RISK MANAGEMENT
pre-analytical, analytical, and post- analytical phases.
n It ensures standardisation and consistency in procedures, reducing variability that can introduce errors.
n It enhances communication among laboratory staff, ensuring that all members understand how risk controls should be implemented.
n It identifies operational inefficiencies, such as delays, bottlenecks, or redundant steps that may contribute to longer turnaround times and reduced productivity.
n Historical perspective: process mapping in industry
Process mapping has been integral to industrial efficiency for over a century, dating back to Frederick Winslow Taylor’s structured workflows in the late 19th century. His work influenced Frank and Lillian Gilbreth, who developed flow process charts – precursors to modern process mapping.
A landmark example is Henry Ford’s assembly line, which revolutionised automobile manufacturing by breaking production into structured, repeatable steps. This concept was later refined by Toyota, leading to Lean manufacturing and Six Sigma, which emphasise process mapping to eliminate waste and improve consistency.
Beyond manufacturing, process mapping has shaped service industries such as banking, retail, and logistics, optimising workflows for speed and efficiency. Fast-food chains, for instance, use it to streamline kitchen operations, while airlines apply structured workflows for check-in and security procedures. In healthcare, process mapping plays
a crucial role in standardising workflows, ensuring regulatory compliance, and improving patient safety, making it an essential tool in laboratory risk management.
n Process mapping in medical laboratories
Process mapping is already widely embedded in laboratory practice, even if it is not always explicitly recognised as such. Standard operating procedures (SOPs) serve as informal process maps, guiding staff through complex workflows with step-by-step instructions. Some specific areas where process mapping is commonly used in laboratories include: 1. Sample reception and accessioning – The path of a sample from collection to reporting follows a structured workflow, with specific points for verification, labelling, and prioritisation. A process map helps reduce sample mix-ups, mislabelling errors, and turnaround time delays.
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2. Quality control (QC) procedures – Daily QC checks in medical laboratories adhere to predefined steps for analysing control materials, assessing deviations, and taking corrective action. Process mapping helps to ensure standardisation across shifts and across different analysers or methods.
3. Automated testing and instrument maintenance – Many laboratories follow mapped-out workflows to integrate automation into their testing processes, defining points where human intervention is needed (eg instrument calibration, reagent verification, and maintenance protocols). 4. Critical result communication and reporting – Reporting critical results follows a well-defined escalation process, ensuring that abnormal findings are rapidly reviewed, verified, and communicated to the responsible clinician. Process maps help eliminate communication gaps that could delay patient care.
5. Incident and error investigation – When laboratory errors occur, retrospective process mapping is often used to reconstruct the sequence of events leading to the failure, helping identify where breakdowns occurred and how they can be prevented in the future.
n How to create a laboratory process map Developing a process map requires breaking down a workflow into its fundamental components. This structured approach ensures that every stage of the process is evaluated for potential risks before applying further analysis tools like FMEA or FTA. A process map typically consists of: 1. Inputs – The elements that initiate the process, such as receiving a sample or generating a test order. 2. Process steps – The individual tasks involved, such as sample centrifugation, reagent preparation, and instrument loading.
3. Decision points – Stages where multiple possible outcomes exist, such as determining whether a QC failure necessitates a re-run. 4. Outputs – The final product of the workflow, such as validated test results being reported to the electronic medical record (EMR).
There are many online resources to show how this is done. These process maps are not often best performed by a single person, it is an opportunity to involve all laboratory staff members in the process, in particular those that routinely perform each task. Let’s face it, if the process isn’t working, the people doing it are the first to know!
n Everyday analogy: preparing a cup of coffee
To illustrate process mapping in an everyday scenario, consider making a cup of coffee. This seemingly simple task can be broken down into a structured workflow, much like laboratory processes, as follows: 1. Input – Selecting a coffee type, filling the kettle, and measuring the coffee. 2. Process steps – Grinding the coffee (if using beans), placing a filter, adding water, and brewing. Or simply adding the boiled water, sugar, milk etc if instant 3. Decision points – Does the coffee taste too weak or too strong? Does it need more sugar or milk? 4. Output – A final cup of coffee, ready to be served.
Errors can occur at multiple points in this workflow. Adding too much coffee might make the drink too strong, just as miscalibrating an analyser might lead to unreliable test results. Forgetting to add water is like missampling a reagent in an assay. These small but systematic process failures illustrate why mapping workflows and identifying potential risks are essential in both daily life and complex laboratory operations.
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Process mapping serves as the foundation, helping laboratories visualise workflows and pinpoint areas of risk. Failure mode and effects analysis provides a structured approach to identifying failure modes before they lead to patient harm, while fault tree analysis allows for in-depth analysis of adverse events that have already occurred
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