Quality Flashcards
Management
is the coordinated activities used to direct and control an organisation—- plan lead and organises staff to fulfil customer requirements
What is a system
set of principles or procedures according to which something is done
QMS definition
- A formalised system that documents the processes, procedures and responsibilities for achieving quality, objectives and requirements
What does quality help to do?
Helps coordinate and direct organisations activities to meet 1. customer and 2. regulatory requirements and improve its effectiveness and efficiency on a continuous basis hence
what is the main purpose of QMS
Manage and control quality throughout all aspects of an organization’s operations
List 7 QM principles- CLEIPER
- customer focus
- leadership
- evidence based decision making
- improvement
- process approach
- engagement with people
- relationship management
Benefits of a QMS
- identify risks and opportunities
-prevent errors reoccurring
-improve employee performance - improve user satisfaction
improve control over environment - identify opportunities for improvement
Benefits of a QMS in a lab
- reliable accurate results in lab
- improve patient safety
- efficiency in lab processes
- ## achieve regulatory requirements
why do Clinical labs need QM
- clinical labs carry highly complex operations where several staff members are involved
Lab results should be… ART [CC]
accurate
reliable
timely
confidential
cost effective
why is it important to implement a QMS in a lab
errors lead to-
1. time being wasted
2. costly repeat of analysis [it cost less to prevent a problem than to fix it]
consequences of no QMS in a lab [x5]
-loss of reputation
-costly repeat of test
-repeat analysis of samples
-revision of procedures
-investigating problems
how does a QMS prevent mistakes
- quality assurance measures
-quality control of analytical results
-thorough documentation of the system
-efficient maintenance of records
-regular audits of all aspects of the system
QMS is divided into?
QC and QA
what is the aim of QC
-control error and provide a quality product by routine technical activities
QC definition
part of quality involved in fulfilling quality requirements and
QA definition
focused on providing confidence that quality requirements will be fulfilled
QC is planned, - - - with the purpose to —-
routine technical activities with the purpose to control error and provide a quality result
QA is planned,- - designed to ensure —-and providing - -
routine technical analysis that the quality control activities are being correctly implemented by providing the best possible results to physician and patients
QA monitors and controls–? x3
- competence of personnel
- quality of materials, methods, reagents and instruments
- reliable reporting of test results [lab reports= correct and on time]
QA in lab stages
- in pre-analytical stage [anything up to the point of testing -you reject/accept a sample based on requirements i.e. correct labelling/correct bottle type
- In Analytical- equipment calibration and maintenance and- are staff trained
- in Post-Analytical Processes- releasing the report, reporting urgent or critical results
QA principles- x2
- fit for purpose [product, result, service should be suitable for the intended purpose and gotten in the right time
-right the first time [mistakes should be eliminated no repeats[
QC vs QA
QC aims @ simply ensuring results generated are correct
QA checks whether test =done on right sample and correct results =sent to correct person @right time
Why is the path workflow essential-> consider in healthcare
because the entire process of managing a sample must be considered- from sample collection@ the beginning to the reporting and saving results and all process in between
implementing QM doesn’t eliminate errors but—
detects errors that may occur and prevent them from reoccurring
What is Quality- definition and rest of dcf
degree to which a set inherent characteristics of an object fulfils requirements
c-conformance to the user requirements and satisfy their needs and expectations
f-fitness of a product or service to meet/exceed intended use by the customer
name 3 quality Gurus
Deming, Juran, Crosby
what did the 3 quality gurus do
they helped develop quality management principles and practices
what is the CE mark
is a certification mark which indicates health, safety and environmental protection standards for products sold within the European Economic Area
Quality can signify
excellence
quality of a diagnostic lab can been seen once they achieve an accreditation standard e.g. ISO15189
who is responsible for quality
everyone
