Control REq

8/8/2019 Control REq

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S. O'Brien, Nov. 2005 1

Quality ManagementQuality Management

SystemsSystems

An Introduction


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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.


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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.


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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.


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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.


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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.


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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.


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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.


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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.


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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


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Management RequirementsManagement Requirements

Organisation and

Management

Examination by

Referral Laboratories

Quality Management

System

Resolution of

Complaints

Document Control Identification and

Control of Non

ConformitiesPersonnel


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Management Requirements contdManagement Requirements contd

Corrective Action Quality and Technical

Records

Preventative Action Internal Audits

Continual

Improvement

Management Review


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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


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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.


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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.


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Quality Management SystemQuality Management System

Quality Policy

Quality Manual

Training Establish Quality Objectives


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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.


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Document Control contdDocument Control contd

For critical activity, materials, equipment

and personnel must be identified.

Access to data must be restricted.


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PersonnelPersonnel

Job Descriptions

Personnel Policies

Induction Training

Professional Qualifications

Competency Testing

Responsibilities Clearly Defined

Training/ Re-Training

Informed of Ethical Issues


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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.


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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.


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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.


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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.


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Corrective and Preventative ActionCorrective and Preventative Action

ContdContd

Effectiveness of corrective and preventative

actions must be monitored and evaluated at

management review.


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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.


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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.


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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


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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


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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.


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Equipment ContdEquipment Contd

There should be procedures for operation

and cleaning.

Specification of reagents and materials must

meet directives on invitro diagnostics andmedical devices.


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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.


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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.


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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.


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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.


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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.


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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


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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.


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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.


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Next StepsNext Steps

Identify team

Organisational charts

Appoint responsible person

Job descriptions

Process flows

What have we already

Identify gaps

Appoint quality person