Quality System Oversight Institut Jules Bordet Brussels Pharm. O. Urbain Quality Coordinator

QUALITY SYSTEM OVERSIGHT A quality management system is a mechanism to ensure that procedures are being carried out in line with agreed standards with full participation by all staff members. (JACIE) Full participation is only possible if the staff members understand correctly the functioning and expectations of the quality system. The Quality system can be fully compliant with all quality standards, it will never be effective if staff members do not fully know it and do not understand it. To propose a tool to oversee the Quality System based on feed back from staff members In order to check the functioning of the quality system

QUALITY SYSTEM OVERSIGHT

1

PRESENTATION & ACCREDITATION PROGRAM

2

QUALITY SYSTEM EVOLUTION IN HEMATOLOGY DEPARTMENT

3

TOOL PREPARATION & DATA ANALYSIS

4

CONCLUSION

PRESENTATION & ACCREDITATION PROGRAM

PRESENTATION & ACCREDITATION PROGRAM

PRESENTATION • Located in Brussels • Part of “IRIS” most important hospital network of Belgium • Institut Jules Bordet (IJB) is an autonomous hospital dedicated to cancer diseases.  Screening missions and clinical care ,  Research activity,  University education

PRESENTATION & ACCREDITATION PROGRAM

Jacie Accredited Since March 2010 HPC Marrow & Apahresis Collection (Paed/Adult)

Stem Cell Bank (Processing)

Autologous & Allogenic Transplantation In Adult Patients

Therapeutic Cell Bank

Hematology Department Prof. D. Bron, Department Head Autologous & Allogenic Transplantation In Paediatrics Patients

Quality Unit : Dr. H. Huynh – Pharm. O. Urbain

Cord Blood Bank

QUALITY SYSTEM EVOLUTION AT HEMATOLOGY DEPARTMENT

QUALITY SYSTEM EVOLUTION AT HEMATOLOGY DEPARTMENT

Quality System organization (before 2012)

Therapeutic Bank Sect Ba Clinical Adults

Sect C CM Collection & Apharesis FAHMP Regulations

JACIE Standards

Cord Blood Bank

Sect Be Clinical

Sect D

Paed

Processing (Stem Cells Bank)

FACTNetcord Standard

8

QUALITY SYSTEM EVOLUTION AT HEMATOLOGY DEPARTMENT

Quality System Organization (current situation)

Sect Ba Cl in ic a l Ad u l t s Sect Be Clinical Paed

Sect C CM & Apharesis

Sect D Processing (Stem Cell Bank)

The highest standard being retained

Quality System Sect CBB Cord Blood Bank Sect Therapeutic Cell Bank 9

QUALITY SYSTEM EVOLUTION AT HEMATOLOGY DEPARTMENT

And now… How to know if my Quality System works correctly ? is understood by users ?

My Quality System must be evaluate by users

Necessary to set up an evaluation matrix based on « Quality Topics » constituting the quality system

TOOL PREPARATION & DATA ANALYSIS

TOOL PREPARATION & DATA ANALYSIS

How to set up the evaluation matrix ?

Four Steps

1

Define key quality topic

2

Edit specification list for each topics

3

Prepare a notation system (In order to

4

evaluate each specification)

Shape the form

TOOL PREPARATION & DATA ANALYSIS

Define key Quality topics

Quality Manual (Accreditation Standards)

Requirements & Management & commitment organization

Personnel

Documentation

Facilities & Equipments

Processes & Interfaces

Monitoring & Continuous Improvement

TOOL PREPARATION & DATA ANALYSIS

Edit a specification list for each topics

Requirements

Management

&

&

Conmittments

Organization

 Commitment declaration for a quality process by management is known  Commitment declaration for a quality process by your responsible is known  Quality Policy of the department / sector is defined  …

 Description of the organization of the sector / department is known  Chart of the sector / department is known  The sector / department considers the management of confidential data  …

Personnel  Human resource needs of the sector / department are defined  Job description including mandatory qualifications is defined  Job description includes a training plan  Staff skills are assessed and maintained  …

TOOL PREPARATION & DATA ANALYSIS

Prepare a notation system Define a notation scale

Personnel Human resource needs of the sector / department are defined

Items Score 0-1-2-3

Job description including mandatory qualifications is defined

0-1-2-3

Job description includes a training plan Management and follow-up of training are performed Staff skills are assessed and maintained

0-1-2-3 0-1-2-3 0-1-2-3

According to specifications and his experience, the user will give a score from 0 to 3

TOOL PREPARATION & DATA ANALYSIS

Shaping :Evaluation Matrix Example

TOOL PREPARATION & DATA ANALYSIS

Collect & analyze datas Sect Ba Sect C

Sect Be Quality System Sect CBB

Sect D Sect BVT

TOOL PREPARATION & DATA ANALYSIS

DATA ANALYSIS

• Various way to analyze data  By sectors  By topics  By staff category …Or a mix

TOOL PREPARATION & DATA ANALYSIS

First Use : Global Dashboard This board allows to have a fast sight on the efficiency of the quality system Global Evaluation Average

Quality System

Global Evaluation Average By Sectors

Global Evaluation Average By Topics 75 to 100 %

No Action

51 to 74 %

To Monitor

0 to 50 %

To Investigate

Sect 1

Requirements & commitment

Management & organization

Sect 2

Personnel

Sect 3

Documentation

Sect 4

Sect 5

Facilities & Equipments

Sect 6

Processes & Interfaces

Monitoring & Continuous Improvement

TOOL PREPARATION & DATA ANALYSIS

Second Use : By Sectors & Topics (crossed analysis)

TopicsF SectorsH

Requirements

Management

&

&

Commitments

Organization

Facilities Documentation

Personnel

Processes

Monitoring &

&

&

Continuous

Equipments

Interface

Equipment

Sector 1 Sector 2 Sector3 Sector 4 Sector 5 Sector 6

To Identify Sectors/Topics « in one shoot » to investigate

To Identify Sectors/Topics « borderline »

TOOL PREPARATION & DATA ANALYSIS

Check specifications score average for a fine tuning ! By using specifications average, we can highlight specifications requiring a particular attention

Personnel Human resource needs of the sector / department are defined Job description including mandatory qualifications is defined Job description includes a training plan Management and follow-up of training are performed Staff skills are assessed and maintained

Specifications Topic Score Score Average Average 2 3 1 2 1

TOOL PREPARATION & DATA ANALYSIS

Exemple 1 : Personnel Topic For All Sectors Global Evaluation Average

57 %

Check specifications score average • Training plan by job description • Skills assessment Meet users

Corrective actions

Revaluation after 3 months

Root cause investigation • training not enough detailled • Lack of information (skills assessment) • To improve training plan (working group) • Information session 71%

TOOL PREPARATION & DATA ANALYSIS

Exemple 2 : Monitoring & Continuous Improvement For Sector 5

Global Evaluation Average

46 %

Check specifications score average

• Nonconformities management • Complaints management

Meet users of sector 5 Corrective action Revaluation after 3 months

Root cause investigation • Procedures not understood • Users retraining 78%

CONCLUSION

CONCLUSION

CONCLUSION

EVEN IF  Can be time consuming (preparation, analyze,..)  Only a “macroscopic” view  Not “really” a gap analysis with quality standards

Positive  Quick Overview of efficiency  Help to prevent deficiencies by highlighting weaknesses  Increase the efficiency  Totally based on feedback from users

CONCLUSION

CONCLUSION Users are Actors of the Quality System

Actors feedback is an essential source for quality management

Thank you for your attention