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Manufacturing Best Practices

Regulatory Robot: What requirements apply to my product?

In addition to meeting the legal requirements described on the Business Education page, you ─ as a manufacturer or importer ─ should take additional steps to ensure that your product not only meets or exceeds the requirements of federal safety laws, but also is designed and manufactured as safely as possible. Here is a brief outline of some of our recommendations, including links to additional in-depth resources: (Footnote: This document is not a list of mandatory CPSC requirements but rather is a list of best practices and suggestions by the CPSC Small Business Ombudsman.)

  • Practice Safety by Design
  • Build Safety in your Supply Chain
    • Draft product specifications that detail the portions required for safety and compliance, especially concerning materials used in children’s products.
    • Use suppliers who can reliably and consistently provide compliant materials and subassemblies.
    • Exercise due care in relying on your supplier by taking affirmative steps like including contractual provisions specifying material usage, visiting applicable factories, or spot-checking products for ongoing compliance with safety requirements.
  • Be Knowledgeable and Aware of the Business and Regulatory Environment
    • Review consumer feedback and assess the safety of your product in light of the information provided to your company through customer service calls, online consumer reviews, and by monitoring feedback about your product provided to CPSC by consumers using SaferProducts.gov, CPSC’s publicly searchable consumer database.
    • Study your legal responsibility to report information about your product that indicates (i) it may fail to comply with CPSC requirements, (ii) it is defective and could create a substantial risk of injury, (iii) is otherwise unreasonably hazardous or dangerous, or that the product is subject to reporting for the legal reasons more fully outlined here.
    • Monitor recalls of products similar to yours through e-mail notification, SaferProducts.gov, Recalls.gov, X (formerly Twitter), our RSS feed.
    • Keep up with the CPSC’s new and updated regulations through e-mail notification and X (formerly Twitter).
  • Be Prepared
    • Have a recall plan in place should you need to act quickly.
    • Consider the use of lot or batch controls to identify products that may be subject to a recall and that could help identify those specific units affected by the noncompliance and/or product safety issue.
  • Document, Document, Document
    • Document the work you’ve done toward complying with CPSC’s requirements and with adhering to the recommendations above.
    • In the event of a product recall, having documentation will allow CPSC to work with you to understand the efforts you made to achieve safe consumer goods and what may have gone wrong.
    • Documentation can also help identify actions to take to ensure future safety and compliance and to avoid additional recalls or other expensive remediation actions.
  • Challenge Yourself to Manufacture the Safest Possible Consumer Product
    • Go above and beyond the mandatory and voluntary standards to make sure that the product is designed as safely as possible.
    • Seek an outside perspective to assist you in honestly appraising the safety and possible consumer uses (and misuses) of a product.
    • Always strive to improve the safety of your products. The safety culture of your company is critically important; strive to maintain a culture that emphasizes and values product safety and compliance with CPSC safety requirements.

Safety by Design

A safe product begins in the design stage. A thoughtful design analysis should identify potential hazards and assess the risks; the analysis should include foreseeable consumer use (and misuse) of the product.

Designers should then seek to eliminate the risk, guard against risk, or warn users of identified risks, in that order. This “safety hierarchy” is a recognition that the safest approach to eliminating risk is to perform a redesign which removes the hazard. If redesigning is not feasible, then the next best approach is to employ a guard or barrier to separate the user from the hazard. And if a guard is not feasible, then the next step is to use a warning. In communicating to consumers how to properly use your product, you should review CPSC’s Manufacturers Guide to Developing Consumer Product Instructions.

When designing your product, you should become familiar with any applicable mandatory standards, along with any voluntary standards that may apply to your consumer product.

There are thousands of voluntary standards in existence and one or more may be applicable to your consumer product. If you are designing a new product in a new product category, although a voluntary safety standard that directly addresses your product may not exist, standards for similar products may be relevant. While some voluntary standards have not been adopted or relied upon by CPSC as mandatory standards, CPSC staff strongly encourages manufacturers to study and comply with the relevant portions of these voluntary standards, if possible. Many manufacturers consider voluntary standards to be a safety floor and they strive to meet and exceed those standards. The guidance and expertise contained in these standards may be extremely valuable to newer designers and manufacturers entering a market. Voluntary standards are technical documents, which are based on the considered judgment and years of experience of other manufacturers, designers, and safety experts who have spent a great deal of time considering a product category.

You can learn more about finding and purchasing voluntary standards here. The page also provides a listing of voluntary standards activities in which CPSC staff currently participates.

See CPSC and Health Canada’s Guidance on the Application of Human Factors to Consumer Products for ideas on how to integrate human factors principles into your product development process.

In addition to CPSC’s free Handbook for Manufacturing Safer Consumer Products, an international voluntary standard is available for purchase that can help you in this process: ISO 10377:2013 “Consumer product safety -- Guidelines for suppliers”. This guidance is intended for “suppliers,” meaning manufacturers, and has valuable advice for manufacturers, including sections on “Safety in design,” “Safety in production,” and “Safety in the marketplace.”

Safety in your Supply Chain

In assessing your supply chain, you should be familiar with CPSC’s requirements on material change testing, periodic testing, and component part testing.

You should be prepared to work closely with your suppliers to make sure they are producing compliant and safe products for your company. You should draft product specifications detailing the relevant portions required for safety and compliance, especially those concerning materials used in children’s products. Use suppliers who can reliably and consistently provide compliant materials and subassemblies. And, in an increasingly global supply chain where you may often not know your supplier, the supplier’s reputation, or track record, you should consider taking extra precautions to protect the integrity of the incoming materials into your supply chain and your finished product. Your diligence efforts may include using contractual provisions specifying the use of certain materials, supply chain best practices, like Carter’s “10 Cs of Supplier Evaluation" model[1] to match your needs with a supplier’s capabilities, and checking CPSC’s public list of firms that have been sent a letter of advice relating to noncompliance with CPSC requirements.

You should be cautious, exercise due care, and take affirmative steps to make sure that the materials in your supply chain meet your performance criteria and meet applicable performance and chemical requirements. Neglecting to specify the use of specific component parts in your contract or leaving yourself vulnerable to unauthorized raw material substitutions through inadequate controls may subject you ─ as a manufacturer or an importer – to the risks associated with defective, unsafe or noncompliant products. The manufacturer and importer are considered to be the responsible parties for compliance with federal product safety laws.

Be Knowledgeable and Aware of the Business Environment

Monitoring news and recalls in your industry can give you an excellent sense of the issues your industry faces. CPSC will expect you, as a business, to be fully conversant in the issues and concerns facing your industry. You should review CPSC’s recall listings, which may be searched by “Product Type” and can provide useful information about CPSC recalls relating to products similar to yours. You should consider signing up for our recall emails. You should review and understand those recalls so that your company doesn’t make the same mistakes.

Monitoring safety reports about your products and similar products in the marketplace also can help provide useful information. You can obtain this type of information by monitoring direct consumer feedback, information from your retailers, information from consumer online reviews and e-tailers, and consumer reports on our publicly searchable database of consumer reports of harm at www.SaferProducts.gov.

We are required to post certain reports of health or safety claims at www.SaferProducts.gov. Businesses have an opportunity to comment on these reports under the law, and registration on SaferProducts.gov will allow us to send you a secure, electronic notification, providing you more time to consider the report and any response that you may wish to make. In addition, www.SaferProducts.gov is a valuable resource for you to monitor the types of hazards, if any, being reported about your product and your brand.

Be Prepared

Experts have shown that one of the best ways to improve the effectiveness of a product recall is to have a recall plan in place and to execute the plan as quickly as possible. A well-thought out, well-executed recall plan can save lives, prevent injuries, and limit damage to your company’s brand and bottom line.

Here is CPSC’s Web page about recall planning. This voluntary standard can also help you develop a plan: ISO 10393:2013; Consumer product recall -- Guidelines for suppliers.

Document, Document, Document

Document the work you have done toward complying with CPSC’s requirements and with following the recommendations above. In the event of a product recall, having documentation will allow CPSC to work with you to better understand the efforts you made to achieve safe consumer goods and what may have gone wrong. Having documentation may demonstrate to us that you took reasonable efforts to produce a safe and compliant product and allow us to work together with you to conduct a successful recall. Documentation is also important to demonstrate compliance with CPSC’s requirements on periodic and material change testing. Lack of documentation may raise questions about the efforts (or lack thereof) you made toward producing safe and compliant products. Adequate documentation can also help identify what actions to take to prevent a recurrence of the conditions that led to the unsafe or noncompliant product.

Challenge Yourself to Manufacture the Safest Possible Consumer Product

You should consider these suggestions above in designing and manufacturing your product to meet or exceed the highest product safety standards.

You should go above and beyond minimum requirements to make sure that the product is designed as safely as possible, that it uses raw materials and component parts that are safe, that you’ve established a reliable supply chain, and that you have considered the foreseeable consumer uses (and misuses) of your product when designing and manufacturing your product. Remember that it is often difficult for a product’s creator to honestly appraise the potential safety hazards and possible consumer misuses of a product. You may consider retaining outside engineers and/or failure analysis firms to work with you into considering the possible hazards that could be associated with your product. At a minimum, you should seek out someone with consumer products safety experience to serve as a “devil’s advocate” in vetting your idea for possible safety hazards.

Strive to build safety into your company culture, your company’s policies and procedures, and into the products that you sell to your customers.

Consult CPSC’s Handbook for Manufacturing Safer Consumer Products for further guidance and best practices.

Ask questions of CPSC’s Small Business Ombudsman if you have further questions about CPSC product safety requirements and your product.

CPSC staff is committed to providing its business stakeholders with accurate, timely, and useful guidance. If you have further suggestions about how we could do better (or have located an error), please contact us.

This document has been prepared for general informational purposes only. This communication contains an interpretation by CPSC staff and is based solely on the information currently available to the staff and the enforcement posture the CPSC staff currently has in effect. The interpretation could be changed if the facts change, and could be changed or superseded by the Commission. This communication does not, and is not intended to, constitute legal advice and has not been reviewed or approved by the Commission, and does not necessarily represent their views. This overview is not intended to replace or supersede any sections of federal law.

In the case of any discrepancies between this overview and federal law, federal law will supersede this overview. The Ombudsman does not serve as an office of legal notice for the agency nor does the Ombudsman address matters already in litigation. The Ombudsman has no authority to delay any statutory, regulatory, or other CPSC deadlines, or make decisions or legal determinations for the CPSC. Any views expressed in this communication may be changed or superseded by the Commission.

[1] Carter’s 10 Cs is one of many supply evaluation models available. The 10 Cs are:

  1. Competency.
  2. Capacity.
  3. Commitment.
  4. Control.
  5. Cash.
  6. Cost.
  7. Consistency.
  8. Culture.
  9. Clean.
  10. Communication.

'The Journal of Purchasing and Supply Management,' Carter, R., 'The Seven C's of Supplier Evaluation,' 44-46, © Elsevier (1995).

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