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.

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]    “Danger! The Legal Duty to Warn and Instruct”, Kenneth Ross, Risk Management Magazine, 2007, http://​www​.rmmag​.com/​M​G​T​e​m​p​l​a​t​e​.​c​f​m​?​S​e​c​t​i​o​n​=​R​M​M​a​g​a​z​i​n​e​&​a​m​p​;​N​a​v​M​e​n​u​I​D​=​1​2​8​&​a​m​p​;​t​e​m​p​l​a​t​e​=​/​M​a​g​a​z​i​n​e​/​D​i​s​p​l​a​y​M​a​g​a​z​i​n​e​s​.​c​f​m​&​a​m​p​;​I​s​s​u​e​I​D​=​2​9​0​&​a​m​p​;​A​I​D​=​3​2​9​0​&​a​m​p​;​V​o​l​u​m​e​=​5​4​&​a​m​p​;​S​h​o​w​A​r​t​i​c​l​e=1, accessed 16-​​Jan-​​2012.

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

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kenrossesqcomcastnet')" onmouseover="this.style.color='#A35353';" onmouseout="this.style.color='#636363';">Acknowledgements: Kenneth Ross, +1 (952) 933‑1195, kenr more…

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