Development and Implementation of a Quality System

The Molecular Diagnostics Research LaboratoryThe Molecular Diagnostics Research LaboratoryUniversity of MalayaUniversity of Malaya

Yap SF

Department of Pathology

University of Malaya

Backbone of the Accreditation Backbone of the Accreditation ProcessProcess

Standards of Laboratory Practice

Criteria against which all laboratories are judged

Requirements for Laboratory AccreditationRequirements for Laboratory AccreditationCAP Checklist 1992CAP Checklist 1992

Planned and systemic QAP QAP in effect at sectional level Documentation, monitoring, evaluation of QA

indicators in each section at all shifts Monitoring & evaluation efforts documented,

reported with appropriate actions Annual internal appraisal of QAP to assess all

elements of the QAP Laboratory director and all professional staff must

participate in the QA activities

Standards and GuidelinesStandards and GuidelinesCPACPA

A set of 6 standards (A-F)Organisation and administrationStaffing and directionFacilities and equipmentPolicies and proceduresStaff development and educationEvaluation

Standards and GuidelinesStandards and GuidelinesISO/IEC 17025ISO/IEC 17025

“General requirements for competence of testing and calibration laboratories”

Released 2/2000 Replaces ISO/IEC guide 25 Encompasses :

“Management System Requirements”

“Technical Requirements” Internationally recognised basic document for

accreditation of laboratories

Structure of ISO/IEC 17025Structure of ISO/IEC 17025

Section 1 : Organisation and Management

Section 2 : Technical RequirementsNew Elements : Control of non-conforming tests

Measurement of uncertainty Verification of standard methods Plan for introduction of analytical

methods

ISO 9000 like Quality Management

Key Elements of ISO/IEC 17025Key Elements of ISO/IEC 17025

Internal QC Participation in external QAS Working procedures or Standard Operating

Procedures (SOPs) Use of traceable standard reference materials Instrument maintenance and calibration Validated methods Report of measurement uncertainty Qualified personnel Records and reports

Standards and GuidelinesStandards and GuidelinesISO/DIS 15189ISO/DIS 15189

“Quality Management in the Medical Laboratory” Drafted by technical committee ISO/TC 212 For clinical laboratory testing Provides requirements relevant to “quality

management” of medical laboratories Encompasses :

“Management System Requirements”

“Resources and Technical Requirements”

Guideline on Development of a Quality Guideline on Development of a Quality SystemSystem

NCCLS doc GP26ANCCLS doc GP26A

A quality system model for healthcare Consistent with requirements of the ISO guide for

quality standards Applicable to any service in a healthcare

organisation Based on the application of a list of quality system

essentials (QSE) applied to ALL operations in the workflow path

Quality System ElementsQuality System Elements

OrganisationPersonnelEquipment

Process Control Documents and Records Purchase and Inventory

Internal AssessmentProcess Improvement

Occurrence Management Service and Satisfaction

OrganisationPersonnelEquipment

Process Control Documents and Records Purchase and Inventory

Internal AssessmentProcess Improvement

Occurrence Management Service and Satisfaction

Quality System Management Quality System Management Requirements Requirements

A Management Policy and System Standardisation of Procedures Documentation of :

- Quality Policies

- Management Procedures

- Operational Procedures Internal Audits External Assessment

Implementation Implementation The Initial PhaseThe Initial Phase

1. Development of a quality manual (QSE : Organisation)

2. Development of Process Control (QSE : Process Control)

a) Analysis and validation of processes

b) Development of SOPs

c) Implementation of process control checks

3. Development of a management system for documents & records (QSE : Document Control)

Development of Processes and Development of Processes and ProceduresProcedures

1. Staff training & competence testing (QSE : Personnel)

2. Equipment management (QSE : Equipment)

3. Purchase and inventory (QSE : Purchase and inventory)

4. Control of non-conforming product (QSE : Occurrence Management)

5. Internal quality indicators and audit (QSE : Internal Assessment)

6. Process improvement (QSE : Process Improvement)

7. Monitoring of service & customer satisfaction (QSE : Service and Satisfaction)

Development of Process ControlsDevelopment of Process Controls

1. Process analysis

2. Process validation

3. Preparation of SOPs

4. Implementation of process controlsQC programme

PT programme

Occurrence log

Development & use of quality indicators

Equipment Management PlanEquipment Management Plan

1. Verification of functional status

2. Determination & documentation of

schedule for service and calibration

3. Preparation of procedure manuals

4. Implementation of instrument logs

5. Prepare inventory

6. Appointment of equipment management

officer

Personnel Orientation, Training and Personnel Orientation, Training and EducationEducation

1. Orientation of new staff

2. Initial instruction & trainingLaboratory safety

General laboratory procedures

Quality laboratory practices

3. Continuous education and competence

monitoring

4. Documentation of training and education

People QualificationPeople Qualification

Analytical Technique

Instrument Operation

Result Interpretation

Basic Troubleshooting

Regulations and Quality Standard Requirements

The 10 Step Implementation PlanThe 10 Step Implementation PlanWhere are we?Where are we?

Develop & implement quality system Develop SOPs Develop organisation infrastructure (including roles

and responsibilities) Train people Validate equipment Validate analytical procedures Develop program to use certified reference materials Develop quality assessment schemes Develop internal audit program Develop procedures for recording & archiving

What is Quality?What is Quality?

A word widely used and apparently well-understood but seldom defined

Crosby “ Quality has much in common with sex”

Everyone is for it (Under certain conditions, of course)

Everyone feels they understand it (Even though they wouldn’t want to explain it)

Everyone thinks execution is only a matter of following natural inclination (After all, we do get along somehow)

And of course most people feel that all problems in these areas are caused by other people (If only they would take time to do things right)

Quality Laboratory Processes (QLP) and Quality Control (QC)

  

QLP : Good processes, procedures and people

  QC : Control of products and processes

QLP and QC can be grouped into 3 areas :

  Pre-analytical

Analytical

Post-analytical

 

Quality Requirements Quality Requirements The Medical Laboratory PerspectiveThe Medical Laboratory Perspective

Staff – qualification, training, experience and competence Facilities – adequate and appropriate Test menu – repertoire, medical usefulness Support – specimen acquisition, transportation,

processing, storage Analysis – appropriate analytical quality Service – fit demand for use, meet needs for TAT Communication – mechanism effective

A Comprehensive QAP for the Clinical A Comprehensive QAP for the Clinical LaboratoryLaboratory

Design control : facility, staffing, analysis Raw material control : standards, controls, reagents,

instruments and equipments, samples, personnel Process control : internal (calibrate and control processes)

& external (monitor proficiency) Output control : result and medical significance Reliability control : test utilisation and patient

needs/outcome Verification control : inspection, accreditation,

productivity, cost analysis

Quality System ElementsQuality System Elements

(Standard) Operating Procedures Method validation Instrument validation, calibration, maintenance Documentation of tasks and procedures Personnel qualification Use of qualified reference material Internal audits Records

Accreditation BodiesAccreditation Bodies

College of Pathologists (CAP) LAP, USA Joint Commission on Accreditation of Hospitals

(JCAHO), USA Clinical Pathology Accreditation (CPA), UK Ltd National Association of Testing Authorities

(NATA), Australia Department of Standards (DSM) Malaysia –

“SAMM”