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

 Assessment—Audit
 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?
 learn “where 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

 Organize
 Plan

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

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
your own O&P
work
Urines

Int. Audit
Consultant,
another Virology
laboratory

Assessment: Audits - Module 9 18

 Internal
Audit
Program

Assign
responsibility
Prepare Schedule
documents regular
checklists
forms 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
to detail

Communicate
Trained
effectively
Important
Skills
for Auditors

Technical/
Quality
Diplomatic
management
expertise

Assessment: Audits - Module 9 25

 Audits Should Lead to Actions

Audit
Take
Action

Identify
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 isn’t what you find…
it’s 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?

Comments?
Purchasing Process Information
& Control Management
Inventory

Documents Occurrence
& Assessment
Management
Records

Process Customer Facilities

Improvement Service &
Safety

Assessment: Audits - Module 9 35