I’ve writ­ten about the Hier­archy of Con­trols in past posts, but I’ve focused on the ‘engin­eer­ing’ side of the con­trol equa­tion: Phys­ic­al changes to machine design to elim­in­ate haz­ards, and mech­an­ic­al or elec­tric­al con­trol sys­tems that can reduce risk.

The first two levels of the Hier­archy, Elimination/Substitution and Engin­eer­ing Con­trols, are typ­ic­ally more chal­len­ging to apply in most people’s minds, because expert know­ledge is required. These levels are also more effect­ive in con­trolling risk than the sub­sequent levels.

The Third Level

The third level of the Hier­archy is ‘Inform­a­tion for Use’, some­times abbre­vi­ated as ‘IFU.’ This level is decept­ively simple, and is fre­quently the level people want to jump to when the oth­er con­trols seem too dif­fi­cult to imple­ment. Done well, inform­a­tion for use can make a sig­ni­fic­ant con­tri­bu­tion to risk con­trol. Unfor­tu­nately, it’s done poorly or not at all more often than it’s done well.

Inform­a­tion for use includes:

• Instruc­tions and Manu­als;
• Oper­at­or Device tags and Legend Plates;
• HMI screens;
• Haz­ard Warn­ing signs and labels;
• Train­ing Mater­i­als (text, video, audio) and Train­ing (face-to-face, webinars, self-dir­ec­ted);
• Sales and mar­ket­ing mater­i­als.

Inform­a­tion for use is needed in all the stages of the product life cycle: Trans­port­a­tion, Install­a­tion, Com­mis­sion­ing, Use, Main­ten­ance, Ser­vice, Decom­mis­sion­ing and Dis­pos­al [1]. At each stage in the life cycle, the con­tent of the inform­a­tion and the present­a­tion may be dif­fer­ent. In every stage it can make a sig­ni­fic­ant con­tri­bu­tion to risk reduc­tion by com­mu­nic­at­ing the safe approach to the tasks in that stage, and the risks related to those tasks. The inform­a­tion should include the inten­ded use and the fore­see­able mis­uses of the product. This is a leg­al require­ment in the EU [2], and is a best-prac­tice in North Amer­ica.

In this art­icle I’m going to focus on instruc­tion manu­als. If you’re inter­ested in Haz­ard Warn­ings, includ­ing signs, labels, and integ­ra­tion into manu­als and instruc­tions, watch for a future post on this top­ic.

Legal requirements and standards

In the European Uni­on, the leg­al oblig­a­tion to provide inform­a­tion with a product is enshrined in law [2].
No North Amer­ic­an jur­is­dic­tions make an expli­cit require­ment for instruc­tions or inform­a­tion for use in law, but many product spe­cif­ic stand­ards include require­ments for the con­tent of manu­als.

CSA Z432 [3] out­lines require­ments for con­tent in Clause 17, and in EN 60204 – 1 [7]. IEC 62079 [4], provides guid­ance on the design and present­a­tion of instruc­tions. ANSI Z535.6 [5], provides spe­cif­ic instruc­tions on inclu­sion of haz­ard warn­ings in manu­als and instruc­tions.

Train­ing require­ments are also dis­cussed in CSA Z432 [3], Clause 18.

5% Dis­count on ISO and IEC Stand­ards with code: CC2011

In the USA, provid­ing inform­a­tion for use with a product is con­sidered to be sound ‘due dili­gence’, how­ever, provid­ing inform­a­tion on resid­ual risk is often seen by liab­il­ity law­yers as dan­ger­ous, since man­u­fac­tur­ers are provid­ing inform­a­tion, in writ­ing, that their product is not ‘per­fectly safe.’ If you’ve read any­thing I’ve writ­ten on risk assess­ment, you’ll know that there is no such state as ‘per­fectly safe.’ If a haz­ard exists, a poten­tial for harm exists, a prob­ab­il­ity can be assessed and thus risk exists, how­ever remote that risk may be. I think that this argu­ment by some liab­il­ity law­yers is fatu­ous at best.

Ken­neth Ross, one of the lead­ing product liab­il­ity law­yers in the USA, dis­cusses the require­ments for warn­ings and instruc­tions in an art­icle pub­lished in 2007 [6]. In the art­icle, he explains the US require­ments:

“Product sellers must provide “reas­on­able warn­ings and instruc­tions” about their products’ risks. The law dif­fer­en­ti­ates warn­ings and instruc­tions as fol­lows:

“Warn­ings alert users and con­sumers to the exist­ence and nature of product risks so that they can pre­vent harm either by appro­pri­ate con­duct dur­ing use or con­sump­tion or by choos­ing not to use or con­sume.”

Instruc­tions “inform per­sons how to use and con­sume products safely.”

A court has held that warn­ings, stand­ing alone, may have no prac­tic­al rel­ev­ance without instruc­tions and that instruc­tions without warn­ings may not be adequate.

There­fore, when the law talks about the “duty to warn,” it includes warn­ings on products in the form of warn­ing labels; safety inform­a­tion in instruc­tions; instruc­tions that affirm­at­ively describe how to use a product safely; and safety inform­a­tion in oth­er means of com­mu­nic­a­tion such as videos, advert­ising, cata­logs and web­sites.

The law says that a man­u­fac­turer has a duty to warn where: (1) the product is dan­ger­ous; (2) the danger is or should be known by the man­u­fac­turer; (3) the danger is present when the product is used in the usu­al and expec­ted man­ner; and (4) the danger is not obvi­ous or well known to the user.”

Read Mr. Ross’ latest art­icle on warn­ings.

This prac­tic­al and sens­ible approach is very sim­il­ar to that in the EU. Note the require­ment that “instruc­tions that affirm­at­ively describe how to use a product safely.” The  old list of “don’ts” doesn’t cut it – you must tell your user how to use the product in an affirm­at­ive way.

Second Best

So why is it that so many man­u­fac­tur­ers settle for manu­als that are barely ‘second best’? In many com­pan­ies, the doc­u­ment­a­tion func­tion is:

• not seen to add value to the product;
• not under­stood to have leg­al import in lim­it­ing product liab­il­ity;
• giv­en little effort.

The per­cep­tion seems to be that manu­als are pro­duced primar­ily to fill fil­ing cab­in­ets and that cus­tom­ers don’t use the inform­a­tion provided. This leads to manu­als that are writ­ten after-the-fact by engin­eers, or worse, the role of ‘tech­nic­al writer’ is seen to be an entry level pos­i­tion often filled by interns or co-op stu­dents, with little over­sight by qual­i­fied people.

End-user train­ing is fre­quently giv­en even less thought than the manu­als. When designed togeth­er, the manu­al will sup­port the train­ing pro­gram, and the train­ers can use the manu­al as one of the primary train­ing tools. This provides con­tinu­ity, and ensures that the train­ing pro­cess is prop­erly doc­u­mented.

My exper­i­ence is that few engin­eers are excel­lent writers. There are some, no doubt. Writ­ing manu­als takes a sound under­stand­ing of edu­ca­tion­al the­ory, includ­ing an under­stand­ing of the audi­ence to whom the mater­i­al is dir­ec­ted. The level of tech­nic­al soph­ist­ic­a­tion required for a simple house­hold product is com­pletely dif­fer­ent from that required for the tech­nic­al sup­port manu­al for an indus­tri­al weld­ing laser.
The engin­eers design­ing and integ­rat­ing an indus­tri­al sys­tem are often too close to the design of the product to be able to write effect­ively to the tar­get audi­ence. Assump­tions about the level of edu­ca­tion that the user will have are often incor­rect, and key steps may be skipped because they are assumed to be ‘com­mon know­ledge.’

Qual­ity doc­u­ment­a­tion is also a cus­tom­er ser­vice issue. Products that are well doc­u­mented require less cus­tom­er ser­vice sup­port, and when cus­tom­ers do need sup­port, they are gen­er­ally more sat­is­fied with the res­ult.

New Delivery Methods

The deliv­ery meth­ods for tech­nic­al doc­u­ments have changed con­sid­er­ably in recent years. Large, ring-bound paper manu­als are being dis­placed by on-line, inter­act­ive doc­u­ment­a­tion that can be accessed at the user inter­face. The use of PDF-format manu­als has jumped, and this brings in the abil­ity to link error mes­sages gen­er­ated by the con­trol sys­tem to the sec­tions of the manu­al that related to that aspect of the sys­tem. Video and anim­a­tions can be added that provide at-a-glance under­stand­ing of the oper­a­tion of the machinery. WiFi net­works in indus­tri­al facil­it­ies, along with the accept­ance of mobile pad-com­put­ing devices like the Apple iPad, mean users can have the instruc­tions where they need them, and tech­ni­cians and ser­vice per­son­nel can take the manu­al with them to the area where a prob­lem exists, and can use the doc­u­ments even in very low-light con­di­tions.

Find­ing tech­nic­al writ­ing resources can be a chal­lenge, par­tic­u­larly if you are look­ing to move away from paper to elec­tron­ic doc­u­ment­a­tion. The stand­ards men­tioned in this art­icle are a good place to start.
Doc­u­ment­a­tion can range from writ­ing through tech­nic­al illus­tra­tions, anim­a­tion and video pro­duc­tion. Find­ing indi­vidu­als who can provide you with pro­fes­sion­al ser­vices in these areas in a timely way and at a reas­on­able price is not an easy task. If you need assist­ance ran­ging from a few ques­tions that need answers to hir­ing a tech­nic­al writer, Com­pli­ance InSight Con­sult­ing can help. Con­tact me for more inform­a­tion!

Are your product manu­als as good as they could be? What kinds of chal­lenges have you had with get­ting them writ­ten, or used? Add your com­ments below!

References

5% Dis­count on ISO and IEC Stand­ards with code: CC2011

[1]    “Safety of machinery – Gen­er­al prin­ciples for design – Risk assess­ment and risk reduc­tion”, ISO Stand­ard 12100, 2010

[2]    “DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 on machinery, and amend­ing Dir­ect­ive 95/16/EC”, Annex 1, Clause 1.7, European Com­mis­sion, 2006.

[3]    “Safe­guard­ing of Machinery”, CSA Stand­ard Z432, Cana­dian Stand­ards Asso­ci­ation, 2004.

[4]    “Pre­par­a­tion of instruc­tions – Struc­tur­ing, con­tent and present­a­tion”, IEC Stand­ard 62079, Inter­na­tion­al Elec­tro­tech­nic­al Com­mis­sion, 2001.

[5]    “Amer­ic­an Nation­al Stand­ard For Product Safety Inform­a­tion in Product Manu­als, Instruc­tions, and Oth­er Col­lat­er­al Mater­i­als”, ANSI Stand­ard Z535.6, Amer­ic­an Nation­al Stand­ards Insti­tute, 2006.

[6]    K. Ross. “Danger! The Leg­al Duty to Warn and Instruct”, Risk Man­age­ment Magazine, [web] 2007, Avail­able: No longer avail­able.

[7]      “Safety of machinery — Elec­tric­al equip­ment of machines — Part 1: Gen­er­al require­ments”, CENELEC Stand­ard EN 60204 – 1, CENELEC, 2009.