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).

01st April 2016

Improve Phase - Develop improvement solutions for the critical X's.

Following on from the Analyse phase and proposed solutions/actions generated from the brainstorming, fishbone diagram and cause and effect analysis the team decided to introduce inspection at Coat Prep for moulding string: Post our moulding process and also during the coat prep process, moulding machine drool string can attach to the distal end of the catheters resulting in a high potential for kinks during seperation of units. To reduce drool factor an extraction system will be added to the Moulding room.

We then drew up our assessment criteria and the Team developed a consensus using multi voting in which team members apportioned 100 points across the assessment criteria.

"Will not impact Quality" and "Will solve the Problem" were deemed most important.

Weighting of assessment criteria

As well as introducing inspection to coat prep and reducing string from the moulding machine introduction of a tip trimming fixture for Tip Form and optimising the position of the tree which holds the catheters during moulding were our top solutions.

As a Team we assessed each proposed solution by scoring each item with a rating of 1 - 10 (10 being best) and summing up the combined weighted score we then drew up a prioritisation matrix.



Tip Trimming Fixture:

We are now ready to move onto the final stage the control phase.

10th March 2016.

Analyse Phase - Search for the key factors that have the biggest impact on process performance and determine the root causes:

The Analyse phase of the project, as agreed by the team, included the following:

In this phase we held brainstorming sessions on the kinks defect for Cath X and Cath Y. Our brainstorming sessions included product builders from the Top Assembly line and the Generic area as well as the core team. The product builders involved in these sessions found them interesting and insightful and were happy to see that all suggestions and opinions were valued and taken note of.

  

When our brainstorming sessions concluded we used the following tools to analyse our data from the Measure phase. Cause and Effect Diagram with cause screening and Defect Analysis by Product builder on each of the stations in the Generic area were carried out.

                        

Example of Defect Analysis by Product Builder

Summary:
Tip Form process has been identified as a key area for fallout, this process is an inspection process which may indicate that kinks are received into the Tip Form stations. The team is now ready to move onto the next phase the Improve Phase.

Measure Phase - Understand the process and its performance.

The measure phase of the project, as agreed by the team, included the following:

During this phase we conducted a Defect Analysis by Station. We used Measle charts as a tool to pinpoint defect location - predominant location of the kink on Cath X. Measle charts were reviewed over a 2 week period for kink defects and results confirm that kinks are predominantly found on the distal section of the catheter.

Following review of the measles chart it became apparent that a second catheter (Cath Y) was experiencing high levels of kink fallout. The team reviewed the process flow for Cath Y and it was clear that both Cath X and Cath Y undergo the same processing steps through out the Generic area, from IMH to Tip Form.
With this information the team and I agreed that it would be best to incorporate Cath Y in the scope of the project for two reasons. Firstly the volume of data which could be gathered would be more accurate and would help in identifiying potential areas of concern and secondly the over all benefit to the value stream by reducing the kinks defects across both Cath X and Cath Y would be greater.

Measles Chart



IPO Process Map

The below process map shows the five process step both catheters go through in the generic area.

The bellow images clearly shows the kink defect on both Cath X and Cath Y

The Team is now ready to move onto the next phase the Analyse Phase. 



Define Phase Kinks Reduction

 

Monday, February 1, 2016

Introduction

 My name is Pamela Considine and I work as a Manufacturing Associate in a Medical Device Plant. We manufacture Catheters for less invasive surgery. The type of project I am working on is yield improvement where we are focusing in on reducing kinks on Cath X which is our highest runner. For the end user a kinked catheter may rupture during the procedure causing vessel trauma or tip detachment during steering manoeuvres. The main area of focus will be the Moulding, Coating and Tip Form processes. I will be using the 5 step DMAIC process and associated tools and I will be documenting each of these steps through this blog.

 

Define Phase

For the period November 2015 - January 2016, kinked catheters on the Cath X product accounted for €20,132 of the total scrap €583,403 attributed to scrap code "C632 Kink" during processing through the Generic area of the Catheters Value Stream. This equates to 3.5% of the total scrap value.

Below some of the tools we used to define the problem:

SIPOC Developed

Critical to Quality Requirements Defined

 

 

Our project charter has been completed and Cross Fuctional Team assembled we are now ready to move onto the Measure phase.