GMP
What does GMP stand for?
Good Manufacturing Practices
Why does Quality matter?
To ensure the safety of the patient
Why is line clearance important before production starts?
To confirm previous job material has been removed and avoid product / material mix-ups
What are examples of things not allowed in the cleanroom?
Food, drink, gum, Non-covered Jewelry, Fur, Cardboard Boxes, Excessive Perfume
What are examples of writing practices that should never be used?
Scribbles, "Pre-recording", Over-write, Back-Dating, Temporary Notes (Sticky Notes)
What ensures measurement results and assets are consistent and accurate over time?
Calibration
Why do we create procedures and train to them?
To ensure consistency in our products and repeatable practices
Who is responsible for Line Clearance?
Everyone
What are the required PPE to enter the cleanroom?
Bouffant Cap, Gown, Booties, Beard Cover (If applicable)
What is the correct way to write the date?
MM/DD/YYYY
What should you do if there is an asset with an out of date calibration sticker?
Alert Team Lead and the Quality Department
If mistakes occur on the floor and they are not caught before shipment, what can they result in?
BONUS: What would be a sign that Line Clearance was not completed?
-Material from two jobs on the same table
-Labels from an old job present
-Mixed paperwork within a DHR
All gloves must be free of this material:
Latex
How should you fill in a blank space?
With appropriate data or N/A and initial and date
Controlled documents on the production floor must have:
Appropriate Document Name, Number and Revision
Bonus: What is a good quality "motto" for our site?
-Quality is everyone's responsibility
-Try your best to meet quality expectations even when no one is watching
When should you wipe the tables, surfaces and fixtures with 70% IPA?
Prior to starting a job.
Bonus: For CME 7 and 9, wipe tables, tools, fixtures and equipment four (4) times per day (beginning of shift, after breaks and lunch)
What is the order in which PPE must be removed when exiting the cleanroom?
1st - Booties, 2nd - Gown, and 3rd - Bouffant Cap
What type of writing utensils are not allowed?
Gel Pens, Pencils, Highlighters and Permanent Markers
What must be completed prior to beginning a production activity?
Training to applicable WI and Procedures must be completed prior to beginning activity and/or Line Clearance.
What the most widely known and used Medical Device Standard around the world?
ISO 13485
What color bin indicates rejected material?
Red
What is the best way to prevent contamination in a cleanroom?
Proper gowning and following entry protocols
Why is it important to correctly document all steps and activities within the production process?
To maintain traceability for patient safety.