Issues & Needs 8 – Standardization of Terminology
By Tom Killam and Cyril Mecwan
November 11, 2021 | Series 1 / No. 12
The standardization of the terminology used in any field is a basic building block to promote discussions and development of the field. A lack of an agreed-upon lexicon in the field creates confusion. There is a need to have a standard lexicon in the field of Product Regulatory Compliance.
Issues:
Standardization around the purpose, scope, definitions, content, and formats for Record Types, Compliance Disciplines, information required by test labs, etc. may produce fewer errors, increase productivity, improve time-to-market and reduce cost. Following are examples and clarifications of few terms:
A. Record Types:
In the field of Product Regulatory Compliance, we are easily dealing with an average of 50 record types, but for the mid-size and large organizations, this number can reach to as many as 100 unique record types. The companies, compliance professionals and testing laboratories use different terminology for a specific record type. The confusion compounds when one is dealing with multiple record types.
Following are a few examples and clarifications:
- Type Approval Certificate: This document is issued by the regulatory authority of a country as a proof of product regulatory approval. A test report is submitted to the regulatory authority as a proof of presumption of conformity. The applicant may also be required to fill out other forms including the application form and submit other supporting documents as required by the regulatory authority.
The Type Approval documents produced by different authorities have many different names, but all essentially allow the product to be sold in the country. A Type Approval Certificate is sometimes also referred to as a Type Examination Certificate. - Example: Sometimes, the regulatory authority appoints a Certification Body (CB) that can conduct the test and provide an approval certificate on behalf of the regulatory authority. In the US, a Nationally Recognized Test Lab (NRTL) is authorized to conduct the product safety testing and issue the Type Approval Certificate for Product Safety. UL, one of the approved NRTLs, issues a certificate titled as a ‘Certificate of Compliance’, which is essentially a Type Approval Certificate for the US.
- Example: In another instance, the Voluntary Control Council for Interference by Information Technology Equipment (VCCI) of Japan, issues an ‘Acceptance of Report of Compliance’, which is an email sent to the applicant as a proof of EMC approval granted by the VCCI. For the purpose of shipping the product to Japan and clear the customs, although VCCI approval is voluntary, this email is considered an authentic approval, and therefore for all practical considerations, it should be considered equivalent to a Type Approval Certificate issued by the regulatory authority (VCCI).
- Example: National Regulator for Compulsory Specifications (NRCS) of S. Africa issues a ‘Letter of Authority’ for product safety, which is essentially a Type Approval Certificate. On the other hand, the South African Bureau of Standards (SABS) issues a ‘Certificate of Compliance’ for EMC, which is essentially a Type Approval Certificate for EMC.
- Example: The Communications & Information Technology Commission (CITC) of Saudi Arabia issues a ‘Conformity Certificate’ for Radio, which is essentially a Type Approval Certificate.
- Lab Certificate: When testing is conducted by a third-party test lab, the test report is sometimes accompanied with the Lab Certificate, where the Test Lab Manager declares the testing is performed on the specified product using a particular standard or set of standards, followed by the signature of the Test Lab Manager (or a Tester). A Test Report holds a high value, but a Lab Certificate is ceremonial in nature, and holds little value while shipping a product to a country, as the market where the product is shipped to recognizes only either a Type Approval Certificate or a Self-declaration – whatever is the country requirement - as a valid proof of approval.
- Critical Component List (CCL): The list of components having a higher probability of exerting a significant impact on the product safety of the system/module in which these components reside, is considered the CCL. The CCL originates from the IECEE CB Scheme’s standardized report format. Power Supplies, Fans, Optical transceivers, Disk drives, Cables, Connectors etc. are examples of critical components. The component characteristics and performance of these components are essential to maintain the integrity of product safety. Therefore, a CB Test Report as well as any other Test Report for product safety must publish a list of the critical components. If there are more than one supplier of a critical component, all suppliers must be identified upfront. It is a good practice to have the Type Approval Certificates of these critical components available during the evaluation of the product safety of the overall system/module as well as throughout the product life.
- Technical Documentation: According to the ‘Blue Guide’ of Official Journal of European Union, ‘Union harmonisation legislation obliges the manufacturer to draw up technical documentation containing information to demonstrate the conformity of the product to the applicable requirements.’1 Therefore, making the technical documentation available is a prerequisite to applying a CE Marking on the product, and placing the product on the market.
The Technical Documentation consists of multiple different documents in support of the requirements. In the marketplace, this group of documentation is also known as ‘Technical Construction File (TCF)’ or ‘Construction Data File (CDF)’.
B. Compliance Disciplines:
Product Safety, EMC, Radio, Telecommunications, Energy Efficiency, Restriction of Hazardous Substances (RoHS), etc. are the compliance disciplines. Following are clarifications around three important disciplines:
- EMC and Radio: As it relates to Product Regulatory Compliance, the Radio discipline is considered a subset of the EMC discipline! And yet, there is a separate focus on Radio/Spectrum in terms of the regulatory requirements. Following is a summary distinction of EMC and Radio:
- EMC is unintentional radiation of electromagnetic waves emanating from a subject product. The testing of this discipline includes measurement of both radiated and conducted emissions. Additionally, this discipline includes immunity testing to ensure that the product functions properly in its intended environment without any anomalies.
- Radio is intentional radiation of electromagnetic waves emanating from a subject product. The testing of this discipline determines how the intentional radiator performs without adversely affecting the radio spectrum.
- Restriction of Hazardous Substances (RoHS): The RoHS is now a requirement for EU, Taiwan, China, UAE, Saudi Arabia, India, Japan, Norway, Turkey, Brazil, EAEU, S. Korea etc. More countries are adopting this compliance requirement in alignment to the EU RoHS. The substances, formats, terminology, content, and product applicability of the Substance Disclosure Tables for some of the countries above differ from each other.
Therefore, it is important that the documents for RoHS requirements of different countries are identified separately for an easy and quick search and sharing compliance details for the relevant requirements.
C. Information required by test labs:
Before a test lab can provide a quote for the purpose of compliance testing, it needs to fully understand the product and the environment in which it will operate. The test labs typically ask the OEMs to provide the description of the product, schematic diagram, block diagram, mechanical assembly drawing, bill of materials, user manual, installation manual etc. More experienced manufactures may also submit the proposed test configuration and test plan for review and acceptance. This information helps the test labs ascertain the compliance requirements necessary to determine the type and extent of testing
Needs:
Using the standardized terminology across the compliance value chain will benefit the businesses throughout the product lifecycle.
An active participation of the compliance professionals in the industry events (IEEE, Product Safety, EMC etc.) through discussions, deliberations, presentations and publications may bring further clarifications and standardization of the compliance terms. Additionally, working with industry experts and consulting with the test labs will also help streamline and standardize the terms and their use, thus promoting a unified way of conducting business.