Identify, prioritise and control risk across the pre-analytical, analytical and post-analytical stages of testing, using FMEA, root cause analysis and CAPA.
3 days in person / 4 weeks online (24 hours)In-personVirtual (live online)Next: 1 to 3 Feb 2027USD 1,050
ISO 31000 defines risk as the effect of uncertainty on objectives. In a laboratory, risk touches operations, technical work, liability and the business itself, and it always combines two things: how likely an event is and how severe its impact would be. A risk management framework gives the laboratory a structured way to identify risks, reduce unanticipated adverse events and protect patients, staff and visitors.
For laboratory professionals and directors, risk management is an essential discipline. It is their responsibility to understand and monitor the many guidelines and rules that govern laboratory testing. This course gives participants a complete understanding of risk management from a clinical laboratory viewpoint and shows how it improves the quality of care patients receive.
Risk-based thinking is required by ISO 15189:2022 and expected by CAP and JCI assessors. Individualized Quality Control Plans (IQCP), covered on day three, are accepted by CAP as a risk-based approach to quality control.
Who this course is for
Laboratory directors, managers and quality managers
Medical laboratory scientists, technologists and technicians
Pathology residents and practising pathologists
Medical laboratory science students and interns
How it is delivered
Competency-based sessions using interactive teaching methods that take laboratory personnel through identifying risks and applying precise control measures across the pre-analytical, analytical and post-analytical processes. Every quarter we run one in-person cohort in Nairobi and one live online cohort, each of 5 to 30 participants.
What you will learn
Define risk and explain why risk management matters in healthcare
Identify the accrediting bodies and regulations that shape laboratory risk management
Recognise risk in the pre-analytical, analytical and post-analytical stages of testing
Apply the main tools of risk management, including FMEA, root cause analysis and hazard vulnerability analysis
Build a risk-based quality control plan and a CAPA process that leads to continual improvement
Syllabus
Day 1
Introduction to risk management
The risk management processPlanning, identifying, handling and monitoring risk
Conformance to consensus standards
Day 2
Failure Mode and Effects Analysis (FMEA)
Root Cause Analysis (RCA)
Hazard Vulnerability Analysis (HVA)
A systems approach to error reduction
Day 3
Corrective and preventive action (CAPA) and continual improvement
Human factors: error detection and reporting
Performance monitoring and the quality control plan
Materials included
Participant guide and training materials
Duration and schedule
Total duration
3 days in person / 4 weeks online
Learning hours
24
Session frequency
In person: 3 consecutive days, 08:00 to 16:00 EAT. Online: 12 two-hour sessions, Mon, Wed and Fri 18:00 to 20:00 EAT, over 4 weeks.
Cohort size
Cohort of 5 to 30 participants
Intake
Sessions
Format and venue
Deadline
Availability
1 to 3 Feb 2027
Mon to Wed, 08:00 to 16:00 EAT (UTC+3)
In-person Nairobi, Kenya
Until the intake is full
Open
8 Feb to 5 Mar 2027
Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3)
Virtual (live online) Zoom
Until the intake is full
Open
26 to 28 Apr 2027
Mon to Wed, 08:00 to 16:00 EAT (UTC+3)
In-person Nairobi, Kenya
Until the intake is full
Open
3 to 31 May 2027
Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3)
Virtual (live online) Zoom
Until the intake is full
Open
26 to 28 Jul 2027
Mon to Wed, 08:00 to 16:00 EAT (UTC+3)
In-person Nairobi, Kenya
Until the intake is full
Open
2 to 27 Aug 2027
Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3)
Virtual (live online) Zoom
Until the intake is full
Open
1 Oct to 1 Nov 2027
Mon, Wed and Fri, 18:00 to 20:00 EAT (UTC+3)
Virtual (live online) Zoom
Until the intake is full
Open
1 to 3 Nov 2027
Mon to Wed, 08:00 to 16:00 EAT (UTC+3)
In-person Nairobi, Kenya
Until the intake is full
Open
Times are shown in the timezone of the venue. Where your browser can work it out, your local time appears underneath.
Need a different date or your whole team trained? Every course can be delivered in-house or virtually on dates that suit you. Mention this in the notes when you register.
Fees and payment
USD 1,050 per participant
Group and in-house rates on request.
How payment works
We invoice after registration. Pay by bank transfer or M-Pesa at least one week before the course starts. Your place is confirmed once payment is received.
Two tea breaks and buffet lunch each day (in-person sessions)
Certificate of completion
First month of Elmenta Lab Pro mentorship, free
Instructors and certificate
Facilitators are experienced medical laboratory experts who work as practitioners and trainers in the field. Named facilitators are confirmed in the joining instructions.
Certificate
Certificate of completion issued by Elmenta Consulting on successful completion of the training. A certificate of completion records attendance and completion; it is not a professional certification and does not confer laboratory accreditation.
A risk-based laboratory biosafety checklist with check frequencies, steps for running a quarterly audit, common findings, and the basics of shipping UN3373 specimens safely.
Common questions
Does this course cover IQCP?
Yes. Individualised Quality Control Plans are covered as part of risk-based quality control on day three.
Can this course be run at our laboratory?
Yes. In-house delivery for a team is available at any time. Choose the in-house option on the registration form.
Is this relevant to CAP or JCI accreditation?
Yes. Both expect laboratories to identify and control risk, and CAP accepts IQCP, which is covered on day three, as a risk-based approach to quality control.
How is payment made?
After you register we send a pro forma invoice. Payment is due at least one week before the course starts, by bank transfer or M-Pesa.
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