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Mike James, MESA International Global Education Committee Chairman
Group Managing Director, ATS International BV firstname.lastname@example.org – mesa.org
• Manufacturing Execution Systems (MES) • Manufacturing Operations Management Systems (MOMS) • Manufacturing Enterprise Systems Association (MESA) • MESA International is a global, non profit making industry organisation for:
– Manufacturers/producers – System Integrators – Software Solution Providers
• MESA shares global best practices
MESA International Global Education Program 2011
Intelligent use of knowledge (use the wheels already invented) 4 Achieve simplified SOA-enabled infrastructure Flexibility 3 Build on the value of previous projects and reuse assets 2 Pick an on-ramp project and start rationalizing 1 Start with disparate systems with complex integration Time .
. .01.04(Future). .02.06 (Proposed) AREA AREA AREA ISA-95 Standard CONTINUOUS PRODUCTION UNIT Copyright © 2011 ISA BATCH PROCESS CELL DISCRETE PRODUCTION LINE ISA-88 Standard 4 MES/MOM Methodology Certificate of Competency (CoC) Program Copyright©2011 MESA . .ISA-95 Scope DISTRIBUTED ENTERPRISE & SUPPLY CHAIN 95.05 SITE 95.03.
0) INVENTORY INVENTORY OPERATIONS OPERATIONS Product MANAGEMENT Product MANAGEMENT Inventory Inventory Control(7.0) MAINTENANCE MAINTENANCE OPERATIONS OPERATIONS MANAGEMENT MANAGEMENT Maintenance Maintenance Management Management (10.0) INVENTORY INVENTORY OPERATIONS OPERATIONS MANAGEMENT MANAGEMENT Procurement Procurement (5.0) (4.0) Material Materialand and Energy Control Energy Control (4.0) Product ProductCost Cost Accounting Accounting (8.0) (9.0) PRODUCTION PRODUCTION OPERATIONS OPERATIONS MANAGEMENT MANAGEMENT Production Production Control Control (3.0) (1.0) (3.0) (6.0) (5.0) Production Production Scheduling Scheduling (2.0) (8.0) QUALITY QUALITY OPERATIONS OPERATIONS MANAGEMENT MANAGEMENT Quality Quality Assurance Assurance (6.0) Control(7.0) (10.0) Marketing Marketing & &Sales Sales MES/MOM Methodology Certificate of Competency (CoC) Program Copyright©2011 MESA Research Research Development Development & &Engineering Engineering 5 .0) Product Product Shipping ShippingAdmin Admin (9.0) (2.ISA-95 Manufacturing Operations Management Order Order Processing Processing (1.
Assurance. Information Information (What to make (What was made Material. Exchanges Today MES/MOM Methodology Certificate of Competency (CoC) Program Copyright©2011 MESA 6 . Equipment.01-2010 Copyright © ISA 2011. Material Segments) (What is available for use) (How to make a product) and what to use) and what was used) Manufacturing Operations and Control Information Area Supervision.00. Most Used Reliability. Operational Management. Production Planning.Levels 3-4 MOM/ERP+ Data Flows: Information Categories Enterprise Information Plant Production Scheduling. etc ANSI/ISA-95. etc Production & Product & Production & Production & Resource Operations Operations Operations Operations Information Capability Definition Schedule Performance (Personnel.
. . Nuts. Freon®. Bases. and grade B aluminum – May be identified as raw.Part 1 Data Object Example: Material Model Material class – Acids. pH factor.. or standard. HCl. intermediate. Cooking Oils. or material strength – Also define the nominal. Material definition – City water. values for material 7 MES/MOM Methodology Certificate of Competency (CoC) Program Copyright©2011 MESA . Screws. Lot T98765 Material class property – Density. or final Material lot / sublot – Lot #123456 – Sublot Barrel 15.
Master and Control are equipment dependent. Well described in ISA-88 Part 1 & 2. 8 MES/MOM Methodology Certificate of Competency (CoC) Program Copyright©2011 MESA . fully described in Part 3.Recipe Hierarchy Enforces Activity Model The necessary set of information uniquely defines the production requirements for a specific product General General Recipe Recipe Site Site Recipe Recipe Master Master Recipe Recipe Control Control Recipe Recipe General and Site recipes are equipment independent. Briefly described in ISA-88 Part 1 & 2.
Good Automated Manufacturing Practices (GAMP) • Developed by the International Society for Pharmaceutical Engineering (ISPE) in 1994 • ISPE is dedicated to educating and advancing pharmaceutical manufacturing professionals and their industry • GAMP is an industry-wide guidance for suppliers to assist in the management and development of computer systems for the life sciences industry. • The result is the Good Automated Manufacturing Practice (GAMP®) Guide for Validation of Automated Systems 9 MES/MOM Methodology Certificate of Competence (CoC) Program Copyright © 2011 MESA .
The latest a Risk Analysis document may be approved is prior to pre-approval of the traditional SLC test plan/documents.Iterative/Prototype GAMP Color Legend Unit/Module/ Integrated System Traditional SLC Risk Analysis Impact Assessment Risk Analysis is conducted as applicable and may be revisited throughout the process. MES/MOM Methodology Certificate of Competence (CoC) Program Copyright © 2011 MESA .
I work in a pharmaceutical plant so why should I care about GAMP or CFR 21? 11 MES/MOM Methodology Certificate of Competence (CoC) Program Copyright © 2011 MESA .
mMDM GAMP & ISA5. 95 Detailed work scheduling Work resource management Work dispatching Work definition management Work data collection Work execution Work tracking Work analysis Management of change layer Operational activity level GAMP & ISA-99 Management of regulatory compliance layer GAMP & CFR 21 Management of security layer mMDM GAMP & SRS. FRS. FRS. FRS. URS. ISA95. URS. DDS Management of documents layer Management of information layer 12 MES/MOM Methodology Certificate of Competence (CoC) Program Copyright © 2011 MESA . DDS DDS Work definitions Work capability Work schedule Work performance GAMP. 88.Have we missed anything? GAMP.
What is the MESA Global Education Program? • More than forty (40) MES/MOM* educational events across 5 continents by mid-2011 – Australia/Asia. North America & South America and Africa • Content created and taught by some of the foremost experts from across the Operations Management landscape • Attendees earn one of 2 MESA Certificates for successfully completing a program – Certificate of Competency (CoC) – Certificate of Awareness (CoA) *MES/MOM = Manufacturing Execution Systems/Manufacturing Operations Management MESA International Global Education Program 2011 13 . Europe.
Programmers. MESA International Global Education Program 2011 14 . high-level program of MES/MOM Business Functions courses geared for executives.Global Education Program – 2 Certificates • MESA Certificate of Competency (CoC) for MES/MOM Methodologies – A 4-day. – The CoA courses are higher level. Architects. comprehensive program of MES/MOM Methodologies courses aimed at Systems Analysts. manufacturing/operations and IT personnel and sales professionals. Project Managers and Consultants. short versions of the CoC program. • MESA Certificate of Awareness (CoA) for MES/MOM Business Awareness – A 2-day.
0 published Jan 2011 by ISA – MESA Guidebooks MESA International Global Education Program 2011 .Global Education Program – Content • Content Development and Coordination between 5 Content Providers who are Primary SME Instructors – 2 from North America – 2 from Europe – 1 from South Africa • Content derived from: – MESA/ISA-95 Working Group White Papers – Book 2.
Overview: Manufacturing Operations Models and Integration Standards (3 hours) 2. MES/MOM Business Case Justification and Return on Investment (ROI) Assessment (4 hours) 6. The Role of MES/MOM Systems in Continuous Improvement and the Collaborative Pull Supply Chain (2 hours) 3. Manufacturing Transformation Strategy: Maturity and Roadmap Modeling (3 hours) 4. MESA International Global Education Program 2011 . MES/MOM Project Management Techniques (4 hours) • The CoC Competency Test must be passed for each course in the program to receive the CoC. Metric Framework for Enterprise Manufacturing Intelligence (EMI): Aligning Financial and Operations Metrics (4 hours) 5. GAMP and Industrial System Development Life Cycle (SDLC) Methods (4 hours) 9. MES/MOM Implementation and Governance: MES/MOM System Requirement Specifications. Request for Proposal and Product Evaluation Method (4 hours) 7.MESA MES/MOM Methodology Certificate of Competency (CoC. MES/MOM Statement of Requirement (SoR). Manufacturing 2. 4 Days) MESA MES/MOM Methodology CoC Program contains comprehensive courses on MES/MOM Methodologies 1.0 Architecture Overview (SOA for Manufacturing) (4 hours) 8.
Strategic Relationships between MES/MOM. Metric Framework for Enterprise Manufacturing Intelligence (EMI): Aligning Financial and Operations Metrics (2 hours) 7. RFP and Product Evaluation Methods (2 hours) 9. The Influence of Management Philosophy on MES/MOM Deployment and Governance (2 hours) 8. The Role of MES/MOM Systems in Continuous Improvement & the Collaborative Pull Supply Chain (1 hour) 6. MESA International Global Education Program 2011 . Justifying Manufacturing Operations System to Business Leaders. Product Lifecycle Management (PLM). Choose the Right Solution: MES/MOM SOW. Supply Chain. 1. Business Case Justification and Return on Investment (ROI) Assessment (3 hours) 5. MES/MOM Project Management Techniques (1 hours) • The CoA AwarenessTest must be passed for each course in the program to receive the CoA. Market Requirement for Adaptive MES/MOM Systems based on Industry Standards (2 hours) 3. 2 Days) MESA MES/MOM Business Value CoA Program consists of high-level courses from CoC Program. Business Process Modeling (BPM) and Automation Initiatives (2 hours) 2.MESA MES/MOM Business Value Certificate of Awareness (CoA. Enterprise Resource Planning (ERP). Manufacturing Transformation Strategy: Maturity and Roadmap Modeling(1 hour) 4.
In-Course Test consisting of 10 questions as the course progresses 2. In-Course Test consisting of 15-20 questions as the course progresses 2.Certificate Testing MESA Certificate of Competency (CoC) • For each course there are 2 parts to the competency test: 1. Post-Course Test consisting of 15-20 questions that are answered within 2 weeks after the course MESA Certificate of Awareness (CoA) • For each course there are 2 parts to the awareness test: 1. Post-Course Test consisting of 10 questions that are answered within 2 weeks after the course MESA International Global Education Program 2011 .
‘Collect.John Southcott. MESA International MESA International Global Education Program 2011 19 . share and publish best practices and guidance to drive greater productivity and the overall profitability of the manufacturing enterprise’.Why launch a Global Education Program? Who will benefit? • Aggressively address the knowledge gap that is the primary barrier to growth of the Operations Management space • Slowing growth inhibits realization of the significant gains available to end users who successfully embrace MES/MOM “Part of MESA’s mission statement is to. What better way to do that than to formally educate our constituents globally?” . Chairman.
james@ats-global. ATS International BV mike.org 20 .MES/MOM Educational Forums to Drive Operations Excellence Globally MOMS Certification Program for R&D Companies Mike James.com – mesa. MESA International Global Education Committee Chairman Group Managing Director.
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