New HSE advice on CE marking assemblies of machinery

This post was ori­gin­ally pub­lished on machineb​uild​ing​.net. Reprinted with per­mis­sion.

By Jon Severn, machineb​uild​ing​.net

Guarded machinery in a plantA degree of con­fu­sion sur­rounds the ques­tion of CE mark­ing assem­blies of machinery under the Machinery Directive 2006/​42/​EC. To help cla­ri­fy the situ­ation, the HSE (Health and Safety Executive) has pub­lished a new page on its web­site entitledIn situ man­u­fac­ture or assembly of work equip­ment and plant. This con­tains plenty of use­ful inform­a­tion for machine build­ers, sys­tem integ­rat­ors, line build­ers and end users. Without wish­ing to repeat the con­tents in their entirety, the fol­low­ing high­lights some of the more import­ant points relat­ing to assem­blies of machinery and the addi­tion of new machinery to exist­ing assem­blies.

What is an ‘assembly of machinery’?

As the HSE web page explains, an assembly of machines must be CE marked as a whole when indi­vidu­al machines are linked in order to per­form a com­mon func­tion, when those machines are inter­con­nec­ted so that an indi­vidu­al machine (or ele­ment) affects the oper­a­tion of oth­ers such that the whole needs to be risk-​assessed, and when there is a com­mon con­trol sys­tem for the con­stitu­ent units. On the oth­er hand, if the con­nec­ted machines func­tion inde­pend­ently, this is not con­sidered to be an assembly of machines for the pur­pose of CE mark­ing to the Machinery Directive.

What about an entire plant?

The HSE says that a com­plete indus­tri­al plant com­pris­ing many indi­vidu­al machines, assem­blies of machines and oth­er equip­ment should be treated as sep­ar­ate sec­tions, with any risks at the inter­faces covered by install­a­tion instruc­tions.

The responsible ‘manufacturer’

Assemblies of machines must be CE marked as a whole by the respons­ible ‘man­u­fac­turer’ – which might be the sys­tem integ­rat­or, line build­er or end user, wheth­er or not they have man­u­fac­tured the con­stitu­ent units. If the indi­vidu­al units are cap­able of oper­at­ing inde­pend­ently then they should be CE marked and be accom­pan­ied by a Declaration of Conformity (DoC); if they are placed on the mar­ket as partly com­pleted machinery (inten­ded for incor­por­a­tion with­in an assembly of machinery, for example), then they should not be CE marked but they should be accom­pan­ied by a Declaration of Incorporation (Dol) and assembly instruc­tions.

Extent of responsibilities

According to the HSE, a ‘man­u­fac­turer’ who is cre­at­ing an assembly of machines is not respons­ible for the design of the indi­vidu­al machines and partly com­pleted machines, provided the ‘man­u­fac­turer’ has checked that the equip­ment came with a DoC or Dol and adequate instruc­tions (cov­er­ing install­a­tion, oper­a­tion, main­ten­ance, etc), is CE marked where appro­pri­ate, and is free from ‘obvi­ous’ defects (the HSE gives the example of dam­aged or miss­ing guards).

Adding new machinery to old assemblies

So far we have con­sidered only new assem­blies of machinery, but the HSE web page for In Situ Manufacture also addresses the ques­tion of assem­blies com­pris­ing new and exist­ing machinery – as might be the case when a line is being mod­i­fied, upgraded or exten­ded. Whether or not the whole assembly needs to be reas­sessed under the Machinery Directive will depend on ta num­ber of factors, so the HSE dir­ects read­ers to the European Commission’s offi­cial Guide to the Machinery Directive 2006/​42/​EC. However, the HSE’s new web page does state ‘where a new machine is added to an assembly you do not have to re-​asses those oth­er machines in the assembly which are not affected in any way.’ Having said that, bear in mind that employ­ers have cer­tain duties under the Provision and Use of Work Equipment Regulations (PUWER), which may have implic­a­tions for older machinery wheth­er or not it is being mod­i­fied.

More inform­a­tion is avail­able on the HSE web­site, in the EC’s offi­cial Guide to the Machinery Directive, and in vari­ous machinery safety guides and White Papers pub­lished by Procter Machine Guarding.

Thanks to Jonathan Severn at machineb​uild​ing​.net!

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Acknowledgements: machineb​uil​ing​.net – Used with per­mis­sion.
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The Third Level of the Hierarchy: Information for Use

This entry is part 3 of 3 in the series Hierarchy of Controls

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

iStock_000009386795Small - Photo of Instruction manualThe 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.

iStock_000012657812Small - Techncial ManualMy 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.

EC Machinery Working Group meets

From our friends at MachineBuilding​.net.

It is now more than a year since the new Machinery Directive (2006/​42/​EC) came into force, but the situ­ation is still fairly flu­id in some respects. The EC Machinery Working Group meets reg­u­larly to dis­cuss mat­ters relat­ing to the Directive and cor­res­pond­ing stand­ards; the last meet­ing took place on 21/​22 December. According to the Stakeholder Report pub­lished in the UK by BIS (the Department for Business, Innovation & Skills), a num­ber of issues were dis­cussed, which demon­strates that the Machinery Directive is not as ‘black and white’ as might be expec­ted.

For example, EN 12635 (Industrial, com­mer­cial and gar­age doors and gates – Installation and use) is cur­rently har­mon­ised to the Machinery Directive, but the UK has raised a form­al objec­tion against this stand­ard, as it would appear that there is scope for improve­ment. Other top­ics under dis­cus­sion ranged from vari­able reach trucks, tail lifts and load­er cranes, to stave split­ters, dynamo­met­ers and ‘grey’ imports of machinery.

If you would like more inform­a­tion, cop­ies of the cur­rent and pre­vi­ous Stakeholder Reports are avail­able in PDF format from the UK Department of Business Information & Skills (BIS) web site.

Machinery Directive stake­hold­er report: February 2011 (PDF, 81 Kb)

Machinery Directive Working Group held on 1 – 2 June 2010, Brussels (PDF, 56 Kb)