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Product Compliance in the EU: Guidance On Creating Technical Files

by Renaud Anjoran on 9 Apr 2018

If you are an importer in the European Union, are you aware of your obligations related to product compliance? Do you know that you need to keep a technical file about every product you place on the market for at least 10 years?

In this post, we'll give you some technical file guidance to help you stay compliant, and will also show how the SynControl quality inspection software can handle the task of building and retaining the files for you... 

What should you be keeping track of for product compliance?

The very basic fields you will need on a technical file are:

  • Product name and unique identifier
  • Supplier name
  • Status (accepted, waiting for some documents…)
  • Date of release of that product on the market
  • Expiration of the technical file
  • Any keywords you might need, in your searches later on (this is particularly valuable if you buy a high number of SKUs)

 

OK, but I'm not in the EU. Does this affect me?

If you are located outside of the EU, you might not be concerned right now, but holding records like this might well become a requirement in the years to come. Having your paperwork in order is always a good thing. Especially in the USA, where missing documents can be seen as a sign of negligence and can cause your liability to skyrocket.

 

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How does SynControl's product compliance function work then?

In SynControl, these fields are shown as headers in the list of technical folders:

list of technical folders in syncontrol

You also need to organize your technical files (think of “chapters”). Here is an example of sections and sub-sections:

technical file sections and sub sections in syncontrol

Obviously, this needs to be configured based on the product categories you buy, and what you’ll need to show your country’s market surveillance authorities should they come and visit you.

 

Do I honestly need quality inspection software though?

No. You can use an Excel file for this, with a link to a folder on a shared drive. That’s perfectly fine for a few products, but be warned, it quickly becomes cumbersome.

Here's an example. If you manage product compliance in an Excel file, you will be able to ‘delegate’ some of the work to your suppliers and your service providers.

A workflow can be set up this way:

  1. You open a new technical file and choose what documents are needed.
  2. You request the supplier, or your testing laboratory partners, to upload some of the documents.
  3. As these documents are uploaded, they are “new”, and after verification you can can set them as “accepted”.
    workflow setup in syncontrol
  4. You keep track of who uploaded what document, when, and what comments they wrote.
    Comments and ID uploaded to syncontrol
  5. You can retrieve that information easily, anytime in the future, with a simple search.

The risks of using a manual product compliance management system

However, the risks of using a manual compliance management solution like Excel sheets are: Users might make typos, or might be so busy they forget to keep it updated. And, in those cases, you might not find what you need.

A good searching & filtering feature is extremely important. Here are 2 examples:

    • You might want to filter all the files and find those “pending for upload," in order to push the suppliers.
    • You might need to search and locate a file very fast, if there is an issue and/or the market surveillance authority comes knocking on your door.
    • You might want to filter the files by expiration date, in order to take action before it is too late.

If that IT tool doubles as your quality inspection software, the factory audits and the product inspection reports will automatically become part of the technical file. No more looking in email messages!

 

Have your say...

Are you using a manual compliance system, or perhaps not at all? What issues or concerns do you have? 
Please let us know by leaving a comment below and we'll be glad to respond.


 

How to manage quality inspectors

Topics: product compliance

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About the Author

Renaud Anjoran

Renaud has 10 years of experience in the quality and manufacturing fields and is a certified ISO 9001 lead auditor and ASQ certified quality engineer. He was quoted in the New Yorker and the LA Times, and his articles have been published in Quality Progress, Business Insider, and more. His role is to ensure SynControl really solves customer's problems and saves them money.

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