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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
product’s 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 ‘A’ 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 manufacturer’s 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 State’s 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 product’s 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
manufacturer’s 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 product’s 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
product’s 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 product’s regulatory compliance over
the product’s 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 Union’s 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 cabinet’s 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 client’s 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
product’s life cycle is required, while maintaining backward traceability of
any product changes.
Author biography
– 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.
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