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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), and describe its main uses relevant to SAP Production Planning (PP) processes
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repetitive, and Process Industry (PP-PI) change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up
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A Definition of QM
Quality Management (QM) is a component of mySAP PLM
used to plan, check, verify, and document the quality of products and processes Three main requirements for a QM system:
Total Quality Management (TQM) Industry-specific standards: FDA and Good Manufacturing
Evolution of QM
Lets see a brief look at the history of software
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 control mySAP ERP QM: All QM-relevant processes (quality planning, quality inspection, quality certificate, quality notification, quality control, test equipment management, stability study)
Classification System
Audit Management Workflow ArchiveLink SAPoffice
Example: QM documents may be managed with DMS (txn CC04) and/or SAPoffice (txn SBWP)
that is required to plan and execute quality inspections Quality inspection identify whether the inspected units fulfill the predefined quality requirements Quality 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
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 equipment Stability study manage basic data, as well as the planning and execution of stability studies
repetitive, and Process Industry (PP-PI) change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up
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Discrete Manufacturing
These are the normal As soon as a planned
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 orders A 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
order is generated from Materials Requirement Planning (MRP), shop floor takes over the information available and adds the orderrelevant data to it to guarantee complete order processing Production orders are used to control production within a company, and also to control cost accounting
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Repetitive Manufacturing
A component in the SAP Implement repetitive
system for planning and controlling repetitive manufacturing and flow manufacturing It enables the perioddependent and quantitydependent planning of production lines, reduces the work involved in production control, and simplifies backflushing (confirmation, Goods Receipt posting)
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 production Routings tend to be simple and do not vary much
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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
to be used for producing materials in your plant, as well as the resources and ingredients required for production Process Orders copy a process described in a Master Recipe and adjust it to the actual production run Process Management coordinate the communication between PP-PI and the process control during the execution of a process order
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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 Recipe When 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)
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repetitive, and Process Industry (PP-PI) change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up
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Production Chain
Production Planning Order release
Sample calculation
Inspection during production Order confirmation Goods movement
Operations + Recording inspection of scrap characteristics Partial lot Inspection creation points Valuation Measured Batch value and classification defects recording SPC control chart Externally processed operations
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QM During Production
Inspection lot origin = 03 Inspection lot is created at the PP order release At Goods Receipt, material immediately entered into
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into QI-Stock
Only usage-decision may move it to unrestricted-use stock
Control is more strict If material did not pass inspection, it cannot be used Production reporting may be on operation level or on
order level
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repetitive, and Process Industry (PP-PI) change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up
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Quality Inspection
Inspection types Inspection for goods movements Assign inspection type for manufacturing order
(per production order type or process order type) Maintain usage decision for catalog type = 3 Define physical sample type, container, and locations
Important: The meaning of the catalogs 0 to 9 Z and A to O is defined by SAP The other catalogs (P to Z) can be defined by the customer
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Quality Certificates
Certificate profile Maintain form Output determination
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Quality Notifications
Notification types and content Additional 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
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Quality Control
In Materials Management (MM): Vendor evaluation In Logistics Information System (LIS): Quality
Management Information System (QMIS) In QM: Definition and evaluation of original documents
Control 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.
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Stability Study
Define physical sample types Define testing schedule category Notification types Catalogs Inspection 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
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repetitive, and Process Industry (PP-PI) change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up
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processes on a long-term basis as Master Records Quality planning provides the basis for inspection processing To do that, quality planning uses cross-application data, such as:
Material Master
Batch classification
Quality documents Work center Serial numbers
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repetitive, and Process Industry (PP-PI) change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up
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No QM data!
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The transactions: CO60 maintain PI sheet QE51N find inspection lot per material QA11 enter usage decision
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repetitive, and Process Industry (PP-PI) change the ways to integrate QM What are the differences between QM during production and QM at the end of production? Main customizing tasks to integrate QM with PP Master data requirements to integrate QM with PP Demo: Process order with and without QM Wrap-up
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Resources
Product information: www.sap.com/plm Product documentation: http://help.sap.com For customers and partners: http://service.sap.com/qm * Information about courses: www.sap.com/education
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 correct If a more strict control is required, you may consider inspecting the material at the end of production
If the production process is long or divided into many
after QM implementation
Do not sacrifice production on the altar of QM
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Your Turn!