QA Technician Role Update

Colin Sorensen

A3 Completed :with Catherine O’Donoghue and Elaine Whitnell

Background and results of A3

Trays was trending in highest GMPS issues across the plant. Catherine was requested to understand and implement countermeasures to improve performance of GMP across the plant

48 Instances of GMP Findings this week (Plant Wk 31) Priortised Problem: Trolley Signage not permantly fixed or

incorrect Countermeasure Plan :Training and communication on Filling

out signs Results: only 18 GMP issues of this category found in past 10

months.

A3 currently working on for certification

Background and current status of A3 for certification

QA technicians found 2 gauges on the production floor that had not been calibrated by the calibration department.

Ultimate Goal: To ensure patient protection by making sure that all gauges are calibrated before being issued to the manufacturing floor

Prioritised Problem: Calibration sticker missing on visual standard part VS445A Global unite stem and when reviewed by calibration it was found that it had not gone through the calibration process.

Actual Target0

0.5

1

1.5

2

2.5 PROBLEM GAP

Series1

GAP

Root cause of visual standard A3

In process of writing up a procedure/work instruction of issuing visual standards to the manufacturing floor.

My Training Matrix

HOLD REVIEW Currently providing support to the trays and sigma value streams by

reviewing the hold report in both value streams and determining disposition as required.

Fully trained on inspections in both areas. Supporting associates on night shift on quality issues

IN HOUSE TRAINING

Continuous improvement Recently completed a certificate in Quality Assurance in CIT,

CR_SQUAS_6. Starting the diploma course in QA management in September. I have just joined the health and safety team to represent

quality along with Lisa McCarty. Main Role and Responsibilities are for this new role are:

Main Role and Responsibilities

1 Attend daily pulse walk (VS safety reps only)2 Attend daily safety walks (all areas) 3 Attend training as required4 Attend safety committee meetings5 Make representation for safety issues from fellow workers in team/Dept.6 Liaise with EHS Manager on safety issues after highlighting them to your TL7 Attend A3 or other investigations following accidents, incidents etc.8 Get involved in site safety initiatives9 Make recommendations for improvement

10 Support safety initiatives and programs including H&S week11 Be open to auditing other areas of site outside your Dept.12 Support with risk assessments in your area once trained to do so