Quality Management ( Chapter 23 ) Flashcards Preview

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Flashcards in Quality Management ( Chapter 23 ) Deck (43):
1

The degree to which a product or service meets requirements

Quality

2

The building blocks of Quality

Quality control , Quality Assurance , Quality Management System

3

Blood bank compliance with federal regulations and accreditation standards is required by the ff. organizations

FDA
Joint Commission
CAP
AABB

4

Evaluate how effectively the facility meets the requirements by detecting errors , deficiencies , and deviations .

Compliance programs

5

Measure the state of the facility's program with respect to the applicable requirements at a single point in time

Compliance inspections

6

Compliance inspection is also known as

Surveys or Assesment

7

When do usually Compliance Inspection conducted

every 1 to 2 years

8

Planned actions that ensure that systems and elements that influenced the quality of the product or service are working as expected , individually and collectively.

Quality Assurance

9

Is actively and continuously practiced by the blood bank leaders , managers and staff throughout all blood bank operation.

Quality Management

10

Mandates an environmental control program that addresses all significant environmental issues for facility management and maintenance such as temp control , electrical safety, fire protection, and so forth

Joint Commission

11

Can be defined as a set of interrelated resources and activities that transform inputs into outputs

Process

12

Is a set of activities that ensures a given work process will keep operating in a state that is continuously able to meet process goals without compromising the process itself

Process control

13

Is the evaluation of the performance of a process, comparison of actual performance to a goal and action taken on any significant difference

Total Process Control

14

Requires that facilities design their processes and procedure to ensure that blood components are manufactured consistently to meet the quality standards appropriate for their intended use

cGMP ( current GOOD MANUFACTURING PRODUCT )

15

Graphically represents the sequence of activities in a process and show how the inputs are converted into outputs.

Flow Chart

16

Involves one or more persons who perform a sequence of activities over a period of time.

Work Process

17

Provide instruction for each activity in the larger process.

Standard Operating Procedures

18

Illustrate the sequence activities in Total Process Control

Process is Flow Charted --->
Procedures are Identified --->
Procedures are drafted ---> Process are validated -->
Procedure are finalized --> Training is performed -->
Initial competence is assested --> Process performance is monitored

19

Test all activities in a new process to ensure that the process will work in the living environment

Validation

20

An example of a process control wherein one laboratory methods and procedures are compared with those of other laboratories for the ability to get the same result on a set of unknown specimens

Proficiency Testing

21

Are approved info contained in a written or electronic format.

Documents

22

Defines the QMS for external inspector and internal staff

Documents

23

Links a facility's policies , process and procedures and ensure that only the latest approved copies of documents are available for use.

Document Control System

24

Are specially design documents either paper or electronic on which are recorded the results or outcomes of performing a given procedure

Forms

25

Activities include using and manipulating the donor or patient information and test results in facility's paper and electronic information system

Information Management

26

Give the 6 Types of Nonconformance

Accident
Adverse rxn
Complaint
Discrepancy
Error
Postdonation

27

A type of Nonconformance . Complications that occured to the donor during or after the donation process or to the recipient of transfused blood component

Adverse Rxn

28

A type of Nonconformance . Expression of dissatifaction from internal customers ( Physician , employess) or external customers ( donor , px )

Complaint

29

A type of Nonconformance . Difference or inconsistency in the outcomes of a process, procedures or test results

Discrepancy

30

A type of Nonconformance attributable to a human or system problem , such as a problem from failure to follow established procedure or a part of a process that did not work as expected

Error

31

A type of Nonconformance generally not attributable to a persons mistake such as a power outage or an aged instruments malfunction

Accident

32

A type of Nonconformance the receipt of information ( call or information letter) from donor with additional details regarding his or her donation such as subsequent illness or neglecting to mention illness or medication

Postdonation

33

The immediate action which is the initial quick fix soln.

Remedial Action

34

A very effective assessment tool that review a specific facility process and determine by examining documents and records , interview and observations whether the facility is meeting the applicable requirements

Internal Audit

35

What are the two types of External Assesment

Proficiency testing and External Inspection

36

Performed by regulatory and accreditation organization for the purposes of obtaining and maintaining the facility license or accreditation

External Inspection

37

The cost of implementing processes and controls to prevent the occurrence of nonconformances

Prevention cost

38

Give the 4 different Types of Quality cost

Prevention Cost
Appraisal Cost
Internal Failure Cost
External Failure Cost

39

The cost of implementing process and controls to appraise or evaluate blood bank, tranfusion service or medical laboratory's performance

Appraisal Cost

40

Bad Quality Cost that expensive and hard to measure because they include both actual and intangible cost incurred to correct a nonconformance.

External Failure Cost

41

Is a name for processes that detect , report , evaluate and correct events in blood bank operations that do not meet the facility's or othere requirements

Nonconformance management

42

Is a group of people who represents different activities in a given process and who have been brought together to identify and implement ways to solve process problems

Process improvement team

43

Challenges all activities in a new process before implementation to provide a high degree of assurance that the process will work as intended

Process validation