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.