Preventing Errors with a Mobile MES - Honeywell … · – Equipment Management: Correct equipment, correct status.. ... Risk Reliability Efficiency Honeywell’s Mission Reduce project

JORNADA TECNICAMES* EN INDUSTRIA FARMACEUTICA 14/05/2010

*MANUFACTURING ENTERPRISE SYSTEMS AADECA ISPE

Preventing Errors with a Mobile MESPreventing Errors with a Mobile MES

DISERTANTE: Daniel Marin EMPRESA: Honeywell

Agenda

• Manufacturing Challenges - MES Benefits

• MES Systems Purpose and Functionality– Integration to other systems– Material Control– Equipment Control

• New technological advances in MES– Web Based– Mobile Apps– Virtualization

• Specification Standard S88


Pharmaceutical Manufacturing

• Processes in Pharma typically involve people

ProcessInput Output

Human factor

• Human factors are unavoidable and when they cause errors it translate to:– Wasted time– Poor quality– Higher cost


What can we do?

Root Cause: Human errorCAPA (Corrective and Prevention Action): Re-train

“The problem is seldom the fault of an individual; it is the fault of the system. Change the people without changing the system and the problems continue.”

Don Norman

Prevention: Poka-Yoke: Fail-safing, mistake proofing…MES


Pharma Examples

• Pharma manufacturing is a combination of automated and manual procedures– Automated processes are usually handled by Automation

Systems with limits, alarms, etc….– Manual procedures is where MES plays a key role

• Regulatory Agencies have required fail-safe procedures for a long time (e.g. double signatures)

• MES Systems enforce that the procedures are followed and provides mistake proofing by:– Sequential electronic work instructions step-by-step– Material Management: Correct material, correct quantity…– Equipment Management: Correct equipment, correct status..


Manufacturing Challenges

Costs of GMP ComplianceMaintaining Paper RecordsOperator Errors and

OmissionsReview of Records Investigating Exceptions

Production EfficiencyMaximizing Equipment UsageMaintenance and CleaningReworkOperator Training

InventoryRaw Materials – Stock Levels, WasteWIP TrackingHolds on Finished GoodsAccurate Inventory & Quality Tracking

Manufacturing FlexibilityNew ProductsExpansionCustomer Demand


Manufacturing Errors are Costly

Costs of Compliance are High

Production Efficiencynot Optimal

• Enforce Best Practices • Reduction and Avoidance of Manufacturing

Errors

• Right Information - Right Time • Drive Production• Integrated Systems

• Reduced Paperwork• Release by Exception• Electronic Compliance Records

Issues Why MES?


What is MES?

A Manufacturing Execution System (MES) is a system that companies can use to measure and control critical production activities. Some of the benefits with regards to MES solutions are increased traceability, productivity, and quality. Other functions served by MES solutions may include equipmenttracking, product genealogy, labor tracking, inventory management, costing, electronic signature capture, defect and resolution monitoring, Key Performance Indicator monitoring and alarming, Executive Dashboards and other various reporting solutions.


traceability, productivity, and quality. equipmenttracking, product genealogy, labor tracking, inventory management, costing, electronic signature capture, defect and resolution monitoring, Key Performance Indicator monitoring and alarming, Executive Dashboards and other various reporting solutions.

Manufacturing Execution System (MES)

ReportReport

Completed Completed Batch RecordBatch Record

MaterialsMaterials

EquipmentEquipment

PeoplePeople

ExecuteExecute

SpecifySpecify

Master Batch RecordMaster Batch Record


Process Integration

SPECS

Execution

MES Functionality

Business Integration

Materials Procedures Equipment

REPORTS


Planning and Supply Chain( ERP)

Order, material consumed, produced

Device

Work Order Management

Material Management

Batch Record / Genealogy Records

Automated

Quality Management

Equipment Management

Batch Procedure

Manual

Process Historian

Instruments, Pumps, Valves Scales, Bar Code, Handheld

EnterpriseRecipe andSpecifications

S88

SchedulingLab System (LIMS)

CAPA/DMSSamples, Assay Data

Training

TrainingRecords

Activity Schedule

QC &Support Data

Device

Fieldbus Serial / Wireless

InteroperableAutomation

Honeywell Application Architecture

External Systems

Automated Unit Unit Procedure

Automated Operation Operation

Phase Phase Phase Instruction

Batch Analysis


Integrated Manufacturing Control

• Combining manufacturing process control and procedural control

Experion PKSDCS

Other DCS PLC

Control System Interface

Scale Instrument

POMSnetProcedure

Direct Connect Device

ERPMaster Recipe

DocumentManagement

LIMS

Data Historian

Other


Interfaced Data

ERP

Inventory Management

Purchasing Management

Planned OrderProduct

Data Mgmt

DistributionMgmt

Resource andCapacity Planning

Receiving

Material andQuality DataManagement

Order/BatchManagement

Recipe

Mat Receiving

DispensingBatch Execution

Mat Management Production Recipe

21 34

5

67

3

4

5

6 9

Item/Material Master Material IssueReport Waste Adjust for SampleAdjust ContainerLot StatusLocation Change

PO DownloadVendor List

Production/Batch Order

Production/Batch StatusMaterial Receipt

AssetMgmt

7

Equipment Status

Recipe / BOM / Routing

Ship Approval /Execution

Report ProductionReport Consumption

Shipping

Shipping

Sales Order Mgmt

8 9

8 Ship Request

ManufacturingProcurement Demand Management

1

2


Do It Right EVERY TIME!

• Integrated Recipes for Manual processes

• Rich Operator Instruction Capability– Enforcement– Verification

• Point-of-Use Verification – Material Management– Equipment Management

• Online SOP’s• Online MSDS


Materials and Quality Control

• Receiving to FG Warehouse Including Intermediates

• Enforce Correct Material Use- Barcoding & Point of Use Verification

• Raw Material Quality, Expiration and Retest• Lot Level and Container Level Inventory• Full Forward and Backward Genealogy• Easily Customized Material Dispensing• Material Reconciliation• LIMS Data (assays, hardness, …)• Standard Transactions for ERP

Receiving ProductionWarehouse Staging Shipping


Equipment Control

• Enforces Correct Equipment– Recipe Requirements– Cleaning– Calibration

• Routings and Connections• Line Clearance• Configurable Status types• Electronic Logs• Status Expiration

– Cleaning and Calibration Expiration

– Use Horizon


Standard Product - Phase Library / Building Blocks

EquipmentEquipment

MaterialMaterial PersonnelPersonnel


Reporting: Electronic Batch Record• EBR

– Release By Exception– Material Consumption– Material Production– Equipment Usage– Operator Actions, Calculations, Comments, E-Signatures– Automated equipment parameters -Temperatures, Weights, pH and Alarms


Why do we need an EBR?

• Reduce batch review and release time– Typical results show 20 – 30% reduction– Release by Exception

• Reduce Errors than need to be Investigated– “Paper on Glass” or “MES”?– 40% of common GMP errors are removed if the EBR

does point of use verification

• Make the EBR electronically available to all stakeholders simultaneously and in real time

• Enhanced Regulatory Compliance


Web Based Benefits

Zero Foot Print Client• Reduced Qualification/Validation

• Reduced Maintenance – no application maintenance

• Increased Accessibility via Intranet/VPN

• No Local Data stored on Client


FastIr

on-II

FO

UN

DR

YN

ET

WO

RK

S

Web Browser (No Code)

Web Browser (No Code)

Wireless

• Mobile System Access and Control• Simplified Installation• Flexible Use, Configuration and Maintenance


Virtualization

Platform Virtualization The decoupling of the Operating System from the underlying hardware upon

which it resides.

• Hardware independence

• Hardware consolidation – fewer servers

• Improved manageability, availability and disaster recovery

FastIro

n-II

FO

UN

DR

YN

ETW

OR

KS


Virtualization

Application VirtualizationThe decoupling of an application from the underlying operating system.

• Application isolation

• Improved compatibility

• Reduced upgrade and installation times

Overall Benefits• Reduce Hardware and OS Change impact

• Improve Resource Utilization (combine apps on common hardware)

• Reduced Energy Costs


POMSnet Specification – S88 Standard

– Product RecipeDefines All Processes, Material- and Resource-Requirements for an End-Product

– RecipeDefines the Process, Materials and Resources to Make a Batch of Intermediate- or End-Product

– Unit ProcedureA Re-usable Strategy for Carrying Out a Contiguous Process Within a Production Unit.

– OperationAn Independent Group of Processing Activities

– PhaseSmallest Reusable Process Activity

Can C

onsist Of

Can C

onsist Of

Can be U

sed By

Can be U

sed By


Bulk Tablets Pack

Setup Mix CIP

Record start time

….. Record end time

e-sign

…..

Dispense Blend GranulateUnit Procedures

Operations

Phases

POMSnet Specification – S88 Standard

MES Executive Summary

• MES systems improve your processes by:• Reducing errors• Reducing Waste• Saving time

• MES systems enable Plant Performance Goals

• Simplified IT infrastructure through Wireless Technology and Virtualization

• Flexibility: Mobile Application


EfficiencyReliabilityRisk

Honeywell’s Mission

Reduce project risk

Improve compliance position

Reliability solutionsto improve your

production profile

Integrated solutions for faster decision making

and reduced production costs

Improving Your Business Performance


Questions?

Thank you!

Daniel Marin

[email protected]


Documents

Preventing Errors with a Mobile MES - Honeywell … · – Equipment Management: Correct equipment, correct status.. ... Risk Reliability Efficiency Honeywell’s Mission Reduce project