Automated MES and DCS Excursion Management Collection System for Real-

Time Excursion Resolution Stephen Britton

New England Controls Senior Business Intelligence Engineer

Booth 3453

• Excursions become the dreaded “D” word

• Lot release delays

• Investigations are costly

• Proceeding at risk – No knowledge of immediate impact

What is the impact of an Excursion?

Current Excursion Detection Practices

Details from systems are read and written – Might have more details than needed – Might be missing the important details

Current Resolution Practices

Supervisor Manufacturing Review Hours or Days later

Quality Review

Days or Weeks Later

Review by Exception

Real-Time Collection and Resolution • Electronic collection of Excursion at the time

of the occurrence

• Quality is represented on floor to witness

• Manufacturing and Quality to Review and Resolve the Excursion at soonest convenience – Initial Impact Assessment – Correct Classification

Excursion Management Architecture

MES Database

DCS DatabaseExcursion Management Web Server

Client Machine

Read and Update Excursions

Process Violation

DCS Alarm Triggered

Anatomy of an Excursion

Anatomy of an Excursion

Excursion Resolution Process Severity / Criticality

– Manufacturing Assigned – QA Assigned

Severity Initial Manu MS QA

0 X X O X

1 X X O N/A

2 X X X N/A

3 X X O X

Owner Severity

Unknown 0

Manu 1

MS 2

QA 3

Initial review

– Operator Context

Initial Review

Performed at nearest convenience

Explains circumstances that

system may not know

Manufacturing Review • Performed by Supervisor or Senior

Associate

• Real-Time equivalent to post batch Manufacturing Review

Quality Review: MS Input

Request input by another group

Quality Review: Create CAPA

Send issue to CAPA System

Quality Review

Real-Time equivalent to post batch Record Review

Types of Automated Excursions EBR Excursions

– Process Based – Free form

DCS Automation Excursions – Alarms – Process Based

Excursions from MES

• Process Violation – Proceeding with Risk – Known Severity

• Workflow violation

• Free form comments

MATERIAL_SCAN:1

Is scanned Container Valid? NO

FAIL_MESSAGE:1

Proceed at Risk?

YES

YES

START

END

Scanned material barcode Lot Code does not match expected Lot.

EBR Excursion Collection

Collect All Details – Batch / Order – Operator Comment – Step / Operational Context – Text from Step – Severity

Excursions from Automation

• Excursion Monitoring Module

• Process Violation

• Recipe Changes – Manual Parameter Changes – Step Changes

And….

Alarms

Excursions from Automation: Alarms

Relevant Alarms only – Activated when Unit is in use

Acronym Process Impact Deviation?

N-KCP Unlikely No

KCP Probably Yes

CCP Yes Yes

Non-Key Controlled Parameter Key Controlled Parameter

Critical Controlled Parameter

DCS Excursion Collection

Dynamic Key Value Pairs

Automated Excursion Creation 1) Interface periodic check for new items

2) New Excursions sent to message processing queue

3) Interface Code Processes Queued Messages

4) Requests sent to Web API

Benefits of Excursion Management

• Quicker Lot Release

• Quality Information at time of Deviation

• Real-Time Release by Exception

Questions?

Be sure to stop by and say hello!

Booth 3453