## Safety Label Format Solutions for Solving Complex Messaging Challenges

This entry is part 3 of 3 in the series Safety Labels

## Safety Label Messaging Basics

Safety label design fol­lows three prin­ciples:

1. Identi­fy the haz­ard
2. Identi­fy the likely degree of injury that could occur

Design­ing warn­ings seems a simple task. How­ever, users may not be Eng­lish speak­ing or lit­er­ate. Depend­ing on the jur­is­dic­tions where your product will be mar­keted, like the EU, text may not be desir­able, so pic­to­graph­ic labels may be the most appro­pri­ate choice.

## Complex Content

The con­tent for your product safety label becomes com­plex when there are sev­er­al ele­ments involved in explain­ing what the haz­ard is and how to avoid it. But, with the latest update to ISO 3864 – 2 came a sig­ni­fic­ant modi­fic­a­tion to the stand­ard that provides a solu­tion to con­sider in these situ­ations: the new “word­less” format that con­veys risk sever­ity.

The word­less label format uses what ISO calls a “haz­ard sever­ity pan­el” but no sig­nal word. In place of words, the level of risk is com­mu­nic­ated through col­our-cod­ing of the haz­ard sever­ity pan­el. ISO-format­ted sym­bols as well as what ISO calls “sup­ple­ment­ary safety sym­bols” – sym­bols without an ISO-colored sur­round shape – can be used.

## Example: Grill Industry Safety Label

As an example, let’s look at a label design cre­ated here at Clari­on as part of Clarion’s work with ISO/TC 145.

When the barbe­que grill industry needed a safety sym­bol that would warn people not to use grills in enclosed spaces, Clari­on volun­teered its design department’s skills to devel­op a new label design. The new label uses the ISO 3864 – 2:2016 word­less format.

The new safety label design includes a haz­ard sever­ity level pan­el at the top. Below the sever­ity label pan­el are five sym­bols: a safety sym­bol that defines the nature of the haz­ard, and four “sup­ple­ment­ary” safety sym­bols. The sup­ple­ment­ary sym­bols give instruc­tions about “mis­uses” and “prop­er use” to help keep people safe. Much like the graph­ic­al instruc­tions used in air­craft emer­gency instruc­tions, the barbe­que grill product safety label uses mul­tiple graph­ics in a pro­gress­ively illus­trated design to com­mu­nic­ate a com­plex mes­sage.

There are mul­tiple format options allowed by the ANSI and ISO stand­ards, and it’s import­ant to under­stand your choices – like this word­less option – so you can make the best decisions for your products or mar­ket. To learn more about how the word­less format can help solve com­plex mes­saging chal­lenges, you can read Clarion’s recent art­icle on this blog and the fea­ture art­icle in the Octo­ber 2017 issue of InCom­pli­ance Magazine.

## Get Help

Unsure where to start? Clari­on is avail­able to help. For more inform­a­tion on effect­ive product safety labeling and resources that you can put to use today, vis­it www.clarionsafety.com. Clari­on also offers com­pli­ment­ary safety label assess­ments, where we use our exper­i­ence with the latest stand­ards and best prac­tices to assess your labels and ensure that they’re up-to-date in meet­ing today’s require­ments.

Copy­right secured by Digi­prove © 2018
Acknow­ledge­ments: Clari­on Safety Sys­tems, LLC

## Machinery Safety Labels: 3 Top Tools for Effective Warnings

This entry is part 1 of 3 in the series Safety Labels

# Machinery Safety Labels

The third level of the Hier­archy of Con­trols is Inform­a­tion for Use. Safety Labels are a key part of the Inform­a­tion for Use provided by machine build­ers to users and are often the only inform­a­tion that many users get to see. This makes the design and place­ment of the safety labels crit­ic­al to their effect­ive­ness. There is as much risk in the under-use of safety labels as there is in the over-use of safety labels. Often, machine build­ers and users simply select gen­er­ic labels that are eas­ily avail­able from cata­logues, miss­ing the oppor­tun­ity to design labels that are spe­cif­ic to the machine and the haz­ards present.

## Product Safety and Liability Limitation

If your com­pany man­u­fac­tures machinery that has poten­tial haz­ards asso­ci­ated with its trans­port­a­tion, install­a­tion, use, main­ten­ance, decom­mis­sion­ing and/or dis­pos­al, you likely have a very strong need to cre­ate effect­ive product safety labels. This task must be done right: product safety labels play an integ­ral role in your company’s product safety and liab­il­ity pre­ven­tion efforts. And that means that people’s lives and your company’s fin­an­cial well-being are on the line. On that note, it’s import­ant to keep in mind these two factors when it comes to effect­ive safety labels:

1. If prop­erly designed, they can dra­mat­ic­ally reduce acci­dents. This not only improves a product’s over­all safety record but adds to a company’s bot­tom line by redu­cing product liab­il­ity lit­ig­a­tion and insur­ance costs.
2. If poorly designed, needed safety com­mu­nic­a­tion does not take place and this can lead to acci­dents that cause injur­ies. With these acci­dents, com­pan­ies face high costs set­tling or fight­ing law­suits because their products lacked “adequate warn­ings.”

With the rise in product liab­il­ity lit­ig­a­tion based on “fail­ure to warn” over the past sev­er­al dec­ades, product safety labels have become a lead­ing focal point in law­suits faced by cap­it­al equip­ment man­u­fac­tur­ers. Let’s look at three best?practice tools for product safety label design. These tools can provide insight to help you cre­ate or improve your safety label strategy in order to bet­ter pro­tect your product users from harm and your com­pany from lit­ig­a­tion-related losses.

## TOOL #1: SAFETYLABELSTANDARDS

As a man­u­fac­turer, you know that your leg­al oblig­a­tion is to meet or exceed the most recent ver­sions of stand­ards related to your product at the time it’s sold into the mar­ket­place. Warn­ing label stand­ards are the first place to turn to when it comes to defin­ing your product safety labels. Up until 1991, there was no over­arch­ing, multi-industry stand­ard in the U.S., or in the rest of the world, which gave defin­it­ive guid­ance on the prop­er format­ting and con­tent for on-product warn­ings. In the U.S., that changed nation­ally with the pub­lic­a­tion of the ANSI Z535.4 Stand­ard for Product Safety Signs and Labels in 1991, and inter­na­tion­ally with the pub­lic­a­tion of ISO 3864 – 2 Design Prin­ciples for Product Safety Labels in 2004.

As of 2017, Canada does not have a warn­ing label stand­ard. Since Canada imports machinery from the U.S. and the EU, it is quite com­mon to see either ANSI Z535 style labels or ISO 3864 style labels on products. Under Cana­dian law, neither is more cor­rect. How­ever, Québec has spe­cif­ic require­ments for French lan­guage trans­la­tions, and many CSA stand­ards pre­scribe spe­cif­ic haz­ard warn­ing labels that do not con­form to either ANSI or ISO styles.

Fol­low­ing the design prin­ciples in ANSI Z535.4 or ISO 3864 – 2 will give you a start­ing place for both the con­tent and format choices you have to make for your products’ safety labels, bear­ing in mind the lan­guage require­ments of your jur­is­dic­tion. Note that both of these stand­ards are revised reg­u­larly, every five years or so, and it’s import­ant to be aware of the nuances that would make one format more appro­pri­ate for your product than anoth­er.

## TOOL #2: RISKASSESSMENT

From an engin­eer­ing per­spect­ive, your job is to identi­fy poten­tial haz­ards and then determ­ine if they need to be designed out, guarded, or warned about. From a leg­al per­spect­ive, your job is to define what haz­ards are “reas­on­ably fore­see­able” and “reas­on­able” ways to mit­ig­ate risks asso­ci­ated with haz­ards that can­not be designed out. This is where risk assess­ment comes into play.

In today’s world, a product is expec­ted to be designed with safety in mind. The risk assess­ment pro­cess helps you to accom­plish this task. At its most basic level, risk assess­ment involves con­sid­er­ing the prob­ab­il­ity and sever­ity of out­comes that can res­ult from poten­tially haz­ard­ous situ­ations. After identi­fy­ing the poten­tial haz­ards related to your product at every point in its life­cycle, you then con­sider vari­ous strategies to either elim­in­ate or reduce the risk of people inter­act­ing with these haz­ards.

The best prac­tice risk assess­ment stand­ards that exist today (i.e. ANSI Z10, ANSI B11, CSA Z432, CSA Z1002, ISO 12100, ISO 31000, ISO 31010) give you a pro­cess to use to quanti­fy and reduce risks. Using these stand­ards as the basis for a form­al­ized risk assess­ment pro­cess will not only help you to devel­op bet­ter safety labels and a safer product, but it will also provide you with doc­u­ment­a­tion that will help you to show the world that you are a safety-con­scious com­pany who uses the latest stand­ards-based tech­no­logy to reduce risks. This will be highly import­ant should you be involved in product liab­il­ity lit­ig­a­tion down the road.

From an engin­eer­ing per­spect­ive, your job is to identi­fy poten­tial haz­ards and then determ­ine if they need to be designed out, guarded, or warned about. From a leg­al per­spect­ive, your job is to define what haz­ards are “reas­on­ably fore­see­able” and “reas­on­able” ways to mit­ig­ate risks asso­ci­ated with haz­ards that can­not be designed out. This is where risk assess­ment comes into play.

## TOOL #3: PICTOGRAPHICSAFETYLABELSFORGLOBALMARKETS

A large num­ber of machinery man­u­fac­tur­ers sell their products around the globe and when this is the case, com­pli­ance with glob­al stand­ards is a require­ment. The ANSI Z535.4 and ISO 3864 – 2 product safety label stand­ards, and the EU machinery dir­ect­ive place an emphas­is on using well-designed sym­bols on machinery safety labels so inform­a­tion can be con­veyed across lan­guage bar­ri­ers.

The EU Machinery Dir­ect­ive 2006/42/EC requires that all inform­a­tion for use be provided in the offi­cial lan­guages of the coun­try of use. Inform­a­tion for use includes haz­ard warn­ing signs and labels that bear mes­sages in text. Adding sym­bols also increases your labels’ notice­ab­il­ity. The use of sym­bols to con­vey safety is becom­ing com­mon­place world­wide and not tak­ing advant­age of this new visu­al lan­guage risks mak­ing your product’s safety labels obsol­ete and non-com­pli­ant with loc­al, region­al and inter­na­tion­al codes. In ISO 3864 – 2’s latest, 2016 update, a major change in ISO label formats was made: a new “word­less” format that con­veys risk sever­ity was added to the stand­ard. This new label format uses what ISO calls a “haz­ard sever­ity pan­el” but no sig­nal word. It com­mu­nic­ates the level of risk through col­our-cod­ing of the haz­ard sever­ity pan­el. This format option elim­in­ates words – mak­ing trans­la­tions unne­ces­sary.

It should be noted that some­times sym­bols alone can­not con­vey com­plex safety mes­sages. In these cases, text is often still used. When ship­ping to non-Eng­lish speak­ing coun­tries, the trend today is to trans­late the text into the lan­guage of the coun­try in which the machine is sold. Digit­al print tech­no­logy makes this solu­tion much more cost effect­ive and effi­cient than in the past.

# Concluding Thoughts

The safety labels that appear on your products are one of its most vis­ible com­pon­ents. If they don’t meet cur­rent stand­ards, if they aren’t designed as the res­ult of a risk assess­ment, and if they don’t incor­por­ate well-designed graph­ic­al sym­bols, your com­pany risks lit­ig­a­tion and non-con­form­ance with mar­ket require­ments. Most import­antly, you may be put­ting those who inter­act with your machinery at risk of harm. Mak­ing sure your product safety labels are up-to-date is an import­ant task for every engin­eer respons­ible for a machine’s design.

For more inform­a­tion on effect­ive product safety labelling and resources that you can put to use today, vis­it www.clarionsafety.com. Clari­on also offers com­pli­ment­ary safety label assess­ments, where we use our exper­i­ence with the latest stand­ards and best prac­tices to assess your labels and ensure that they’re up-to-date in meet­ing today’s require­ments.

Ed. note: Addi­tion­al Cana­dian mater­i­al con­trib­uted by Doug Nix.

Copy­right secured by Digi­prove © 2017
Acknow­ledge­ments: Derek Evers­dyke, Clari­on Safety Sys­tems, LLC
Some Rights Reserved

## ISO 13849 – 1 Analysis — Part 5: Diagnostic Coverage (DC)

This entry is part 5 of 9 in the series How to do a 13849 – 1 ana­lys­is

# What is Diagnostic Coverage?

Under­stand­ing Dia­gnost­ic Cov­er­age (DC) as it is used in ISO 13849 – 1 [1] is crit­ic­al to ana­lys­ing the design of any safety func­tion assessed using this stand­ard. In case you missed a pre­vi­ous part of the series, you can read it here.

In the last instal­ment of this series dis­cuss­ing MTTFD, I brought up the fact that everything fails even­tu­ally, and so everything has a nat­ur­al fail­ure rate. The bathtub curve shown at the top of this post shows a typ­ic­al fail­ure rate curve for most products. Fail­ure rates tell you the aver­age time (or some­times the mean time) it takes for com­pon­ents or sys­tems to fail. Fail­ure rates are expressed in many ways, MTTFD and PFHd being the ways rel­ev­ant to this dis­cus­sion of ISO 13849 ana­lys­is. MTTFis giv­en in years, and PFHd is giv­en in frac­tion­al hours (1/h). As a remind­er, PFHd stands for “Prob­ab­il­ity of dan­ger­ous Fail­ure per Hour”.

Three of the stand­ard archi­tec­tures include auto­mat­ic dia­gnost­ic func­tions, Cat­egor­ies 2, 3 and 4. As soon as we add dia­gnostics to the sys­tem, we need to know what faults the dia­gnostics can detect and how many of the dan­ger­ous fail­ures rel­at­ive to the total num­ber of fail­ures that rep­res­ents. Dia­gnost­ic Cov­er­age (DC) rep­res­ents the ratio of dan­ger­ous fail­ures that can be detec­ted to the total dan­ger­ous fail­ures that could occur, expressed as a per­cent­age. There will be some fail­ures that do not res­ult in a dan­ger­ous fail­ure, and those fail­ures are excluded from DC because we don’t need to worry about them – if they occur, the sys­tem will not fail into a dan­ger­ous state.

Here’s the form­al defin­i­tion from [1]:

3.1.26 dia­gnost­ic cov­er­age (DC)

meas­ure of the effect­ive­ness of dia­gnostics, which may be determ­ined as the ratio between the fail­ure rate of detec­ted dan­ger­ous fail­ures and the fail­ure rate of total dan­ger­ous fail­ures

Note 1 to entry: Dia­gnost­ic cov­er­age can exist for the whole or parts of a safety-related sys­tem. For example, dia­gnost­ic cov­er­age could exist for sensors and/or logic sys­tem and/or final ele­ments. [SOURCE: IEC 61508 – 4:1998, 3.8.6, mod­i­fied.]

That brings up two oth­er related defin­i­tions that need to be kept in mind [1]:

3.1.4 fail­ure

ter­min­a­tion of the abil­ity of an item to per­form a required func­tion

Note 1 to entry: After a fail­ure, the item has a fault.

Note 2 to entry: “Fail­ure” is an event, as dis­tin­guished from “fault”, which is a state.

Note 3 to entry: The concept as defined does not apply to items con­sist­ing of soft­ware only.

Note 4 to entry: Fail­ures which only affect the avail­ab­il­ity of the pro­cess under con­trol are out­side of the scope of this part of ISO 13849. [SOURCE: IEC 60050 – 191:1990, 04 – 01.]

and the most import­ant one [1]:

3.1.5 dan­ger­ous fail­ure

fail­ure which has the poten­tial to put the SRP/CS in a haz­ard­ous or fail-to-func­tion state

Note 1 to entry: Wheth­er or not the poten­tial is real­ized can depend on the chan­nel archi­tec­ture of the sys­tem; in redund­ant sys­tems a dan­ger­ous hard­ware fail­ure is less likely to lead to the over­all dan­ger­ous or fail-to- func­tion state.

Note 2 to entry: [SOURCE: IEC 61508 – 4, 3.6.7, mod­i­fied.]

Just as a remind­er, SRP/CS stands for “safety-related parts of con­trol sys­tems”.

## Failure Math

### Failure Rate Data Sources

To do any cal­cu­la­tions, we need data, and this is true for fail­ure rates as well. ISO 13849 – 1 provides some tables in the annexes that list some com­mon types of com­pon­ents and their asso­ci­ated fail­ure rates, and there are more fail­ure rate tables in ISO 13849 – 2. A word of cau­tion here: Do not mix sources of fail­ure rate data, as the con­di­tions under which that data is true won’t match the data in ISO 13849. There are a few good sources of fail­ure rate data out there, for example, MIL-HDBK-217, Reli­ab­il­ity Pre­dic­tion of Elec­tron­ic Equip­ment [15], as well as the data­base main­tained by Exida. In any case, use a single source for your fail­ure rate data.

### Failure Rate Variables

IEC 61508 [7] defines a num­ber of vari­ables related to fail­ure rates. The lower­case Greek let­ter lambda, $\lambda$, is used to denote fail­ures.

The com­mon vari­able des­ig­na­tions used are:

$\lambda$ = fail­ures
$\lambda_{(t)}$= fail­ure rate
$\lambda_s$ = “safe” fail­ures
$\lambda_d$ = “dan­ger­ous” fail­ures
$\lambda_{dd}$ = detect­able “dan­ger­ous” fail­ures
$\lambda_{du}$ = undetect­able “dan­ger­ous” fail­ures

### Calculating DC

Of these vari­ables, we only need to con­cern ourselves with $\lambda_d$, $\lambda_{dd}$ and $\lambda_{du}$. To under­stand how these vari­ables are used, we can express their rela­tion­ship as

$\lambda_d=\lambda_{dd}+\lambda_{du}$

Fol­low­ing on that idea, the Dia­gnost­ic Cov­er­age can be expressed as a per­cent­age like this:

$DC\%=\frac{\lambda_{dd}}{\lambda_d}\times 100$

## Determining DC%

If you want to actu­ally cal­cu­late DC%, you have some work ahead of you. Rather than going into the details here, I am going to refer you hard­core types to IEC 61508 – 2, Func­tion­al safety of electrical/electronic/programmable elec­tron­ic safety-related sys­tems – Part 2: Require­ments for electrical/electronic/programmable elec­tron­ic safety-related sys­tems. This stand­ard goes into some depth on how to determ­ine fail­ure rates and how to cal­cu­late the “Safe Fail­ure Frac­tion,” a num­ber which is related to DC but is not the same.

For every­one else, the good news is that you can use the table in Annex E to estim­ate the DC%. It’s worth not­ing here that Annex E is “Inform­at­ive.” In stand­ards-speak, this means that the inform­a­tion in the annex is not part of the “norm­at­ive” text, which means that it is simply inform­a­tion to help you use the norm­at­ive part of the stand­ard. The design must con­form to the require­ments in the norm­at­ive text if you want to claim con­form­ity to the stand­ard. The fact that [1, Annex E] is inform­at­ive gives you the option to cal­cu­late the DC% value rather than select­ing it from Table E.1. Using the cal­cu­lated value would not viol­ate the require­ments in the norm­at­ive text.

If you are using IFA SISTEMA [16] to do the cal­cu­la­tions for you, you will find that the soft­ware lim­its you to select­ing a single DC meas­ure from Table E.1, and this prin­ciple applies if you are doing the cal­cu­la­tions by hand too. Only one item from Table E.1 can be selec­ted for a giv­en safety func­tion.

## Ranking DC

Once you have determ­ined the DC for a safety func­tion, you need to com­pare the DC value against [1, Table 5] to see if the DC is suf­fi­cient for the PLr you are try­ing to achieve. Table 5 bins the DC res­ults into four ranges. Just like bin­ning the PFHd val­ues into five ranges helps to pre­vent pre­ci­sion bias in estim­at­ing the prob­ab­il­ity of fail­ure of the com­plete sys­tem or safety func­tion, the ranges in Table 5 helps to pre­vent pre­ci­sion bias in the cal­cu­lated or selec­ted DC val­ues.

If the DC value was high enough for the PLr, then you are done with this part of the work. If not, you will need to go back to your design and add addi­tion­al dia­gnost­ic fea­tures so that you can either select a high­er cov­er­age from [1, Table E.1] or cal­cu­late a high­er value using [14].

## Multiple safety functions

When you have mul­tiple safety func­tions that make up a com­plete safety sys­tem, for example, an emer­gency stop func­tion and a guard inter­lock­ing func­tion, the DC val­ues need to be aver­aged to determ­ine the over­all DC for the com­plete sys­tem. [1, Annex E] provides you with a meth­od to do this in Equa­tion E.1.

Plug in the val­ues for MTTFD and DC for each safety func­tion, and cal­cu­late the res­ult­ing DCavg value for the com­plete sys­tem.

That’s it for this art­icle. The next part will cov­er Com­mon Cause Fail­ures (CCF). Look for it on 20-Mar-17!

In case you missed the first part of the series, you can read it here.

## Book List

Here are some books that I think you may find help­ful on this jour­ney:

[0.2]  Elec­tro­mag­net­ic Com­pat­ib­il­ity for Func­tion­al Safety, 1st ed. Steven­age, UK: The Insti­tu­tion of Engin­eer­ing and Tech­no­logy, 2008.

## References

Note: This ref­er­ence list starts in Part 1 of the series, so “miss­ing” ref­er­ences may show in oth­er parts of the series. Included in the last post of the series is the com­plete ref­er­ence list.

[16]     “IFA – Prac­tic­al aids: Soft­ware-Assist­ent SISTEMA: Safety Integ­rity – Soft­ware Tool for the Eval­u­ation of Machine Applic­a­tions”, Dguv.de, 2017. [Online]. Avail­able: http://www.dguv.de/ifa/praxishilfen/practical-solutions-machine-safety/software-sistema/index.jsp. [Accessed: 30- Jan- 2017].