Green Belt Project Gowning Improvements

1. Green Belt Project Gowning Improvements

2. Overview • Project Background • DMAIC Method • Summary • Questions

3. 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

4. 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,

5. 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 6

7. 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 8

9. IMPROVE STORYBOARD

10. 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

11. Improve STANDARD WORK TEMPLATE

12. Kanban System implemented to control gowns in the changing room Restock level indicated ensures correct sizes available Improve

13. 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 Improve

14. 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

15. Control Technician is qualified until qualification expiry date. Technicianis qualified but must complete gowning before qualification expiry date. Technician is not qualified.

16. Assesment sheet design is based on standard work to maintain consistency Control PDCA CYCLE

17. 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

18. Gowning Improvements Any Questions?