Acronyms
FDA
What is the Federal Drug Administration?
21CFR 820
What is the code of federal regulations for Medical Device Quality Management?
Incorporate customer feedback into design of new products.
Who is Engineering?
ESD
What is Electrostatic Discharge?
Two digit day, three letter month, and four digit year.
What is the acceptable date format used on all GMP documentation?
cGMP
What is current Good Manufacturing Practices?
ISO 13485
What is the international standard for Medical Device Quality Management Systems?
Document how suppliers will be evaluated and provide feedback for corrective action to suppliers.
Who is Procurement?
Safety Glasses and ESD smock
What are the required PPE for production areas?
Draw a single line through, correct, initial and date.
What is how to make a correction on GMP documentation?
CFR
What is Code of Federal Regulations?
ISO 170205
What is the international standard for testing and calibration laboratories?
Communicate with customers regarding contracts, order handling, and receiving customer feedback including complaints.
Who is Customer Service?
Candy, gum, food, drinks that are not contained in a spill proof cup.
What are items that cannot be out on the production lines?
If it isn't recorded...
What is, "It didn't happen."?
ISO
What is the International Organization for Standardization?
Good Automated Manufacturing Practice (GAMP) 5
What is the compliance guideline for computerized systems?
Record all activities necessary to manufacture a product and ensure it's effective operation.
Who is Manufacturing or Operations?
Green, Orange, Red, Yellow and Blue.
What are muster point location colors?
Signing a document prior to completion of the work being documented.
What is pre-dating a document?
ALCOA
What are Attributable, Legible, Contemporaneous, Original and Accurate?
Quality Management System Regulation (QMSR) Final Rule
What is the FDA issued guidance that incorporates the ISO 13485 standards into 21CFR820?
Follow written procedures including, Policies, Manufacturing Procedures, Standard Operating Procedures, Work Instructions exactly as written.
Everyone
Cutting your finger while cutting your bagel in the breakroom.
What is an OSHA reportable incident?
Amber's biggest annoyance regarding documentation practices.
What is using post-it notes?