Control REq
-
Upload
hishamawan4083 -
Category
Documents
-
view
232 -
download
0
Transcript of Control REq
-
8/8/2019 Control REq
1/41
S. O'Brien, Nov. 2005 1
Quality ManagementQuality Management
SystemsSystems
An Introduction
-
8/8/2019 Control REq
2/41
-
8/8/2019 Control REq
3/41
S. O'Brien, Nov. 2005 3
Key Steps in the ProcessKey Steps in the Process
Select the required Quality ManagementSystem.
Using the selected standard, define therequirements across the different areas.
Train all staff in the specific requirementsand auditing techniques.
Establish a multifunctional team.
Carry out internal audits across the differentareas to identify the gaps (if any).
Draw up action plans to plug the gaps.
-
8/8/2019 Control REq
4/41
S. O'Brien, Nov. 2005 4
In Parallel Accreditation/ AuthorisationIn Parallel Accreditation/ Authorisation
Requires that:Requires that:--
The Laboratory/ department organises for
quality.
&
Key documentation needs to be established,
implemented and maintained.
-
8/8/2019 Control REq
5/41
S. O'Brien, Nov. 2005 5
Quality Management SystemQuality Management System --
DefinitionDefinition
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.
-
8/8/2019 Control REq
6/41
S. O'Brien, Nov. 2005 6
Benefits of Accreditation/Benefits of Accreditation/
AuthorisationAuthorisation
It provides assurance to the service usersthat their requirements will be met.
It allows management to communicate
organisational quality objectives in anefficient manner.
A Quality Management System involvingall staff ensures an integrated approach and
promotes quality awareness and teamwork. It brings a culture of step wise continuous
improvement to an organisation.
-
8/8/2019 Control REq
7/41
S. O'Brien, Nov. 2005 7
Benefits of Accreditation/Benefits of Accreditation/
Authorisation ContdAuthorisation 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.
-
8/8/2019 Control REq
8/41
S. O'Brien, Nov. 2005 8
Process ApproachProcess Approach
International standards promote theadoption 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.
-
8/8/2019 Control REq
9/41
S. O'Brien, Nov. 2005 9
Quality Management SystemQuality Management System
General RequirementsThe organisation shall:-
Identify the processes needed for the
Quality Management System. Determine the sequence and interaction of
these processes.
Determine criteria and methods needed toensure that both the operation and control of
these processes are effective.
-
8/8/2019 Control REq
10/41
S. O'Brien, Nov. 2005 10
Quality Management System ContdQuality Management System Contd
General R
equireme
nts
The organisation shall:-
Ensure the availability of resources andinformation necessary to support the
operation and monitoring of theseprocesses.
Monitor, measure and analyse theseprocesses.
Implement actions necessary to achieveplanned results and continual improvementof these processes.
-
8/8/2019 Control REq
11/41
S. O'Brien, Nov. 2005 11
Support from Hospital ManagementSupport 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
-
8/8/2019 Control REq
12/41
S. O'Brien, Nov. 2005 12
Management RequirementsManagement Requirements
Organisation and
Management
Examination by
Referral Laboratories
Quality Management
System
Resolution of
Complaints
Document Control Identification and
Control of Non
ConformitiesPersonnel
-
8/8/2019 Control REq
13/41
S. O'Brien, Nov. 2005 13
Management Requirements contdManagement Requirements contd
Corrective Action Quality and Technical
Records
Preventative Action Internal Audits
Continual
Improvement
Management Review
-
8/8/2019 Control REq
14/41
S. O'Brien, Nov. 2005 14
Management Requirements contdManagement 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
-
8/8/2019 Control REq
15/41
S. O'Brien, Nov. 2005 15
Organisation and ManagementOrganisation and Management
RequirementsRequirements
The organisation shall be legally
identifiable.
The organisation must have a Quality
Management System which meets allrequirements of the EU directive.
The services, including interpretation and
advisory services, must meet patient needsand requirements of clinical personnel.
-
8/8/2019 Control REq
16/41
S. O'Brien, Nov. 2005 16
Organisation and ManagementOrganisation and Management
Requirements ContdRequirements 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 Systemmanagement reviews.
Prepare organisational charts.
-
8/8/2019 Control REq
17/41
S. O'Brien, Nov. 2005 17
Quality Management SystemQuality Management System
Quality Policy
Quality Manual
Training Establish Quality Objectives
-
8/8/2019 Control REq
18/41
S. O'Brien, Nov. 2005 18
Document ControlDocument Control
Describe the Document Control system.
Documents must be reviewed andauthorised.
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.
-
8/8/2019 Control REq
19/41
S. O'Brien, Nov. 2005 19
Document Control contdDocument Control contd
For critical activity, materials, equipment
and personnel must be identified.
Access to data must be restricted.
-
8/8/2019 Control REq
20/41
S. O'Brien, Nov. 2005 20
PersonnelPersonnel
Job Descriptions
Personnel Policies
Induction Training
Professional Qualifications
Competency Testing
Responsibilities Clearly Defined
Training/ Re-Training
Informed of Ethical Issues
-
8/8/2019 Control REq
21/41
S. O'Brien, Nov. 2005 21
Resolution of ComplaintsResolution of Complaints
There must be documented procedures for
handling complaints.
Records of complaints, their investigation
and corrective action taken by theorganisation must be maintained.
Staff should be aware of such activities.
-
8/8/2019 Control REq
22/41
S. O'Brien, Nov. 2005 22
Identification and Control of NonIdentification and Control of Non
ConformitiesConformities
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.
-
8/8/2019 Control REq
23/41
S. O'Brien, Nov. 2005 23
Identification and Control of NonIdentification and Control of Non
Conformities ContdConformities Contd
Each non conformance must be documented
and these records must be reviewed at
regular intervals by LaboratoryManagement.
-
8/8/2019 Control REq
24/41
S. O'Brien, Nov. 2005 24
Corrective and Preventative ActionCorrective and Preventative Action
Internal and external data is reviewed to
identify problems and appropriate
corrective and preventative actions (user
satisfaction and complaints, internal systemand process audits, external QA data,
quality improvements)
Procedures for corrective and preventativeactions must include an investigation to
determine root causes.
-
8/8/2019 Control REq
25/41
S. O'Brien, Nov. 2005 25
Corrective and Preventative ActionCorrective and Preventative Action
ContdContd
Effectiveness of corrective and preventative
actions must be monitored and evaluated at
management review.
-
8/8/2019 Control REq
26/41
S. O'Brien, Nov. 2005 26
Continuous ImprovementContinuous Improvement
Action plans for improvement shall bedeveloped, documented and implemented asappropriate.
Prepare training plan. Management shall monitor effectiveness of
the improvement action plan at managementreview.
Results of the improvement programmemust be communicated to all staff.
-
8/8/2019 Control REq
27/41
S. O'Brien, Nov. 2005 27
Internal AuditsInternal Audits
Documented internal audit programme.
Prepare annual internal audit programme.
This programme must evaluate both the
Quality Management System and everyprocess in the loop.
Review audits.
-
8/8/2019 Control REq
28/41
S. O'Brien, Nov. 2005 28
Management ReviewManagement Review
Goals and objectives versus progress
Close out of complains and nonconformances
Monthly quality meetings Quality monitors
External audits
Third party assessments Feedback from clinicians/ patients
-
8/8/2019 Control REq
29/41
S. O'Brien, Nov. 2005 29
Facilities/ PremisesFacilities/ 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
-
8/8/2019 Control REq
30/41
S. O'Brien, Nov. 2005 30
EquipmentEquipment
Equipment must be shown to be capable ofachieving the performance required
(qualification).
The Laboratory must have documentedcalibration and preventative maintenance
programmes.
Each piece of equipment must be uniquelyidentified.
-
8/8/2019 Control REq
31/41
S. O'Brien, Nov. 2005 31
Equipment ContdEquipment Contd
There should be procedures for operation
and cleaning.
Specification of reagents and materials must
meet directives on invitro diagnostics andmedical devices.
-
8/8/2019 Control REq
32/41
S. O'Brien, Nov. 2005 32
Procurement of Human TissueProcurement 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 testsrequired for donors.
-
8/8/2019 Control REq
33/41
-
8/8/2019 Control REq
34/41
S. O'Brien, Nov. 2005 34
Storage and ReleaseStorage and Release
Procedures must comply with the followingcriteria:-
- Maximum storage time must be
specified for each type of storagecondition.
- Must be a system ofhold for tissue/cells to ensure they cannot be released
until all requirements are satisfied.
-
8/8/2019 Control REq
35/41
S. O'Brien, Nov. 2005 35
Storage and Release ContdStorage and Release Contd
Procedures must comply with the followingcriteria:-
- System to identify released from
quarantined from rejected.- Record show authorised person released
tissue/ cells.
- Documented procedures for exceptional
release.
-
8/8/2019 Control REq
36/41
S. O'Brien, Nov. 2005 36
Distribution and RecallDistribution and Recall
Procedures must comply with:-
- 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 forrecall.
-
8/8/2019 Control REq
37/41
S. O'Brien, Nov. 2005 37
Distribution and Recall ContdDistribution and Recall Contd
Procedures must comply with:-
- 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 returnedproducts must be in place.
-
8/8/2019 Control REq
38/41
S. O'Brien, Nov. 2005 38
LabellingLabelling
Primary container must indicate donationID or code and type of tissue. Also:-
- Date and time of donation
- Hazard warnings- Nature of additive
- For autologous use only
- Directed donation must identifyrecipient
- Label shipping container
-
8/8/2019 Control REq
39/41
S. O'Brien, Nov. 2005 39
Adverse Events/ ReactionsAdverse Events/ Reactions
Procedures must be in place to:-
- Notify tissue establishment of any
serious adverse reactions or events.
- Communicate to the IMB as soon asinformation is available about adverse
events.
- Complete serious adverse reactionnotification.
-
8/8/2019 Control REq
40/41
S. O'Brien, Nov. 2005 40
TraceabilityTraceability
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.
-
8/8/2019 Control REq
41/41
S. O'Brien, Nov. 2005 41
Next StepsNext Steps
Identify team
Organisational charts
Appoint responsible person
Job descriptions
Process flows
What have we already
Identify gaps
Appoint quality person