Identifying equipment with R2 equipment categories (REC)

Under requirement 6.(b)(1) how can equipment be “identified” with its corresponding R2 equipment category if a physical label is not required, and how would this be audited?

In some cases, REC categories can be tracked to individual items through barcodes, serial number tracking, or other tracking mechanisms already maintained by the R2 Facility. However, the categories do not need to be applied to individual pieces of equipment, components or materials, and instead can be assigned to specific processing and storage areas, where the proper handling and movement of the items through the process can be used to demonstrate the categorization.  Sometimes this identification can be accomplished by using a special type of bin, rack or location that the items are stored in, where they are then physically moved to different locations, racking, etc. once processed.  Auditing of REC categorizations will include examining the conditions taken into account to determine the categorization and ensuring that the items are handled accordingly and follow the proper R2 processing pathway.

It is also important to note that the REC categories will change as items are processed.  As a result, the R2 Facility must effectively manage any changes in categories to ensure the correct REC status is identified at all times throughout the receipt, processing and shipment of items.

The first step in this process under Core 6.(a)(2) is for the R2 Facility to document the applicable REC Categories, or other correlated categories, used for any items under the control of the R2 Facility.  Next, any points in the process or operations where the categories may need to be re-evaluated for any changes in REC Category must be identified.  For example, a work instruction or matrix may be developed to identify the REC categories used, the points at which they may change, and the subsequent categorization possibilities and processing pathways based on the evaluation.  This may include a change from an R2 Controlled Stream to Unrestricted Stream for non-FMs after being removed and segregated from other devices and materials; or a change from Pre-Sanitization to Non-Data after devices are successfully data sanitized.

The REC Applicability Examples guidance provides an overview of how equipment and material categories can change at different points throughout processing.