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Driving Quality Improvement with anOperations-Focused Quality Management System

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What is

Manufacturing

Quality

Management

?

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Documents and Procedures

Execution and Interaction

Quality Policy

Quality Objectives

Quality Manual

Organizational Structure

Change Management

Resource Tracking

Training and Qualification Records

Supplier Audits

Document Control

Engineering Change Control

Process Validation

Internal Audits

Data Management

Processes and Procedure Adherence

Traceability

Process Connectivity

Raw Material Quality

Reject Rates

Statistical Process Control (SPC)

Hazard Analysis and Critical Control Points (HACCP)

Continuous Improvement

Reporting and Analysis

Maintenance

Sustainability

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Quality Management Execution Requirements

Understand the state of the process

Connect to process automation and measuring devices for

data collection

Integrate with existing business systems for electronic data

exchange (ERP, PLM, EQMS, etc.)

Display data, analysis and warnings within plant

floor interfaces

Collect manual data about responses and corrective actions to

“close the loop”

Processes

People

Systems

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Manufacturing Operations Management(The Solution)

Manufacturing Operations Management (MOM) software provides end-to-end visibility of manufacturing processes with tools to manage their operation and execution in real-time

• Process modeling• Data acquisition• Interactive involvement• Real-time and historical information

ERPEnterprise Resource Planning

Mfg ProcessesPeople, Material, Equipment

MOMManufacturing Operations Management

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MOM and Continuous Improvement

How does this fit within my Continuous Improvement or Operational Excellence Program?

MOM solutions should not only fit with current operations and processes, but work within the framework of any continuous improvement methodology

DEFINE

Configuration and Modeling

MEASURE

Data Acquisition(Manual, Auto)

ANALYZE

Reports and Dashboards

IMPROVE

Preemptive Alarms and Notifications

CONTROL

Workflow and Task Management

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MOM and Quality Management

Let’s examine how the various

features and capabilities of MOM

solution platforms are used to

implement operations-focused

quality management systems

Quality Management System

ANDON Displays

Quality Forms

Defect Tracking

SPCStops & EventsAlarms &

Warnings

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20

40

60

80

100

120

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10121416

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UCL

5ConsecAboveMean

InvalidLabor

LabelerJam

Quality Events

Acquire and MeasureSolutions Examples

Capture and manage critical quality-related events

• Machine statuses when defects occur

• Unacceptable process variability

• Unfulfilled resource requirements(personnel and qualifications)

• High rate of defects and scrap

• Necessary for root cause analysis

MEASURE

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Analysis and TrendsSolution Examples

Identify root causes for defects, rejects, and scrap

• Where did it originate from?

• Was the process under control?

• SPC sample data and decision rules

• Who was operating the process?

• What other factors are being tracked?

• Product/SKU, material lots, suppliers, etc.

Defects

SPC

Labor

Equipment

Materials

ANALYZE

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Engage and ImproveSolution Examples

IMPROVEInvolve and engage personnel in quality initiatives

• Data available from existing plant-floor interfaces

and computers

• Contextualized for operators, supervisors, and other operations

personnel

• Real-time monitoring, alarming, and visualization of the process

from a quality perspective

• Allows for proactive, preemptive actions to be taken!

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Manage and ControlSolution Examples

CONTROLDevelop and enforce standard operating procedures and workflows

• Quality checks, HACCP, CAPA activities

• Task management and escalation

• Quick access to digital SOPs and instructions

• Enforcement of personnel qualifications

• Retrieve labor data from external administrative QMS

• Deviation alarms, responses, and reporting

• CLOSE THE LOOP!

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Operating Procedures and WorkflowsSolution Examples

CONTROL

MOM adds HACCP Check to work queue

Complete on-time?

Exceptions?MOM adds Exception Check to work queue

Close the Loop!

Escalate

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Operational VisibilitySolution Examples

VIEWImprove accessibility to quality records and reports

• Web-based visibility and report delivery

• Digital access with search criteria to necessary analytics and manufacturing intelligence

• Contextualize with data from operations

• Complete Electronic Production Reports (EPRs)

• Direct access to traceability/genealogy data from quality records

• Include data from other systems not available to operations

Lot Batch Product Delivery

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Adoption Strategies and Best Practices

• Define a project/solution scope

• Start with a pilot implementation

• Proceed with a phased rollout to solve specific problems

• Consider “single-application” solutions versus a collection of

independent modules

• Select solution platforms that adapt to your operations

• Work with MOM-experienced integrators

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Summary

MOMOperational

QualityManagement

ConnectSystems

Plant FloorVisibility

MessageAnd

Alarm

CloseThe

Loop

ManageWorkflow

DataAcquisition

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