ANSI Z535.6 and How To Create Compliant Manuals for the US
This article was originally published in ISTC Communicator, Autumn 2016.
In this article, I will show you how I create compliant user manuals for the US market. And I am able to do this based on or simultaneously with the European documentation, with a minimum of extra time and effort. With this method, which also includes parts of the ANSI Z535.6, you can do exactly the same. I will outline the strategy in detail.
How to use the U.S.er-Manual-Method to achieve compliance
Using the method, which I have named the U.S.er-Manual-Method, will give you the following benefits. You will:
- get an idea of how product compliance and product safety in the US is organised.
- know how to find out which products are regulated/non-regulated in the US.
- be seen within your company, as an expert on the US market.
- know how to warn for product risks.
- know which standards to use for creating user instructions.
- know which standard to use for safety messages.
- know how to use the ANSI Z535.6
- be able to create compliant manuals for the US market.
- be able to create better documentation for the European market, which can be easily adapted to compliant documentation for the US market
Let’s break it all down into actionable steps.
The 8 steps to using the U.S.er-Manual-Method to drawing up compliant manuals
There are eight steps in the U.S.er-Manual-Method:
- Identify the applicable acts, laws, and regulations for your product.
- Identify the competent federal agencies for your product.
- Identify which standards are mandatory for your product.
- Identify which standards are voluntary for your product.
- Identify the minimum specific requirements for adequate instructions.
- Verify the product-specific requirements from both the voluntary and mandatory standards.
- Implement ANSI Z535.6
- Write the instructions (and other technical documentation) according to the requirements.
Step 1: Identify the applicable acts, laws, and regulations for your product.
Product safety in the US is regulated by various federal agencies.
Once Congress has enacted a product safety law, the appropriate federal agency (for example, the Consumer Product Safety Commission, the Federal Trade Commission, the National Highway Traffic and Safety Administration, et al.) may create the regulations or rules to implement the law.
Together, the enabling acts and laws and the final regulations provide a framework for the implementation and enforcement of most federal laws in the United States.
To identify the applicable acts, laws and regulations for your product:
- Go to www.usa.gov/laws-and-regulations
- Have a look around to learn about some of the best-known U.S. laws and regulations
- This step is not mandatory to create compliant manuals, but contributes to a better understanding of product safety legislation in the US.
- The European equivalent to identify laws and regulations is http://eur-lex.europa.eu
Step 2: Identify the competent federal agencies for your product.
The different US Federal Agencies regulating products and situations are divided into the following main groups: Health/Body, Vehicles/Vehicle-Related Products, Hazards/Safety/Firearms, and Other.
The Health and Body group oversees agencies that cover alcohol, tobacco, food, and cosmetics. Vehicles is the watchdog for categories such as aircraft, automobiles, watercraft, amusement park rides, and child car seats. Hazard-Safety-Firearms covers the agencies that administer ammunition, radioactive materials, commercial and industrial products, and more.
The nature and characteristics of the product or situation determine which Federal Agency is involved. An important federal agency, when it comes to consumer product safety, is the US Consumer Product Safety Commission (CPSC).
The goal of the CPSC is to provide consumers protection against any unreasonable risk of life-threatening injury (or death) from products under its jurisdiction. The CPSC has jurisdiction over thousands of types of consumer products used at home, in schools, in recreation, or otherwise. This includes products that may create an electrical, mechanical, fire, or chemical hazard or any products that may be injurious to children including power tools, household chemicals, cigarette lighters, toys, children’s clothing, and cribs.
The Consumer Product Safety Act (CPSA) was passed in 1972 and the act established the CPSC. In that law, Congress directed the Commission to “protect the public against unreasonable risks of injuries and deaths associated with consumer products”.
In addition to the CPSA, the Consumer Product Safety Improvement Act (CPSIA) of 2008 is a United States law imposing new testing and documentation requirements. The CPSIA establishes updated levels for some substances and changes the requirements for manufacturers of the products that the CPSIA covers.
CPSC attempts to achieve the goal to protect the public against unreasonable risks of injuries and deaths associated with consumer products through education, (mandatory) safety standards activities, developing and publishing regulations, enforcement of the statutes and, if necessary, banning products.
To collect the necessary information on the legal requirements applying to your product, first make sure you know which jurisdiction your product is to be marketed and then which federal agency or federal agencies is/are responsible.
To identify the competent federal agencies for your product:
- Go to www.cpsc.gov/en/Regulations-Laws--Standards/Regulations-Mandatory-Standards-Bans
- Check the list of Regulated Products to make sure if your product is in CPSC's jurisdiction.
- Go to www.cpsc.gov/en/Regulations-Laws--Standards/Products-Outside-CPSCs-Jurisdiction
- Check the list of Federal Agencies to find out if your product is in another jurisdiction.
- If you know the jurisdiction but your product is not on the lists of regulated products, you most likely market an unregulated product. Unregulated products do not have standards or bans.
- For all unregulated products you must report defective or dangerous products.
Step 3: Identify which standards are mandatory for your product.
When Congress has enacted a law, the federal agencies often develop or use existing standards to implement the law.
Section 102 of the CPSIA requires every manufacturer or importer of consumer products that must comply with the rules set forth by CPSC to create certificates stating the product is in compliance with each regulation, standard, or ban.
Product specific standards may include requirements regarding the instructions for use.
To identify which standards are mandatory for your product:
- Go to the website of the relevant federal agency (for example, www.cpsc.gov)
- Navigate to the page with the overview of mandatory Standards (for example, www.cpsc.gov/en/Regulations-Laws--Standards/Regulations-Mandatory-Standards-Bans)
- Click on the link to more information about your product (for example, for Toys, find Toys, mandatory standard in the left column. Click on the hyperlink in the right column. The following page opens: www.cpsc.gov/en/Business--Manufacturing/Business-Education/Toy-Safety)
- See which standard is mandatory (for example, the toy safety standard, ASTM F963-11).
- Whereas standards in the EU as a rule are voluntary, they can be mandatory in the US. Mandatory standards in the US are free available.
Step 4: Identify which standards are voluntary for your product.
Voluntary standards can provide product-specific requirements regarding instructions. Standards are voluntary unless “Incorporated by Reference” in a regulation.
To identify which standards are voluntary for your product:
- Go to the website of the relevant federal agency (for example, www.cpsc.gov)
- Navigate to the page with the overview of voluntary Standards (for example, www.cpsc.gov/en/Regulations-Laws--Standards/Voluntary-Standards)
- Click on any relevant link to more information about voluntary standards for your product (for example, for Toys click on the hyperlink Toys. The following page opens: www.cpsc.gov/en/Regulations-Laws--Standards/Voluntary-Standards/Topics/Toys)
- See which standards are voluntary.
Step 5: Identify the minimum specific requirements for adequate instructions.
Apart from product specific mandatory and voluntary standards, there are some commonly used international standards that set out requirements for just the instructions for use. Some of these commonly used standards for user’s instructions are:
- IEC 82079-1 Preparation of instructions for use
- ISO/IEC Guide 37:2012 - Instructions for use of products by consumers
To identify which standard suits your product best:
- Choose the standard that fits your product best.
- Purchase the relevant standard.
Step 6: Verify the product-specific requirements from both the voluntary and mandatory standards.
Now that you have an overview of both the mandatory and voluntary standards and the standards for user instructions, it is time to acquire and search them to find the specific requirements on the instructions.
To identify the requirements on the instructions:
- Acquire the relevant standards(s).
- Use Ctrl + F and type
instructionsto find the requirements regarding the instructions. Type
labellingto find the requirements regarding the labelling.
As an example, the ASTM F963-11 standard gives the requirement shown in Figure 1.
Figure 1: Requirement from the F963-11 standard.
Step 7: Implement ANSI Z535.6
Warnings play a very important role in the US due to:
- The way product liability is organised
- Case laws
- The requirement for importers, manufacturers, distributors, and retailers of consumer products to report
- ANSI Z535.6
The United States has not established common law and has set no product liability regulation. All 50 states have individual standards that define product liability. The typical scenario is that liability claims fall into the following situations:
- specific liability theory (is there a product defect, regardless of whether there was negligence on the part of the manufacturer?),
- negligence (focus on the conduct of the manufacturer rather than the defect of the product),
- fraud (‘intentional tort’) or
- warranty theory (contract).
Furthermore, most states have some form of consumer protective statute. Within the US product defects may be determined under a consumers’ expectations test or a risk utility test. The risk utility test tries to balance the utility of the product against the risks of its specific design. A product may be deemed defective on the basis of:
- a manufacturing defect
- a design defect
- a warning defect.
Failure to properly warn of any potential risk of damage from the product sets a warning defect. Typical warning defects arise where:
- Inadequate (for example, unclear or incomplete) warnings or instructions are given;
- The foreseeable danger of the product might have been minimised or avoided if the manufacturer (or another person responsible for the product compliance) had provided reasonable warnings or instructions;
- The failure to provide such warnings or instructions rendered the product not reasonably safe.
The test for defects in design and warnings and instructions is very subjective and based on reasonableness factors to be decided by a jury. Determining when there is a duty to warn or instruct and how far that duty extends is a difficult question that every manufacturer needs to answer.
The (final) manufacturer, the manufacturer of individual components of the product, or the importer may be liable under a strict product liability claim for damage caused by a defective product. In the US, as well as in the EU product strict liability claims, the causation standard applies that the injured person must prove beyond reasonable doubt that the injury was a direct result of a defect in the product.
According to case law, a manufacturer has a duty to warn where:
- the product is dangerous;
- the danger is or should be known by the manufacturer;
- the danger is present when the product is used in the usual and expected manner; and
- the danger is not obvious or well-known to the user.
This can be similarly stated as the warnings are inadequate when risks of product harm that should have been foreseen could have been mitigated or avoided by providing reasonable instructions or warnings, and the omission renders the product not reasonably safe.
The fact that adequate instructions are provided, assisting the operator in the correct operation of the product, does not necessarily discharge the duty to provide an adequate warning. A warning may still be required to call attention to the dangers of using the product.
The purpose of instructions is to provide reliable information to consumers as to the proper ways to safely consume or use the products. Warnings should effectively alert all consumers to any risks associated with product use. Obviously, warnings are usually negative statements regarding what to avoid or affirmative statements about things always to do. Instructions tend to describe in more detail how to do something safely and correctly.
Requirement to report
Federal agencies like the CPSA require importers, manufacturers, distributors, and retailers of (consumer) products to report product risks.
Specifically, these entities must immediately report any information that leads to a reasonable conclusion that the product in question is not compliant with CPSC regulations, or is defective in a manner that would possibly create a significant hazard including the risk of significant injury or death.
As an example, under Section 15 (b) of the Consumer Product Safety Act (CPSA), manufacturers, importers, distributors, and retailers are required to report to CPSC within 24 hours of obtaining information, which reasonably supports the conclusion that a unregulated product does not comply with a safety rule issued under the CPSA, or contains a defect which could create a substantial risk of injury to the public or presents an unreasonable risk of serious injury or death.
Because of the importance of warnings in the US, a specific standard has been developed dealing with the content, location and the ways warnings are presented: ANSI Z535.6, Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials.
ANSI Z535.6 offers directives to all companies or other entities that create collateral materials.
For these purposes, collateral materials are defined as any printed documentation accompanying a product, such as manuals, safety warnings, instruction pamphlets, etc.
According to the ANSI Z535.6 safety messages can contain a signal word (DANGER, WARNING, CAUTION or NOTICE) in combination with a safety alert symbol. The signal word and safety alert symbol are placed in a so-called signal word panel. The standard defines the type, style and size of the signal words as well, see Figure 2.
Figure 2: Example of a signal word panel
Together the signal word panel (or in some cases just the safety alert symbol) and the conveyed safety message form the safety message as it can be used in collateral materials, see Figure 3.
Figure 3: Example of a safety message
The ANSI Z535 download gives four types of safety messages:
- Grouped safety messages
- Section safety messages
- Embedded safety messages
- Supplemental directives
Grouped, section and embedded safety messages should identify hazards, give an indication on how to avoid them and explain the consequences when not avoiding the hazards (for example, “Highly corrosive chemicals. Risk of severe eye and skin injuries. Avoid contact. Wear eyes and body protection”).
Grouped safety messages need to be provided in a separate chapter or in a different document. They are more general in nature and apply to the entire document.
Section safety messages are placed in the first part of the specific section to which they apply.
Embedded safety messages have to be integrated with the non-safety messages, for example, with the specific task to which the embedded safety message applies.
Supplemental directives, normally placed in the introduction of a document, may often be generic.
- General safety implications of a document (for example, “read all instructions before use to avoid injury”)
- Generic messages regarding the handling of safety information (for example, “Keep these instructions for future reference”)
- General safety implications of grouped safety messages (for example, “to avoid serious injury, follow the safety information in this section”)
To implement ANSI Z535.6:
- Purchase the ANSI Z535 pdf (there is no ansi z535.6 free download) and fully read and understand the standard.
- Determine product defects and draw up warnings according to the ANSI Z535.6 pdf.
Step 8: Write the instructions according to the requirements.
At this point we have all information to make your documentation US-compliant.
To make your documentation US compliant:
1. Analyse the following gathered information:
- The requirements from the mandatory standards
- The requirements from the voluntary standards
- The requirements from the standards for adequate user instructions
- The safety messages and requirements from the ANSI Z535.6
2. Draw up or optimise your documentation taking these requirements into acount
Conclusion: drawing up compliant US user manuals
In the EU, a manufacturer can use European harmonised standards to comply with the relevant essential health and safety specifications of CE directives for marking with that marking affixed accordingly.
Some CE marking directives establish the parameters for instructions for use.
Even though similarities exist, complying with product directives within the US is slightly different from the process of EU compliance.
By following the steps of the methods described, you should be able to create compliant documentation for the US market. Reas also this case study on how to create (ANSI Z535.6) compliant user manuals.
CPSC ‘Products Under the Jurisdiction of Other Federal Agencies and Federal Links’ www.cpsc.gov/en/Regulations-Laws--Standards/Products-Outside-CPSCs-Jurisdiction (accessed July 2016)
- CPSC ‘Regulations, Mandatory Standards and Bans’ www.cpsc.gov/en/Regulations-Laws--Standards/Regulations-Mandatory-Standards-Bans (accessed July 2016)
- CPSC ‘The Consumer Product Safety Improvement Act (CPSIA) 2008’ www.cpsc.gov/en/Regulations-Laws--Standards/Statutes/The-Consumer-Product-Safety-Improvement-Act (accessed July 2016)
- CPSC ‘Toys’ www.cpsc.gov/en/Regulations-Laws--Standards/Voluntary-Standards/Topics/Toys (accessed July 2016)
- CPSC ‘Unregulated Products’ www.cpsc.gov/en/Regulations-Laws--Standards/Unregulated-Products (accessed July 2016)
- CPSC ‘Voluntary Standards’ www.cpsc.gov/en/Regulations-Laws--Standards/Voluntary-Standards (accessed July 2016)
- CPSC www.cpsc.gov (accessed July 2016)
- USA.gov ‘Popular Federal Laws and Regulations’ www.usa.gov/laws-and-regulations (accessed July 2016)
- EUR-lex ‘ European Union law’ http://eur-lex.europa.eu (accessed July 2016) - See more at: http://instrktiv.com/en/blog/law-and-legislation/ansi-z5356/#sthash.H06dJjCt.dpuf
Founder of INSTRKTIV and keen to help users become experts in the use of a product, and thus to contribute to a positive user experience. Eager to help organisations to reduce their product liability. Just loves cooking, travel, and music--especially electronic. You can also find him on:
Profile Page, Google+, Linkedin and Twitter!
You may also be interested in
03 November 2017
ANSI Z535.6 and product safety in the US
Going to sell your product on the US market? In this post I explain how to create compliant manuals and avoid legal pitfalls....
21 February 2017
CE marking: How To Create Compliant Manuals for the EU
This blog post is available in German....