Before you place an order, get clear answers—and written commitments—on five things: whether the manufacturer can make your product at the required volume, how production and delivery will work, how quality and acceptance will be handled, who controls sites and materials, and what happens to costs, designs, and inventory if plans change. Use the questions below to compare suppliers and turn a promising conversation into terms you can verify.
Can the manufacturer make your product at the required volume?
Ask for evidence of relevant experience, not just a general claim that the factory can make your product. Request examples of the same or similar products, the production process and equipment involved, and references or other proof of capability.
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- What quantity can you commit to producing during the proposed production window?
- How much capacity is already booked, and what materials, equipment, or processes could constrain output?
- Which parts of the product or process are new to your team?
The U.S. Department of Commerce’s OTEXA supplier due-diligence guidance identifies recent production of the same or similar products, capacity, timetables, and supplier expertise as relevant capability evidence. It is guidance for a particular trade process, not a universal rule: OTEXA’s FTA Commercial Availability FAQ.
What happens between sample approval and delivery?
Ask for a product-specific schedule that separates development, samples, testing, your approval, material procurement, production, inspection, packing, and shipping. A single “lead time” figure can conceal which steps are included and whose decisions or inputs the schedule depends on.
- What assumptions does each milestone depend on?
- What events could change the dates, and who will notify you if a milestone slips?
- When does the production clock start—for example, after sample approval, deposit, or receipt of materials?
There is no reliable generic lead time for an unspecified product. OTEXA notes that development time varies with product complexity and testing needs, and treats current capacity and standard production timetables as relevant capability evidence. Ask the supplier to put its own schedule and assumptions in writing.
How will quality be controlled and acceptance decided?
Agree on how you will determine whether the delivered product conforms before production begins. Ask the manufacturer to identify the specifications and tolerances that govern, the documented inspection and quality processes used for your product, and who performs in-process and final inspections.
- What tests and inspection records will you receive, and when?
- How will samples, defects, rework, and rejected units be handled?
- What inspection method, defect categories or thresholds, and notification window will apply?
- What remedy applies if an order fails the agreed acceptance criteria?
Put the acceptance procedure in the order or agreement; do not rely on an undefined promise to meet “standard quality.” In U.S. federal procurement, first-article testing and approval can be used to establish whether a contractor can furnish a conforming product. The Federal Acquisition Regulation says decision-makers should weigh its effect on cost and delivery, the risk of omitting it, and less costly quality methods. This is not a general requirement for private buyers. See FAR Part 9 and FAR Part 46.
Does your product need a separate quality agreement?
For drugs subject to current good manufacturing practice (CGMP), FDA’s November 2016 guidance recommends quality agreements that define the parties’ manufacturing activities and responsibilities. Ask which party is responsible for specifications, component-supplier qualification, sampling and testing, equipment and process qualification, material status and inventory control, site operations, audit access, regulatory inspection communications, and escalation of quality problems.
FDA’s guidance is specific to drug contract manufacturing; it should not be treated as a rule for every industry. If your product is regulated, confirm which requirements apply to your product and markets. The guidance is available at FDA’s Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry.
Which factories and subcontractors will work on the order?
Ask for the legal name and location of every factory that will perform a production step, what each site does, and the identity and role of subcontractors or collaborating suppliers. Find out whether the manufacturer can move work or engage a subcontractor without notifying you or obtaining approval.
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OTEXA’s supplier capability review considers information about subcontractors and collaborators. For drug manufacturing, FDA’s guidance says quality agreements should identify manufacturing sites and their contracted services. The relevant sources are OTEXA’s FAQ and FDA’s drug quality-agreement guidance.
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Who owns the design, tooling, and project improvements?
Ask the manufacturer to distinguish technology or processes it already owns from work created for your project. State in writing who owns product designs, drawings, specifications, molds, dies, jigs, fixtures, process documentation, and project-specific improvements.
- Who pays for tooling, where is it stored, and who can access it?
- Can the manufacturer use it for other customers or products?
- Who maintains it, and how will it be returned or transferred if the relationship ends?
- What confidentiality obligations apply to designs, business information, and trade secrets?
There is no universal ownership rule established for tooling or improvements; these are contract terms to negotiate. The U.S. Department of Commerce’s IP guidance is specifically about Pakistan and recommends due diligence and explicit contractual treatment of intellectual property and confidential information. Its country-specific legal observations should not be generalized to other jurisdictions: Pakistan – Protecting Intellectual Property.
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What exactly is included in the quote?
Request an itemized quote so you can compare the full cost and identify what may change. Ask the manufacturer to separate:
- Development and sample charges
- Tooling or setup
- Unit prices at each quoted quantity and the minimum order quantity
- Packaging, testing, and inspection
- Freight and applicable duties
- Recurring fees or other charges
Confirm the quote’s assumptions, currency, payment schedule, deposit and balance triggers, late or cancellation charges, and how extra work must be authorized. Federal procurement rules treat price, other costs, payment terms, quality, testing, and delivery as relevant terms, but they do not establish standard prices or payment terms for private manufacturing orders. See FAR Part 9 and FAR Part 46.
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How will materials and production changes be controlled?
Clarify who buys and approves materials, how substitutions are authorized, how lots are identified and recorded, and how inventory is stored and reconciled. Set a written notice and approval process for changes to materials, processes, equipment, production locations, or subcontractors.
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- How will a shortage, nonconforming input, or quality event be documented and escalated?
- Who can approve a substitute material, and what evidence or testing is required first?
- What records will let you trace materials through production?
FDA’s guidance discusses supplier responsibilities, testing, inventory identification, and material handling for drug manufacturing. Apply those details only where the regulated context fits: FDA’s drug quality-agreement guidance.
Can the manufacturer sustain the relationship?
Verify the company’s identity and ownership as appropriate, its relevant history and references, its financial ability, and who has authority to make commitments. Ask what could disrupt production if the factory loses a key customer, faces a capacity interruption, or depends on a sole-source component.
The U.S. Department of Commerce’s commercial guidance for U.S. firms operating in New Zealand recommends checking a partner’s identity, financial ability, and capacity to deliver over the contract’s life. Its market context is country-specific, but those are useful diligence questions elsewhere too: New Zealand – Distribution & Sales Channels.
What happens if the order goes wrong or the relationship ends?
Write down procedures for late delivery, failed samples, out-of-spec production, rework, replacement, credits or refunds, cancellation, force majeure, and dispute resolution. Specify notice and cure periods, who owns and returns tooling and inventory, how records transfer, and how confidential information is handled or destroyed. Have counsel review the agreement in light of the governing law and the markets involved. The applicable remedies depend on the transaction and jurisdiction; the sources here do not establish one set of terms for every private order.
How should you compare manufacturers?
Use the same questions and evidence requests for each supplier. Compare their answers against the order you actually need, not just their headline price.
| Decision area | What to compare |
|---|---|
| Capability | Relevant product and process experience, evidence of past work, and committed capacity for your quantity |
| Schedule | Milestone detail, dependencies, and credibility of the production and delivery plan |
| Quality | Inspection and test records, specifications, and a workable acceptance and remedy process |
| Production visibility | Named facilities and subcontractors, material sources, and change-control commitments |
| Commercial terms | Total landed cost, quote assumptions, payment exposure, and authorization of additional work |
| Protection and exit | Written treatment of IP, tooling, defects, changes, inventory, and termination |
For covered U.S. federal procurements, the FAR identifies financial and technical ability, quality, cost, and delivery among relevant considerations. Those rules govern federal acquisition, not every commercial order: FAR Part 9 and FAR Part 46.
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