Product Documentation Compliance: Reduce Risk with a CCMS

Compliance and Documentation: What risks?

The European Commission recently published the latest version of its guide The ‘Blue Guide' on the implementation of EU product rules 2016 covering among other things the documentation produced.

The opportunity to come back to a few questions, notably via section 4.3. TECHNICAL DOCUMENTATION, on European requirements in terms of technical documentation...

What is the responsibility of the product manufacturer?

It must first be remembered that, except for a few very specific machines (pressure vessels, certain medical devices, measuring devices, etc.), this is a question ofself-certification. The manufacturer may therefore be liable if the documentation produced does not follow the rules.

These basic rules are simple:

• The manufacturer must prepare technical documentation;

• The technical documentation is designed to provide information on the design, manufacture and use of the product.

What are the requirements on this product documentation?

According to the Directive, documentation must meet specific criteria:

• The documentation shall demonstrate compliance of the product with the applicable requirements.

• Documentation is available at the time of placing the product on the market.

• It must be available for 10 years after a product is last placed on the market.

• It contains a risk analysis and how these risks are taken into account to ensure regulatory compliance.

And finally the different versions of the documentation, for the different versions of the product, must remain available. Indeed, when checking, you will have to present the correct version of the product documentation!

The most demanding point in this list is undoubtedly the analysis of risks and their consideration. A real methodology must be implemented (frequency, gravity, etc.) to identify them and reassure the public about the means used to prevent these risks.

What about the translations?

Again the common sense applies: the documentation produced should be in a language accepted by the customer, and understandable by a possible control body.

Writing tools structured to rescue

Fortunately, the structured authoring tools will enable a methodology to be put in place to minimising risks while industrializing production of this documentation on increasingly complex products, and evolving more and more rapidly:

• Collaborative work so that everyone can intervene on their skills in design, manufacturing or use;

• Collaborative work to identify and address risks;

• Traceability of changes and automatic history;

• Facilitation of translations.

The simple and efficient solution developed by NeoDoc : Calenco

Structured authoring tools exist but remain reserved for an elite of computer developers used to XML , XSLT , etc.

With over 12 years of experience in technical writing, NeoDoc has developed CALENCO a simple, easy-to-use solution by non-informatics professionals.

Many of NeoDoc's major customer accounts (EDF, SNCF, Bouygues, General Electric...), as well as SMEs/PMI hardware manufacturers (Carrier , Tecnoma, Saint Gobain ...) quickly adopted the Calenco solution for the drafting of technical documents.

Benefits and benefits of the Calenco solution

• Productivity gain: Industrialize document production by optimizing reusable content;

• Customize documentation according to user profile, product, destination country etc.;

• Quickly produce product documentation : Time to market ;

• Automatically update all documentation from a single source;

• Disseminate up-to-date product documentation on various media (Paper, PDF, Web, Tablets ..);

• Ensure consistent and consistent quality in compliance with the company's graphic charter.

The Calenco solution is available in SaaS mode, accessible to any type of company faced with the complexity of technical writing whatever its size... from a single user.

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