Inspections, Compliance, Enforcement, and Criminal Investigations
Guide to Inspections of Low Acid Canned Food 42
Manufacturers - 2
Entry can be made by pen, pencil, or the pushing of a button on a keyboard. Record entry by a computer, and computer generated records are not acceptable to meet the requirements of the regulation unless the system has been reviewed and acknowledged in writing by CFSAN, to be sufficiently equivalent to a record system generated manually. Computer controlled retorts are acceptable if written records are kept in addition to computer generated records.
Not later than 1 working day after the actual process, and before shipment or release for distribution, a representative of plant management who is qualified by suitable training or experience must review all processing and production records for completeness and to ensure that the product received the scheduled process, including fill weight records or any other records recording critical factors pertaining to the process. The records, including the recording thermometer chart(s), must be signed or initialed and dated by the reviewer.
Per 21 CFR 113.100(d) records must be maintained to identify the initial distribution of the finished product to facilitate recall if necessary.
21 CFR 113.100(e) requires retention of all production and processing records (except those required under section 21 CFR 113.83 establishing scheduled processes), to be retained at the processing plant for a period of not less than 1 year from the date of manufacture, and at the processing plant or other reasonable accessible location for an additional 2 years. If, during the first year of the 3-year record-retention period, the processing plant is closed for a prolonged period between seasonal packs, the records may be transferred to some other reasonably accessible location at the end of the seasonal pack.
Although process establishment records are not required to be stored at the plant, they may be requested for review by FDA through issuance of a 'Written Request for Information', as referenced in Part 1 of this guide- Guide to Inspections of Low Acid Canned Food Manufacturers-Administrative Procedures\Scheduled Processes, under the 'Inspectional Authority' section.
The selection of production records for evaluation is determined by the firm's history of compliance, observations made during the physical inspection of the firm, initial review of records and review of the firm's process deviation file.
The minimum number of processing records to be reviewed can be determined by using the Statistical Sampling Schedule for Records Review (see Attachment 12). This method of record selection is used only for those firms in which no apparent deviations constituting a potential or an identified health hazard have been found. Using the random number table in attachment 12, a maximum of 7 days of production is selected for record review depending upon the number of days production over the previous 90 days. These records are examined to find out if unidentified process deviations have occurred, if the required process information is accurately recorded, if records have been reviewed and signed, and that other record keeping requirements have been met. In cases where record review suggests failure of the record keeping procedures, additional records may have to be selected from additional production days, and covering extended periods of production of up to 3 years to document the extent of the noted problem.
An additional method of record selection used by some experienced investigators, is to figure out the most likely time that the record keeping system will fail, (e.g., at the end of a shift, at the beginning of a production season, before a holiday, before a weekend, on the night shift, when additional shifts are added during seasonal production etc.). Records are then selected from those days and times when failures are most likely to occur. Record selection normally extends back over a three months to six months period for the products being covered during the inspection. In the event that record keeping failures are noted the number of records selected and the time period covered may have to be extended to document the extent of the problem. For example, if a major process failure is observed during the EI or record review (such as process deviations, seamer failure, swollen cans -observed or identified from consumer complaint, etc.) and the process failure is identifiable by record review, the records to be reviewed should bracket the time period during which the process failure occurred.
All lacf firms are required to maintain process deviation files. Examination of the process deviation files not only provides the investigator with areas of production that may need further evaluation but also may provide the investigator with clues as to the types of records to review during the inspection.
FDA 483 observations regarding record keeping deviations should include information that identifies the records involved, the date of the record, the product involved, the lot number(s) involved and the deviation from the record keeping requirement. Including the number of records examined and the number of records containing the deviation in the observation, helps to put the deviation in perspective for both the firm and the FDA reviewer.
Examples of deviations from record keeping requirements should be collected as exhibits to the inspection report. When the record keeping deviation is a recurring event over an extended