OMs for the USA – minimising the liability risk
What are the important points when designing operating manuals in order to minimise product liability risk in the USA – this is the key question of the article below. What can we in Technical Documentation do in order to limit the risk?
Legal framework
While in Europe the courts of justice are divided by subject specialisation, the legal system in the USA includes various types of court, both at state and federal level (district courts), including the supreme court, which is the highest court of appeal for federal law only. In addition, each state has its own supreme court as the highest court of appeal. It follows that anybody exporting to the USA has to take account of the law of 52 individual states. A product liability law as such does not exist. Liability claims are dealt with under state legislation because the laws can differ from state to state. In addition, when an accident occurs, local ordinances, the regulations of employers’ liability insurance associations and possibly federal regulations may apply. It is therefore almost impossible to cover all risks 100%.
Operating manual and warning signs – integral parts of a product
“Made in Switzerland” has a special reputation worldwide, representing quality and reliability. However, does that also apply to operating and instruction manuals etc. for the USA?
At the beginning of a case, the claimant’s solicitor is usually not so interested in whether standards and regulations have been complied with, because to prove such a point with expert witnesses is costly. He will usually look straight away for a weak point, e.g. the inadequacies in European manuals. The so-called instruction risks are of particular importance – these are the risks associated with operating and instruction manuals, warnings and all other manufacturer statements. In the USA, instruction risks are higher than in any other country; production and design defects account for only about 30% of all product liability cases whereas cases based on instruction risk account for 44%, a much larger proportion. Any error in the operating manual renders the entire delivered product faulty.
Target group analysis – essential prerequisite for a safe OM
When a product is used, the associated risk depends largely on the knowledge and skills of the user group. For this reason, IEC 82079-1:2012 makes a fundamental distinction between “consumers” and “skilled persons”. But there are also other characteristics that impact on the content and design of operating manuals. Limitations, such as impaired vision, and language ability have to be taken into account. Of key importance therefore are the machine users’ degree of knowledge and skill.
Target group analysis – essential prerequisite for a safe OM
When a product is used, the associated risk depends largely on thoperating manuals. Limitations, such as impaired vision, and language ability have to be taken into account. Of key importance therefore are the machine users’ degree of knowledge and skill.
- How do users handle the machine?
- What are the conditions in the working environment when working with the machine; what are the risks arising therefrom?
- What can be assumed about user knowledge and skill, and what cannot be assumed?
- What training/competence can be assumed?
A user group analysis is likely to be useful even before the risk assessment, because for a risk assessment to be good, the users must be known. It is best to carry out this analysis in a team, e.g. involving personnel from sales and service as well as editors; in this way, benefit is derived from the widest experience. This then results in clear guidelines for producing operating manuals:
- Consideration of the training standard.
- Straightforward access to information based on a good table of contents and key word index.
- Clear instructions in accordance with the step-by-step principle.
- Use of straightforward, simplified illustrations.
- Avoidance of specialist terms and abbreviations.
Risk assessment
Good risk assessment is the basis for a safe and reliable operating manual. The result aimed for is an identification and assessment of what are referred to as residual risks, i.e. those risks involved in the design and construction that cannot be further reduced with commercially reasonable and technically appropriate means. The US standard for risk assessment is ANSI B11.0 “Safety of Machinery; General Requirements and Risk Assessment”.
Specific requirements
Some US standards contain detailed information and worded texts which have to be quoted in the operating manuals. In order to ensure that this happens, the relevant standards have to be researched, procured and worked through. Underwriters Laboratories (UL) issue numerous standards for certain machines and plant that are comparable to the European C standards relating to the safety of certain types of machinery.
One manual for all markets
That machines for the US market are “essentially” like the machines for other markets is a widespread but incorrect belief; even just a different supply voltage can result in significant changes to be made at various places in an operating manual, e.g. the connection, the troubleshooting and repairs sections. The instructions for a product for the US market must fully reflect the respective product and therefore have to be adjusted in all cases.
Ease of understanding
The ease of understanding and the thoroughness of instructions are particularly important. If a machine manipulation is not carried out, or incorrectly carried out, because the instructions are not easy to understand and this results in an accident, then the inadequacy of the instruction is deemed to contribute to the cause. As a general principle, inadequate clarity in the instruction must not be compensated for by warning signs. It follows that operating manuals for the US market must primarily be easy to understand.
Contact & Information:
Peter Rudnicki
CEO & Head of Documentation machine and plant construction
+41 71 727 98 89
rudnicki@dogrel.com
Infotrend June 2016