The provider identifies, designs and plans the activities that directly affect the validity of the scheme and carries them out to prescribed procedures, considering relevant standards for the objectives (for example the laboratory, medical laboratory and inspection body standards) and safety and ethical issues. Before introducing a significant change that can affect validity, such as a new item production approach, a new homogeneity or stability assessment, a new way of setting the assigned value, new statistics or a new activity type, it identifies and manages the risk so validity is maintained. A documented plan is developed before the scheme starts, addressing its objectives, purpose and basic design and including, with reasons for selection or exclusion where appropriate: the personnel involved; external providers' activities and contacts; participation criteria; how many participants of what type are expected; the activities participants perform and results they report; the expected range of values or characteristics of the items; the major potential sources of error; requirements for producing, quality-controlling, storing and distributing items; arrangements against collusion and falsification and the procedure if suspected; the information supplied to participants and the schedule; for continuous schemes the distribution dates, result deadlines and test dates; any methods participants are required to use for storing, handling, preparing, shipping or disposing of items and for performing tests; the methods for homogeneity, stability and where applicable biological viability testing; standardised reporting formats; a detailed account of the statistics to be applied; the origin, traceability and uncertainty of assigned values (including contributions from inhomogeneity, instability and interlaboratory differences); the treatment of results from different methods; performance evaluation criteria; the data, interim reports or information returned to participants; the extent to which results and conclusions will be made public; and actions for lost, delayed or damaged items.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.