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Quality Managment > Quality Manual > Flashcards

Quality Manual Flashcards

1
Q

why is documentation important?

A
  1. Precise instructions specify all quality-related topics
  2. Cocumented results demonstrate appropriate implementation
  3. According reports summarize and evalute the results
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2
Q

what’s the definition of Quality Manual

A

it is a document that describes the quality management system of an organization (IOS 15189)

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3
Q

what’s the purpose of quality manuel?

A

Clearly communicate information
serve as a framework for meeting quality system requiremnets
convey managerial commitment to the quality system

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4
Q

What is important while having the quality manual?

A

everyone should be instructed on its use and application, should be kept up to date and responsibility for the updating should be assigned

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5
Q

what are the key points of quality manual?

A

there is only one offical version
the quality manual is never finished
it should bbe read, understood and accepted by everyone
it should be writting in clear, easily understood languge
the qaulity manual should be dated and signed by the management

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6
Q

what are the importnat regulatory background of the quality manual?

A

PharmBetrv requirement
ICH Q10
ISO:900:2008

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7
Q

PharmBetrv requirement are?

A

QA system which includes the quality manual, SOP’s, instruction manuals

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8
Q

according to what is the ICH Q10 comprises

A

the description of the pharmaceutical quality system

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9
Q

what is the ISO standard ?

A

documents the measures of modern quality management

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10
Q

on what is the ISO standard based on?

A

basis for a QMS

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11
Q

what are QMS

A

they are process-oriented, not product-oriented

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12
Q

to what are products (serves) subjected?

A

they are subjected to specific requirement

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13
Q

to which department must products be comply?

A

with the quality assurance measures

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14
Q

For what is the EN ISO used for?

A

defines the terms and priniciples of QMS

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15
Q

what are the seven quality managment principles?

A
  1. Customer focus
  2. Leadership
  3. Engagement of people
  4. Process approach
  5. Improvement
    6 Evidence-based decision making
  6. Relationship management
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16
Q

Why customer focus?

A
  1. centre of every corporate activity

2. deside success or failure

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17
Q

Leadship?

A

responsible for the improvement of quality by motivating the employees

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18
Q

Engagement of people

A

motivation and skilles employees

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19
Q

Process approach

A

interrelationships and interdependencies between all activities and associated resources

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20
Q
  1. Improvement
A

long-term sucsess

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21
Q

6 Evidence-based decision making

A

Exact analysis of datat and information, understanding cause and effects relationships their consequences

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22
Q
  1. Relationship management
A

Organization and their interested parties dpends on each other

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23
Q

What’S the Histroy of EN ISO 9001

A

their focued was first on testing the quality of final products and product quality through precentives ations
over to concentrated on QM rather tehan quality control
Now: towards a comprehensive integrated elements or corporate mangement

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24
Q

Why do the companies used the ISO standards?

A

to fulfill these requiremnets to reach customer satisfaction and fulfill requlatory demands

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25
Q

Definition of ISO standard 9001?

A

it is a standard to organize a QM system and therevy to improve the competitiveness of a company by cost-effciently rendering products and services

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26
Q

Where can you put the ISO 9001 within th supply chain?

A

in the organisation

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27
Q

why is the ISO 9001 in the organiation of the supply chain?

A

becuase each activity in an organisation is considered as “process”

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28
Q

what’s the definition of the process?

A

it is defined as a system of activities that covert input into resuluts/ outpout with the help of resurces

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29
Q

which clauses are included in the general contents, no requirements

A

Scope
Normative references
terms of conditions

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30
Q

what are the mandatory requirements?

A 
contect of organization
leadership
planning
support
operation
performanace evaluation
improvement
31
Q

on what does the managenet-system standards based on?

A

PDCA (Plan, Do, Chekc and Act) cycle

32
Q

what is the main change from ISO 9001-ISO 2015

A

thee contect of organization was mentioned as mandatory documents, whereas in ISO 2015 there is just documented information

33
Q

which points are under PLAN?

A
  1. Understanding the organization
  2. understanding the need of expectations of intrested parties
    3 Determining the scope of the QMS
    4 QMS and its Process
34
Q
  1. Understanding the organization
A

internal and external factors which can effect the panning and sucessful implementation of the QM should be considered

35
Q
  1. understanding the need of expectations of intrested parties
    what are some parties?
A

stakeholder such as customer, employees, public, authorities

36
Q

3 Determining the scope of the QMS

A

possible exclusions: procuremnet and maintenance

37
Q

4 QMS and its Process

A

requires documented iinformation:
that supports the operation of the processess;
as evidence that processes are carried out as planned

38
Q

leadership includes

A

leadership and commitment
policy
organisation, roles, responsibility and authorities

39
Q

policy

A

defines by the top managment, has to be presented to the employees

40
Q

organisation, roles, responsibility and authorities

A

displayed as organizational chart

41
Q

what are the foure types of organization charts?

A

Functional Top-Down
Divisional structure
Matrix organizationla chart
Flat organization chart

42
Q

Functional Top-Down

A

it reflects traditional business structure
it is divided into traidtions department
employees wit similar skillsets and specialization are grouped together

43
Q

Divisional structure

A

it refelcts a company organized alonga product line
different divisions
each divisi than has it own functions structure
can be used when one division is sufficiently indpendent from another

44
Q

Matrix organizationla chart

A

employees are divied into teams ny projects or product lead
operates by using cross-functiona groups instead of vertical silos
faciitate better, more open communication, but can also create confusion and frustration

45
Q

Flat organization chart

A

shows few or no levles of mangenet between executies and all other employess
empowers self- mangement and greater decision making ability for every employee

46
Q

Planning includes?

A

Action to adress risk and opportunites
quality objectives and plannig to achieve them
pplanning of changes

47
Q

Action to adress risk and opportunites

A

used of HACCP and FMEA

48
Q

HACCP and FMEA stands for?

A

HACCp: Hazard, Anaylsis, Critical, Control, Points
FMEA: Faluire Mode Effect Analysis

49
Q

DO includes?

A

Support and operations

50
Q

DO , Support includes which points?

A

Resources, Competence, Awarenes, Communication and documented information

51
Q

Support : Resources

A

employees, infrastructure, environment, time, information

52
Q

Support : Awearness

A

regarding the quality policy

53
Q

Support : Communication

A

in house and etern

54
Q

Support : documented information

A

what are documents about?
for which process to used them
Who is responsible?
Why should the proces be done

55
Q

numbers of Types of documented information

A

4 levels

56
Q

what are the four levels?

A

Quality manual–> 1 level
Guidelines and responsibilities of individual departments –> 2 Level
Standard Operation Procedures instruction manuals –> 3 Level
Documentation including possible forms–> 4 Level

57
Q

level 1- 3 represent?

A

specifications

58
Q

level 4

A

quality recording, have the more detailed informtion

59
Q

Operation includes which points?

A

Operational palnning and control
control of externally provided processes, products and sevices
production and service provision

60
Q

Operational palnning and control

A

Beneficial: using flow chart including resonsibilities

61
Q

production and service provision

A

Risk Management

62
Q

Check is done by

A

Performance evaluation

63
Q

Performance evaluation includes which points

A

monitoring measurement, analysis and evaluation

64
Q

monitoring measurement, analysis and evaluation

A

should be in relation to their impact on the conformity (product) and effectiveness

65
Q

Tool to assess date and improve quality

A

quality control charts

66
Q

ACT: improvement includes

A

continual improvement process (CIP)

67
Q

Core Principles of CIP is

A

is the self reflection of processes (Feedback9

68
Q

purpose of CIP?

A

is the idnetification, reduction, and elimination of suboptimal processes (Efficiency)

69
Q

the emphasis of CIP is on?

A

on incremnetal continual steps rather than giant leaps (Evolution)

70
Q

What are some alternatives to create a quality manual?

A

Alternative 2: comprising all quality-based non product-related documentsin one single document

71
Q

Name some Business process modeling techniques

A

Event-driven process chain and Harbarian proces modelling

72
Q

what does the ICH Q10 omprises of?

A

quality policy, the scope of the mangement system, the designation of each process with the PQA, the relation between the processes, accoring managemnet resonsibilities

73
Q

what is importnat when writting a quality manual?

A

the target group should be kept in mind and use visualization where appropriate

Quality Managment (8 decks)

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