3. 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.
5. 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.
GAP
6. Root cause of visual standard A3
In process of writing up a procedure/work instruction of
issuing visual standards to the manufacturing floor.
8. 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
9. 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 required
4 Attend safety committee meetings
5 Make representation for safety issues from fellow workers in team/Dept.
6 Liaise with EHS Manager on safety issues after highlighting them to your TL
7 Attend A3 or other investigations following accidents, incidents etc.
8 Get involved in site safety initiatives
9 Make recommendations for improvement
10 Support safety initiatives and programs including H&S week
11 Be open to auditing other areas of site outside your Dept.
12 Support with risk assessments in your area once trained to do so