As a manufacturer or product designer, a primary goal is to make a high-quality product that is reliable and functions as intended for customer use. But just as important, you are also responsible for ensuring that your product is safe for customer use. If this goal is not met your product could ultimately cause product related accidents, recalls and subsequent lawsuits, which may have a significant impact on revenue and profits.
An effective approach to creating a safe product is by incorporating a comprehensive product safety management program throughout your product’s life cycle. An effective product safety management program can help reduce accidents and recalls, and provide a more defensible product in the event of litigation.
There are several steps involved in a product safety management program: one important and fundamental step is compliance with industry product safety standards. Product safety standards are meant to be a guide for incorporating proven methods of safety into your product design. They aid in promoting consistency not just in your operations, but within your entire industry.
This article will highlight the reasons compliance with product safety standards are important by understanding the types of compliance standards, benefits and limitations of compliance, as well as guidance on incorporating standards within your organization.
What are standards?
In general, a product standard describes a guide for a characteristic of a product or process, that, if adhered to, promotes a higher quality of that product or process.
Types of product safety compliance standards
There are two main categories of standards in product safety compliance: mandatory and voluntary. Mandatory standards are issued by federal, state, county, or municipal governments. Generally, there is no option for non-compliance with mandatory standards. Non-compliance with mandatory standards may result in criminal or civil penalties.
Voluntary standards are consensus standards that are prepared by representative companies from the industry where the standard will be applicable, or by voluntary standards organizations (such as the American Society for Testing and Materials [ASTM] or the American National Standards Institute [ANSI]). Government and consumer groups may also be involved in the preparation of a voluntary standard. Although compliance with these standards is voluntary, they are frequently used as the basis for expert testimony in court as to what is customary in industry.
In general, a key difference between the two types of compliance standards is mandatory standards are the lowest safety level the government will accept, and voluntary standards are the lowest safety level an industry intends to meet. Regardless of the impositions that compliance with product safety standards present, manufacturers may find many benefits in such compliance.
Benefits of compliance with product safety standards
Compliance with product safety standards can be beneficial in many ways. One of the most important benefits is the introduction of previously evaluated methods of safe design. Generally, product safety standards are created to avoid the recurrence of accidents or the presentation of hazards associated with similar products. These standards take the guess work out of deciding which safety measures or methods to incorporate in product design and manufacturing.
Additional benefits of complying with product safety standards are as follows:
- Promotes consistency and an accepted practice across an industry.
- Promotes a basic level of safety and dependability.
- Reduces the possibility of accidents.
- Reduces the possibility of liabilities and lawsuits.
- May be a viable defense in a product liability lawsuit.
- Promotes proper adherence to laws, codes, and other legal criteria.
As noted, there are several benefits that compliance with product safety standards offer; however, compliance also offers some limitations.
Limitations with standards compliance
Compliance with product safety standards does come with a few limitations; and some of these limitations may also depend on the type of standard. One of the most important limitations to consider is that compliance with a product safety standard may not fully absolve you of liability resulting from a product-related accident or claim. As mentioned previously, compliance with product safety standards is just one step in a product safety management program.
Another key limitation, which is primarily centered around the core process in voluntary standards, is the fact that they are consensus standards generated by industry representatives. In most cases, consensus standards may only promote the lowest levels of acceptance members of that industry intend to meet or what they feel is economically justified. As a result, some voluntary standards may not incorporate all the desired product safety design requirements needed.
Finally, as a manufacturer, the courts will likely hold that you must be an expert about your product. The key is understanding whether the standard, mandatory or voluntary, establishes that a duty or standard of care was exercised for you as the manufacturer. A duty of care is the basis for negligence, which is conduct that falls below the standards established by law for the protection of others against unreasonable risk of harm. It is the basis for most product-safety related litigation.
Due diligence must be exercised to ensure that all known or foreseeable hazards are controlled to an acceptable level even if not emphasized or identified in the associated standards. It is best to know all the requirements set by the applicable product safety standards and any good engineering practices that change with the state-of-the-art.
Guidance on incorporating standards
Product safety standards should be an integral part of your product safety management program. As highlighted above, product safety standards are meant to be a guide, practice or set of characteristics for safe product design. Below are few tips to consider when incorporating product safety standards:
- Determine what standards are applicable to your product; whether the standards are mandatory or voluntary, and incorporate the standard requirements into the product design.
- Review voluntary standards for product safety adequacy and make improvements if necessary.
- Test and inspect products for conformance with standard requirements.
- For new state-of-the-art products, a formal exemption or waiver should be considered if mandatory requirements don’t meet the desired safety level needed.
- Always monitor and review product safety standards activity, as it relates to your products, for new standards under development, or standard revisions.
- Have a program that documents all practices and procedures.
- For assistance with locating various standards, the American National Standards Institute (ANSI) offers an online database for standards that have been referenced in the US Code of Federal Regulations (CFR), IBR Standards Portal.
- American National Standards Institute (ANSI). (2021, September 7). Resource: Glossary. Retrieved from StandardsPortal.org, A Resource for Global Trade: https://www.standardsportal.org/usa_en/resources/glossary.aspx#Definitions.
- Hammer,W. (1993). Product Safety Management and Engineering Second Edition. Des Plaines, IL: American Society of Safety Engineers.
- International Organization for Standardization (ISO) and Internal Electrotechnical Commission (IEC). (2004). ISO/IEC Guide 2: 2004, Standardization and Related Activities-General Vocabulary. Geneva: CH: ISO.
- Negligence: Background. (2018, November 29). Retrieved from https://wwwfindlaw.com: https://www.findlaw.com/injury/accident-injury-law/negligence-background.html.
This material is provided for informational purposes only and does not provide any coverage or guarantee loss prevention. The examples in this material are provided as hypothetical and for illustration purposes only. The Hanover Insurance Company and its affiliates and subsidiaries (“The Hanover”) specifically disclaim any warranty or representation that acceptance of any recommendations contained herein will make any premises, or operation safe or in compliance with any law or regulation. By providing this information to you, The Hanover does not assume (and specifically disclaims) any duty, undertaking or responsibility to you. The decision to accept or implement any recommendation(s) or advice contained in this material must be made by you.