Quality Management Training Curriculum: Opening Ceremony

QUALITY MANAGEMENT TRAINING
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
blood safety
strategy for blood safety requirements for the strategy for blood safety • Describe the WHO
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
Management
Quality Management • Quality Management improving the safety and the QMP
Programme (QMP)
Programme (QMP) and Training adequacy of national • Emphasize the
Quality Management blood supplies principles of active
for Blood
Transfusion
Training (QMT) • QMT courses are held in learning in QMT courses
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 Curriculum/1 of 42 © World Health Organization, 2004

QMT 1.3 To introduce the WHO • Modular approach • The overall structure of • Ensure participants • Outline the structure and ½ hour
Introduction to the
QMT course • Role of the facilitators the course is modular understand the course content of the course
WHO QMT course • Role of the participants • The course will help objectives and structure • 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’
expectations
from the QMT course of the QMT course • Follow-up and support expectations realistic applying the principles of
• 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
Module 2 Introduction to 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
Activity • Creates a negative consequences of poor
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
Tour of the Blood
with the layout and building • Quality is a continuing particular interest in quality system that lead
Transfusion Centre
activities of the BTC • Opportunity to observe a process relation to quality to consistency and
(BTC) working blood • Quality involves all staff • Do not get drawn into fitness for purpose
transfusion centre (BTC) specifics about the way
Activity • Introduction to a working in which the BTS works
quality system

Module 3 Quality Systems
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
their control processes and processes and • Define critical control
procedures • 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

Module 4 Organizational Management
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
Activity • Formal approval and customers as well as its • Focus on simplicity and principles and ultimately
acceptance of the policy own structure and 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
outline authority, the right person for the specific job descriptions person specifications
responsibility and • Competence
delegation responsibility and
• Authority/responsibility
right job and person • Identify the importance
delegation • Staff should be well- specifications of authority and
Presentation • Effective personnel trained and competent • Reinforce the responsibility
management
• Job descriptions and importance of the • 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
• Appropriate manager’s role in duties and
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

Module 5 Standards for Quality Systems
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
• Regulatory standards • Quality standards help • Emphasize the the BTS of using quality
• Quality standards and ensure a systematic and importance of identifying standards
Presentation
audits consistent approach to appropriate standards • 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

Module 6 Documentation
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 • Use scenarios where a
• Relationship between processes and documents used in a
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
• Resources required must be provided: • Emphasize the need to identified training needs
Presentation preparing training plans
• The trainer and the • Funds ensure training plans • 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
plan • Developing an identified needs and comprehensive • 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
• Monitoring the • All training should be • Highlight the importance and training records
need to monitor and
effectiveness of training documented of regular reviews of • Produce effective
Presentation evaluate training
• Training procedures training and their documentation covering
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

Module 8 Assessment within the Quality System
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
Presentation • Principles of calibration calibration programme event of calibration preventive maintenance
• 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
Quality monitoring
monitoring and some • Monitoring tools way of looking at what is are different for data analysis
tools
examples of quality
• Benchmarking actually happening approaches to quality • 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
Activity • Critical analysis of data performance different types of performance
• 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
• Error reporting • Systems to report between mistakes and and their reporting
with errors
• quality incidents need to errors • Explain the importance
Presentation Error analysis
• Correction, corrective
be in place so that they • Discuss the differences of taking action to
can then be between mistakes, correct errors and
action and preventive investigated prevent further
action errors and non-
• Systems of correction, compliance occurrences
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
preparing an SOP on • Reporting and recording essential error reporting reporting for their BTS
on error reporting
dealing with errors 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
the quality system quality audits
auditing • Audit planning of quality audit
• • Audits must be • Stress the importance • Describe the audit
Presentation Benefits and value of
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 • Demonstrate an ability
serious failure in the often identifies a • 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
Module 9 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
• Quality policy: • Finalize a quality policy system in the BTS system in the BTS
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 • Stress the importance
• Delivery checks critical items must be can influence storage
• Quarantine of materials maintained at all times of correct storage conditions
• Inspection of incoming • All incoming materials conditions • Explain the principles of
materials must be appropriately • Emphasize the need for quarantine/release
checked before use contingency plans for procedures
• Correct storage of
perishable materials • Quarantine and release refrigerator/ freezer • List essential
procedures must be in failure documentation and
• Monitoring correct place for certain items • Reinforce the records for stock control
storage conditions
• Monitoring of usage can importance of
• 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 plans to blood supply which the safety and and adequacy of the
contingency • The continuity of the
planning ensure an adequate supply • Plans and procedures blood supply is adequacy of the blood blood supply
of safe blood products at
• Major disasters or essential supply may be • Develop a contingency
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
• Identify priority areas vary considerably
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

Module 10 Hygiene and Safety in the BTS
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
• Responsibilities for
hygiene and safety • Identify the role of the
should be defined quality manager in
safety
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
• Actions needed to workplace
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
recruitment and selection ensures that: populations to identify processes of donor
and selection • 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
and samples • Discuss the additional required to ensure
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
system enables the importance of
Presentation evaluation
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 retention donor is treated as an • Emphasize the donor satisfaction which
donor satisfaction and important customer importance of leads to retention
retention • Donor complaints
retention • 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

Module 12 Quality Systems in Laboratory Testing
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
immunohaematology to be planned carefully countries and use of
haematology • Validation
reagents reagents
• Control during routine • The characteristics that • Promote the ideal with an immunohaematology
should be examined acceptance of the reality reagents
Presentation use
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-transmissible in the BTS countries and use of TTI test kits
transfusion- • Validation
transmissible infections (TTIs)
• Control during routine • Batch testing is • Promote the ideal with an • Identify the role of the
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
• Benefits of EQA confidence in the overall schemes • Define the role of EQA
(EQA) schemes EQA schemes
• Organization and
performance in the • Encourage participation in a quality system
laboratory in EQA schemes • Identify the role of the
Presentation process of EQA
• 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 • Focus on the key monitoring the critical
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
production and we producing what we component production
component
management
• Monitoring plans are meant to be and management
production
• 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
quarantine and release quarantine on receipt release
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
and transportation of blood be controlled to ensure "vein to vein" quality in storage and
transportation of • Transportation
blood components components
• Maintenance of the
the quality of products is • Explore different transportation
Presentation blood cold chain
maintained from donor 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
• Security during required to ensure a
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
• Documentation
includes the returning blood for • Identify the role of the
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 system for requisite documented documented
documentation • Labelling
system for blood blood component
• Traceability • GMP guidelines should • Give examples of the • Identify the basic
component production 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
component production

Module 14 Quality Systems and the Clinical Interface
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
• The role of a hospital of blood
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
• Using documentation in required to establish an
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
• Storage of blood products meet quality • Emphasize the role of a transfusion process
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
requests and at the bedside quality at the bedside quality at the bedside
hospital • 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
quality of the hospital and the results to crossmatch : to improve hospital
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
• Defining the timescale plans
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

Quality Management Training Curriculum: Opening Ceremony

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QUALITY MANAGEMENT TRAINING

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Module 9 Quality Management in the BTS

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