Designing for 5S

 

 

                                              THE PROBLEM STATEMENT

u Multiproduct Expansion Project is introducing a new Purification Suite u Design for 5S in the workplace is required to ensure that all items needed to run operations in the area, can fit in a restricted space and that the work is organised with no waste, the visual work place is created and times for picking parts/tools are minimised. If the project is not implemented the new equipment will not fit into the new area impacting future production plan of record. u There is a need to ensure that Unnecessary Waste (motion, transportation, inventory, waiting) is not added to production system and multiproduct operation u Design for 5S in the area is focusing on the first two elements of Sort and Set in Order.

 

 

	Project Details
Project Description	Design for 5S in New Purification Suite
Problem Statement	The Multi Product project will introduce a new Purification Process area within Drug Substance. Design 5S in the workplace is required to ensure that all items needed to run operations in the area, can fit in a restricted area and that the work is organised with no waste, that the visual work place is created and times for picking parts/tools are min.
Business Case	If the project is not implemented the new equipment will not fit into the new area impacting future production plan of record. Unnecessary Waste (motion, transportation, inventory, and waiting) will be added to the new production process and subsequent multiproduct operations.

Project Goals	Metric	Goal
Design the new Purification Suite in the best way to facilitate multiproduct production	Reduction/Avoidance of number of steps to complete set-up.	50% reduction
Expected Business Results	An Operations area that can manufacture multiple products and is easy to operate in with minimum motion, transport, defect and waiting waste
Expected internal &/or external Customer Benefits	Capability to manufacture multiple products to enable quick product changeover in the future. Rooms ready for demo batches and PV that will pilot the design and subsequently lead to 5S certification

 

u Initial area layout had only major pieces of equipment and walls. The small equipment and consumables locations were not defined.

u Where the initial layout didn’t have the proposed location for the item, the optimum location will be identified using the following tools:

•          Spaghetti maps of the activities

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  3-D Model review

•          Analysis of potential waste in the area

 

•          Location of items in the room defined based on the analysis of potential waste to avoid waste and spaghetti maps used in the proactive sense (to identify best location)

u Following on from review of the Y’s of this project, it was determined that there were multiple X’s for this project to be improved

 

 

#	Potential waste. What could happen if design for 5S was not implemented	Tool	Significant (yes/no)	Comment
X1	Location of consumables to far from  where they are required	TIMWOOD	Y	Consumables located  to far  would create extra motion and crossover operations
X2	High amount of time require to collect all materials required for setup. Eg MBR, Filters	Spaghetti Maps	Y	Motion and transportation waste
X3	Tools and PPE not located where required for use	TIMWOOD	Y	That would create extra motion
X4	Restricted Access and utilising space    - to Base vessel scales    -  to Vent filter on the production vessels     - to the Sample valves     -to the transfer panels	TIMWOOD	Y	Would create extra motion and obstruction
X5	No space and location all in process lab equipment	TIMWOOD	Y	If the equipment was located elsewhere it would require extra movement.
X6	Layout of the Column Pack equipment.	Spaghetti Maps	Y	The layout is creating a lot of movement during difficult operation.
X7	Additional steps when performing the Pressure test of the Valve ring filter housing	TIMWOOD	Y	Motion waste in checking the manual pressure transmitters

 

This is the overview of the potential waste that would be in the area if the Design for 5S project was not implemented. Significant X’s were identified in

 

#	Potential waste. What could happen if design for 5S was not implemented	Improvements identified
X1	Location of consumables to far from  where they are required	Location was determined based on movement analysed with use of spaghetti mapping.  -Where posssible items were located on the wall. -Consumables centralised to allow for one trip and collection of all required consumable onto one trolley
X2	Movements required to collect all materials required  e.g. pbr, filters	- The location of the PBR collection area has been moved to outside the entrance to the Room airlock on the supply side. This reduces the
X3	Tools and PPE not located where required for use	-Tools will be localized.
X4	Design layout for access - to Base vessel scales -  to Vent filter on the production   vessels   - to the Sample valves   -to the transfer panels	-       The original layout was to have the floor scales in front of the Base Vessel, now to save space and allow for ease of access it located in the corner beneath the stairs -       Vent filter was positioned on the vessel to allow ease of access by operators and to reduce the possibility of reaching across hot pipe work. -       Sample valves positioned to allow ease of access and minimise movement around the vessel. -       Mobile steps added for ease of access -       Allocation of space improved by having the transfer panels recessed
X5	Design & locate benches for all in process lab equipment	-The location of the PBR collection area has been moved to outside the entrance to the Room airlock on the supply side
X6	Layout of the Column Pack equipment	-Spaghetti mapping identified that  changes were required to optimise the room space -       It is now possible to perform all column packing operations in one room and therefore multiproduct manufacturing simultaneously. -       MCS terminal added to the room.
X7	Pressure test of Valve ring filter	By introducing an automated pressure test it eliminates the necessity of the operator walking up to the mezzanine to physically check the pressure transmitter.



 

Project Goals	Metric	Goal	Actual Achieved
Reduction in set up steps	% of reduction of steps taken to complete set up	50%	60% reduction steps
632 steps before,    250 steps after
Comment on Goals Achieved / Any Issues: The actualisation of the goals will happen once the project is fully implemented by mid-2015

 

u The room layouts design will be implemented by May 2015

u All tools identified have been ordered and received, will be put in place in June2015

u All Consumables identified and storage location defined – min max stock levels, replenishment process will be implemented by July 2015

u CI loop, auditing process and process confirmation – part of the certification project – to be completed by Aug 2015

u It very beneficial, as the project reduced waste by 60% before the facility was build where the cost of change was low. Majority of implemented changes wouldn't be possible during sustaining operation of the facility.

u Has to follow the timelines of facility design/ construction project

Key Learnings

u Fail to prepare then prepare to fail.

u Problems solved early will prevent high cost resolutions later