Green Belt ProjectGreen Belt ProjectGowning ImprovementsGowning Improvements

Overview

1) Project Background

2) DMAIC Method

3) Summary

4) Questions

Define

Problem Statements:

• Multiple SOPs describe the gowning method

» Duplication of information in each one

» Multiple DCRs (Document Change Request) required to maintain up to date Sops

» DVD also requires to be maintained up to date

• Gowning a Hot Topic for IMB

» Changes made to gown in response to citation

Define

Goal:

To streamline the content of gowning procedures & simplify the training for clean-room personnel

Project Type:

Compliance

Team Members:

F Casey, M McNulty, J Hughes, T McNally, C Cawley,

Measure

• Control of Garbing and cleanroom behaviour is outlined in 5 SOPs, one for general facility garbing and one each for the classified areas within the facility.

• BV9 017, BV9 002, BV1 071, BV6 046 & BV15 013

• DVD is used as a training aid and is based on SOP but not aligned to the detail of the procedures

IMB Citation on the control and training for cleanroom behaviour and gowning.

• DVD was not aligned to SOP

• SOP extremely prescriptive and difficult to follow

• Training is complicated by the number of SOPs for garbing and cleanroom behaviour

6

Analyze

Process Flow Map was generated of the current gowning process

• Each step in process flow was used to perform risk assessment

HACCP (Hazard Analysis Critical Control Point) used to identify the critical control points (CCP) in the process

• Each CCP was identified as the critical to quality step in the process

• Therefore only CCP steps were required to be detailed in SOP, all other detail was removed

Analyze

HACCP

8

Improve

Storyboard used to develop the DVD, each CCP became a step in the storyboard

• This permitted the DVD to be aligned to the SOP

Change Control opened to outline all proposed process improvement / enhancements

IMPROVE

STORYBOARD

Improve

Standard Work Template replaced lengthy process flow diagram in the SOP• Only CCP steps were described• Five SOPs were amalgamated into one which included the standard work

template

DVD prepared and aligned to new SOP by using only CCPs and storyboard for content

Training process was simplified using standard work template and centralising all cleanroom behaviour training into one SOP

Improve

STANDARD WORK TEMPLATE

Improve

Kanban System implemented to control gowns in the changing room

•Restock level indicated ensures correct sizes available

Improve

Poke Yoke implemented to provide instruction at point of use•Instruction in red line on blue shoe cover•Permitted # personnel labelled on doors•Automated towel dispensers installed

Control

Andon System implemented on training program for cleanroom personnel SOP & DVD

• Current listing was colour coded to restrict access to cleanroom until completion of training on new DVD and SOP

Communication Plan was employed as part of the training program to create buy-in, understand problems, identify better solutions for future proofing.

• This served to identify 47 additional process improvement opportunities in cleanroom garbing and cleanroom behaviour

PDCA Cycle implemented by performing gowning assessments on frequent basis using a defined assessment checklist as a measure of adherence

Control

15

Name Level of access

Last date in core Gowning Qualification Expiry Date

Gowning Assessment completed Date

DVD Qualification expiry date

Others John Gavin C1 04/10 04/11 0710

James Fahey C1 05/09 05/10 0710

Declan C1 12/09 12/10 07/10

Kevin Powell C1 04/09 04/10 07/10

David Crowe C1 02/10 02/11 07/10

Padraig Gavin C2 02/10 02/11 07/10

EM Monitors Zita McHale D,E 03/10 09/10 01/10 07/10Criostoir O Haolain D,E 04/10 10/10 07/10Sean Conroy D,E 04/10 10/10 04/10 07/10Maintenance Tony Dolan D 04/10 10/10 07/10Michael Clarke D 04/10 10/10 07/10Brendan Mc Donagh D 04/10 10/10 07/10Ray O’Brien D 04/10 10/10 01/10 07/10Wesley Kilcawley D 04/10 10/10 01/10 07/10Peter Faulkner D 04/10 10/10 01/10 07/10Technologist Phil Lyons D+E 04/10 10/10 07/10Hubie MacEvilly D+E 04/10 10/10 07/10

Technician is qualified until qualification expiry date.

Technician is qualified but must complete gowning before qualification expiry date.

Technician is not qualified.

Control

Assesment sheet design is based on standard work to maintain consistency

PDCA CYCLE

Summary

Changes Implemented

• 5 SOPs down to 1 SOP

• DVD aligned to SOP

• Standard Work Template implemented

• Training completed on changes

• Gown improvements identified – Communication Plan

• Kanban system – gown stock levels

• Poke Yoke – labelling at point of use

• Standard Assessment procedure developed

Gowning Improvements

Any Questions?