Quality Assurance Flashcards
How to consider an analysis to be under statistical control?
- free of bias
- characterized by well-defined confidence intervals
Define the goal of quality assurance program (3)
- identifies the practices necessary to bring a system into statistical control
- allows us to determine if the system remains in statistical control
- suggests a course of corrective action if the system falls out of statistical control
Components of quality assurance (2)
- Quality control
- Quality assesment
Define quality control
encompasses all activities that bring an analysis into statistical control
totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs
quality
organizational structure, procedures, processes, and resources needed to implement quality management
quality system
all activities of the overall management function that determine the quality policy, objectives and responsibilities, and implement them by means such as quality planning, quality control, quality assurance, and quality improvement within the quality
system
quality management
ISO meaning
International Organization for Standardization
develops standards and guides to encourage good practice in accreditation and certification
ISO
ISO does not carry out _____ and does not issue or approve certificates
certification/accreditation
It means that an independent, external body has audited an organization’s management system and verified that it conforms to the requirements specified in the standard
Certification (registration)
It means the formal approval by a specialized body that a certification body is competent to carry out ISO
Accreditation
Certificates issued by specialized bodies may be perceived on the market as having increased credibility (not required for companies)
Accredited certificates
ISO certification for “general requirements for the competence of testing and calibration laboratories”
ISO 17025:2017
ISO certification for “quality management system”
ISO 9001:2015
ISO certification for “environmental management system”
ISO 14001:2021
ISO certification for “Occupational Health and Safety” to protect employees and visitors from work-related accidents and diseases
ISO 45001:2018
ISO certification for “managing psychosocial risks at work” (psychological health and safety)
ISO 45003:2021
ISO certification for “information security management system”
ISO 27001:2013
ISO certification for “food safety management system”
ISO 22000:2018
HACCP meaning and goal
Hazard Analysis Critical Control Point
- a system which identifies, evaluates and controls hazards which are significant for food safety
- ensure safety than detect
HACCP method whereas all the potential hazards are identified before there is a problem
systematic
HACCP method whereas it concentrates the control effort at the stages where the risk is potentially the highest
efficient
HACCP method whereas the processes can be controlled immediately by the food business
on the spot
Differentiate GLP and GMP
Good Laboratory Practices (GLP)
- describe the general laboratory operations that we must follow in any analysis
Good Measurement Practices (GMP)
- describe those operations specific to a technique
provide instructions for maintaining, calibrating, and using equipment and instrumentation.
Good Measurement Practices
involves the principle of waste elimination through workplace organization
Good housekeeping (5S)
provide a methodology for organizing, cleaning, developing, and sustaining a productive work environment.
5S Pillars
Keep only necessary items in the workplace (5S)
Sort - Seiri
Arrange items to promote efficient workflow (5S)
Set in Order - Seiton
Clean the work area so it is neat and tidy (5S)
Shine - Seiso
Set standards for a consistently organized workplace (5S)
Standardize - Seiketsu
Maintain and review standards (5S)
Sustain - Shitsuk
written procedure which states what steps will be taken and how they will be carried out are the bulwark of quality assurance
Standard Operating Procedure (SOP)
most detailed of the written quality control
directives
Protocol for a Specific Purpose (PSP)W
What set of written instructions must be followed step by step?
Protocol for a Specific Purpose (PSP)
process of collecting data to show that analytical procedures are operating within specified limits verifying that final results meet use objectives
Quality Assessment
List all the components and subcomponents of quality assessment
- Internal method of quality assessment
- prescriptive approach (specification and method validation)
- performance-based approach - External method of quality assessment
- proficiency testing
general approaches to developing a
quality assurance program
internal method of quality assessment
prescribe an exact method of quality assessment and a way of applying quality control
prescriptive approach
use any form of quality assessment, provided an acceptable level of statistical control can be demonstrated (use of control charts)
performance-based approach
provides a system to gauge how good the numbers need to be and what precautions are required in the analytical procedure
specification