ANNEXDetailed rules on good manufacturing practice

F1B.Quality assurance system for plastic recycling processes covered by Regulation (EC) No 282/2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006

1.

The quality assurance system implemented by the recycler must give adequate confidence in the capability of the recycling process to ensure the recycled plastic meets the requirements in the authorisation.

2.All the elements, requirements and provisions adopted by the recycler for his quality assurance system must be documented in a systematic and orderly manner in the form of written policy statements and procedures.

That quality system documentation must permit uniform interpretation of the quality policy and procedures, such as quality programmes, plans, manuals, records and measures taken to ensure traceability.

It must include, in particular:

  1. (a)

    a quality policy manual, containing a clear definition of the recycler’s quality objectives, the organisation of the business and in particular the organisational structures, the responsibilities of the managerial staff and their organisational authority where manufacture of the recycled plastic is concerned;

  2. (b)

    the quality control plans, including those for input and recycled plastic characterisation, suppliers’ qualification, sorting processes, washing processes, deep cleansing processes, heating processes, or any other part of the process relevant for the quality of the recycled plastic including the choice of points which are critical for the quality control of the recycled plastics;

  3. (c)

    the managing and operative procedures implemented to monitor and control the whole recycling process, including the inspection and quality assurance techniques at all the manufacturing stages, especially the establishment of critical limits at the points which are critical for the quality of the recycled plastics;

  4. (d)

    the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired recycled plastic quality, including control of products which fail to conform;

  5. (e)

    the tests and analytical protocols or any other scientific evidence applied before, during and after recycled plastic production, the frequency with which they will take place, and the test equipment used; it must be adequately possible to trace back the calibration of the test equipment;

  6. (f)

    the recording documents adopted.