Why should you get involved in Standards Development?

Committee groupIt’s now been more than 30 years since I first learned about stand­ards, in the form of the Ontario Electrical Code. I was study­ing elec­tri­city and elec­tron­ics in high school, and Steve Struk, the Electricity Teacher at Erindale Secondary School in Mississauga, intro­duced us to the rules. My first encounter with inter­na­tion­al stand­ards was 25 years ago, when I was tasked with doing some envir­on­ment­al stress test­ing using a thermal, humid­ity and vibra­tion cham­ber at Hammond Manufacturing in Guelph. Standards were, and are, an import­ant part of engin­eer­ing and tech­no­logy, and they play increas­ingly import­ant roles in busi­ness and occu­pa­tion­al health and safety. Writing stand­ards takes time. Lots of time. That time has to be provided by inter­ested people and organ­iz­a­tions who recog­nize the value that stand­ards bring to their work and their busi­nesses. Most people involved in stand­ards com­mit­tees are “paid volun­teers”, mean­ing that they are volun­teer­ing their time, but their employ­ers are pay­ing them for the time they spend engaged in stand­ards work. Some, like me, are true volun­teers, where the time spent on stand­ards work is giv­en without any com­pens­a­tion except the know­ledge that we are con­trib­ut­ing some small part to mak­ing Canada a bet­ter place to live and work.

So why should you get involved in stand­ards work? A recent SCC com­mu­niqué said it very well:

SCC’s mem­ber­ship in the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) provides Canadian busi­ness, gov­ern­ment and con­sumer stake­hold­ers with the oppor­tun­ity to sit at the table of glob­al experts mak­ing the rules that will then dic­tate the glob­al trade agenda with­in their field. As a mem­ber of a com­mit­tee devel­op­ing an inter­na­tion­al stand­ard, Canada becomes part of a com­munity of nation­al experts cre­at­ing the stand­ard they need, and can bene­fit greatly through great­er involve­ment in the devel­op­ment process.

As a mem­ber on a tech­nic­al com­mit­tee at ISO or IEC, a busi­ness can influ­ence the future of its mar­ket, get early access to cut­ting edge inform­a­tion and define its com­pet­it­ive envir­on­ment inter­na­tion­ally. Simply put: par­ti­cip­a­tion in inter­na­tion­al stand­ards devel­op­ment provides Canadians with an oppor­tun­ity to influ­ence a doc­u­ment that could affect their lives or busi­ness in the future.”

Getting involved in stand­ards writ­ing is reward­ing, chal­len­ging, work. Getting involved gives you a chance to con­trib­ute your know­ledge and expert­ise to Canada’s future, and provides an ”…oppor­tun­ity to influ­ence a doc­u­ment that could affect their lives or busi­ness in the future.”

Get involved. Contribute. It’s worth it!

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Acknowledgements: Standards Council of Canada
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Risk Assessment Blunders

Analysis TeamUpdated 7-​Jul-​2014

Recently I read a blog post writ­ten by David Cant, called, “Are You Making These Risk Assessment Blunders?”. Writing in the UK, Mr. Cant spoke to some of the com­mon kinds of prob­lems that can occur when employ­ers con­duct risk assess­ments. Many his points are equally applic­able to machine building:

  1. No Risk Assessment – This seems self evid­ent, since you can’t work to con­trol what you don’t know exists. Unfortunately, some liab­il­ity law­yers have advised cli­ents NOT to con­duct risk assess­ments, on the basis that you can’t be blamed for some­thing you knew noth­ing about. This pos­i­tion is chan­ging, since risk assess­ment has become a fun­da­ment­al piece of the machinery design pro­cess and is included in US, Canadian, International, EU, and Australian stand­ards to name a few. What remains as a liab­il­ity are poorly done risk assess­ments, and those can cer­tainly hurt a com­pany in a liab­il­ity case. See Point 3.
  2. Not Properly Identifying Hazards – This is anoth­er big one. Machine build­ers some­times fail to under­stand the haz­ards that are incor­por­ated into their machinery, espe­cially in the case of sys­tem integ­rat­ors. Identification is the first step, ana­lys­is is the second step. Once the haz­ard has been iden­ti­fied, the assessors must ana­lyze the haz­ard to under­stand the mag­nitude of injury that can occur, e.g., a paper cut, hear­ing loss, per­man­ent mus­cu­lo­skelet­al dis­order, fatal­ity, etc.
  3. Creating an inad­equate risk assess­ment – If you “phone it in”, any know­ledgable per­son will be able to see that, and you can be sure that pro­sec­utors will bring that to the atten­tion of the court! Any claim that is made will be refuted by a know­ledgable per­son hired by the prosecution.
  4. Assuming Safety Because You Have a Document – A risk assess­ment report nev­er pro­tec­ted any­one from harm. Actions based on the report are what pro­tect people from harm. Simply com­plet­ing a risk assess­ment and stick­ing the report in the design file fixes noth­ing, and going back to the liab­il­ity dis­cus­sion, will cre­ate prob­lems when it becomes clear that a) You knew about the risks, b) You thought out mit­ig­a­tion meas­ures for the risks, but c) You failed to act on your own recommendations.
  5. Not involving your employ­ees – I would change this to read, “Not involving the cus­tom­er or end user.” Getting a risk assess­ment done by an out­side indi­vidu­al is likely going to res­ult in a poor out­come, if that per­son does not work with the know­ledgable people in your organ­iz­a­tion. If this is an intern­al risk assess­ment for a pro­cess used in-​house, then you need the work­ers involved with the pro­cess to be part of the risk assess­ment team. You also need the pro­cess design­ers (elec­tric­al, mech­an­ic­al, soft­ware, etc.). If this is a product devel­op­ment risk assess­ment, then you will need product design­ers, mar­ket­ing or sales people, and end-​users. In all cases you may also need out­side experts to help with haz­ard ana­lys­is and mit­ig­a­tion, since you may not have the expert­ise in-​house. A good example of this is the use of indus­tri­al lasers into processes.
  6. Assessing risk gen­er­ic­ally – this goes back to point 3 – a risk assess­ment has to be rel­ev­ant to the pro­cess, product or ser­vice that it describes. Using a risk assess­ment developed by someone else for some oth­er sim­il­ar product, pro­cess or ser­vice lim­its your think­ing to just what they decided was rel­ev­ant. Better to start with a blank sheet, and only at the end look at other’s work to see if you may have missed any­thing they included.
  7. Doing the risk assess­ment after the machine has been designed, built and put into use – This is a com­mon prob­lem, and espe­cially affects work­places that buy off-​the-​shelf machinery and used machinery. Many machine build­ers are not famil­i­ar with risk assess­ment or the bene­fits to their products, their liab­il­ity expos­ure, and their repu­ta­tion in the mar­ket­place, let alone the bene­fits to their cus­tom­ers. Conducting the risk assess­ment after the equip­ment is in use means that the first stage of the Hierarchy of Controls can­not be used. Since this is the only stage that can achieve 100% risk reduc­tion, this is a HUGE loss. In addi­tion, this means that any changes needed to mit­ig­ate risk require expens­ive changes when the machinery is already in pro­duc­tion, com­pound­ing the expense with lost pro­duc­tion. If you have no oth­er option – for instance, you’ve taken over an exist­ing busi­ness and no risk assess­ments have been done in the past, then late is bet­ter than nev­er, but it should be a last resort and not the first choice. Special thanks to Douglas Florence for sug­gest­ing this added blunder!

All of this brings me to some import­ant stand­ards. The Canadian Standards Association released CSA Z1002, Occupational health and safety – Hazard iden­ti­fic­a­tion and elim­in­a­tion and risk assess­ment and con­trol, in 2012. This is a land­mark stand­ard, because it addresses work­place risk assess­ment. No oth­er stand­ards devel­op­ment organ­iz­a­tion has released any­thing quite like it. There are some innov­at­ive ideas in the stand­ard, includ­ing the idea of “risk trans­fer.” This concept explains how risk is trans­ferred from the developer or sup­pli­er of a product, pro­cess or ser­vice, called the “extern­al con­text”, to the user organ­iz­a­tion, called the “intern­al con­text”, and then to the work­er. At each trans­fer point, the risk should have been reduced so that the worker’s expos­ure is as low as pos­sible, and cer­tainly no high­er than per­mit­ted by law.

In the machinery world, the “moth­er stand­ard” is ISO 12100, Safety of machinery — General prin­ciples for design — Risk assess­ment and risk reduc­tion. This stand­ard affects many of the machinery safety stand­ards developed world­wide, includ­ing CSA Z432 and the ANSI B11 stand­ards, and is har­mon­ized under the Machinery Directive as EN ISO 12100. This stand­ard lays out the pro­cess for safe machine design and provides the frame­work for machinery risk assess­ment. A com­pan­ion doc­u­ment, ISO/​TR 14121 – 2, Safety of machinery – Risk assess­ment – Part 2: Practical guid­ance and examples of meth­ods, provides guid­ance on how to con­duct a risk assess­ment, and offers up some example tools that could be used for this pur­pose. In the US, ANSI pub­lishes ANSI B11-​TR3, Risk Assessment and Risk Reduction – A Guide to Estimate, Evaluate and Reduce Risks Associated with Machine Tools, provid­ing sol­ar guides to users of the B11 fam­ily of standards.

Need to know more? Contact me for inform­a­tion train­ing and risk assess­ment work in your facility!


Why YOU need a Certification Strategy

How compliance efforts go wrong

Clients call when they have prob­lems. They sent some product to a cer­ti­fic­a­tion body, some tests were done and the product failed. Now what? Usually the deliv­ery date for the cer­ti­fied product is approach­ing quickly, and no time is avail­able to react. Delivery is delayed and the cus­tom­er is upset. The busi­ness may even be lost.

This pro­cess goes wrong for a num­ber of reasons:

  1. The end goal for the cer­ti­fic­a­tion and the inter­me­di­ate require­ments were not considered
  2. The cer­ti­fic­a­tion body chose the stand­ard, and the man­u­fac­turer had no idea what the stand­ard required
  3. The samples were not care­fully pre­pared for the cer­ti­fic­a­tion body
  4. Information was miss­ing or par­tially missing

Certification Motivation

What motiv­ates a man­u­fac­turer to cer­ti­fy a product? The decision to cer­ti­fy comes about for a vari­ety of reas­ons, including:

  1. Legal require­ment for the market
  2. Customer request
  3. Liability lim­it­a­tion
  4. Marketing advant­age over competitor’s offerings

I’ve talked about the dif­fer­ences between CE Marking and tra­di­tion­al Certification pro­cesses in a num­ber of art­icles, includ­ing this one recently, so I won’t repeat myself here. In Canada, Federal [1, 125(m)(iii)] and Provincial law [2, 113] requires any­one selling an elec­tric­al product to ensure that it bears an elec­tric­al safety mark, and this is sup­por­ted in the Canadian Electrical Code [3, 2 – 024]. This require­ment is often over­looked in the indus­tri­al /​ com­mer­cial mar­ket where post-​installation equip­ment inspec­tion, called “Field Evaluation”, is common.

In the US, each State has a slightly dif­fer­ent approach, so you will need to check out the require­ments in the states where your product is sold so that you can ensure com­pli­ance with the loc­al require­ments. From a work­place per­spect­ive, the US OSHA requires that all elec­tric­al products used in the work­place bear a mark from a Nationally Recognized Testing Laboratory (NRTL) [5].

Certifying your product provides some degree of liab­il­ity lim­it­a­tion, in that it shows that you met the min­im­um leg­al require­ments for your mar­ket­place. To really lim­it your liab­il­ity effect­ively, you will need to do more than just meet the min­im­um require­ments, and you will need doc­u­ment­a­tion of everything done to meet or exceed those requirements.

If you offer cer­ti­fied products in a mar­ket where this is uncom­mon, you have a mar­ket­ing advant­age as long as your cus­tom­ers under­stand the advant­ages cer­ti­fied product brings. If cer­ti­fic­a­tion is rare in your mar­kets, you may need to under­take some edu­ca­tion­al mar­ket­ing to help cus­tom­ers “get it”.

Another key point needs to be con­sidered: Product volume. Certification costs money and takes time. If you are selling less than 200 units per year of a giv­en product in your line, cer­ti­fic­a­tion for that product is unlikely to be feas­ible. For product volumes from one to 200 units per year, Field Evaluation provides a much more time and cost effect­ive way to get your product marked.

The dia­gram shows the gen­er­al pro­cess flow for this activ­ity. If you are choos­ing to use Field Evaluation instead of Certification, sub­sti­tute “Field Evaluation” wherever you see “Certification” in the diagram.

Flow chart showing certification process flow.
Certification Process Flow

Selecting standards

Selecting the “right” stand­ard for your product can be a chal­lenge, espe­cially in the indus­tri­al mar­ket where products are often highly spe­cial­ized, “one-​off” products. In many of these cases, no stand­ard that spe­cific­ally cov­ers the product may exist. For rel­at­ively simple products, or for products that are very com­mon, like TV’s, com­puters, and audio-​video equip­ment, there are “Product Family” stand­ards that spe­cific­ally cov­er these types products.

Not every stand­ard is a cer­ti­fic­a­tion stand­ard. Most of the cer­ti­fic­a­tion stand­ards are focused on elec­tric­al and fire safety. The con­cerns are the pre­ven­tion of elec­tric­al shock, arc flash, and fire. Certification stand­ards will typ­ic­ally include spe­cif­ic tests that must be passed to show com­pli­ance with the require­ments. Design stand­ards, on the oth­er hand, will provide gen­er­al per­form­ance require­ments and some­times pre­script­ive fea­ture require­ments, but no test require­ments. This is typ­ic­al in the indus­tri­al machinery sec­tor where stand­ards like CSA Z432 [6] and the ANSI B11 fam­ily [7] of stand­ards apply. In these cases, you may be able to have the product cer­ti­fied for elec­tric­al safety, but not for machinery safety. This does not elim­in­ate cor­por­ate liab­il­ity for the machinery haz­ards, requir­ing man­u­fac­tur­ers to be know­ledge­able and dili­gent in apply­ing design standards.

Developing a Certification Strategy

To devel­op a sound strategy, I recom­mend a “bottom-​up” approach. To apply this idea, start with the bill of mater­i­als for the product. Look first at the pur­chased products: How many of these items are either already cer­ti­fied by their man­u­fac­turer? All of the cer­ti­fied items can be elim­in­ated from fur­ther con­sid­er­a­tion for the moment. Next, con­sider the pur­chased but un-​certified products. Contact all of your sup­pli­ers to determ­ine which of these products can be pur­chased cer­ti­fied, and adjust the bill of mater­i­als to reflect the part num­bers for the cer­ti­fied versions.

Now, the harder part. All of the remain­ing items on the bill of mater­i­als need to be looked at for cer­ti­fic­a­tion. Anything that can­not or need not be cer­ti­fied, e.g., nuts and bolts, oth­er mech­an­ic­al parts that are not pres­sure bear­ing, can be excluded from con­sid­er­a­tion. You now have a short list of uncer­ti­fied com­pon­ents that require certification.

For each item on the short list, research the stand­ards avail­able. The Scope of the stand­ards will help guide you regard­ing their applic­ab­il­ity. Once you have a matched list of com­pon­ents and stand­ards, you can extend that research to include the top level product.

Now you have the begin­ning of a com­pli­ance strategy. The next piece of the puzzle involves the intern­al eval­u­ation of each com­pon­ent against the stand­ards chosen. This give you the abil­ity to revise your think­ing, either of the stand­ard you chose or of the design and con­struc­tion of the com­pon­ent. Making good choices at this stage to either cor­rect issues found in the design or con­struc­tion of the com­pon­ent, or in the selec­tion of the stand­ard, can save you huge amounts of time and effort once the cer­ti­fic­a­tion body gets involved.

Once the com­pon­ents have suc­cess­fully passed the intern­al “pre-​compliance” eval­u­ation, you can get the cer­ti­fic­a­tion body involved, and start the form­al com­pli­ance pro­cess for each com­pon­ent. As this part of the pro­cess pro­gresses, the cer­ti­fic­a­tion body may have addi­tion­al ques­tions or requests for inform­a­tion. To reduce these in-​process ques­tions, make sure that each com­pon­ent is clearly iden­ti­fied, that you have unique part num­bers for each part, and that you have provided inform­a­tion on the mater­i­als used in the con­struc­tion of the com­pon­ent, as well as detailed engin­eer­ing drawings.

As the com­pon­ent cer­ti­fic­a­tion work pro­gresses, you can start on the top level product cer­ti­fic­a­tion work. The top level product needs to go through the same sort of intern­al pre-​compliance pro­cess as the com­pon­ents so that you can be as cer­tain as pos­sible that the product will meet the require­ments when it gets to the cer­ti­fic­a­tion lab.

Preparation of the data pack­age and the sample(s) of the top-​level product that will be sub­mit­ted must be done care­fully. Construction of the samples must match the man­u­fac­tur­ing draw­ings and instruc­tions as closely as pos­sible. Once everything is ready, the samples can be sub­mit­ted for evaluation.

Working with your Certifier

Dealing with a Certification Body can be very chal­len­ging. Much of the exper­i­ence will be based on the pro­ject engin­eer that is respons­ible for your product’s eval­u­ation. It’s import­ant to set up a good rela­tion­ship with this per­son at the begin­ning, because once prob­lems start to crop up in the lab you will need to be able to talk to this per­son. Making sure that you have the “right” stand­ards selec­ted for your product is really import­ant, and the pro­ject engin­eer must agree with you. They can refuse to cer­ti­fy a product if they feel that the stand­ard chosen is incor­rect, and since they have the final word, there is no arguing with them. An open dis­cus­sion at the begin­ning of the pro­ject to dis­cuss the stand­ards selec­ted is a good place to start. If your ideas and theirs devi­ate in a big way, you may have to com­prom­ise on their selec­tion, or worse, stop the pro­ject and review the prob­lems encountered.

Once the product is cer­ti­fied, the Certification Body will con­duct reg­u­lar audits on the man­u­fac­tur­ing facility(ies) to make sure that the pro­duc­tion test­ing is being done, pro­duc­tion records are kept, and that the QA pro­grams are ensur­ing that only good product leaves the plant.

An import­ant part of the QA pro­cess is the Customer Complaints Program. Manufacturers must have a pro­gram in place to record cus­tom­er com­plaints, and to respond to those com­plaints. A decision tree that helps cus­tom­er ser­vice rep­res­ent­at­ives dif­fer­en­ti­ate between safety-​related and non-​safety related com­plaints should be developed. Safety related com­plaints should res­ult in engin­eer­ing review of the prob­lems and determ­in­a­tions about the cause of the prob­lems. If these are related to man­u­fac­tur­ing or design issues, and espe­cially if these are related to com­pli­ance with the require­ments of the cer­ti­fic­a­tion stand­ard, a recall of the product may be needed. If this is the case, get the Certifier involved as soon as pos­sible. Failure to act, and fail­ure to inform the cer­ti­fi­er can res­ult in the cer­ti­fic­a­tion being revoked.

References

[1]     Canada Labour Code, [online]. Available: http://​can​lii​.ca/​t​/​5​2​2fd. Accessed: 2014-01-27.

[2]     Ontario Electricity Act – Marking require­ments Avaialble:Ontario Electricity Act. Accessed: 2014-01-27.

[3]     Canadian Electrical Code, CSA C22.1. 2012.

[4]     National Electrical Code, NFPA 70. 2014.

[5]     Occupational Safety and Health Standards, 1910 Subpart S, Electrical, Installatin and Use. 29 CFR 1910.303(b)(2), [online]. Available: https://​www​.osha​.gov/​p​l​s​/​o​s​h​a​w​e​b​/​o​w​a​d​i​s​p​.​s​h​o​w​_​d​o​c​u​m​e​n​t​?​p​_​t​a​b​l​e​=​S​T​A​N​D​A​R​D​S​&​a​m​p​;​p​_​i​d​=​9​880. Accessed: 2014-01-27.

[6]     Safeguarding of Machinery. CSA Z432. 2004.

[7]     Safety of Machines. B11​.org, [online]. Available: http://​b11stand​ards​.org/​s​t​a​n​d​a​r​ds/. Accessed: 2014-01-27.