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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
Definition of ISO standard 9001?
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
26
Where can you put the ISO 9001 within th supply chain?
in the organisation
27
why is the ISO 9001 in the organiation of the supply chain?
becuase each activity in an organisation is considered as "process"
28
what's the definition of the process?
it is defined as a system of activities that covert input into resuluts/ outpout with the help of resurces
29
which clauses are included in the general contents, no requirements
Scope Normative references terms of conditions
30
what are the mandatory requirements?
``` contect of organization leadership planning support operation performanace evaluation improvement ```
31
on what does the managenet-system standards based on?
PDCA (Plan, Do, Chekc and Act) cycle
32
what is the main change from ISO 9001-ISO 2015
thee contect of organization was mentioned as mandatory documents, whereas in ISO 2015 there is just documented information
33
which points are under PLAN?
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
1. Understanding the organization
internal and external factors which can effect the panning and sucessful implementation of the QM should be considered
35
2. understanding the need of expectations of intrested parties what are some parties?
stakeholder such as customer, employees, public, authorities
36
3 Determining the scope of the QMS
possible exclusions: procuremnet and maintenance
37
4 QMS and its Process
requires documented iinformation: that supports the operation of the processess; as evidence that processes are carried out as planned
38
leadership includes
leadership and commitment policy organisation, roles, responsibility and authorities
39
policy
defines by the top managment, has to be presented to the employees
40
organisation, roles, responsibility and authorities
displayed as organizational chart
41
what are the foure types of organization charts?
Functional Top-Down Divisional structure Matrix organizationla chart Flat organization chart
42
Functional Top-Down
it reflects traditional business structure it is divided into traidtions department employees wit similar skillsets and specialization are grouped together
43
Divisional structure
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
Matrix organizationla chart
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
Flat organization chart
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
Planning includes?
Action to adress risk and opportunites quality objectives and plannig to achieve them pplanning of changes
47
Action to adress risk and opportunites
used of HACCP and FMEA
48
HACCP and FMEA stands for?
HACCp: Hazard, Anaylsis, Critical, Control, Points FMEA: Faluire Mode Effect Analysis
49
DO includes?
Support and operations
50
DO , Support includes which points?
Resources, Competence, Awarenes, Communication and documented information
51
Support : Resources
employees, infrastructure, environment, time, information
52
Support : Awearness
regarding the quality policy
53
Support : Communication
in house and etern
54
Support : documented information
what are documents about? for which process to used them Who is responsible? Why should the proces be done
55
numbers of Types of documented information
4 levels
56
what are the four levels?
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
level 1- 3 represent?
specifications
58
level 4
quality recording, have the more detailed informtion
59
Operation includes which points?
Operational palnning and control control of externally provided processes, products and sevices production and service provision
60
Operational palnning and control
Beneficial: using flow chart including resonsibilities
61
production and service provision
Risk Management
62
Check is done by
Performance evaluation
63
Performance evaluation includes which points
monitoring measurement, analysis and evaluation
64
monitoring measurement, analysis and evaluation
should be in relation to their impact on the conformity (product) and effectiveness
65
Tool to assess date and improve quality
quality control charts
66
ACT: improvement includes
continual improvement process (CIP)
67
Core Principles of CIP is
is the self reflection of processes (Feedback9
68
purpose of CIP?
is the idnetification, reduction, and elimination of suboptimal processes (Efficiency)
69
the emphasis of CIP is on?
on incremnetal continual steps rather than giant leaps (Evolution)
70
What are some alternatives to create a quality manual?
Alternative 2: comprising all quality-based non product-related documentsin one single document
71
Name some Business process modeling techniques
Event-driven process chain and Harbarian proces modelling
72
what does the ICH Q10 omprises of?
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
what is importnat when writting a quality manual?
the target group should be kept in mind and use visualization where appropriate

Quality Managment (8 decks)

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