Quality Manual Flashcards
why is documentation important?
- Precise instructions specify all quality-related topics
- Cocumented results demonstrate appropriate implementation
- According reports summarize and evalute the results
what’s the definition of Quality Manual
it is a document that describes the quality management system of an organization (IOS 15189)
what’s the purpose of quality manuel?
Clearly communicate information
serve as a framework for meeting quality system requiremnets
convey managerial commitment to the quality system
What is important while having the quality manual?
everyone should be instructed on its use and application, should be kept up to date and responsibility for the updating should be assigned
what are the key points of quality manual?
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
what are the importnat regulatory background of the quality manual?
PharmBetrv requirement
ICH Q10
ISO:900:2008
PharmBetrv requirement are?
QA system which includes the quality manual, SOP’s, instruction manuals
according to what is the ICH Q10 comprises
the description of the pharmaceutical quality system
what is the ISO standard ?
documents the measures of modern quality management
on what is the ISO standard based on?
basis for a QMS
what are QMS
they are process-oriented, not product-oriented
to what are products (serves) subjected?
they are subjected to specific requirement
to which department must products be comply?
with the quality assurance measures
For what is the EN ISO used for?
defines the terms and priniciples of QMS
what are the seven quality managment principles?
- Customer focus
- Leadership
- Engagement of people
- Process approach
- Improvement
6 Evidence-based decision making - Relationship management
Why customer focus?
- centre of every corporate activity
2. deside success or failure
Leadship?
responsible for the improvement of quality by motivating the employees
Engagement of people
motivation and skilles employees
Process approach
interrelationships and interdependencies between all activities and associated resources
- Improvement
long-term sucsess
6 Evidence-based decision making
Exact analysis of datat and information, understanding cause and effects relationships their consequences
- Relationship management
Organization and their interested parties dpends on each other
What’S the Histroy of EN ISO 9001
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
Why do the companies used the ISO standards?
to fulfill these requiremnets to reach customer satisfaction and fulfill requlatory demands
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
Where can you put the ISO 9001 within th supply chain?
in the organisation
why is the ISO 9001 in the organiation of the supply chain?
becuase each activity in an organisation is considered as “process”
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
which clauses are included in the general contents, no requirements
Scope
Normative references
terms of conditions
what are the mandatory requirements?
contect of organization leadership planning support operation performanace evaluation improvement
on what does the managenet-system standards based on?
PDCA (Plan, Do, Chekc and Act) cycle
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
which points are under PLAN?
- Understanding the organization
- understanding the need of expectations of intrested parties
3 Determining the scope of the QMS
4 QMS and its Process
- Understanding the organization
internal and external factors which can effect the panning and sucessful implementation of the QM should be considered
- understanding the need of expectations of intrested parties
what are some parties?
stakeholder such as customer, employees, public, authorities
3 Determining the scope of the QMS
possible exclusions: procuremnet and maintenance
4 QMS and its Process
requires documented iinformation:
that supports the operation of the processess;
as evidence that processes are carried out as planned
leadership includes
leadership and commitment
policy
organisation, roles, responsibility and authorities
policy
defines by the top managment, has to be presented to the employees
organisation, roles, responsibility and authorities
displayed as organizational chart
what are the foure types of organization charts?
Functional Top-Down
Divisional structure
Matrix organizationla chart
Flat organization chart
Functional Top-Down
it reflects traditional business structure
it is divided into traidtions department
employees wit similar skillsets and specialization are grouped together
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
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
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
Planning includes?
Action to adress risk and opportunites
quality objectives and plannig to achieve them
pplanning of changes
Action to adress risk and opportunites
used of HACCP and FMEA
HACCP and FMEA stands for?
HACCp: Hazard, Anaylsis, Critical, Control, Points
FMEA: Faluire Mode Effect Analysis
DO includes?
Support and operations
DO , Support includes which points?
Resources, Competence, Awarenes, Communication and documented information
Support : Resources
employees, infrastructure, environment, time, information
Support : Awearness
regarding the quality policy
Support : Communication
in house and etern
Support : documented information
what are documents about?
for which process to used them
Who is responsible?
Why should the proces be done
numbers of Types of documented information
4 levels
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
level 1- 3 represent?
specifications
level 4
quality recording, have the more detailed informtion
Operation includes which points?
Operational palnning and control
control of externally provided processes, products and sevices
production and service provision
Operational palnning and control
Beneficial: using flow chart including resonsibilities
production and service provision
Risk Management
Check is done by
Performance evaluation
Performance evaluation includes which points
monitoring measurement, analysis and evaluation
monitoring measurement, analysis and evaluation
should be in relation to their impact on the conformity (product) and effectiveness
Tool to assess date and improve quality
quality control charts
ACT: improvement includes
continual improvement process (CIP)
Core Principles of CIP is
is the self reflection of processes (Feedback9
purpose of CIP?
is the idnetification, reduction, and elimination of suboptimal processes (Efficiency)
the emphasis of CIP is on?
on incremnetal continual steps rather than giant leaps (Evolution)
What are some alternatives to create a quality manual?
Alternative 2: comprising all quality-based non product-related documentsin one single document
Name some Business process modeling techniques
Event-driven process chain and Harbarian proces modelling
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
what is importnat when writting a quality manual?
the target group should be kept in mind and use visualization where appropriate
