Quality Management Systems: S. O'Brien, Nov. 2005 1

S. O'Brien, Nov.
2005 1
Quality Management
Systems
An Introduction
S. O'Brien, Nov. 2005 2
Objectives
Understand the requirements of the EU
Directive 2004/23/EC.
Appreciate the benefits that a Quality
Management System brings to an
organisation.
Be able to initiate the process toward being
accredited/ designated, authorised or
licensed.
Key Steps in the Process
Select the required Quality Management
System.
Using the selected standard, define the
requirements across the different areas.
Train all staff in the specific requirements
and auditing techniques.
Establish a multifunctional team.
Carry out internal audits across the different
areas to identify the gaps (if any).
Draw up action plans to plug the gaps.
In Parallel Accreditation/ Authorisation
Requires that:-
The Laboratory/ department organises for
quality.
&
Key documentation needs to be established,
implemented and maintained.

Quality Management System -
Definition
The Quality Management System is defined
as the organisation structure,
responsibilities, activities, resources and
events that together provide organised
processes and techniques of implementation
to ensure the capability of the organisation
to meet quality requirements.
Benefits of Accreditation/
Authorisation
It provides assurance to the service users
that their requirements will be met.
It allows management to communicate
organisational quality objectives in an
efficient manner.
A Quality Management System involving
all staff ensures an integrated approach and
promotes quality awareness and teamwork.
It brings a culture of step wise continuous
improvement to an organisation.
Benefits of Accreditation/
Authorisation Contd
It allows the organisation to benchmark
itself against similar organisations.
Accreditation provides evidence to external
parties that the organisation has reached the
standard required to carry out prescribed
functions.
Process Approach
International standards promote the
adoption of a process approach when
developing a Quality Management System.
For an organisation to function effectively,
it has to identify and manage numerous
linked activities.
These activities can be considered
processes. The output from one process
directly forms the input to the next.
Quality Management System
General Requirements
The organisation shall:-
Identify the processes needed for the
Quality Management System.
Determine the sequence and interaction of
these processes.
Determine criteria and methods needed to
ensure that both the operation and control of
these processes are effective.
Quality Management System Contd
General Requirements
The organisation shall:-
Ensure the availability of resources and
information necessary to support the
operation and monitoring of these
processes.
Monitor, measure and analyse these
processes.
Implement actions necessary to achieve
planned results and continual improvement
of these processes.
Support from Hospital Management
Hospital Manager
Consultant Haematologists
Laboratory Manager
Information Technology Department
Chief Medical Scientist
Human Resources Department
Haemovigilance, Phlebotomy, Nursing,
Clerical and Quality Officer

Management Requirements
Organisation and
Management
Examination by
Referral Laboratories
Quality Management
System
Resolution of
Complaints
Document Control

Identification and
Control of Non
Conformities
Personnel
Management Requirements contd
Corrective Action

Quality and Technical
Records
Preventative Action

Internal Audits
Continual
Improvement
Management Review
Management Requirements contd
Facilities/ Premises Distribution and Recall
Equipment/ Materials Labelling
Procurement of
Human Tissue/ Cells
Adverse Reactions/
Events
Processing Traceability
Storage and Release of
Products
Organisation and Management
Requirements
The organisation shall be legally
identifiable.
The organisation must have a Quality
Management System which meets all
requirements of the EU directive.
The services, including interpretation and
advisory services, must meet patient needs
and requirements of clinical personnel.
Organisation and Management
Requirements Contd
Appoint a responsible person.
Nominate a medical registered practitioner.
Establish a quality organisation.
Appoint a Quality Manager.
Provide adequate resources (personnel,
equipment and facilities).
Conduct regular Quality Management System
management reviews.
Prepare organisational charts.

Quality Management System
Quality Policy
Quality Manual
Training
Establish Quality Objectives
Document Control
Describe the Document Control system.
Documents must be reviewed and
authorised.
SOP for retention and storage of records.
SOP for control of archive documentation.
Amending documents.
Audit quality documents annually.
Master list of documents and retention
times.
Document Control contd
For critical activity, materials, equipment
and personnel must be identified.
Access to data must be restricted.
Personnel
Job Descriptions
Personnel Policies
Induction Training
Professional Qualifications
Competency Testing
Responsibilities Clearly Defined
Training/ Re-Training
Informed of Ethical Issues
Resolution of Complaints
There must be documented procedures for
handling complaints.
Records of complaints, their investigation
and corrective action taken by the
organisation must be maintained.
Staff should be aware of such activities.
Identification and Control of Non
Conformities
There must be a documented procedure
describing the actions taken when non
conformities are detected.
These procedures must include a definition
of what constitutes a non conformity, what
actions are taken and who is responsible for
this, what is done to prevent reoccurrence.
Identification and Control of Non
Conformities Contd
Each non conformance must be documented
and these records must be reviewed at
regular intervals by Laboratory
Management.
Corrective and Preventative Action
Internal and external data is reviewed to
identify problems and appropriate
corrective and preventative actions (user
satisfaction and complaints, internal system
and process audits, external QA data,
quality improvements)
Procedures for corrective and preventative
actions must include an investigation to
determine root causes.
Corrective and Preventative Action
Contd
Effectiveness of corrective and preventative
actions must be monitored and evaluated at
management review.
Continuous Improvement
Action plans for improvement shall be
developed, documented and implemented as
appropriate.
Prepare training plan.
Management shall monitor effectiveness of
the improvement action plan at management
review.
Results of the improvement programme
must be communicated to all staff.
Internal Audits
Documented internal audit programme.
Prepare annual internal audit programme.
This programme must evaluate both the
Quality Management System and every
process in the loop.
Review audits.
Management Review
Goals and objectives versus progress
Close out of complains and non
conformances
Monthly quality meetings
Quality monitors
External audits
Third party assessments
Feedback from clinicians/ patients
Facilities/ Premises
Suitable design and workflow
Critical parameters controlled and
monitored
Storage conditions defined
Specified air quality- validated
Written gowning instructions
Segregate storage in quarantine/ released/
rejected
Security/ restricted access
Cleaning
Equipment
Equipment must be shown to be capable of
achieving the performance required
(qualification).
The Laboratory must have documented
calibration and preventative maintenance
programmes.
Each piece of equipment must be uniquely
identified.
Equipment Contd
There should be procedures for operation
and cleaning.
Specification of reagents and materials must
meet directives on invitro diagnostics and
medical devices.
Procurement of Human Tissue
There shall be SOPs for the verification of:-
- Donor identity
- Details of donor on donor family
consent
- The assessment of the selection criteria
for donors
- The assessment of the Laboratory tests
required for donors.
Processing
Procedures must comply with:-
- Critical processes must be validated
- Process can be carried out consistently
and effectively
- Microbial inactivation procedure must
be specified, documented and validated
- Before change is implemented, the
modified process must be validated
and documented.
Storage and Release
Procedures must comply with the following
criteria:-
- Maximum storage time must be
specified for each type of storage
condition.
- Must be a system of hold for tissue/
cells to ensure they cannot be released
until all requirements are satisfied.
Storage and Release Contd
Procedures must comply with the following
criteria:-
- System to identify released from
quarantined from rejected.
- Record show authorised person released
tissue/ cells.
- Documented procedures for exceptional
release.
Distribution and Recall
- Critical transport conditions
temperature and time limit must be
defined.
- Container must ensure that tissue/ cells
are maintained in specified conditions.
- Authorised personnel to assess need for
recall.
Distribution and Recall Contd
- SOP must be in place for recall and
include notification to the competent
authority.
- Rules for allocation of tissue/ cells must
be documented.
- Procedure for handling returned
products must be in place.
Labelling
Primary container must indicate donation
ID or code and type of tissue. Also:-
- Date and time of donation
- Hazard warnings
- Nature of additive
- For autologous use only
- Directed donation must identify
recipient
- Label shipping container
Adverse Events/ Reactions
Procedures must be in place to:-
- Notify tissue establishment of any
serious adverse reactions or events.
- Communicate to the IMB as soon as
information is available about adverse
events.
- Complete serious adverse reaction
notification.
Traceability
Data to be retained for 30 years.
Have effective, unique and accurate ID and
labelling systems.
Maintain registers of received, processed,
stored and distributed or discarded tissues.
Access to archive frozen serum samples for
at least 2 years.
Next Steps
Identify team
Organisational charts
Appoint responsible person
Job descriptions
Process flows
What have we already
Identify gaps
Appoint quality person

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