Disposable glove supplier audit checklist for 2026

Supplier qualification asks whether an organisation is a suitable counterparty with credible controls. Product approval asks whether one exact glove is supported for one intended use and destination market. A strong result in one audit does not automatically pass the other.

• Supplier file - legal identity, ownership, sites and subcontractors, roles, quality system, ethical due diligence, financial and continuity review.
• Product file - exact SKU and formulation, intended use, declarations, test evidence, labels, instructions, shelf life, packaging and approved changes.
• Lot file - purchase order, production and inspection records, lot code, release decision, shipment documents, delivered stock and complaint history.

Write the purchasing scenario first. Otherwise, suppliers may send a broad certificate pack that looks complete but does not answer the actual requirement.

• Countries of sale or use, importer and distributor route, and any public-procurement framework.
• Intended users and tasks, including whether the glove protects a wearer, patient, food, product or more than one of these.
• Required medical-device, PPE, food-contact or other product status, kept as separate evidence tracks.
• Material, colour, size range, texture, cuff, thickness or weight, packaging and private-label scope.
• Known chemicals, mixtures, biological exposure, allergy policy and other workplace hazards.
• Expected volumes, service expectations and launch constraints, recorded as planning inputs rather than supplier capability claims.

Confirm the contracting entity and the organisations that manufacture, own the brand, import, distribute, act as an authorised representative or UK responsible person, and release product. These roles carry different duties and can vary by product and market.

For PPE in Great Britain, HSE and GOV.UK guidance distinguish manufacturer, authorised representative, importer and distributor duties. For medical devices, MHRA guidance requires registration before placement on the GB market and a UK responsible person where the manufacturer is outside the UK. Check the live rules for the actual destination and date.

• Registered legal name, company number, address, tax and bank details matched independently.
• Manufacturing-site name and address, plus the contractual relationship if production is outsourced.
• Written role map for manufacturer, brand owner, importer, distributor, representative and conformity-assessment body.
• Insurance, licences and registrations where relevant, checked with the issuing authority rather than a screenshot alone.
• Named owners for regulatory, quality, complaints, change control and emergency communication.

List every claim in one column and the supporting document in the next. The document must match the exact product reference, formulation, colour or size scope where relevant, intended use and destination market.

• Current specification and instructions for use with document number, revision and approval date.
• Declaration of conformity, applicable certificate and registration evidence, with manufacturer and product identifiers aligned.
• Medical glove reports, chemical permeation, penetration and degradation data, food-contact evidence or other tests required by the brief.
• Labels and packaging artwork showing responsible economic operators, conformity marking, lot, shelf life, warnings and required languages.
• A scope check confirming that one report or certificate has not been extended to an unsupported range, market or intended use.
• A gap log with an owner and decision. Missing mandatory evidence means hold, not approve subject to later paperwork.

A quality-management certificate can support confidence in a system, but it is not a product approval and does not prove that every delivered glove meets your specification. Verify the certificate with its issuer, then test how the controls work in practice.

• Certificate status, site address, activity scope, issuing body and expiry or surveillance position.
• Incoming raw-material controls and formulation or compounding traceability.
• In-process checks for dimensions, weight, visual defects and other approved characteristics.
• Defined lot formation, sampling plan, test methods, acceptance rules and release authority.
• Calibration and maintenance records for relevant inspection and production equipment.
• Nonconformity, corrective action, complaint, return and recall procedures, with anonymised examples where appropriate.

Choose one recent representative lot and trace it in both directions. The supplier should connect the approved specification and purchase order to raw materials, production, testing, release, packing, shipment and customer distribution records.

• Can a carton lot code identify the factory, production period and release record?
• Do inspection results use the same product reference, size, colour and specification revision as the order?
• Can the supplier identify customers or distribution points that received an affected lot where its legal role requires this?
• Are retained samples, record-retention periods and escalation contacts defined?
• Can a mock hold or recall be completed without spreadsheets that rely on one unavailable employee?

Approve a sample as a controlled reference, not as a visual promise. Link it to the product reference, formulation, factory, size, colour, thickness or weight, surface finish and evidence revision that production must follow.

Private-label packaging needs the same discipline. Brand artwork, product claims, barcodes, languages, carton counts and legal-role details should have named approvers and locked revisions before production.

• Golden-sample identity and storage, plus objective measurements that can be reproduced.
• Pre-production and production approval stages, each with acceptance evidence.
• Written notification and buyer approval before changes to formulation, site, process, former, texture, dimensions, packaging, documents or critical subcontractors.
• Rules for assessing whether a change requires new testing, conformity work, labels or customer notification.

Capacity claims should be tested against evidence and the proposed programme, without assuming fixed lead times, minimum orders or stock availability. Ask how the supplier plans, escalates and communicates when demand or logistics change.

• Capacity allocation for the proposed SKU and sizes, including constraints and competing demand.
• Critical raw materials, single-source dependencies, utilities, labour and subcontracted processes.
• Lead-time assumptions by stage, Incoterms, shipping route, customs responsibilities and contingency options.
• Shelf-life remaining at dispatch and receipt, storage conditions and stock-rotation controls.
• Price basis, currency, index or review mechanism, tooling or artwork ownership and exit arrangements.
• Service measures for order confirmation, document turnaround, deviations, complaints and corrective action.

Responsible sourcing needs evidence of risk assessment and follow-through, not a policy document alone. UK government modern-slavery guidance and PPN 009 provide useful due-diligence prompts for organisations in scope, while public buyers should also apply the exclusions and debarment rules relevant to their procurement and jurisdiction.

• Workforce, recruitment-fee, grievance, working-hours and accommodation risks at the manufacturing site and labour providers.
• Supply-chain mapping and risk-based checks beyond the immediate contracting entity.
• Modern-slavery statement or equivalent where applicable, plus evidence of monitoring and corrective action.
• Environmental claims and carbon information tied to defined boundaries, methods and reporting periods.
• For covered public procurement, current exclusion and debarment checks for the supplier and relevant associated, connected or subcontracting parties.

Use a weighted scorecard with mandatory pass-fail gates. Commercial strength cannot compensate for missing product evidence, and a certificate count should not outweigh an unresolved scope mismatch.

• Red flag - product names or references differ across specification, declaration, certificate, report and artwork.
• Red flag - reports are cropped, undated, unverifiable or issued to another manufacturer without a documented relationship and scope.
• Red flag - one medical, PPE or food-contact claim is used as proof of another.
• Red flag - the supplier will not identify the manufacturing site, change-control process or lot-release authority.
• Red flag - samples cannot be linked to the formulation and evidence intended for delivered production.
• Red flag - audit findings close with promises but no root cause, owner, evidence or effectiveness check.

Finish with a controlled decision record that another buyer or auditor can understand without relying on email history.

• Approved supplier, manufacturing site, legal roles and destination markets.
• Approved exact product references, sizes, colours, intended uses and specification revisions.
• Evidence matrix, verified source links and expiry or review dates.
• Open risks, conditions, owners and deadlines, with mandatory gaps clearly marked as blocking.
• Approved sample identity, artwork versions, change-control requirements and incoming-inspection plan.
• Decision authority, review date and triggers for requalification or suspension.