Quality

Question 1

Management

Answer 1

is the coordinated activities used to direct and control an organisation—- plan lead and organises staff to fulfil customer requirements

Question 2

What is a system

Answer 2

set of principles or procedures according to which something is done

Question 3

QMS definition

Answer 3

• A formalised system that documents the processes, procedures and responsibilities for achieving quality, objectives and requirements

Question 4

What does quality help to do?

Answer 4

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

Question 5

what is the main purpose of QMS

Answer 5

Manage and control quality throughout all aspects of an organization’s operations

Question 6

List 7 QM principles- CLEIPER

Answer 6

• customer focus
• leadership
• evidence based decision making
• improvement
• process approach
• engagement with people
• relationship management

Question 7

Benefits of a QMS

Answer 7

• identify risks and opportunities
  -prevent errors reoccurring
  -improve employee performance
• improve user satisfaction
  improve control over environment
• identify opportunities for improvement

Question 8

Benefits of a QMS in a lab

Answer 8

• reliable accurate results in lab
• improve patient safety
• efficiency in lab processes
• ## achieve regulatory requirements

Question 9

why do Clinical labs need QM

Answer 9

• clinical labs carry highly complex operations where several staff members are involved

Question 10

Lab results should be… ART [CC]

Answer 10

accurate
reliable
timely
confidential
cost effective

Question 11

why is it important to implement a QMS in a lab

Answer 11

errors lead to-
1. time being wasted
2. costly repeat of analysis [it cost less to prevent a problem than to fix it]

Question 12

consequences of no QMS in a lab [x5]

Answer 12

-loss of reputation
-costly repeat of test
-repeat analysis of samples
-revision of procedures
-investigating problems

Question 13

how does a QMS prevent mistakes

Answer 13

• 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

Question 14

QMS is divided into?

Answer 14

QC and QA

Question 15

what is the aim of QC

Answer 15

-control error and provide a quality product by routine technical activities

Question 16

QC definition

Answer 16

part of quality involved in fulfilling quality requirements and

Question 17

QA definition

Answer 17

focused on providing confidence that quality requirements will be fulfilled

Question 18

QC is planned, - - - with the purpose to —-

Answer 18

routine technical activities with the purpose to control error and provide a quality result

Question 19

QA is planned,- - designed to ensure —-and providing - -

Answer 19

routine technical analysis that the quality control activities are being correctly implemented by providing the best possible results to physician and patients

Question 20

QA monitors and controls–? x3

Answer 20

1. competence of personnel
2. quality of materials, methods, reagents and instruments
3. reliable reporting of test results [lab reports= correct and on time]

Question 21

QA in lab stages

Answer 21

1. 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
2. In Analytical- equipment calibration and maintenance and- are staff trained
3. in Post-Analytical Processes- releasing the report, reporting urgent or critical results

Question 22

QA principles- x2

Answer 22

• 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[

Question 23

QC vs QA

Answer 23

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

Question 24

Why is the path workflow essential-> consider in healthcare

Answer 24

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

Question 25

implementing QM doesn’t eliminate errors but—

Answer 25

detects errors that may occur and prevent them from reoccurring

Question 26

What is Quality- definition and rest of dcf

Answer 26

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

Question 27

name 3 quality Gurus

Answer 27

Deming, Juran, Crosby

Question 28

what did the 3 quality gurus do

Answer 28

they helped develop quality management principles and practices

Question 29

what is the CE mark

Answer 29

is a certification mark which indicates health, safety and environmental protection standards for products sold within the European Economic Area

Question 30

Quality can signify

Answer 30

excellence
quality of a diagnostic lab can been seen once they achieve an accreditation standard e.g. ISO15189

Question 31

who is responsible for quality

Answer 31

everyone