Transcript Allergan Catherine Cawley

Green Belt Project
Gowning 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
•
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•
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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
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
6
Analyze
HACCP
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
8
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
Name
Others
John Gavin
James Fahey
Declan
Kevin Powell
David Crowe
Padraig Gavin
EM Monitors
Zita McHale
Criostoir O Haolain
Sean Conroy
Maintenance
Tony Dolan
Michael Clarke
Brendan Mc Donagh
Ray O’Brien
Wesley Kilcawley
Peter Faulkner
Technologist
Phil Lyons
Hubie MacEvilly
Level of
access
Last date in core
Gowning Qualification
Expiry Date
C1
C1
C1
C1
C1
C2
04/10
05/09
12/09
04/09
02/10
02/10
04/11
05/10
12/10
04/10
02/11
02/11
D,E
D,E
D,E
03/10
04/10
04/10
09/10
10/10
10/10
D
D
D
D
D
D
04/10
04/10
04/10
04/10
04/10
04/10
10/10
10/10
10/10
10/10
10/10
10/10
D+E
D+E
04/10
04/10
10/10
10/10
Gowning Assessment
completed Date
DVD Qualification expiry
date
0710
0710
07/10
07/10
07/10
07/10
01/10
04/10
07/10
07/10
07/10
01/10
01/10
01/10
07/10
07/10
07/10
07/10
07/10
07/10
07/10
07/10
Technician is qualified until qualification expiry date.
Technician is qualified but must complete gowning before qualification expiry date.
Technician is not qualified.
15
Control
PDCA CYCLE
Assesment sheet design is based on
standard work to maintain consistency
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?