A product safety management program is an organizational structure that encourages good import practices. Such a structure typically includes clearly defined job functions and responsibilities; established procedures, including those for oversight and quality systems; adequate training for personnel; and appropriate communication mechanisms.
Recommended elements in a product safety management program include:
- Establishing a clear management structure for product safety;
- Assigning responsibility for product control and compliance to specific individuals;
- Ensuring that the assigned individuals have the necessary training, knowledge, experience, skills, and competence to perform product compliance and control responsibilities;
- Maintaining appropriate control activities by having clearly documented policies, specifications, and procedures to ensure product safety; also, maintaining records to demonstrate how compliance with requirements was achieved;
- Establishing a process to analyze and evaluate risks in the product life cycle and developing an approach to control those risks appropriately;
Developing and maintaining a communication system that allows the sharing of relevant information on safety and compliance within the organization and, where appropriate, with third parties, including federal, state, and local authorities; and
- Establishing a formal, documented quality-assurance program to control, monitor, and improve operations continually to ensure the safety of products and compliance with all applicable requirements.
Know the Product
Knowing the product means knowing the applicable regulatory requirements (including those in the countries of production) and the compliance history of the products and the firms involved in the products’ design, production, and handling. For some products, a great deal of knowledge is needed to ensure compliance. Typical areas of expertise include:
- The product’s packaging, size, quantity, quality, composition, specifications, and specific safety concerns.
- Whether the product has been manufactured for commercial distribution in the United States. If not, the product may never have been intended to meet U.S. requirements.
- Knowledge of whether any firm or individual involved in the product’s life cycle has previously experienced product-safety problems, including in their resident countries. An importer should find out about the firm’s reputation through available public-source information or interviews with other customers of the firm.
- Ownership of the firm. For example, is the firm a subsidiary of a larger company, and will the importer have recourse against the parent company if the subsidiary defaults on its obligations?
- Familiarity with the relevant U.S., foreign, and international organizations, such as trade associations, that can alert the importer to emerging problems with the imported products.
- Whether the product was or could have been exposed to pesticides, other chemicals, or contaminants or improper storage conditions during its growth, harvesting, manufacture, processing, packing, receipt, transportation, storage, importation, or distribution and, if so, whether those circumstances could affect compliance and/or product safety.
Verify Life-Cycle Compliance
An importer should ensure that the product complies with all applicable U.S. requirements, that all foreign firms responsible for manufacturing/producing the product are also compliant with U.S. requirements applicable to that product and its producers, and that the foreign firms have appropriate preventive controls in place to ensure the product is safe. If there are gaps, the importer should work with the foreign firms to ensure that those firms develop appropriate controls at critical points, monitor those points, and periodically evaluate them to make certain they are effective. Moreover, the importer’s responsibility could continue after the product has moved into distribution within the United States.
Specific recommendations include:
- Know which preventive controls, if any, must be instituted at each critical point in the product’s life cycle and the steps that must be taken to ensure that those controls are being appropriately applied so that the product is safe for end users.
- Obtain a written guarantee of product compliance from company representatives, if appropriate, based on consideration of the risks associated with noncompliance and other conformity-assessment procedures employed. Insist on compliance with U.S. requirements in the purchasing contract, and impose remedies if the firm sells you noncompliant products for export to the U.S. Be as specific as possible about safety requirements.
- Ask appropriate questions if there are unusual aspects of the product’s history or transportation route to its final destination, such as: Did the product take an atypical route to get to the United States? Is it from a country that does not ordinarily supply that product? Is the price for the product much lower than expected? Is there evidence another country or firm rejected it? Is it entering through a port through which it does not ordinarily enter?
- Obtain guarantees or certifications subject to substantiation, if appropriate, that products vulnerable to moisture, contaminants, temperature, or other environmental conditions have been maintained under acceptable conditions during transit.
- Consider using a licensed customhouse broker who is knowledgeable and trained and understands the critical nature of accurately filing information to help ensure the accuracy and timeliness of your import filing.
- Establish procedures for the routine review and handling of safety complaints from consumers and customers to help ensure that safety problems are identified and addressed quickly.
Take Corrective and Preventive Action
Procedures should be in place to identify problems before a product reaches consumers. The importer should then have and execute corrective and preventive measures to ensure similar problems do not recur. Recommended actions include:
- Establishing procedures for developing corrective action plans and for taking corrective and preventive actions if noncompliance with a U.S. requirement or a safety concern should occur.
- Identifying and investigating the root causes of noncompliance with U.S. requirements for imported products and by foreign firms with which the importer does business.
- Taking steps to remediate and prevent harm from present and future shipments and ensure that noncompliance and safety problems do not recur. Measures may include product relabeling, product reworking or further processing, product export or destruction (if the violative product is already at a U.S. port-of-entry or in U.S. commerce), or a decision not to offer the product for entry into the United States.
The agencies’ Good Importer Practices is at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125805.htm.