Quality Management with SAP S/4HANA

English (original)

1.1 Organizational Structure in SAP S/4HANA At the start of an SAP S/4HANA implementation project, one of the first and most intensive activities undertaken is the finalization of the organizational structure. This involves having intermodular and intramodular discussions and deliberations to © 37 1.1 Organizational Structure in SAP S/4HANA ensure that the SAP S/4HANA system can both cover the legal aspects of the company’s organizational structure and attend to area-specific reporting needs. In other words, the business process owners, business analysts, and SAP consultants review the exist- ing organizational structure of the company and then simultaneously begin mapping it in the SAP S/4HANA system. A practical approach to adopt while finalizing the organizational structure in SAP S/4HANA is to ensure that the organizational structure isn’t so generic that it loses its signifi- cance and prevents the business process owner from extracting the required informa- tion from the system, nor is it so minute or detailed that it becomes cumbersome to collate and consolidate the information. You should also keep a forward-thinking view of your organizational structure. If you foresee that you’ll need certain organizational elements in your SAP S/4HANA system in the future, for example, it’s better to have them available in the system than to add them at a later point. Although QM itself doesn’t have any of its own organizational structure to configure from an implementation perspective, you need to understand the important organiza- tional units: client, company code, plant, storage location, and warehouse number. In this chapter, we’ll review the structure as it applies to QM. If QM integrates with the procurement processes, it requires an understanding of the purchasing organization and purchasing group. Similarly, if QM integrates with SAP S/4HANA Sales business processes, then you need to have a decent understanding of the sales organization, dis- tribution channel, and division, which together form the sales area. If the company has also implemented and is using embedded extended warehouse management (EWM) in SAP S/4HANA, then a decent understanding of the EWM structure is helpful for a QM consultant and business user. We’ll also discuss the importance of the organizational units and explain how they work together to accomplish the organizational, legal, and reporting requirements of the company. The organizational structure in the SAP S/4HANA system is equally applicable to all important business functions that we cover in the entire book. Figure 1.1 shows the cli- ent as the highest level of the organizational structure in the SAP S/4HANA system. The profitability analysis of the company is performed at the controlling area level, and the cost center and profit center accountings are performed at that level as well. A company can consist of several legal entities, each including separate, individual financial statements that must be prepared at the end of the financial year. This is reflected as a separate company code for each legal entity. The valuation area represents the level at which the company values its material stock consistently. It’s part of the logistics area of the SAP S/4HANA system. A one-to-one relationship exists between the valuation area and the plant. For example, a material at one plant may have a different standard price than at another plant, where its price control may be a moving average. 1 Quality Management in SAP S/4HANA 38 Figure 1.1 Organizational Structure in SAP S/4HANA Figure 1.2 represents the organizational unit of the logistics area in the SAP S/4HANA system, in which the company code attains the highest level. Within each company code, there can be one or multiple plants, and within each plant, there can be one or multiple physical and virtual storage locations. Figure 1.2 Plants and Storage Locations We’ll discuss these elements in the following sections. Client Controlling area 1000 Company code 1000 Valuation area 1000 Valuation area 1100 Valuation area 1200 Valuation area 0001 Plant 1000 Plant 1100 Plant 1200 Plant 0001 Company code 0001 Company code 0002 Controlling area 1200 Plant 1000 Plant 1100 Storage location 0001 Storage location 0002 Storage location 0001 Storage location 0002 Storage location 0003 © 39 1.1 Organizational Structure in SAP S/4HANA

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בתחילת פרויקט יישום S/4HANA, אחת הפעילויות הראשונות והאינטנסיביות היא גמר המבנה הארגוני — דיונים בין-מודולריים ותוך-מודולריים להבטחה שהמערכת מכסה את ההיבטים החוקיים ואת צורכי הדיווח. בעלי התהליכים, האנליסטים והיועצים סוקרים את המבנה הקיים וממפים אותו ב-S/4HANA. גישה מעשית: המבנה לא גנרי מדי (שמאבד משמעות ומונע הפקת מידע) ולא מפורט מדי (שמקשה על איחוד). שמרו על ראייה קדימה — אם צופים צורך באלמנטים ארגוניים בעתיד, עדיף שיהיו זמינים מראש. אף ש-QM עצמו אינו מגדיר מבנה ארגוני משלו, יש להבין את היחידות החשובות: client, ‏company code, ‏plant, ‏storage location, ו-warehouse number. אם QM משולב ברכש — נדרשת הבנת purchasing organization ו-purchasing group. אם משולב ב-Sales — sales organization, ‏distribution channel, ו-division (יחד = sales area). אם יושם embedded EWM — הבנת מבנה ה-EWM מועילה. המבנה ישים לכל הפונקציות בספר. ה-client הוא הרמה הגבוהה ביותר (Figure 1.1). ניתוח הרווחיות, ‏cost center ו-profit center accounting — ברמת ה-controlling area. חברה יכולה לכלול מספר ישויות משפטיות, כל אחת עם דוחות כספיים נפרדים — מיוצגת כ-company code נפרד. ה-valuation area הוא הרמה שבה מוערך המלאי באופן עקבי — חלק מאזור הלוגיסטיקה, ביחס 1:1 ל-plant. למשל, חומר במפעל אחד עשוי במחיר תקני שונה ממפעל אחר (moving average). Figure 1.2 — היחידה הארגונית של הלוגיסטיקה: ה-company code ברמה הגבוהה; בכל company code, מפעל אחד או יותר; בכל מפעל, מיקומי אחסון פיזיים ווירטואליים. (Figure 1.1 — מבנה ארגוני: ‏Client → Controlling area → Company code → Valuation area / Plant → Storage location.)

English (original)

1.1.1 Client A client represents the highest element of the SAP S/4HANA system’s organizational structure. Often, the client represents a company or group of companies, within which there are several independent company units. An SAP S/4HANA system can contain several clients in logical units. The additional organizational elements and the master and transaction data are created and managed within a client. From the SAP S/4HANA system’s landscape perspective, you normally have at least three clients (systems): DEV (development), QAS (quality assurance system), and PRD (production). The actual configuration of the SAP S/4HANA system takes place in the DEV system and is then transported to the QAS system for testing and training. The final configuration eventually moves to PRD, which is the final live system in which the business process owners of the company make real-time, live entries.

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ה-client הוא האלמנט הגבוה ביותר במבנה הארגוני. לרוב מייצג חברה או קבוצת חברות, ובתוכו מספר יחידות עצמאיות. מערכת אחת יכולה להכיל מספר clients ביחידות לוגיות. האלמנטים הנוספים ונתוני האב/הטרנזקציה נוצרים ומנוהלים בתוך client. מבחינת ה-landscape, בד"כ לפחות שלושה clients (מערכות): ‏DEV (פיתוח), ‏QAS (אבטחת איכות), ו-PRD (ייצור). התצורה מתבצעת ב-DEV ומועברת ל-QAS לבדיקה והדרכה. התצורה הסופית עוברת ל-PRD — המערכת החיה.

English (original)

1.1.2 Company Code The company code is the level below the client in the SAP S/4HANA system, and it reflects the level at which the company legally reports income statements and balance sheets. It’s an organizational element (unit) of the financial accounting area. You can have a separate company code for each line of business—for example, textiles and chemicals—so long as the two are legally separate entities. Similarly, separate company codes can exist if the company has operations in foreign countries.

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ה-company code הוא הרמה מתחת ל-client, ומשקף את הרמה שבה החברה מדווחת חוקית דוחות רווח והפסד ומאזנים. יחידה ארגונית של תחום הנהלת החשבונות. ניתן company code נפרד לכל קו עסקי (טקסטיל, כימיקלים) כל עוד הם ישויות משפטיות נפרדות, או לפעילות במדינות זרות.

English (original)

1.1.3 Plant A plant is an organizational unit in the logistics area. You can classify a plant from the point of view of production, procurement, maintenance, warehouse, and planning. The plant can be, for example, a manufacturing site, a head office, or a distribution center within a company. It organizes the tasks for logistics, and it can be a physical produc- tion site or the logical grouping of several sites in which materials are produced or goods and services are provided.

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מפעל (plant) הוא יחידה ארגונית בלוגיסטיקה. ניתן לסווגו מבחינת ייצור, רכש, אחזקה, מחסן ותכנון. יכול להיות אתר ייצור, משרד ראשי, או מרכז הפצה. מארגן את משימות הלוגיסטיקה — אתר ייצור פיזי או קיבוץ לוגי של אתרים שבהם מיוצרים חומרים או מסופקים שירותים.

English (original)

1.1.4 Storage Location A storage location is a physical or virtual storage site for materials. Examples of physi- cal storage locations include raw material store, components store, returned goods store, finished goods store, and so on, whereas a virtual storage location can be self- defined and may be a scrapyard, a production shop floor in which semifinished goods are temporarily stored, and so on. 1 Quality Management in SAP S/4HANA 40

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מיקום אחסון (storage location) הוא אתר פיזי או וירטואלי לחומרים. דוגמאות פיזיות: מחסן גלם, מחסן רכיבים, מחסן מוצרים מוחזרים, מחסן מוצרים גמורים. דוגמאות וירטואליות: גרוטאות (scrapyard), רצפת ייצור לאחסון זמני של חצי-גמורים.

English (original)

1.1.5 Warehouse Number A warehouse complex is represented in the SAP S/4HANA system as a warehouse num- ber, and all the warehouse processes, such as picking and putaway, are executed using this warehouse number. The warehouse number doesn’t have an address but has a short descriptive text. This is unlike a storage location, which holds an address. Within the SAP S/4HANA system, assignment of a warehouse number to a plant and storage location combination identifies which storage location is controlled by the warehouse management system (WMS).

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מתחם מחסן מיוצג כ-warehouse number, וכל תהליכי המחסן (picking, ‏putaway) מבוצעים באמצעותו. ל-warehouse number אין כתובת אלא טקסט תיאורי קצר — בניגוד למיקום אחסון (שמחזיק כתובת). הקצאת warehouse number לצירוף מפעל+מיקום אחסון מזהה איזה מיקום נשלט ע"י ה-WMS.

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1.2 Quality Management in the SAP Landscape QM offers a wide range of functions and business processes that fully integrate with SAP Product Lifecycle Management (SAP PLM) and focuses on ensuring and managing the quality of products and assets. Accordingly, QM is an integral part of the SAP PLM solution map under the main process product development and collaboration (see Table 1.1). It includes the prevention of quality-related problems and offers continuous process improvement abilities through collaboration and sustained quality control. So, in the broader sense, QM focuses on the entirety of all QM-relevant processes for a product (quality planning, quality certificate, quality notification, quality control, test equipment management, and stability study). Product Management Product Development and Collaboration Product Data Management SAP PLM Foundation Product strategy and planning Engineering and research and develop- ment (R&D) collabora- tion Product data and structure manage- ment Product compliance Product portfolio management Supplier collaboration Specification and recipe management Product intelligence Innovation man- agement Manufacturing collab- oration Service and mainte- nance structure management Product costing Requirements management Service and mainte- nance collaboration Visualization and publications Tool and workgroup integration Market launch management Product quality man- agement Configuration man- agement Project and resource management - Product change man- agement - Document manage- ment Table 1.1 SAP PLM Solution Road Map © 41

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QM מציע מגוון רחב של פונקציות ותהליכים המשולבים במלואם ב-SAP Product Lifecycle Management (SAP PLM), בדגש על הבטחת וניהול איכות מוצרים ונכסים. ‏QM הוא חלק בלתי-נפרד מ-SAP PLM תחת התהליך הראשי product development and collaboration (Table 1.1). כולל מניעת בעיות איכות ושיפור תהליך מתמשך. במובן הרחב, ‏QM מתמקד בכל תהליכי ה-QM למוצר (תכנון איכות, תעודת איכות, הודעת איכות, בקרת איכות, ניהול ציוד בדיקה, מחקר יציבות). טבלה 1.1 — מפת הדרכים של SAP PLM (תחומים עיקריים): | Product Management | Product strategy/planning; product portfolio management; innovation management; requirements management; market launch management | | Product Development and Collaboration | Engineering/R&D collaboration; supplier collaboration; manufacturing collaboration; service/maintenance collaboration; **product quality management** (כולל QM) | | Product Data Management | Product data/structure management; specification/recipe management; service/maintenance structure management; visualization/publications; configuration management; product change management; document management | | SAP PLM Foundation | Product compliance; product intelligence; product costing; tool/workgroup integration; project/resource management |

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1.3 Business Processes in Quality Management Hardly any business process owner works in an SAP S/4HANA system without coordi- nating and collaborating with multiple areas. These areas reflect different business functions, processes, or needs of the company. Depending on the scope of your QM activities or QM implementation in your organization, you’ll probably use other sup- porting areas, including the following:  Logistics and supply chain management To cover all the functional areas available in logistics, for example, SAP S/4HANA Sales, materials management (MM), inventory management, embedded EWM in SAP S/4HANA, production planning (PP), plant maintenance (PM), logistics execu- tion, and so on. A significant portion of this book is devoted to showing QM integra- tion with the PP, MM, SAP S/4HANA Sales, embedded EWM, and PM areas.  Financial accounting and controlling To perform activities within financial accounting and controlling, such as analyzing quality cost, setting up labor rates and overhead rates, and so on.  Classification system To set up quality catalogs for recording results, for multiple specification, and for using within batch management (see Chapter 9).  Engineering change management To control the change process for quality documents, inspection plans, and so on (see Chapter 13).  Document Management System (DMS) To store quality documents, such as manuals, procedures, or quality certificates.  Audit management To use the audit processes, including audit plans, audit questionnaires, and so on (see Chapter 14).  Equipment serialization To conduct quality tests on calibration equipment that is managed using serial numbers (see Chapter 7). 1.3 Business Processes in Quality Management We’ll now discuss the four important pillars of QM that are vital to a company’s contin- ued business success and the business processes they cover:  Quality engineering  Quality assurance and control  Quality improvement  Product change management 1 Quality Management in SAP S/4HANA 42

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כמעט אף בעל תהליך אינו עובד ללא תיאום עם תחומים מרובים. בהתאם להיקף ה-QM, סביר שתשתמשו בתחומים תומכים: • **לוגיסטיקה ושרשרת אספקה:** Sales, ‏MM, ניהול מלאי, ‏embedded EWM, ‏PP, ‏PM, ‏logistics execution. חלק ניכר מהספר מוקדש לאינטגרציית QM עם PP, ‏MM, ‏Sales, ‏EWM, ו-PM. • **הנהלת חשבונות ובקרה:** ניתוח עלות איכות, הגדרת שיעורי עבודה ותקורה. • **מערכת סיווג (Classification):** קטלוגי איכות לרישום תוצאות, multiple specification, וניהול אצוות (פרק 9). • **ECM:** בקרת תהליך השינוי למסמכי איכות ותוכניות בדיקה (פרק 13). • **DMS:** אחסון מסמכי איכות (מדריכים, נהלים, תעודות). • **Audit management:** תהליכי ביקורת, תוכניות, שאלונים (פרק 14). • **Equipment serialization:** בדיקות איכות על ציוד כיול המנוהל במספרים סידוריים (פרק 7). ארבעת עמודי התווך של QM: • Quality engineering (הנדסת איכות) • Quality assurance and control (אבטחה ובקרת איכות) • Quality improvement (שיפור איכות) • Product change management (ניהול שינויי מוצר)

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1.3.1 Quality Engineering Simply put, quality engineering ensures that quality standards are incorporated into and ingrained in every important business process. This process helps organizations eliminate defects, improve product quality, reduce customer complaints, and more by designing (that’s engineering here!) an excellent quality product. It’s important to have the correct quality planning strategies, processes, tools, and mechanisms in place during the early stages of product design and development. Qual- ity engineering provides the functions and tools to incorporate these quality aspects throughout the entire product development process, which is why it plays such a fun- damental role during new product development and introduction (NPDI). The goal of quality engineering is to promote “quality by design” rather than “quality by test.” The quality engineering process includes closed-loop inspection planning. A closed- loop inspection plan is an integrated inspection planning process for goods receipt inspection and inspection during production. It’s an iterative process in which changes can be initiated from any activity in the loop, and it provides functions and features for understanding the effect of the change on the other objects (the closed loop). Closed- loop inspection planning enables you to perform FMEA, set up a control plan, and set up the inspection planning details. This process includes efficient supplier manage- ment, maintenance of quality-related documents, and recipe management when required. Quality engineering is focused on incorporating quality into the entire product devel- opment process. The quality engineering business processes ensure that the quality of your products is correct from product idea through product delivery and into service at the customer’s site. The quality engineering process often starts with the setup of a project, which can include defined deliverables, quality gates, and stability studies. After these initial stages, you continue quality engineering by closed-loop inspection planning. Quality engineering can have a very high impact on other logistics supply chain business pro- cesses within an organization because quality is crucial for most industries, is part of the integrated value chain, and has a strong influence on costs. Two related concepts that are important to quality engineering are FMEA and control plans; these both play a role in the closed-loop inspection planning process. These are relatively new concepts, and their steps fulfill important requirements for several industries. However, they aren’t required to perform quality engineering activities or to set up an inspection planning process or complaints processes. You can find more information about FMEA in Chapter 16. The quality engineering process starts with closed-loop inspection planning. Let’s examine the business processes of quality engineering: © 43 1.3 Business Processes in Quality Management 1. Define the development project Efficient project management is one of the cornerstones of successful product development. Quality management during product development starts with defin- ing the deliverables and quality gates, which includes inspection planning, effi- ciently managing suppliers, and setting up quality-related documents. In several industries (mainly process industries), this process includes the performance of sta- bility studies. 2. Manage the quality master data and inspection plans In general, quality planning consists of all the activities required to ensure the prod- uct’s quality and provides the basis for effective quality assurance and control. It’s a continuous iterative process managed by multiple departments (e.g., procurement, production, and quality engineering) and requiring a high degree of collaboration. 3. Plan and execute stability studies Stability studies give you a means of testing and evaluating products during various stages of the product lifecycle so you can determine how products or product batches will hold up under controlled environmental conditions over predefined periods of time. For example, you can use a stability study to investigate a product’s shelf life based on conditions such as temperature, moisture, atmospheric pressure, and brightness. Stability studies during product development are also often used to determine the ideal product composition and/or the most suitable product packag- ing. They allow you to meet legal requirements, such as GMP. In addition to being suitable for use in process industries (e.g., chemicals, pharmaceuticals, cosmetics, and foods), stability studies can be conducted in specific areas of discrete manufac- turing (e.g., to test the stability of paints in the automotive supplier industry). 4. Maintain a quality manual Companies use the quality management system as a tool for analyzing and improv- ing their business processes. Various industry standards also require companies to establish and maintain a process-oriented quality manual. You can also include other quality management documentation—standard operating procedures, qual- ity certificates, and quality manuals—and store that documentation with DMS. After quality engineering, the next logical QM activity is quality assurance and control, which enables you to maintain and improve the attained level of product quality. Qual- ity assurance and control involves inspections at all stages of a product’s lifecycle, its continuous monitoring, and quick intervention to deal with unexpected events.

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הנדסת איכות (quality engineering) מבטיחה שתקני האיכות מוטמעים בכל תהליך חשוב — מסייעת לבטל פגמים, לשפר איכות, ולהפחית תלונות, בעיצוב מוצר איכותי ("engineering"). חשוב להגדיר אסטרטגיות, תהליכים וכלים נכונים בשלבים המוקדמים של עיצוב ופיתוח המוצר. הנדסת איכות מספקת כלים להטמעת היבטי האיכות לאורך כל הפיתוח — תפקיד יסודי ב-NPDI (new product development and introduction). המטרה — "quality by design" ולא "quality by test". התהליך כולל closed-loop inspection planning — תכנון בדיקה משולב לבדיקת goods receipt ובדיקה בייצור. תהליך איטרטיבי שבו ניתן ליזום שינויים מכל פעילות, ומבין את ההשפעה על אובייקטים אחרים (הלולאה הסגורה). מאפשר FMEA, הקמת control plan, ופרטי תכנון בדיקה. כולל ניהול ספקים יעיל, תחזוקת מסמכי איכות, וניהול recipe. ההשפעה על שאר תהליכי שרשרת האספקה גבוהה (האיכות חלק משרשרת הערך ומשפיעה על עלויות). ה-FMEA וה-control plans (פרק 16) חדשים יחסית ומשמשים בלולאה הסגורה — אך אינם חובה. התהליך: 1. **הגדרת פרויקט הפיתוח:** ניהול פרויקט יעיל — הגדרת deliverables ו-quality gates (כולל תכנון בדיקה, ניהול ספקים, מסמכי איכות). בתעשיות תהליכיות — מחקרי יציבות. 2. **ניהול נתוני אב QM ותוכניות בדיקה:** תכנון איכות = כל הפעילויות להבטחת איכות המוצר; בסיס לאבטחה ובקרה. תהליך איטרטיבי מתמשך עם מחלקות מרובות (רכש, ייצור, הנדסת איכות). 3. **תכנון וביצוע מחקרי יציבות (stability studies):** בדיקה והערכה בשלבי מחזור החיים — כיצד המוצר/האצווה יחזיקו בתנאי סביבה מבוקרים (טמפרטורה, לחות, לחץ, בהירות). לקביעת חיי מדף, הרכב אופטימלי, ואריזה מתאימה. לעמידה בדרישות חוקיות (GMP). לתהליכי (כימיקלים, תרופות, קוסמטיקה, מזון) ולבדיד (יציבות צבעים בספקי רכב). 4. **תחזוקת מדריך איכות (quality manual):** מערכת ה-QM ככלי לניתוח ושיפור. תקנים דורשים מדריך מכוון-תהליך. ניתן לאחסן תיעוד נוסף (SOPs, תעודות, מדריכים) ב-DMS. הפעילות הלוגית הבאה — אבטחה ובקרת איכות.

English (original)

1.3.2 Quality Assurance and Control After your quality processes are in place, you need to maintain and improve the attained level of quality. Quality control involves inspections at all stages, continuous monitoring, and intervening quickly to deal with unexpected events. Quality assur- ance and control checks can be performed during any step within the logistics value 1 Quality Management in SAP S/4HANA 44 chain with the goal of ensuring that the quality of a product conforms to the necessary quality standards. The quality assurance and control business processes describe general logistics quality assurance activities, such as requesting and checking quality certificates from suppliers and/or suppliers at the time of goods receipt of a purchase order. On goods receipt at a storage location (e.g., a warehouse), the incoming certificate is checked and electroni- cally stored as part of quality assurance. Another quality assurance activity—and the main activity that QM supports—is the set up and performance of quality inspections as part of the logistics supply chain. The quality inspection process includes the setup of the master data relevant for quality inspection, quality planning, the quality trigger (an event, e.g., a goods receipt, goods issue, or customer complaint), the sample infor- mation, the inspection itself, the recording of the results, and the validation of the results, followed by a usage decision and any follow-up activities. Often, batch manage- ment is used to provide full traceability of the used ingredients or components. Basically, all the quality inspection process steps can be divided into four distinct phases: the trigger, the request for an inspection, the inspection itself, and any follow- up activities, as shown in Figure 1.3. Figure 1.3 Quality Inspection Process Steps Let’s also briefly consider other supplementary areas often conducted with QM. The following supplementary QM functions are often covered under the quality assurance and quality control process:  Test equipment interfacing A standardized interface for connecting measuring subsystems and for external control of inspection operations on the shop-floor level.  Statistical process control The application of statistical techniques to control a process. This is used inter- changeably with statistical quality control. Six Sigma approaches are supported to analyze measured values and nonconformance data, such as the use of various qual- ity control charts, Western Electric rules, capability indicators, Pareto analysis, trend analysis, and exception analysis. In addition, SAP Manufacturing Integration and What triggers an inspection? • Unexpected event • Planned event • Analytical event What and how much is inspected? • Inspection lot and instruction • Sample drawing instruction What are the results of the inspection? • Result recording • Defects recording What should happen to the goods? • Usage decision Trigger Request for inspection Inspection Decision © 45 1.3 Business Processes in Quality Management Intelligence (SAP MII) can be used as a frontend tool to visualize quality data from QM and execute statistical process control.  Laboratory information management system (LIMS) Facilitates the testing of samples that routinely pass through an analytical lab. The trend of shifting from isolated data islands to global information is followed due to its tight integration into supply chain components, which offers functions for inventory control and batch tracking, as well as problem handling and management of corrective action and preventive action.  GAAP compliance (according to ISO 9000) Good Clinical Practice/Good Laboratory Practice/Good Manufacturing Practice (GCP/GLP/GMP) include guidelines for enterprises that are regulated by the FDA. SAP S/4HANA provides all the functions necessary to fulfill such requirements. For example, it supports FDA document control, digital signature, audit trial, batch traceability, and electronic batch records. SAP’s development and service organiza- tions are certified according to ISO 9000. While ISO 9000 is a family of ISO stan- dards that provide a general framework for quality management standards, ISO 9001 is a subgroup of the ISO 9000 family that lays out the requirements for meet- ing quality management standards as discussed later in Table 1.2 in this chapter.  Quality costs Includes the cost associated with inspecting a product to ensure that it meets the internal or external customer’s needs and requirements. It includes the costs associ- ated with providing poor quality products or services. Once you’ve established your quality processes and can maintain them, it’s time to take them to the next level with quality improvement.

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לאחר הקמת תהליכי האיכות, יש לתחזק ולשפר את הרמה. בקרת איכות כוללת בדיקות בכל השלבים, ניטור מתמשך, והתערבות מהירה באירועים בלתי-צפויים. ניתן בכל צעד בשרשרת הערך הלוגיסטית, במטרה להבטיח התאמה לתקנים. התהליכים מתארים פעילויות אבטחה כלליות — בקשה ובדיקת תעודות איכות מספקים ב-goods receipt. בקבלה במיקום (מחסן), התעודה נבדקת ונשמרת אלקטרונית. פעילות עיקרית — הקמה וביצוע של quality inspections בשרשרת. תהליך הבדיקה כולל: נתוני אב, תכנון איכות, ה-trigger (אירוע — GR, ‏GI, תלונת לקוח), מידע הדגימה, הבדיקה, רישום התוצאות, אימותן, ו-usage decision ופעולות המשך. לעיתים קרובות ניהול אצוות מספק עקיבות מלאה. ארבעה שלבים (Figure 1.3): ה-trigger; הבקשה לבדיקה; הבדיקה; פעולות ההמשך. (Figure 1.3 — שלבי תהליך הבדיקה: Trigger [אירוע בלתי-צפוי/מתוכנן/אנליטי] → Request for inspection [inspection lot והוראה, sample drawing] → Inspection [רישום תוצאות ופגמים] → Decision [usage decision].) פונקציות QM משלימות תחת אבטחה ובקרה: • **Test equipment interfacing:** ממשק תקני לחיבור תת-מערכות מדידה ולבקרה חיצונית של פעולות בדיקה ברצפה. • **Statistical process control (SPC):** טכניקות סטטיסטיות לבקרת תהליך (= statistical quality control). גישות Six Sigma — control charts, ‏Western Electric rules, מדדי יכולת, ניתוח Pareto, מגמות וחריגות. ‏SAP MII כ-frontend להמחשת נתוני איכות ולביצוע SPC. • **LIMS (laboratory information management system):** בדיקת דגימות במעבדה אנליטית. אינטגרציה הדוקה לשרשרת — בקרת מלאי, מעקב אצוות, טיפול בבעיות וניהול corrective/preventive action. • **תאימות GAAP (לפי ISO 9000):** ‏GCP/GLP/GMP — הנחיות לחברות המפוקחות ע"י ה-FDA. ‏S/4HANA מספק בקרת מסמכי FDA, חתימה דיגיטלית, audit trail, עקיבות אצווה, ו-electronic batch records. ארגוני SAP מוסמכים ISO 9000. ‏ISO 9000 — משפחת תקנים; ‏ISO 9001 — תת-קבוצה עם דרישות (Table 1.2). • **Quality costs:** עלות בדיקת מוצר להבטחת התאמה, ועלות איכות ירודה. לאחר הקמה ותחזוקה — הצעד הבא הוא שיפור איכות.

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1.3.3 Quality Improvement Quality improvement records quality problems and includes problem-solving by sys- tematically determining their cause, solution, follow-up, and actions. The quality noti- fication process is available to document problems of any type for this purpose— especially problems related to poor quality of a product, such as processing complaints against suppliers and complaints from customers. It can also be used to process an internal company problem relating to processes and products and for handling posi- tive events, such as proposals for improvement. The notification is the document used to capture these events. Let’s walk through the process: 1. Record problems Via the notification, you can record and process different types of problems, such as those resulting from poor-quality goods or services received from a supplier or deliv- ered to a customer. During notification processing and inspection processing, you can be alerted about similar or related problems, helping you prevent a repetition. 1 Quality Management in SAP S/4HANA 46 2. Manage and coordinate problem notifications The quality coordinator defines the problem details, the individual defects, the defect causes, and a priority (often including response times), and then dispatches the notification to suitable experts by assigning them the follow-up tasks and activ- ities. 3. Analyze individual problems and causes The quality coordinator generally requires the assistance of a technical specialist to weigh in on the product’s defects. The expert investigates the problem, detects the causes, suggests a solution, and records these findings in the notification to enable standardization and reporting. When set up, the expert can use the solution data- base, which can assist in finding an appropriate solution based on the symptoms of the problem. 4. Assign corrective and preventive actions After finalizing the defects and their causes, the technical specialist will typically consult the people responsible for the defect causes to cooperate with them in defin- ing corrective actions and preventive actions and assigning the partners responsible for processing these tasks. 5. Carry out corrective and preventive actions Within the notification worklist, you can see the outstanding corrective actions and preventive actions. Corrective tasks must be processed in a series of traceable steps. For example, the automotive industry uses the Eight Disciplines of Problem-Solving (8D) process, in which all eight steps are required to solve a problem and must be documented. 6. Monitor problems and actions After processing and completing all the outstanding corrective actions and preven- tive actions, and once the solution has been approved by the problem initiator, com- munication to other interested parties may be required, after which the notification can be considered as completed. Quality managers can use the quality management information system (QMIS) to per- form the following QM analytics:  Compare the frequency of similar notifications and defects for different reference objects (e.g., with reference to different materials, suppliers, or customers) to infer the main problem sources.  Analyze the recorded defects, and monitor the correction of these problems by checking that the corrective actions and preventive actions have been followed up within the established time frames.  Evaluate the problem data. You can, for example, perform a Pareto analysis of the most frequent defect types and defect causes, or perform a Pareto analysis of the materials and business partners most frequently affected by problems to find the main problems and starting points for improvements. © 47 1.3 Business Processes in Quality Management  Perform exception analyses, which identify apparent exceptional situations related to the problem and thereby provide impetuses for defect prevention and improve- ment tasks. Apart from using the QMIS, you can use additional reporting tools, such as SAP Busi- ness Warehouse (SAP BW), SAP BusinessObjects Business Intelligence (SAP Business- Objects BI), or both, with the activation of QM-specific content. Notification data can be analyzed with SAP BusinessObjects BI, in which advanced evaluation tools are available to quality managers. Quality improvement is the last area within the scope of product quality management. We’ll continue with product change management within engi- neering change management.

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שיפור איכות (quality improvement) מתעד בעיות וכולל פתרון שיטתי — קביעת סיבה, פתרון, מעקב ופעולות. תהליך ה-quality notification מתעד בעיות מכל סוג — בעיקר איכות ירודה (תלונות מול ספקים ומלקוחות), בעיות פנימיות, ואירועים חיוביים (הצעות שיפור). ה-notification הוא המסמך הלוכד. התהליך: 1. **רישום בעיות:** דרך ה-notification, סוגי בעיות שונים. בעיבוד notification/inspection, מתקבלת התראה על בעיות דומות. 2. **ניהול ותיאום הודעות:** מתאם האיכות מגדיר פרטים, פגמים, סיבות, ועדיפות (זמני תגובה), ומפנה למומחים בהקצאת משימות. 3. **ניתוח בעיות וסיבות:** המתאם נעזר במומחה טכני. המומחה חוקר, מזהה סיבות, מציע פתרון, ומתעד ב-notification. ניתן solution database לפי הסימפטומים. 4. **הקצאת corrective ו-preventive actions:** המומחה מתייעץ עם האחראים לסיבות להגדרת פעולות והקצאת שותפים. 5. **ביצוע ה-actions:** ב-worklist רואים פעולות פתוחות. למשל, תעשיית הרכב משתמשת ב-8D (Eight Disciplines of Problem-Solving) — שמונה צעדים מתועדים. 6. **ניטור בעיות ופעולות:** לאחר השלמה ואישור היוזם, ייתכן צורך בתקשורת, ואז ה-notification נחשב מושלם. מנהלי איכות משתמשים ב-QMIS (quality management information system): • השוואת תדירות notifications/פגמים לאובייקטי ייחוס שונים (חומרים, ספקים, לקוחות) לזיהוי מקורות הבעיה. • ניתוח הפגמים וניטור התיקון (בדיקת corrective/preventive בזמן). • הערכת נתוני הבעיה — ניתוח Pareto לסוגי הפגמים/הסיבות התכופים, או לחומרים/שותפים המושפעים. • ניתוחי חריגות (exception analyses) לזיהוי מצבים חריגים. מלבד QMIS, ניתן SAP BW, ‏SAP BusinessObjects BI (עם תוכן QM). הבא — product change management ב-ECM.

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1.3.4 Product Change Management Product change management represents the definition and efficient management of engineering changes to ensure that your product data is up-to-date (i.e., representing the latest changes) and that product quality in all phases of the product lifecycle is met. Product change management is addressed by SAP PLM’s engineering change manage- ment, available within the SAP system. It includes all types of changes (e.g., form, fit, and function) with processes and procedures that manage how changes are proposed, reviewed, approved, and incorporated into a product and its associated data items. This engineering change management process provides the means to proactively manage all product changes before product information is handed over to supply chain opera- tions (manufacturing, procurement, service/maintenance, recalls, etc.), along with workflows and full visibility of the impact when changes are initiated from supply chain operations. Companies can achieve the following business goals and objectives by implementing engineering change management:  Increases customer satisfaction, service, and delivery with last-minute changes by reducing product errors, constantly improving product quality, and capturing prod- uct changes easily and quickly.  Satisfies the requirement to document and monitor the change process by includ- ing the change history of the affected object with a before and after status to ensure consistency of products. It includes the ability to specify that changes are effective only under defined conditions and the ability to group changes that belong together.  Integrates with the logistics value chain, where changes can automatically be per- formed for a sales order, a process order, material requirements planning (MRP) set- tings, or product details based on a release key.  Ensures that all people affected by the changes—including data consumers—are involved in the change process. The change process can be flexibly configured to cater to specific business requirements, which can optionally use workflow-driven tasks. 1 Quality Management in SAP S/4HANA 48  Increases transparency and accountability for the secure and reproducible change process for the package of all objects affected by the change, which provides a single source of truth. Parallel processing of changes is possible due to optimal use of change packages.  Reduces operating costs and increases efficiency by reducing product returns, reducing rework required on production orders, and providing seamless, rule-based transfer of product structure changes to operative production orders via order change management.  Reduces time to volume due to the phased release of the engineering change order to subsequent areas. Let’s now review the role of QM in inbound and outbound logistics and supply chain management, as well as how it integrates with these areas.

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ניהול שינויי מוצר (product change management) מגדיר ומנהל ביעילות שינויים הנדסיים — להבטחת נתוני מוצר עדכניים ואיכות בכל שלבי המחזור. מטופל ע"י engineering change management של SAP PLM. כולל כל סוגי השינויים (form, ‏fit, ‏function) עם נהלים לאופן ההצעה, הסקירה, האישור וההטמעה. מנהל את כל השינויים לפני מסירת המידע לתפעול (ייצור, רכש, שירות, recalls), עם workflows ונראות מלאה. מטרות עסקיות ביישום ECM: • מגביר שביעות לקוח, שירות ואספקה בשינויי-רגע-אחרון — בהפחתת שגיאות ושיפור איכות. • ממלא דרישת תיעוד וניטור של תהליך השינוי (היסטוריה עם סטטוס לפני/אחרי, תנאי תוקף, וקיבוץ שינויים). • משולב בשרשרת הערך — שינויים אוטומטיים להזמנת מכירה, הזמנת תהליך, הגדרות MRP, או פרטי מוצר לפי release key. • מבטיח שכל המושפעים מעורבים. התהליך גמיש להגדרה (workflow-driven). • מגביר שקיפות ואחריותיות — מקור-אמת יחיד. עיבוד מקבילי של שינויים ב-change packages. • מפחית עלויות תפעול — פחות החזרות ו-rework, והעברה מבוססת-כללים של שינויי מבנה להזמנות ייצור דרך order change management. • מפחית time to volume בשחרור מדורג של ה-engineering change order.

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1.4 Integration with Other Areas The importance of building quality checks and material inspections into every stage of the supply chain can’t be overemphasized. Besides saving time and money in the short term, integrating QM into critical processes can deliver greater business benefits well into the future. Figure 1.4 represents a generalized logistic value chain: the diamonds represent quality gates that you can implement and through which the product must pass in the logistics and supply chain processes before it moves on to the next step. Figure 1.4 Quality Gates in Logistics Sales Procurement Material handling Production Shipping Service © 49 1.4 Integration with Other Areas In the following sections, we’ll briefly review some of the business processes in which QM integrates with logistics areas.

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אי אפשר להפריז בחשיבות שילוב בדיקות איכות בכל שלב בשרשרת האספקה. מלבד חיסכון בזמן וכסף בטווח קצר, השילוב מספק יתרונות לטווח ארוך. Figure 1.4 — שרשרת ערך לוגיסטית כללית: היהלומים מייצגים quality gates שניתן ליישם, שדרכם המוצר חייב לעבור לפני הצעד הבא. (Figure 1.4 — Quality Gates: Procurement → Material handling → Production → Shipping → Sales → Service.) להלן תהליכים שבהם QM משולב עם הלוגיסטיקה.

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1.4.1 Materials Management The QM integration with materials management (MM) attends to quality inspections of all procured materials. Inspections can be triggered even before goods are delivered, which allows a company’s representatives to visit suppliers to check the quality of the goods they produce. The scope and complexities of MM are very large, so we restrict ourselves to covering either the integration points of QM with MM or where business processes in MM directly impact QM. The following subfunctions are heavily integrated with QM:  Procurement  Inventory management For business processes in the procurement area, you’ll need MM’s organizational struc- ture, such as the purchasing organization and purchasing group. For inventory man- agement business processes, you’ll need the plant and storage location, which we covered previously. The following are the organizational units that you need to ensure are available in the system so that your procurement processes run in the system and with which you can integrate QM:  Purchasing organization A purchasing organization can be a logical or actual division of a company’s pur- chasing functions and is responsible for managing and reporting procurement func- tions. For example, a purchasing organization can be a local or imports business.  Purchasing group A purchasing group is a person or group of persons responsible for the procurement of group of materials or services. Examples of purchase groups are raw materials, chemicals, maintenance spares, or consumables. When you create a purchasing group, it’s important to ensure that it isn’t created with a person’s name because that person’s role or area of responsibility may change.

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אינטגרציית QM עם MM מטפלת בבדיקות איכות של כל החומרים הנרכשים. בדיקות יכולות להתחיל אף לפני האספקה (ביקור אצל הספק). היקף MM גדול — נתמקד בנקודות האינטגרציה. תת-פונקציות המשולבות מאוד: • רכש (Procurement) • ניהול מלאי (Inventory management) לרכש נדרש מבנה MM (purchasing organization ו-purchasing group); לניהול מלאי — plant ו-storage location. היחידות הנדרשות: • **Purchasing organization:** חלוקה לוגית/ממשית של פונקציות הרכש, אחראית לניהול ודיווח. למשל, עסק מקומי או יבוא. • **Purchasing group:** אדם/קבוצה האחראים לרכש קבוצת חומרים/שירותים. למשל גלם, כימיקלים, חלפי תחזוקה, מתכלים. אל תיצרו עם שם אדם (תפקידו עשוי להשתנות).

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1.4.2 Production Planning When integrated with production planning (PP), QM adds two additional types of qual- ity inspections: in-process and finished goods. During the production process, an in- process inspection ascertains the quality of goods in production. In this situation, the user performs the QM results recording, defects recording, and usage decision steps before releasing the material to the next stage of production. It’s also possible to embed quality controls in the production process so that the next step of a production 1 Quality Management in SAP S/4HANA 50 process only begins after the quality results and usage decision from the previous step are recorded in the system. Further, it’s also possible to incorporate quality inspection processes as soon as compo- nents or materials required in the production processes are issued out. For finished goods, the user performs the three quality steps before the stock is released for sale or consumption. In summary, three types of quality inspections are possible in a produc- tion process—goods issue, in-process, and goods receipt inspection—and in all three manufacturing types: discrete, process, and repetitive. The quality management processes work well even when a company has implemented the embedded production planning and detailed scheduling (PP-DS) functionality of PP in SAP S/4HANA.

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בשילוב עם PP, ‏QM מוסיף שני סוגי בדיקות: in-process וגמורים. בייצור, בדיקת in-process קובעת את איכות הסחורה בייצור — המשתמש מבצע רישום תוצאות, רישום פגמים ו-usage decision לפני שחרור לשלב הבא. ניתן להטמיע בקרות כך שהשלב הבא מתחיל רק לאחר רישום התוצאות וה-usage decision של הקודם. ניתן גם בדיקה ב-goods issue של רכיבים. לגמורים, המשתמש מבצע את שלושת הצעדים לפני שחרור למכירה/צריכה. בסיכום, שלושה סוגי בדיקות בייצור — goods issue, ‏in-process, ו-goods receipt — בכל שלושת סוגי הייצור (בדיד, תהליכי, חוזר). תהליכי QM עובדים גם עם embedded PP-DS.

English (original)

1.4.3 Sales If the customer requires additional quality checks before goods can be dispatched, QM can handle them once it’s integrated with SAP S/4HANA Sales. When goods are issued against a sales order, the SAP S/4HANA system creates an automatic inspection lot that must first be checked for compliance with the customer’s quality specifications. QM can also trigger an inspection when a customer returns defective goods. The business processes in SAP S/4HANA Sales are generally the starting point in the entire chain of business events. These are the organizational units of SAP S/4HANA Sales:  Sales organization A sales organization can be a logical or actual division of a company’s sales functions and is responsible for managing and reporting sales functions. For example, a sales organization can be a local or exports business.  Distribution channel A distribution channel is the logical or actual way or channel through which the company distributes or sells its products. Examples of distribution channels include retail, wholesale, institutional, government, or large corporate clients.  Division A division is the actual or logical group of a company’s products for which it wants to see its sales results or profits. Divisions can be cars, spare parts, or services for the automobile industry, or medicines, cosmetics, or consumer products for an herbal pharmaceutical company.

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אם הלקוח דורש בדיקות איכות נוספות לפני המשלוח, ‏QM מטפל בכך בשילוב עם Sales. בהנפקה מול הזמנת מכירה, המערכת יוצרת inspection lot אוטומטי שיש לבדוק להתאמה למפרט הלקוח. ‏QM יכול גם להפעיל בדיקה בהחזרת סחורה פגומה. תהליכי Sales הם בד"כ נקודת ההתחלה. היחידות: • **Sales organization:** חלוקה לוגית/ממשית של פונקציות המכירה. למשל מקומי או יצוא. • **Distribution channel:** הערוץ שדרכו החברה מפיצה/מוכרת. למשל קמעונאות, סיטונאות, מוסדי, ממשלתי, או לקוחות גדולים. • **Division:** קבוצת מוצרים שעבורה רוצים לראות תוצאות/רווחים. למשל מכוניות, חלפים, שירותים; או תרופות, קוסמטיקה, מוצרי צריכה.

English (original)

1.4.4 Plant Maintenance If plant maintenance (PM) is used for routine, preventive, or predictive plant mainte- nance, companies should perform additional quality checks on equipment to ensure © 51 1.4 Integration with Other Areas that it adheres to minimal maintenance criteria. They can do so by integrating QM with PM. It’s also possible to use QM to map inspection scenarios into other business processes, including the following:  Plant-to-plant inspections, in which goods transferred among various plants or dis- tribution centers within the company go through quality checks to ensure that there are no damages during transportation  Physical sample inspections, in which a company’s or competitor’s sample is evalu- ated to help in important decisions, such as whether to buy the material from a new supplier or change product specifications to match those of competitors  Manual inspections in such situations as creating inspection lots for stored raw materials or finished goods or after natural or manmade disasters  Inspections for stability studies performed on products under development to ensure that they meet certain physical or chemical specifications  Custom inspections when the standard inspections in QM fail to meet particular business needs, such as integration with third-party quality management tools or inspection results from laboratory equipment

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אם PM משמש לאחזקה שגרתית/מונעת/חזויה, יש לבצע בדיקות איכות נוספות על הציוד לעמידה בקריטריונים מינימליים — בשילוב QM עם PM. ניתן גם למפות תרחישי בדיקה לתהליכים אחרים: • **בדיקות מפעל-למפעל:** סחורה המועברת בין מפעלים/מרכזים עוברת בדיקות (נזקי הובלה). • **בדיקות דגימה פיזית:** הערכת דגימת חברה/מתחרה להחלטות (לרכוש מספק חדש, לשנות מפרט). • **בדיקות ידניות:** למשל יצירת inspection lots לגלם/גמורים מאוחסנים, או לאחר אסונות. • **בדיקות למחקרי יציבות:** על מוצרים בפיתוח לעמידה במפרט פיזי/כימי. • **בדיקות מותאמות:** כשהתקניות אינן מספיקות (אינטגרציה עם כלי QM צד-שלישי או תוצאות מעבדה).

English (original)

1.4.5 Embedded Extended Warehouse Management Embedded extended warehouse management (EWM) in SAP S/4HANA has introduced significant improvements in the entire logistics and supply chain in general and QM in particular. The need to create and replicate embedded EWM master data, such as prod- uct master or location, is eliminated in SAP S/4HANA, making it faster and smoother to run embedded EWM integrated business processes. There is, however, still a need to set up queued remote function calls (qRFCs) in SAP S/4HANA for embedded EWM so that the transactional data communicates between SAP S/4HANA and embedded EWM. Almost all embedded EWM integrated business processes are available in embedded EWM in SAP S/4HANA, and the ones that aren’t available yet are slated to be available in future releases.

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embedded EWM ב-S/4HANA הביא שיפורים משמעותיים בשרשרת ובפרט ב-QM. הצורך ליצור ולשכפל נתוני אב EWM (product master, ‏location) בוטל — מהיר וחלק יותר. עדיין נדרש להקים queued remote function calls (qRFCs) ב-S/4HANA ל-embedded EWM כך שנתוני הטרנזקציה יתקשרו בין S/4HANA ל-EWM. כמעט כל תהליכי ה-EWM המשולבים זמינים; שאינם — צפויים בגרסאות עתידיות.

English (original)

1.4.6 ISO 9001 Certification Process and SAP S/4HANA Table 1.2 shows the core elements of the ISO 9001 standard and the options for imple- menting them using the SAP S/4HANA system. Here, only a few essential standard requirements are dealt with because a complete analysis of the standard with all its requirements would go far beyond the scope of this table. 1 Quality Management in SAP S/4HANA 52 Standard ISO 9001 Requirement Implementation Option in SAP S/4HANA QM system: Processes must be identified and defined. The system must be docu- mented, and documents and records must be controlled. You’ve identified and defined the processes through the introduction of the SAP S/4HANA system and the selection of functionalities, especially QM. The documentation of the implementation, which is required anyway, can also be used for the documentation of your QM system, or it can be par- tially referred to for this reason. Documentation require- ments: The documentation of the management system must adhere to certain requirements. Documents and records must be con- trolled. The entire SAP S/4HANA system is designed in such a way that this requirement is fulfilled. Each creation and modifica- tion of documents and records (as long as they are processed through the SAP system) is recorded with user name, date, and time. This means that relevant proof is always available. The release after inspection is implemented via a status con- cept, and the appropriate personnel are defined through the authorization concept and the responsibility for certain pro- cesses. Special authorizations are to be implemented using a digital signature. DMS is particularly suitable for implement- ing this standard requirement. Management responsibility: Responsibility and authority must be specified and docu- mented, resources must be provided, and QM evaluation must be performed. The implementation of the SAP S/4HANA system, the use of the required modules, the responsibilities for the mapped processes, and the authorization concept ensure that numer- ous requirements are met directly. The SAP S/4HANA infor- mation systems provide access to nearly all facts you require for the QM evaluation. Capability, consciousness, and training: The training require- ment must be identified, nec- essary qualifications must be attained, and records on the training status must be maintained. You can meet the requirement to record the training status by using the human resources (HR) functionality. There you can manage the corresponding information for each employee. Evaluating the contractual requirements with regard to the product (contract check- ing and managing changes): Checking the requirements and the capability to meet them. This element is supported by the SAP S/4HANA system in dif- ferent areas. You can manage contracts using DMS. The material master data enables you to review a part of the requirements. You can use PP and standalone SAP EWM and embedded EWM to check the capacity. The engineering change management with the change master record (date, processor, etc.) allows you to manage contract changes, and the entire system records all management data. In addition, you can create or supplement records with comment fields in different transactions and by using the notification tool. Table 1.2 How SAP S/4HANA Supports the ISO 9001 Certification © 53 1.4 Integration with Other Areas Development (design control): Development and phase planning; defining organiza- tional and technical inter- faces; establishing and documenting development entries; verifying, document- ing, and validating results; and documenting changes. These requirements can for the most part be covered by existing areas. You can plan a development project and its phases with the project system (PS) functionality. SAP PLM ensures integration into the supply chain and QM. You’ll find the organizational and technical interfaces at different points in the SAP S/4HANA system, and you must define and describe them there. Important interfaces for a development and production company include purchasing (MM) and pro- duction (PP). The procurement specifications are all available in the sys- tem (e.g., material master with individual purchase order texts, purchasing info record, supplier info record, quality info record, etc.), and you can refer to them when ordering, when goods are received, or during incoming goods inspec- tion. For verification, precisely plannable inspections are available in QM. Controlling production and services (process control): Pro- duction, assembly, and ser- vice processes must be planned and executed under controlled conditions. Routings provides the best options for planning the produc- tion and assembly processes or services. You can specify the type of production and service, including the relevant pro- duction resources and tools or operating supplies. You can plan the maintenance of your products and production facili- ties with customer services and PM for preventive mainte- nance. Identification and traceability (and inspection status): The product must be clearly iden- tified during production; that is, the inspection status of a product must be indicated everywhere. SAP S/4HANA is quite flexible with regard to product identifi- cation and can easily meet the standard requirements. In each phase, you can print out the corresponding papers for identification and attach them to the goods, for example, the receipt of goods certificate for the inbound delivery, the pro- duction order for production, or the delivery note and the test certificate for the outbound delivery. It’s possible to print out labels with a barcode, if required. Identification and traceability (and inspection status): The product must be clearly iden- tified during production; that is, the inspection status of a product must be indicated everywhere. SAP S/4HANA is quite flexible with regard to product identifi- cation and can easily meet the standard requirements. In each phase, you can print out the corresponding papers for identification and attach them to the goods, for example, the receipt of goods certificate for the inbound delivery, the pro- duction order for production, or the delivery note and the test certificate for the outbound delivery. It’s possible to print out labels with a barcode, if required. Standard ISO 9001 Requirement Implementation Option in SAP S/4HANA Table 1.2 How SAP S/4HANA Supports the ISO 9001 Certification (Cont.) 1 Quality Management in SAP S/4HANA 54 SAP S/4HANA also supports the management of physical samples and batches. Serial number management enables you to trace individual products, if necessary. The status of the products is documented in the system, for instance, via confirmation messages for certain operations. If required, you can also print out work papers or labels to indicate the inspection status. The system can be configured so that no product can be dis- patched without having completed the required inspections and having documented them. Property of the customer (products provided): The prop- erty of the customer must be identified, verified, and pro- tected. You can carry out verification with SAP S/4HANA, for instance, via goods receipt inspection. Product maintenance (stor- age, etc.): Suitable methods and processes for identifica- tion, handling, packing, stor- age, protection, and dispatch must be adopted. You can adjust your system to these standard requirements with MM, embedded EWM, and SAP S/4HANA Sales. For instance, for methods and processes that have to be adhered to at certain stages of the production process or with regard to product maintenance, you can include detailed descrip- tions as long texts at any time in routings and inspection plans. Control of monitoring and test equipment (test equip- ment monitoring): Test equipment, provided it’s nec- essary for the fulfillment of quality requirements, must be released and calibrated or verified at regular intervals. Records must be kept on the calibration and verification results. The combined possibilities of the PM and QM areas of SAP S/4HANA enable complete test equipment monitoring. This test equipment monitoring contains the master data for all test equipment, the status (locked, free, etc.), the manage- ment (who has which item of test equipment where), and the calibration monitoring, which ensures that each item of test equipment subject to monitoring is regularly recali- brated on the basis of a maintenance plan. As usual, all data on test equipment monitoring is stored in the system data- base and is available for information or further evaluation. It’s also possible to integrate a subsystem that may already exist for test equipment monitoring, which communicates with the SAP S/4HANA system through a dedicated interface. Standard ISO 9001 Requirement Implementation Option in SAP S/4HANA Table 1.2 How SAP S/4HANA Supports the ISO 9001 Certification (Cont.) © 55

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טבלה 1.2 מציגה את אלמנטי הליבה של תקן ISO 9001 ואפשרויות היישום ב-S/4HANA (רק דרישות מהותיות; ניתוח מלא חורג מהיקף הטבלה): טבלה 1.2 — כיצד S/4HANA תומך בהסמכת ISO 9001 (דרישת ISO 9001 | אפשרות יישום): | **מערכת QM:** זיהוי והגדרת תהליכים, תיעוד, ובקרת מסמכים ורשומות | התהליכים זוהו והוגדרו בהכנסת S/4HANA ובבחירת הפונקציונליות (בפרט QM). תיעוד היישום משמש גם לתיעוד מערכת ה-QM. | | **דרישות תיעוד:** בקרת מסמכים ורשומות | המערכת מתוכננת כך שהדרישה ממולאת. כל יצירה/שינוי נרשמים עם שם משתמש, תאריך ושעה. השחרור לאחר בדיקה ב-status concept, וההרשאות ב-authorization concept. הרשאות מיוחדות — חתימה דיגיטלית. ‏DMS מתאים במיוחד. | | **אחריות הנהלה:** הגדרת אחריות וסמכות, אספקת משאבים, והערכת QM | היישום, השימוש במודולים, האחריויות לתהליכים, וה-authorization concept מבטיחים עמידה. מערכות המידע מספקות גישה לכמעט כל העובדות להערכת QM. | | **יכולת, מודעות והדרכה:** זיהוי דרישת ההדרכה, השגת כישורים, ותחזוקת רשומות | ניתן לעמוד בדרישת רישום סטטוס ההדרכה ב-HR. | | **הערכת דרישות חוזיות למוצר (בדיקת חוזה וניהול שינויים):** בדיקת הדרישות והיכולת | נתמך בתחומים שונים. חוזים ב-DMS; אב החומר לסקירת הדרישות; ‏PP ו-EWM לבדיקת קיבולת; ‏ECM עם change master record לניהול שינויי חוזה. | | **פיתוח (design control):** תכנון פיתוח ושלבים, ממשקים, אימות ותיקוף תוצאות, תיעוד שינויים | מכוסה ברובו בקיים. תכנון פרויקט ושלבים ב-PS; ‏SAP PLM לאינטגרציה לשרשרת ול-QM. הממשקים החשובים — רכש (MM) וייצור (PP). מפרטי הרכש זמינים (אב חומר, ‏purchasing info record, ‏supplier info record, ‏quality info record). לאימות — בדיקות מתוכננות ב-QM. | | **בקרת ייצור ושירותים (process control):** תכנון וביצוע מבוקרים | מסלולים (routings) לתכנון; ‏customer services ו-PM לאחזקה מונעת. | | **זיהוי ועקיבות (וסטטוס בדיקה):** זיהוי ברור של המוצר בייצור | גמיש מאוד — ניתן להדפיס ניירות זיהוי בכל שלב (תעודת GR, הזמנת ייצור, תעודת בדיקה, label עם ברקוד). תומך בניהול דגימות ואצוות; ‏serial number management לעקיבת מוצרים בודדים. ניתן להגדיר שאף מוצר לא יישלח ללא בדיקות מושלמות ומתועדות. | | **רכוש הלקוח:** זיהוי, אימות והגנה | אימות ב-goods receipt inspection. | | **תחזוקת מוצר (אחסון וכו'):** שיטות לזיהוי, טיפול, אריזה, אחסון, הגנה ומשלוח | התאמה ב-MM, ‏EWM, ו-Sales. תיאורים מפורטים כ-long texts במסלולים ובתוכניות בדיקה. | | **בקרת ציוד ניטור ובדיקה:** שחרור, כיול/אימות במרווחים, ושמירת רשומות | שילוב PM ו-QM מאפשר ניטור מלא — נתוני אב, סטטוס (נעול/חופשי), ניהול (מי/היכן), וניטור כיול (recalibration לפי maintenance plan). ניתן לשלב subsystem קיים דרך ממשק ייעודי. | | **Internal audit:** תכנון תוכנית ביקורת (קריטריונים, היקף, תדירות, שיטות), ותחזוקת רשומות | נתמך ישירות; ניתן גם quality notification לתיעוד ועקיבת ביקורות. | | **שיפורים (corrective/preventive action):** הערכת שגיאות (כולל תלונות לקוח), קביעת סיבות, מניעת הישנות, יזימת פעולות, רישום והערכה | יישום ישיר ב-QM וב-PP. ‏corrective/preventive עובדים דרך רישום השגיאות לתוצאות הבדיקה ול-usage decision. ניתן action catalogs, או free texts ו-quality notifications, עם עקיבה וניטור לאורך זמן. תלונות לקוח נרשמות ומנוטרות דרך ה-notification. |

English (original)

1.5 Summary 1.5 Summary This chapter began with covering what QM is and the importance of QM integration with logistics and areas of supply chain management. The QM master data objects are important during processes relevant for ensuring product quality. We continued with the business processes within QM, starting with quality engineering. Then, we also quickly showed you how QM relates to the rest of the SAP S/4HANA landscape, as it’s important to understand the enterprise structure of various SAP S/4HANA systems that you’ll use throughout the book. Setting up the correct and complete enterprise struc- ture is one of the key success factors for ensuring effective reporting that eventually helps in making important and strategic business decisions. The chapter also covered how SAP S/4HANA supports the ISO 9001 certification process. In the next chapter, we begin our journey in the QM area with a look at quality plan- ning. Internal audit: An audit pro- gram must be planned— criteria, scope, frequency, and methods must be defined— and records must be main- tained. Audit management is directly supported by the SAP S/4HANA system. You can also use the quality notification to document and trace audits. Improvements (corrective and preventive action): Corrective measures must evaluate errors, including customer complaints. You’ll find the direct implementation of these requirements in the QM and PP areas in particu- lar. You can create, trace, and determine causes, prevent recurring errors, initiate mea- sures, record results, and evaluate measures. Preventive measures must determine possible errors and causes, prevent the occurrence of errors, initiate actions, record results, and evaluate actions; corrective and preven- tive actions work directly through error recording for the inspection results and the use decision. You can use your own action catalogs or initiate individual measures or actions using free texts and quality notifications, and you can trace and monitor these over time. All information and quality records are available from in-process and final inspec- tions involving production. You can record customer com- plaints, initiate corresponding actions, and further trace them via the quality notification. The SAP S/4HANA system can provide information at any time on all actions, steps, and their processing status, as well as provide information for a QM evaluation. Standard ISO 9001 Requirement Implementation Option in SAP S/4HANA Table 1.2 How SAP S/4HANA Supports the ISO 9001 Certification (Cont.) ©

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הפרק פתח במהות QM ובחשיבות האינטגרציה עם הלוגיסטיקה ושרשרת האספקה. אובייקטי נתוני האב חשובים בתהליכים להבטחת איכות. המשכנו בתהליכי QM, החל מהנדסת איכות, ובקשר של QM לשאר ה-S/4HANA landscape (חשוב להבין את המבנה הארגוני של המערכות בספר). הקמת מבנה ארגוני נכון ומלא — גורם הצלחה מרכזי לדיווח יעיל ולהחלטות אסטרטגיות. הפרק כיסה גם כיצד S/4HANA תומך בהסמכת ISO 9001. הפרק הבא — תכנון איכות (quality planning).