QMS and anything Quality
P80109, CD6000
What are the Quality Manuals
CD30011
What is the Risk Management Procedure (for QMS)?
Also known as the NOQ, it provides support for Quality direction, guidance and support at the corporate level.
What is the National Office of Quality?
Founded in 1996, this company started at 270 E. Grand Avenue, also known to many as Building 1 or B1.
What is ViroLogic?
A process in MasterControl where approvers are not able to make edits.
What is Final Approval?
Labcorp's online training system
What is LP or LearningPath?
A measure and determination that a corrective action(s) has (has not) eliminated the root cause or the problem.
What is Effectiveness Check?
She was the first to report to the NOQ.
Who is Shannon Utter?
This pair are still employed at Monogram and were the first 2 hired in Pre-Analytical/Accessioning.
Who are Jonas and Liza/Carmeliza?
A type of meeting where participants discuss in person.
What is Face-to-Face or F2F?
While QA refers is proactive and focuses on preventing nonconformances through process improvements, this Quality process is reactive and identifies issues through reviews, inspections and testing.
What is QC or Quality Control?
At Monogram, this is referred to as the process of assessing, responding to, monitoring, controlling and reporting risks.
What is Risk Management?
She was the only Labcorp VP of Quality who visited Monogram twice.
Who is Edna/Edna Parker?
It is the Japanese term or concept for Continuous Improvement.
What is Kaizen?
A period in product or software development where no changes are allowed. This period is implemented prior to verification and validation activities.
What is Design Freeze or Code Freeze?
At Monogram, it is a type of software testing where real users test the software application to make sure business requirements are met. This process is a pre-requisite prior to QA turnover of the project.
What is UAT or User Acceptance Testing?
This ISO reference specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices.
What is ISO 14971?
A group at the NOQ responsible for submitting required demographic and result data to state DOHs.
What is the State Reporting group?
A Monogram pioneer, he a rockstar in his field and is also known as Captain Virus!
Who is CJP or Chris P or Christos Petropoulos?
A nonconformance, issue, exception observed during software protocol execution
What is Failure?
The process used to evaluate a laboratory’s performance. A tool used to: 1. Verify testing accuracy and reliability. 2. Validate the entire testing process, including the testing personnel competency.
What is PT or Proficiency Testing?
According to IVD regulations, a CDx must meet this highest EU risk classification under IVDR due to its critical role in patient treatment decisions
What is Class C?
Monitored by the NOQ and the executive leadership, this important platform tracks missing or potentially compromised irreplaceable samples/specimens across the corporation.
What is MOB or Man Overbaord?
Also known as the Master of Quality Assurance and Continual Improvement, this person was influential in was post WWII Japan where he taught top managers and engineers the methods for improving how they worked and learned together.
Who is William Edwards Deming or William Deming or Deming?
It is a step-by-step approach to identify and prioritize possible failures in a design, manufacturing or assembly process, product, or service.
What is FMEA or Failure Mode and Effects Analysis?