labman g6 quality assurance Flashcards
it is the degree to which an object or entity satisfies a set of requirements
Quality
a positive declaration intended to give confidence and certainty
Assurance
is any systematic process of determining whether the product or service meets the specified requirements
Quality Assurance
is to target customers expectations and standards
Quality Assurancr
it is focusing on a big picture and creating the environment for success
Quality Assurance
it ensures that each specific test or analysis meets the quality standards
quality control
develop and maintain comprehensive SOPs for all laboratory processes and procedures to ensure consistency and compliance
Standard Operating Procedures
ensure all laboratory personnel are adequately trained and their competencies regularly assessed and documented
Personnel Training and Competency
Regularly calibrate and maintain laboratory equipment to ensure accuracy and reliability of results
Equipment Calibration and Maintenance
It is a test with a known result that ensures the accuracy of a testing process, serves as a benchmark for identifying deviations and errors, and facilitates corrective actions
Quality Control Samples
participate in external proficiency testing programs to benchmark laboratory performance against peers
Proficiency Testing
this ensures that test methods meet established standards and regulatory requirements
Proficiency Testing
it refers to the management and organization of laboratory documents
Document Control
it ensures that only current and approved versions are in use
Document Control
it focuses on the quality of the data
Data Integrity
ensuring that the data is accurate, reliable, and not changed in any wrong way
Data Integrity
ensures proper storage of data on hardware and physical copies and available access to it
Physical Integrity
ensures that data remains unchanged while being used in different ways through relational databases
Logical Integrity
aims to protect data from human error issues
Logical Integrity
how we collect, store, organize, and use data properly
Data Management
it is about the processes and systems for handling data
Data Management
Data must be correct
Data Accuracy
Data should match across different systems
Data Consistency
Protect data from unauthorized access or theft
Data Security
Check the data before it’s entered
Data Validation
A plan to get your data back if it’s lost or damaged
Data Recovery
Always have copies of your data in case something goes wrong
Data Back up
Decide who can see or edit data
Data Access Control
Managing data from its creation to deletion
Data Lifecycle
Consists of improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations
Corrective and Preventive Actions
Actions taken after a problem has happened to fix the issue and prevent it from getting worse
Corrective Actions
Actions taken before a problem happens to stop it from happening in the future
Preventive Actions
are reviews conducted within an organization to check how well its systems, processes and controls are working
Internal Audits
Identify areas that need improvement, ensure that organization is following laws and regulations, and reduce risk such as fraud or financial errors
Internal Audits
