Guide to Control Plans

This page was last updated on 21st June 2022

Monitoring Activities

EU Regulation 2018/858 Annex IV paragraph 3 requires the authority issuing an approval to monitor the manufacturer’s conformity controls.  That section and the clauses in some of the individual regulations also require the authority – when not satisfied with the manufacturer’s assurance of conformity – to select samples and subject them to type approval tests. A good understanding between the manufacturer and VCA will establish arrangements where such special action is the exception.

VCA has a responsibility to periodically monitor the implementation of the control plan arrangements.  This will normally be by visiting the sites where the actions are carried out (as certain Regulations require – though other arrangements may be agreed).  Records of decisions, actions or results should be retained for a realistic period (which can be agreed with VCA).  In the case of ECE Regulations this should be at least 10 years.  Several aspects will be relevant to the monitoring activity, for example:

1. monitoring arrangements will review any changes which the manufacturer has made to the initial control plan with particular reference to aspects discussed above;
2. the frequency of monitoring will be kept to a minimum and will be discussed according to the plan content, any specific legislative requirement and previous review findings;
3. where some of the controls outlined are to be carried out by a supplier VCA may wish to verify that the supplier and the products or services concerned are acceptable to the manufacturer as defined within the quality system (e.g., is on an approved suppliers list, with an appropriate rating, with oversight by the CoP holder to ensure tests and checks are being conducted)