Product documentation and EC compliance: What are the risks?

The European commission recently published the latest version of its guide "The Blue Guide on the implementation of EU product rules 2016 ", covering product documentation, among other things.

An opportunity to revisit several issues, notably via section "4.3. TECHNICAL DOCUMENTATION", on European requirements regarding technical documentation...

Prévenir des dangers

What is the product manufacturer's responsibility?

First of all, we must remember that in all but a few very specific machines (pressure vessels, certain medical devices, measurement devices, etc.), it's a question of self-certification. The manufacturer may thus be held responsible if the documentation does not follow the rules.

These basic rules are simple:

  • The manufacturer must develop technical documentation

  • Technical documentation is designed to supply information on the design, manufacturing and use of the product.

What are the requirements for this product documentation?

According to the directive, the documentation must meet very precise criteria:

  • The documentation proves the conformance of the product with applicable requirements.

  • The documentation is available at the time the product is put on the market

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

  • It contains an analysis of the risks associated with the product and how these risks are taken into account to assure compliance with regulations.

An lastly, the various versions of the documentation for various versions of the product must remain available. In fact, during an inspection, the correct version of the documentation must be presented!

The most demanding point in this list is, without a doubt, the analysis of risks and their coverage. A veritable methodology must be established (frequency, severity...) to list them and reassure the public of the steps taken to counter these risks.

And translations ?

Here again common sense applies: product documentation should be in a language that is accepted by the customer, and comprehensible by a potential oversight body.

Structured writing tools to the rescue

Luckily, structured writing tools are going to establish a methodology to minimize risks while standardizing production of this documentation for products that are increasingly complex and changing at a rapid pace.

  • Working collaboratively, so that everyone can take part depending on his skills in terms of conception, manufacturing or use;

  • Working collaboratively to determine risks and counter them;

  • Modification tracking and automatic logging;

  • Facilitating translations.

The simple and effective solution developed by NeoDoc: Calenco

Structured writing tools exist, but remain reserved for elite computing developers, accustomed to languages such as XML, XSLT, etc.. With more than 12 years' experience in technical writing, NeoDoc developed simple-to-use tools, easy for non-computing experts to use. Many of NeoDoc's large account clients (EDF, SNCF, Bougues, General Electric...), as well as small to medium-sized manufacturers of equipment (Carrier, Tecnoma, Saint Gobain...) quickly adopted the Calenco solution for writing technical documents.

They are motivated by gains in productivity, reassured by how easy it is to deploy and use, and how uncompromising it is with regard to the safeguarding of content disseminated on various media (paper, PDF, screens, tablets...) The Calenco solution is available in SaaS mode, accessible to any type of company confronted with the complexity of technical writing no matter its size.. starting with one user.

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