1 assessment: audits. assessment: audits - module 9 2 learning objectives at the end of this...
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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