Implementation Best Practices

Transcription

1 QM Functionality in SAP ERP: Implementation Best Practices Mike Krug October 6,

2 Agenda Introduction to QMS and Our Team SAP Software: Quality Overview Implementation Best Practices Demo The QMS Lab Further Benefits Thank You and Q&A

3 About QMS About QMS Quality Management Solutions Inc (QMS) is an solutions provider specializing in the quality management (QM) functionality of the SAP ERP application We understand the role of Quality in an organization, and the way it impacts the organization end to end QMS s knowledge base includes a deep understanding of the functional and technical side of the QM functionality, with the Principals having over 28 years experience and Team members averaging 10 plus years experience coupled with business and process knowledge QMS maintains strategic networks that include liaisons with SAP America and SAP AG, as well as partnerships with other Niche solution providers

4 About QMS New QM Implementations From basic to complex Small or large We have you covered Replacing LIMS Systems One of our specialty areas; We can help you retire your LIMS system using QM functionality from SAP Calibration Leverage the integration of SAP software with Plant Maintenance to handle your calibration schedules and calibration results history Notifications Solutions Using a legacy application for capturing customer / vendor complaints? Replace it with notification system software that offers flexibility to identify, track, resolve, and report on problems that effect your business

5 About QMS Sample COA Integration & Best Practices Being a touch point with your customer, the COA is critical to your business and we can help you to implement it right the first time Implementing the Bells and Whistles of QM Not using all that SAP software has to offer? Let us show you how to use SPC Charting or Instrument Integration to maximize your quality application Evaluating existing implementations Most QM implementations were part of a core implementation. Have us help you identify and fix improvement areas in your existing solution And more

6 Why Implement Quality Management? Sample Drivers for Implementing QM Functionality Re-calls / Returns of failed product Difficulty in calculating Quality metrics (KPI) Meet regulatory requirements (i.e. FDA) Officers/Directors can be liable Improve traceability of products Integrate Quality into ERP software solutions Save on separate licensing/support costs, retire legacy systems Eliminate paper forms, spreadsheets, local syst. Standardize and automate QM Process across Plants & Divisions Better Quality Metrics If you can t measure it, you can t manage it

7 Quality Management with SAP Software Facts & Figures Value Proposition QM is integral part of the SAP ERP application and seamlessly integrated into supply chain processes and the SAP Manufacturing solution QM is a cross-application topic supporting multiple end-to-end processes QM offers comprehensive functionality, flexible and easy to adapt Customer Adoption More than 5,600 customers globally across all industries / > 500,000 users (Manufacturing industries process/discrete = 50:50) Key drivers Compliance for processes and products supporting industry standards and legal requirements Operational efficiency (integrated QM, Lean & Six Sigma, Corrective & Preventive Actions) Interoperability (SOA, partner collaboration) Quality Management with SAP ERP can be used as enterprise-wide Laboratory Information and Management System (LIMS) or as a Computer Aided Quality (CAQ) System across all industries QMS - Quality Management Solutions, QM Experts. All Rights Reserved

8 Quality Management with SAP ERP 4 Main Pillars Audit Management Quality Engineering Quality Assurance & Control Quality Improvement Supplier audits Product audits Process audits System audits Environmental audits Assessments/ Revisions Specifications Sampling plans Document management Stability studies Failure mode & Effects Analysis Control Plan Sample & Batch Management Quality Control Statistical Process control Problem handling Certificates Corrective & Preventive Actions (CAPA) Complaint management Quality analysis SAP ERP QMS - Quality Management Solutions, QM Experts. All Rights Reserved

9 Implementation Best Practices

10 Leverage Integration Lab 1 Lab 3 Lab 2 Horizontal Integration QM functions in all processes of the supply chain: Product Development, Procurement, Production, Sales Vertical Integration Technical Integration QM data in all hierarchy levels: Single values, statistical mean values, summarized statistics, QM information system No interfaces to other core functionalities of SAP ERP : Controlling, Purchasing, Materials Management, Production, Sales & Distribution, Consistent data, real-time processing Enterprise LIMS SAP ERP QMS - Quality Management Solutions, QM Experts. All Rights Reserved

11 Leverage Integration Document Management Allow Procedures to be accessed during results entry Incorporate into Nonconformance Management Easy Document Management Simplified User Interface Use Content Repository to store all Quality Documents

12 Reduce Overall Testing Lot Copy/Inheritance Pull Results forward based on parent/child relationship Automatic or Manual Dynamic Modification Skip Lot Processing Increase or Decrease testing based on history Skip at Lot Level or Characteristic Level

13 Reduce Overall Errors Sample Labels Speed of Data Entry Reduced Errors Streamlined Process Flow

14 Reduce Overall Errors Test Equipment Integration PCo (SAP Plant Connectivity) QM-IDI Interface Enterprise Service (SOA) Simple Data Transfer Connectivity Framework for external devices (PCo) Data Agents Complementary Partner Product (no full-blown LIMS, e.g. IDOS, Dr. Eilebrecht SSE *) Direct integration, e.g. with CDS ES Bundles Integration of QM Systems (IQM) and Easy Inspection Planning (EIP) Flexible Web Services RS232 serial interface File transfer Interface Boxes (e.g. Steinwald) Keyboard Wedges Steinwald interface box; Simple Test Equipments Complex Test Equipment (e.g. HPLC) QM Data Exchange with consumer applications (e.g. SAP MII, 3rd party systems) Simple Test Equipments (e.g. balances, colorimeter etc. QMS - Quality Management Solutions, QM Experts. All Rights Reserved

15 Reduce Overall Errors Transfer of Measured Values Using Keyboard Wedge Manually triggered by the inspector (switch on measuring equipment) Data is transferred to QM results recording in the form of electronic signals via the hardware (keyboard wedge) No additional programming required Technique replaces manual entry Example: Caliper gauge, barcode reader

16 Reduce Overall Errors Transfer of Measured Values Using Serial/Network Interface Can be triggered manually or automatically using the program Data is transferred to QM results recording via a serial interface (V24) in the form of electronic signals (one channel) Programming: Driver software is required Example: Electronic scales

17 Increase Usability Portals Quality Inspector Portal Role Web Dynpro for ABAP Internet Explorer or SAP GUI

18 Increase Usability SAP Manufacturing Integration and Intelligence (SAP MII) Results Entry SPC Charting Capability SAP MII Drilldown Capability

19 Increase Usability SAP MII Pareto Charts Multiple Data Sources QMS - Quality Management Solutions, QM Experts. All Rights Reserved

20 Increase Usability QM Cockpit for Evaluations Ad-hoc evaluations of quality notifications and results Specific graphics types: Pareto Chart Scatter Plot Control Chart Queries & figures via SAP NetWeaver BW Analyze data from Notifications / Tasks Audits inspection lots Predefined queries Supplier evaluation Quality of purchased parts Quality Scores Audit Results QMS - Quality Management Solutions, QM Experts. All Rights Reserved

21 Lower Cost of Poor Quality QMS - Quality Management Solutions, QM Experts. All Rights Reserved

22 Lower Cost of Poor Quality Problem and Complaint Management Corrective and Preventive Action Quality Analytics Workflow Classification Quality-related costs Follow-up actions with standard examples Solution Database Web-based entry via SAP MII Status Management Tracking and Monitoring Use of Catalogs QM Evaluation cockpit for ad-hoc reporting Predefined queries and key figures in SAP NetWeaver BW Supplier evaluation Full-text search QMS - Quality Management Solutions, QM Experts. All Rights Reserved

23 Demo

24 Further Benefits of Quality Management Supporting Processes with LIMS functions and more Ad Hoc Reporting Audit Management Batch Management Barcode / Labeling Calibration Management Certificates of Analysis Complaint / Problem / Event Management Corrective and Preventive Action (CAPA) Digital Signature / GMP Document Management Engineering Change Management Goods Receipt Inspection In-Process Control / Post-Process Control Inspection Methods Interfaces (QM-IDI, QM-STI) Inventory Management Invoicing/Billing Non-conformance Reporting Quality Data Interchange Quality Disposition Recurring Inspection Sample Management Specification Management / Multiple Specs. Stability Management Statistical Process Control (SPC) Test Equipment Interfacing Vendor Evaluation Workflow QMS - Quality Management Solutions, QM Experts. All Rights Reserved

25 THANK YOU Quality Management Solutions 146 Lowell Street, Suite 300B Wakefield, MA (800)