December 1997 

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6. Identification and Traceability - 21 CFR 820.60 

The manufacturer is required to have written procedures for identifying products during all stages of receipt, production, distribution and installation to prevent mix-ups. The manufacturer has flexibility to identify product by whatever means they describe in their procedure. 

Review DHRs against the DMRs to assure the appropriate components were used in each stage of the manufacturing process. Further compare the DHRs against the incoming and in-process acceptance records to assure only acceptable (passed) product was used in each subsequent stage of the manufacturing process. 

For certain devices; 

a. Intended for surgical implant into the body, 

b. or to support or to sustain life, 

c. and whose failure when properly used in accordance with labeled instructions for use can be reasonably expected to result in a significant injury to the user, the manufacturer must have written procedures for identifying each unit, lot or batch of finished device or where appropriate components with a control number. The procedures should facilitate taking corrective action, and the identification must be documented in the DHR. 

This control number can be the same as the Identification number used to prevent mix-ups during manufacture or may be different. The control number is used for those devices that used to be defined as "critical." However, the list of "critical devices" was last updated in 1988 and there are no plans to update it. Therefore, the definition needs to be used to determine if a manufacturer has any devices that must meet this QS/GMP requirement. 

Traceability need only go the level of the initial consignee, which is the first person(s) outside of the manufacturer's control. This control number would be used to facilitate complaint investigations, recalls, market withdrawals, market corrections, etc. 

The traceability requirement should not be confused with the tracking regulation under 21 CFR 821. The tracking regulation requires certain devices to be tracked to the end user or patient through the entire distribution process. 

Components of a device subject to traceability requirements must be identified with a control number where appropriate. Manufacturers must define which components are to be identified with control numbers and provide justification for those that are not identified with control numbers. 

The manufacturer can utilize the definition of critical component in the original GMP regulation as guidance. However, they should perform some sort of risk analysis first on the finished device, and subsequently on the components of that device to make this determination. 

Manufacturers must evaluate their device and identify the components that "are essential to the proper functioning of the device" i.e. "critical." When an investigator chooses to challenge a manufacturer's selection or non-selection of a component as "essential to the proper functioning of the device," documentation for CDRH evaluation must be collected to support this challenge. 

The QS/GMP requires manufacturers to evaluate their suppliers and to evaluate their quality data for problems. One method of doing this, similar to the requirements in the old GMP, is to record the percentage of "essential" component rejects per lot, as well as the percentage of lots rejected. If the manufacturer has the raw accept/reject data in a form that can be evaluated to determine supplier performance, and is periodically doing this evaluation, this would be acceptable in lieu of recorded percentages.