Quality Management Systems

An Introduction

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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.

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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.
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In Parallel Accreditation/ Authorisation Requires that:

The Laboratory/ department organises for quality. & Key documentation needs to be established, implemented and maintained.

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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.

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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.
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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.

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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.
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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.
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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.
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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
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Management Requirements
Organisation and Management Quality Management System Document Control Examination by Referral Laboratories Resolution of Complaints Identification and Control of Non Conformities

Personnel
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Management Requirements contd Corrective Action Preventative Action

Continual Improvement

Quality and Technical Records Internal Audits

Management Review

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Management Requirements contd

Facilities/ Premises Equipment/ Materials Procurement of Human Tissue/ Cells Processing Distribution and Recall Labelling Adverse Reactions/ Events Traceability

Storage and Release of Products

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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.
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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.
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Quality Management System

Quality Policy Quality Manual Training Establish Quality Objectives

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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.
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Document Control contd

For critical activity, materials, equipment and personnel must be identified. Access to data must be restricted.

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Personnel

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 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.

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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.

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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.

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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.
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Corrective and Preventative Action Contd

Effectiveness of corrective and preventative actions must be monitored and evaluated at management review.

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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.
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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.

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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
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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
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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.

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Equipment Contd

There should be procedures for operation and cleaning. Specification of reagents and materials must meet directives on invitro diagnostics and medical devices.

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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.
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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.
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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.

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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.

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Distribution 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 for recall.
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Distribution 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 returned products must be in place.
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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
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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.
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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.

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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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