Document Control
This document outlines the scope of the QMS and references procedures.
What is the Quality Manual?
Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, usability, reliability, safety, effectiveness, or performance of a device after it is released for distribution is this.
What is a Complaint?
Equipment used in production must be regularly checked through this process.
What is the calibration / PM process?
Before a supplier is added to the ASL, they must go through this process.
What is a supplier evaluation?
This is the name of the grab-n-go at the Hub.
What is Market Xpresso?
This is the candy typically found on Marixa’s desk.
What are Nerds Gummy Clusters?
This group is responsible for conducting and documenting results of both complaint and concomitant devices associated with a specific complaint record.
Who are the Failure Analysis or product analysis & investigation groups?
Training records must demonstrate this about employees.
What is competence?
CAPA effectiveness must be verified through this activity.
What is an effectiveness check?
This is the preferred company format for date entries on quality records.
What is YYYY-MM-DD?
This is the number of people on the Quality Team.
What is 39 people?
This is the room number of the Failure Analysis Lab.
What is Room 632?
What does Sunny say when leaving every day?
See you folks!
Supplier performance must be monitored through these activities.
What are supplier audits or scorecards?
GDP is an acronym for this.
What are Good Documentation Practices?
This document outlines requirements for document control.
What is SOP01?
This person has a climbing rope in their living room.
Who is Jerome Miko?
This record documents the manufacturing history of each device.
What is the Device History Record (DHR)?
Supplier Controls are defined in this document.
What is SOP05?
True or False: The last BSI Auditor to visit IHFM has a cat named BamBam and a dog named TedTed.
What is True?
ISO 13485 requires records to be maintained for this minimum period.
What is the device's expected lifetime?
The complaint process is defined in this document.
What is SOP41?
Processes that cannot be fully verified must undergo this.
What is process validation?
This person's favorite Transformer is Optimus Prime.
Who is Nancy Garcia?
Internal audit findings are documented here.
What is the Internal Audit Report FM4569?