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Repair common Windows errors and clear accumulated junk for a smoother, more stable PC - no reinstall needed.Free scan · no reinstallBefore you place an order, confirm that the manufacturer can make your product at your required volume, show a credible path from approved sample to delivery, and agree in writing on quality, costs, changes, intellectual property, and remedies. Ask for evidence—not just assurances—and make the answers part of the quote, purchase order, or manufacturing agreement.
The questions below are a practical diligence checklist, not a universal legal standard. Requirements vary by product, sales market, and governing law. FDA drug-manufacturing guidance and U.S. federal procurement rules apply only in their respective contexts.
1. Can you make this product at the required volume?
Ask for evidence that the factory has made the same or a similar product using the relevant process. Then establish whether it can commit capacity during your production window—not merely whether it has made that quantity at some point before.
- Which equipment and processes will be used, and where?
- What quantity can you commit to producing during the proposed window?
- How much capacity is already booked, and what materials or processes could constrain output?
- Can you provide relevant references or other evidence of your experience?
The U.S. Department of Commerce’s OTEXA supplier-capability guidance treats recent experience with the same or similar product, capacity, timetables, and expertise as relevant diligence. It is guidance for a specific trade process, not a universal rule for private buyers: OTEXA FTA Commercial Availability FAQ.
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2. What happens between sample approval and delivery?
There is no dependable generic lead time for an unspecified product. Ask the manufacturer for a product-specific schedule with separate estimates for development, samples, testing, your approval, material procurement, production, inspection, packing, and shipping.
- What assumptions does each milestone depend on?
- Which events could move the dates, and who must notify you if they do?
- When does the production clock start—for example, after sample approval, deposit, or receipt of materials?
- Are shipping dates estimates or commitments, and what happens if a milestone slips?
OTEXA notes that development time depends on product complexity and testing needs, and identifies capacity and standard production timetables as relevant capability information. Ask for the supplier’s own schedule and assumptions in writing rather than relying on a generic industry estimate: OTEXA FTA Commercial Availability FAQ.
3. How will quality and acceptance be defined?
Agree on what “conforming” means before production begins. A quality promise is not a usable acceptance process unless the specifications, inspection method, records, deadlines, and remedies are clear.
- Which drawings, specifications, tolerances, and approved samples govern?
- What documented quality and inspection processes apply to this product?
- Who performs in-process and final inspection, and what test or inspection records will you receive?
- How will samples be approved, and can the manufacturer proceed without written approval?
- How are defects categorized, reported, and handled—including rework, replacement, rejection, or credit?
- How long do you have to inspect and notify the manufacturer after delivery?
For a U.S. federal procurement, first-article testing and approval can help establish that a contractor can furnish a conforming product. Federal Acquisition Regulation (FAR) guidance says decision-makers should consider its effects on cost and delivery, the risk of omitting it, and less costly quality methods. It is not a general requirement for private orders. Federal quality-assurance requirements vary with the acquisition: FAR Part 9 and FAR Part 46.
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4. Who is responsible for each quality activity?
For drugs subject to current Good Manufacturing Practice (CGMP), FDA guidance recommends a quality agreement that delineates each party’s manufacturing activities and responsibilities. Ask which party owns each relevant task, including:
- Specifications and component-supplier qualification
- Sampling, testing, and material status or inventory control
- Equipment and process qualification and site operations
- Audit access and communication about regulatory inspections
- Escalation and documentation of quality problems
The FDA guidance is specifically for drug contract manufacturing; it should not be treated as a rule for unrelated industries. It states that an agreement should allow owners to evaluate and audit contract facilities for CGMP compliance in the operations performed: FDA, Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry.
5. Which facilities and subcontractors will handle the order?
Get the legal name and location of every production site, the operation performed at each, and the identity and role of subcontractors or collaborating suppliers. Ask whether the manufacturer may change a site or subcontractor without notice or your approval, and specify the required notice and consent process.
OTEXA’s capability review includes information about subcontractors and collaborators. FDA drug-quality guidance likewise discusses identifying manufacturing sites and their contracted services. These sources support asking for visibility; the FDA guidance applies in its drug-manufacturing context: OTEXA FAQ and FDA quality-agreements guidance.
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6. Who owns the design, tooling, and project-specific improvements?
Separate what the manufacturer already owns from what is created or purchased for your project. Put ownership, permitted use, access, maintenance, and transfer terms in writing.
- Which pre-existing technology, processes, or materials does the manufacturer bring to the project?
- Who owns the product design, drawings, specifications, process documentation, and project-specific improvements?
- Who pays for molds, dies, jigs, and fixtures, and who owns them?
- Where will tooling be stored, who can access it, and may it be used for other customers?
- How will tooling and records be maintained and returned or transferred when the relationship ends?
- How will confidential information and trade secrets be protected, used, and handled at termination?
There is no universal tooling-ownership rule established here; these are terms to negotiate. The U.S. Department of Commerce’s intellectual-property guidance for Pakistan recommends due diligence and explicit contractual treatment of IP and confidential business information. Its observations about local law and enforcement are country-specific, not a basis for generalizing to other jurisdictions: Commerce Department guidance on protecting intellectual property in Pakistan.
7. What exactly is included in the quote?
Request an itemized quote so you can distinguish the unit price from development costs, setup, and delivery expenses. Ask the manufacturer to identify assumptions that could change the price.
- Sample and development charges; tooling or setup costs
- Unit prices by quantity and minimum order quantity
- Packaging, testing, inspection, freight, and applicable duties
- Recurring fees or other charges not included in the unit price
- Payment currency, schedule, deposit, and balance triggers
- Late, cancellation, or change charges, and how extra work must be authorized
Federal procurement rules recognize price and other costs, payment terms, quality, testing, and delivery as relevant acquisition terms, but do not establish standard private-market prices or payment schedules. For a commercial order, negotiate and document your own terms: FAR Part 9 and FAR Part 46.
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8. How are materials and production changes controlled?
Clarify who buys and approves materials, how substitutions are authorized, and how material identity and inventory are tracked. Define advance notice and written approval requirements for changes to materials, processes, equipment, production location, or subcontractors.
- How are shortages, nonconforming inputs, and quality events reported and documented?
- How are material lots identified, stored, and reconciled?
- Can the factory substitute a material or supplier without your approval?
- How are changes assessed for their effect on specifications, testing, schedule, and cost?
FDA drug-manufacturing guidance discusses component-supplier responsibilities, testing, inventory identification, and material handling. Apply those specific regulatory details only if the product and arrangement fall within that context: FDA quality-agreements guidance.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.9. Can the manufacturer sustain the relationship?
Verify the company’s identity and relevant history, speak with references, and establish who has authority to commit the factory to price, capacity, and schedule. Where appropriate to the size and risk of the order, assess its financial ability to perform over the contract term.
- What happens to your order if the factory loses a key customer or has a capacity disruption?
- Does production depend on a sole-source component, process, or subcontractor?
- What backup or recovery plan exists for a disruption?
The Department of Commerce advises U.S. firms evaluating a partner in New Zealand to confirm identity, financial ability, and capability to deliver over the contract life. That guidance is market-specific, though the diligence questions can be useful elsewhere: Commerce Department guidance on New Zealand distribution and sales channels.
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10. What happens if the order fails or the relationship ends?
Write down the process for late delivery, failed samples, out-of-spec production, rework, replacement, credits or refunds, and cancellation. Define notice and cure periods, any applicable force-majeure process, and how disputes will be handled under the agreement’s governing law.
Also specify what happens to paid-for inventory, work in progress, tooling, and production records at termination, and how confidential information will be returned or destroyed. The appropriate remedies and enforceability depend on the transaction and jurisdiction; have counsel review the agreement for the relevant governing law and sales markets. The cited sources do not prescribe remedies for every private manufacturing contract.
How to compare manufacturers
Compare evidence and written commitments, not confidence or the lowest quoted unit price alone. A useful scorecard is:
- Relevant experience with the same product and process
- Capacity committed for your required quantity and production window
- Specificity and credibility of the sample, production, and delivery schedule
- Inspection records and a workable acceptance procedure
- Visibility into sites, subcontractors, and material sources
- Total landed cost and payment exposure
- Willingness to document IP, change control, defect handling, and exit terms
FAR procurement rules consider factors such as technical and financial ability, quality, cost, and delivery in covered federal acquisitions. They do not govern every commercial order, but those categories offer a useful framework for comparing suppliers: FAR Part 9 and FAR Part 46.
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