Two approaches:
1. Compiling a list of all processes that have key value for organization
2. Systematic approach - sequentially highlighting the following elements: the organization's strategy, which is determined and shaped by: stakeholders who: have certain expectations regarding the organization's products, thanks to: the business processes through which these products or services are produced, and also provide support and the possibility of their production
The process is represented as a block. An incoming arrow attached to the block on the left represents process inputs. It is used to describe resources (what is processed within the process). Accordingly, an exiting arrow attached to the block on the right indicates the outputs of the process. This arrow indicates the product produced by the process.
The inputs and outputs of a process can be both tangible and intangible (for example, information) objects. Examples of inputs and outputs are: materials, components, components, information, etc.
Main purpose of a process map– is to represent the technology for performing the process. By creating a process map, it is documented; as a result, the organization has the opportunity to manage this process, make changes to it, and evaluate the effectiveness and efficiency of the process.
The process map should represent the process to the extent necessary to obtain consistent and acceptable process results. There is no need for a process map to include all the details that qualified employees are required to know themselves. Typically, a process map represents the flow of work that moves from department to department. Therefore, another purpose of a process map is to solve “joint problems” between departments involved in the process. The results of the work of one division (or organizational unit) must be fully required by the subsequent division, and these results must be sufficient to complete the work. Those. " exits " from one unit must fully comply " entrances » another. To ensure such “docking”, process maps are developed.
In order for a process map to serve its purpose, there are mandatory elements that must be included in the map.
These elements include:
§ process operations;
§ process resources (material, technical, human, information, etc.);
§ special conditions process execution (if any);
§ competence and qualifications of personnel;
§ documents establishing requirements for the product of the process and their changes during the transition from operation to operation;
§ ways to monitor the process;
§ methods of inspection, control and testing of the process product;
§ reporting created during the process.
In the event that it is created new process, all these elements can change during the “trial operation” of the process. In order to be able to evaluate improvements in such processes, it is necessary to provide methods for checking the effectiveness of the process in the process map.
47. Application of statistical methods to assess the effectiveness of QMS processes;
The effectiveness of the QMS depends on the effectiveness of each of the processes that make up the QMS. Therefore, when performing the QMS Analysis process, it is also necessary to determine and analyze the effectiveness of each QMS process.
5.1.1 Requirements for the planned results of each QMS process must be presented in the QMS documentation in the form of relevant process indicators and criteria for their evaluation.
The criterion for assessing an indicator must contain the standard (planned) value of the process indicator, expressed in measurable units, as well as the requirement for the conditions for assessing the actual value of the indicator.
5.1.2 For each QMS process, the procedure for conducting its monitoring must be regulated, during which information on the actual value of each process indicator is collected at an established frequency.
Organization officials responsible for managing specific QMS processes must analyze the compliance of the actual values of process indicators with the established criteria.
The results of the analysis should be used to make objective decisions on the operational management of the process.
5.1.3 Information on the fulfillment of process criteria should also be regularly reported to the organization's senior management.
5.1.4 To subsequently determine the effectiveness of the process, it is necessary to calculate the performance coefficient for each indicator (the ratio of the actual value of the indicator to its planned value).
5.1.5 It is recommended to determine the effectiveness of the QMS process (RP) according to the “weak link” rule - the effectiveness of the process is assigned smallest value of all calculated performance coefficients.
5.1.6 To assess the effectiveness of the process, it is recommended to use the following assessment options:
The process functions effectively and does not require the development of any actions if Рп = 1;
The process functions effectively, but requires the development of preventive actions if x 1< Рп< 1;
The process functions effectively, but requires the development of minor corrective actions if x 2< Рп< х 1 ;
The process is not functioning effectively enough and requires the development of significant corrective actions if x 3< Рп< х 2 ;
The process is ineffective and requires intervention senior management, if 0< Рп< х 3 .
The values x 1 ... x 3 are established during the development of the QMS and must be in the range from 0 to 1.
5.1.7 Upon achieving process stability as a result of improving the QMS (after the effectiveness of all processes does not fall below 0.999), it is advisable to move from the above-described methodology to the implementation of the Six Sigma methodology.
5.1.8 It is also possible to use other methods for calculating performance, for example, taking into account differences in the importance of each of the QMS indicators by assigning different “weighting coefficients” to them. It must be taken into account that the use of more complex methods significantly increases the complexity of performance calculations, and their use must be justified.
48. Criteria for selecting a QMS certification body;
Certification of management systems is an activity not subject to licensing. However, certification bodies providing management system certification services in Russia must nevertheless have a set of documents confirming the legitimacy of their activities.
When choosing a certification body in Russia, first of all, you need to make sure that it has the right to carry out certification activities for management systems. The certification body must work within the framework of the certification system. Certification systems operating on the territory of the Russian Federation must be registered with the Federal Agency for Technical Regulation and Metrology of the Russian Federation. The fact of registration is confirmed by the Certificate of Registration of the certification system. Confirmation that a body has the right to work in a specific certification system is an Accreditation Certificate issued by the owner of the system.
The world places much greater importance on the accreditation procedure. It is established that in each country there is one national accreditation body, which undergoes the procedure for joining the International Accreditation Forum (IAF), and then, if certain criteria for personnel qualifications, objectivity and independence are met, the procedure for joining the Multilateral agreement on mutual recognition of accreditation results (Multilateral Recognition Arrangement, MLA). Confidence in the ongoing compliance of IAF member accreditation bodies with established criteria is ensured through regular mutual audits within the IAF.
In accordance with Russian legislation, it is sufficient that the certification body is properly registered (as legal entity), had an accreditation certificate for carrying out work within the framework of the certification system registered by the Federal Agency for Technical Regulation and Metrology of the Russian Federation. However, if an organization wants to be sure that the certification work will be carried out by specialists top class, and the issued certificate will be recognized throughout the world, of course, you should choose a body that has an internationally recognized accreditation as a member of the IAF.
There are other options for ensuring that a certification body's certificate is recognized around the world. The most effective is recognition through membership of a certification body in a large professional organization. The largest union of certification bodies for at the moment is the International Certification Network (IQNet) - an association that unites 38 certification bodies from 34 countries. A client who has a certificate from an IQNet member certification body can, without additional verification, receive a certificate from any IQNet member, and these are certificates with 50 different accreditations (many IQNet members have accreditations from two or more accreditation bodies).
Unions of certification bodies. One of the most important criteria for choosing a certification body is also the competence of experts who directly carry out certification work. Experts must have experience and special training on certification of quality management systems. The more experts a certification body has, the more likely it is that an expert can be selected to carry out the inspection
Competence of experts . Organization and will bring to the organization itself greatest benefit. An important advantage is also the registration of experts in national and, what is more valuable, international personnel certification bodies.
When choosing a certification body for an organization, it is important to remember that the certification process should not only lead to a certificate, but also provide benefit and added value to the organization itself. A certification audit carried out by qualified specialists from a large and recognized certification body provides an organization with many benefits. useful information to further improve the QMS.
49. The procedure for development and preparation for QMS certification according to ISO 9001;
Preparation for certification to ISO 9001 is, in fact, the development and implementation in the company quality management systems(QMS), the main task of which is to increase the likelihood of achieving the company's goals.
The development and implementation of a QMS in a company is a serious and large-scale undertaking, which, like any business, begins with an initial study. Namely, an analysis of the company's existing processes should be performed. Therefore, preparation for certification consists of three main stages:
1. Analysis of the existing QMS
2. Improvement of the QMS to meet the requirements of ISO 9001
3. Implementation of activities for certification to ISO 9001
The procedure for development, implementation, preparation for QMS certification according to ISO 9001:
Management decision making
Choosing a certification body
Selection of consultants to support work on the development and implementation of a QMS
Carrying out diagnostic examination enterprises
Organization and planning of work within the enterprise
Organization of training of employees in the basics of QMS
Construction and description of the process model
Optimization if necessary organizational structure
Development of QMS documentation
Implementation of QMS
Preparation for certification
QMS certification for compliance with ISO 9001.
Process models. The next task after compiling a preliminary list of processes is to create process models that have the following properties:Brief information the process can be described in an identification card (IC), a kind of process passport. The content and form of this type of document have been repeatedly cited in the literature and are used by many enterprises 2 . As an example, let's give the following form IR.
1.Name and designation of the process.
2.Process manager.
3. Division (divisions are indicated, the activity or part of the activity of which is described by this process. This information determines the application of processes in the organization).
4. Purpose of the process. A qualitatively defined task or result to be achieved through a process. Answers the question: “Why was this process created?” The purpose must be consistent with other processes and reflect the requirements of internal and external customers. For example, the purpose of the production process is to produce products that meet the requirements of regulatory documentation, corresponding nomenclature, volume, within a given time frame. For the documentation management process - providing users with regulatory documentation that is adequate, relevant, necessary and sufficient for the implementation of activities. A correctly formulated process purpose will help in determining process evaluation indicators.
5.Process inputs and supplier processes.
6. Process outputs and consumer processes. (Information (clauses 5 and 6) will be in demand when describing the interaction of QMS processes, for example, in the form of interaction diagrams, which is a requirement of clause 4.2.2c of GOST R ISO 9001-2001, as well as for assessing the interaction between processes, which is advisable to carry out process managers for review of the QMS by senior management.)
7.Process resources:
(The types of process resources given are not quoted from the text of the ISO 9001 standard, which only indicates human resources, infrastructure and production environment, but also do not contradict it. As already mentioned, the organization must have its own classification of resources. You can expand this list to a dozen, adding time, finance, intellectual resources, etc., while assessing their need for process management purposes. The section should provide brief description resources or links to existing standards.)
8. Process evaluation indicators.
The information presented in the IC provides an initial understanding of the process. A detailed description of the process, reflecting the sequence of actions, composition and content of individual stages, can be said to be already customary to be performed in the form of flowcharts (Scheme 3). This form of description of the process gives a clear idea of the sequence of work, requirements for the implementation of stages, and responsible performers. It is quite informative and easy to use for mid-level personnel.
The block diagram is drawn up taking into account following rules.
1. A basic process flow diagram is drawn strictly from top to bottom, which is a reflection of the simplest and most economical process option without any complications or deviations.
2. Inputs and outputs are indicated by ellipses, stages (operations) by a rectangle, and a complication point by a rhombus. The rectangle contains the name of the stage (in verbal form), the performer of the stage.
3. Basic flowcharts consist not only of stages (operations) of the process, but also contain questions that reveal the essence of the point of complication. If we answer “no” to this question, then the process follows the basic model; if the answer is “yes,” then the process becomes more complicated.
4. To the right of the points of complications, process deviations are drawn. Without completing the variance work, you cannot return to the basic process model.
5.The process flow diagram is placed on the left (see diagram 3). Opposite each stage there is information about the requirements for the method of performing work at this stage or a link to the regulatory document, as well as information about input and output documents and messages.
6.When developing the first version of flowcharts, you can use a different color to highlight blocks of operations that do not exist, but which, in the opinion of the process manager, should exist.
7. The resulting process flow diagram should be analyzed for compliance with the requirements. First, it should reflect the PDCA cycle (plan - do - check - improve actions). Secondly, the process must comply with the requirements of the ISO 9001 standard and the internal requirements of the organization for the performance of these works. Thirdly, it is advisable to agree on the flowchart with the managers of the consumer processes to take into account their requirements.
8. A separate type of analysis of the process model - the presence and reflection of the necessary components in the block diagram effective management, including clear requirements for products and work performance, as well as actions in case of process deviations.
Experience has shown that it usually takes several attempts before a satisfactory process flow diagram is produced. But this work is worth the effort. The result is a clear and adequate description of the process that can be used by:
Process evaluation indicators. Processes can be assessed in different ways. For the effectiveness of this assessment, it is important to link into a single system the goals of the organization, the assessment of processes, departments, each employee with a system of incentives and remuneration. For process evaluation indicators, you can use the following indicators:
In general, process evaluation indicators characterize the quality of the process output (therefore, the names “quality indicators”, “quality criteria”, etc. are often used). They must be set and be adequate to the purpose of the process, the requirements of internal and external consumers, and the goals of the organization, including quality goals.
Assessment indicators common to all QMS processes may include: the following indicators effectiveness:
Other indicators will be of a specific nature, inherent this process. For example, the number of product returns to suppliers for the purchasing process; quantity of defects - for the production process; number of new consumers - for marketing research.
Evaluation indicators must be measurable values, calculated on the basis of data obtained from reliable sources of information. For indicators, it is necessary to determine not only the name, but also the units of measurement, standard values with which the measured values of the indicator will be compared, data sources, calculation formulas, and frequency of assessment.
Standard values for the evaluation indicator are established depending on the quality objectives and statistical data on the characteristics of the process for previous periods. In some cases, it is necessary to develop a methodology for collecting data and calculating an indicator.
It is recommended that information specifying process assessment indicators be documented in separate documents for each QMS process. The intended title is “Process Monitoring Plan”. This document is reviewed at the same frequency as the organization's Quality Policy and Objectives. The decision to revise process assessment indicators can be made when analyzing the QMS. A representative of the QMS management (quality director) can approve monitoring plans.
In order not to complicate calculations and reporting on process assessment indicators, initial stage implementation, it is recommended to accept that all developed indicators characterize the effectiveness of the process. If the assessment indicators are within standard values, then the process is considered effective. In case of deviations from the norm, you can calculate in percentage how effective the process is. If the evaluation indicators of the process under consideration completely coincide with other processes or it is difficult to determine the result (output) of this process, and, consequently, the indicators of its evaluation, then the correctness of defining the boundaries of this process and its purpose in the QMS is checked. It may be necessary to make changes to the list of QMS processes, since the absence or “blurring” of the result (output) of the process contradicts the essence of the process approach: each activity should be aimed at obtaining a result that can be measured to be able to manage and achieve the overall goals of the organization.
The described method for determining evaluation indicators is simplified and is suitable as a “test of strength” and testing the reporting mechanism for evaluation indicators. Other methods for determining evaluation indicators have been studied and described in works and can significantly supplement management experience using a process approach.
The identification process consists of a number of successive stages.
Preliminary Study - Isolation maximum quantity identification features of each of the studied objects.
Comparative research - comparison of identified identification features, identification of similar and different ones.
In a comparative study, features are compared from general to specific. This sequence is most optimal - when significant differences are established already at the comparison stage common features This study allows you to exclude the object from being tested.
Evaluation of results.
The result of forensic identification may be the following conclusion:
1) about the presence of identity of the object;
2) about the absence of identity of the object;
3) about the impossibility of solving the identification problem.
The conclusion about the presence or absence of identity can be categorical or probabilistic.
A conclusion about the identity of an object can be made even in the presence of insignificant differences. As a rule, these differences are natural and can be explained.
Identification studies can be of the following types.
Object identification by ideal mappings.
Establishing the whole object in parts. In such a study, the identifiable object is the object before it is divided into fragments; the identifying fragments are its fragments (shards, scraps of paper, etc.).
Establishing group affiliation - assigning an object to a certain type, group (i.e. to a certain set of homogeneous objects). This type of research is also carried out when it is impossible to give an unambiguous answer about the identity of the object. One of the types of research to establish group affiliation is to determine a single source of origin of an object.
Depending on the method of their preparation, samples for identification are divided into:
experimental - samples obtained specifically for identification;
free - samples that did not arise in connection with the investigation and the need for identification. The value of these samples is higher, since they usually contain more features.
The form of identification can be procedural or non-procedural.
The procedural form of identification is associated with the procedural action within which it is carried out (for example, during an inspection of a crime scene, a search, etc.).
A non-procedural form of identification is carried out by an investigator (or, for example, a specialist) during a preliminary examination of evidence, checking criminal records, etc.
Before you begin documenting a business process, ensure that the process is identified. In some cases this may turn out to be not an easy task, since it is not always obvious in which process a particular department of an enterprise that has a structure built on a functional principle is involved. To understand the situation, let's consider two complementary approaches proposed by D. Peppard in his work. The first and simplest approach is to make a list of all the business processes that are believed to be of key importance to the organizations. This work is often based on existing, previously written process descriptions or procedures performed at one time, for example, for certification of a plant in accordance with the ISO 9000 standard or for other purposes.
The second, more fruitful and systematic approach is to highlight the following sequence of elements: the enterprise strategy, which is determined and shaped by: stakeholders (i.e. organizations, institutions or individuals who have a legitimate interest in organizing it business process) that: have specific expectations about the products or services provided by the organization through: the business processes that produce those products and services, and the support and capability to produce them.
By going through this sequence of elements one by one, it is much easier to identify business processes and understand what is needed to meet the expectations of stakeholders.
It is important that every business has a clear formulation of its strategy. If this is not the case, then there is no readiness to switch to a process orientation. If the strategy is clearly formulated, then stakeholders can be identified quite easily, even if they include more than just the obvious ones (for example, consumers). Important stakeholders include owners, employees, suppliers, government, local community, etc. All stakeholders have certain expectations about the organization. Setting these expectations usually makes things easier, even if stakeholder interactions sometimes arise.
Once all of these expectations have been identified and ranked based on priority preferences, you can begin to identify the business processes that are implemented to fulfill these expectations.
When moving backwards from outputs to stakeholders through primary and supporting processes and their inputs, some tension appears in business processes. Even if any business process is not taken into account by this approach, although it operates in the organization, then it is actually the same. If you leave it out of consideration, nothing will change.
Once the key business processes have been identified, you can begin real work on documenting each individual process. When documenting a process, the following two-step procedure may be useful: Define the process and describe it qualitatively. Preferably using an analysis called relationship mapping. Ego involves answering questions like: Who is the consumer of the business process and what is its output? Who is the supplier of this process and what is its input? What are the input and output requirements for this process? What is the internal flow of activities of this process? Draw a flowchart of the process.
The remainder of the chapter is devoted to the following methods documenting the process: mapping relationships; process flow diagram; cross-functional block diagram; multi-level block diagram.
