1

Assessment: Audits

Assessment: Audits - Module 9 2

Learning Objectives

At the end of this activity, you will be able to:

Develop a process to prepare your laboratory staff for an external audit.

Plan and manage an internal audit. Discuss how to use results from a

laboratory audit. Advocate for the importance of

taking corrective actions.

Assessment: Audits - Module 9 3

Problem Scenario

You are the quality manager in your laboratory and you want to organize an internal audit.

What steps will you take?

Assessment: Audits - Module 9 4

The Quality Management System

Organization Personnel Equipment

Purchasing &

Inventory

Process Control

Information Management

Documents&

Records

Occurrence Management Assessment

Process Improvement

Customer Service

Facilities &

Safety

Assessment: Audits - Module 9 5

Assessment—Audit systematic examination of some

part (or all) of the quality management system

conformance with requirements

Assessment: Audits - Module 9 6

What is an assessment?

Someone is asking:What is being done?

How does this comply with written policies and procedures?

Assessment: Audits - Module 9 7

Why perform an assessment? learn “where we are” in terms of

quality management measure gaps need information for:

planning and implementationmonitoring continuous improvement

Assessment: Audits - Module 9 8

Outside group or agency

Internal audit

External audit

Quality Laboratory

Assessment: Audits - Module 9 9

Path of Workflow

THE PATIENT Test selection Sample Collection

Sample Transport

Laboratory Analysis Examination Phase

Report CreationReport Transport

Preexamination Phase

Result Interpretation Postexamination Phase

Assessment: Audits - Module 9 10

Auditing1. Gather information about:

process, operating procedures staff, equipment, test methods environment, handling of samples quality control verification activities recording and reporting practices

Assessment: Audits - Module 9 11

2. compare findings with documented quality management system

3. identify breakdown in system or departure from procedures

4. do something with audit results

Auditing

Assessment: Audits - Module 9 12

Health authoritie

s

Accreditation body

Public health

program

Funding program

External Auditors

Laboratory

Assessment: Audits - Module 9 13

Organize Organize

Schedule with staff

External Audit Preparation

Gather information and records

Plan

Assessment: Audits - Module 9 14

External Audit Report and Plan of Action

Identify gaps

Record results and actionsWrite report

Plan corrective actions

Develop timelineAssign responsibility

Laboratory understands recommendations

Auditor’s closing

summary and report

Assessment: Audits - Module 9 15

Flexible

Costs less

Internal Audit

required by ISO standardsconducted on a regular basisconducted when problems identified

Look at your own processes

Assessment: Audits - Module 9 16

Value of Internal Audits

prepare for external audit increase awareness opportunity for improvements preventive and corrective actions opportunity for continuing education meeting quality standards

Assessment: Audits - Module 9 17

Internal Audits: ISO Requirements

must have an audit programmust document proceduresauditors independent of activityresults documented and reported to management for reviewprompt follow-up action

Assessment: Audits - Module 9 18

Virology

O&P

Urines

Int. A

ud

it

Int. Audit

Int.

Aud

it

Bacteriology

Quality LaboratoryInternal Audits

Do not audit your own work

Consultant,another

laboratory

Assessment: Audits - Module 9 19

Prepare documents

checklistsforms

Prepare documents

checklistsforms

Schedule regular audits

Schedule regular audits

Internal Audit

Program

Internal Audit

Program

Assign responsibility

Assign responsibility

Assessment: Audits - Module 9 20

Laboratory Director

determines the internal auditing

policy

assigns responsibility for the internal audit program – Quality Manager

internal audit outcomes

supports corrective action measures

Assessment: Audits - Module 9 21

Quality Manager Responsibilityestablish and maintain an internal audit system

coordinate the

audit process

manage corrective

actions

develop schedul

e

internal audit

outcomesreport to staff

select & train

auditors

report to management

Assessment: Audits - Module 9 22

Conducting an Internal Audit

develop plan write checklists opening meeting collect and analyze information record results conduct closing meeting

report

Assessment: Audits - Module 9 23

Establishing an Audit Schedule conduct regularly more frequent audits for problems or areas needing

improvement over time audits should look at all of the quality system

essentials

Assessment: Audits - Module 9 24

Documents checklists

develop forms for documenting corrective actions and reports

Assessment: Audits - Module 9 25

Communicate effectively

Communicate effectively

Technical/ Quality

management expertise

Technical/ Quality

management expertise

DiplomaticDiplomatic

TrainedTrained

Attention to detail

Attention to detail

Important Skills

for Auditors

Important Skills

for Auditors

Assessment: Audits - Module 9 26

AuditAudit

Audits Should Lead to Actions

IdentifyOFI

IdentifyOFI

Take Action

Assessment: Audits - Module 9 27

Corrective and Remedial Actions

These actions are the steps taken to improve a process or to correct a problem

Who is responsible? Quality Manager

Assessment: Audits - Module 9 28

Taking corrective action

using problem-solving team: investigate root causesdevelop appropriate corrective action

implement corrective action examine effectiveness record all actions and findings monitor

Assessment: Audits - Module 9 29

Opportunity for Improvement Form

Assessment: Audits - Module 9 30

Continuous monitoring is the key element to success in the Quality System

Assessment: Audits - Module 9 31

Monitoring &

Evaluationcustomer satisfaction

quality controlproficiency testing

audits

Corrective Action Plan

Quality Improvement

Plan

Continuous Quality

Improvement

Assessment: Audits - Module 9 32

“It isn’t what you find…it’s what you do

about what you find.”

Philip Crosby

Assessment: Audits - Module 9 33

Summary

Assessment is important in monitoring the effectiveness of the laboratory quality management system.

Both external and internal audits yield useful information.

An outcome of assessment is finding root causes of problems and taking corrective actions.

Assessment: Audits - Module 9 34

Key Messages

All laboratories should establish an internal audit program. Conducted on a regular basis, it will provide information for continual improvement.

Problems become opportunities for improvement.

Assessment: Audits - Module 9 35

Questions?

Comments?

Organization Personnel Equipment

Purchasing &

Inventory

Process Control

Information Management

Documents&

Records

Occurrence Management Assessment

Process Improvement

Customer Service

Facilities &

Safety