Assessment:

Audits

1
 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 2

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 3

 The Quality Management System

Organization Personnel Equipment

Purchasing Process Information

& Control Management
Inventory

Documents Occurrence
& Assessment
Management
Records

Process Customer Facilities

Improvement Service &
Safety

Assessment: Audits - Module 9 4

 AssessmentAudit
systematic examination of some
part (or all) of the quality
management system
conformance with requirements

Assessment: Audits - Module 9 5

What is an assessment?

Someone is asking:
What is being done?

How does this comply

with written policies
and procedures?

Assessment: Audits - Module 9 6

 Why perform an assessment?
learnwhere we are in terms of quality
management
measure gaps
need information for:
planning and implementation
monitoring
continuous improvement

Assessment: Audits - Module 9 7

 Quality Laboratory
External
Internal audit
audit

Outside
group or
agency

Assessment: Audits - Module 9 8

 Path of Workflow
THE PATIENT Test selection Sample Collection

Preexamination Phase

Sample Transport

Laboratory Analysis
Examination Phase

Report Transport Report Creation

Result Interpretation Postexamination Phase

Assessment: Audits - Module 9 9

 Auditing
1. 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 10

 Auditing

2. compare findings with documented

quality management system
3. identify breakdown in system or
departure from procedures
4. do something with audit results

Assessment: Audits - Module 9 11

 External Auditors
Accreditation
Health body
authoritie
s
Laboratory

Public
Funding
health
program
program
Assessment: Audits - Module 9 12
External Audit Preparation

Plan Organize
Organize

Schedule Gather
with staff information
and records
Assessment: Audits - Module 9 13
External Audit Report and Plan of Action
Laboratory understands
Auditors
recommendations
closing
summary
Identify gaps
and report

Plan corrective
actions
Record results
and actions Develop timeline
Write report Assign responsibility

Assessment: Audits - Module 9 14

 Internal Audit
Flexible
Look at
your own
processes

Costs less
required by ISO standards
conducted on a regular basis
conducted when problems identified

Assessment: Audits - Module 9 15

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 16

Internal Audits: ISO Requirements

must have an audit program

must document procedures
auditors independent of activity
results documented and reported to
management for review
prompt follow-up action

Assessment: Audits - Module 9 17

Internal Audits
Quality Laboratory

Bacteriology
Do not audit
dit
your own Int
.A
u
O&P
work
Urines

Int. Audit
it
ud
Consultant, .A
Int
another Virology
laboratory

Assessment: Audits - Module 9 18

 Internal
Internal
Audit
Audit
Program
Program

Assign
Assign
responsibility
responsibility
Prepare
Prepare Schedule
Schedule
documents
documents regular
checklists
checklists
regular
forms
forms audits
audits

Assessment: Audits - Module 9 19

 Laboratory Director

determines the supports

internal auditing corrective
policy action
measures

internal
assigns responsibility
for the internal audit program
audit
Quality Manager outcomes

Assessment: Audits - Module 9 20

 Quality Manager Responsibility
establish and maintain an internal audit system

develop
schedule coordinate
manage
the corrective
select & audit process actions
train
auditors

internal
audit
report outcomes report to
to staff management

Assessment: Audits - Module 9 21

 Conducting an Internal Audit
develop plan
write checklists
opening meeting
collect and analyze information
record results
conduct closing meeting
report

Assessment: Audits - Module 9 22

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 23

 Documents
checklists

develop forms for documenting corrective actions

and reports

Assessment: Audits - Module 9 24

 Attention
Attention
to
todetail
detail

Communicate
Communicate Trained
Trained
effectively
effectively
Important
Important
Skills
Skills
for
forAuditors
Auditors

Technical/
Technical/
Quality
Quality Diplomatic
Diplomatic
management
management
expertise
expertise

Assessment: Audits - Module 9 25

 Audits Should Lead to Actions

Audit
Audit
Take
Action

Identify
Identify
OFI
OFI

Assessment: Audits - Module 9 26

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 27

Taking corrective action
using problem-solving team:
investigateroot causes
develop appropriate corrective action
implement corrective action
examine effectiveness
record all actions and findings
monitor

Assessment: Audits - Module 9 28

Opportunity for Improvement Form

Assessment: Audits - Module 9 29

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

Assessment: Audits - Module 9 30

 Monitoring
&
Quality
Evaluation
Improvement
customer satisfaction
Plan
quality control
proficiency testing
audits Continuous
Quality
Improvement

Corrective
Action Plan

Assessment: Audits - Module 9 31

 It isnt what you find
its what you do
about what you find.

Philip Crosby

Assessment: Audits - Module 9 32

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 33
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 34

 Organization Personnel Equipment

Questions?

Purchasing
&
Process
Control
Information
Management
Comments?
Inventory

Documents Occurrence
& Assessment
Management
Records

Process Customer Facilities

Improvement Service &
Safety

Assessment: Audits - Module 9 35