checking purchased materials and components is also called incoming inspection. If, when describing procurement, we talked about the coordination of methods and verification procedures, then in the product verification section we are talking about the implementation of the verification process itself in the company, that is, about the organization of incoming control and legal interaction with suppliers.

In-process inspection(operational control) by inspection and testing carried out at specified points in the production process to confirm compliance.

The location of these checks and their frequency depend on the significance of the characteristics and the convenience of checking during the process. As a rule, testing should be done as close as possible to the point at which the characteristic is generated. But this is not always possible. For example, when creating televisions, the quality of the connection of all elements (the quality of soldering contacts) is of great importance for their reliability. Ideally, it was best to check the quality after soldering the contact. Today, the entire TV is assembled, placed on a vibration stand, and after a given number of vibrations, the image quality is assessed. And by this final result the quality of the connections of the elements (soldering) is judged.

Operational control costs a lot of money, but it allows you to reduce losses from the costs of all subsequent operations that occur after the one being checked, if it is performed reliably.

Checking finished products, which before the introduction of quality systems was the main means of preventing low-quality products from reaching the customer (buyer), has now acquired a slightly different meaning. It has become not so much a means of sorting products into good and bad, but rather a signal for assessing the stability of the production process, that is, a means of preventing the creation of unusable products. Finished products are checked in two ways:

Acceptance control;

Testing on sample units.

Acceptance control can be continuous, that is, all units of production are checked, or random control of product batches, or continuous random control.

Checking on sample units presented from a complete batch means that all products included in the batch are not checked at all, but the presented product is checked thoroughly, and the entire batch is judged by it.

The content of inspections will be discussed in more detail in the chapter devoted to this type of activity.

Control of instrumentation and test equipment includes:

· selection of measuring instruments, if standard instruments are used, or development and production, if it is necessary to create special instruments;

· selection or development of testing equipment (for example, vibration stands for the mentioned televisions or hydraulic presses for testing pipes with internal pressure);

· development of measurement or testing technology that provides the necessary accuracy;

· ensuring that measuring and testing instruments are maintained in working condition;

· organization, systematic verification of accuracy by the company or specialized metrological organizations.

Management of Nonconforming Products includes:

· identification, that is, identifying defective products and marking them in such a way that in the future they cannot be confused with suitable products. Identification means can be marking, branding, magnetic tags, separate storage, etc.;

· isolation from suitable products;

· examination by specially appointed personnel to determine the possibility of eliminating identified defects and using them for another purpose;

· accounting for the number of nonconforming products, indicating the types of defects and operations in which the defects arose and were identified;

· disposal of non-conforming products.

7. Packaging and storage

Includes organizing ways to protect products from deterioration of their characteristics during storage and transportation and creating the necessary storage conditions. Products that can be subject to corrosion can be oiled, coated with anti-corrosion coatings, and painted to prevent rust from appearing when stored in warehouses. On the other hand, storage conditions must be such that they do not provoke corrosion: certain humidity, acidity; Temperature, dust, and vibration are also taken into account.

8. Sales and distribution of products

Includes the development and adherence to methods of transportation, loading and unloading, storage in intermediate warehouses, ensuring the preservation of product properties at the level that was created in production.

Loading schemes, handling technology and storage conditions must be clearly documented, and the manufacturer is obliged, when concluding agreements with all intermediaries involved in the distribution process, including retailers, to provide for their responsibility for complying with the rules developed by the manufacturer.

9. Installation and commissioning includes:

· development of installation procedures that ensure compliance of operational characteristics with the requirements of the technical documentation, and, if necessary, installation by the manufacturer or organizations trained and certified by him;

· development of documentation for adjustment and, if necessary, implementation of adjustment by the manufacturer or organizations trained and certified by him.

10. Technical assistance and service should include:

· technical consultations;

· provision of spare parts;

· performing warranty and post-warranty repairs, if the consumer needs it, by the manufacturer or organizations trained and certified by him.

11. Post-sales activities should include:

· creation of a system for diagnosing the condition of products for the purpose of early detection of failures and prevention of emergency failure;

· creation of a system for collecting and analyzing information about comments and wishes of consumers on product quality in order to implement corrective actions at the stage of design, manufacturing or operation.

12. Disposal after use should include:

· development by the manufacturer of environmentally acceptable methods for processing products that have expired and become unusable;

· organizing the collection and restoration of products or their components and parts, if technically possible.

Experience shows that a well-thought-out recycling system not only relieves the consumer of the problems associated with the impossibility of endless storage of worn-out products, but also turns out to be economically beneficial for those involved in recycling. Problems of ecology and recycling of resources are becoming the most pressing today, and those manufacturers who, earlier than others, understand the need to consider the possibility of recycling at the stage of product development will be winners in the competition.

We examined the content of various activities that affect quality, using the stages of the product life cycle (quality loops) to designate these activities.

In addition to the above classification of activities that affect quality, there is also a classification by function:

1. Financial quality management;

2. Statistical methods in the quality system;

3. Personnel management in the quality system.

1. Financial quality management allows you to evaluate the effectiveness of the quality system, including:

· efficiency of improving the quality of the project, i.e. comparison of the costs of increasing the design level of quality with the increase in revenue from the sale of products of improved quality;

· effectiveness of activities to ensure the planned level of quality, i.e. comparison of costs for ensuring quality of workmanship in the reporting and previous periods.

Since a special chapter “Economics of Quality” is devoted to this type of activity, for now we will limit ourselves to this brief definition.

2. Statistical methods in the quality system

The ISO 9004-94 standard provided for the possibility of applying and developing documented procedures for the application of statistical methods in:

· planning of experiments and factor analysis;

· variance and regression analysis;

· control charts and cumulative sum methods;

· statistical sampling control;

· criteria of significance.

When choosing objects to use statistical methods, each enterprise takes into account the specifics of its products and its production processes, but in general it can be said that an enterprise that does not use statistical methods at all will soon look insufficiently modern and does not inspire confidence in the consumer.

3. Personnel management in the quality system includes the following types of work:

· training in quality management issues with differentiation of training according to

three criteria: administrative and management personnel, technical personnel and production personnel;

· ensuring the required level of qualifications and its documented confirmation for personnel performing certain specialized operations, primarily related to measurements, tests, checks of metrological tools, etc.;

The topic of ensuring product quality is relevant for every enterprise. Modern production organization requires the presence of a quality management system, one of the main goals of which is to ensure the release of high-quality products.

This is achieved by system processes and procedures that must function on an ongoing basis. To increase the effectiveness of these processes and, as a result, improve product quality, the principle of continuous improvement must be applied - PDCA

According to the PDCA principle, to improve a process, it is necessary to determine its current state, which will be the starting point for subsequent improvements. In the case of quality, this is an objective picture of the quality of products in each division of the enterprise.

If an enterprise has problems with product quality, then it is not a fact that the reason lies in the competence of the personnel who make the wrong decisions. Perhaps management decisions are not based on objective data. And therefore the activity is chaotic and does not bring the required result.

The product “8D.Quality Management” will help solve problems in the field of collecting and analyzing information in order to obtain a basis for making decisions to improve quality.

The system performs the following functions

1 Collection and analysis of information on product quality

The following lifecycle stages are supported:

acceptance (incoming quality control);
production;
delivery (quality control is carried out by the consumer at his own enterprise);
warranty (warranty and post-warranty operation)

The amount of information in the log must be processed, so our system contains a number of tools for analyzing statistical data on product nonconformities.

Analytical tools allow you to answer a number of pressing questions:

Which supplier supplies the most defective products and which ones?
Which workshop, area, equipment or contractor produces the largest volume of non-conforming products?
top 10 reasons why non-conforming products occur in production?

and many others.

The results of the analysis can be used to develop a program to improve product quality.

2 Accounting for quality products

The system allows you to take into account the results of all methods for determining product compliance with requirements. And if, when non-conforming products are identified, it is possible to initiate corrective actions or permission to reject, then the positive results of control, measurements, and tests can be used when generating an electronic passport of product quality.

Thus, having received a sample of information on the quality of a specific product (by serial number), it is possible to obtain a report that will be an objective confirmation that the product meets the requirements, and therefore is of high quality.

3 Corrective actions

This is a mandatory procedure for any quality management system (business). Used to eliminate the consequences and causes of inconsistencies. The difficulty of implementing the procedure lies in the large number of participants and stages. If several corrective actions are open at the same time, then it is necessary to monitor the implementation of many stages and coordinate the work of departments as part of solving quality problems.

The product uses the 8D corrective action methodology, which has already proven its effectiveness around the world. The procedure is based on 8 stages, which from each problem allow you to actually create a case for solving it.

Main functions:

administration of corrective actions (control of deadlines);
displaying a list of tasks for a specific performer for all open corrective actions;
storage of all documentation that arises as a result of solving the problem;
monitoring the effectiveness of corrective actions.

The use of the system will make it possible to implement the requirements of the standard and make corrective actions at the enterprise traceable and manageable.

4 Permission for deviations

The procedure allows you to authorize the use of products with deviations in production. Used in cases where it is not possible to take corrective actions. An expert team is created in the system, each member of which expresses their opinion on the admissibility of using products with deviations. The final decision maker reviews the team's opinions and makes a final decision.

Using the system will make the process of issuing permits for deviations traceable, recording the decisions of responsible persons and using each case of registration as a case in the enterprise knowledge base.

5 Enterprise knowledge base

By filling the system with information about inconsistencies, problems and their solutions in the form of corrective actions and permits for deviations, you thereby form the knowledge and experience base of your enterprise.

When another quality problem is identified, it will be possible to access the knowledge base and obtain information on how to solve a similar problem.

In addition to reducing the time to resolve problems, the system will allow you to meet the requirements of quality standards related to the formation of the organization's knowledge base.

You can try the product for free for 45 days. To do this, go to the product website and fill out the form.

General provisions
Actions with nonconforming products must also be regulated at the level of the entire QMS in the form of a documented procedure, although in paragraph 4.2.3 we could see that the requirements of this procedure can be combined with the requirements of the instructions for developing documents.
Regulation of actions with non-conforming products is intended to: ensure that materials, raw materials and products that do not meet the established requirements cannot be unintentionally used in the production and delivery process; analyzing nonconformities and obtaining quality data to develop corrective and preventive actions; development and implementation of procedures for refinement, restoration and downgrading of non-conforming products;
disposal of products recognized as non-conforming and not suitable for modification, restoration and downgrading; material accounting of non-conforming products.
Procedures for dealing with non-conforming products include
includes: registration of deviations of product quality from the requirements of the RD; identification of nonconforming products; separation of such products from corresponding ones; conducting an analysis of the causes and possible consequences of nonconformity; making decisions on further use of products; actions in case of detection of non-conformity after shipment of products to the customer; recycling and accounting of rejected products. Deviation registration
Deviations of product quality from the requirements of regulatory documentation (ND) occur during the production process (service provision) and are discovered during control operations or at the customer’s site.
All established cases of deviation of products from the requirements of the RD must be registered.
Deviations of product quality or conditions of its production, control, storage, transportation and delivery from the standards established in the RD (including in the description of the process) are subject to registration.
The method and place of registration of deviations are established in the working documentation for the process or individual operations of the process. Identification of nonconforming products
All products recognized as not meeting ND standards must be identified. The identification method is selected based on the type of product and should exclude the possibility of unintentional use of non-conforming products.

For identification, as a rule, inscriptions, stickers, tags, marks in the accompanying documentation, assignment of additional
The identification method must provide a clear picture of the status of the product. The status may have the following types: products are in the process of control;
Method of status identification: containers with the inscription “For control” and indicating the time of sampling for control; an unfilled sheet of incoming material inspection before completion of all incoming inspection procedures for incoming inspection of materials; another way; the product has been found non-conforming and is awaiting a decision;
Method of status identification: a label glued to containers with samples of products recognized as non-conforming by the consumer. A decision on such products (for the entire supply or part of it) is made after analyzing the consumer’s complaint; designation of products (materials) that have been in the warehouse for more than the period established by the ND. A decision on further use of such a product or material may be made after further testing; mark in the accompanying documentation; placing products in containers with an inscription or a specified color (for example, red); labeling of the product itself, if it does not cause additional damage to the product; another way; the product is considered defective and must be disposed of;

Method of status identification: containers for rejected products with the inscription “Reject”; product labeling; moving products to the “Defective Isolator” for safekeeping by Quality Control Department before the start of the destruction procedure; another way. Separation of non-conforming products
Products recognized as not complying with ND standards must be separated from those that comply to eliminate the possibility of their unintentional use.
Note. Separation of nonconforming products is inherently one of the identification methods and consists of placing nonconforming products in a specially designated area. In cases where the labor intensity of separating non-conforming products is too high, it is permissible to make do only with the identification of such products. Conducting an analysis of causes and possible consequences
inconsistencies and making decisions about further
use of products
To make a decision on measures to eliminate the causes of detected product nonconformity, the documentation regulating the process indicates typical types of nonconformity and those responsible for carrying out the analysis for each of them. For example, misgrading of products, deviations in technical parameters of products, incomplete supply of materials, etc.
The results of the analysis and the decision made on the further use of the product are documented by the person responsible for the analysis in the form established by the organization.

Decisions about the further use of products may include: carrying out sorting; carrying out additional tests; obtaining consumer consent for the supply of products deviating from the technical specifications; decision on disposal due to the impossibility of further use; decision to return to the supplier material whose non-compliance was detected during incoming inspection or during production; other. Actions in case of detection of non-conformity after
supply of products to the customer
If a nonconformity is discovered after delivery of the product to the customer (starting to use nonconforming incoming materials), actions must be described to immediately identify such products, notify the customer of the incident, conduct an analysis of the causes and consequences of the deviation and, if necessary, replace the product with a conforming one.
Note. These actions are described for all cases of production of inadequate quality products, including those tested using measuring instruments (MI) that have lost metrological accuracy.
If the customer discovers a non-conformity of the product during use and makes quality claims, actions must be described to immediately obtain the necessary information from the customer, an analysis of the non-conformity must be carried out, the result of the analysis and the decision made must be communicated to the customer and, if necessary, the product must be replaced with a corresponding one (or other actions agreed with the customer). Disposal and accounting of rejected products
Where appropriate, a system for recording quantities and/or types of nonconforming products shall be described. Quantity
cases of nonconformity, the volumes of nonconforming and rejected products should be included in the performance indicators of the process and participate in the work of its owner when implementing section 8.4 “Data Analysis”.