*What This Session Will Cover, and Why! Due to regulations put forth by the Food & Drug Administration (FDA), the Federal Aviation Association (FAA), Sarbanes-Oxley (SOX), and others, SAP customers are compelled to use the Quality Management (QM) component more than ever

*QM is increasingly viewed as a business advantage (as with Motorola Six Sigma plan Statistical Process Control [SPC])

This session will introduce the Quality Management component (QM), and describe its main uses relevant to SAP Production Planning (PP) processesWhat This Session Will Cover, and Why! (cont.)

*What Well Cover What is QM?How different manufacturing strategies discrete, repetitive, and Process Industry (PP-PI) change the ways to integrate QMWhat are the differences between QM during production and QM at the end of production?Main customizing tasks to integrate QM with PPMaster data requirements to integrate QM with PPDemo: Process order with and without QMWrap-up

*A Definition of QMQuality Management (QM) is a component of mySAP PLM used to plan, check, verify, and document the quality of products and processesThree main requirements for a QM system: Total Quality Management (TQM)Industry-specific standards: FDA and Good Manufacturing Practice (GMP)Standards for QM systems (ISO 9000)

*Evolution of QMLets see a brief look at the history of software development in the quality management area SAP R/3 QM: Planned and event-controlled processes in quality management for purchasing and production, with little functionality (compared to todays)mySAP PLM QM: Functional area of mySAP PLM, encompassing quality engineering, quality improvement, and quality assurance and controlmySAP ERP QM: All QM-relevant processes (quality planning, quality inspection, quality certificate, quality notification, quality control, test equipment management, stability study)

*What Does QM Include?Quality Management is integrated in the SAP system and uses basic and cross-application functions, such as: Document Management System (DMS)Engineering Change Management (ECM)Classification SystemAudit ManagementWorkflowArchiveLinkSAPofficeExample: QM documents may be managed with DMS (txn CC04) and/or SAPoffice (txn SBWP)

*Quality planning create and manage the master data that is required to plan and execute quality inspections Quality inspection identify whether the inspected units fulfill the predefined quality requirementsQuality certificate certify the quality of a material (contains texts, specification values, and inspection results) Quality notification record and process internal and external problems that are primarily caused by poor-quality goods or services

Functions of the Quality Management Area

*Functions of the Quality Management Area (cont.)Quality control implement various preventive, monitoring, and corrective activitiesSpecifications from quality planning and evaluations from quality inspections and quality notifications, form the basis for quality control Test equipment management manage master data, as well as plan and process calibration inspections for test equipmentStability study manage basic data, as well as the planning and execution of stability studies

*Quality Management (QM) in Production Planning (PP)QM in PP covers the following areas:Integrating inspection planning/production operations Inspection operations can be directly included in routines (discrete manufacturing and repetitive manufacturing) or Master Recipes (process industry)Controlling inspections during production Inspection lot origin 03 (during production)Inspection lot origin 04 (Goods Receipt [GR] from production) Statistical Process Control (SPC)For example, control chart with mean value and standard deviation for an inspection characteristicProcessing internal problem notifications notification type Q3

*What is QM? How different manufacturing strategies discrete, repetitive, and Process Industry (PP-PI) change the ways to integrate QMWhat are the differences between QM during production and QM at the end of production?Main customizing tasks to integrate QM with PPMaster data requirements to integrate QM with PPDemo: Process order with and without QMWrap-upWhat Well Cover

*Discrete ManufacturingThese are the normal production orders Each material is produced individually (i.e., an individual production order for each production lot)The work processes within a company are executed using production ordersA production order defines which material is to be processed, at which location, at which time, and requiring how much work It also defines which resources are to be used and how the order costs are to be settled

As soon as a planned order is generated from Materials Requirement Planning (MRP), shop floor takes over the information available and adds the order-relevant data to it to guarantee complete order processingProduction orders are used to control production within a company, and also to control cost accounting

*Repetitive ManufacturingA component in the SAP system for planning and controlling repetitive manufacturing and flow manufacturing It enables the period-dependent and quantity-dependent planning of production lines, reduces the work involved in production control, and simplifies backflushing (confirmation, Goods Receipt posting)Implement repetitive manufacturing if the following is true of your production process:You produce the same or similar products over a lengthy period of time You do not manufacture in individually defined lots. Instead, a total quantity is produced over a certain period at a certain rate per part-period. Your products always follow the same sequence through the machines and work centers in productionRoutings tend to be simple and do not vary much

*Process Industry Manufacturing (PP-PI)With PP-PI, SAP provides an integrated planning tool for batch-oriented process manufacturing It is primarily designed for the chemical, pharmaceutical, food, and beverage industries, as well as the batch-oriented electronics industries PP-PI uses terms such as:Master Recipes the processes to be used for producing materials in your plant, as well as the resources and ingredients required for productionProcess Orders copy a process described in a Master Recipe and adjust it to the actual production runProcess Management coordinate the communication between PP-PI and the process control during the execution of a process order

*QM Changes According to Production MethodQM uses different blocks (customizing, master data, etc.) according to the production method (discrete, process, and repetitive). Here are some examples:When process order is used inspection planning may reside in the Master RecipeWhen production order is used inspection planning may reside in the routine (txn CA03)When PP-PI is used inspection results shall be recorded in the PI sheet (txn CO60)When discrete or repetitive is used inspection results shall be recorded in the inspection lot (txn QE51N)

*What Well Cover What is QM?How different manufacturing strategies discrete, repetitive, and Process Industry (PP-PI) change the ways to integrate QMWhat are the differences between QM during production and QM at the end of production?Main customizing tasks to integrate QM with PPMaster data requirements to integrate QM with PPDemo: Process order with and without QMWrap-up

*ProductionPlanningOrderreleaseInspectionduringproduction Order confirmation Goods movementSample calculationInspection lot creationApproval procedureRecording of scrapPartial lot creationValuationBatch classificationGR in warehouseBatch proposalBatch classificationRelease of batch recordOperations + inspection characteristicsInspection pointsMeasured value and defects recordingSPC control chartExternally processed operations

Production Chain

*QM During ProductionInspection lot origin = 03Inspection lot is created at the PP order releaseAt Goods Receipt, material immediately entered into unrestricted-use stockControl is less strict Materials with bad inspection may enter the good stockIf better control is required, production reporting should be on the operation levelIn this case, it should be forbidden to move to the next operation if the previous one was not accepted

*QM at the End of ProductionInspection lot origin = 04Inspection lot is created at Goods ReceiptAt Goods Received, the produced material is received into QI-Stock Only usage-decision may move it to unrestricted-use stockControl is more strictIf material did not pass inspection, it cannot be usedProduction reporting may be on operation level or on order level

*What Well Cover What is QM? How different manufacturing strategies discrete, repetitive, and Process Industry (PP-PI) change the ways to integrate QMWhat are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PPMaster data requirements to integrate QM with PPDemo: Process order with and without QMWrap-up

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Customization Tasks to Integrate QM with PPSeparate transaction for QM customization: QCC0Quality planningInspection characteristics, inspection methodsSample determinationDefine task list types, usage, and statusDefine control key for inspection operationsThe required Task List Usages can be created in customizingThe Task List Usage is entered in the headers of the task lists and in customizing of the inspection types

*Assign Task List Type to Material Types

*Quality InspectionInspection typesInspection for goods movementsAssign inspection type for manufacturing order (per production order type or process order type)Maintain usage decision for catalog type = 3Define physical sample type, container, and locations

Important:The meaning of the catalogs 0 to 9 Z and A to O is defined by SAPThe other catalogs (P to Z) can be defined by the customer

*Define Control Keys for Inspection Operations

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Quality Certificates

Certificate profileMaintain formOutput determination

*Quality NotificationsNotification types and contentAdditional notification functions (action box and follow-up actions) Q: What are Quality Notifications?A: Quality Notifications are the central medium in QM for processing problems and unplanned events

*Quality ControlIn Materials Management (MM): Vendor evaluationIn Logistics Information System (LIS): Quality Management Information System (QMIS)In QM: Definition and evaluation of original documentsControl Chart: Form for the graphical display of characteristics values that occur during an inspection. The control chart compares the displayed values with the action limits and, in this way, supports the quality-related control of the process.The run-chart is a graphical display of the single values of a quantitative characteristic in a run time. You cannot valuate inspection results using the run-chart.

*Stability StudyDefine physical sample typesDefine testing schedule categoryNotification typesCatalogsInspection types

Stability Studies are performed in the chemical, pharmaceutical, and food industries to examine how different conditions affect a product over a specified period of time

*What Well Cover What is QM?How different manufacturing strategies discrete, repetitive, and Process Industry (PP-PI) change the ways to integrate QMWhat are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PPMaster data requirements to integrate QM with PPDemo: Process order with and without QMWrap-up

*Quality Planning as a Foundation for Master DataIn quality planning, you define information and processes on a long-term basis as Master RecordsQuality planning provides the basis for inspection processingTo do that, quality planning uses cross-application data, such as:Material MasterBatch classification Quality documentsWork centerSerial numbers

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Master Data: Material Master QM View

*Master Data: Routine View

*Master Data: Routine View (cont.)

*Quality Planning as Part of QMQuality planning uses QM-specific basic data such as:Master inspection characteristicsInspection methodsSampling proceduresQM work center (with its capacity)Catalog

*Quality Planning and Inspection Planning DataQuality planning uses inspection planning data such as: Inspection plansPP-PI: Master Recipe, ResourceRoutingMaterial specifications

*What Well Cover What is QM? How different manufacturing strategies discrete, repetitive, and Process Industry (PP-PI) change the ways to integrate QMWhat are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PPMaster data requirements to integrate QM with PPDemo: Process order with and without QMWrap-up

*Process Order Without QMWhen production is complete, enter a Goods Receipt of the material into stockThe Transaction is CO60 maintain PI sheet

*DEMO Process Order Without QM No QM data!

*Process Order with QM When production is complete, enter the following:Inspection results (through characteristics)Usage decision Only then, enter Goods Receipt of the material into stockThe transactions:CO60 maintain PI sheetQE51N find inspection lot per materialQA11 enter usage decision

*Enter QM data here!DEMO Process Order with QM

*DEMO Process Order with QM (cont.)

*DEMO Process Order with QM (cont.)

*DEMO Process Order with QM (cont.)

*What Well Cover What is QM? How different manufacturing strategies discrete, repetitive, and Process Industry (PP-PI) change the ways to integrate QMWhat are the differences between QM during production and QM at the end of production?Main customizing tasks to integrate QM with PPMaster data requirements to integrate QM with PPDemo: Process order with and without QMWrap-up

*ResourcesProduct information: www.sap.com/plmProduct documentation: http://help.sap.comFor customers and partners: http://service.sap.com/qm *Information about courses: www.sap.com/education*Requires login credentials to the SAP Service Marketplace

*7 Key Points to Take HomeQM became crucial in recent yearsNow, more than ever, it is important to implement it in PPBefore starting the QM project, make sure your implementation complies to the rules and regulations of your companys business (SOX, FDA, etc.)To allow the QM process to work, allocate the necessary resources to ensure that master data is correctIf a more strict control is required, you may consider inspecting the material at the end of productionIf the production process is long or divided into many processes, you may consider inspecting during production, also

*7 Key Points to Take Home (cont.)Focus on the main customizing and master data tasksDo not try to achieve everything right at the beginningUse notification wisely. It is very powerful.Make sure you allow production to continue working after QM implementationDo not sacrifice production on the altar of QM

*Your Turn!How to contact me:Isaac MazliachISAAC@SDM-C.COM