MES systems
- 1. Manufacturing Execution Systems in the GxP Environment B Curry
- 2. • Introduction • MES Definition - What is MES? - Why MES? • MES System Types • GxP Design Life Cycle - Validation of MES & Data Integrity • Implementation of MES in GxP Environments - New Manufacturing Processes - Existing Manufacturing Processes • MES in Regulatory Audits • Q & A Manufacturing Execution Systems Agenda
- 3. Manufacturing Execution Systems What is MES? MES – Manufacturing Execution System MES - a software based system that drives and monitors the manufacturing of a production batch, streamlines batch review, and maintains an electronic record of the batch and associated quality information in a validated and compliant environment The output of an MES system is an Electronic Batch Record Paper Batch Record Electronic Batch Record
- 4. Paper Batch Records Execution and Data Collection Batch Record Review Batch Report Secure Storage Regulatory Audit Batch record Review Batch Report Secure Storage Regulatory Audit Execution and Data Collection Electronic Batch Records Manufacturing Execution Systems MES – What is it?
- 5. Level 4 • ERP • Supply Chain Level 3 • Manufacturing Execution Systems Level 2 • SCADA/Historian • PLC/DCS/ Automation Process Control Level 1 • Equipment • Instrumentation Manufacturing Execution Systems MES ISA 95 Model
- 6. Manufacturing Execution Systems MES - Data Flow ERP (SAP) System MES System Process Control System and Equipment Production Order Operator Instructions Production Batch Info Production Data Operator Input Order Release Set Up Manufacture / Process Production Review Quality Review Release to ERP Demand In Equipment Management Cleaning Management Environmental Monitoring Electronic Log Books Deviations / Atypicals Electronic Batch Record Product Delivery
- 7. Why MES? 1. Enforced Workflows – Ops can only to the right thing 2. Quality Review by Exception 3. Reduced effort and improved performance in Batch Review 4. Reduction of paper usage – resulting in elimination of documentation errors – reduced non RFT 5. Improved quality of product into the supply chain 6. Improved Batch reporting – retrieval of Data 7. Makes investigations and product recalls ( )easier 8. Increased Data Integrity - ALCOA Manufacturing Execution Systems What is MES?
- 8. Manufacturing Execution Systems Data Integrity - ALCOA ALCOA 1.Attributable - Data can be attributed to who, what when and why 2.Legible – can the data be read? 3.Contemporaneous – is the data recorded at the time of the activity was performed 4.Original - is the data recorded from an original observation, source or certified copy 5.Accurate – is the information complete, consistent and accurate FDA - Data Integrity and Compliance With CGMP Guidance for Industry – April 2016
- 9. Manufacturing Execution Systems Data Integrity – FDA Warning Letters 2008 - 2017 Source: FDA • Failure to record data contemporaneously • Back-dating of in-process checks • Use of unapproved forms • Data transcription errors • Missing information • Overwritten data entries • Falsified Records • Log books incorrectly completed and reviewed • Incomplete records The message here is clear – the regulatory authorities are gaining more experience in this area and audits are increasing their focus on Data Integrity
- 10. Manufacturing Execution Systems Types of MES Systems Type Meaning Benefits Challenges Fully Integrated All decisions, workflows, actions, Critical Params, Recipes Controlled in MES Removes practically all DI and Quality risks associated with systems Installations can be complex, lengthy and expensive Paper on Glass A Direct electronic representation of the Paper Batch Record Eliminates paper errors, implementation is fast Users can become data entry “clerks” Limited Functionality One element of business is electronic – Logbooks or Weigh and Dispense Removes many risks, quick to implement Heavy reliance on paper records and user data entry Note: there is no “perfect system” – it is unique to each plant, application, product and supply chain – it must work for your business.
- 11. Manufacturing Execution Systems GxP Software Design Life Cycle Specify URS Design Build Test Qualify Operate Conventional Approach - Waterfall Advantages Challenges • Dependable and Robust • Well proven and Documented • Widely used in Industry • Understood and Accepted • Rigid and inflexible • Closes off design too early in the process • Expensive and Time Consuming • Normally results in numerous updates to URS Design Review All Design Documents Complete All User Requirements Fully Defined and Approved Under Change Control
- 12. Manufacturing Execution Systems Emerging Approach – “Agile” Advantages Challenges • More Flexible than conventional approach • User requirements are built with the design • Dry run testing demonstrates system operation • Docs are still approved in the correct sequence for GxP Compliance • Road test the solution multiple times • Low rates of test failure / deviations • Takes more hands on management • Needs daily meetings • Team needs to be able to change priority/tasks regularly Specification URS Draft Design Dev Build Dry Run Testing Prototyping User Requirements Complete All Design Documents Complete System Build Test Qualify Operate Under Change Control
- 13. Manufacturing Execution Systems Types of MES Implementation Type Benefits Challenges System Implementation on New Process • No bad habits, design best solution from scratch • No business change to manage • Process is being developed at the same time • Business requirements are not fully known • Other project factors will impact system implementation System Implementation on an Existing Process • Process is running • Business requirements are clear • Old habits die hard – cultural change to manage • Significant business change element • Impact on existing production Note: The journey from Paper to Electronic records is the biggest challenge regardless of the project type.
- 14. Audits (but you should be doing this anyway !!!) Anyone likely to be questioned by an inspector or anyone who uses the system needs to understand: • What – what is the system? What you have and what does it do? • Why – what are the benefits of the system? Why use MES? • How – how do we use the system? – SOPs / Batch Review • The clear distinction between the system, batch record, the batch report and the batch review process Ensure SMEs, Leads have access to and are familiar with the Validation Plan, Validation Summary Report / System Release Criteria, Data Integrity Management Plan or equivalent Manufacturing Execution Systems MES in Audits
- 15. Audits (but you should be doing this anyway !!!) Ensure that user access and training for users is in Control. Ensure quick and easy access to view a batch record. Consider here if there are deviations (or atypicals) and be prepared to answer on how they were managed – SOPs/Policies In preparation for the audit – what 3 questions would you not like to be asked?? If you find a problem/issue during the audit – be transparent. Demonstrate to the inspector what procedures you have in place to manage an issue and follow those procedures Manufacturing Execution Systems MES in Audits
- 17. Manufacturing Execution Systems Thank You barry@systeme.ie @projectsdoctor Ph: 059 9105092 systeme.ie