Yo CAPA CAPA!
This procedure is intended to facilitate improvement activities & address existing and potential product, process and quality system nonconformities - while meeting the requirements of the standards and regulations NDI follows
What is the CAPA quality document?
A combination of text, graphics, data or other representative information that is created, modified, maintained, retrieved or archived by a computed system
What is an Electronic Record?
The characteristics to include in your E-signature when signing an online QMS document.
What is your full name, date/time executed, signature meaning (review / approval / recorded)?
You should always share ID codes and passwords with your coworkers, falsify E-records where you're able to and keep serious "controlled" documents editable to the public.
What is NO (or false)?
The first game played during our QMS training.
What is Kahoot?
An action taken to eliminate the cause of an exisiting NC to prevent recurrence
What is a Corrective Action?
An FDA regulation describing the criteria under which the FDA will accept electronic records and signatures and the equivalent to paper records and handwritten signatures
What is 21 CFR Part II?
This is our internal training coordinator at NDS.
Who is Darren Poquette?
This is a Free Space.
Enjoy the 200 points?
This employee is returning to NDS in early August.
Who is Andres Segura?
A CAPA in significant violation of quality policy, regulatory requirement that requires immediate action to be resolved
What is a Major Nonconformance?
The legally binding equivalent to an individual's hand-written signature.
What is an Electronic Signature?
Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or effectiveness or performance of a device after it is released for distribution.
What is a Complaint?
The primary cause in the series of events creating a Nonconformance.
What is a Root Cause?
This special treat was provided to us by Jason at one of our team lunches.
What is Tearaway Bread / Monkey Bread?
An action taken to eliminate the cause of a potential nonconformity to prevent occurrence
What is a Preventative Action?
The employee training quality document defines the training and development activities at NDI. These are three levels of understanding material?
What is Awareness, Competency, and Proficiency?
Relevance to the employee's role, training provider's accreditation, budget and other relevant considerations are used for approving this for employees.
What is External Development Training?
This department is in responsible for:
- Completing documented orientation of new employees
- Responsible for NDI specific training
- Retaining copies or records for all external trainings completed for all employees
What is HR (Human Resources)?
This brave soul manned the grill at our recent NDS picnic.
Who is Josh Baker?
List at least 5 ways that a CAPA can be generated!
1. Customer Complaints
2. Regulatory observations or Non conformances
3. Internal audits or post-market surveillance observations
4. Equipment out of Calibration
5. Incoming inspection or received components
6. Failed final inspection of manufactured products
7. Unsatisfactory trend
List the 4 Documents you are being trained on today!
1. Corrective and Preventative Action Procedure
2. QMS Document Control
3. Electronic Signature Acknowledgement
4. Employee Training
List at least 4 of the 6 items in the DCO process (in TLM) that the QMS document control procedure guides you on!
1. Creating a New Document
2. Document Change Orders (DCO) - how to start it
3. Document Management
4. Reviewing a Document
5. Releasing a Document
6. Obsoleting a Document
Free for all! Please write your answer on scrap paper.
Your host pulls out a random card from his wallet and it has 16 digits listed... how many of them are odd numbers?
(price is right rules, you can't go over - closest answer wins)
500 points to someone!
Breakout your papers because this is Family Feud.
Top 5 answers on the board - players to get them right will receive 100 points for each correct answer.
1. French Fries (32%)
2. Refrigerator (28%)
3. Remote (28%)
4. Harry Potter (36%)
5. Fear of Heights (29%)