Process family
Laboratory investigations: six templates from quality event to closed CAPA
Laboratory investigation flowcharts in sequence: quality event triage, OOS investigation, root cause analysis, laboratory CAPA, effectiveness check and investigation closure, plus deviation, nonconformance, incident and escalation routes.
A laboratory investigation is what happens when a result, an event or a record cannot be taken at face value: an out-of-specification result, a departure from the procedure, a nonconformance, an instrument failure with data impact. This family orders six templates from the first triage of a reported concern to the quality-reviewed closure of the corrective action, and gathers the other routes that feed the same chain.
Everything enters through quality event triage: log the facts, apply safeguards, classify, route to investigation or local correction. An OOS result takes the OOS investigation route: secure data and sample, assignable-cause assessment, validity decision, impact assessment, with retesting justified by evidence, not by a preferred result. Root cause analysis turns the problem into a tested explanation; laboratory CAPA plans, implements and verifies the action; effectiveness review asks whether it worked; and closure takes evidence and open actions to quality review.
The failures are well known: an OOS closed as laboratory error without an assignable cause, a root cause that was the first plausible one, a CAPA closed at implementation with no effectiveness check. Each step above exists to stop one of them. The other entry routes are the deviation investigation for a departure from the expected process, the nonconformance for a departure from a defined requirement and the general laboratory investigation for an atypical event or result; all three converge on root cause, CAPA and closure. Incident management and laboratory escalation give an incident, or an issue that needs authority, a controlled path to the people who can provide it.
One gap is worth stating: there is no out-of-trend (OOT) investigation template. A trend signal is detected by control chart review in the testing family or by environmental monitoring trend review, and the OOS procedure is the shape a laboratory adapts for it. The site-wide system this family is the laboratory instance of is nonconformance to CAPA; an excursion in environmental monitoring and a calibration found out of tolerance both arrive here as quality events.
The sequence
Step 1: Quality event triage process flowchart
An editable quality event triage workflow for logging facts, applying immediate safeguards, classifying an event, routing investigation or correction work and escalating material impact.
Step 2: Out-of-specification (OOS) investigation process
An OOS investigation workflow for securing data and samples, initial laboratory review, assignable-cause assessment, validity decisions, expanded investigation, impact assessment and CAPA.
Step 3: Laboratory root cause analysis process flowchart
An editable laboratory root cause analysis workflow for defining a problem, mapping contributing factors, testing evidence, developing corrective options and approving an action handoff.
Step 4: Laboratory CAPA process flowchart
A laboratory CAPA workflow for problem definition, containment, root-cause analysis, corrective-action planning, implementation, effectiveness checks, QA review and closure.
Step 5: Corrective action effectiveness process flowchart
An editable corrective action effectiveness workflow for defining the intended outcome, reviewing follow-up evidence, identifying recurrence or shortfall, revising action plans and recording review results.
Step 6: Laboratory investigation closure process flowchart
An editable laboratory investigation closure workflow for compiling evidence, reviewing impact and action status, resolving open risks, obtaining quality acceptance and updating the closure record.
Also part of this family
- Laboratory investigation process flowchart — A laboratory investigation workflow for securing evidence, defining the event, assessing an assignable cause, determining data validity, impact assessment, corrective action and closure.
- Laboratory deviation investigation process flowchart — An editable laboratory deviation investigation workflow for containment, evidence gathering, cause assessment, impact review, CAPA or escalation follow-up, and quality-approved closure.
- Laboratory nonconformance process flowchart — A laboratory nonconformance workflow for containment, classification, correction, investigation, sample or data impact assessment, corrective action and quality-approved closure.
- Laboratory incident management process flowchart — An editable laboratory incident management workflow for protecting people, work and evidence, assessing impact, routing investigations, escalating leadership decisions and recording closeout.
- Laboratory escalation process flowchart — An editable laboratory escalation workflow for recording an issue, controlling immediate risk, assessing urgency and scope, involving leadership or specialist groups, and communicating accountable next steps.
Used in these industries
Related guides
- How to create a root cause analysis flowchart — How to draw a root cause analysis flowchart that picks the technique for you: the evidence gate that precedes every method, the branch that separates one chain from many, and where each method stops.
- How to create a CAPA process — How to design a CAPA process: separate correction from corrective action, gate full investigations on risk, require a verified root cause, and check effectiveness before closing.
- How to create a non-conformance process — How to design a non-conformance process: contain and quarantine first, classify by impact, decide disposition through a defined authority, and route only the ones that warrant it into CAPA.