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Compliance Folders

Introduction:

Compliance Folders are now becoming the norm, to document and track the Regulatory Compliance of many types of products

The format of the Compliance Folder can be either paper or electronic, or any combination of the two. Different countries have different requirements for the contents of the Compliance Folder. The Compliance Folder must document the productís Electromagnetic Compatibility (EMC), Safety, and Telecom (if applicable) regulatory compliance.

Today, Australia and the European Union mandate the use of a Compliance Folder to validate Self-Declaration. The United States and Canada have adopted a similar method of Self-Declaration for Telecommunications Terminal Equipment.

What is a Compliance Folder?

Definition: A Compliance Folder is a collection of Test Reports, Test Certificates, Declarations of Conformity, and other associated documents which prove that a product conforms, and continues to conform, to the relevant Regulatory Requirements.

The Compliance Folder must contain the relevant documents that fully substantiate a Declaration of Conformity, which states that the product meets the appropriate and applicable regulatory requirements when examined by an independent Surveillance Authority. At present, the Compliance Folder scheme is always linked to self-certification regulatory schemes.

The manufacturer must choose the applicable regulatory standards, (or determine to which Network Operating Specification(s) the product will be designed and interwork), conduct type testing to these requirements, obtain compliant Test Reports, and publish a Declaration of Conformity. All documents that were generated during conformity assessment, including the Declaration of Conformity and all user documentation, are used for generation of the Compliance Folder.

History of the Compliance Folder

Australia: The Compliance Folder concept was first initiated in Australia, when the Australian Communications Authority (ACA) introduced Telecom Compliance by Self-Declaration. This was an entirely new approach to conformity assessment, since it placed the responsibility on the manufacturer to choose the standards to which the product would be assessed, and then to obtain the test reports against the chosen standards.

 Once testing is completed and compliant test reports are generated, the manufacturer produces a Declaration of Conformity stating that the product is compliant, applies the A Tick Mark, and places the product on the Market. This new process bypasses assessment of the Test Reports by the ACA and does not require the manufacturer to obtain a license from the ACA. Although, there is a supplier registration process that must be completed before the ĎAí tick mark can be applied.

All documents that were generated during conformity assessment, including the Declaration of Conformity and all user documentation, are used for generation of the Compliance Folder. The ACA audits the Compliance Folder to ensure that the manufacturerís product is compliant with the relevant standards and the proper testing to verify compliance has been conducted.

United States, FCC Part 15 for ITE and TTE: The FCC has implemented a similar scheme for Information Technology and Telecommunications Terminal Equipment Emissions, to reduce time to market. Again, the manufacturer is responsible for obtaining a compliant Test Report from an FCC Authorized Test Lab prior to declaring the product compliant and applying the FCC Part 15 Label. The compliant EMC Test Report must be made available to the FCC upon request.

European Union, EMC Directive (amended by 93/68/EEC): The "Electromagnetic Compatibility" (EMC) Directive uses Self-Declaration, for various types of equipment, as one of the Conformity Assessment routes.

European Union, Low Voltage Directive (amended by 93/68/EEC): The Low Voltage (LV) Directive uses Self-Declaration, for various types of equipment, as one of the Conformity Assessment routes. Annex IV requires a Technical Documentation File to be kept and maintained by the manufacturer.

European Union, R&TTE Directive: The "Radio and Telecommunications Terminal Equipment" (R&TTE) Directive uses Self-Declaration for Radio Equipment, Satellite Ground Station Equipment and Telecommunications Terminal Equipment as one of the Conformity Assessment routes. Annex II requires a Technical Documentation File to be kept and maintained by the manufacturer.

Any EU Member Stateís Market Surveillance Authority may ask to review the product's Compliance Folder at any time, once the product is placed on the market. If the product is found to be non-compliant by any Market Surveillance Authority, the manufacturer can be directed to remove the product from all EU Member States' markets. The bottom line: if the product is not compliant, the risk of lost revenues could be enormous.

Product Life Cycle - Extending the Range of the Compliance Folder

A natural extension of the Regulatory Compliance Folder concept is also to incorporate product changes, which could or did affect the EMC, Safety, and Telecom product compliance. By maintaining a Change Control Log within the Compliance Folder, all Engineering Change Orders that could or did affect the products compliance can also be tracked. Thus, all product changes and modifications that affect regulatory compliance, and any compliance validation testing, can be included in the productís Compliance Folder.

Compliance Folder Contents

Australia, the Compliance Folder contents can be summarized as follows:

  •     Original Declaration of Conformity

  •     A copy of the statement incorporated in documentation supplied with the item setting out specifications for the correct installation and operation of the item.

  •     A test report made by a recognized testing authority against applicable standards

  •    Current model number and related model numbers of the system

  •    Photograph of the equipment clearly identifying various modules and models that make the complete equipment (if test report does not have it)

  •     A reference to the version of any software that is incorporated in the customer equipment

  •     A list of all modular pieces of equipment that can be used with the base item

  •    Technical specifications of the item (if manual supplied does not have them)

  •    Circuit diagram(s) (optional)

  •     User / Installation Manual which must contain specifications for the correct installation product. If the installation or operation can by configured by the user, in a way which will not be compliant with the applicable standards, then such a warning must be placed in the User / Installation Manual.

United States, FCC Part 15 EMC:

  •     Class A equipment: A compliant verification test report is required for the Compliance Folder. After which, the User / installation manual needs to have the required statements included and the product needs to have the proper marking statement applied.

  •     Class B equipment: A compliant test report is required for the compliance folder. After which, the User / installation manual needs to have the required statements included and the product needs to have the FCC label properly applied.

 European Union, R&TTE Directive (Annex II, Module A) & LV Directive (Annex IV):

The manufacturer must generate all necessary technical documentation and the manufacturerís authorized EU representative must retain the technical documentation for at least ten years after the last product has been manufactured. The manufacturer, or his authorized EU representative, creates a written Declaration of Conformity and then affixes the CE marking to each product.

The technical documentation must substantiate the productís conformity to the essential requirements to which it was originally assessed. The technical documentation must cover the design, manufacture and operation of the product to include:

  •    A general description of the product;

  •    Conceptual design and manufacturing drawings and schemes of components, subassemblies, circuits, etc.;

  •    Descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product;

  •     A list of the standards referred to in the applicable Directive, applied in full or in part, and descriptions and explanations of the solutions adopted to meet the essential requirements of the Directive where such standards have not been applied or do not exist;

  •     Results of design calculations made, examinations carried out, etc.;

  •    Test reports.

The manufacturer, or his authorized EU representative, must maintain a copy of the productís Declaration of Conformity with the technical documentation. The manufacturer must take all measures necessary to ensure that the manufacturing process does not violate or negate the compliance of the manufactured product.

Manufacturing Quality Systems

One of the major problems with maintaining a productís regulatory compliance over the productís life cycle is concerned with inconsistencies within the manufacturing quality system. By documenting the product specific manufacturing requirements, purchasing requirements and floor procedures into a Product Specific Quality Plan, the total product quality and continuation of compliance can be ensured.

 The Product Specific Quality Plan can be incorporated into the Compliance Folder to support this essential requirement of the European Unionís R&TTE Directive

Why Should A Compliance Folder Be Generated?

Many of our clients still maintain large paper depositories for product regulatory compliance documentation. However, once the Regulatory Engineer moves to another company or takes a new position, usually the contents of large metal file cabinets become obscure to anyone attempting to extract specific test reports or test certificates for a given product. Thus, the metal file cabinetís role is one of storage of paper documents, however many times the product has fallen out of compliance without anyone realizing what has happened.

Electronic Compliance Folders

Electronic Compliance Folders are the way of the future. Each product or class of similar products may have its own Compliance Folder. By use of hyperlinks, the Compliance Folder can be organized for easy review by any knowledgeable Regulatory Engineer, the engineering manager, or Market Surveillance Authority. Using hyperlinks, any document can be easily located and either viewed on screen, transmitted electronically to any remote location for on site printing, or printed locally.

We have conducted studies that support the cost effectiveness of scanning all regulatory compliance documents onto a hard drive or CD-ROM for archival storage. This makes the process of locating a particular document faster, and it can be transmitted electronically to any location in the world for on site printing.

As the cost of hard drives continues to plummet, and CD-ROM Media can be purchased for one US Dollar, maintaining compliance folders on Magnetic Media or CD-ROM media becomes extremely cost effective. The payback for investing in a high-speed scanner, CD-ROM Burner, and associated software is usually less than 2 years. With scanners that can process 30 pages per minute, we can now maintain clientís Compliance Folders and all relevant Regulatory and Industry Standards on the same CD-ROM.

The final Compliance Folder CD-ROM needs to be organized in such a manner that, when copied to an internal Intranet Server, all of the hyperlinks remain pointing to their respective target files.

Conclusion

The most difficult part of the compliance process is developing a consistent approach to the generation of the initial Electronic Compliance Folder. Necessary foresight of how to keep the Compliance Folder up-to-date over the productís life cycle is required, while maintaining backward traceability of any product changes.


Author biography Ė David Patton, President Patton & Associates, Inc. received his Bachelor of Science in Electrical Engineering from Oklahoma State University in 1969. Mr. Patton was employed at Honeywell Defense Systems between 1969 and 1977 in the design of high speed data modems, secure voice, and voice recognition equipment for connection to the PSTN, Military Networks, and Private Networks. Mr. Patton was Director, Advanced Computer Network Systems between 1977 and 1982 where he directed the development and implementation of advanced computer network maintenance systems.

Telecommunications Regulatory Compliance
patton@patton-assoc.com       Tel +1.928.771.2900 USA

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Last updated: February 25, 2010
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