Juran Trilogy (Quality Planning, Quality Control, Quality Improvement)

This topic is part of the SG Systems Global quality & compliance glossary series.

Updated October 2025 • Quality Management • See also: CAPA, ISO 13485, GMP / cGMP, ICH Q10, 21 CFR Part 11, Internal Audit, CPV, SPC

The Juran Trilogy—coined by Dr. Joseph M. Juran—frames quality management as three interlocking managerial processes: Quality Planning (designing products and processes that meet customer needs), Quality Control (keeping performance on target via monitoring and corrective action), and Quality Improvement (systematically elevating performance to new levels). The trilogy is deliberately practical: it treats quality not as an after-the-fact inspection activity but as a cross-functional discipline spanning product development, manufacturing operations, supply chain, and service. In regulated industries, the trilogy maps naturally onto lifecycle concepts in GMP/cGMP, ISO 13485, and ICH Q10, where risk-based planning, vigilant control, and evidence-backed improvement are mandatory.

“Quality doesn’t happen by accident; it is planned, controlled, and improved—again and again—until your default state is excellence.”

1) What It Is (Unbiased Overview)

Quality Planning. Juran begins with the premise that most quality problems are born in planning. Planning clarifies the “customers” (external buyers and internal downstream processes), translates their needs into product and process requirements, and creates features, tolerances, and controls that are capable of meeting those needs under real-world variation. In manufacturing this means robust specifications, well-structured BOMs and routings, risk analyses such as FMEA or HAZOP where appropriate, and clear acceptance criteria for raw materials and intermediates. Effective planning also defines the data required to prove conformity—e.g., incoming inspection attributes, identity testing, and in-process controls (IPC)—and how those data will be captured in controlled records such as eBR/eBMR with audit trails and Part 11 signatures.

Quality Control. Whereas planning aspires to capability “by design,” control preserves capability in the face of day-to-day variation. Juran’s control loop is simple: evaluate actual performance, compare to the goal, and act on the difference. In operations this often appears as statistical surveillance using SPC charts, process alarms tied to alert/action limits, and well-defined hold & release rules. For regulated lifecycle control, plants implement Continued Process Verification (CPV) to demonstrate that a process remains in a state of control after validation. Quality control also includes deviation/nonconformance management and data integrity practices (ALCOA+) to ensure that monitoring data are trustworthy.

Quality Improvement. Juran separates “sporadic spikes” (special-cause upsets resolved by control) from chronic waste—structural losses built into the status quo. Improvement projects target chronic waste via root cause analysis, experimentation, and change control. Typical targets include yield gaps, rework loops, long cycle times, and high complaint rates. In formal systems, improvements are captured as CAPA or project charters, validated where necessary via CSV/GAMP 5 methods, and then institutionalized through document control and training to hold the gain.

2) Core Mechanics, Roles & Metrics

Organizations operationalize the trilogy through a portfolio of activities. In planning: voice-of-customer capture, critical-to-quality flowdown, design FMEA, supplier qualification, and specification setting with verifiable tests (HPLC methods, dimensional inspection, sensory panels, etc.). In control: standard work, calibrated assets, IPC checks at the right frequency, cycle counting for inventory fidelity, and tiered response plans for out-of-trend signals. In improvement: cross-functional teams run structured problem solving (5-why, fishbone), pilot countermeasures, and manage change via change control to avoid unintended consequences.

Accountability is explicit. Executives fund the improvement portfolio and sponsor breakthrough goals; quality leaders own the management system and audit program (Internal Audit, supplier audits, and, in pharma, Annual Product Review (APR)); engineering and operations own process capability and control plans; regulatory/compliance ensures alignment with standards like ISO 13485 or ICH Q10. Metrics mirror the trilogy: planning quality shows up in “right-first-time,” PPAP/DHF completeness, and supplier PPM; control quality shows up in OOS/OOT rates, Cp/Cpk, and batch review times; improvement shows up in CAPA effectiveness, complaint trend reductions, scrap/rework cost, and release cycle compression.

3) Alignment with Regulated Frameworks (Unbiased)

The trilogy’s logic is deeply compatible with compliance. In pharmaceuticals and biologics, ICH Q10 articulates a pharmaceutical quality system whose enablers (knowledge management, risk management) echo Juran’s planning step, while process performance and product quality monitoring parallels control and CAPA/management review channel improvement. For APIs, ICH Q7 requires documented procedures, validated processes, and change control—again, planning, control, improvement. Medical device makers use ISO 13485 to structure design controls, production controls, and improvement via CAPA and DHR feedback. Food manufacturers integrate trilogy practices into HACCP and preventive controls programs, where planning defines hazards and critical limits, control executes monitoring and verification, and improvement acts on deviations and trend data.

4) How This Fits with V5

V5 by SG Systems Global provides the digital scaffolding to run the Juran Trilogy end-to-end and prove it in audits. During Quality Planning, V5 controls masters in recipe/formulation and BOM libraries, enforces specification versions via document control, and captures risk and test definitions that flow into eBR/eBMR steps. Supplier quality is tied to Goods Receipt with automatic quarantine and scheduled incoming inspection/ID testing. For Quality Control, V5 orchestrates IPC checkpoints, collects instrument results (e.g., HPLC) into lot histories, and triggers hold & release decisions with expiry controls and system-directed picking (FIFO/FEFO). Statistical surveillance uses SPC with alert/action limits and CPV dashboards. For Quality Improvement, V5 routes exceptions to NCR and escalates to CAPA, linking changes through change control and preserving evidence with audit trails and electronic signatures per Part 11. Finally, Finished Goods Release and CoA generation pull from the same single source of truth, closing the loop.

5) Practical Walkthrough (Example)

Planning: A device maker launches a new kit. Marketing VOC becomes measurable CTQs; engineering sets tolerances; suppliers are qualified; inspection plans and FAI criteria are defined; sampling plans and IPC frequencies are set; records and e-signatures are designed per Part 11. Control: Production runs with calibrated equipment; operators follow eBR prompts; SPC dashboards catch drift; suspect lots are quarantined under hold & release; mislabels are prevented via poka-yoke scans and GS1/GTIN validation. Improvement: Trend data show frequent minor rework; a CAPA project identifies two misfit fasteners and a training gap; engineering updates the BOM and WI, purchasing updates supplier specs, and changes are released via controlled workflow; CPV shows the rework loop disappears and first-pass yield climbs.

6) FAQ

Q1. How is the Juran Trilogy different from Deming’s PDCA?
PDCA is a universal problem-solving cycle. Juran’s trilogy is a management architecture for running the whole quality function. Think of PDCA operating within each trilogy leg: plan better during Planning, control more intelligently during Control, and execute improvement projects during Improvement.

Q2. Where do risk management and FMEA fit?
Predominantly in Planning—anticipating failure modes and designing detection/prevention into the process—but also in Improvement to prioritize the largest risk or cost contributors. See FMEA.

Q3. Isn’t “control” just inspection?
No. Control means understanding variation and acting early. Inspection is one control method; better is process control via SPC, standardized work, and equipment capability so defects don’t manifest.

Q4. How do we avoid improvement projects fizzling out?
Use a gated CAPA lifecycle with executive sponsors, clear problem statements, data-driven root cause, effectiveness checks, and formal change control to embed the fix and train operators. Audit for “hold the gain.”

Q5. Do we need separate teams for each trilogy element?
Not necessarily. Many organizations run a centralized quality team plus embedded quality engineers in operations and development. What matters is explicit ownership and cadence: planning reviews, control tier meetings, and an improvement portfolio review.

Q6. How does the trilogy support regulatory inspections?
Inspectors want consistent storylines: risks identified (Planning), controls effective (Control), and issues addressed with sustained results (Improvement). Evidence lives in eBRs, audits, CPV charts, CAPA files, and training records with audit trails.

Q7. What metrics best reflect trilogy maturity?
Planning: RFT (right-first-time), supplier defect rates, on-time document releases. Control: OOS/OOT, Cp/Cpk, deviation rate, batch review cycle time. Improvement: CAPA closure lead time, CAPA effectiveness, complaint reduction, scrap/rework cost, OTIF improvement.

Q8. Does the trilogy apply to warehousing and distribution?
Yes. Planning defines label/data standards (GS1/GTIN, EPCIS), storage conditions, and bin location logic; Control uses cycle counts, directed picking, and expiry controls; Improvement reduces mispicks, dwell time, and temperature excursions.

Q9. How does trilogy thinking interact with digitalization?
Digital tools amplify all three legs—planning with master-data governance, control with real-time visibility and alarms, and improvement with analytics. But tools must be validated and governed under Part 11, GAMP 5, and local procedures.

Q10. Where do audits fit?
Audits check that Planning produced coherent systems, Control runs as designed, and Improvement is effective. See Internal Audit and supplier audits; outputs feed the improvement portfolio and the APR or management review.

Further Reading & Related
• Lifecycle & Systems: ICH Q10 | ICH Q7 | ISO 13485 | GMP / cGMP
• Control & Monitoring: SPC | CPV | In-Process Controls
• Records & Data Integrity: 21 CFR Part 11 | Audit Trail (GxP) | ALCOA+
• Execution & Release: eBR/eBMR | Hold & Release | Finished Goods Release | CoA
• Problem-Solving & Risk: CAPA | FMEA | HAZOP