BASIC CONCEPTS IN QUALITY MANAGEMENT

Transcription

1 BASIC CONCEPTS IN QUALITY MANAGEMENT Ivana Ferrero Processing inspector Inspection Report Assessor Stem Cell Transplantation and Cellular Therapy Unit City of Health and Science of Turin - Italy #EBMT2015

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3 B4 C4 Quality Management Quality Management

4 THE QUALITY MANAGEMENT SYSTEM The QMS could be implemented applying the cycle for continuous improvement model known as Plan-Do-Check-Act - PDCA (Demin cycle) MISSION OBJECTIVES PROCESSES RISK ASSESSMENT CORRECTIVE ACTIONS MONITORING

5 Plan Define the scope of your QMS Identify what processes within the scope are most important, which need to be done correctly: CLINICAL-COLLECTION-PROCESSING PROCESSES Identify what behaviours are most important Identify those staff who are involved in the important processes Involve them in defining what the targets should be used to measure the quality of the process. Ensure staff know how they can contribute to achieve the performance required.

6 B4.2 C4.2 D4.2 The Processing Facility shall establish and maintain a written Quality Management Plan. B4.3 C4.3 D4.3 The Quality Management Plan shall include, or summarize and reference, an organizational chart of key positions and functions within the Cellular Therapy program, including clinical, collection and processing.

7 ELEMENTS OF A QUALITY MANAGEMENT PLAN STANDARD JACIE ISO 9001 LEGISLATIVE, REGULATORY AND INSTITUTIONAL REQUIREMENTS EXTERNAL GUIDELINES CODE OF ETHICS CLIENT/PATIENT REQUIREMENTS Quality policy Quality objectives Quality manual Organizational structure and responsibilities Data Management Processes - including purchasing Product quality leading to Customer satisfaction Continuous improvement including corrective and preventive action

8 B4.4 C4.4 D4.4 The Quality Management Plan shall include, or summarize and reference, policies and Standard Operating Procedures addressing personnel requirements for each key position in the Clinical Program, Collection and Processing Facilities. Job description (number of procedures) Training records (CV, qualifications) Competency (GMP) Re-training (congress, specific course) B-C-D Initial qualifications. B-C-D New employee orientation. B-C-D Initial training and retraining when appropriate for all procedures performed. B-C-D Competency for each critical function performed. B-C-D Continued competency at least annually. B-C-D Continuing education.

9 THE TRAINING QUALITY MANAGEMENT GUIDE Second Ed. March 2013

10 B4.5 C4.5 D4.5 The Quality Management Plan shall include, or summarize and reference, a comprehensive system for document control and management. B-C-D There shall be policies and procedures for development, approval, implementation, review, revision, and archival of all critical documents. «SOP for SOPs» B-C-D4.5.2 Controlled documents shall include at a minimum: B-C-D Policies and Standard Operating Procedures B-C-D Worksheets B-C-D Forms B-C-D Labels

11 THE DOCUMENT SYSTEM The quality system is a documented system NEVER a system of documents! QUALITY MANUAL STANDARD OPERATING PROCEDURES OPERATIONAL DOCUMENTATION, FORMS, EXTERNAL DOCUMENTS QUALITY RECORDS

12 THE QUALITY MANUAL 1. Organisational Profile (Facility description) 2. Definition of the Quality Management Programme 3. Process impact of the Quality Management Programme 4. Quality Assurance 5. Organisational Structure 6. Agreements 7. Key Personne: Roles & Responsibilities 8. Personnel Qualifications, Training & Competency 9. Document management 10. Patient Information/Data 11. General Patient Care 12. Process control 13. Measurements 14. Health & Safety 15. Process Improvement Plan 16. Annexes

13 STANDARD OPERATING PROCEDURE (SOP) SOP: detailed, written instructions to achieve uniformity of the performance of a specific function Ref. International Conference on Harmonization applied in pharmaceutical processing and related clinical studies 1.Aim 2.Responsabilities 3.Equipments 4.References 5.Definitions 6. Procedure Forms 8. Annexes Description of the activities: WHAT-WHO-WHERE-WHEN-WHY

14 QUALITY MANUAL - PROGRAMME DESCRIPTION - ORGANIZATION - QUALITY MANAGEMENTS - TRAINING - MEASUREMENTS - SOPs - CRYOPRESERVATION - VALIDATION - PRODUCT RECALL - LABELLING - WORK INSTRUCTIONS - CD34 COUNT - INVENTORY OF REAGENTS - INSTRUMENTS MANTAINANCE FORMS, RECORDS - REQUESTS - CHECKLISTS - PATIENT RECORDS - REGISTRATIONS OF ERRORS -

15 PROCESSING FACILITY SOPs 1. General Staff training Laboratory Safety Environmental monitoring Validation of equipment and methods Quality control testing of products and reagents 2. Data management Process and results validation and reporting Database entry and report generation Data storage and archiving 3. Procedures CD34 count Other manipulation Buffy coat preparation Viability testing Red cell depletion Microbiological screening CD34 selection 4. Labelling 5. Cryopreservation 6. Storage 7. Thawing procedure 8. Transport 9. Policy for disposal 10. Internal audit 11. Policy for outcome review (engraftment)

16 B4.7 C4.7 D4.7 The Quality Management Plan shall include, or summarize and reference, policies and procedures for review of outcome analysis and cellular therapy product efficacy to verify that the procedures in use consistently provide a safe and effective product.

17 B4.11 C4.11 D4.11 The Quality Management Plan shall include, or summarize and reference, policies and procedures for cellular therapy product tracking and tracing that allow tracking from the donor to the recipient or final disposition and tracing from the recipient or final disposition to the donor.

18 B4.12 C4.12 D4.12 The Quality Management Plan shall include, or summarize and reference, policies and procedures for actions to take in the event the Processing Facility s operations are interrupted. «DISASTER PLAN» «DISASTER RECOVERY PLAN» electronic record systems drug shortages power outages equipment failures

19 B4.13 C4.13 D4.13 The Quality Management Plan shall include, or summarize and reference, policies and procedures for qualification of critical supplies, manufacturers, vendors, reagents, equipment, and facilities. FIRST IN FIRST OUT FOR REAGENTS CALIBRATIONS FOR CRITICAL INSTRUMENTS QUALIFICATION OF SUPPLIERS Remote audits by questionnaire External audit sharing of internal audit findings and corrective action A documented review of the suppliers past performance history

20 C4.14 D4.14 D4.14 The Quality Management Plan shall include, or summarize and reference, policies and procedures for validation and/or verification of critical procedures to achieve the expected end-points. Implementation of a critical procedure A change of reagents used A change of method Labelling Transport Electronic systems

21 Check B4.8 C4.8 D4.8 The Quality Management Plan shall include, or summarize and reference, policies, procedures, and a schedule for conducting, reviewing, and reporting audits of the Clinical/Collection/Processing Facility s activities to verify compliance with elements of the Quality Management Program and operational policies and procedures. Audit plan Audit report External audit Follow-up and actions to take after audit

22 B4.10 C4.10 D4.10 The Quality Management Plan shall include, or summarize and reference, policies and procedures for errors, accidents, biological product deviations, serious adverse events, and complaints,. Errors&Accidents = Any unforeseen or unexpected deviations from applicable regulations, standards, or established specifications that may affect the safety, purity, or potency of a cellular therapy product. Adverse event = Any unintended or unfavorable sign, symptom, abnormality, or condition temporally associated with an intervention that may or may not have a causal relationship with the intervention, medical treatment, or procedure. Adverse reaction = An unintended response suspected or demonstrated to be caused by the collection or infusion of a cellular therapy product or by the product itself. Deviations = The action of departing from an established course or accepted standard. Complaints = Any written, oral, or electronic communication about a problem associated with a cellular therapy product or with a service related to the collection, processing, storage, distribution, or administration of a cellular therapy product.

23 B-C-D Detection B-C-D Investigation B-C-D Documentation B-C-D Reporting B-C-D Corrective/preventive actions

24 MONITORING THE SYSTEM

25 Through a questionnaire sent to JACIE-accredited centers and responses from 32 programs (or 40%), 293 indicators have been identified. Types of indicators collected: measurement, analysis and improvement (54/293 or 18%) donor collection (49/293 or 16%) processing and storage of cell therapy products (37/293 or 12.5%) administration of HSCs (67/293 or 23%)

26 Act B C D Corrective and preventive action. D Appropriate corrective action shall be implemented if indicated, including both short-term action to address the immediate problem and long-term action to prevent the problem from recurring. D Follow-up audits of the effectiveness of corrective actions shall be performed in a timeframe as indicated in the investigative report. CAPA PLAN

27 Patients who received an allogeneic HSCT between 2004 and 2006 Center accredited Center not-accredited Accreditation as an indicator for quality driven work was the single most important contributing factor to the substantial improvement over time. The introduction of a quality management system can induce visible changes in a medical team, long before final accreditation.

28 #EBMT2015 Eoin McGrath Iris Bargalló Raquel Espada Carole Charley