The Methodology of QMS Planning Author: Martsynkovsky D. A. Introduction One of the basic aspects of functioning and Quality Management System (QMS) development is a planning stage which is focused on provision of necessary controlled conditions in development, implementation, maintenance and continual improvement of QMS. In ISO 9001, clause 5.4.2 "Planning of establishment, maintenance and improvement of Quality Management System" the following requirements are contained: "Top management shall ensure that: a). the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and b). the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. ISO 9001, clause 4.1 "Quality Management System. General requirements", in its turn, includes the requirements for identification, development and implementation of the processes directed to QMS effectiveness growth. Thus, the main purpose of QMS planning is to improve the processes effectiveness and, as a result, organization activity as a whole. According to the definition given in 3.2.2 of ISO 9000:2005, "Quality planning - part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives". In turn, according to ISO 9000:2005, 3.2.5, definition: "Quality objectives - something sought, or aimed for, related to quality". In practice, the fulfillment of the given requirement in a number of cases comes to the formal posing of Quality objectives and development of Plan Arrangements for QMS implementation, each of these arrangements are intended to demonstration of appropriate Standard requirements fulfillment during external audits, carried out by Certification Bodies. Therewith, the quality objectives are to a greater extent focused on QMS certification, for example:" To certify QMS till XX.YY.ZZ" or "To carry out QMS internal audit in conformity to QMS internal audits Program". In its turn, Plan of Arrangements for QMS implementation in its essence frequently represents the Program of Actions, providing the successful preparation to Certification or to Surveillance Audit, but not the enhancing of QMS effectiveness (and namely on this aspect it should be focused on!). As an example one can refer to some "typical" arrangements which are included in this Plan: "To train not less than two internal QMS auditors"; "To develop the Procedure for QMS Documents control"; "To distribute the controlled copies of QMS documents". The above mentioned situation is inherent to organizations which are at the beginning of QMS system implementation. While such an approach has its usefulness to QMS planning, it is necessary to notice that the objectives and arrangements, listed above, are some of the integral elements of QMS planning, but they do not in full ensure an effectively functioning of QMS. Moreover, such a formalistic approach to the system planning creates a higher risk of the QMS becoming a paper chase not reflecting the real production/practices of an Organization. This then results in an established system which is ineffective. This publication offers the readers the methodology of QMS planning directed on practical implementation of Quality Policy and achievement of Quality Objectives. Basic stages of QMS functioning QMS functioning, in general, can be represented as a set of successive and interrelated stages (figure 1). Characteristics of each QMS functioning stages are presented below. 1. Assessment and review for improvement. At this stage the top management carries out the comprehensive review of the Organization activity, assesses achievements and imperfections, defines Quality Policy and Quality Objectives which serve as a starting basis for forming a QMS planning concept. 2. Planning for conformity and improvement QMS is used as the main mechanism of Quality Policy realization and Quality Objectives achievement. At this stage the formation/revision of the system Process model are carried out, also the development of Quality Plans, the assignment of the officials and the criteria of processes' effectiveness, required resources, standardizing and documenting the basic procedures and work implementation methods. It is this very stage where the controlled conditions are not only necessary for the achievement of key targets in production plans, but also to enhance the company's customer satisfaction programme. 3. Requirements fulfillment The implementation of planned stages, programs, arrangements and requirements is carried out by Organization staff within the framework of organizational structure, the assigned duties and allotted authorities in composition of documented QMS. An organizational structure, duties and authorities, system procedures should be documentary defined, put into action and maintained. 4. Monitoring, control and measurement of conformity and improvement Any Organization operates under conditions, which are characterized by definite instability of external and internal factors of influencing on its activity. For ensuring an effective feedback it is necessary to develop and to enter into a system a number of effective instruments of quality management system monitoring. As an example we will give the most widespread instruments: Internal audits of Organization QMS; Results of external audits carried out by a competent and independent Body of management systems certification; Operational monitoring during QMS processes' implementation; Evaluation results of Organization's customers satisfaction; Monitoring of Quality Plans implementation; Handling and inquiries analysis on corrective and preventive actions coming from Organization subdivisions. The data generated as a result of monitoring, form a basis for evaluation, analysis both timely development and use of control actions, correction, corrective and preventive actions within the stage "Assessment and review for improvement". Thus, QMS functioning is carried out pursuant to the methodology of the Demig-Shewhart cycle, known as well as cycle P-D-C-A. The main aspects of Quality Policy and Quality Objectives definitions, and also the methodology of quality management system planning will be considered below. Quality Policy Quality Policy is a foundation member of all quality management system, since namely it defines: Directions and prospects for development of QMS and Organization as a whole, Official responsibilities of top management in quality. In accordance with the requirements of ISO 9001, clause 5.3, Quality Policy shall: correspond to strategic targets of the company, include the top management commitment to be in line with the requirements of customers, internal values and organization's interests; permanently increase QMS effectiveness, provide a basis for QMS development and analysis of Quality Objectives. QMS results of management review are served as an input data for Quality Policy development (see figure 1 and requirements of ISO 9001, clause 5.6). In turn, the Policy should provide a basis for posing the Quality Objectives. Quality Objectives If the Quality Policy defines the general line of QMS development, then the Quality Objectives set up specific and measurable results, which are necessary to achieve. The Quality Objectives have been established further to Quality Policy and should serve as a guide line for the whole Organization. The Quality Objectives define the desirable results, promote optimal planning of activity and resources use for achieving these results. For implementation of such baseline principles of quality management, as "focus on a customer" and "continual improvement", Quality Objectives should be matched with the products' requirements established by both internal and external customers, and by management commitment to continuous perfection of activity. The Quality Objectives should be measurable during a particular interim, since it allows top management to use one more baseline principle of management - "decision making on the basis of facts". In this case activity on achieving the objectives is capable to render maximum positive influence on products quality, activity effectiveness and financial indices of Organization, and, therefore, on satisfaction and confidence of the parties concerned. The advised list of input data used for the Quality Objectives development is presented below. Depending on Organization specificity the given list can be revised: Strategic targets of Organization; Budget indices; Quality Policy; Different legislative and branch statutory acts and specifications; Proposals on Quality Objectives arrived from the personnel; QMS functioning on the basis of top management review output (figure 1). While Quality Objectives forming it is recommended to use the known instrument - system model of balanced indices. The given model assumes the differentiation of target indices on the most significant for Organization activity segments (prospects): Indices on achieving customer's satisfaction (both internal, and external); Financial indices; Indices of in-company's management (functioning of internal QMS business-processes); Indices of personnel training and development of Organization; As the practice shows, at first it is enough to establish the Quality Objectives on two main directions: Objectives, directional on achieving of customer satisfaction; Objectives, directional on improvement of in-company's management quality. It is expedient to establish the objectives, directional on reaching the customer satisfaction, on basic aspects of activity (basic business-processes), in relation to which the quality management system is designed (or is being developed). The quality purposes in company's management are the derivatives of the objectives in the products quality and are intended for satisfaction of internal requirements and top management expectations in point of enhancing the company's business effectiveness. It is necessary also to notice, that a number of companies set at once a great many of the objectives, on reaching which the considerable resources are required. As the practice shows, more profitable is the posing three to five quality objectives on the most important or problem spheres of the company activity that allows to focus attention on the most "narrow" places of Organization operation, instead of "spraying" efforts on several fronts. Deploying of Quality Objectives at different Organization levels ISO 9001, clause 5.4.1 "Quality Objectives" requires, that the Quality Objectives should be established at relevant levels within the Organization. In other words, it is not enough to elaborate the Objectives, measurable and matched with Quality Policy, it is necessary also to provide their decomposition (deploying) on hierarchical levels within the Organization. We have considered above the philosophy of quality Objectives forming and their segmentation on areas of activity. At deploying the quality Objectives it is expedient to use HOSHIN KANRY method. The method of Objectives (quality programs) deploying through out all company has been developed by Japanese company "Bridgestone" in 1968. The method is based on the approach, at which the policy is annually revised and is introduced in all divisions (subdivisions) of the company. At forming the Objectives is used the "Catch-ball" method ("pojmaj myach" - in Russian) for transforming the Objectives, that have been defined by the top management, into the Objectives of all employees, thus, increasing their motivation. Chart of the Quality Objectives deploying based on HOSHIN KANRY method is shown on figure 2. Further to quality Objectives by each of organization's divisions (subdivisions) are developed quality plans. If quality Objectives answer a question: "What we should achieve in the field of quality?"- Quality plan represents the document, defining, what measures, kinds of activity and resources are necessary for reaching the Quality Objectives. The quality plan, in turn, answers a question - "How the quality Objectives will be reached?" The indicators for successful implementation of measures fixed in quality plans, in turn, serve as the indices of QMS processes effectiveness. On the basis of QMS process effectiveness are determined, respectively, the operation indices of the divisions (subdivisions) involved in a given process and indices of the employee effectiveness. The enormous advantage of this approach is the involvement of all employees in QMS planning process and creation of transparent mechanism of measuring and activity estimation at all levels within the Organization. By the way, namely this last advantage serves as an initial cause of that circumstance, that the given method is perceived far not in all companies with due enthusiasm. At Quality Objectives decomposition a number of Organizations are also faced one more problem. One can well understand that for company's divisions (subdivisions), which directly participate in implementation of main business processes, the target indices of activity and quality plans directly depend on Quality Objectives, then how to set up the target indices of activity of those divisions (subdivisions), which provide the basic manufacture - for example, transport, communication or office? In this case it is recommended to use the following algorithm of Quality Objectives deploying (for convenience and visualization of algorithm consideration is given the example of Q-factor definition for office work). Definition of target indices for office work Base principles and stages of quality management system planning When QMS planning, the following tasks should be solved: Ensure deploying of Quality Objectives at all organizational levels of the company in accordance with the provisions of HOSHIN KANRY methodology; Planning of measures on Quality Objectives achievement (development of Quality Plans by Organization's subdivisions); Definition of indispensable resources for reaching the Quality Objectives; Appointment of responsible persons and terms for measures implementation on reaching the Quality Objectives. It is necessary to notice, that QMS planning represents of itself rather creative iterative process, than not formalized, during implementation of which it is necessary to achieve fine "adjustment" of system under the needs and necessities of Organization. Naturally, that the given process also requires a certain degree of standardization in succession and interaction of its basic stages. Below is presented the advised chart of measures on QMS planning implementation, approved on practical experience. Within the framework of QMS planning it is necessary to provide deploying (differentiation) of the Quality Objectives at different levels of the Organization. Thus, "QMS Planning" process consists of three interdependent and interacting stages: Revision of QMS process model; Development of Quality Plans; Revision and updating of QMS documents. In figure 3 is shown "QMS Planning" process chart, on which are indicated the succession and interaction of above-listed stages. Revision of QMS Process Model Quality Objectives are the main control action for revision of QMS process model, since the process model defines the most important directions of activity (processes) required for QMS operation - basic instrument for achievement of formulated object. When revising the process model the output of top management QMS review are also taken in to account. When analyzing the adequacy of QMS process model it is recommended to answer a number of the following problems: What basic risks can be marked out in not achieving the formulated quality objects? What processes are necessary for our management system in a context of formulated objectives? Whether any of these processes are transmitted on outsourcing? What are the input/output parameters for each process? Who is "the customer" of processes? What are the requirements of these customers (clients, regulating instances)? Who is "the owner" of the process? In addition to above-listed when analyzing and revising Process model it is necessary to take into account the following factors: Impact of process output result on commodity Organization's products; Risk of customer' dissatisfaction; Economical risk. After forming the updated List of QMS processes it is necessary also to determine their succession and interaction. For this purpose it is necessary to answer the following questions: What groups of processes can be marked out? How we can describe their interaction (in the form of charts or diagrams)? What flows of interaction (contact points) between our processes are? At definition of criteria and methods necessary for successful processes control it is necessary to take into account the following problems: What are the characteristics of expected and unplanned results of the process? What are the criteria for monitoring, measuring and analysis? How we can include it in planning of our management system and output processes? What are economical aspects (cost, time, wastes, other)? What methods are reasonable to data acquisition? The provision of QMS processes with resources is reasonable to perform as per the following check-list: What resources are necessary for each process? What information channels are? How do we give the external and internal information on the process? How do we receive a feedback? What data we should collect? What records we should maintain? The definition of measuring, monitoring and analysis characteristics of the process should answer the following questions: How the process implementation control is monitored? What measurements are indispensable? What is the best way for analyzing the collected information? About what the result of this analysis speaks? It is necessary also to notice, that the requirement of clause 8.5 "Improvement" of ISO 9001 standard sets up the mechanisms, directed on a fine "adjustment" and correction of the Process model under the Organization needs. First of all it concerns the mechanisms of corrective (8.5.2 ISO 9001) and preventive (8.5.3 ISO 9001) actions. All top management should take part in the process model revision. The given analysis is better to organize in a kind of "brainstorming" within the framework of specific-purpose meeting. Development of Quality Plans In line with the definition of clause 3.7.5 of ISO 9000:2005?: "Quality Plan - document specifying which procedures and associated resources shall be applied by whom and when to a specific project, process or contract". Depending on the Organization sizes, complexity of its organizational structure and specificity of business processes, in framework of QMS can be developed one (for small companies) or some (usually on large subdivisions of the Organization) Quality Plans. At Quality Plan development it is necessary to answer a question: "How formulated Organization's Quality Objectives will be achieved? Quality Plans are prepared on the basis of the outputs of QMS top management review and updated QMS Process model (Figure 3). At Quality Plan development it is recommended to use well proved QMS instrument - Isikawa diagram (cause-and-effect diagram), built on the base of "5?" model. Model "5?" is focused on the first-priority provision of the main components of activity effectiveness: Man - personal; Method - operation methods; Machine - equipment; Monitoring - monitoring; Material - material. Within the framework of each activity priority it is recommended also to analyze the following aspects of activity ("secondary bones"): Personnel: Personnel qualification; Manning of personnel list; Personnel motivation. Technology: Adequacy of used technology (updating of technological documentation); Adequacy (degree of conformity of used technology to formulated production tasks); Sufficiency of technology description (availability of required technological process sheets and flow charts, working instructions). Machinery: Sufficiency and productivity of machinery; Reliability; Conformity of used machinery to applied technology. Production inspection: Metrological provision; Control of non-conforming products (reject); Sufficiency of production inspection volume; Adequacy of applied production inspection to the technology used. Materials: Completeness and requests conformance to required needs in materials; Delivery terms; Procedures for incoming inspection; Conformance of delivered and declared materials with regard to their nomenclature and quality. If necessary, in Quality Plan can be included other arrangements intended to achievement of formulated Quality Objectives. After Quality Plans approval the Organization quality service develops explanations and internal requirements for Quality Plans implementation. Revision and updating of QMS documents The internal normative documents define the requirements to QMS processes implementation. They contain indices and criteria of process effectiveness, which should be adequate to formulated quality Objectives and to Quality Plans prepared, to furnish the process principal with reliable and informative data, which act as status indicators of Quality Objectives achievement. Besides, the internal normative documentation should: be adequate in content to QMS processes identified within the frameworks of QMS Process model; take into account output of QMS top management review. It is clear, that at Process model revision for maintenance the integrity of QMS it is also necessary to update the documentation describing a course of implementation and the control by QMS processes. Frequently, main difficulty when QMS processes description, act the aspects, bound with determination of indices and criteria of processes effectiveness. In Figure 5 is presented the baseline algorithm, which is recommended to be used at formation of a system of processes effectiveness indices. The conclusion The considered methodology of quality management system planning is based on the theory of constant improvement through the system applying of Demig-Shewhart cycle. It is necessary also to notice, that the questions, connected with QMS planning are, first of all, the liability of the top management. Namely at planning stages is laid the foundation of a steady and effective company development in case when the given functions are transferred only to quality service without participation of top management representatives, then the planning turns out as "one-sided" since it does not take into consideration all the aspects of organization functioning. Summarizing all stated above, one can do the following main conclusions: The Quality management system will benefit only in that case when it is adequate to specificity and the company targets; The basic skeleton of a quality management system is laid out at its planning stage. At planning it is necessary to take into account a lot of factors and aspects, which influence on the Organization functioning; The purpose of QMS planning is its "fine" adjustment under the internal needs and necessities of the Company - in this case the QMS is an effective instrument of increase the company's competitive strength, instead of being "a dead" superstructure in a management system. Literature: [1]. International Standard ISO 9001:2000 "Quality management systems. Requirements". [2]. International Standard ISO 9000:2005 "Quality management systems. Fundamentals and Vocabulary". [3]. International Standard ISO 9000:2005. "Quality management systems -- Guidelines for quality plans". [4]. ISO/TR 10013:2001 "Guidance on quality management system documents". [5]. Text-book of Certification Association RR ?006.00-405. "Methodical text-book for quality and engineering management in management systems of organizations". [6]. "Guide for risk-management". /D. A. Martsynkovsky, A.V. Vladimirtsev, O.A. Martsynkovsky; Certification Association "Russian Register".

Figure 1. Basic stages of QMS functioning. Figure 2. Deploying of Quality Objectives in line with HOSHIN KANRY method Figure 3. "QMS Planning" process chart. Figure 4. Quality Plan development using the cause-and-effect diagram Figure 5. Algorithm of determination the indices and criteria of processes effectiveness.