Nephrology · Clinical Tool · Dialysis Unit Operations / Quality

PDSA, RCA & FMEA Worksheets — the CQI Method Toolkit

Three working documents for the CQI engine: a PDSA charter and cycle tracker for a Performance Improvement Project, a structured RCA worksheet (5-Whys + fishbone, with corrective-action strength ranking) for a sentinel event or near miss, and an FMEA/RPN calculator to prioritise prospective risk before it becomes next quarter's RCA. Fill in, print into your CQI minutes.

Published: References: 5 Read time:

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How to use. Pick a tab: PDSA to charter and track a Performance Improvement Project (Model for Improvement + Plan–Do–Study–Act cycles), RCA to work a sentinel event or near miss to its systemic root cause, or FMEA to score prospective risk before rolling out a new process, machine, or supplier. Everything is filled in directly on the page. Use Print / Save PDF to file the worksheet in your CQI minutes. All computation runs in your browser; no data is stored or transmitted.

The CQI Method Toolkit

1 · Charter (Model for Improvement)

Answer the three questions before you cycle. A vague aim produces a vague project.

2 · PDSA cycles

Small, fast, low-risk tests. Add a row per cycle; each should build on the last.

#DatePlanDoStudyAct

1 · Event

2 · Timeline

Reconstruct what happened, when, in order — before memories fade.

TimeWhat happened

3 · 5 Whys

Ask "why" past the first answer, to a system-level cause. Stop when the next "why" would just re-state the same fact.

4 · Fishbone (Ishikawa)

Sort candidate causes into the classic dialysis categories.

People
Process
Equipment / Technology
Environment
Materials / Supplies
Management / Policy

5 · Root cause(s) & corrective actions

Rank each action's strength. Forcing functions/design are strongest; education/reminders are weakest and most over-used — don't let the list end there.

Corrective actionStrengthOwnerDue date

Process under review

Failure modes

List each process step's possible failure mode. Score 1 (rare/mild/obvious) – 10 (frequent/catastrophic/undetectable). RPN = Severity × Occurrence × Detectability — attack the highest first.

Process stepFailure modeEffectSev (1–10)Occ (1–10)Det (1–10)RPN
Important: These are structured worksheets for a dialysis unit's leadership team, not automated diagnostic instruments. RCA and FMEA depend entirely on the quality and honesty of the input — protect the "just culture" precondition so staff can report freely. Severity/Occurrence/Detectability scores in the FMEA tool are your team's clinical judgment, not a validated external scale. No data leaves your browser.

Where These Methods Come From

PDSA (Plan–Do–Study–Act) is the Model for Improvement's test cycle, formalised by Langley, Moen, Nolan, and colleagues and adopted as the Institute for Healthcare Improvement's default improvement engine; systematic review shows most healthcare PDSA applications under-document the sequence of iterative small-scale cycles this tool is built to enforce. Root Cause Analysis is the standard retrospective, blame-free, systems-focused method for sentinel events, using the 5-Whys and fishbone/Ishikawa categories (People, Process, Equipment, Environment, Materials, Management) common in patient-safety practice; corrective actions are strongest as forcing functions/design changes and weakest as education/reminders — the hierarchy this worksheet is built to surface. Failure Mode and Effects Analysis is the standard prospective risk tool, scoring Severity × Occurrence × Detectability into a Risk Priority Number to prioritise design changes before harm occurs. All three methods are explained with a worked dialysis example in the QAPI vs. CQI field manual, Sections 5 and 7.

References 5 sources
  1. Langley, G. J., Moen, R. D., Nolan, K. M., Nolan, T. W., Norman, C. L., & Provost, L. P. (2009). The improvement guide: A practical approach to enhancing organizational performance (2nd ed.). Jossey-Bass. https://www.worldcat.org/isbn/9780470192412
  2. Taylor, M. J., McNicholas, C., Nicolay, C., Darzi, A., Bell, D., & Reed, J. E. (2014). Systematic review of the application of the plan-do-study-act method to improve quality in healthcare. BMJ Quality & Safety, 23(4), 290–298. https://doi.org/10.1136/bmjqs-2013-001862
  3. Charles, R., Hood, B., Derosier, J. M., Gosbee, J. W., Li, Y., Caird, M. S., Biermann, J. S., & Hake, M. E. (2016). Root cause analysis and actions for the prevention of medical errors: Quality improvement and resident education. Orthopedics, 39(4), e625–e631. https://doi.org/10.3928/01477447-20160427-01
  4. Card, A. J. (2017). The problem with '5 whys'. BMJ Quality & Safety, 26(8), 671–677. https://doi.org/10.1136/bmjqs-2016-005849
  5. DeRosier, J., Stalhandske, E., Bagian, J. P., & Nudell, T. (2002). Using health care failure mode and effect analysis: The VA National Center for Patient Safety's prospective risk analysis system. Joint Commission Journal on Quality Improvement, 28(5), 248–267. https://doi.org/10.1016/S1070-3241(02)28025-6
Dr. William Gregory M. Rivero, MD

William Gregory Rivero, MD, FPCP, DPSN

Internal Medicine · Nephrology · Nutrition · Philippines · PRC 0105184

Educational quality-improvement worksheets. Not automated diagnostic instruments — outputs are only as good as the team's honest input. No data leaves your browser.

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