Rightway FACTS™ —
Factory Audit Checklist (Free)

A factory audit is a structured review of a supplier’s quality system, processes, capacity, and compliance against international standards and your requirements. It’s not just about a product sample—it’s about whether the factory itself can consistently deliver to spec over time.

Supplier vetting is the first filter: reviewing company background, certifications, product range, and basic capacity to decide if a supplier is even worth considering. Factory audit is the deep dive: an on-site evaluation of systems, processes, and compliance to confirm if a supplier can consistently deliver quality and scale with you. Rightway helps you move from supplier vetting to factory audit — using our local presence and decades of experience in Asia to save time, reduce cost, and lower risk. Vetting gives you options; our FACTS™ factory audits give you confidence.

A factory audit evaluates a supplier’s systems and capabilities (quality management, production processes, capacity, compliance, supplier control) to judge whether they can consistently meet your requirements over time. A product inspection checks specific units/lots against your specs and AQL at a point in time (pre-production, in-process, or pre-shipment). They’re complementary: audit = long-term capability, inspection = this shipment’s conformity. Rightway makes both faster, cheaper, and lower-risk Rightway delivers both services: the Rightway FACTS™ — Factory Audit Framework for system-level assurance, and on-site product inspections for shipment-level control. Because our team is embedded in Asia’s factory ecosystem (Taiwan/China/SEA) with bilingual engineers and decades of cumulative, hands-on experience, we: Save time & travel cost by coordinating audits and inspections in-region with rapid scheduling. Improve efficiency with one plan, one team: audit findings feed directly into inspection focus (critical specs, PTCs, labeling/pack), closing the loop. Reduce risk by enforcing must-pass gates (e.g., MSA/Gage R&R, Control Plans, traceability) in audits and validating them on the line during inspections. Audit protects your sourcing strategy. Inspection protects your shipment. With Rightway, you get both—locally executed, tightly integrated, results-driven.

Typical audit checklists cover: Quality certifications (ISO/IATF) Change control & documentation Process controls (PFMEA ↔ Control Plan, setup sign-off, work instructions) Measurement systems (MSA/Gage R&R, calibration) Traceability & nonconformance handling Supplier & incoming quality management These areas confirm both compliance and practical readiness.

This page is for startup founders, CTOs, product managers, and supply-chain managers who need a repeatable way to qualify factories—especially when operating in unfamiliar regions or stepping from prototypes to small-batch production. Use it if you’re: Selecting your first contract manufacturer. Adding a second source to de-risk supply. Bringing a new variant or rev change into production. Recovering from quality drift and looking for root causes.

Run an audit before you send PO #1—and again whenever risk changes: Pre-award: shortlist → on-site audit → final selection. Pre-ramp: confirm capacity, preventive maintenance, and control plans match the ramp profile. Post-change: any major design/process change, supplier switch, or surge in demand. Signals of trouble: rising defects, missed deliveries, labeling/traceability mistakes, or unexplained yield dips. Rule of thumb: audit when stakes or complexity increase. It’s cheaper than firefighting after launch.

Duration: A startup-focused audit usually takes 1–2 days on site, depending on factory size and product complexity. Frequency: Best practice is to audit before first PO, and then every 12–24 months, or immediately after major changes (e.g., new line, process shift, ownership change, critical issue).

Auditors don’t just look at paperwork—they check proof of execution, such as: PFMEA & Control Plan updates tied to actual shop-floor instructions MSA / Gage R&R reports for CTQs Calibration stickers/logs at point of use Traceability records (lot → shipment) Incoming inspection reports & quarantine logs CAPA records showing closure dates and lessons learned

Paper certifications, no practice. ISO docs exist, but line work is off-procedure. Expired calibration or “shared” gages. CTQs measured with uncalibrated tools. Over-committed capacity. Bottlenecks with no PM; “we’ll buy equipment after your PO.” Weak change control. ECOs not briefed at stations; old instructions at the bench. Traceability gaps. Mixed lots, handwritten labels, relabeling without audit trail. Containment missing. Non-conforming parts flow freely; red tags live in WIP 8D theatre. Issues “closed” with sorting, no root cause or effectiveness check. Two or more red flags across different pillars usually means no-go until controls are real.

Systemic quality lapses escalate fast. Aviation regulators found ongoing production-quality and process-control issues on the 737 program and imposed enhanced oversight and output caps—a reminder that paperwork alone isn’t enough; you need line-level controls and verification. Superficial supplier oversight risks legal action. In Italy, probes into luxury supply chains led courts to place units under administration/receivership for supplier abuses and poor oversight—a stark example of reputational and operational damage when upstream auditing fails. Shipments can be detained at the border. U.S. CBP actively uses Withhold Release Orders and UFLPA enforcement to stop goods tied to forced labor—detentions that create immediate cash-flow and delivery shocks. Rightway FACTS™ closes these gaps with quantified scoring and must-pass gates, plus local, bilingual execution so you catch risks before they hit your schedule.

If your product requires CE, FCC, automotive, or regulated market access, then APQP/PPAP disciplines help you avoid compliance delays. For most startups, a light APQP (feasibility, PFMEA, Control Plan, run-at-rate) is enough at EVT/DVT. Rightway integrates these tools into FACTS so founders don’t get buried in forms, but still meet the minimum gates investors and customers expect.

That’s a signal. Agree on redacted evidence or on-screen review—but lack of transparency is a risk by itself.

Problem statement (measurable): “Lot mix-ups in final pack for SKU X (2 incidents in 30 days).” Root cause (5-Why/Fishbone): “Similar label IDs + no scanner interlock.” Action plan (who/when): “Install scanner interlock, unique ID schema, operator training—Owners: PE/QA, Due: Oct 5.” Verification of effectiveness: “0 incidents across 10k units; spot audits weekly x 4 weeks.” Standardization: Update work instructions, add to internal audit check. Tie each CAPA back to a pillar so you track systemic improvement—not just firefighting.

Documents & on-site prep ISO/IATF certificates, org chart, internal audit plan APQP tracker, PFMEA & Control Plans, process flow, WI/SOP（latest, operator language） MSA/Gage R&R, calibration logs, gauge inventory for CTQs REACH/RoHS/IMDS declarations, conflict minerals AVL/PO clauses, IQC sampling plans, quarantine procedure, nonconformance logs Language, culture, calendars, local compliance Bilingual engineer/PM on site（Rightway provides this） Align around holiday peaks（LNY/Golden Week/peak export weeks）for audit slots and pilot runs Confirm label/pack/marking rules and market access docs (CE/FCC, material declarations, origin) early

09:00–09:30 Kickoff, scope, risks, CTQs. 09:30–11:00 Document & data review (certs, audits, KPIs, CAPAs). 11:00–12:30 Line walk (incoming → WIP → lines → test → pack). 13:30–14:30 Interviews (process, QA, maintenance, training). 14:30–15:30 Evidence consolidation, sampling checks, photos. 15:30–16:00 Close-out: findings, must-fix list, CAPA owners/dates, re-audit plan.