Quality Management Training For Blood Transfusion Services: EHT/05.03 A Restricted

EHT/05.
03 A
Restricted
Quality Management
Training for
Blood
Transfusion
Services
Facilitator’s Guide
This publication forms part of a series of training materials developed specifically for use
in WHO Quality Management Training courses. Its distribution is restricted to approved
QMT training centres, course coordinators, facilitators and participants.
© World Health Organization, 2005.
All rights reserved.
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Contents
Preface
Acknowledgements
FACILITATOR’S GUIDE
Introduction 3
The need for quality management
WHO Quality Management Programme 3

Components of the QMP
Quality Management Training 4

Creating a culture of quality
Facilitator’s Toolkit 5
Course contents 6
Curriculum 6
Introduction
Part 1: Basic Principles of Quality
Part 2: Applying Quality Management in the BTS
Curriculum structure
Weekly programme of work 8

Presentation notes 8
PowerPoint presentations 9
Using the PowerPoint slides
PowerPoint handouts
Using the PowerPoint projector
Supplementary materials
Making your presentation
Activities 11
Activity notes: facilitator
Activity notes: participants
Activity materials
Facilitating an activity
Group work
Role play
Quality Status Questionnaire 14

Course evaluation form 15
Participant’s final report 15
Glossary 15
Participant’s Workfile 15
CORE COURSE MATERIALS

Course contents 19
Curriculum 23
Example of a weekly programme of work 65
Participant’s final report 68
Glossary 71
Preface
The availability of safe blood and blood products is a public health responsibility that is an essential
to modern medical care. Blood safety also plays a crucial role in preventing the transmission of
HIV, hepatitis viruses and other bloodborne pathogens through transfusion.
The World Health Organization (WHO) advocates the following integrated strategy to national
health authorities to promote the safety and accessibility of blood and blood products and reduce
the risks associated with transfusion.
1 Establishment of a well-organized, nationally-coordinated blood transfusion service
(BTS) that can provide adequate and timely supplies of safe blood and blood products to
meet the transfusion requirements of the patient population.
2 Collection of blood only from voluntary non-remunerated blood donors from low-risk
populations and the use of stringent criteria for assessing the suitability of donors.
3 Quality-assured testing of all donated blood for transfusion-transmissible infections,
including HIV, hepatitis viruses, syphilis and other infectious agents, and blood grouping
and compatibility testing.
4 Reduction in unnecessary transfusions through the appropriate clinical use of blood and
the safe administration of blood and blood products.
5 Implementation of effective quality systems, covering all aspects of BTS activities,
including quality management, the development and implementation of quality
standards, effective documentation systems, the training of all staff and regular quality
assessment.
WHO supports its Member States in implementing each element of this strategy for blood safety
through advocacy, training, materials development and technical support.
WHO Quality Management Programme

Consistent quality and the safety and availability of blood transfusion cannot be achieved without
effective quality systems, yet evidence from the WHO Global Database on Blood Safety 2001–
2002 (WHO, 2004) indicates a lack of trained quality management staff in blood transfusion
services, particularly in developing countries. An Aide-Mémoire: Quality Systems for Blood Safety
(WHO, 2003) outlines the requirements for quality systems for blood transfusion services.
To address the challenge of a lack of quality systems, WHO established the Quality Management
Programme (QMP) as a cornerstone of its initiatives to support Member States in ensuring the
overall safety of the transfusion process, from the recruitment of blood donors to the transfusion
of blood and blood products and follow-up of the recipients. The programme was developed to
build regional and national capacity in quality management and promote the establishment of
quality systems in blood transfusion at all levels of the health system in Member States.
Quality Management Training (QMT) lies at the core of the programme. Since the launch of the QMP
in 2000, BTS directors and quality managers from over 100 countries have been trained in the basic
principles of quality management for blood transfusion services. Initially conducted at regional and
inter-regional levels, QMT has now cascaded to national and local levels with post-course follow-up
and support from WHO, WHO Collaborating Centres and other centres of excellence designated as
Regional Quality Training Centres. WHO has also established regional external quality assessment
(EQA) schemes in blood group serology and virology and has published Quality Assessment of
Transfusion Laboratory Practice: Guidelines on Establishing an EQA Scheme in Blood Group
Serology (WHO, 2004) to support the establishment of national EQA schemes.
The Quality Management Training Facilitator’s Toolkit has been developed to provide a standardized
curriculum and training materials to ensure consistency in teaching in all regions of the world. The
curriculum was developed through an process of extensive consultation with experts in quality in
blood transfusion services from all regions of the world. The training materials were prepared by a
team of international facilitators and quality experts and were further refined following testing in a
series of regional, sub-regional and national QMT courses. The interactive course is based on two
main components: formal presentations and activities to enable course participants to apply what they
have learned.
The QMT Facilitator’s Toolkit has been produced in two formats: print and CD-ROM. The printed
edition, containing five books, has been produced to assist QMT course coordinators and facilitators in
planning and preparing for QMT courses. In addition to a Facilitator’s Guide, it contains the curriculum,
presentations in handout form, facilitator notes on presentations and activities and other resource
materials. The CD-ROM accompanying the Facilitator’s Guide contains all the materials required for a
QMT course, including PowerPoint presentations for use in teaching and materials for activities.
For further information on the WHO Quality Management Programme and Quality Management
Training, contact Blood Transfusion Safety, Department of Essential Health Technologies at:
bloodsafety@who.int. Website: http://www.who.int/bloodsafety.
Dr Neelam Dhingra
Coordinator, Blood Transfusion Safety
Department of Essential Health Technologies
World Health Organization
Acknowledgements
The Blood Transfusion Safety team in the WHO Department of Essential Health Technologies wishes to
express its thanks to the following experts in quality management in blood transfusion services for their
contribution to the development of the Quality Management Training Facilitator’s Toolkit.
Project director
Dr Neelam Dhingra, Coordinator, Blood
Transfusion Safety, Department of Essential
Health Technologies, WHO
Authors and editorial team

Dr Alan Kitchen, Head, National Transfusion Dr Neelam Dhingra, Coordinator, Blood
Microbiology Reference Laboratory, National Transfusion Safety, Department of Essential
Blood Service, England and Wales Health Technologies, WHO
Mrs Shân Lloyd, former Technical Officer, Blood Dr Jean C. Emmanuel, former Director,
Transfusion Safety, Department of Essential Department of Blood Safety and Clinical
Health Technologies, WHO Technology, WHO
Mr Neil Rosen, National Quality Manager, South Ms Jan Fordham, Technical Officer, Blood
African National Blood Service, South Africa Transfusion Safety, Department of Essential
Profesor Maurice Chassaigne, Delegate, Health Technologies, WHO
International Cooperation, Etablissement
Français du Sang, France
Critical readers and other contributors

Dr Jean-Baptiste Tapko, Regional Adviser, Blood Dr M.E. Chitiyo, Medical Director, National Blood
Safety, WHO Regional Office for Africa Transfusion Service, Zimbabwe
Dr José Ramiro Cruz-Lopez, Regional Adviser, Dr Janiet Merza Niqur, Director, National Blood
Laboratory and Blood Services, WHO Regional Bank, Jordan
Office for the Americas/Pan American Health Dr Faten Moftah, Medical Director, National
Organization Blood Transfusion Center, Ministry of Health,
Dr Nabila Metwalli, Regional Adviser, Blood Safety Egypt
Laboratory and Imaging, WHO Regional Office for Dr Rachanee O’Charoen, Director, National
the Eastern Mediterranean Blood Centre, Thai Red Cross Society, Thailand
Dr Valentina Hafner, Medical Officer, Quality of Mr Patrick Prakash, Senior Laboratory Officer,
Health Systems, Division of Country Support, Centre for Transfusion Medicine, Health
WHO Regional Office for Europe Sciences Authority, Singapore
Dr Rajesh Bhatia, Regional Adviser, Blood Safety Professor Cees Th. Smit Sibinga, Academic
& Clinical Technology, WHO Regional Office for Institute for International Development of
South-East Asia Transfusion Medicine, University of Groningen,
Dr Yu Junping, Blood Safety Specialist, WHO Sanquin Blood Bank Noordoost, Netherlands
Regional Office for the Western Pacific Dr Liliane Siransy-Bogui, Chief, Laboratory
Ms Susan Best, General Manager, National Services, Centre National de Transfusion
Serology Reference Laboratory, Australia Sanguine, Côte d’Ivoire
Professor Kamel Boukef, Director, National Blood Dr Diana Teo, Director, Centre for Transfusion
Transfusion Centre, Ministry of Public Health, Medicine, Health Sciences Authority, Singapore
Tunisia Dr Lenka Walterova, Head, Department of
Dr Pimol Chiewsilp, Quality Manager, National Clinical Haematology, Regional Hospital Liberec,
Blood Centre, Thai Red Cross Society, Thailand Czech Republic
Facilitator's Guide
Introduction
The Quality Management Programme (QMP) is a major global initiative developed by the
World Health Organization (WHO) to support its Member States in ensuring the overall
quality and safety of blood transfusion practice, from the collection of donated blood to the
clinical use of blood and blood products. The QMP was launched in 2000 with the objective
of helping to build national capacity in the effective quality management of blood transfusion
services (BTS), supporting the development of national quality systems and increasing the
awareness of BTS staff of the need for quality in all activities related to blood transfusion.
WHO has played a major role in supporting countries in ensuring the safety of blood and
blood products and their accessibility to all patients requiring transfusion. It works at global,
regional and country levels through advocacy at the highest level, supporting the
development and implementation of national blood policies and plans, helping to mobilize
resources and capacity building at regional and national levels. In support of these activities
WHO has developed advocacy, teaching and training materials which have been used widely
in workshops, technical training and other activities to support countries in the development
of strategies to ensure the safety and adequacy of the blood supply and safe clinical
transfusion practice.
The need for quality management

Blood transfusion is an essential and life-saving support within the health care system but,
globally, the safety and availability of transfusion is not assured. Particular threats include:
An insufficient number of voluntary non-remunerated blood donors to ensure an
adequate supply of safe blood and blood products
Risk of the transmission of infections such as HIV, hepatitis B and C, and syphilis
through unsafe transfusion
Unnecessary transfusions, which needlessly expose patients to the risk of acute or
delayed reactions and transfusion-transmitted infection
Errors in the transfusion of blood and blood products.
The focus of WHO initiatives and strategies has been the development of well-organized
national blood programmes that can provide timely supplies of safe blood and blood products,
collected only from voluntary non-remunerated donors. In order to ensure sustainability,
consistency of quality and the overall safety of the entire transfusion process, an effective
quality management system is required to provide the framework within which the blood
programme functions.
There are many definitions of quality, one of the simplest and most appropriate being “fit for
purpose”. In the context of blood transfusion, this means the setting and meeting of basic
national or international quality standards and then continual quality improvement to ensure
the safety of the transfusion process.
WHO Quality Management Programme

The WHO Quality Management Programme (QMP) is a global programme that is designed
to support countries in improving the safety and adequacy of blood transfusion by:
1 Building capacity in quality management in all aspects of blood transfusion through an
integrated approach of training and assessment.
2 Supporting the establishment of sustainable national quality systems in blood
transfusion services.
QMT/Facilitator's Guide 3
The QMP is a dynamic programme which aims to assist all national blood programmes to
reach common minimum standards, whilst offering flexibility to meet the needs of individual
countries. It was launched in 2000 and is coordinated at global level by WHO Headquarters.
At regional level, the QMP is coordinated by WHO Regional Offices, in partnership with
Regional Quality Training Centres, WHO Collaborating Centres, national blood transfusion
services, international nongovernmental organizations and experts in quality and transfusion
medicine.
Components of the QMP

The Quality Management Project has six integrated components:
Quality Management Training (QMT) to train at least two persons from each country in
every region as BTS quality managers/officers
Designation of at least one Regional Quality Training Centre (RQTC) in each region to
coordinate regional QMT courses and support national courses
Post-training support and follow-up of course participants
Expansion of External Quality Assessment Schemes in blood group serology and
transfusion-transmissible infections
Regional Quality Networks for the exchange of information and experience between
Regional Quality Training Centres, course participants and blood transfusion services
Development of advocacy and training materials to support QMT courses and the
establishment of national quality systems.
The long-term effectiveness of the QMP lies in the cascading of QMT from regional to
national level, with post-training follow-up to identify problems and provide additional support
through visits to individual participating countries, further training courses and the
involvement of global and regional partners in supporting quality management training at all
levels.
The success of the QMP depends on the individuals trained in regional QMT courses
applying what they have learned in developing quality systems within their own BTSs,
initiating and organizing national QMT courses and playing an active role in the development
of the regional and national quality networks. These are vital in ensuring continued
communication between course participants and providing the support needed for the
development of effective and sustainable national quality systems.
The expected outcomes of the programme are that the quality, safety and accessibility of
blood transfusion will be improved in all countries that have participated in the QMP,
including:
The establishment of a sustainable national quality system in each country, with a
quality area in each blood transfusion centre
An increase in blood donation by regular, voluntary non-remunerated blood donors
from low-risk populations
Quality-assured testing of all donated blood
A reduction in unnecessary transfusions and safe clinical transfusion practice.
Quality Management Training

Quality Management Training (QMT) courses are the foundation of the QMP. At regional
level, QMT courses are held in blood centres or other institutions designated as Regional
Quality Training Centres and are organized and facilitated by Regional Quality Training
Teams, comprising the Regional Quality Management Programme (QMP) Coordinator and
regional facilitators. A team of international facilitators provides additional technical support,
where required.
Regional and sub-regional QMT courses are normally attended by at least two participants
from each country, usually a person designated as the BTS quality manager and one or
more senior laboratory technicians. Prior to QMT courses, regional meetings are held to
sensitize directors of blood transfusion services and/or national blood programmes to the
need for quality systems to ensure blood safety and availability and to introduce them to the
Quality Management Programme. As the number of regional courses has increased, WHO
Regional Offices have decentralized training by supporting sub-regional and national QMT
courses.
Each 18-day course follows a standard curriculum that has been developed by an
international team of experts in quality management in blood transfusion services and has
been extensively reviewed and tested in QMT courses. It uses core training materials,
provided on the CD-ROM, in order to promote consistency in teaching, ensure common
understanding of quality terminology and concepts and provide tools that will enable QMT
participants to apply quality principles in their own working environments.
Each course is interactive in approach, using a combination of formal presentations, for
which Microsoft PowerPoint slides are provided, and a series of activities that are designed
to enable participants to apply what they have learned. Following an introduction to the QMP
and QMT, the course addresses general concepts and basic principles of quality and their
application in general manufacturing/service scenarios and then focuses on their application
to blood transfusion, including the organization, management and costing of blood
transfusion services, donor management and blood collection, laboratory testing, blood
component production, the issue of blood and the clinical interface and blood usage.
QMT courses focus on quality and quality systems and how they should be applied in all
aspects of the blood transfusion service through effective quality management. They are not
designed to train participants in technical areas such as blood donor management or
laboratory testing. Where a need for training on specific technical issues is identified,
additional courses may be planned as part of post-course follow-up and support.
Creating a culture of quality

A safe and adequate blood supply cannot be assured without quality – and quality comes
from the individual. Quality will not happen unless every member of staff, from the medical
director to the cleaners, understands that everyone is responsible for quality and that
everyone plays a part in developing and maintaining the quality system. A fundamental aim
of QMT courses is therefore to instill an understanding in participants that a culture of quality
has to be created in BTSs and that all staff need to be fully aware of this culture and play
their part in putting it into practice. An important part of the thrust of the QMT course, and a
measure of its effectiveness, must therefore be to ensure that course participants are aware
of their central role in this process and to stimulate their interest and enthusiasm for quality.
One of the fundamental objectives of QMT courses is to help participants to develop a
realistic plan of action for establishing an effective quality system in their own BTS and
assisting in the development of a national quality system.
Facilitator’s Toolkit
The five books of printed material comprising the QMT Facilitator's Toolkit are designed for
use in course planning by QMT course coordinators and facilitators. Book 1 contains the
Facilitator's Guide, overview of course contents, curriculum, example of a weekly programme
of work, glossary and the template for the participants' report to be completed at the end of
the course. Books 1–5 contain notes for facilitators on handling each session, handouts from
the PowerPoint presentations and instructions for conducting activities. They also contain
additional resource materials for use in activities.
The Facilitator's Toolkit is also provided on an interactive CD-ROM which contains the same
materials in .pdf format plus PowerPoint presentations (slide show) and activity notes for
participants. The CD-ROM has been designed for use during the course itself. If no CD-ROM
has been provided for a QMT course, please request one from the WHO Regional Office for
your region or from WHO Headquarters (e-mail: bloodsafety@who.int).
QMT materials are described below.
Course contents
The list of course contents provides a brief overview of a QMT course. It shows the modules
in each part of the course and lists the presentations and activities that are included in each
module.
Curriculum
The course curriculum provides a detailed guide to the structure and content of QMT courses.
It is a generic curriculum that has been designed for use in all QMT courses in order to
maintain a consistent approach to teaching. QMP Coordinators and facilitators should
therefore follow the curriculum and not omit any presentations or activities. However, there is
some in-built flexibility to allow local adaptation, where appropriate. In addition, where time
permits, additional presentations and activities may be included.
The curriculum is divided into fifteen modules. You should familiarize yourself with the entire
curriculum and its associated presentations and activities so that you can see where your
own sessions fit in with those of other facilitators. It is particularly important to look carefully
at all the presentations and activities in the modules that you will be involved in teaching in
order to avoid any duplication with other facilitators. Since each module builds on previous
modules, it is also essential to be aware of how they relate to other modules earlier or later in
the course. Modules in Part 1, for example, introduce concepts of quality in a general context;
these are expanded on in Part 2 where they are addressed specifically in the context of
blood transfusion services. Effective coordination and communication with other facilitators is
therefore vital during the course, and preferably also in advance.
The course consists of 57 presentations and 69 activities, including assessment. These are
organized into 15 modules which are presented as follows:
Introduction (1 module)
Part 1: Basic Principles of Quality (7 modules)
Part 2: Applying Quality Management in the BTS (7 modules).
Introduction
The Introduction is designed to place the course in context by outlining the WHO strategy for
blood safety and the need for quality in all aspects of blood transfusion and to introduce the
Quality Management Programme and the QMT course. It contains a single module.
Module 1 The WHO Quality Management Project
Part 1: Basic Principles of Quality

Part 1 explores the basic principles of quality and quality systems. Since many participants
will be unfamiliar with quality concepts and terminology, the curriculum is designed to
introduce quality in a general context by using familiar examples, including general
manufacturing and service scenarios, to illustrate the basic components of a quality system.
Part 1 contains the following seven modules.
Module 2 Introduction to Quality
Module 3 Quality Systems
Module 4 Organizational Management
Module 5 Standards for Quality Systems
Module 6 Documentation
Module 7 Training
Module 8 Assessment within the Quality System
Part 2: Applying Quality Management in the BTS

Part 2 focuses on the application of quality principles and systems within the blood
transfusion service. It begins by exploring the specific organizational requirements for quality
and then addresses the components of a quality system for all aspects of the BTS, from
blood donor recruitment to the administration of blood and follow-up of the patient. It focuses
particularly on the actions that need to be taken and the role of the quality manager in
establishing a quality system. Participants are introduced to the concept of action planning
and the final module draws together their work on the course when they finalize an action
plan for implementing a quality system in their own blood centre and assisting in the
establishment of a national quality system.
Part 2 contains the following seven modules.
Module 9 Quality Management in the BTS
Module 10 Hygiene and Safety in the BTS
Module 11 Quality Systems in Donor Management and Blood Collection
Module 12 Quality Systems in Laboratory Testing
Module 13 Quality Systems in Component Production and the Issue of Blood
Module 14 Quality Systems and the Clinical Interface
Module 15 Finalization of Participants’ Action Plans and Completion of the Course
Curriculum structure
The curriculum outlines the following information about each session.
1 Title: the number, title and type of session: i.e. presentation or activity.
2 Teaching aim: the purpose of the session.
3 Core topics: the main topics that will be covered in the session.
4 Key points: a summary of the most important messages that the session is designed
to convey and that you expect participants to remember.
5 Teaching focus: brief guidance on the recommended approach to handling this
session.
6 Learning outcomes: a brief summary of what participants should be able to do after the
presentation or completing the activity:
The learning outcomes for presentations generally specify what participants should
be able to describe or explain to demonstrate their knowledge and understanding of
topics covered in the presentation
The learning outcomes for activities focus more on the application of knowledge to
practice since the course is designed to assist participants to relate what they have
learned directly to their own blood transfusion service.
7 Timespan: the suggested time allocated for the presentation or activity plus discussion,
based on experience in field testing.
Weekly programme of work

The course has been designed to take place over a period of 18 days. Experience from
earlier QMT courses has demonstrated that it is not possible to complete the course in a
shorter period of time. Participants will be unfamiliar with many of the concepts that will be
presented to them during the course and will need time to understand the principles of quality
and learn how to apply them.
Your QTC should provide you with a copy of the weekly and daily programme of work in
advance, including the dates and times of presentations and activities, as well as a list of
facilitators for each session. The programme of work should be explained to participants in
session QMT 1.3. An example of a weekly programme of work is included in this book and
on the CD-ROM.
You should be present throughout the days allocated for your involvement as a facilitator and
attend presentations made by other facilitators so that you are familiar with the topics that are
being covered in other sessions. You should also be present during activities facilitated by
other facilitators so that you can assist participants in group work.
The QMP Coordinator should organize evening debriefing meetings and brief you on the
programme for the following day. You will also find it helpful to talk informally with other
facilitators to ensure a coordinated approach to teaching.
Presentation notes
The PowerPoint presentations provided on the CD-ROM are the core training material. Each
PowerPoint presentation is accompanied by notes that provide guidance on how to present
the session, identify the key messages in the presentation and suggest ways of ensuring that
these messages are understood. It is essential to familiarize yourself with both the
presentation notes and the PowerPoint presentation in advance of the session. You may
wish to add your own handwritten notes on the handouts showing the slides; these are also
provided on the CD-ROM. The presentation notes include the following information, some of
which is also included in the curriculum for easy reference.
1 Teaching aim.
2 Core topics.
3 Key points.
4 Teaching focus.
5 Learning outcomes: participants generally find learning outcomes helpful because they
specify what each individual should have learned from the session. You should also
find learning outcomes useful because they will help you to evaluate the effectiveness
of the session and assess whether further teaching is required on particular topics.
6 Materials required:
Some materials, such as examples of documentation and case studies, are
provided on the CD-ROM
Publications: these should be supplied in advance by the QTC or WHO.
Wherever possible, provide examples of documentation from your own region or

country.
The QTC is responsible for providing copies of any materials that need to be
distributed to participants during the session. However, you should check that all
materials required are available in sufficient quantities in advance of the session.
7 List of PowerPoint slides in the presentation.
8 Presentation notes: these provide guidance on how to use the PowerPoint slides
during the session and suggest points for emphasis or discussion. Where the notes
indicate that topics are covered in other sessions, you should simply provide a brief
introduction and explain to participants that these topics will be discussed in more
depth later in the course or remind them of the sessions in which they have already
been covered.
9 Related activities: most presentations are followed by activities that are designed to
assist participants to apply what they have learned from the session. Ensure that you
are familiar with any activities (and other presentations) related to the sessions that
you will be presenting and understand the objectives and the instructions for
conducting the activities effectively. Explain how the activities link in with the sessions
that precede and follow them and how they are designed to help participants to apply
what they have learned from the presentations.
10 Timespan: suggested allocation of time for the session, including discussion.
PowerPoint presentations
The 57 PowerPoint presentations are the main teaching resource for the course and are
designed to strengthen participants’ knowledge and understanding of quality principles and
how they can be applied in the BTS.
Please note that the copyright of the PowerPoint files belongs to WHO and the files should
not be amended without permission.
Each presentation has a similar structure and contains the following common slides that
have been taken from the curriculum:
Title
Teaching aim
Core topics
Key points
Learning outcomes.
Using the PowerPoint slides

However experienced you are as a teacher, preparation is the key to making an effective
presentation. It is essential that you study the slides and the accompanying presentation
notes in advance and plan how you will use them to cover the topics allocated to you. While
the same presentations will be used by all facilitators, each facilitator will present them in a
different way because each of you will draw on your own experience of quality, quality
systems and quality management to talk about the points covered by the slides. Remember
that you should use all the slides provided but, if you wish, you can prepare an additional
PowerPoint file to expand on issues in the presentation, particularly if you wish to add
examples or introduce regional or local issues.
The slides provide a framework for your teaching, but do not provide the total content of your
presentation. In effect, they provide a series of headings for you to expand on during the
session. Plan carefully what you will say about each of the topics presented on each slide.
Talk to the QMP Coordinator if you find the meaning of any slides unclear or do not feel
confident about presenting them. Don’t present a session without being thoroughly familiar
with the slides and preparing your talk.
PowerPoint handouts
For each presentation, a handout is provided which shows the slides in the presentation,
three to a page, with space for you to add notes. The handouts should also be photocopied
and given to participants to add to their Workfiles.
Using the PowerPoint projector

PowerPoint presentations are made using a special projector which should be available in
the training centre. Check that the file has been loaded onto the hard disk of the computer in
advance of the session. If you have not used a PowerPoint projector before, ask one of the
staff of the training centre to demonstrate and practise in advance until you feel confident
about moving from one slide to the next throughout the presentation.
Supplementary materials
Before the session, prepare any supplementary materials, such as examples of
documentation, that you want to provide for participants. Check that sufficient copies are
available before the session starts.
Making your presentation

While the PowerPoint slides cover the key issues to be covered in the session, they simply
provide a framework for your teaching and you must use your own experience to illustrate
and expand on the points in the slides.
Keep the following principles in mind when making your presentation.
1 Emphasize that the purpose of the course is not to provide training on technical
aspects of blood transfusion services, but rather to enable participants to develop the
knowledge and skills to establish and maintain an effective quality system in their own
BTS. Don’t allow the sessions to be diverted into discussions on technical issues such
as the characteristics of anti-HIV screening assays, but keep the focus on the action
required to ensure quality in each area of BTS activity. If you identify a need for
specific technical training, discuss this with the QMP Coordinator as workshops on
specific technical issues in blood transfusion may be organized as part of post-course
follow-up.
2 The course is very intensive and participants will be introduced to many new and often
complex concepts. Your communication skills and the way in which you make your
presentation will therefore play an important part in promoting participants’ interest and
understanding and creating an effective learning experience for them. Avoid simply
reading the points on the slides and use a lively style of delivery to explain the
concepts you are introducing. You may find it helpful to use a flipchart, whiteboard or
overhead projector transparencies to illustrate key issues in more depth or to
summarize points that have arisen in discussion.
3 Be flexible and creative in your approach and be prepared to adjust the level of your
teaching in response to participants’ needs. Check for understanding by questioning
and observing participants; you can learn a great deal from their body language. If
they look bored or confused, you may need to vary your style or pace of presentation
or to address some issues in more depth. If they are unresponsive to questions, they
may have found it difficult to understand some of the concepts you have presented or
feel that, in practice, it would be difficult to apply them in their own BTS. Whatever the
reason, you need to find out whether they have achieved the learning outcomes
specified for the presentation or whether any further teaching or discussion is required.
4 Use general examples to introduce new topics and then progress to BTS-specific
examples. Participants who have little experience of quality management may be
overwhelmed by new ideas and concepts unless these are first introduced in a simple
way that they can relate to their own experience. Some of the presentations use
simple daily activities to illustrate quality principles, such as making a cup of coffee or
general manufacturing processes in food production. Use your own experience to
provide additional examples that will be meaningful and will help participants to
understand how quality concepts relate to their everyday lives as well as their work.
5 The course is designed to be highly interactive so promote questions and discussion.
Some participants may be unfamiliar with an active style of learning and may need
encouragement to ask for clarification or express their opinions. Acknowledge that
some quality issues may initially be difficult to understand and check that participants
have understood the points you have explained.
6 Be prepared for any question and always answer honestly. If you don’t know the
answer, use the question as an opportunity to explore the issue with the participants
through discussion.
7 Encourage and positively reinforce participants’ learning, but be realistic in your
expectations. Some participants may work in BTSs that have not yet established
quality systems; don’t criticize them for any current limitations in their BTS or their own
experience or expect that they will be able to establish a quality system in a short
period of time. Participants who are made to feel inadequate will not learn effectively.
Recognize and discuss any constraints they may face in setting up a quality system,
such as working within a fragmented, hospital-based blood programme, and focus on
helping them to understand how they can begin to apply quality principles in their own
work environment. Don’t be too prescriptive: keep reminding participants that there are
many ways of doing things.
8 Identify any continuing learning needs of individual participants as well as the group as
a whole and discuss these with the QMP Coordinator as feedback from facilitators is
essential in:
Shaping the remainder of the course to the needs of the specific group of
participants
Identifying priorities for post-course follow-up and support.
Activities
The course is designed not only to enhance participants’ knowledge and understanding of
quality principles and concepts, but also to assist them in developing the skills needed to
establish a quality system in their own BTS. The course should therefore be as interactive as
possible.
Most topics are covered by a presentation and one or more activities; the activities are an
essential part of the training process because they complement and reinforce the topics
covered and enable participants to practise applying what they have learned. In particular,
they are designed to encourage participants to explore quality concepts from their own
perspectives and give them some experience in planning and developing components of
quality systems.
The course contains 69 activities.
Activity notes: facilitator

For each activity, the following information is provided for facilitators.
1 Teaching aim.
2 Core topics.
3 Key points.
4 Teaching focus.
5 Learning outcomes.
6 Type of activity: the majority of activities are conducted in small groups followed by
plenary discussion, but some involve role play or individual exercises.
7 Materials required:
Most activities will require flipcharts (or overhead projector transparencies) and
pens for participants to summarize their discussions and report back to the plenary
group
Where additional materials are required, they are provided on the CD-ROM
You may wish to provide additional materials as examples or to relate the topics
more specifically to regional or national issues.
8 Instructions for conducting the activity: ensure that you clearly understand the
instructions for the activity and how it relates to the preceding presentation. See below
for further guidance on facilitating an activity.
9 Review of the activity: guidance is provided on the main issues to be covered in
discussion when the activity has been completed and the participants have
reassembled in the plenary group. Ensure that the key points have been addressed
and assess whether participants have achieved the learning outcomes.
10 Timespan.
Activity notes: participants

Instructions on completing each activity are provided for participants on the CD-ROM. These
should be printed out and photocopied in advance and distributed to participants at the start
of the activity.
Activity materials
Where applicable, activity sheets are provided on the CD-ROM, including case studies,
instructions on role plays and activity work sheets. These should be printed out and
photocopied in advance and distributed to participants at the start of the activity.
Facilitating an activity
It is essential to familiarize yourself with the activities to ensure that you understand what
they are designed to achieve and can explain the instructions to participants, some of whom
may have little or no experience of group work. You may find it helpful to test out the activity
in advance, perhaps with a group of your colleagues.
There will normally be a range of different abilities, backgrounds and levels of responsibility
among the participants and you will need to take this into account in facilitating the activities.
Participants are often unfamiliar with activity-based learning and may need encouragement
to participate fully. You will need to be flexible and creative in your approach to conducting
activities and to be prepared to steer the discussion back to the core topics and key points if
participants stray from them.
Group work
The majority of activities are conducted in small groups, although assessment and a small
number of other activities are undertaken on an individual basis. Group work plays an
important part in the course because it provides an opportunity for in-depth discussion and a
free exchange of views, enabling participants to learn from each other as well as from the
facilitators. It also promotes more active participation by individuals who are hesitant or shy
about speaking in the larger plenary group. At the beginning of the course, the QMP
Coordinator should already have divided the participants into small groups of 5-8 people,
depending on the total number of participants, ensuring a good mix of personalities and
experience in the groups. Ideally, there should be a separate room available for each small
group but, if this is not possible, arrange the groups in the space available so that they can
talk without being distracted by participants in other groups.
At least one additional facilitator should be present to assist in facilitating each activity.
Where possible, these facilitators should have attended the sessions to which the activities
relate so that they are familiar with the issues addressed in the presentations and can
reinforce them with examples and ideas from their own experience.
When facilitating an activity, keep the following principles in mind.
1 Explain the aim and anticipated learning outcomes for the activity and distribute the
instructions. Check that participants have understood them. Ensure that any materials
for the activity are distributed to participants at the appropriate time.
2 Instruct each group to designate one person to act as moderator to focus the
discussion and another as rapporteur to take notes and report on the discussion to the
plenary group at the end of the activity. The roles of the moderator and rapporteur
should be rotated throughout each group to prevent the discussions being dominated
by more articulate or confident participants and to ensure that each person has the
opportunity to report on activities. A flipchart or blank overhead projector
transparencies and pens should be provided for each rapporteur to summarize the
group’s discussion.
3 Once the group work has started, the facilitators should move between the groups to
ensure that they have understood the purpose of the activity and what they are
expected to do. Make sure that participants remain focused on the task and do not
become diverted from the key issues. Check that all members of the group, particularly
the quieter ones, are participating actively and, if necessary, specifically encourage
individuals to express their ideas and opinions.
4 Answer any questions raised by participants, but avoid spending all your time with one
group or dominating the discussion. Use the review session with the plenary group at
the end of the activity to highlight key issues, answer common questions, promote
further discussion and summarize the session.
5 Encourage participants to be creative in their thinking and to share their experience in
identifying problems, constraints and possible solutions. The groups must develop
their own communication dynamics.
6 At the end of the work in small groups, bring all the participants together in the plenary
group. Ask the rapporteurs to summarize their groups’ discussion and conclusions.
Encourage further discussion of the activity and what participants have learned from it.
Use the guidance notes to ensure that the key points have been addressed and check
whether participants feel that they have achieved the learning outcomes.
7 Keep in mind that the time allocated for each activity includes time for discussion in
the plenary group. Allow approximately five minutes for each rapporteur to make their
reports and for questions and answers.
Role play
Two activities, QMT 8.13 and 8.15, are built around role play, in which participants simulate
real-life situations by acting out a scenario, using instructions and player briefs that are
provided on the CD-ROM. The role play is followed by plenary discussion. This technique is
a lively way of demonstrating key issues and generating insights in a way that is not possible
through lectures or discussion and is one of the most effective ways of bringing learning
close to real life.
Most participants are unlikely to have participated in role play before, so it is essential to give
them clear instructions on what they have to do. Encourage them to use their imagination in
acting out their roles, but reassure them that their enthusiasm and enjoyment are more
important than their performing ability. Role play is intended to be fun, while at the same time
illustrating serious points. Explain that the role play will help them in understanding key
concepts and that they should use their skills of observation and analysis throughout the
activity. The review of the activity is particularly important to highlight issues that have
emerged from the scenario.
QMT 8.15: Analysing Quality System Failures is a complex role play, called Smartosis
Cocoanaemia, which is designed to illustrate the problems that can occur in the absence of
an effective quality system. Most participants find it very enjoyable and enlightening, but its
success depends on good preparation and skilful facilitation. The role play involves all
participants and requires various materials to be prepared in advance and distributed to the
correct participants. If you are involved in facilitating this activity and are not fully familiar with
the scenario, talk to the QMP Coordinator about how it should be handled and the issues that
should be raised in discussion afterwards.
Quality Status Questionnaire

In QMT 9.7: Quality Status Analysis, each participant is requested to complete a Quality
Status Questionnaire (QSQ) for the centre in which he or she works. The QSQ is designed
both as an assessment tool as a means of generating baseline information for use at the
institutional level in assessing progress in implementing quality systems, evaluating the
impact of QMT courses and identifying follow-up requirements. All QMT participants will
complete the same questionnaire, regardless of the level of the health system in which they
work.
The questionnaire will be distributed by the QMP Coordinator to participants before they
attend the QMT course in order to give them an opportunity to collect the required
information and begin filling in the questionnaire.
QMT 9.7 is an individual activity in which participants finish filling in the questionnaire. By this
stage of the course, they should be familiar with quality concepts and terminology and should
be able to answer all the questions. If you are facilitating this session, check whether
participants have any remaining difficulties in completing the questionnaire and provide any
clarification or assistance they may require. Assess whether any participants have any
difficulty in understanding specific quality concepts since this will indicate a need for further
teaching.
Each participant’s responses to the questionnaire will indicate their priorities for action when
they return to their own countries. Ensure that these priority areas are addressed in the
individual action plans that they will begin to prepare in Activity QMT 9.9 and will complete in
Module 15.
Course evaluation form

The course concludes with an evaluation of the course by participants. Ensure that each
participant completes the course evaluation form (QMT 15.7) as this will help to identify any
modifications that may be needed when the next course is planned.
Participant’s final report

As you facilitate sessions during the course, you will have a variety of opportunities to
observe participants and to talk to them about the course and how they will implement what
they have learned from it. An important part of your role as a facilitator is to liaise with the
QMP Coordinator and provide feedback at regular intervals on participants’ strengths and
weaknesses and, in particular, any areas in which they will require further support, both
during and after the course.
A final report form for each participant should be completed by the QMP Coordinator and
facilitators. Add your comments at the end of each module in which you have facilitated
sessions and ensure that you have completed all the forms before your departure.
Glossary
The Glossary provides definitions of quality terminology used in QMT courses. Where
possible, accepted definitions from ISO 9000 are included but, in some cases, the terms
used within the course are not defined within the most recent ISO standard. In the absence
of any other formal definitions, the most commonly accepted definitions have been used.
Participants should find the glossary helpful in defining terms that have similar meanings or
new terms with which they are not familiar.
Keep in mind that the language of the course may not be the participants’ mother tongue and
you may have to be flexible in defining some terms used during the course. When
introducing new terms, explain them when they first appear in a presentation or activity and
check that participants have understood them before proceeding.
Participant’s Workfile
At the beginning of the course, each participant will receive a Participant’s Workfile. This
consists of a folder to which the following materials will be added:
Presentation handouts: printouts of the slides in each presentation with space for them
to add their own notes
Activity notes containing instructions on what participants are required to do during
each activity
Resource materials, such as examples of documentation, published material and
materials required to complete activities
Glossary.
At the end of the course, participants will be given a copy of the CD-ROM containing the
Facilitator’s Toolkit.
Core Course Materials
QUALITY MANAGEMENT TRAINING
COURSE CONTENTS
INTRODUCTION
Module 1 The WHO Quality Management Programme
QMT 1.1 WHO strategy for blood safety Presentation
QMT 1.2 WHO Quality Management Programme (QMP) for blood Presentation
transfusion services
QMT 1.3 Introduction to the WHO QMT Course Presentation
QMT 1.4 Participants’ expectations Activity
QMT 1.5 Pre-course assessment Activity
PART 1 BASIC PRINCIPLES OF QUALITY

QMT 2.1 The importance of quality in the blood transfusion Presentation
service
QMT 2.2 The consequences of poor quality in the blood Activity
transfusion service
QMT 2.3 Introducing quality Presentation
QMT 2.4 Quality characteristics Activity
QMT 2.5 Tour of the Blood Transfusion Centre (BTC) Activity

QMT 3.1 Quality systems Presentation
QMT 3.2 Processes and procedures Presentation
QMT 3.3 Flowcharting as a tool for mapping processes Presentation
QMT 3.4 Developing a process flowchart Activity

QMT 4.1 Management responsibility for quality Presentation
QMT 4.2 Developing a quality policy Activity
QMT 4.3 Organizational structure and role of the quality manager Presentation
QMT 4.4 Developing an organigram Activity
QMT 4.5 Job descriptions, responsibility and delegation Presentation
QMT 4.6 Writing a job description Activity
QMT 4.7 The cost of quality Presentation
QMT/Core Course Materials 19

QMT 5.1 Introduction to standards for quality systems Presentation
QMT 5.2 Principles of good manufacturing practice Presentation
QMT 6.1 Documentation in quality systems Presentation
QMT 6.2 Standard operating procedures Presentation
QMT 6.3 Writing an SOP Activity
QMT 6.4 Validating an SOP Activity
QMT 6.5 Document control Presentation
QMT 6.6 Controlling a document Activity
Module 7 Training
QMT 7.1 Training in the quality system Presentation
QMT 7.2 Training needs and plans Presentation
QMT 7.3 Creating a training plan Activity
QMT 7.4 Monitoring and evaluation of training Presentation

QMT 8.1 Assessment within quality systems Presentation
QMT 8.2 Validation Presentation
QMT 8.3 Preparing a validation plan Activity
QMT 8.4 Maintenance and calibration of equipment Presentation
QMT 8.5 Designing a maintenance and calibration plan Activity
QMT 8.6 Quality monitoring tools Presentation
QMT 8.7 Analysing data and monitoring performance Activity
QMT 8.8 Error management Activity
QMT 8.9 Preparing an SOP on error reporting Activity
QMT 8.10 Audits and auditing Presentation
QMT 8.11 The audit process Presentation
QMT 8.12 Developing an audit plan Activity
QMT 8.13 Identifying non-compliances against a set of standards Activity
QMT 8.14 Audit of a work area Activity
QMT 8.15 Analysing quality system failures Activity
QMT 8.16 Mid-course assessment Activity
PART 2 APPLYING QUALITY MANAGEMENT IN THE BTS

QMT 9.1 Applying quality management in the BTS Presentation
QMT 9.2 Identifying critical control points and preparing flowcharts Activity
for BTS activities

QMT 9.3 Steps in developing a quality system in the BTS Presentation
QMT 9.4 Costing activities in a blood transfusion service Presentation
QMT 9.5 Principles of stock control Presentation
QMT 9.6 Quality aspects of contingency planning Presentation
QMT 9.7 Quality status analysis Activity
QMT 9.8 Preparing an action plan Presentation
QMT 9.9 Preparing a draft action plan Activity

QMT 10.1 Introduction to hygiene and safety in the BTS Presentation
QMT 10.2 Hygiene in the BTS Presentation
QMT 10.3 Biological and chemical safety in the BTS Presentation
QMT 10.4 Safety issues and minimizing risks Activity
Module 11 Quality Systems in Blood Donor Management

QMT 11.1 Introduction to quality systems in blood donor Presentation
management
QMT 11.2 Donor recruitment and selection Presentation
QMT 11.3 Donor recruitment and selection Activity
QMT 11.4 Blood collection Presentation
QMT 11.5 Blood collection Activity
QMT 11.6 Developing a documentation system for blood donor Presentation
management
QMT 11.7 Donor care, satisfaction and retention Presentation
QMT 11.8 Donor satisfaction Activity
QMT 11.9 Identifying and monitoring critical control points in blood Activity
donor management

QMT 12.1 Introduction to quality systems in laboratory testing Presentation
QMT 12.2 Evaluation and use of immunohaematology reagents Presentation
QMT 12.3 Evaluation and use of test kits for transfusion- Presentation
transmissible infections
QMT 12.4 Selecting reagents and test kits Activity
QMT 12.5 Developing a documentation system for the laboratory Presentation
QMT 12.6 External quality assessment (EQA) schemes Presentation
QMT 12.7 Identifying and monitoring critical control points in Activity
laboratory testing
Module 13 Quality Systems in Component Production and Management

QMT 13.1 Introduction to quality systems in blood component Presentation
production and management
QMT 13.2 Quality monitoring of blood component production Presentation

QMT 13.3 Evaluation and monitoring of blood component Activity
production activities
QMT 13.4 Quarantine and release Presentation
QMT 13.5 Storage and transportation of blood components Presentation
QMT 13.6 Storage and transportation of blood components Activity
QMT 13.7 Blood stock management Presentation
QMT 13.8 Developing a documentation system for blood Presentation
component production
QMT 13.9 Identifying and monitoring critical control points in blood Activity

QMT 14.1 Introduction to quality systems at the clinical interface Presentation
QMT 14.2 Policy and guidelines on the clinical use of blood Presentation
QMT 14.3 Role of the BTS at the clinical interface Activity
QMT 14.4 Documentation in the hospital transfusion process Presentation
QMT 14.5 Designing a blood request form Activity
QMT 14.6 Quality in the hospital transfusion process Presentation
QMT 14.7 Quality in the hospital transfusion process Activity
QMT 14.8 Monitoring and evaluation of the hospital transfusion Presentation
process
QMT 14.9 Haemovigilance Presentation
QMT 14.10 Identifying and monitoring critical control points for the Activity
clinical interface and the administration of blood
Module 15 Finalization of Participants’ Action Plans and Completion of

the Course
QMT 15.1 Review of the course Activity
QMT 15.2 Laboratory/clinic visits in BTS Activity
QMT 15.3 Completing individual action plans Activity
QMT 15.4 Discussion of individual action plans Activity
QMT 15.5 Review of quality systems Presentation
QMT 15.6 Post-course assessment Activity
QMT 15.7 Course evaluation Activity
QMT 15.8 Final discussions Activity

CURRICULUM
Opening Ceremony
Introduction
Module 1 The WHO Quality Management Programme
Title Teaching Aim Core Topics Key Points Teaching Focus Learning Outcomes Time
QMT 1.1 To introduce course • WHO strategy for global • The WHO strategy for • Ensure participants Participants should be able ¼ hour
participants to the WHO blood safety blood safety defines understand the WHO to:
WHO strategy for
strategy for blood safety requirements for the strategy for blood safety • Describe the WHO
blood safety
safety, adequacy and strategy for blood safety
Presentation accessibility of national
blood supplies
QMT 1.2 To introduce course • Quality Management • The WHO QMP aims to • Ensure participants • Explain the purpose of ½ hour
participants to the WHO Programme assist Member States in understand the goals of the QMP and QMT
WHO Quality
Quality Management • Quality Management improving the safety and the QMP
Management
Programme (QMP) and Training adequacy of national • Emphasize the
Programme (QMP)
Quality Management blood supplies principles of active
for Blood
Training (QMT) • QMT courses are held in learning in QMT courses
Transfusion
Services each region to support
the establishment of
Presentation quality systems in blood
transfusion services in
all Member States
• QMT course participants
will play a central role in
establishing national
quality systems

QMT 1.3 To introduce the WHO • Modular approach • The overall structure of • Ensure participants • Outline the structure and ½ hour
QMT course • Role of the facilitators the course is modular understand the course content of the course
Introduction to the objectives and structure
WHO QMT course • Role of the participants • The course will help • Identify their role and
participants to • Ensure participants responsibilities in the
Presentation implement quality recognize the active role QMT course
systems in their they are expected to
BTS/blood centre take in the learning
• The role of the process
facilitators is to ensure • Encourage participants
that there is active to ask questions about
learning the course
QMT 1.4 To find out what course • Discussion of the • QMT is not designed to • Help to keep • Explain how the QMT 2 hours
participants expect to gain objectives and structure provide technical training participants’ course will assist them in
Participants’ from the QMT course of the QMT course expectations realistic applying the principles of
expectations • Follow-up and support
• Identification of will be provided after the and focused on quality quality in their own BTS
Activity participants’ specific course rather than on technical
interests and learning • If identified as a need, issues
needs in relation to technical training will be
quality management provided after the
course
QMT 1.5 To determine participants’ • Assessment of • The pre-course • Emphasize that the pre- • Assess their own level of ¾ hour
current levels of knowledge participants’ knowledge assessment aims to course assessment is knowledge and
Pre-course and understanding about and understanding of generate baseline not an examination understanding of quality
assessment quality quality information about issues
Activity • Determination of the participants
range of knowledge • It will help facilitators to
within the group in order focus the course on
to plan an appropriate areas of particular
level of training weakness or need

Part 1 BASIC PRINCIPLES OF QUALITY
QMT 2.1 To introduce the overall • The need for quality in • Quality is essential to • Encourage participants • Explain the importance ½ hour
The importance of concept of quality in the the BTS ensure that blood to identify additional of quality in blood
quality in the blood blood transfusion service • Factors affecting quality transfusion is safe and positive outcomes of transfusion
transfusion service • Results of quality efficacious quality • Identify the positive
• Quality applies to all • Emphasize that quality is outcomes of quality in
Presentation BTS activities everybody’s the BTS
• Quality involves all staff responsibility
• Quality benefits all
• Quality improvement is
achievable, even when
resources are limited
QMT 2.2 To contrast the • The consequences of Poor quality: • Encourage participants • Identify some of the ¾ hour
The consequences consequences of poor poor quality for blood • Endangers patients’ to discuss some reasons for poor quality
of poor quality in quality with the benefits of donors, recipients, staff lives examples of poor quality in the transfusion
the blood good quality and the BTS • Undermines the in relation to blood process
transfusion service credibility of the BTS transfusion and the • Identify the
reasons why they may consequences of poor
Activity • Creates a negative
occur quality
attitude towards blood
donation and transfusion • Do not force reluctant
participants to reveal
• Contributes to poor staff
deficiencies in their own
morale and job
BTS at this early stage
insecurity
of the course
• Acknowledge the
problems and
constraints posed by
limited staff and
resources
• Emphasize that the
QMT course will focus in
a practical way on how
every BTS can work
towards quality

QMT 2.3 To introduce the concept of • What is quality? • Quality is a continual • Ensure all participants • Demonstrate an ¾ hour
Introducing quality quality • Benefits of quality process of striving for have a clear understanding of the
• Quality as a process of improvement to ensure understanding of basic broad concepts of
Presentation consistently high quality principles of quality quality
continuous improvement
• Basic quality principles • Quality products and • Recognize the
services are fit for their importance of quality in
• Basic quality definition purpose everyday life and in the
• Fitness for purpose BTS
• Quality characteristics
QMT 2.4 • To demonstrate how the • Quality is "fitness for • Customers want a high • Ensure that the aim of • Identify the quality 1 hour
Quality term ‘fitness for purpose’ purpose" quality product/service the activity is clear characteristics of a
characteristics is a broad definition of • Quality extends beyond • Everything about a • Ensure an product
quality simply producing a product defines its understanding of • Demonstrate an
Activity • To demonstrate how product quality defining and meeting understanding of fitness
quality applies to • Quality relates to customer needs for purpose and
common, everyday products, production, customer needs
situations packaging and service
• To introduce the concept
of quality characteristics
QMT 2.5 To familiarize participants • Familiarization with the • Quality is visible • Point out areas of • Identify elements of a 1½ hours
with the layout and building • Quality is a continuing particular interest in quality system that lead
Tour of the Blood activities of the BTC relation to quality to consistency and
Transfusion Centre • Opportunity to observe a process
working blood • Quality involves all staff • Do not get drawn into fitness for purpose
(BTC)
transfusion centre (BTC) specifics about the way
Activity • Introduction to a working in which the BTS works
quality system

QMT 3.1 To introduce the concept of • Quality and quality • Quality systems are • Use examples of simple, • List the key elements of ½ hour
Quality Systems quality systems systems designed to control generic quality systems a quality system
• Key elements of a processes to ensure understanding • Demonstrate an
Presentation quality system: • There are five key • Where appropriate, understanding of the
─ Organizational elements in a quality encourage participants interrelationship
management system: to discuss their own between these key
─ Standards for quality ─ Organizational quality systems elements
systems management
─ Documentation ─ Standards for quality
─ Training systems
─ Assessment ─ Documentation
─ Training
─ Assessment
QMT 3.2 To introduce the concept of • Processes • An organization’s • Check for understanding • Define processes and ½ hour
Processes and processes, procedures and • Procedures operations consist of of the concepts of procedures
procedures their control processes and processes and • Define critical control
• Critical control points
procedures procedures points and indicators
Presentation • Indicators
• Critical control points • Emphasize that there • List the characteristics of
need to be identified in are critical control points indicators
each procedure in every process
• Indicators for measuring
control of the procedure
must be identified and
analysed

QMT 3.3 • To introduce the use of • Main elements of the • Processes and • Use simple examples of • List factors that need to 1 hour
Flowcharting as a flowcharts for analysing analysis of processes procedures must be processes be considered in
tool for mapping processes and procedures analysed in order to • Use conventional process analysis
processes • To illustrate the use of • Preparing flowcharts identify critical control flowcharting symbols • Design a flowchart of a
flowcharts for identifying points and terminology process
Presentation critical control points • Several important
questions should be
asked when analyzing a
process:
─ Is the task critical to
the outcome?
─ Can the task – or the
outcome of the task –
be measured?
• Flowcharting provides a
simple picture (map) of
the overall process
QMT 3.4 To demonstrate to • Breakdown of a specific • Processes are made up • Focus on the basic • Identify the individual 1½ hours
Developing a participants that the process of individual procedures processes, from raw elements in a specific
process flowchart concept of process flow • Analysis of the process • Flowcharts help to clarify materials to final product process
can be applied to any given using a flowchart the individual elements and distribution • Develop a simple
Activity situation of processes and • Emphasize the need for process flow chart
procedures, including simplicity
critical control points • Provide a specimen
flowchart for the process

QMT 4.1 To introduce • Quality management • Commitment by • Emphasize the • Define management’s ½ hour
Management management’s terminology management to quality importance of top-level responsibilities for
responsibility for responsibilities for the • Organizational is essential support and action quality
quality quality system responsibility for quality • Responsibility for quality • Emphasize the role of all • Define commonly used
• Quality policy as a part should be outlined in the staff in ensuring quality quality management
Presentation quality policy and plan terminology
of the organization’s
strategic plan • Quality must first be • List the key elements of
• Planning and planned by management a quality policy
implementing a quality • The involvement and
system commitment of all staff is
• Managing a quality essential to develop a
system "culture of quality"
QMT 4.2 To consolidate participants’ • Full and active support • The quality policy must • Ensure that the policies • Write a quality policy for 1½ hours
Developing a learning about quality from senior reflect the needs of the reflect the organization a generic organization
quality policy policies management organization’s and its customers • Apply the general
• Formal approval and customers as well as its • Focus on simplicity and principles and ultimately
Activity own structure and
acceptance of the policy the use of simple write a quality policy for
• Key quality principles capabilities wording their own BTS
upon which the policy is • Whatever standards are • Ensure there is a section
based adopted, they must be for top management to
• Identifying appropriate appropriate to the sign the policy
standards organization
• The support of senior
management is central
to successful
implementation of the
quality policy

QMT 4.3 To highlight the importance • Authority and • Every organization • Emphasize that • Explain why a clear ½ hour
Organizational of a reporting structure in responsibility for the needs a formal structure organizational structures organizational structure
structure and role an organization and the organization’s activities • A clear organizational need not be complex to is an important part of a
of the quality role of the quality manager • Importance of a clear structure is essential for be effective quality system
manager definition of all activities smooth functioning • Ensure participants • Prepare a basic
and responsibilities in an • Authority and understand the organizational chart
Presentation organization definitions of authority (organigram)
responsibility within the
• Role and responsibilities organization must be and responsibility and • List the responsibilities
of the quality manager defined how the two are related of the quality manager
• Structures should be in an organization
developed that maintain
and strengthen the
organization as a whole
• The quality manager is
responsible for the
implementation and
maintenance of the
quality system
• The quality manager
must be independent of
operational activities
• The quality manager
reports to the head of
the organization or
institution
QMT 4.4 To provide practice in • Preparation of • Organigrams simplify the • Ensure the participants • Draw an organizational 1 hour
Developing an preparing a simple organizational charts presentation of keep to a simple chart
organigram organizational chart • Consolidation of the use organizational structures organizational structure • Demonstrate their
(organigram) of organigram for generic organization knowledge of lines of
Activity responsibility and
reporting structures

QMT 4.5 To highlight the importance • Job descriptions • All organizations must • Emphasize the • List the key elements of 1 hour
Job descriptions, of job descriptions that • Person specifications ensure that they employ importance of clear and job descriptions and
responsibility and outline authority, the right person for the specific job descriptions person specifications
• Competence
delegation responsibility and right job and person • Identify the importance
delegation • Authority/responsibility specifications
• Staff should be well- of authority and
Presentation • Effective personnel trained and competent • Reinforce the responsibility
management importance of the
• Job descriptions and • Explain the importance
• Delegation person specifications set delegation of authority of delegation
out precisely what a job
involves and the kind of
person needed
• Responsibility must
come with authority
• Delegation enables
managers to make the
best use of their time
and develop junior staff
• Delegation is the sign of
a good manager and a
good quality system
QMT 4.6 To provide practice in • The job description as a • All job descriptions in an • Ensure key elements are • Prepare a simple job 1½ hours
Writing a job preparing a job description structured document organization should included in the job description and person
description to a given format • Key elements of a job have the same format descriptions specification
description and should include the • Emphasize the quality • Include the appropriate
Activity key elements of the job manager’s role in duties and
• Appropriate
responsibilities and ensuring a standardized responsibilities in the job
duties for a job approach to the description
development of job
descriptions
QMT 4.7 To demonstrate that a • Definition of the cost of • Poor quality leads to • Give a range of • Analyse processes and ½ hour
The cost of quality quality-based approach quality failures and rejected examples where the procedures to identify
saves money • Cost of quality products actual cost is higher where poor quality
Presentation • Poor quality increases than expected due to increases costs
• Elements of quality
costs operational costs poor quality
• Poor quality costs more

QMT 5.1 To introduce various quality • Quality standards • Quality standards are • Explain the usefulness • Explain the role of ½ hour
Introduction to standards that may be • National and key elements of the of quality standards to quality standards
standards for used by blood transfusion international standards quality system the BTS • Describe the benefits to
quality systems services • Quality standards help • Emphasize the the BTS of using quality
• Regulatory standards
• Quality standards and ensure a systematic and importance of identifying standards
Presentation consistent approach to appropriate standards
audits • Explain the role of the
the development of for the particular BTS quality manager in
quality systems ensuring that relevant
• Quality standards must quality standards are
be relevant to the BTS identified and
implemented
QMT 5.2 To introduce the principles • The BTS as a • BTSs are manufacturers • Focus on the BTS as a • Describe the role of 1 hour
Principles of good of Good Manufacturing manufacturer of therapeutic products manufacturer GMP within the quality
manufacturing Practice (GMP) within the • GMP as a part of the • Implementing GMP is • Ensure an system
practice quality system quality system essential to assure good understanding of the • List the elements of
• Key elements of GMP quality products concept of manufacture GMP
Presentation applied to blood/blood
products

QMT 6.1 To explain the key role of • Definitions relating to • Documentation is key to • Illustrate the importance • Explain the role and ½ hour
Documentation in documentation in quality documentation a quality system of documentation by need for documentation
quality systems systems • Basic types of • Documentation helps to using examples from in a quality system
documents ensure consistency of your own experience • List different types of
Presentation processes and • Use scenarios where a documents used in a
• Relationship between
documents procedures lack of documentation quality system
• Dangers of too much • Documentation gives may have/has caused
documentation traceability problems
• Good documentation • Ensure that participants
indicates a good quality understand the value of
system documentation
• Training is easier if
there is good
documentation to train
to
QMT 6.2 To describe how to plan • Planning and writing • SOPs are an essential • Focus on the value and • Identify key 1 hour
Standard and write an effective SOP SOPs part of the quality use of SOPs generically characteristics of an
operating • Validation of SOPs system • Do not be too effective SOP
procedures • Use of SOPs • SOPs should be written prescriptive about • Describe how to plan
for all the key layout and design of SOPs
Presentation procedures in an SOPs • Prepare SOPs
organization • Explain the use of
• SOPs must be clear, SOPs
concise and easy to
follow
• SOPs should be used
for staff training
• SOPs should be
validated
• SOPs should be living
documents
• Staff must have easy
access to the SOPs
• SOPs must be followed

QMT 6.3 To provide practice in • Identifying the • SOPs define the way in • Ensure the SOPs follow • Write an SOP of a 1½ hours
Writing an SOP preparing an SOP for a components of the which a procedure is to the principles taught simple familiar activity
simple, familiar activity activity be carried out • Keep the SOPs focused • List the key components
Activity • Preparation of a usable • SOPs must be written to on simply making the of an SOP
SOP be used coffee
• Ensure that SOPs reflect
the actual procedure
QMT 6.4 To demonstrate how • Creating a validation • No SOP should be • Ensure that the SOPs • Validate an SOP 1 hour
Validating an SOP SOPs are validated protocol for an SOP introduced without first are followed as written • Identify missing steps in
• Identifying and being validated • Ensure that all aspects an SOP through the
Activity understanding any • The procedure must of the SOPs are validation process
problems with the result in an acceptable reviewed
validation of SOPs outcome
• Correcting any problems
identified
QMT 6.5 To introduce the • The importance of • All documents related to • Emphasize the kind of • Identify the key aspects ½ hour
Document control mechanisms and document control quality should be problems likely without a of document control
reasons for control of • Mechanisms of controlled document control system • State which documents
Presentation documents document control • Control mechanisms • Stress the need for must be controlled and
• Distribution of cover: simplicity in document how
documents • Distribution control systems
• Document revisions • Review • Make clear the
• Change distinction between
revision and a new
document
QMT 6.6 To illustrate the process • Identifying a simple • Revision of documents is • Ensure that the revision • Identify the errors that 1½ hours
Controlling a of document control revision required to an an ongoing activity is correctly identified result from lack of
document SOP • Document control • Ensure that the key document control.
• Incorporating the systems ensure that the changes needed have • Identify how to take
Activity revision into a new correct document is in been identified corrective action
version of the SOP use • Ensure the control
• Correct annotation of the • Revisions must be system is simple and
revised SOP validated before the easy to follow
• Ensuring document release of the document • Review the difference
control procedures have between the revision of a
been followed document and need for a
new document

Module 7 Training
QMT 7.1 To highlight the importance • Importance of training • Staff are a major • Emphasize that quality • Explain why training is a ½ hour
Training in the of training in the quality • Organization’s variable in processes problems are likely if requirement of quality
quality system system responsibility for training • Training of staff is staff are not trained systems
• Types of training essential to ensure • Reinforce the value of • List the benefits of staff
Presentation consistent performance training to the training to the
of duties organization and the organization and to the
• Every organization individual staff themselves
should take
responsibility for the
continuing training of its
staff
• The organization
benefits from having a
skilled and motivated
workforce
QMT 7.2 To examine the • Identifying the need for • Training must be well • Highlight the need to • Identify training needs ½ hour
Training needs importance of assessing job-specific training planned identify all job-specific in the BTS
and plans training needs of all • Planning the training • The required resources training • Develop a plan to meet
categories of staff and must be provided: • Emphasize the need to identified training needs
• Resources required
Presentation preparing training plans ensure training plans
• The trainer and the • Funds • Identify the skills
trainee • Appropriate trainers are realistic required to train others
• Training materials • Materials effectively
• How to impart training • The trainer must be
• The distance learning able to impart his/her
approach knowledge to trainees
QMT 7.3 To provide practice in • Identifying key skills • Training plans must be • Check that training • Identify specific job 1 hour
preparing a training plan required for the job designed to meet plans are appropriate needs
Creating a training identified needs and comprehensive
plan • Developing an • Create a training plan
appropriate, effective • Review and • Ensure that they are for BTS staff
Activity and deliverable training assessment of training deliverable • Critically review a
programme plans are essential • Check that training training plan to ensure it
• Reviewing training plans plans are effective and is suitable and
to ensure that all complete deliverable
aspects have been
covered

QMT 7.4 To establish the • Documenting the • Quality principles apply • Emphasize the • Demonstrate an ½ hour
Monitoring and importance of training program to training as much as importance of training understanding of the
evaluation of documentation and • Training records any other BTS process records need for documentation
training records in training and the • All training should be • Highlight the importance and training records
• Monitoring the
need to monitor and documented of regular reviews of • Produce effective
effectiveness of training
Presentation evaluate training training and their documentation covering
• Training procedures
should be defined, documentation the training syllabus and
agreed on and its delivery
documented • Develop a training
• Both the overall training programme that
plan and the actual includes monitoring and
training need to be evaluation
monitored and
evaluated
• Evaluation should be
used to improve training
in the future

QMT 8.1 To introduce assessment • The need for • Continual assessment • Emphasize the value • List key elements of ½ hour
Assessment within of the quality system assessment is essential for the and importance of assessment and their
quality systems • Elements of maintenance and monitoring and use within quality
assessment improvement of the evaluation in the systems
Presentation ─ Evaluation quality system maintenance of a
─ Validation • There are a number of quality system
─ Monitoring interrelated tools that
should be used for
• Quality assessment
quality assessment
schemes
• Errors and error
management
• Audits
QMT 8.2 To explain the importance • Basic principles of • Validation ensures: • Emphasize the risks of • Describe the main 1 hour
Validation of validation within the validation ─ Everything to be a failure to validate new purposes of validation
quality system • Principles for the used in a process, activities or changes • Develop a validation
Presentation validation of processes, including the process • Clarify the distinction plan
equipment, reagents itself, is working to between validation and
and software documented evaluation
• Planning validations specifications before
use
─ Everything used
remains within
specifications (re-
validation)
• Validation controls the
impact of change
QMT 8.3 To provide practice in • Identifying critical • Planning is essential • Focus on validation, not • Describe the main 2 hours
Preparing a producing an effective and validation points • No matter how small the evaluation activities when
validation plan appropriate validation plan • Appropriate validation change, validation is • Ensure participants validating reagents,
• The difference between needed keep validation plans processes, equipment
Activity simple and software
validation and
evaluation • Ensure understanding • Identify the use of
• Examples of validation of the difference documentation in
plans between validation and validation procedures
evaluation

QMT 8.4 To introduce the reasons • Need for equipment • Prevention is better • Emphasize the value of • List the main reasons ¾ hour
Maintenance and for and the basic principles maintenance than cure preventive maintenance for the maintenance and
calibration of of maintenance and • Organizational and user • An effective • Discuss in depth the calibration of equipment
equipment calibration of equipment responsibilities maintenance and action to be taken in the • Discuss the value of
• Principles of calibration calibration programme event of calibration preventive maintenance
Presentation
• Action in the event of is required for all failure • Outline the basic
calibration failure equipment that has any • Discuss the importance principles of calibration
impact on the quality of of the reliability of and how to apply them
• Records and the final product
documentation previous results • Develop documentation
• Maintenance and obtained with that for the maintenance and
calibration should be equipment calibration of equipment
regular, appropriate and
comprehensive
• Staff must be trained in
the correct use,
maintenance and
calibration of equipment
• All maintenance and
calibration must be
documented
QMT 8.5 To provide practice in • Identifying the • There are different • Emphasize the • Produce an appropriate 1½ hours
Designing a producing appropriate maintenance and approaches to importance of designing maintenance and
maintenance and maintenance and calibration needs of maintenance and simple and appropriate calibration schedule
calibration plan calibration plans equipment calibration maintenance and • Identify key
• Determining appropriate • Maintenance and calibration plans documentation for the
Activity calibration methods calibration plans must • Ensure participants maintenance and
be sustainable understand the value calibration of equipment
and use of
documentation and
records for maintenance
and calibration

QMT 8.6 To introduce quality • Monitoring performance • Quality monitoring is a • Emphasize that there • List some simple tools ¾ hour
monitoring and some • Monitoring tools way of looking at what is are different for data analysis
Quality monitoring examples of quality actually happening approaches to quality
tools • Benchmarking • Describe how these
monitoring tools • Looking at key monitoring simple tools may be
Presentation indicators can identify • Encourage participants used to monitor
trends and help prevent to try different methods performance
problems occurring
• Monitoring is an active
process that requires
appropriate data
analysis to make best
use of the monitoring
system
• Visualization of data is
one of the best ways of
looking at what is going
on
QMT 8.7 To illustrate the value of • Using different types of • Many BTS activities • Explain why certain data • Analyse some typical 1½ hours
Analysing data monitoring the data that data generate data have limited monitoring laboratory data
and monitoring are generated • Appropriate analysis of • Not all data are a value • Prepare simple charts
performance data measure of • Give examples of to monitor and evaluate
• Critical analysis of data performance different types of performance
Activity
• Recognizing potential • Monitoring focuses on analysis and their • Use SPC (SPM) to
problems what is actually advantages and demonstrate and
happening disadvantages monitor trends
• Statistical process
control (SPC)/(SPM) • Visual presentation of • Keep the work focused
data is an effective on a simple analysis of
• Identifying and the data
monitoring trends method of analysis and
understanding • Explore possible
reasons for trends in
data

QMT 8.8 To demonstrate the • Defining errors • Errors (quality incidents) • Define "errors" • Demonstrate an ¾ hour
Error importance of putting • Error policy must be defined clearly • Discuss the boundary understanding of errors
management systems in place to deal • Systems to report between mistakes and and their reporting
• Error reporting
with errors quality incidents need to errors • Explain the importance
Presentation • Error analysis
be in place so that they • Discuss the differences of taking action to
• Correction, corrective can then be correct errors and
action and preventive between mistakes,
investigated errors and non- prevent further
action occurrences
• Systems of correction, compliance
corrective and
preventive action need
to be in place
• All staff and users of
products/services must
be aware of these
systems
• Incidents must be used
to improve processes/
procedures, not punish
staff
QMT 8.9 To provide practice in • Identifying errors • Reporting of errors is • Focus on the benefits of • Write an SOP on error 1½ hours
preparing an SOP on • Reporting and recording essential error reporting reporting for their BTS
Preparing an SOP dealing with errors
on error reporting errors • Staff need to feel able • Ensure feedback • Clearly define errors,
• Analysing errors to report errors without mechanisms are reporting mechanisms
Activity fear of punishment included and action required
• Corrective and
preventive action • Reinforce the definition
of errors and their
reporting
• Emphasize the need for
corrective and
preventive action

QMT 8.10 To introduce the • Audits and auditing • Audits are essential to • Reinforce the • Define quality audit 1 hour
Audits and importance of audits within • Audit definitions maintain and improve importance and value of • List the different types
auditing the quality system quality audits of quality audit
• Audit planning
• Benefits and value of • Audits must be • Stress the importance • Describe the audit
Presentation performed and received of preparing for audits
audits planning process
as positive events • Consider any relevant • Outline the benefits and
• Audits should be viewed national standards value of an audit
as "improvement
opportunities"
• Appropriate and
relevant standards must
be used
• All staff should become
involved and be able to
contribute to the audit
and its outcome
QMT 8.11 To describe the audit • Audit process • The audit process • Emphasize the need for • Describe the steps in ¾ hour
The audit process process and how to report • Audit reports involves the following auditors to prepare the audit process
on the findings steps: carefully before an audit • State the main elements
Presentation ─ Preparation • Stress the importance of an audit report
─ Performance of auditing to the
─ Conclusion standards
─ Report • Emphasize the
─ Follow-up importance of making
• Audit findings must be the audit a positive
documented in the form experience
of a report which should
be controlled and follow
a defined format
• The audit is incomplete
until any corrective
action required is taken
QMT 8.12 To provide participants • Types of audit • Audit plans should be • Remember that the • Design an audit plan 1 hour
Developing an with practice in preparing • Using standards as a simple course does not aim to
audit plan an audit plan basis for an audit • Audit plans should train auditors, but to
reflect the standards give participants a tool
Activity being used for monitoring their
• Pre- and post-audit quality system
meetings are essential • Ensure the plans are
simple and appropriate

QMT 8.13 • To illustrate a typical • Identifying non- • The auditor must be • Ensure that participants • Identify non- 1½ hours
Identifying non- audit situation compliances able to identify and understand the aim of compliances from
compliances • To provide practice in • Relating non- understand the key the activity observations made
against a set of identifying non- compliances to audit quality elements in a • Encourage questions during an audit
standards compliances and standards procedure about the players’ audit
observations in an audit • Defining observations • It is important to be very technique
Activity situation specific about any non- • Ensure all non-
compliances identified compliances are
and document them identified
carefully
QMT 8.14 To illustrate the experience • Using an audit plan to • Audits must be • Control the audit • Demonstrate an 1½ hours
Audit of a work of an audit from the conduct an audit performed in a • Ensure that all understanding of the
area perspective of an auditor • Identifying non- professional, sensitive members of the groups audit process
compliances and positive way are involved
Activity • Successful audits are • Reinforce the
systematic importance of recording
• It is essential to have observations
pre- and post-audit • Invite the auditees to
meetings to outline the participate in the review
process and review the of the audit
findings
QMT 8.15 To illustrate the problems • System failures affect • The consequences of a • Explain the activity • Explain how quality 1½ hours
Analysing quality that can occur without quality quality failure can be clearly failures can affect the
system failures good quality systems • Minor errors can serious • Ensure all participants quality of products and
combine to create one • An analysis of failures take part services
Activity serious failure in the often identifies a • Demonstrate an ability
• Keep the role play light-
quality system number of minor errors hearted and fun to identify errors and
as the cause • Ensure that all the potential errors in
quality failures are processes
identified
QMT 8.16 To assess participants' • Participants should • Demonstrate improved 1 hour
Mid-course broad understanding of have achieved knowledge and
assessment Modules 1−8 improved knowledge understanding of the
and competence in the topics covered in
Activity topics covered in Modules 1−8
Modules 1−8

PART 2 APPLYING QUALITY MANAGEMENT IN THE BTS

QMT 9.1 To introduce how quality • WHO strategy for blood • Modules 9−14 will • Ensure participants • Explain the WHO ½ hour
Applying quality systems are applied to safety demonstrate how to understand that Part 2 strategy for blood safety
management in blood transfusion • Quality systems for apply knowledge about of the course will assist • Define the key elements
the BTS processes blood safety quality systems to the them in applying what of the WHO Aide-
• Introduction to Part 2 of BTS: they have learned to the Mémoire: Quality
Presentation ─ Quality management various areas of the Systems for Blood
the course
in the BTS BTS Safety
─ Hygiene and safety • Emphasize that the
─ Donor management modules are designed
and blood collection to guide participants in
─ Laboratory testing what to do, but not
─ Blood component necessarily how to do it
production and
management
─ The clinical interface
QMT 9.2 • To analyse some • Analysing processes • An understanding of • Use common BTS • Review processes in 1½ hours
Identifying critical activities within the and procedures in the processes and processes BTS activities
control points and transfusion process and transfusion process procedures is vital to • Focus only on the • Identify critical control
preparing identify critical control • Identifying critical ensure quality critical control points points
flowcharts for BTS points control points in BTS • Critical control points • Ensure that all the • Produce accurate and
activities • To draw a flowchart of activities can be identified for all critical control points consistent flowcharts of
the selected activities • Using flowcharts to BTS activities have been identified BTS processes and
Activity
analyse BTS processes • Flowcharts assist in • Focus on problems procedures
and procedures analysing activities arising from the
incorrect identification of
critical control points

QMT 9.3 To highlight the steps in • Commitment and • Commitment from all • Focus on achievable • List the steps in ½ hour
Steps in developing and support concerned is essential steps in developing and developing and
developing a implementing a quality • Quality working group for success implementing a quality implementing a quality
quality system in system in the BTS • Finalize a quality policy system in the BTS system in the BTS
• Quality policy:
the BTS ─ National • Develop a quality plan • Be sensitive to the
─ Local ensuring: varying situations of the
Presentation participants
• Standards ─ All processes and
their appropriate
• Documentation
quality needs are
• Activity plan identified
• Training ─ Monitoring and
• Assessment evaluation are built
into the plan
• The plan must be
documented, followed
and monitored
QMT 9.4 To highlight the importance • Definition of costing • The quality manager • Focus on simplicity • Explain the value of ¾ hour
Costing activities of costing all BTS activities • Benefits of costing needs to understand the • Concentrate on basic comprehensive costing
in a blood • WHO manual "Costing principles of costing principles and practice of all BTS activities
transfusion Blood Transfusion • Accurate costing of BTS rather than trying to • Define key factors that
service Services" activities enables identify specific costs need to be taken into
Presentation • Basic cost analysis of accurate budget • Give a range of account in costing the
BTS activities planning and resource examples where the activities of a BTS
mobilization actual cost is higher
• Sustainability of the than expected due to
BTS is not achievable poor quality
without costing
procedures
• Costing BTS activities
contributes to quality
monitoring

QMT 9.5 To highlight the importance • Stock control and • All BTSs need a good • Highlight the problems • Describe methods of ¾ hour
Principles of stock of stock control and correct ordering stock management of stock control when monitoring the stock
control storage conditions • Perishable and non- system delivery times cannot be control system
perishable materials • Sufficient stocks of guaranteed • Identify the factors that
Presentation critical items must be • Stress the importance can influence storage
• Delivery checks
• Quarantine of materials maintained at all times of correct storage conditions
• All incoming materials conditions • Explain the principles of
• Inspection of incoming
materials must be appropriately • Emphasize the need for quarantine/release
checked before use contingency plans for procedures
• Correct storage of refrigerator/ freezer
perishable materials • Quarantine and release • List essential
procedures must be in failure documentation and
• Monitoring correct place for certain items • Reinforce the records for stock control
storage conditions importance of
• Monitoring of usage can
• Documentation help ensure adequate documenting the
stock levels are monitoring of storage
maintained conditions
QMT 9.6 To encourage the • Maintaining the safety • Things do go wrong • Provide examples of • Identify situations that ½ hour
Quality aspects of development of and adequacy of the • Disasters do happen different situations in may threaten the safety
contingency contingency plans to blood supply which the safety and and adequacy of the
• The continuity of the
planning ensure an adequate supply • Plans and procedures adequacy of the blood blood supply
blood supply is
of safe blood products at supply may be • Develop a contingency
• Major disasters or essential
Presentation all times compromised plan for the BTS
incidents • Contingency planning is
• Responsibility: role of essential
the quality manager • Documented
• Planning to minimize procedures need to be
adverse outcomes in place, available to all
• Co-ordination with other staff and reviewed at
agencies appropriate intervals
• BTS plans need to be
incorporated into
appropriate national and
local contingency plans

QMT 9.7 To assist participants to • The use of the Quality • The Quality Status • If necessary, assist • Use the information in 1 hour
Quality status assess the quality status of Status Questionnaire as Questionnaire will help participants in the questionnaire to
analysis their BTS a tool for education and participants to begin the answering the questions monitor their own
monitoring process of preparing • Be sensitive to possible progress
Activity their action plans language problems
• Be alert to indications of
a participant being
unable to answer due to
lack of understanding –
this could be an
indicator for some
reinforced learning for
the particular participant
QMT 9.8 To introduce participants • Introduction to • The action plan should • Emphasize that the • List the main areas to ½ hour
Preparing an to the preparation of their preparing an action plan include all the main suggested steps are consider when
action plan individual action plans • Steps in the action plan elements of a quality only examples and that preparing the first draft
• Identifying priority areas management system participants’ plans will of a basic plan of action
Presentation vary considerably
• Identify priority areas
from the quality status depending on their own
questionnaire situation
• Action plans developed • Emphasize the need to
during the course will base the action plan on
form a foundation for identified needs
planning participants’ • Encourage simplicity
quality systems
QMT 9.9 To assist participants in • The first draft of the • Participants should • Encourage participants • Identify priority areas 3 hours
Preparing a draft drafting their individual action plan will be initially focus on the to be honest and from the quality status
action plan action plans refined at the end of the next 6–12 months realistic about what is questionnaire
course • Plans should be realistic achievable • Apply the knowledge
Activity • Participants will have an and achievable • Try to identify specific gained in the course to
opportunity for • Plan to succeed problems in participants’ prepare an action plan
individual discussion individual BTSs
with facilitators • Look for gaps in the
• Other help will be participants’ plans
available, as required • Suggest alternatives
activities, where
appropriate

QMT 10.1 To review the elements of • Hygiene and safety as • A safety policy is an • Emphasize that the • Identify quality issues in ½ hour
Introduction to a quality system in relation quality issues essential component of quality manager is relation to hygiene and
hygiene and to hygiene and safety in • Safety policy and the elements of the responsible for ensuring safety in the BTS
safety in the BTS the BTS procedures quality system a hygiene and safety • Define key elements of
• Biosafety • The safety policy should policy is in place a safety policy for a
Presentation reflect the commitment • Provide examples of BTS
• Other safety issues -
Mechanical/electrical/ by the organization to safety policies • Identify the
chemical/fire/radiation hygiene and safety responsibilities of the
safety issues organization and staff
• Disposal of waste • Responsibilities for for hygiene and safety
hygiene and safety • Identify the role of the
• Responsibilities for should be defined
safety quality manager in
ensuring hygiene and
safety in the BTS
QMT 10.2 To demonstrate the • Hygiene in work areas • Good hygiene requires • Emphasize the • Explain why hygiene is ¾ hour
Hygiene in the importance of hygiene and as a quality requirement cleanliness and tidiness importance of hygiene a quality requirement
BTS cleanliness in the BTS • Personal hygiene • Cleanliness and tidiness for the quality of the • Identify the actions
of the work area is a product and the required to ensure
Presentation quality requirement to protection of staff and hygiene in the BTS
protect donors, staff and donors
products • Emphasize the need for
• Personal hygiene is the continual cleaning of
essential surfaces, equipment,
etc.
• Ensure participants
understand that
cleaning is the
responsibility of all staff

QMT 10.3 To demonstrate the • Types of hazardous • Universal safety • Ensure that participants • Identify the actions ¾ hour
Biological and importance of biological material precautions must be are familiar with required to ensure
chemical safety in and chemical safety in the • Universal safety followed at all times for universal safety biological and chemical
the BTS BTS precautions the protection of staff, precautions safety in the BTS
• Safe handling of the environment and the • Discuss the role of the
Presentation general public quality manager in
hazardous material
• Safe disposal of • Potentially hazardous ensuring there is a
hazardous waste material must be system for the correct
handled safely and handling and disposal of
disposed of in the hazardous waste
correct manner
• Biohazardous material
must be appropriately
labelled and transported
in appropriate
containers
• All hazardous spills
must be contained and
decontaminated
QMT 10.4 To provide participants • Identification of key • An analysis of the • Give examples of the • Identify key BTS safety 1½ hours
Safety issues and with practice in identifying safety issues safety aspects of all types of potential risk to issues
minimizing risks safety issues and how to • Creating awareness of processes and staff, donors and the • List the key elements of
resolve them safety issues procedures is essential public maintaining a safe
Activity • Ensure that safety plans workplace
• Actions needed to
minimize risks are feasible and cover • Design a plan for safety
key areas checks in the BTS

Module 11 Quality Systems in Blood Donor Management
QMT 11.1 To review the elements of • Elements of a quality • The quality system in • Acknowledge and • Identify the actions ½ hour
Introduction to a quality system in relation system as applied to blood donor expand on the required to ensure
quality systems in to blood donor blood donor management should differences in approach quality in blood donor
blood donor management management focus on the activities by different BTSs management
management • Quality issues in donor of: • Regular low-risk blood • Identify the role of the
management: ─ Recruitment donors are the quality manager in
Presentation ─ Recruitment ─ Selection foundation of a safe and ensuring quality in blood
─ Selection ─ Collection adequate blood supply donor management
─ Blood collection ─ Documentation • Discuss the role of the
─ Documentation ─ Donor care, quality manager in
─ Donor care, satisfaction and ensuring quality in blood
satisfaction and retention collection
retention
• Role of the quality
manager
QMT 11.2 To demonstrate how to • Donor recruitment • Applying quality to • Explain the importance of • Identify the quality 1 hour
Donor recruitment apply quality to donor • Donor selection donor recruitment an analysis of issues related to the
and selection recruitment and selection ensures that: populations to identify processes of donor
• Assessment
─ The lowest risk blood groups to target or avoid recruitment and
Presentation donor populations • Emphasize that quality selection
are identified means meeting and • Identify the action
─ The safest donors exceeding the customer’s required to ensure
are recruited and expectations quality in blood donor
retained • Ensure that all relevant recruitment and
WHO recommendations selection
and guidelines are • Identify the role of the
included in the quality manager in
presentation blood donor recruitment
and selection
QMT 11.3 To enable participants to • Quality awareness • Donor recruitment staff • Discuss the adverse • Explain the importance 1 hour
Donor recruitment examine the benefits of training of the staff in should understand the affect of poor donor of quality in blood donor
and selection introducing a quality donor recruitment and impact of quality on the recruitment strategies recruitment and
system in blood donor selection BTS and attitudes selection
Activity recruitment and selection
activities

QMT 11.4 To demonstrate how to • Pre-donation checks of • Quality in blood • Introduce the topic in a • Identify the quality ¾ hour
Blood collection apply quality to blood equipment and collection protects the very broad way issues related to the
collection materials donor and the recipient • Be aware of significant process of blood
Presentation • Donor identification • Quality in blood differences between collection
• Donor arm cleansing collection ensures the countries in the way in • Identify specific quality
• Venepuncture and quality of the product which blood is collected issues related to blood
collection • Keep the focus on quality collection at mobile
aspects of blood donor sessions
• Care of the donor
collection • Identify the action
• Handling of donations required to ensure
and samples • Discuss the additional
problems in applying quality in blood
• Quality issues at mobile quality in mobile donor collection
donor sessions sessions • Identify the role of the
quality manager in
ensuring quality in blood
collection
QMT 11.5 To enable participants to • The role of the quality • Applying standard • Ensure the participants • Explain the importance 1 hour
Blood collection examine the benefits of manager in blood procedures to collection clearly understand the of good quality in blood
introducing a quality collection activities role of the quality collection
Activity system to blood collection • Monitoring of blood • Training of blood manager in blood • Explain the role of the
activities collection activities collection staff collection quality manager in
blood collection
QMT 11.6 To demonstrate how to • Types and levels of • Each activity in the • Keep the focus on the • Apply the principles of ½ hour
Developing a develop an effective documents required donor clinic, and the need for simplicity of all documentation in quality
documentation documentation system for • Traceability – donor to outcome of each records systems to blood donor
system for blood blood donor management donation activity, should be • Discuss why traceability management
donor • Confidentiality documented is essential • Explain the need for
management • Monitoring and • A documentation • Emphasize the traceability
evaluation system enables the importance of
Presentation BTS to manage the confidentiality
blood donor programme
e.g.
─ Assists in donor
recall and retention
─ Ensures traceability
─ Records and
analyzes successes
and failures
─ Assists in error
analysis

QMT 11.7 To emphasize the • Donor care • The quality system • Introduce the concept of • Explain how high quality ½ hour
Donor care, importance of high quality • Donor satisfaction should ensure that the the donor as a customer donor care promotes
satisfaction and donor care in ensuring donor is treated as an • Emphasize the donor satisfaction which
• Donor retention
retention donor satisfaction and important customer importance of leads to retention
retention • Donor complaints
• Donor satisfaction and recognizing and • Identify the actions
Presentation retention are directly understanding donors’ required to ensure high
influenced by the quality needs quality donor care
of donor care • Explain the role of the
• Complaints must be quality manager in
formally investigated ensuring donor
both to satisfy the donor satisfaction
and to critically examine
BTS practice
QMT 11.8 • To encourage • The importance of • Donor satisfaction is • Emphasize that donor • Explain how a quality ½ hour
Donor satisfaction participants to examine donor satisfaction essential to achieve satisfaction can be very focused approach can
any aspects of the • Communication retention of voluntary dependent upon staff play a major part in
Activity donor selection and between the donor and donors attitude and ensuring blood donor
blood collection process the BTS • All staff need to be responsiveness satisfaction
that may lead to donor aware of the importance • Acknowledge the need
dissatisfaction of donor satisfaction for specialized
• To assist participants to communication skills in
examine those aspects the blood donor clinic
of a quality system that
would promote donor
satisfaction
QMT 11.9 To identify the critical • Using flowcharts to • The selection of donors • Emphasize the reasons • Identify the critical 1½ hour
Identifying and control points for identify critical control is the first step in for monitoring control points in the
monitoring critical assessing the processes in points in the process of ensuring the safety of • Ensure that appropriate process of blood donor
control points in blood donor management blood donor the blood supply monitoring tools are management
blood donor management • The quality of the blood identified • Identify indicators and
management • Identifying indicators collection process may • Focus on the key appropriate tools for
and tools for monitoring directly affect the quality indicators monitoring the critical
Activity and controlling the of the raw material control points in the
blood donor process of blood donor
management process management

QMT 12.1 To review the elements of • Elements of a quality • A quality system is • Emphasize that all • Identify the actions ½ hour
Introduction to a quality system in relation system as applied to essential in the laboratories have similar required to ensure
quality systems in to laboratory testing laboratory testing laboratory to ensure the quality needs quality in laboratory
laboratory testing • Quality issues in correct results for the testing
laboratory testing: correct donation/donor • Identify the role of the
Presentation ─ Equipment and patient quality manager in
─ Samples • The quality system in ensuring quality in
─ Selection and use of the laboratory should laboratory testing
reagents and test kits cover:
─ Quality control ─ Organization and
─ Laboratory staff
documents ─ Facilities and
─ Handling of test equipment
results ─ Reagents/test kits
─ Documentation
─ Samples
─ Handling of test
results
─ Quality control
─ Assessment
QMT 12.2 To demonstrate how to • Definitions • Selection of immuno- • Be aware of the • Identify the actions ¾ hour
Evaluation and apply quality to the • Selection and haematology reagents limitations on required to ensure
use of immuno- evaluation and use of evaluation is a process that needs procurement in different quality in the evaluation
haematology immunohaematology to be planned carefully countries and use of
• Validation
reagents reagents • The characteristics that • Promote the ideal with an immunohaematology
• Control during routine reagents
use should be examined acceptance of the reality
Presentation include specificity, • Identify the role of the
sensitivity, potency, quality manager in the
avidity evaluation and use of
• Overall performance immunohaematology
depends upon a reagents
number of factors,
including methodology
and staff
• Testing needs and the
resources available to
meet those needs must
be taken into account in
selection of reagents

QMT 12.3 To demonstrate how to • Definitions • The basic principles of • Be aware of the • Identify the actions ¾ hour
Evaluation and apply quality to evaluation • Selection and selection and evaluation limitations on required to ensure
use of test kits for and use of test kits for evaluation apply to all assays used procurement in different quality in the evaluation
transfusion- transfusion-transmissible in the BTS countries and use of TTI test kits
• Validation
transmissible infections (TTIs) • Batch testing is • Promote the ideal with an • Identify the role of the
• Control during routine
infections use essential acceptance of the reality quality manager in the
• Other factors influence • Demonstrate the evaluation and use of
Presentation TTI test kits
choice potential false economy
─ Constraints of using cheap test kits
─ Resources
QMT 12.4 To provide practice in • General criteria for • Importance of selecting • Emphasize the balance • Analyse requirements 1½ hours
Selecting reagents selecting reagents and test selecting reagents and high quality, cost- between what is needed and list key criteria for
and test kits kits for specified activities test kits effective reagents and and what is available selecting test kits and/or
• Identifying the correct test kits • Encourage discussion reagents
Activity reagents and test kits to • Constraints on the over different ways to
use selection of ideal solve problems
reagents and test kits
• Selection is deciding
"fitness for purpose"
QMT 12.5 To demonstrate how to • Essential • Laboratory • Clarify the information • Identify the types of ¾ hour
Developing a develop an effective documentation in the documentation is that needs to be documents that are
documentation documentation system in laboratory essential for traceability documented required in the
system for the the laboratory • Laboratory records • Laboratories produce • Give examples of laboratory
laboratory • Recording and large amounts of data different types of • List the essential
analysing laboratory • Data should be documentation laboratory records that
Presentation should be maintained
data analysed and used to
improve laboratory • Identify the data that
performance should be analysed to
ensure continuous
improvement
QMT 12.6 To promote the • Principles of EQA • External quality • Give examples of • List the objectives and ¾ hour
External Quality participation of BTS • Objectives of EQA assessment provides national and international benefits of EQA
Assessment laboratories in appropriate confidence in the overall schemes • Define the role of EQA
• Benefits of EQA
(EQA) schemes EQA schemes performance in the • Encourage participation in a quality system
• Organization and laboratory
process of EQA in EQA schemes • Identify the role of the
Presentation • EQA is one of the tools
• WHO EQA schemes quality
used to monitor and
improve quality

QMT 12.7 To identify the critical • Using flowcharts to • Ensuring a well-defined • Emphasize the need for • Identify the critical 1½ hours
Identifying and control points for identify critical control flow of work in the well-defined flowcharts control points in the
monitoring critical assessing and controlling points in the processes laboratory leads to • Emphasize the reasons processes in the testing
control points in the processes in the in the testing laboratory improved quality for monitoring and laboratory
laboratory testing testing laboratory • Indicators and tools for • The laboratory analysing data in the • Identify indicators and
monitoring and environment provides laboratory appropriate tools for
Activity controlling the much data for analysis monitoring the critical
• Focus on the key
processes in the and use as indicators indicators control points
laboratory • Indicators in the
laboratory should be
monitored through the
use of SPC

Module 13 Quality Systems in Component Production and Management
QMT 13.1 To review the elements of • Elements of a quality • All the activities • Remember that some • Identify the actions ¾ hour
Introduction to a quality system in relation system as applied to associated with the BTSs do not prepare required to ensure
quality systems in to blood component blood component processing of blood components quality in blood
blood component production and production and components must be • Provide examples of component production
production and management management well-controlled and fully product specifications and management
management • Quality issues in blood documented • Reinforce the use of • Identify the role of the
component production • Quality systems must flowcharts in analysing quality manager in
Presentation and management: be in place to ensure ensuring quality in blood
processes
─ Equipment that: component production
─ Selection of ─ Untested or and management
methodology unsuitable blood
─ Labelling components are
─ Quarantine and segregated from
release those that are
─ Blood stock suitable for use
management ─ Blood components
─ Storage and are stored and
transportation transported in a way
that prevents
─ Issue of blood
deterioration
components
─ Blood stocks are
─ Documents
adequately managed
─ Quality monitoring
QMT 13.2 To demonstrate how to • Specifications • The purpose of • Keep the emphasis on • Identify what needs to ¾ hour
Quality monitoring apply quality monitoring in • Incoming blood units monitoring is to answer GMP be monitored to ensure
of blood blood component • Product monitoring the basic question – are quality in blood
component production and we producing what we component production
• Monitoring plans are meant to be and management
production management
• Analysis and use of producing? • Identify the role of the
Presentation results • The parameters to be quality manager in
monitored need to be quality monitoring
matched to the product
and its intended use
• Monitoring is a tool to
generate data – positive
or negative – to feed
back into the process
• Monitoring is an integral
part of any production
process

QMT 13.3 To provide practice in • Identifying the • Critical control points in • Ensure that the terms • Outline the principles of 1½ hours
Evaluation and analysing component monitoring points the process need to be "monitoring" and monitoring and
monitoring of production activities and available identified "evaluation" are clearly evaluation of
blood component identifying appropriate • Identifying monitoring understood component production
production monitoring methods strategies and • Ensure the plans are • Prepare a plan for
activities evaluation methods feasible monitoring and
• Ensure the plans do not evaluation of
Activity components
interfere with the
workflow
QMT 13.4 To demonstrate how to • Principles • All donated blood • Explore the issue of • Explain the importance ¾ hour
Quarantine and develop systems for • Quarantine should be placed in responsibility for release of quarantine and
release quarantine and release quarantine on receipt release
• Release
from collection teams • List the key elements of
Presentation • Responsibility
• There should be clear an effective quarantine
• Concessions physical segregation of and release system
• Documentation tested and untested • Identify the role of the
products quality manager in
• Responsible persons quarantine and release
need to be identified
who can authorize the
release of products
• A concession system
may be needed in
defined circumstances
QMT 13.5 To demonstrate how to • Storage • Storage and • Focus on the need to • Identify the actions ½ hour
Storage and apply quality in the storage • Packaging transportation need to protect the product from required to ensure
transportation of and transportation of blood be controlled to ensure "vein to vein" quality in storage and
• Transportation
blood components components the quality of products is • Explore different transportation
• Maintenance of the maintained from donor
Presentation blood cold chain methods of transporting • Explain what is meant
to patient, from "vein to products to maintain the by the blood cold chain
• Documentation vein" blood cold chain • Describe the elements
• The blood cold chain of an effective blood
needs to be maintained cold chain
• Transportation • Identify the role of the
conditions are quality manager in
especially important ensuring quality in
• Monitoring is essential storage and distribution

QMT 13.6 To provide practice in • Quarantine and release • All staff should be made • Explore all possible • Develop standards for 1 hour
Storage and developing standards and procedures aware of the impact of scenarios, keeping in storage, transportation
transportation of policies for the storage, • Blood cold chain poor quality during mind that many countries and distribution
blood components transportation and maintenance storage, transportation do not have the • List the documents
distribution of blood and distribution of blood resources available to required to ensure a
• Security during
Activity components products countries in the quality approach
transportation
developed world
QMT 13.7 To demonstrate how to • Importance of blood • The proper • Stress the importance of • Explain the importance ¾ hour
Blood stock apply quality to blood stock stock management management of stock is managing stocks to of managing blood
management management • Managing blood stocks essential for the BTS to ensure the availability of stocks
• Managing fluctuations in be able to provide desired components or • Identify the actions
Presentation clinical users with particular blood groups required to ensure that
supply and demand
sufficient products at all times blood stocks are
• Minimum blood stock
levels • Stock management • Explore the issue of managed effectively
includes the returning blood for • Identify the role of the
• Documentation management of the re-use quality manager in
other factors that can • Highlight the importance ensuring effective blood
affect the stocks of of minimizing the stock management
blood number of blood units
• Minimum stock levels that expire
and actions to be taken
to replenish stocks need
to be defined
QMT 13.8 To demonstrate how to • What to document • A documentation • Clarify the information • Identify the information ½ hour
Developing a develop an effective • Types of documents system is an essential that needs to be that needs to be
documentation documentation system for requisite documented documented
• Labelling
system for blood blood component • GMP guidelines should • Give examples of the • Identify the basic
production • Traceability
component be followed different types of labelling requirements
production • All processing and documentation on blood products
Presentation associated activities
need to be documented
• The labelling of
products is a critical
area with the potential
for major errors if not
effectively controlled

QMT 13.9 To identify the critical • Using flowcharts to • The principles of quality • Emphasize the reasons • Identify the critical 1½ hours
Identifying and control points for identify critical control systems and GMP for monitoring control points in the
monitoring critical monitoring blood points in blood should be applied to the • Ensure the appropriate processes at which
control points in component production component production production of blood monitoring tools are monitoring should take
blood component • Indicators and tools for components identified place
production monitoring and • SPC assists in • Focus on the key • Identify indicators and
controlling blood monitoring and indicators tools for monitoring
Activity component production controlling the
processes in blood

QMT 14.1 To review the elements of • Definition of the clinical • The need for quality • Acknowledge the • Identify the actions ½ hour
Introduction to a quality system in relation interface continues after the different relationships required to ensure
quality systems at to the clinical interface • Elements of a quality blood leaves the BTS between BTSs and quality at the clinical
the clinical system as applied to the • The BTS has an hospitals in different interface
interface clinical interface important role in countries • Identify the role of the
• Quality issues at the ensuring the quality of • Refer to WHO quality manager in
Presentation the clinical transfusion recommendations and ensuring quality at the
clinical interface:
─ Importance of an process learning materials on the clinical interface
effective clinical • The needs of both the clinical use of blood
interface patient and the clinician
─ Role of the must be considered in
BTS/hospital blood determining how to
bank ensure customer
─ Hospital transfusion satisfaction
process • The quality system of
─ Appropriate clinical documentation extends
use of blood to the clinical interface
• All staff involved in the
clinical interface require
training
• Effective
communication is
required between the
BTS and the hospital
QMT 14.2 To demonstrate how a • Policy on the clinical • The BTS should play a • Refer to WHO • Explain the importance ¾ hour
Policy and policy and guidelines on use of blood key role in the recommendations and of the appropriate
guidelines on the the clinical use of blood • Guidelines on the development of a other relevant material, clinical use of blood for
clinical use of can improve the quality of appropriate clinical use national policy and including learning safe transfusion
blood clinical transfusion practice of blood guidelines on the clinical materials: The Clinical • Identify the actions
• The role of the BTS in use of blood, in Use of Blood required to promote the
Presentation collaboration with • Provide examples of appropriate clinical use
the development of a
national policy and national health national policies of blood
guidelines on the authorities and clinical • Identify the role of the
appropriate clinical use specialists BTS in promoting the
of blood • Transfusion committees, appropriate clinical use
both national and of blood
• The role of a hospital
hospital-based, need to
transfusion committee
be formed to ensure
effective policy making
and monitoring

QMT 14.3 To explore the role of the • The BTS has an • The BTS/hospital • Discuss different • Describe the role of the 1 hour
Role of the BTS at BTS at the clinical important role to play in communication link is a approaches to ensure the BTS at the clinical
the clinical interface the appropriate clinical two-way process "quality" use of blood interface
interface use of blood • Continuous quality products • List the players in
• Ensuring the improvement requires establishing quality at
Activity appropriate clinical use quality data from the clinical interface
of blood requires hospitals supplied by
effective collaboration the BTS
between the BTS and
prescribers of blood
QMT 14.4 To demonstrate how an • Information to be • All stages of the • Emphasize the • Identify the information ½ hour
Documentation in effective documentation recorded transfusion must be importance of full that needs to be
the hospital system can be used to • The importance of documented, from the traceability of donations documented in relation
transfusion improve the hospital documentation in the time the patient is • Focus on the lack of to the hospital
process transfusion process hospital transfusion identified and the traceability if records are transfusion process
process sample taken to the incomplete or inaccurate • Identify the actions
Presentation time the transfusion is required to establish an
• Using documentation in
the hospital transfusion completed effective system for
process for • Noting all staff involved documenting the
improvement of all helps to identify training hospital transfusion
aspects of blood needs and clarify errors process
transfusion • Identify the role of the
BTS in developing an
effective system for
documenting the
hospital transfusion
process
QMT 14.5 To determine the key • Relevant clinical • Transfusion should only • Remind participants of • List the essential 1 hour
Designing a blood information required to information occur when clinically the importance of the information required on
request form identify a patient and • Simplifying indicated basic information a blood request form
his/her blood needs documentation to focus • Patient details must be required • Explain why this
Activity only on that which is completed accurately to • Emphasize the information is required
needed ensure correct importance of legibility • Produce an appropriate
• Identifying who should identification • Discuss relevant and and effective blood
design a blood request irrelevant information request form
form

QMT 14.6 To identify the role of the • Hospital transfusion • The BTS has a • Stress the importance of • Identify the actions ¾ hour
Quality in the BTS in ensuring quality in process responsibility to ensure the role of the BTS in the required to ensure
hospital the hospital transfusion • Positive identification that hospitals using its transfusion process quality in the hospital
transfusion process products meet quality • Emphasize the role of a transfusion process
• Storage of blood
process components standards in transfusion documentation system in • Identify the role of the
practice ensuring patient, BTS/blood bank in
Presentation • Requests for blood
• The BTS should assist specimen and product ensuring quality in the
• Responsibilities of the hospitals to develop identification hospital transfusion
compatibility testing policies and SOPs for process
laboratory each stage of the • Identify the role of the
• Administration of blood clinical transfusion quality manager in
• Role of the BTS/blood process ensuring quality in the
bank hospital transfusion
process
QMT 14.7 To identify key quality • Sample identification • The BTS has an active • Discuss the different • List the documents 1 hour
Quality in the aspects of transfusion • Patient identification role in ensuring quality approaches to ensuring needed to ensure
hospital requests and at the bedside quality at the bedside quality at the bedside
• Product identification
transfusion administration of blood • Correct sample from the
process products correct patient
• Correct product for
Activity
correct patient
QMT 14.8 To demonstrate how • Monitoring and • All aspects of the • Illustrate the importance • Explain how data from 1 hour
Monitoring and monitoring and evaluation evaluation process of transfusion of monitoring and monitoring and
evaluation of the can be used to improve the • Indicators should be monitored feedback with reference evaluation can be used
hospital quality of the hospital and the results to crossmatch : to improve hospital
• Analysing and using
transfusion transfusion process analysed and acted on transfusion ratios transfusion practice
data for improvement in
process all aspects of blood • A hospital transfusion • Emphasize the • Identify the actions
transfusion committee should be importance of using required to develop a
Presentation established in every monitoring data to reduce system for the
hospital unnecessary transfusions monitoring and
• The BTS and hospital • Give examples of evaluation of the
blood bank should be national monitoring and hospital transfusion
represented on the reporting systems process
hospital transfusion • Identify the role of the
committee BTS in the monitoring
• The clinical use of blood and evaluation of the
should be monitored hospital transfusion
using defined indicators process

QMT 14.9 To promote the • Definition • To be effective • Emphasize the • Explain how a ¾ hour
Haemovigilance development of a national • Principle haemovigilance importance of using the haemovigilance system
reporting system for requires open and information gathered to can help to improve the
• Requirements
Presentation adverse transfusion events honest reporting and improve blood safety quality of every aspect
• Benefits investigation of blood transfusion
• Haemovigilance • Describe the elements
depends upon of a haemovigilance
traceability in the system
hospital and the BTS • Identify the actions
• Haemovigilance is an required to establish a
essential part of the national haemovigilance
quality system in system
BTS/clinical interface • Identify the role of the
• Information is fed back quality manager in
into the transfusion developing a national
system to improve the haemovigilance system
overall safety and and utilizing the data to
quality of transfusion improve transfusion
practice in the BTS and practice
the hospital
QMT 14.10 To identify critical control • Identifying the • Critical control points in • Emphasize the • Identify the critical 1 hour
Identifying and points at the clinical monitoring points the process must be importance of good control points in the
monitoring critical interface and plan systems available identified communication between process at which
control points for for monitoring • Identifying the the BTS/blood bank and monitoring should take
the clinical monitoring strategies the hospital place
interface and the and evaluation methods • Emphasize the role of the • Identify the kind of
administration of hospital transfusion monitoring that should
blood committee in ensuring take place
the safety of the patient
Activity requiring transfusion

Module 15 Finalization of Participants’ Action Plans and Completion of the Course
QMT 15.1 To enable participants to • Review any aspects of • Identify the specific 1 hour
Review of the identify any areas where the course that require issues
course clarification/additional work clarification or additional • Clarify/explain, using
is needed discussion relevant examples where
Activity possible
QMT 15.2 To explore specific aspects • Detailed look at the BTS • Ensure as best as 1–2
Laboratory/clinic of BTS activities in detail from a quality possible that participants’ hours
visits in BTS perspective information needs are
• Discussion of met
Activity approaches taken by
the BTS and the
reasons for them
• Review of any areas or
activities of specific
interest
QMT 15.3 To ensure each participant • Producing an • Plans need to be • Ensure plans are realistic • Identify needs 2–3
Completing produces an appropriate appropriate and realistic appropriate and realistic and achievable • Prepare a draft action hours
individual action and achievable action plan plan • Emphasize the value of plan for their BTS
plans • Planning: what, how developing short,
often and when medium and long-term
Activity plans
• Defining the timescale
for the plan (i.e. short,
medium and long-term)
QMT 15.4 To assist participants in • Overall strengths and • If possible, obtain the • Produce an amended 1½
Discussion of finalizing their action plans weaknesses of input of the facilitator who action plan for their BTS hours
individual action participants’ action gave comments on the
plans plans draft plans
• Finalization of action • Guide discussions to
Activity plans ensure they are positive
and constructive
QMT 15.5 To review the role of • Review of key aims and • All BTS activities • Summarize the key • Outline the reasons for ½ hour
Review of quality quality in blood transfusion principles of quality contribute to quality elements of the course establishing quality
systems systems • Quality is only as good • Bring everything to a systems in a BTS
• Quality in all BTS as the weakest link in suitable conclusion • List the major elements
Presentation activities the chain in establishing quality
systems

QMT 15.6 To determine participants’ • Determining • Post-course • Ensure that participants • Demonstrate increased ½ hour
Post-course levels of knowledge and participants’ knowledge assessment is not an understand that the knowledge and
assessment understanding of quality and understanding of examination assessment is not an understanding of quality
and quality systems quality in comparison • It will help subsequent examination and quality systems in
Activity with the pre-course courses by identifying the BTS
assessment how to strengthen areas
of weakness or gaps in
the curriculum
QMT 15.7 To obtain feedback on the • Evaluating the • Honest opinions are • Make clear to the • Freely express their ½ hour
Course evaluation quality and overall effectiveness of the needed participants that their views and/or concerns
effectiveness of the course training, including • Feedback is needed views are genuinely about the course
Activity presentations, activities, about course methods required
facilitators, facilities and effectiveness
QMT 15.8 To provide a forum for final • Outstanding issues • The final forum for • Clear up any outstanding • Identify any final issues 1 hour
Final discussions discussion and clarification • Follow-up courses and discussion problems, queries or that require clarification
other QMP/QMT issues or discussion
Activity activities
• Strengthening the links
and collaboration
between the training
centre and other
countries in the region
Closing Ceremony

EXAMPLE OF A WEEKLY PROGRAMME OF WORK
Week One
Monday Tuesday Wednesday Thursday Friday Saturday
QMT 1.1 QMT 2.3 QMT 3.4 QMT 4.5 QMT 6.3 QMT 7.4
WHO strategies for Introducing quality Developing a process Job descriptions, Writing an SOP Monitoring and
blood safety flowchart responsibility and evaluation of training
delegation
WHO Quality Quality characteristics Management Writing a job Validating an SOP Assessment within
Management responsibility for quality description quality systems
Programme (QMP) for
blood transfusion
services
Introduction to the Tour of the Blood Developing a quality The cost of quality Document control Validation
WHO QMT course Transfusion Centre policy
Participants’ Quality systems Organizational Introduction to Controlling a document Preparing a validation
expectations structure and role of the standards for quality plan
quality manager systems
Pre-course assessment Processes and Developing an Principles of Good Training in the quality Maintenance and
procedures organigram Manufacturing Practice system calibration of
equipment
QMT 2.1 QMT 3.3 QMT 6.1 QMT 7.2 QMT 8.5
The importance of Flowcharting as a tool Documentation in Training needs and Designing a
quality in the BTS for mapping processes quality systems plans maintenance and
calibration plan
QMT 2.2 QMT 6.2 QMT 7.3

The consequences of Standard operating Creating a training plan
poor quality in the BTS procedures
Week Two
Quality monitoring tools Developing an audit Steps in developing a Introduction to hygiene Blood collection Introduction to quality
plan quality system in the and safety in the BTS systems in laboratory
BTS testing
Analyzing data and Identifying non- Costing activities in a Hygiene in the BTS Blood collection Evaluation and use of
monitoring performance compliance against a BTS immunohaematology
set of standards reagents
Error management Audit of work area Principles of stock Biological and chemical Developing a Evaluation and use of
control safety in the BTS documentation system test kits for transfusion-
for blood donor transmissible infections
management (TTIs)
Preparing an SOP on Analysing quality Quality aspects of Safety issues and Donor care, satisfaction Selecting reagents and
error reporting system failures contingency planning minimizing risks and retention test kits
Audits and auditing Mid-course assessment Quality status analysis Introduction to quality Donor satisfaction Developing a
systems in blood donor documentation system
management for the laboratory
The audit process Applying quality Preparing an action Donor recruitment and Identifying and External Quality
management in the plan selection monitoring critical Assessment (EQA)
BTS control points in blood schemes
donor management
QMT 9.2 QMT 9.9 QMT 11.3
Identifying critical Preparing a draft action Donor recruitment and
control points and plan selection
preparing flowcharts for
BTS activities

Week Three
Identifying and Storage and Introduction to quality Quality in the hospital Review of the course Discussion of individual
monitoring critical transportation of blood systems at the clinical transfusion process action plans, as
control points in components interface appropriate
laboratory testing
Introduction to quality Storage and Policy and guidelines Monitoring and Laboratory/clinic visits Review of quality
systems in blood transportation of blood on the clinical use of evaluation of the in BTS systems
component production components blood hospital transfusion
and management process
Quality monitoring of Blood stock The role of the BTS at Haemovigilance Completing individual Post-course
blood component management the clinical interface action plans assessment
production
QMT 13.3 QMT 13.8 QMT 14.4 QMT 14.10 QMT 15.7
Evaluation and Developing a Documentation in the Identifying and Course evaluation
monitoring of documentation system hospital transfusion monitoring critical
component production for the blood process control points for the
activities components production clinical interface and
the administration of
blood
QMT 13.4 QMT 13.9 QMT 14.5 QMT 15.8
Quarantine and release Identifying and Designing a blood Final discussions
monitoring critical request form
control points in
and the issue of blood
QMT 14.6
Quality in the hospital
transfusion process

Participant's Final Report
QMT COURSE
Quality Training Centre
Date of course
Course Coordinator
Facilitators
PARTICIPANT
Name
Qualifications
Length of service
Position
Organization
Address
Country
Tel. no.
Fax. no
E-mail

LANGUAGE
Course language
Participant’s First Second Third Other
language
ASSESSMENT RESULTS
Pre-course assessment
Mid-course assessment
Post-course assessment
FACILITATORS’ OBSERVATIONS
Understanding of generic concepts of quality
Understanding of quality concepts in relation to the blood transfusion service
Participation in group work
Action plan

PRIORITIES FOR FOLLOW-UP AND SUPPORT
Facilitators’ comments
Participant's comments
Signed
Course Coordinator Date
Facilitator(s) Date
Participant Date

QMT GLOSSARY
This glossary has been produced to help clarify the terminology and wording used in QMT materials. The use of specialized terminology is
common in quality and it is essential that all words and phrases used are clearly defined to ensure that there is no misunderstanding or
confusion about their use.
It is, however, acknowledged that definitions are often a source of intense debate. Consequently, accepted definitions from ISO 9000 (2000) are
used, together with alternative definitions where they exist and are presented in a simpler and more meaningful way. However, not all of the
terms used within the materials are defined within the most recent ISO standard; in these cases, the most commonly accepted definitions have
been used. In situations where there is any doubt about the meaning of any of the terms used within the materials, the definition given in this
glossary should be applied.
Accreditation Process by which an independent and authorized agency certifies the quality and competence of an organization on
the basis of certain predefined standards
Accuracy Agreement between the results obtained and the true value
Audit Systematic, independent and documented examination to determine whether activities comply with a planned and
agreed quality system
Systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine
the extent to which audit criteria are fulfilled – ISO 9000 (2000)
Audit client Person or organization requesting an audit – ISO 9000 (2000)
Audit conclusions Outcome of an audit decided by the audit team after consideration of all the audit findings – ISO 9000 (2000)
Audit criteria Set of policies, procedures or requirements against which collected audit evidence is compared – ISO 9000 (2000)
Audit evidence Records, verified statements of fact or other information relevant to the audit – ISO 9000 (2000)
Audit findings Identified compliances and non-compliances against the standards used for the audit
Results of the evaluation of the collected audit evidence against audit criteria – ISO 9000 (2000)
Audit programme Set of audits to be carried out during a planned timeframe – ISO 9000 (2000)
Audit scope Extent or range of a given audit – ISO 9000 (2000)

Audit team The individual(s) performing the audit
One or more auditors conducting an audit, one of whom is appointed as leader – ISO 9000 (2000)
Auditee Process, department, organization being audited

Organization being audited – ISO 9000 (2000)
Auditor Person qualified and competent to conduct audits – ISO 9000 (2000)
Benchmarking The study of a competitor's product or business practices in order to improve the performance of one's own
company
Blood cold chain The maintained storage of blood and products at the appropriate storage temperature and conditions from the point
of collection to the point of use – "from vein to vein"
Calibration The set of operations which establish, under specified conditions, the relationship between values indicated by a
measuring instrument or measuring system, or values represented by a material measure, and the corresponding
known values of a reference standard
Capability Ability of an organization, system or process to realize a product that fulfils the requirements for that product
– ISO 9000 (2000)
CEO Chief executive officer
Characteristic Distinguishing feature – ISO 9000 (2000)
Clinical interface The relationship between the producers and users of blood and blood products
Compliance Meeting required standards
Concession Authorization to use or release a product that does not conform to specified requirements – ISO 9000 (2000)
Conformity Fulfilment of a requirement – ISO 9000 (2000)
Consistency Doing the same thing time after time, which makes the outcome more predictable and allows for reduced variation in
products and processes
Continuous quality improvement The ongoing improvement process at the centre of all quality systems: plan, do, check and act, as encapsulated in
the Deming Cycle
Contract Formal agreement of intention to supply a product or service in accordance with agreed specifications
Contract review Systematic activities carried out by the purchaser to ensure that contractual requirements have been met

Correction Remedial action taken to rectify a non-compliance or other situation in which an error has occurred
Action taken to eliminate a detected nonconformity – ISO 9000 (2000)
Corrective action Action taken to eliminate the cause of a detected nonconformity or other undesirable situation – ISO 9000 (2000)
Critical control points Those steps in a process or procedure that, without control, will lead to a poor quality outcome
Customer Organization or person that uses a product or service

Organization or person that receives a product – ISO 9000 (2000)
Customer dissatisfaction Customer’s opinion of the degree to which a transaction has failed to meet the customer’s needs and expectations
– ISO 9000 (2000)
Customer satisfaction Customer’s opinion of the degree to which a transaction has met the customer’s needs and expectations – ISO
9000 (2000)
Defect Failure of a product or procedure to meet part or all of its given specification
Non-fulfilment of a requirement related to an intended or specified use – ISO 9000 (2000)
Deming cycle The Plan-Do-Check-Act Cycle
Dependability Collective term used to describe the availability performance and its influencing factors: reliability performance,
maintainability performance and maintenance support performance – ISO 9000 (2000)
Design and development Set of processes that transforms requirements into specified characteristics and into the specification of the product
realization process – ISO 9000 (2000)
Deviation permit Authorization to depart from the originally specified requirements of a product prior to realization, for a limited
quantity of product or period of time, and for a specific use – ISO 9000 (2000)
Documentation Written policies, instructions and records involved in providing a product or service
Information and its support medium – ISO 9000 (2000)
Document control Formal control of the issue, use and review of authorized documents within the quality system
Effectiveness Measure of the extent to which planned activities are realized and planned results achieved – ISO 9000 (2000)
Efficiency Relationship between the result achieved and the resources used – ISO 9000 (2000)
EQAS External quality assessment scheme

Error An incident where the quality system has failed
Evaluation The specific selection process to determine the suitability of a procedure or material (e.g. reagent, blood pack,
equipment)
External quality assessment The external assessment of a laboratory’s performance using samples of known, but undisclosed, values and
(EQA) comparison with the performance of other laboratories
External quality assessment A recognized scheme for organizing EQA. This can be a local scheme or organized at national, regional or
scheme (EQAS) international levels
Fitness for purpose Suitability of a product or service for the purpose for which it is intended
GLP Good laboratory practice
GMP Good manufacturing practice
Good manufacturing practice That part of quality assurance which ensures that products are consistently produced and controlled to the quality
standards appropriate for their intended use and legal requirements
Guidelines Document stating recommendations or suggestions – ISO 9000 (2000)
Haemovigilance The monitoring, reporting and investigation of adverse incidents/near misses related to all blood transfusion
activities
Indicator Information gathered directly or indirectly at the critical control points in a process or procedure
Infrastructure System of permanent facilities and equipment of an organization – ISO 9000 (2000)
Inspection Conformity evaluation by observation and judgement accompanied, as appropriate by measurement, testing or
gauging – ISO 9000 (2000)
Interested party Person or group having an interest in the performance or success of an organization – ISO 9000 (2000)
Internal quality assessment The assessment of a laboratory’s overall quality system by the process of halving a sample, analysing each half in
(IQA) the same manner and comparing the results
ISO International Organisation for Standardisation
Management Coordinated activities to direct and control an organization – ISO 9000 (2000)
Management system System to establish policy and objectives and to achieve those objectives

Measurement Set of operations having the object of determining the value of a quantity – ISO 9000 (2000)
Measurement process Set of interrelated resources, activities, and influences related to a measurement – ISO 9000 (2000)
Monitoring The (on-going/continual) collection and analysis of data about an activity
Non-compliance Not meeting required standards (GMP). See also Nonconformity
Nonconformity Non-fulfilment of a requirement – ISO 9000 (2000)
Objective evidence Data supporting the existence or verity of something – ISO 9000 (2000)
Organization Group of people and facilities with an orderly arrangement of responsibilities, authorities and relationships
– ISO 9000 (2000)
Organizational structure Orderly arrangement of responsibilities, authorities and relationships between people – ISO 9000 (2000)
Policy A high-level overall document embracing the general goals and intentions of an organization
Precision Reproducibility of the quantifiable outcomes of processes and procedures
Preventive action Action taken to prevent the recurrence of potential non-conformity, defect or other cause of error
Action taken to eliminate the cause of a potential nonconformity or other potentially undesirable situation – ISO 9000
(2000)
Procedure Specific activity that forms the basic unit of a process

Specified way to carry out an activity or a process – ISO 9000 (2000)
Process A series of steps or actions that lead to a desired result or output

System of activities which uses resources to transform inputs into outputs – ISO 9000 (2000)
Product Result of a process – ISO 9000 (2000)
Project Unique process consisting of a set of coordinated and controlled activities with start and finish dates undertaken to
achieve an objective conforming to specific requirements including the constraints of time, cost and resources
– ISO 9000 (2000)
QAS Quality assessment scheme

Qualification Combination of personal attributes, minimum education, training, work and audit experience, and competencies
possessed by an individual
Combination of personal attributes, minimum education, training, work and audit experience, and competencies
possessed by an auditor – ISO 9000 (2000)
Quality Totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs
Ability of a set of inherent characteristics of a product, system or process to fulfil requirements of customers and
other interested parties – ISO 9000 (2000)
Quality assurance The overall range of activities and systems that provide confidence within the organization and authorities that all
quality requirements are met
Part of quality management focused on providing confidence that quality requirements are fulfilled – ISO 9000
(2000)
Quality characteristic Inherent characteristic of a product, process or system derived from requirement – ISO 9000 (2000)
Quality control Checks put in place to ensure that processes, procedures and products meet the quality requirements
Part of quality management focused on fulfilling quality requirements – ISO 9000 (2000)
Quality department The identified and authorized department within an organization responsible for the overall development,
organization and management of quality and quality systems
Quality evaluation Systematic examination of the extent to which an entity is capable of fulfilling specified requirements
Progression in the principles of a quality system from inspection, quality control, quality assurance, total quality
management
Quality improvement Part of quality management focused on increasing effectiveness and efficiency – ISO 9000 (2000)
Quality loop or quality spiral Conceptual model of interacting activities that influence quality at the various stages from identification of the needs
to the assessment of satisfaction
Quality management Coordinated activities to direct and control an organization with regard to quality – ISO 9000 (2000)
Quality management system System to establish a quality policy and quality objectives and to achieve those objectives – ISO 9000 (2000)
Quality manager The appointed, responsible and authorized individual within an organization with the responsibility for developing
and managing the quality system
Quality manual Document specifying the quality management system of an organization – ISO 9000 (2000)

Quality objective Something sought, or aimed for, related to quality – ISO 9000 (2000)
Quality officer An individual who works within the quality department of an organization and who is primarily concerned with the
day-to-day operation and maintenance of the quality system
Quality plan Document specifying the quality management system elements and the resources to be applied in a specific case
– ISO 9000 (2000)
Quality planning Part of quality management focused on setting quality objectives and specifying necessary operational processes
and related resources to fulfil the quality objectives – ISO 9000 (2000)
Quality policy Overall intentions and direction of an organization related to quality as expressed by top management – ISO 9000
(2000)
Quality requirement Requirement for inherent characteristics of a product, process or system – ISO 9000 (2000)
Quality system Organizational structure, processes, procedures and resources needed to implement quality requirements
Quarantine Non-authorization to proceed to next stage of a process until specified standards / conditions are met
Record Document stating results achieved or providing evidence of activities performed – ISO 9000 (2000)
Release Authorization to proceed to next stage of a process – ISO 9000 (2000)
Repair Action taken on a non-conforming product to make it conform to the requirements
Requirement Expression of need as defined quantitative or qualitative requirements

Need or expectation that is stated, customarily implied or obligatory – ISO 9000 (2000)
Responsible person An individual formally designated as being responsible for the quality of defined operations or outcomes within an
organization
Review Activity undertaken to ensure the suitability, adequacy, effectiveness and efficiency of the subject matter to achieve
established objectives – ISO 9000 (2000)
Service Intangible product that is the result of at least one activity performed at the interface between the supplier and
customer – ISO 9000 (2000)
Software Intellectual product consisting of information on a support medium – ISO 9000 (2000)
SOP - Standard operating procedure

Specification Document stating requirements – ISO 9000 (2000)
Standard Minimum level required
Standard operating procedure Written instructions for the performance of a specific procedure
Supplier Organization or person that provides a product – ISO 9000 (2000)
System Set of interrelated or interacting elements – ISO 9000 (2000)
Technical expert Person who provides specific knowledge or expertise with respect to a particular subject field to be audited
– ISO 9000 (2000)
Test Technical operation that consists of the determination of one or more characteristics of a given product, process or
service according to a specified procedure – ISO 9000 (2000)
Top management Person or group of people who direct and control an organization at the highest level – ISO 9000 (2000)
Total quality management Management approach of an organization centred on quality based on the participation of all its staff and aiming at
long term success through customers satisfaction and benefits to all staff and to society
Traceability Ability to trace the history, application or location of that which is under consideration – ISO 9000 (2000)
Validation That part of a QA system that evaluates in advance the steps involved in operational procedures or product
preparation to ensure quality, effectiveness and reliability (GMP)
Confirmation and provision of objective evidence that the requirements for a specific intended use or application
have been fulfilled – ISO 9000 (2000)sp
Work environment Set of conditions under which a person operates – ISO 9000 (2000)

Quality Management Training For Blood Transfusion Services: EHT/05.03 A Restricted

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WHO Quality Management Programme 3

Quality Management Training 4

Weekly programme of work 8

Quality Status Questionnaire 14

CORE COURSE MATERIALS

WHO Quality Management Programme

Authors and editorial team

Critical readers and other contributors

The need for quality management

WHO Quality Management Programme

Components of the QMP

Quality Management Training

Creating a culture of quality

Part 1: Basic Principles of Quality

Part 2: Applying Quality Management in the BTS

Weekly programme of work

Wherever possible, provide examples of documentation from your own region or

Using the PowerPoint slides

Using the PowerPoint projector

Making your presentation

Activity notes: facilitator

Activity notes: participants

Quality Status Questionnaire

Course evaluation form

Participant’s final report

PART 1 BASIC PRINCIPLES OF QUALITY

Module 3 Quality Systems

Module 4 Organizational Management

QMT/Core Course Materials 19

Module 8 Assessment within the Quality System

PART 2 APPLYING QUALITY MANAGEMENT IN THE BTS

QMT/Core Course Materials 20

Module 10 Hygiene and Safety in the BTS

Module 11 Quality Systems in Blood Donor Management

Module 12 Quality Systems in Laboratory Testing

Module 13 Quality Systems in Component Production and Management

QMT/Core Course Materials 21

Module 14 Quality Systems and the Clinical Interface

Module 15 Finalization of Participants’ Action Plans and Completion of

QMT/Core Course Materials 22

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