Manufacturing Regulatory Compliance Checklist

Pull each controlled SOP from the document control system and confirm rev matches the routing/traveler in use on the floor. For ISO 9001 and IATF 16949 shops, verify any clause-driven procedures (8.5 production control, 8.7 nonconforming output) reflect the current revision and that obsolete copies have been pulled from work centers.

Sample five recent work orders and trace lot/heat numbers from receiving through the traveler to finished goods. Common gap: the heat number is captured at receiving but lost at the kitting step, breaking traceability for any aerospace or pressure-vessel work.

Run the calibration report from the gauge management system. Red-tag and remove from service any gauge past due — micrometers, calipers, pin gauges, CMM probes, hardness testers. Past-due gauges in service mean every measurement since the prior cal date is suspect.

Cross-check the training matrix against active ECNs and PFMEA changes from the last quarter. Any operator running an op affected by a process change needs documented re-training acknowledgement before next run.

Pull the NCR queue from the QMS. Flag any NCR open more than 30 days without disposition and any CAR closed without an effectiveness verification (defect-free run for the agreed cycle count or follow-up audit).

Build the escalation list with NCR number, age, owner, and reason for delay. Plant manager assigns a closure date; warehouse confirms segregated parts have not been un-segregated by accident during the delay.

Recalculate monthly RCRA generator status — VSQG, SQG, or LQG — based on the last 12 months of waste accumulation. Crossing into LQG triggers contingency plan, biennial reporting, and personnel training requirements that catch shops by surprise.

Pull the rolling 12-month emissions tally for VOC, HAP, NOx, and PM. Compare against the permit cap. Coatings, solvents, and welding emissions are the typical drift sources; an unreported new spray booth is the typical citation.

TRI reporting is due July 1 for the prior calendar year. Manufacture/process threshold is 25,000 lb; otherwise-use threshold is 10,000 lb. Tier II (EPCRA 312) is due March 1 — keep both deadlines on the same compliance calendar.

Walk every aboveground oil tank, drum storage area, and transformer pad. Confirm secondary containment volume is at least 110% of the largest container, drains are closed, and the SPCC plan reflects current tank inventory. PE recertification is required every five years.

Download the quarter's e-manifests from RCRAInfo and match each to the on-site accumulation log and TSDF receipt. Any manifest without a corresponding signed Copy 5 within 35 days needs an exception report.

Form 300A summarizing the prior calendar year must be posted Feb 1 through Apr 30 in a location visible to employees. Establishments with 20+ employees in covered NAICS codes also submit electronically via OSHA ITA by March 2.

Walk the floor with the equipment list. Each machine with a hazardous energy source needs a written, machine-specific LOTO procedure (29 CFR 1910.147) plus annual periodic inspection by an authorized employee other than the one performing the lockout.

1910.178 requires equipment-specific evaluation every three years and refresher training after a near-miss, accident, or assignment to a new truck class. An operator certified on counterbalance is not certified to drive a reach truck or order picker.

Walk the chemical cabinet and the storage shed. Every container needs a GHS-aligned label with pictograms; every chemical on the inventory needs a current SDS within reach of the operators who use it. New chemical introductions over the quarter trigger targeted HazCom training.

Calculate quarter-to-date TRIR and DART against the plant target. Pull the top three near-miss categories from the EHS system; if any near-miss pattern matches a prior recordable, escalate to a JSA refresh on that operation.

Pull the product certification register. Any product with a BOM change since the last test report needs an engineering review to decide whether re-test, delta evaluation, or supplier substitution coverage applies. Expired UL files block shipment to retail customers.

For chemical products shipped downstream, confirm labels carry the correct GHS pictograms, signal word, hazard statements, and precautionary statements matching the SDS Section 2. Mismatch between label and SDS is the most common HazCom citation on outbound product.

Review CPSC reportable-event criteria against the quarter's field complaints, returns, and warranty claims. A defect that creates substantial product hazard requires a Section 15(b) report within 24 hours of meeting the threshold — not at the end of the quarter.

Open the recall playbook: notify counsel, file the CPSC Section 15(b) report, freeze the affected lot in ERP, draft customer and distributor notice, and stand up the return-and-replace process. Same-day floor notification stops further bad units from shipping.

For products sold into EU or California, confirm supplier declarations on the BOM still cover RoHS substances, REACH SVHC list (current edition), and Prop 65 listed substances above the safe-harbor level. Update outbound declarations and warning labels where suppliers have changed formulations.

For new and revised drawings released in the quarter, run the export classification: ITAR USML category, EAR ECCN, or EAR99. Defense article technical data triggers DDTC registration, deemed-export controls on foreign-national employees, and supply chain flow-down obligations.

Pull the access matrix from SolidWorks PDM, Windchill, Teamcenter, or Arena. Confirm controlled-data folders are walled to authorized US persons; remove access for separated employees; verify any foreign-national engineer has either a deemed-export license or a verified exclusion.

Engineering, sales, and customer-program staff retake the customer-NDA training annually. Cover the most common slips: emailing prints to personal accounts, photographing the floor for LinkedIn, and using customer-supplied tooling on a non-authorized job.

Conflict Minerals Reporting Template (3TG) requests come through OEM supplier portals on an annual cadence. Pull the latest CMRT from each upstream smelter via the supplier portal, confirm RMI conformance status, and resubmit at the customer's required level (company-wide or product-specific).

EHS manager and quality manager jointly sign. Capture the headline finding, narrative on any open items, and supporting evidence package. The signed record is the audit trail for the next ISO surveillance visit and any agency inspection.