FDA tentatively concludes that it is appropriate to apply the requirements of part 11 to the records that would be required to be kept under proposed part 507. However, the Agency requests comment on whether there are any circumstances that would warrant not applying part 11 to records that would be kept under proposed part 507. For example, would a requirement that electronic records be kept according to part 11 mean that current electronic records and recordkeeping systems would have to be recreated and redesigned, which the Agency determined to be the case in the regulation "Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (69 FR 71562,
2. Proposed SEC 507.102(a)(2)
Proposed SEC 507.102(a)(2)would require that records contain the actual values and observations obtained during monitoring. It is neither possible to derive the full benefits of a preventive controls system, nor to verify the operation of the system, without recording actual values and observations to produce an accurate record. Notations that monitoring measurements, such as heat treatment temperatures, are "satisfactory" or "unsatisfactory," without recording the actual times and temperatures, are vague and subject to varying interpretations and, thus, will not ensure that controls are working properly. In addition, it is not possible to discern a trend toward loss of control without actual measurement values.
3. Proposed SEC 507.102(a)(3), (a)(4), and (a)(5)
Proposed SEC 507.102(a)(3), (a)(4), and (a)(5) would require that records be accurate, indelible, and legible (proposed SEC 507.102(a)(3)); be created concurrently with performance of the activity documented (proposed SEC 507.102(a)(4)); and be as detailed as necessary to provide a history of work performed (proposed SEC 507.102(a)(5)). Proposed SEC 507.102(a)(3) and (a)(4) would ensure that the records are useful to the owner, operator, or agent in charge of a plant or facility in complying with the requirements of proposed part 507, for example, in documenting compliance with monitoring requirements and verifying compliance with the food safety plan. These proposed requirements would also ensure that the records would be useful to FDA in determining compliance with the requirements of proposed part 507. Proposed SEC 507.102(a)(5) would provide flexibility to plants and facilities to tailor the amount of detail to the nature of the record.
4. Proposed SEC 507.102(b)
Proposed SEC 507.102(b)would require that the records include: (1) The name and location of the plant or facility; (2) the date and time of the activity documented; (3) the signature or initials of the person performing the activity; and (4) where appropriate, the identity of the product and the production code, if any. The name and location of the plant or facility and the date and time would allow the owner, operator, or agent in charge of a plant or facility (and, during inspection, an FDA investigator) to assess whether the record is current, to identify when and where any deviation occurred, and to track corrective actions. The signature of the individual who made the observation would ensure responsibility and accountability. In addition, if there is a question about the record, a signature would ensure that the source of the record will be known. Linking a record to a specific product (and, when applicable, the production code) would enable the owner, operator, or agent in charge of a facility to isolate product that has not been processed properly when there has been a problem, thereby limiting the impact of the problem (such as the need to reprocess product or to recall product) to only those lots with the problem.
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