Complaints, Recalls & Post-Market Surveillance — When Product Leaves the Plant but Risk Stays With You

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

Updated November 2025 • complaint handling, returns & RMA, recall readiness, mock recalls, one-up / one-down traceability, DSCSA, UDI, MDR/FSCA, APR/PQR, CPV, supplier links, SQM & CAPA • Pharma, Biologics, Medical Devices, Food & Beverage, Meat, Bakery, Cosmetics, Dietary Supplements, Chemicals

Complaints, recalls and post-market surveillance are where the outside world tells you what your system is really worth. You can ace internal audits and still fall apart the first time a hospital calls with a device failure, a retailer reports foreign material, or a regulator flags nitrosamine or allergen incidents in your category.

At that point, your glossy procedures don’t matter. What matters is how fast you can see the real scope of the problem, how well you can separate noise from signal, and whether your response looks like a controlled, risk-based operation—or a panic.

“The market doesn’t care how many CAPA forms you have. It cares whether you can find, fix and prevent issues before they damage people and your brand.”

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1) Complaint handling — the front door of post-market surveillance

Your complaint handling glossary defines the basic pipeline:

• Capture. Complaints arrive via customer service, sales, portals, regulators, retailers, hospitals or direct consumers. They include product IDs, symptoms, context, sometimes photos or returned samples.
• Classification. Complaints are classified (e.g., quality defect, labelling error, transport damage, foreign material, suspected AE) and triaged for urgency.
• Evaluation. QA and, for devices/drugs, safety/medical teams assess potential impact on patient/consumer safety, regulatory reporting thresholds and need for further action.
• Investigation. Complaints are linked to production and distribution data: lots, batches, processes, equipment, operators, time windows, suppliers.

The key is traceability: you must be able to tie complaints to specific lots and batches. In V5, that means capturing product and lot data as part of the complaint and then using genealogy and WMS data to find related batches, pallets and shipments quickly.

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2) Returns, RMA & reverse logistics — product coming back, not just out

Complaints often bring product back with them. Your returns, RMA & reverse logistics entry covers the basics:

• RMA issuance. Authorising returns with clear IDs so inbound complaints & returns can be linked to cases and lots.
• Inspection. Evaluating returned product for confirmation (defect present or not), storage conditions, tampering, mis-use.
• Disposition. Deciding whether returned goods go to rework, downgrade, destruction or are held for further investigation.
• Feedback. Feeding returns data into complaint, CAPA and SQM processes.

V5 WMS can treat returns as a special inbound flow: lots and serials are scanned back in, locations flagged as “quarantine – returns,” and links to complaint IDs maintained. That keeps returns out of normal inventory while still feeding data into investigations and analytics.

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3) Traceability, recall readiness & mock recalls

Recall readiness is where your traceability stack meets the real world. You’ve already documented key concepts:

• End-to-end lot genealogy & one-up / one-down. Lot traceability and one-up / one-down require you to know where each lot came from and where it went.
• Recall readiness & rapid traceability response. Recall readiness is the capability to identify affected product, customers and inventory quickly enough to matter.
• Mock recall performance. Mock recalls are the real test: can you execute an upstream or downstream trace in hours, not days?
• Mass balance. Mass balance checks whether material in, plus rework and yields, matches material out and remaining stock.

When complaints or adverse events hit, these capabilities determine whether you can run a surgical, lot-specific recall or end up pulling entire product ranges “out of an abundance of caution.” V5’s lot genealogy, batch-to-bin and WMS shipment data are the backbone of this response.

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4) Regulatory reporting — MDR, corrections & removals, DSCSA & UDI

Depending on the sector, complaints and quality events may trigger formal regulatory reporting:

• Medical devices.
  • 21 CFR 803 — Medical Device Reporting (MDR) of adverse events.
  • 21 CFR 806 — corrections & removals (field safety corrective actions).
  • UDI — device identifiers and production identifiers that tie complaints to specific DIs/PIs and, in some regions, to databases like GUDID, AusUDID.
  • 21 CFR 821 — device tracking for certain high-risk devices.
• Pharma & biologics.
  • DSCSA — serialisation and traceability expectations for US prescription drugs.
  • Other vigilance and defect reporting paths (national and regional) that rely on batch/lot data.
• Food & cosmetics.
  • Mandatory notifications for certain serious adverse events and contamination incidents.
  • Retailer-specific reporting and withdrawal expectations.

All of these require you to connect external events (complaints, AEs, field data) back to specific products, lots, serials, markets and time windows. That’s not possible without solid MES/WMS/label/serialization integration—exactly what you’ve been building with V5.

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5) EPCIS, DSCSA & downstream traceability

For serialised and GS1-enabled supply chains, you’ve already captured the backbone in EPCIS traceability standard and related entries:

• EPCIS events. Commissioning, aggregation, shipping, receiving and transformation events describe what happened to each GTIN/lot/serial at each node.
• DSCSA transactional data. For pharmaceuticals, DSCSA relies on event data linked to serialised units and cases over time.
• Retailer & regulator visibility. EPCIS or equivalent events may feed trading partners, traceability networks or regulators directly.

In a complaint or recall, this downstream visibility can show where affected serials or lots went after leaving your warehouse: which distributors, pharmacies, hospitals or retailers still hold stock, and which units have already been dispensed or sold. V5 WMS and label/GS1/serialisation integrations provide the upstream data that feeds those EPCIS events.

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6) Complaints into CAPA, APR/PQR & CPV — learning instead of just firefighting

Complaints and recalls are not just “finished goods problems.” They’re inputs into your quality and lifecycle processes:

• CAPA integration. Significant complaints and recall drivers should trigger CAPA, not just ad-hoc fixes. Root causes may lie in formulation, process, equipment, lab methods, labelling, training or suppliers.
• Supplier CAPA (SCAR). If issues stem from raw materials or third-party services, SCAR and SQM must be part of the response.
• APR/PQR. APR / PQR require complaint trends per product and market, and how they relate to process changes, deviations, CAPAs and yield.
• CPV. CPV can correlate complaints with CPP/CQA drifts and deviations over time.

V5’s integrated data model makes this loop possible: complaints are tied to lots and batches; those batches have full genealogy, process data and deviation histories; CPV and APR/PQR analyses draw on that; QMS drives CAPA and recipe/equipment/practice changes; MES/WMS implement them. The end state is fewer repeats and more robust products, not just better paperwork.

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7) Retailer & customer-driven withdrawals

Retailers (and large B2B customers) play a special role in post-market risk:

• Code & label compliance. Programmes like Walmart SQEP and retailer codes of practice can generate “non-conformances” that are effectively complaints, even if product is technically in spec.
• Supplier portal events. Retailers may open cases in their portals that must be mirrored into your complaint and CAPA systems.
• Withdrawals vs recalls. Many issues result in withdrawals or quality notifications rather than full regulatory recalls—but the traceability and investigation expectations are similar.

V5 can help by aligning outbound data (GTIN/lot/serials, ASNs, manifests) with what retailers see, reducing coding and labelling errors that trigger SQEP-style hits, and by tying retailer cases to lots and batches in the same way as direct complaints.

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8) How V5 Traceability supports complaints, recalls & post-market surveillance

V5 Traceability gives you the operational picture you need when things go wrong:

• Complaint context. Complaints in V5 QMS (or integrated systems) can be linked to specific products, GTINs, lots, batches, serials and shipments from V5 WMS/MES.
• One-click genealogy. From an affected lot or serial, V5 can show upstream (suppliers, raw lots, processes, equipment) and downstream (cases, pallets, customers, routes) within the recall window.
• Mock recall dashboards. Traceability and mock recall exercises can be run directly from live data to test readiness, not just from theoretical scenarios.
• Integration with serialisation & EPCIS. V5 feeds and consumes GS1, EPCIS and serialisation events so DSCSA/UDI traceability data is consistent with internal records.
• Analytics & lifecycle feedback. Complaint and recall data flow into V5’s CPV/APR/PQR analyses and QMS CAPA workflows, closing the loop between field issues and operations.

The objective isn’t to pretend issues will never happen; it’s to make sure that when they do, you can see them clearly, contain them quickly and learn from them efficiently.

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FAQ — Complaints, Recalls & Post-Market Surveillance

Q1. How many complaints are “acceptable” for a product?
There’s no magic number. Volume depends on product risk, market size, complexity and maturity. What matters is trend and content: are complaint rates stable, reducing or climbing? Are there clusters in specific lots, markets or formats? Are serious complaints being escalated and investigated properly? V5’s data can help you answer those questions, not just count tickets.

Q2. What’s the difference between a withdrawal and a recall?
Terminology varies, but generally a recall involves a formal regulatory dimension and public notification, whereas a withdrawal may be a voluntary removal from distribution or retail channels for quality reasons. Traceability and investigation work are similar; the regulatory and public-communications implications differ.

Q3. How often should we perform mock recalls?
Typically at least annually per site (and often per major product family), or as required by GFSI schemes and internal policy. Many organisations cycle mock recalls by risk (e.g., high-risk products more frequently) and use results to refine traceability, documentation and response playbooks.

Q4. Do we need EPCIS for recalls if we already have good internal traceability?
For non-serialised, domestic flows, robust internal MES/WMS traceability may be enough. EPCIS becomes important when you have to share traceability data across multiple independent systems (distributors, 3PLs, pharmacies, hospitals, retailers) at scale, particularly under DSCSA or similar regulations. It’s about interoperability, not just internal control.

Q5. How do we avoid turning every complaint into a full CAPA project?
Use risk-based triage. Many minor complaints can be handled via simple investigation and correction; recurring patterns or serious risks should trigger CAPA. Define criteria for when CAPA is required (e.g., patient/consumer safety impact, regulatory thresholds, repeated occurrences) and let V5 QMS enforce them via workflows.

Q6. Where should we start if our current complaint and recall process is mostly email and Excel?
Start by enforcing structured complaint intake: a single system or form capturing product, lot, date, issue type and basic context. Link that to V5 WMS/MES to resolve lots and shipments quickly. Then formalise recall procedures and run a mock recall based on real data. As you gain control, integrate QMS for CAPA and connect to lab, SQM and serialisation where relevant.

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Related Reading (Glossary)
• Complaints & Returns: Complaint Handling | Returns / RMA / Reverse Logistics
• Traceability & Recalls: Traceability | Lot Traceability | One-Up / One-Down | Recall Readiness | Mock Recall Performance | Mass Balance
• Regulatory & Serialisation: DSCSA | UDI | EPCIS Traceability Standard | 21 CFR 803 | 21 CFR 806
• Lifecycle & Improvement: APR | PQR | CPV | CAPA | SCAR
• V5 Platform: V5 Solution Overview | V5 MES | V5 WMS | V5 QMS | V5 Connect API