4.2.3-2 Audit approach
Illuminating the Path to ISO 15189 (SLMTA 3) e-Learning Course Download Video
- Overview
- Resources
PURPOSE:
The most important phase of the internal audit is the preparation phase. The audit begins when the audit coordinator initiates the audit by defining the purpose, scope, and method approach to be used.
In this activity, participants learn how to prepare for an audit by creating an audit plan.
KEY MESSAGES:
- The audit coordinator is responsible for initiating the audit.
- The scope specifies the start and stop boundaries of the process being audited.
- The audit plan keeps the audit on schedule by giving everyone a detailed plan to follow.
SELF ASSESSMENT:
Can you:
- Understand the purpose of an audit plan?
- Articulate when to apply a horizontal or vertical approach?
- Design an audit plan that fulfills the objectives?
Instructor(s)
Janet Scholtz
Ms. Scholtz helped redesign the classroom-based SLMTA 3 curriculum for on-line delivery and will serve as an instructor and facilitator of the e-learning course. Ms. Scholtz is a Quality Manager, Regional Western and Northern Cape, at National Health Laboratory Services (NHLS), South Africa. She is a certified auditor for The South African National Accreditation System (SANAS). Ms. Scholtz has a Medical diploma in Biomedical Technology. She is a SLMTA master trainer and has trained numerous laboratorians in the past decade.
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Course contents
Course OverviewMANAGEMENT RESPONSIBILITY
1.1 Management Responsibility Introduction
Introduction
1.2 Management Tools
Process Mapping
- 1.2.1-1 Introduction to Management Tools and Process Mapping Activity Part -1 2024 5:57
- 1.2.1-2 Process Mapping Activity Part-2 2024 3:17
Using the Model for Improvement
- 1.2.2-1 MFI Part 1 3:08
- 1.2.2-2 MFI Part 2 9:31
- 1.2.2-3 MFI Part 3 4:14
- 1.2.2-4 MFI Part 4 4:29
- 1.2.2-5 Review of Worksheet 2 4:30
- 1.2.2-6 Introduce the activity 1:34
Managing Performance
- 1.2.3-1 Introduction to the Balance Scorecard Using Data to Improve the Laboratory Processes and Performance 2024 29:34
- 1.2.3-2 Balance Scorecard Activity Part 1 Introducing Quality Indicators 2024 2:11
- 1.2.3-3 Balance Scorecard Activity Part 2 Relating QI's to the Process Map 2024 4:49
Creating a Management Calendar
1.3 Quality Management System
Designing a Continuously Improving QMS
- 1.3.1-1 Introduction 10:27
- 1.3.1-2 Process-based Model 5:26
- 1.3.1-3 Model Overview 3:22
- 1.3.1-4 Introduce the Activity 5:22
Designing Fit-for-Purpose Processes
1.4 Documents and Records
Introduction to Documentation System
Documents Process Map
Why Was the Outdated Version Used
- 1.4.3-1 Why was the outdated Version Used Document Control Elements 2024 19:46
- 1.4.3-2 Why Was the Oudated version Used? Activity 2024 2:35
Records Process Map
1.5 Planning and Conducting a Staff Meeting
RESOURCE MANAGEMENT
2.1 Personnel
Personnel Management Process Map
- 2.1.1-1 Personnel Introduction 4:56
- 2.1.1-2 Personnel Process Map Part 1 4:52
- 2.1.1-3 Personnel Process Map Part 2 6:29
- 2.1.1-4 Introduce the Activity 1:17
Competency Assessment Program
Creating a Personnel File
- 2.1.3-1 Introduction 3:42
- 2.1.3-2 Introduce the activity Part 1 1:32
- 2.1.3-3 Introduce the Activity Part 2 2:14
How Do You Assign Personnel to Tasks
2.2 Infrastructure and Safety
Process + Structure = Outcome
- 2.2-1 Introduction to Infrastructure and Safety 10:42
- 2.2.1-1 P+S=O Introduction 2024 14:00
- 2.2.1-2 P+S=O Activity Part-1 2024 3:52
- 2.2.1-3 P+S=O Activity Part-2 2024 5:46
Improving a Problem Floor Plan
Mapping Out and Improving the Floor Plan of your Laboratory
- 2.2.3-1 Mapping out and Improving the Floor Plan of your Laboratory Activty Part-1 2024 5:51
- 2.2.3-2 Mapping out and Improving the Floor Plan of your Laboratory Activity Part-2 2024 8:46
Workstation Set-Up
Laboratory Safety Demonstrations
- 2.2.5-1 Laboratory Safety Demonstrations 2024 8:28
- 2.2.5-2 Demonstration 1-Aerosolization 5:02
- 2.2.5-3 Demonstration 2-Blood Splatter 0:37
Assessing Safety Incidents
- 2.2.6-1 Assessing Safety Incidents Requirements for Safety Programs 2024 21:04
- 2.2.6-2 Assessing Safety Incidents Activity2 2024 3:19
- 2.2.6-3 Safety Incident 1-Role Play 2024 2:22
- 2.2.6-4 Safety Incident 2-Role Play 2024 0:34
Conducting a Safety Audit
What did we see on the Site Visits
2.3 Purchasing and Inventory
Purchasing and Inventory Process Map
- 2.3.1-1 Introduction 7:52
- 2.3.1-2 Purchasing & Inventory Process Map 7:32
- 2.3.1-3 Introduce the Activity 1:46
Forecasting and Calculating Ordering Amounts
- 2.3.2-1 Forecasting and Calculating Order Amounts Introduction 2024 9:48
- 2.3.2-2 Forecasting and Calculatting Ordering Amounts Key terms and Concepts 2024 9:48
- 2.3.2-3 Forecasting and Calculating Ordering Amounts Activity 2024 2:05
Did You Receive What You Ordered
2.4 Equipment
Equipment Management Process Map
- 2.4.1-1 Introduction 9:36
- 2.4.1-2 Equipment Process Map 7:15
- 2.4.1-3 Introduce the Activity 1:14
- 2.4.1-4 Equipment Patient Testing 5:25
- 2.4.1-5 Selection Phase Part 1 7:28
- 2.4.1-6 Selection Phase Part 2 6:23
- 2.4.1-7 Selection Phase Part 3 3:12
- 2.4.1-8 Acquisition Phase 3:14
- 2.4.1-9 Confirmation Phase 6:45
- 2.4.1-10 Implementation Phase 4:23
Creating a Maintenance and QC Log
- 2.4.2-1 Introduction 4:49
- 2.4.2-2 Managing Equipment Records 8:38
- 2.4.2-3 Elements of logs 6:47
- 2.4.2-4 Supervisor review conclude 11:03
Making a Service Call
PATH OF WORKFLOW
3.1 Pre-Examination
Specimen Management
- 3.1.1-1 Specimen Management 2024 5:54
- 3.1.1-2 Specimen management Role Play 1 2024 0:40
- 3.1.1-3 Specimen Management role Play 2 2024 0:37
Packaging Specimens for Shipment to Referral Sites
- 3.1.2-1 Packaging Specimes for Shipment to Referral Sites Introduction & Activity Part 1 2024 13:10
- 3.1.2-2 Packaging Specimens for Shipment to Referral Sites Activity Part II 2024 7:45
Tracking Referral Specimens
3.2 Examination
Overview of Examination Phase
Using Standard Operating Procedures
Is QC That Important
Is There More to QC Than Just Plotting the Data?
3.3 Post-Examination
Validation of Test Results
Is the Test Report Ready to be Released?
Customer Service
- 3.3.3-1 Customer Service 2024 7:35
- 3.3.3-2- Customer Service Role Play 2024 1:30
- 3.3.3-3 Customer Service Activity 2024 1:28
Meet the Clinician
EVALUATION & CONTINUAL IMPROVEMENT
4.1 Occurrence Management
Occurrence Management System - Section Overview
Occurrence Management System Overview
Mapping Nonconformities
- 4.1.2-1 Introduction 6:06
- 4.1.2-2 NCE Process Map 3:26
- 4.1.2-3 Detect, Document Steps 2:42
- 4.1.2-4 Investigate, Action Steps 4:31
- 4.1.2-5 Introduce the activity 1:06
Just Culture
- 4.1.3-1 Introduction 2:03
- 4.1.3-2 Define Just Culture 2:36
- 4.1.3-3 Balanced accountability 2:25
- 4.1.3-4 Introduce the activity 0:55
Selecting the Winning Problem(s)
- 4.1.4-1 Introduction 3:31
- 4.1.4-10 Introduce the activity 2 1:02
- 4.1.4-2 NCE Investigation 4:44
- 4.1.4-3 Selection Criteria 4:07
- 4.1.4-4 Risk based scoring 6:16
- 4.1.4-5 Appropriateness Criteria 4:12
- 4.1.4-6 Collective data analysis 7:46
- 4.1.4-7 Introduce the activity 2:32
- 4.1.4-8 Aggregate data analysis 3:14
- 4.1.4-9 Sorting Data Excel 4:45
Root Cause Analysis
- 4.1.5-1 Introduction RCA 1:47
- 4.1.5-2 ISO review 2024 4:13
- 4.1.5-3 CA and RCA 2024 5:15
- 4.1.5-4 RCA level of causes 4:59
- 4.1.5-5 RCA model part 1 2024 14:52
- 4.1.5-6 RCA model 2 12:30
- 4.1.5-7 RCA tools 1 8:04
- 4.1.5-8 RCA tools 2 8:17
- 4.1.5-9 RCA Activity Assignments 5:18
Risk Management Process
4.2 Internal Auditing
Internal Audit - Section Overview
Introduction to Internal Audit
- 4.2.1-1 Introduction to Internal audit 2024 6:48
- 4.2.1-2 Theory of audit 3:52
- 4.2.1-3 Audit Key message 2:32
How to Set-up an Internal Audit Programme
- 4.2.2-1 Introduction to internal audit programme 5:14
- 4.2.2-2 Roles and Responsibility 2024 V1 4:38
- 4.2.2-3 Audit scheduling 2024 2:17
- 4.2.2-4 Auditor training 7:22
- 4.2.2-5 Internal Audit procedure 2024 V1 3:13
- 4.2.2-6 Audit Programme conclude 3:24
Internal Audit Planning and Preparation
- 4.2.3-1 Introduction to Audit planning and preparation 2024 3:37
- 4.2.3-2 Audit approach 9:07
- 4.2.3-3 Audit preparation 5:10
- 4.2.3-4 Audit sampling and meeting 9:07
- 4.2.3-5 Creating an Internal Audit Plan activity instructions 2:55
Internal Audit Methods
Audit Techniques and NCE Writing
- 4.2.5-1 Introduction to Audit techniques 5:41
- 4.2.5-2 Questioning 7:32
- 4.2.5-3 NCE writing 10:00
- 4.2.5-4 Writing NCE activity instructions 1:12
Audit Reporting
4.3 Management Review Process
Management Review - Section Overview
Management Review