Quality Management Process

This topic is part of the SG Systems Global quality governance, compliance execution & continuous improvement glossary.

Updated December 2025 • Quality Management, QMS, Quality Assurance Process, QA vs QC, Quality Control System (QCS), QC in Manufacturing, Document Control, Change Control, Deviation Management, Nonconformance Management, CAPA, QRM, Risk Matrix, Internal Audit, Data Integrity

Quality Management Process is the end-to-end operating loop an organisation uses to define quality expectations, control execution, verify results, correct problems, and continuously improve. It’s not a single SOP and it’s not “QA’s job.” It’s the connected set of processes that turn external requirements (regulatory, customer, standard) into daily, auditable control of people, documents, materials, equipment, data, product and decisions.

In a mature organisation, quality management is a predictable machine: requirements flow into controlled documentation and training; execution is guided and constrained; results are verified; exceptions trigger fast containment and investigation; CAPA and change control drive prevention; audits and management review keep leadership accountable. In an immature organisation, quality management is reactive: firefighting, paper chasing, and “we’ll fix it later” decisions that accumulate until a customer or inspector forces a reset.

“If quality only shows up after something goes wrong, you don’t have a quality management process — you have a damage-control habit.”

1) What “Quality Management Process” Actually Means

Quality management is often confused with quality assurance, quality control, or “the quality department.” In reality, the quality management process is the integrated system that ensures the organisation consistently delivers conforming product and trustworthy records. It blends three concepts that must stay linked:

• Quality management: governance, objectives, process ownership, continuous improvement.
• Quality assurance process: prevention, system controls, process design, audits, training and oversight.
• Quality control: detection and verification through inspection/testing and disposition decisions.

Quality management is therefore not “QA vs QC” — it’s the system that orchestrates both. If your QA and QC teams are good but disconnected, quality management still fails because issues fall through gaps: unreviewed trends, uncontrolled changes, “informal” workarounds, and late discovery of defects.

2) The Backbone: Plan–Do–Check–Act (PDCA)

Most effective quality systems follow a PDCA loop whether they use that label or not:

• Plan: define requirements, quality policy, objectives, process maps, risks, controls, resources.
• Do: execute controlled processes with trained people, approved documents, qualified equipment and verified materials.
• Check: verify outcomes through testing, inspection, monitoring, trending, and audits.
• Act: correct and prevent problems with investigations, CAPA, and controlled change.

What matters is not the diagram. What matters is whether your organisation actually closes the loop. If “Check” happens but “Act” is weak, you get repeat deviations. If “Act” happens but “Plan” is weak, you get random changes that destabilise processes. The quality management process exists to keep the loop tight and real — not theoretical.

3) Governance: Quality Policy, Objectives, and Ownership

Quality management starts with leadership making quality a managed system rather than a slogan. A quality policy and objectives should not be vague. They should translate into measurable commitments and named owners. Typical governance elements include:

• Quality policy: high-level statement of intent and obligations (customer, regulatory, ethical).
• Quality objectives: measurable targets such as right-first-time documentation, reduction in recurring deviations, improved release cycle time, reduced complaints, improved audit closure performance.
• Process ownership: named owners for document control, training, deviation/NC, CAPA, change control, audits, supplier quality, validation.
• Decision rights: who can approve deviations, release product, approve changes, accept risk, and close CAPA.

A weak governance model looks like this: QA is responsible for everything, operations is responsible for output, and no one owns systemic improvement. A strong model looks like this: operations owns execution compliance, QA owns governance and oversight, and leadership owns resourcing and performance accountability.

4) Document Control: Turning Requirements into Controlled Work

The quality management process cannot exist without tight document control. Documents are not bureaucracy; they are the mechanism that prevents every shift from reinventing the process. A defensible document-control system typically ensures:

• Single source of truth: approved versions only; uncontrolled copies are explicitly managed or banned.
• Structured authorship and approval: technical review + quality approval + management approval where required.
• Effective dates and training triggers: new/changed documents drive training requirements through a controlled matrix.
• Periodic review: documents stay aligned to actual practice and current regulations.
• Retention and retrieval: records and superseded documents are retained per policy and retrievable for audits.

Document control is also where many organisations leak risk: uncontrolled templates, “temporary” work instructions that never get controlled, and record forms that quietly change without approvals. If you want predictable quality, stop letting work instructions mutate in the wild.

5) Risk Management: Prioritising Controls Where Failure Hurts

Quality management is fundamentally risk management. A mature QMS applies QRM to focus effort where impact and likelihood justify it. Risk is not just a meeting; it’s a discipline that drives:

• Control design: what controls exist, where they exist, and how hard they gate execution.
• Validation depth: what needs qualification and requalification, and how often.
• Sampling/testing strategy: where you rely on in-process controls vs end testing.
• Escalation rules: what triggers immediate containment vs routine investigation.

Tools vary by sector and maturity: risk registers, hazard analysis, PFMEA, and simple risk matrices. The red flag is using “risk-based” as an excuse for under-control. Risk-based means “focused and justified,” not “lighter because we prefer it.”

6) Execution Control: Making the Right Way the Easy Way

The quality management process must shape day-to-day execution. That’s where quality shifts from paperwork to operational reality. Effective execution control includes:

• Clear procedures and work instructions: not ambiguous “tribal knowledge” steps.
• Training and competency evidence: role-based training with current records (not verbal assurances).
• Equipment status control: qualified/calibrated/clean status visible and enforced.
• Material status control: approved/quarantined/expired conditions prevented at the point of use.
• Structured records: executed records that are complete, legible, and traceable (for example BMR/DHR in regulated manufacturing).

In modern plants, this is where MES, digital work instructions and electronic records become part of the QMS. If execution is “paper and memory,” your QMS is vulnerable to late entries, missing checks, and inconsistent performance. Quality management is supposed to reduce that variability.

7) QC and Verification: Proving Outcomes, Not Guessing Them

No matter how strong prevention is, you still need verification. That’s the role of QC testing and release evidence, inspection programs, and defined acceptance criteria. A robust verification layer includes:

• Defined test methods and sampling plans: tied to risk and regulatory/customer requirements.
• Clear disposition rules: release, quarantine, reject, rework, return decisions based on evidence.
• Traceable results: results linked to lots, batches, materials and equipment; supported by Certificates of Analysis (CoA) where relevant.
• Data integrity: test results are trustworthy, attributable, and protected from manipulation.

Quality management fails when verification becomes performative: tests run without understanding risk, results recorded without review, and out-of-spec patterns treated as “bad luck.” Verification exists to prove control and reveal drift before customers do.

8) Handling Exceptions: Deviations and Nonconformances

Exceptions are normal. What matters is how you manage them. The quality management process must ensure that deviations and nonconformances are captured early, contained fast, and investigated correctly. A disciplined model usually includes:

• Immediate containment: stop the bleed, protect product, isolate impacted material, stabilise the situation.
• Classification: severity and impact assessment; what is minor vs major; what triggers escalation.
• Investigation: structured facts, timeline, contributing factors and evidence (not opinions).
• Disposition: clear decisions for product/batch impact, rework/reprocess, or rejection.
• Linkage: deviations/NCs feed CAPA and change control when they reveal systemic causes.

A mature site treats deviation management and nonconformance management as the front door to improvement. An immature site treats them as paperwork to minimise, delay, or reclassify until the pressure goes away. Inspectors notice the difference immediately.

9) CAPA: Turning Problems into Prevention

CAPA is the muscle of the “Act” phase. It exists to stop recurrence and reduce systemic risk. In practice, good CAPA is not “write an action and close it.” It is:

• Root cause discipline: using evidence-driven analysis (for example RCA) rather than blaming operators or “training” by default.
• Right-sized actions: corrective actions to fix the current gap and preventive actions to reduce future likelihood.
• Ownership and deadlines: real owners with real due dates; aging is tracked and managed.
• Effectiveness checks: proof that the action changed outcomes (not just that the action was completed).

CAPA failure modes are predictable: “train people” as the universal fix, actions that don’t address systemic contributors, and closure without evidence. A strong quality management process treats CAPA like engineering: hypothesis, intervention, measurement, confirmation.

10) Change Control and Validation: Changing Without Breaking Compliance

Quality management is not about freezing the organisation; it’s about changing safely. That’s why change control is a core process. A defensible change-control system typically includes:

• Impact assessment: quality, regulatory, validation, supply chain, labeling, training, data integrity impacts.
• Risk evaluation: what could go wrong, how likely, and what controls are needed.
• Approval routing: appropriate technical, quality and regulatory approvals based on impact.
• Implementation evidence: updated documents, trained staff, updated system configurations, validated changes where needed.
• Post-change review: confirmation that the change achieved intended outcomes without unintended harm.

In regulated manufacturing, change control also ties tightly to validation and CSV. If software or automation changes can influence product quality or records, they must be controlled and tested. “We only changed the screen” is not a valid excuse when the screen controls data capture and approvals.

11) Supplier Quality and Outsourced Work: Extending the QMS Beyond Your Walls

Quality management fails when it stops at the site boundary. Most modern supply chains involve external suppliers, labs, service providers, and sometimes CMOs. A mature QMP includes:

• Supplier qualification: risk-based evaluation, audits where appropriate, quality agreements.
• Incoming controls: identity testing, inspection, and verification of supplier documentation (for example supplier verification of CoAs).
• Performance monitoring: defect trends, late delivery, deviation patterns, SCAR/CAPA interactions.
• Change communication: supplier changes are captured and assessed before they become your failures.

If supplier quality is weak, your internal controls become expensive and slow because you’re compensating for upstream chaos. Good quality management uses supplier controls to prevent defects entering the plant in the first place.

12) Audits, Reviews and Oversight: Keeping Leadership Honest

A quality management process needs oversight mechanisms that detect drift, confirm compliance, and force decisions. The three usual pillars are:

• Internal audits: systematic verification that processes are followed and effective; findings feed CAPA and change control.
• Product / quality reviews: periodic reviews such as PQR or APR that evaluate quality performance over time.
• Management review: leadership review of QMS performance, metrics, major risks, audit outcomes and resource needs.

If management review is a slide deck exercise with no actions, quality management becomes hollow. Inspectors look for evidence that leadership actually runs the QMS: decisions, resourcing, accountability, follow-through.

13) Data Integrity: The Hidden Load-Bearing Wall

Quality decisions are only as good as the data behind them. That’s why data integrity is not a compliance “module”; it is a foundational quality control. A credible quality management process explicitly includes:

• Attribution: unique users, no shared logins, clear responsibility for entries.
• Contemporaneous recording: data captured when work is done, not reconstructed later.
• Audit trails: changes are traceable (see audit trail expectations).
• Secure systems: access controls, permissions, segregation of duties.
• Review discipline: routine review of trends, exceptions, and audit trail signals.

Most data integrity failures come from “reasonable shortcuts” under pressure: backdating, copying results, uncontrolled spreadsheets, offline notes that later get typed in. A good quality management process designs those shortcuts out by using structured workflows and enforced controls.

14) Implementation Roadmap & Practical Tips

Improving quality management is not about adding more forms. It is about building a loop that works. A practical roadmap:

• 1) Map the real process. Document how quality decisions and records actually flow today (not the ideal).
• 2) Identify the weak links. Typical candidates: document control discipline, training evidence, deviation/CAPA aging, change control quality, supplier controls, data integrity.
• 3) Make controls explicit. Define what must happen, who must do it, and what evidence proves it.
• 4) Hard-gate where it matters. For high-risk steps, don’t rely on “please remember.” Use system enforcement where possible.
• 5) Measure and trend. Pick a small number of load-bearing KPIs and review them routinely in management review.
• 6) Close the loop fast. Recurrence is the enemy. Use CAPA effectiveness checks and change control discipline to reduce repeat events.
• 7) Simplify the system. Eliminate redundant forms and unclear SOPs; complexity drives noncompliance.

The end-state is straightforward: quality controls are integrated into work; exceptions are visible and acted on; evidence is easy to retrieve; and leadership can see system health without waiting for an auditor to point it out.

15) What This Means for V5

On V5, the quality management process can be executed as one joined-up, audit-trailed operating system rather than a patchwork of disconnected tools. V5’s advantage is not “more software” — it’s fewer gaps between quality governance and operational execution.

• V5 Solution Overview
  • Provides a single architecture where quality, manufacturing and warehouse controls share a consistent data model and traceability backbone.
  • Makes it possible to show auditors one coherent quality story across systems instead of a “tour of tools.”
• V5 QMS – Quality Management System
  • Runs the governance layer: document control, training, deviations, nonconformances, CAPA, audits, risk registers and change control.
  • Ensures approvals, e-signatures and audit trails are built into the workflow, strengthening evidence and data integrity.
  • Connects quality events to the operational records that matter (batches, lots, materials, equipment) so investigations start with facts, not file hunting.
• V5 MES – Manufacturing Execution System
  • Executes controlled work (recipes, routings, digital work instructions) while capturing structured evidence into electronic records.
  • Hard-gates execution on quality prerequisites: trained personnel, released materials, qualified equipment, required checks completed.
  • Feeds deviations and exceptions directly into V5 QMS with the relevant execution context attached, reducing investigation cycle time.
• V5 WMS – Warehouse Management System
  • Controls material status (quarantine/release), location, lot genealogy and movement history as part of quality control, not separate “warehouse paperwork.”
  • Links receiving and consumption to quality decisions so traceability and disposition are consistent end-to-end.
• V5 Connect API
  • Integrates ERP, LIMS, PLM and external portals so that quality-critical data move through controlled interfaces rather than spreadsheets and emails.
  • Supports multi-site and partner scenarios where quality evidence and master data must be exchanged securely and consistently.

Net effect: V5 makes the quality management process visible and enforceable. Instead of “quality is a department,” quality becomes a controlled flow of work, decisions and evidence — from document control to execution to release to improvement.

FAQ

Q1. Is “quality management process” the same thing as a QMS?
Not exactly. A QMS is the overall system (structure, documents, processes, governance). The quality management process is the operational loop that runs that system day to day: plan, execute, verify, correct and improve.

Q2. Where do QA and QC fit into the quality management process?
QA focuses on prevention and system governance; QC focuses on verification through testing/inspection and evidence for disposition. Quality management coordinates both and ensures the loop closes through deviations, CAPA and change control.

Q3. What are the most common weak points in a quality management process?
The repeat offenders are uncontrolled documents/templates, weak training evidence, poor deviation discipline (late/low-quality investigations), CAPA aging and weak effectiveness checks, rubber-stamped change control, and data integrity shortcuts (uncontrolled spreadsheets, late entries).

Q4. How do we make quality management less “paperwork heavy”?
Reduce duplication, simplify SOPs, and use structured digital workflows that capture evidence as work happens. Paperwork grows when controls are unclear and evidence has to be reconstructed. When the process is well designed, the record is a natural byproduct of execution.

Q5. What does “good” look like in management review for quality?
A real management review tracks a small set of load-bearing KPIs (deviation recurrence, CAPA aging, audit performance, release cycle time), reviews major risks and trends, assigns actions with owners and deadlines, and shows evidence of follow-through. If management review produces no decisions, it isn’t management review — it’s a meeting.

Related Reading
• Quality System Basics: Quality Management | QMS | Quality Assurance Process | QA vs QC | QA Systems
• Control & Improvement: Document Control | Change Control | Deviation Management | Nonconformance Management | CAPA | Corrective Action Plan
• Risk & Oversight: QRM | Risk Matrix | Internal Audit | PQR | APR
• Data & Evidence: Data Integrity | Audit Trail | Certificate of Analysis (CoA) | QC Testing & Release Evidence
• V5 Platform: V5 Solution Overview | V5 QMS | V5 MES | V5 WMS | V5 Connect API