How compliance efforts go wrong

Clients call me 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 few arti­cles, includ­ing this one recent­ly, so I won’t repeat myself here. In Cana­da, Fed­er­al [1, 125(m)(iii)] and Provin­cial law [2, 113 (1) ©] require 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 typ­i­cal.

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 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 ben­e­fits cer­ti­fied prod­ucts bring. 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.

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 exists that specif­i­cal­ly cov­ers the prod­uct. For rel­a­tive­ly sim­ple prod­ucts, or for prod­ucts that are very com­mon, like TVs, 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, etcetera, 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 gives you the abil­i­ty to revise your think­ing, either of the stan­dards 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 a Certification Body

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 essen­tial, 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 an excel­lent 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://laws-lois.justice.gc.ca/eng/acts/L-2/. Accessed: 2018-01-10.

[2]     Ontario Elec­tric­i­ty Act — Mark­ing require­ments Avail­able: https://www.ontario.ca/laws/statute/98e15?search=electrical+safety#BK245. Accessed: 2018-01-10.

[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, Instal­la­tion and Use. 29 CFR 1910.303(b)(2), [online]. Avail­able: https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9880. Accessed: 2014-01-27.

[6]     Safe­guard­ing of Machin­ery. CSA Z432. 2016.

[7]     Safe­ty of Machines. B11.org, [online]. Avail­able: http://b11standards.org/standards/. Accessed: 2014-01-27.

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