15th April

Control Phase - Implement the solution and control plan:

The Control stage began in early April. In the initial stage of the project we noted the following:

Observation – High level of kinks observed in the Generic area with a negative trend in November.

Initial Action – Measles chart put online to establish where kinks were occurring on the catheter. (Laser marking and Coat Prep)

Outcome – Issues observed as follows:

- Charts were being removed/not filled in across all shifts.

- Insufficient information obtained.

Action taken by the Team to combat this:

Updated measles charts were introduced to include stations.

Define Location of Kink on Catheter

Station	Signature/Date	Kinks noticed pre station (Qty)	Kinks noticed post station (Qty)	Hub	Proximal	Mid	Distal
Reflow
Moulding
Print hubs
Coat prep
Coating
Tip form 1
Tip form 2
Tip form 3
Pre-shape

Outcome – Issues observed as follows

Charts were filled in regardless if kinks were noticed or not.

Immediate impact as kinks significantly reduced.

The next action is to maintain and control the reduction in kinks for the foreseeable future.

Potential Options:

v  Keep the measles charts as a permanent fix?

v  LST review kink trend daily/weekly/monthly?

v  Kink champion from each shift onus on PB’s driven by PB’s on line

v  Implementation of updated Standard Audit to support long term sustainability?

v  Weekly Team Meetings

Weekly Team Meetings:

Team meetings are conducted by myself or the Production Team Lead. Going forward the Manufacturing Engineer/Technician for the line will present on the issues from the daily meetings to the Product Builder team. Historically when we have highlighted issues of concern to the PB group we have found that they respond very quickly to help solve issues. However once the initial reaction has worn off we tend to see the same issues come back again in order to combat this we believe that a weekly update will keep the focus for this group and improve the yield and output of the Generic area.

Potential Savings:

v  €96,216 per annum in scrap.

v  2,088 units, based on lot sizes of 54 this would mean 39 extra lots per annum.

Scrap Cost	Nov-15	Dec-15	Jan-16	Feb-16	Mar-16
Catheter x	11260	6854	2345	2785	2207
Catheter y	1909	5438	3290	1638	1873
Total	13169	12292	5635	4423	4080

From the graph above you can see the improvement from the solutions put in place to tackle the kink issue we were having on Cath X and Cath Y. In November 2015 we had a scrap cost of €13,169 there is now a significant drop in scrap cost which is evident in March of 2016 (scrap cost of €4,080).