How compliance efforts go wrong
Clients call me when they have problems. They sent some products 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 several reasons:
- The end goal for the certification and the intermediate requirements were not considered
- The certification body chose the standard, and the manufacturer had no idea what the standard required
- The samples were not carefully prepared for the certification body
- Information was missing or partially missing
Motivation to Certify a Product
What motivates a manufacturer to certify a product? The decision to certify comes about for a variety of reasons, including:
- The legal requirements for the market
- Customer request
- Liability limitation
- 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) (c)] 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.
Each state has a slightly different approach in the US, so you will need to check out the requirements in the states where your product is sold to 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) .
Certifying your product provides liability limitations 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 educational marketing to help customers get it.
Another key point that needs to be considered: Product volume. Certification costs money and takes time. If you sell 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 choose Field Evaluation instead of Certification, substitute “Field Evaluation” wherever you see “Certification” in the diagram.
Selecting the right standard for your product can be challenging, especially in the industrial market, where products are often highly specialized and one-off. In many of these cases, no standard specifically covers the product. For relatively simple products or very common products, like TVs, computers, and audio-video equipment, there are Product Family standards that specifically cover these types of products.
Certification standards vs Design Standards
Not every standard is a certification standard. Most of the certification standards are focused on electrical and fire safety, although some, like IEC 62368-1 , have introduced a wider view of product safety. The concerns are preventing electrical shock, arc flash, and fire. Certification standards will typically include specific tests that must be passed to show compliance with the requirements. On the other hand, design standards will provide general performance and sometimes prescriptive feature requirements but no test requirements. This is typical in industrial machinery, where standards like CSA Z432  and the ANSI B11 family  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
I recommend a bottom-up approach to develop a sound strategy, starting with the product you wish to certify. 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 already certified by their manufacturer? What specific certifications do they carry? Make a list of all the certified products and their relevant certifications. All of the certified items can be eliminated from further consideration for the moment. Next, consider the purchased but uncertified products. Contact your suppliers to determine which products can be purchased certified and adjust the bill of materials to reflect the part numbers for the certified versions.
Now you have the beginning of a compliance strategy.
Review the Bill of Materials
Now, the harder part. All 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 shortlist of uncertified components that require certification.
For each item on the shortlist, 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.
The next piece of the puzzle involves the internal evaluation of each component against the standards chosen. This allows you 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 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, ensure that each component is 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.
Completing the process
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. The 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 responsible for your product’s evaluation. It’s important to carefully nurture 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 frankly and openly. Making sure you have the right standards 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 are few ways to appeal this decision. 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 ensure that the production testing is done, production records are kept, and that the QA programs are ensuring that only good product leaves the plant.
Managing Customer Complaints
An important part of the QA process is the Customer Complaints Program. Manufacturers must have a program to record customer complaints and 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 an engineering review of the problems and the cause. If these are related to manufacturing or design issues, and especially if these are related to compliance with the certification standard’s requirements, 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 inform the certifier can revoke the certification. Remember that consumer and medical products are subject to government oversight in most jurisdictions, such as Health Canada, the US Consumer Product Safety Commission, and the US Food and Drug Administration. These organizations can force a manufacturer to recall a product. It is always better to act before the government forces actions that may damage your business.
 Canada Labour Code, [online]. Available: http://laws-lois.justice.gc.ca/eng/acts/L-2/. Accessed: 2018-01-10.
 Ontario Electricity Act – Marking requirements Available: https://www.ontario.ca/laws/statute/98e15?search=electrical+safety#BK245. Accessed: 2018-01-10.
 Canadian Electrical Code, CSA C22.1. 2012.
 National Electrical Code, NFPA 70. 2014.
 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.
 Safeguarding of Machinery. CSA Z432. Canadian Standards Association (CSA), Toronto. 2016. Available: https://www.csagroup.org/store/product/Z432-16/. [Accessed: 2022-02-10].
 Safety of Machines. B11.org. [Online]. Available: https://www.b11standards.org/current-standards. [Accessed: 2022-02-10].
 Audio/video, information and communication technology equipment – Part 1: Safety requirements. IEC 62368-1, webstore.iec.ch, 2018. [Online]. Available: https://webstore.iec.ch/publication/27412. [Accessed: 2019-07-02].
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