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9 e Audit
9 e Audit
9 e Audit
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.
Documents Occurrence
& Assessment
Management
Records
Someone is asking:
What is being done?
Outside
group or
agency
Preexamination Phase
Sample Transport
Laboratory Analysis
Examination Phase
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
Costs less
required by ISO standards
conducted on a regular basis
conducted when problems identified
Bacteriology
Do not audit
your own O&P
work
Urines
Int. Audit
Consultant,
another Virology
laboratory
Assign
responsibility
Prepare Schedule
documents regular
checklists
forms audits
internal
assigns responsibility
for the internal audit program
audit
– Quality Manager outcomes
develop
schedule coordinate
manage
the corrective
select & audit process actions
train
auditors
internal
audit
report outcomes report to
to staff management
Communicate
Trained
effectively
Important
Skills
for Auditors
Technical/
Quality
Diplomatic
management
expertise
Audit
Take
Action
Identify
OFI
Who is responsible?
Quality Manager
Corrective
Action Plan
Philip Crosby
Comments?
Purchasing Process Information
& Control Management
Inventory
Documents Occurrence
& Assessment
Management
Records