Quality Assurance Process

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • QMS Governance & Workflow • QA, RA, Operations, Engineering, IT

The Quality Assurance (QA) process is the structured, repeatable way an organization plans, controls, verifies, and improves how products and services are delivered so they consistently meet regulatory, customer, and internal requirements. It turns the Quality Management System (QMS) into day-to-day practice: defining standards, translating them into procedures and training, monitoring execution, reacting to issues through deviations / nonconformances and CAPA, and feeding learning back into design and operations. Where QC tests the product, the QA process tests the system.

“The quality assurance process is the factory’s nervous system: it senses problems, coordinates responses, and rewires habits so the same mistakes don’t happen again.”

1) Core Stages of the Quality Assurance Process

Across industries and standards (e.g. ISO 13485, GMP, ISO 9001), the QA process typically follows these stages:

• Plan: define requirements, risks, and controls; author policies, SOPs, and quality plans.
• Enable: train people, qualify suppliers, validate processes and systems.
• Execute: run processes under controlled conditions in production, labs, and warehouses.
• Monitor: gather evidence through QC tests, in-process checks, audits, deviations, complaints, KPIs.
• React: investigate issues, perform root cause analysis, implement CAPA and change control.
• Improve: review performance and risk, update controls, and re-prioritize resources.

A mature QA process is continuous and cyclical, not a one-off project before an inspection.

2) Inputs & Outputs of the QA Process

Key inputs include:

• Regulatory requirements (e.g. MDR/IVDR, FDA QMSR, FSMA, USDA, GFSI schemes).
• Customer and market requirements (specifications, SLAs, quality agreements).
• Internal standards, policies, and risk criteria.
• Historical data: complaints, NCs, audits, stability, and process capability.

Key outputs include:

• Controlled documents (policies, SOPs, work instructions, forms).
• Qualified people, equipment, and suppliers.
• Released batches / devices with complete eDHR/eBR and traceability.
• Records of deviations, CAPA, change control, audits, and risk assessments.
• Quality metrics and management-review decisions.

Together these outputs form the defendable evidence that the QMS is effective, not just documented.

3) Relationship to QA Systems, QMS & QC

Think of the Quality Assurance Process as the operating mode of your QA system:

• QA Systems define the architecture—what modules and responsibilities exist.
• The QMS is the formalized set of processes, SOPs, and tools that implement that architecture.
• The QA process is the day-to-day flow of how those processes are used and improved.
• QC (lab tests, inspections) is one stream of evidence inside the QA process, not the whole thing.

Auditors often test the QA process by tracing a single issue through all these layers—from shop-floor event to QMS record to system change and effectiveness evidence.

4) Key Sub-Processes in Quality Assurance

The QA process is usually broken into interconnected sub-processes such as:

• Document Control: create, approve, distribute, revise, and retire controlled documents; ensure only current versions are in use.
• Training & Competency: map roles to required competencies and SOPs; assign and track training; verify effectiveness.
• Deviation / Nonconformance Management: log, assess, investigate, and disposition NCs.
• CAPA: manage structured investigations, root cause analysis, and implementation of corrective & preventive actions.
• Change Control (MOC): evaluate and approve changes to processes, equipment, materials, software, and documents.
• Risk Management: use risk matrices, FMEA, and risk registers to prioritize controls and improvements.
• Supplier Quality: qualify suppliers, manage audits, track supplier NCs and performance.
• Audit & Inspection Management: plan internal audits, respond to findings, and track commitments.
• Post-Market Surveillance (PMS): collect and analyze complaints and field performance for regulated products.

A coherent QA process ensures these modules share data instead of operating as disconnected “mini systems”.

5) Risk-Based Quality Assurance

Modern QA processes are driven by risk, not by equal treatment of every event:

• Use QRM tools to rank processes and products by patient/consumer impact and compliance risk.
• Scale depth of investigation, validation, and documentation according to risk category.
• Prioritize CAPA and change control resources where risk reduction is greatest.
• Integrate risk review into Management Review and planning.

Risk-based QA is expected under frameworks like ICH Q9, ISO 13485, ISO 14971, and GFSI codes—not optional “nice to have”.

6) Digital Quality Assurance Process (QMS + MES + WMS)

In digital plants, the QA process runs across multiple systems:

• QMS / eQMS: orchestrates document control, training, events, CAPA, change control, audits, and risk.
• MES: executes batches, operations, and in-process checks; generates eDHR/eBR records and triggers deviations in real time.
• WMS: enforces QA status and traceability on materials, intermediates, and finished goods.
• ERP/LIMS/PLM: provide additional master data, lab results, and design context.

A robust QA process explicitly defines how data and workflows move between these systems—who does what where, and how evidence is synchronized and controlled.

7) QA Process Metrics & Health Checks

To know if the QA process is actually working, organizations track metrics such as:

• Number and severity of deviations / NCs per batch, line, and site.
• CAPA volume, cycle times, overdue items, and recurrence rates.
• Change control throughput and on-time implementation for high-risk changes.
• Training completion and competency for critical roles and new/changed SOPs.
• Audit findings by process area and their closure performance.
• Complaint and PMS trends for regulated products.

These metrics feed into Management Review, budget decisions, and continuous-improvement roadmaps—not just management dashboards.

8) Common Weaknesses in the Quality Assurance Process

• “Paper QMS” only. SOPs exist but are not embedded in MES/WMS or daily routines.
• Firefighting culture. Deviations and CAPA are reactive; little preventive action or risk-driven improvement.
• Data silos. QA, production, warehouse, and labs each run their own tools with no integrated view.
• Poor root cause analysis. CAPA dominated by “human error” and retraining; limited system or design changes.
• Backlogs and drift. Overdue CAPA, NCs, audits, and change controls; commitments quietly slipping.
• Weak feedback loop. Complaints and PMS data do not meaningfully influence design, risk, or process controls.

These patterns show up quickly in regulatory inspections and customer audits as repeat observations and “paper-only” QMS findings.

9) What Belongs in a Documented Quality Assurance Process

Organizations typically describe their QA process across several SOPs and in the QMS manual, covering:

• Scope and objectives of QA (products, sites, regulatory regimes).
• Process maps showing interactions between QA, QC, operations, engineering, IT, and supply chain.
• Key workflows (deviation, CAPA, change control, document control, training, audits, risk).
• Roles and responsibilities, including independence of the Quality Unit.
• Use of digital systems (QMS, MES, WMS, LIMS, ERP) and data flows between them.
• Governance (quality councils, management reviews, escalation paths).

This documented process becomes the “exam paper” for auditors; daily practice must match it closely enough to be credible.

10) How the Quality Assurance Process Fits with V5 by SG Systems Global

Process orchestration in V5 QMS. The V5 Quality Management System (QMS) module is the engine for running the QA process electronically: it manages document control, training, deviations, CAPA, change control, audits, supplier quality, and risk records in configurable workflows with e-signatures, effective dating, and audit trails aligned to ISO 13485 and GxP expectations.

Execution linkage via V5 MES. The V5 MES connects QA process decisions directly to production: SOPs and work instructions governed in QMS are presented at the terminal; in-process checks and limits are enforced; deviations can be opened directly from the line; and all activity is captured in structured eDHR/eBR records that QA can review and approve.

Material status & traceability via V5 WMS. The V5 WMS turns QA decisions into hard constraints on materials and finished goods: QA status (quarantine, released, blocked) is enforced at scan points; UDI, lot, and serial traceability align with nonconformance and CAPA records; and kitting rules ensure only approved, in-date components reach production and customers.

Platform-wide QA visibility through the V5 Solution Overview. The broader V5 Solution Overview shows how the QA process flows across QMS, MES, and WMS: events in production and warehouse automatically create or update QA records; QA approvals control what operations can do; management dashboards combine data across modules to support risk-based decisions.

Integration & analytics via V5 Connect API. With the V5 Connect API, QA process data (NCs, CAPA, training, audits, risk scores) can be integrated with ERP, LIMS, PLM, and BI tools. That lets organizations analyze QA performance across plants, product families, and time—supporting continuous improvement and inspection-readiness without manual spreadsheet work.

Bottom line: V5 provides the digital backbone for the Quality Assurance Process, ensuring that policies and SOPs in QMS translate into real behavior in MES and WMS, with complete, audit-ready evidence that quality is controlled and continuously improved.

11) FAQ

Q1. How is the Quality Assurance Process different from the QMS?
The QMS is the documented framework (policies, SOPs, procedures); the Quality Assurance Process is how those documents are applied, monitored, and improved in practice. In audits, regulators test the QA process by checking whether real behavior matches the documented QMS.

Q2. Who owns the Quality Assurance Process?
The Quality Unit (QA) is typically accountable for designing and governing the process, but operations, QC, engineering, IT, and supply chain all share responsibility for executing within it. QA sets standards and approves critical decisions; line functions generate the evidence.

Q3. Does every deviation need to go through the full QA process?
Every deviation should enter the QA process, but depth of handling is risk-based. Minor, well-understood events may be corrected and documented with limited investigation, while higher-risk events may require full CAPA, change control, and management review.

Q4. How often should the QA process be reviewed?
At least annually via formal Management Review and more frequently via internal audits, KPIs, and risk reviews. Major changes in products, volume, regulation, or technology should also trigger targeted QA process reassessment and updates.

Q5. What are warning signs that the QA process is failing?
Growing backlogs of deviations and CAPA, repeated findings, frequent last-minute document updates before audits, data-integrity concerns, and surprise issues in customer or regulatory inspections all indicate that the QA process is not keeping up with operational risk.

Q6. How do digital platforms like V5 improve the Quality Assurance Process?
Digital platforms like V5 embed QA workflows directly into production and warehouse systems, enforce approvals and data integrity, centralize events and CAPA, and provide real-time dashboards and analytics. That moves the QA process from reactive and document-centric to proactive, integrated, and evidence-driven.

Related Reading
• QA & QMS: QA Systems | Quality Management System (QMS) | ISO 13485 Requirements | Management Review
• Events & Risk: Deviation / Nonconformance (NC) | Nonconformance Management | CAPA – Corrective & Preventive Action | Risk Management (QRM)
• Data & Execution: Data Integrity | Audit Trail (GxP) | eDHR Software
• V5 Platform: V5 Solution Overview | V5 QMS | V5 MES | V5 WMS | V5 Connect API