JSQC Standard Guidelines for Daily Management 2013 PDF

## JSQC STANDARD Guidelines for Daily Management JSQC-Std 32-001 (E): 2013 Established 2013.05.22 Published by The Japanese Society for Quality Control ## Table of Contents Preface Introduction 1. Scope 2. Normative references 3. Terms and definitions 4. Fundamentals of Daily Management 4.1 Role o...

## JSQC STANDARD Guidelines for Daily Management JSQC-Std 32-001 (E): 2013 Established 2013.05.22 Published by The Japanese Society for Quality Control ## Table of Contents Preface Introduction 1. Scope 2. Normative references 3. Terms and definitions 4. Fundamentals of Daily Management 4.1 Role of Daily Management in Total Quality Management (TQM) 4.2 Concept of Daily Management 4.3 Daily Management method - SDCA cycle 4.4 Standardization and standard 4.5 Control point and control level 5. Implementation of Daily Management 5.1 Clarification of mission and the role of a job unit 5.2 Analysis and deployment of a Job 5.3 Clarification of a job process 5.4 Standardization of the process 5.5 Determination of control point and control level, and visualization of abnormality 5.6 Detection and sharing of abnormality and immediate remedy 5.7 Root cause investigation and recurrence prevention for abnormality 5.8 Making Daily Management ingrained in the organization 6. Senior manager's role 6.1 Securing and providing the management resources for Daily Management 6.2 Systematization of mission/role and Control Points/Control Levels 6.3 Review of the implementation status of Daily Management and provision of instructions 7. Division-wise Daily Management 7.1 Design and development 7.2 Production 7.3 Sales 7.4 After-sales-service 7.5 Administrative and staff functions 8. Daily Management promotion 8.1 Promotion planning 8.2 Education and training of Daily Management 8.3 Establishment of systems to promote Daily Management 8.4 Programs to promote Daily Management 8.5 Evaluation of the levels of Daily Management References ## Preface This Standard has been established by the Japanese Society for Quality Control (hereinafter JSQC) through the deliberations of the Technical Board, consisting of practitioners and academics under the administrative provisions of the JSQC. This Standard represents work protected under the Copyright Act. Note that one or several parts of the Standard may conflict with patents, patent applications after the laying open of the applications, utility model rights or utility model right applications after the laying open of the applications. JSQC shall not be responsible for confirming whether one or several parts of the Standard infringes upon any of these patents, patent applications after the laying open of the applications, utility model rights or utility model right applications after the laying open of the applications. ## Introduction Even if attractive new products and services are planned and designed with the understanding of needs of customers and society, it will be impossible to beat competitors if those products are not manufactured and provided as planned and designed. It is often said in the world of Quality Management, “Quality is achieved through the process.” This is the simple expression to show that establishing and following the process is a better way than inspecting and verifying the finished products in order to economically generate the planned products and services. However in large organizations it is often the case that an important part of the process is unclear, or even if the process is well-established, the work is not performed according to the standards. The process, therefore, will most likely not achieve the planned performance under such a situation. “Daily Management” is the methodology devised to deal with this problem. Daily Management is the foundation of organizational management, and its quality significantly affects the profitability of the organization. Daily Management, therefore, should be thoroughly implemented and enhanced in all job units and hierarchies of the organization. This Standard consists of the fundamentals of Daily Management, guidelines to implement Daily Management, and the guidelines to promote Daily Management throughout an organization. It is applicable to many types of organizations. Daily Management should be applied not only to organizations that follow set routines (e.g. manufacturing), but also to organizations whose jobs differ depending on the situation (e.g. research and development, sales and marketing, after-sale service, administrative and staff functions, etc.). The fundamentals of Daily Management are discussed in Chapter 4. A general way to implement Daily Management is discussed in Chapter 5 and important points in various fields are discussed in Chapter 7. Daily Management should not be limited to the front line employees and managers. Senior management and those responsible for Daily Management promotion should also be actively involved. The role of senior management including the top management is discussed in Chapter 6. Daily Management promotion in the whole organization is discussed in Chapter 8. ## Scope This Standard provides recommendations by the JSQC with regard to Daily Management as one of the major activities of Quality Management. ## Normative References The following standard will be incorporated into this Standard by reference. Only the version of the stated year will be incorporated. No revised versions and supplements will be incorporated. JSQC-Std 00-001: 2011 Terminologies for Quality Control ## Terms and Definitions The terms and definitions in JSQC-Std 00-001 and the following terms and definitions will be applied in this Standard. The following terms and definitions include those cited from other standards and reproduced. ### Daily Management All activities to effectively achieve the objectives with regard to the job that every job unit of the organization is charged with (Same as JSQC-Std. 00-001) Note 1 Daily Management is not the job itself, but the activities to make the job effective and efficient. Note 2 Especially in this standard, Daily Management means the maintenance-plus-Enhancement activities, which set a current or extended level as a target and ensure that the job dose not deviate from the target, and when it deviates from the target, the job can be quickly restored and enhanced to achieve higher performance. ### Standard (1) Agreement for unification or simplification to equally benefit related organizations and people Note 1 Subject of standard includes physical object, performance, capacity, layout, condition, movement, procedure, method, formality, responsibility, duty, authority, point of view, concept and so on. Note 2 Standard written in a document is called “documented standard.” Note 3 Among standards, the agreement on the technical aspects directly or indirectly related to a product, service, process or system is called “specification.” The agreement on contents, formalities or methods related to an organization or job is called “procedure.” (2) Normative method or physical objects used to provide universality to measurements Note Examples include prototype kilogram as the measure of mass, fixed point of temperature and the platinum resistance thermometer to realize International Temperature Scale, standard substances as the measure of density, standard hardness tester and standard indenter as the measure of the hardness, color chart to be used in the color sensory test and etc. ### Control Point Items selected as the rating scale to manage the achievement of the objective (Same as JSQC-Std 00-001) (Same as JIS Q 9023:2003) ### Check Point Items selected as the constantly monitored characteristics or conditions to prevent process abnormality or easily identify the causes when it occurs, from the cases that have significant impact on the outcome(s) of the process and are directly controllable ### Control Level Value or range which the process in the stable or planned condition shows Note 1 The process can be evaluated whether it is in the stable or planned condition by comparing the actual value with the control level. Note2 Control level can be expressed as mean or mean ± 3 × standard deviation. (Same as JSQC-Std. 00-001) ### Process abnormality/abnormality A state where the process is not under the controlled condition Note Controlled condition is defined as the stable condition at the economically and technically desirable level. (Same as JSQC-Std 00-001) ### Nonconformance Product, service, process or system that does not meet the specified requirements (Same as JSQC-Std 00-001) ### Immediate Remedy Activities taken to prevent further loss resulting from nonconformance, process abnormality or other undesirable events for which causes are unknown, or even if causes are clear, but it is impossible to take countermeasures directly due to some restrictions (Same as JSQC-Std 00-001) ### Recurrence Prevention Actions taken to prevent the recurrence of a detected nonconformance, process abnormality or other undesirable events in the same product, service, process or system due to the same cause Note Definition of the "same" differs depending on the organization and/or industry (Same as JSQC-Std. 00-001) ### Process Set of interrelated and interacting activities, which transforms inputs into outputs Note Inputs and outputs include hardware, software, service, information and energy. (Same as JIS Q 9000:2006) ### Process Flow Multiple processes designed to provide the planned value by configuring the relationship so that the outputs of the previous steps become the inputs of the subsequent steps Note Output of one previous step may become the input of multiple subsequent steps. ### Process Ensurance Activities that ensure the outputs of the process meet the specified requirements (Same as JSQC-Std 00-001) ### System A collection of the components or processes that are interrelated and interacting to accomplish a specific objective (Same as JSQC-Std 00-001) ## Fundamentals of Daily Management To learn Daily Management, first of all, it is necessary to understand the role of Daily Management in Total Quality Management (TQM). It is also important to understand the statistical control chart concept, which is the starting point of Daily Management. The SDCA cycle shows the fundamental steps to promote Daily Management. Standardization and standard as well as control points and control levels are essential elements in the cycle. Based on the understanding of the role of Daily Management and the statistical control chart concept, the SDCA cycle and all of the elements in the cycle must be understood. ### Role of Daily Management in Total Quality Management (TQM) Total Quality Management (TQM) is the activity; - whose aim is the long term success through the provision of products and services that meet the needs of customers and society as well as the satisfaction of employees, - for maintaining, improving, and innovating processes and systems, - by all the divisions and levels of the organization, - to achieve effective and efficient organizational management in a dynamic business environment. Core activities in TQM are the maintenance-plus-enhancement, improvement and innovation of processes and systems (Fig.1). - **Maintenance-plus-enhancement** (management in a narrow sense): activities which set the current or extended level as a target and ensure that the job dose not deviate from the target, and when it deviates from the target, the job can be restored quickly and enhanced to achieve higher performance - **Improvement**: activities which set a higher target than the current level or extended level, and then solve problems and achieve tasks repeatedly. - **Innovation**: drastic changes in processes or systems by the introduction and application of new know-how from outside of the organization or other divisions in the organization, different from the maintenance-plus-enhancement and improvement activities which are based on the enhancement of the know-how through operations and learnings of processes or systems in the organization. Maintenance-plus-enhancement and improvement are collectively called "improvement" in a broad sense. It is important to implement maintenance-plus-enhancement, improvement and innovation in a balanced manner. Maintenance-plus-enhancement alone cannot maximize the potential of the process and system. It leads to a mannerism, reduces the interests in the process and system, and lowers the performance gradually. On the other hand, improvement and innovation alone cannot sustain achievements. This reduces motivation towards improvement and innovation, and results in poor performance. It is important that job know-how obtained through improvement and innovation becomes inputs to the maintenance-plus-enhancement and utilized, while issues and problems which are difficult to solve by maintenance-plus-enhancement become inputs to the improvement and innovation. An organization is required to systematically address Quality Ensurance, Policy Management, Daily Management, Small Group Activity, and Education and Training on Quality Management in order to constantly implement maintenance-plus-enhancement, improvement and innovation with the participation of all the divisions and at all levels of the organization, and link it to the provision of products and services that meet the needs of customers and society as well as the satisfaction employees (Fig. 2). - **Quality Ensurance**: Organizational systematic activities ensure, confirm and demonstrate that the needs of customers and society are met. Although sometimes confused with inspection, claim handling, preparation for external audits and so on, it has a broader meaning. It includes "Process Ensurance" which establishes the process that can produce the targeted product and service effectively and efficiently and allows customers to purchase products and use services with confidence, and "New Product Development Management" which develops new products and services to meet customers' needs effectively and efficiently. Active maintenance-plus-enhancement, improvement and innovation are essential as a foundation of Quality Ensurance. - **Daily Management and Policy Management**: To put maintenance-plus-enhancement into practice, it is essential to enable every job unit and person in charge to continuously and steadily perform their own roles. The organization should clarify job roles and the processes to perform them as well as factors affecting job performance and methods of controlling them, and establish a system to perform the processes and methods steadily even if people change and rotate. Despite these efforts, it is often the case that the results do not turn out as intended. The organization should also establish the ways to measure the performance, share the results which contradict the normal results with persons concerned, and investigate their causes. These activities are called "Daily Management." Daily Management is often confused with the routine job done by every job unit. Daily Management, however, is not the routine job itself, but the activity to maintain and enhance the job. On the other hand, to put the improvement and innovation into practice in areas where only maintenance-plus-enhancement is not sufficient, it is essential to establish objectives and strategies to respond to changes in the customers' needs and the business environment and to clarify the issues and problems to be challenged based on the principles of "objective-oriented" and "priority focus." These activities are called "Policy Management." (Fig 3) - **Small Group Activities (Small Group Improvement Activities)**: Activities of forming small teams, which enable close communication for the issues and problems faced in Daily Management and Policy Management, challenging the issues and problems in a speedy manner, and achieving skill enhancement, self-realization, and development of trust. It includes cross-functional team activities, project team activities in a job unit, and QC circle activities by front line employees. - **Education and Training on Quality Management**: To activate maintenance-plus-enhancement, improvement and innovation, it is important for the members of an organization to acquire knowledge and skill to perform maintenance-plus-enhancement, improvement and innovation as well as to get to hold same value and consciousness. The organization should establish a hierarchy-wise and field-wise education and training system, prepare opportunities for learning through practice, and set targets for required skills and develop them in a planned manner. ### Concept of Daily Management The concept of Daily Management has evolved from statistical control chart by Walter A. Shewhart (Fig. 4). The first step of Daily Management is to determine a measurement (metric) to evaluate the performance of the process. The next step is to prepare the graph with the central line and control limits calculated by the statistical distribution of the measurement. Then, data are plotted on the graph at proper intervals. Basically, if the point is within the limits, assignable causes are not considered to exist and jobs should be continued as they are. On the other hand, if one or more points exceed the control limits or have any specific trend, assignable causes should be considered to exist, and immediate remedies and the actions to prevent the recurrence should be taken. A statistical control chart is a method which enables users to establish a stable process through the repetition of the procedure. The concept of the statistical control chart has come to be used widely for the measurement which does not strictly follow a specific statistical distribution, and it has become an applicable tool to a variety of jobs. For the statistical control chart to effectively function, however, the measure to evaluate the performance of the process should follow a certain distribution. Therefore, establishing the agreement (standard) and the system to ensure that the job is implemented according to the agreement (standardization) is assumed. Also, it is essential to focus on the agreement when investigating the causes and taking actions when abnormalities are detected. Daily Management consists of statistical control chart and a series of activities necessary for the functioning of the statistical control chart. Daily Management is the activities to establish the processes and systems which can achieve a certain level of stability. Daily Management is essential not only for quality related activities to meet the needs of customers and society, but also for securing other management aspects such as volume, delivery, cost, safety and environment. Autonomous management (a self-sustaining management of the processes and systems by job units or persons in charge) is presupposed in Daily Management. Thorough implementation of Daily Management will enable the establishment of processes and systems, which can achieve a certain level of stability and transfer of responsibilities and authorities. Conversely, Daily Management is difficult to implement without the establishment of autonomous management, which ensures a responsible and self-sustaining management by individual job units and persons in charge, because Daily Management should be applied in all jobs performed in an organization. ### Daily Management method - SDCA cycle The SDCA cycle is a useful concept when practicing maintenance-plus-enhancement. This is the concept to establish the processes and systems which can surely achieve a certain performance level by rotating a cycle of "Standardize, Do, Check and Act" steadily and repeatedly (Fig.5). The SDCA cycle simply shows the way to implement maintenance-plus-enhancement by setting the current or extended level as a target and determining organizational agreements (standards) based on current job methods in the Plan step of the PDCA cycle that is the more comprehensive method to implement maintenance-plus-enhancement, improvement and innovation. - **Standardize**: It is necessary to keep operations, facilities, materials and measurement which influence the results in a certain condition so that desirable results are obtained. The organization, therefore, should determine the agreement (standard) and ensure that it is definitely followed. Prior to the determination of the agreement, the organization should clarify a process to produce the results and knowledge with regard to the relationship between the process and the results. Standardization also includes providing necessary education and training and applying methods to let the agreement kept. - **Do**: The process is implemented according to the agreement. A responsible person observes whether the process is implemented according to the agreement, and when necessary, conducts additional education and training or supplements the methods to let the agreement kept. - **Check**: It is often the case that the contents of the agreement are not sufficient, or the process is not implemented as agreed upon even if the above efforts are made. It is important to quickly detect the occurrence of an abnormality and to identify the causes, i.e., insufficiency of the agreement or weakness of the system to observe the agreement. - **Act**: Contents of the agreement or the system to observe the agreement are improved based on the result of the Check step. Repeating the SDCA cycle by job units and persons in charge enables the achievement of maintenance-plus-enhancement and establish the processes and systems that can achieve a certain level of stability. Although the SDCA cycle seems simple, its implementation is not necessarily easy. The organization should make the efforts to overcome the difficulties of each step after understanding them (Table 1). | Steps | Difficulties | Points to overcome the difficulties | |---|---|---| | S | Jobs that are difficult to standardize | Analyze the cause-effect relationship of the process | | | Too many standards | Discard unnecessary standards | | | Complex structure of the standards | Establish a system of standards | | | Difficult to follow the standards | Thoroughly implement education and training. | | D | Not noticing abnormalities | Apply methods to let the standards kept. | | | Failing to identify causes | Clarify the normal state | | | | Quickly share the abnormality information throughout the workplace | | A | Ending in simple adjustment level without any preventive action level, so that the level of the standard are not improve. | Analyze the abnormality from the viewpoint of the standardization | ## Standardization and Standard "Standardization" is the basis of Daily Management. Standardization is the activity to decide and utilize the agreement which is used commonly and repeatedly for the purpose of the effective and efficient management of the organization. The agreement is called the "standard." Efficiency decreases and the variation in the results increase if people conduct work their own way in a large organization. Standardization is the method to set the best way as a standard and make all people act according to it to achieve effective and efficient work. There are 4 benefits of Standardization: - **Standardization brings interchangeability**: Products manufactured or results evaluated in different places or times can be used as they are without rework and adjustment. This is a very important feature considering the time and effort spent in the replacement and repair at breakdown or the inspection in shipping. - **Standardization abbreviates communication of thoughts or information**: It is often the case that efficiency decreases due to lack of the standardization because decisions and adjustments are necessary whenever needed. Although standardization restricts individual freedom to some extent just as traffic rules do, overall efficiency is enhanced, resulting in the promotion of individual activities. - **Standardization enables achievement of products and services which meet customers' needs more effectively and efficiently**: This is the case where it is not enough to determine a standard, and it is necessary to create a standard that contains some technical rationale. - **Standardization enhances technical level**: Improvement will not be achieved without standardization because in the absence of a standard, operations may vary from person to person, which makes it difficult to understand the current undesirable situations. In standardization, first of all, standards should be created. Standards are typically expressed in writing. However, they can also be in the form of images, figures, and actual samples and not limited to writings. It is important to create standards so that good results will be achieved if jobs are done according to the standards. Because there are countless conditions that need standardization, it is advised that non-significant conditions should be neglected and influential conditions should be addressed, considering what conditions impact results. Also, the standard should include a measurement method and the criteria for the result as well as the agreement with regard to the causes. That will enable person in charge to make judgments on the necessity of the immediate remedy and process improvement. No matter how good the standards are, they are useless if not followed. Establishing the standards is not the end of the story. It is important that the standards are followed. It is an education issue if the person in charge does not know the standards. On the other hand, it is a matter of skill training if the person in charge cannot follow the standards. Furthermore, it is a motivation issue if a person in charge intentionally fails to comply with a standard. Standards should be implemented only after proper education, skill training and motivation are provided. In addition, there are cases in which omissions or mistakes arise due to carelessness even though the person has enough knowledge, skill and the intention to follow the standards. Error proofing is the key in order to prevent these unintentional errors effectively. It is an activity to improve machines, materials or procedures to prevent errors or to make a system immune to errors. It is also known as "fool proofing" or "poka-yoke." Error proofing can be understood as an activity to review and improve the standards from the view of unintentional errors. Every job should be standardized to some extent. The starting point of Daily Management is to recognize what roles the standards play when doing jobs and to connect the causes and countermeasures with the standards. ### Control Point and Control Level The results of a process may vary due to diverse causes. There are common causes which have little effect on results and are technically or economically difficult or meaningless to identify and remove. On the other hand, there are assignable causes which should not be overlooked to achieve stable results such as not following standards, changes of raw materials, and performance degradation of facilities. These causes should be investigated and removed immediately to prevent recurrence. Events which result in deviation from the normal stable situation because of the assignable causes are called “process abnormality” or “abnormality”. Note Control point is sometimes called "Managing Point" or "Key Performance Indicator." For example, in the "molding" process of Fig. 10, "thickness" or "burr" will be the candidate for the control point. There is no need that all of these will be control points. The organization should choose the control points to assess the achievement status of job unit exactly and to detect abnormality sooner and surely. ### How to determine control level In order to detect abnormality by control point, process data are compared with the determined control level (central value and control limit) of the control point. Control level should be determined based on the normally achieved level, differentiating from the specification value which is based on the desirable level. For determining the control limit, it is recommended that statistical methods such as statistical control chart is used, with collecting data from the current process and after eliminating apparent abnormalities. If it is difficult to determine control levels statistically, the control level may be determined based on the effects caused by overlooking the abnormality or the man-hours required for cause investigation and immediate remedy against the abnormality. Control levels should be given not only for the undesirable side, but also for the desirable side. This is because latter side is also a good hint to improve the process. For example, effective countermeasures against defectives can be obtained if causes are pursued even when defectives are greatly reduced. Control levels should be determined considering the process change such as changeover of product type, or environmental change. Fig. 11 (A) shows the case wherein a certain level is expected to be maintained, and (B) shows the case wherein the level is expected to be changed with time. ### Interval/frequency of management What should be the interval/frequency of collecting data and checking control point - once a day, once a week, once a month or once a quarter?. Interval/frequency should be decided based on the frequency of occurrence of the abnormality and man hour necessary for the data collection. For example, if abnormality may occur day by day, once a day frequency is recommended to find the abnormality. By the shorter interval of data collection and check, the possibility of the detection of the abnormality becomes earlier, however man hours for managing process increase. Fig. 12 shows the relationship between interval of data collection and check and detection of abnormality. The left graph uses once a month interval and detects the deviation from the control level in May. Abnormality can be detected in mid- April if data is collected daily and checked as shown in the right graph. ### Visualization of abnormality For the selected control point, it is advised to judge whether the process is under the stable state by preparing a statistical control chart or a graph for managing process which shows the transition of the control points. It is advised to let everybody in the job unit recognize the occurrence of the abnormality, display the statistical control chart and the graph of managing process at noticeable places in the job unit. In addition, it is recommended to implement devices (e.g. graphical representation, color and so forth) so that the abnormality can be judged at a first glance. In addition to the graph of managing process, using abnormality alarm equipment (ANDON: an electrical alarm equipment for abnormality) is also effective in the sense that the occurrence can be immediately detected. ### Registration of control point It is advised that selected control points should be shared in an organization summarizing as "list of control points" or "QC Process Chart (Control Plan)" together with interval/frequency of data collection and check. The person responsible for the judgment of abnormality and person responsible for the treatment of the abnormality should be clarified. Table 5 shows an example of list of control points. This table includes control points coming from Policy Management as well as control points coming from Daily Management. The control points coming from Policy Management are required to determine whether measures taken to achieve year end plan are giving expected outcomes. Therefore, the features of the control points coming from Policy Management are different from control points coming from Daily Management, which are aimed to find abnormalities. However, in practice, control points coming from Policy Management are often transferred to control points for Daily Management after the completion of the management as control points for Policy Management. On the other hand, if control points of Daily Management are needed to be drastically improved, it will be taken care under Policy Management. Thus, in some cases, control points for Daily Management and Policy Management are put together in one table and marked either control point for Daily Management or Policy Management. ### Detection and sharing of abnormality and immediate remedy #### Detection of abnormality There are two approaches to detect abnormality: control point based and the others. Daily data have to be plotted on the statistical control chart or the graph for managing process in order to effectively detect the occurrence of abnormality in the process. The followings should be considered: - Plotting on the statistical control chart or the graph for managing process at each time after data collection - Judgment as to whether abnormality exists or not should be made by comparing the plots with the control level. In addition, to detect out of control, there is a need to consider the trends also such as run, ascending/descending, and cyclical. In addition to the abnormality detected by the control point, there may be other abnormalities, that is, something different from the usual. In the working process by following the standard, events are notified by the sense of something different from the usual even they are not covered by control points. If these abnormalities were left unsolved, big issues might be caused. In addition, good results obtained by the efforts might be overlooked. The followings should be noted to detect abnormality by the sense of something from the usual: - Clarifying the criteria to judge as to whether "abnormal state" or "normal state" - Abnormality can be detected by human feeling and five senses (eyesight, hearing, smell, taste and touch). It is difficult to express the above in writing. It is important that everyone should be conscious on quality. #### Sharing of abnormality It is necessary to share the fact among the concerned people that abnormality has occurred and clarify the treatment immediately. It is a fight against time to deal with the abnormality where there is no moment to waste. Delay might lead to a big accident or loss. Because information on the process is getting lost as time goes by, the organization should investigate the cause of accident immediately after the happening. Abnormalities are most often found by the front line people. They sometimes avoid reporting the abnormalities to superiors even if they occurred. In order to make the atmosphere where people who identify abnormalities, report to their superiors immediately, the following should be taken care of: - Communicating within the work place and creating an atmosphere to where anything can be discussed freely. - It is most important is to create trust and relationship between superiors and subordinates. Greetings and encouragements from superior is are very effective to build this relationship The fact of abnormality should be shared with everybody in the workplace. To do that, periodical meetings should be held at the specified time every day by all the people. Discussion on the abnormality should be made with checking the working condition (rotation of person in charge, trouble of the facilities and so on) and the standard should be reconfirmed. It is preferable that each participant should speak at least once. Abnormalities should be summarized as a record such as Process Abnormality Report to share the occurrence of abnormality within the organization. Process Abnormality Report should include the condition when the abnormality occurred, whether immediate remedy was taken or not, whether the recurrence prevention was taken or not and the reporting status to related units and so forth. Also, the information contained in the Process Abnormality Report should be summarized, understood and shared, where the information includes the detection of abnormality, the implementation status of immediate remedy, and the implementation status of the root cause investigation and recurrence prevention. There might be technical difficulties on the abnormalities for which root cause investigation and recurrence prevention has not been taken. Such abnormality treatment process should be used as an organization wide activity. #### Immediate remedy for abnormalities When abnormality occurs, the process should be stopped and the abnormality removed from the process in order to prevent it from affecting others. After that, an immediate remedy should be taken for it. For example, manufacturing process is immediately stopped, abnormal products are removed by exchanging parts and supplying substitutes, and the abnormal products are inspected to identify whether nonconformity or not. In case of service, process should be stopped and immediate remedy should be taken immediately to the service recipient. On that basis, the organization should identify the causes of the abnormality and take action to reinstate all factors in the process to the original condition. For those immediate remedies as above, the organization should establish standards considering possible abnormalities and provide education and training. ### Root cause investigation and recurrence prevention for abnormality When abnormality occurs, the organization should take immediate remedy, investigate root cause, take countermeasures and prevent recurrence. The effective countermeasures for recurrence prevention should be reflected in the process through revision of the standard and reviewing education and training. For the root cause investigation of abnormality, it is important to investigate "what were different from the normal status" in the process. Also, the organization should investigate when the abnormality occurred and utilize this information effectively. Furthermore, abnormalities often occur when conditions regarding people, parts, materials and facilities are changed. The organization should therefore clarify the change points of people, parts and materials, facilities and standards and display them near the statistical control chart and graph for managing process which are utilized to detect abnormality in order to investigate the cause of abnormality easily. If abnormalities often occur such as initiating state of process, treating all the abnormalities at once make the root cause investigation and recurrence prevention difficult. In this case, abnormalities should be classified into treating individual and group-wise by utilization of priorities. #### Utilization of Information about Timing and Time of the Occurrence of Abnormality The information as to when the abnormality occurred should be utilized to investigate the causes of abnormality. For example, causes can be narrowed down by reviewing the report with regard to the change of the parts and materials, rotation of workers and facility maintenance because the causes are believed to be closely linked to the operation provided to the process at the timing. Similarly, if it is found that the same type of abnormalities are occurring repeatedly, it is advisable to investigate which operations correspond to the frequency of such abnormalities. #### Types of Abnormality and their Causes The followings are the types of the abnormalities. - Sporadic (transient, not lasting long) - Chronic (prolonged once happened) - Tendency (increase in degree of abnormality as the time goes by) - Cyclic (occurred regularly or cyclically) Identifying the type of abnormality makes it easy to infer the cause of abnormality. For example, sporadic abnormality is considered to have occurred due to carelessness of person in charge or mixing up the inappropriate material. They are caused by insufficient operation management such as insufficient preparation of the standard, or inadequate training and education. On the other hand, the chronic or tendency abnormality is likely to be caused by deterioration or variation of the parts/material lot or failure of the facilities. #### Investigating Root Cause of Abnormality The organization should ask itself "why" repeatedly to investigate and identify the root causes of abnormality (analyzing causes). This is sometimes called as "why-why analysis." It will enable logical thinking, GENCHI-GENBUTSU, scientific approach by fact and data, as a result, the organization can identify the root causes without making mistakes. The organization should refer the Cause Investigation Flow in Fig. 13 when asking itself "why." This flow is prepared based on the idea where abnormalities can be classified from the viewpoint of standard into the three cases: case in which standard did not exist, case in which standard existed but was not followed and case in which standard existed and was followed. The case in which standard was not followed is sub-divided into four cases: case in which the person in charge did not know, case where person in charge could not follow the standard, case where the person in charge intentionally did not follow the standard, and case where the person in charge unintentionally did not follow the standard.. When the person in charge did not know the standard, it is because of lack of education. When the person in charge could not follow the standard, it is because there were problems in training. When the person in charge intentionally did not follow the standard even though the person had knowledge and skills, it is because the importance of the standard was not understood. Sometimes the person in charge does not follow the standard, unintentionally. Error proofing is effective in such cases. Repeating "why" is effective in all the above cases. The organization should distinguish abnormalities by following the flow, clarify the frequently occurring cases and drill down for root causes. For example, the organization should investigate the reason why standard was not prepared when there are many cases in which standard did not exist, the reason why standard was not well known when there are many cases in which the person in charge did not know the standard, and the reason why the operation was not error proofed when there are many cases in which the person in charge did not follow the standard unintentionally. #### Making Daily Management ingrained in the organization Once the organization has established Daily Management, it may soon lose its substance when it is not maintained well. Therefore, managers of job unit such as departmental manager, group leader including supervisor of manufacturing, should continuously practice the activities shown from sub-clauses 5.1 to 5.7 as well as make efforts for preparing and reviewing the systems and tools, developing human resources and creating culture of workplace in order to make Daily Management ingrained in the organization. #### Preparing and reviewing of systems and tools In order to make Daily Management take ingrained in the organization, the organization should prepare and review the systems and tools (refer to sub-clauses 5.1 to 5.7) for rotating SDCA cycle. Managers of job unit should periodically review whether the systems and tools are effectively working and are in just the right amount. The following issues should be considered in the review: - The reasons why the existing systems and tools are not understood and shared sufficiently. Thus, activities became formalized with loosing substance. - The system and tools established in the past have not been reviewed according to organizational changes and do not fit to the realty. - Relationships among the system and tools are not clear, therefore these system and tools do not lead to facilitate the rotation of SDCA cycle. In addition, self-assessment should be utilized for the review (refer to sub-clause 8.5) #### Human resource development and building up culture of workplace Human resource development and building