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.

Author: Doug Nix

+DougNix is Managing Director and Principal Consultant at Compliance InSight Consulting, Inc. (http://www.complianceinsight.ca) in Kitchener, Ontario, and is Lead Author and Managing Editor of the Machinery Safety 101 blog.

Doug's work includes teaching machinery risk assessment techniques privately and through Conestoga College Institute of Technology and Advanced Learning in Kitchener, Ontario, as well as providing technical services and training programs to clients related to risk assessment, industrial machinery safety, safety-related control system integration and reliability, laser safety and regulatory conformity.

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