One check sample result that is determined to be a statistical outlier (according to Grubbs Test for statistical outliers) will result in a letter asking the laboratory to review its process and make any necessary corrections. If corrections are found necessary, they and their corrective action will be reported to the Program Manager and the ACP.
Two consecutive unsatisfactory (outliers) results in 10 consecutive check samples, regardless of the approval year, and the laboratory will be required to analyze an additional sample. If the result of the additional sample is also unsatisfactory, a discussion between the laboratory and the Program Manager will be held and an on-site review may follow. If an on-site review is necessary in addition to the yearly review, the laboratory will be responsible for the travel and per diem expenses of the reviewer.
Three consecutive unsatisfactory analyses in 10 consecutive check samples, regardless of the approval year, will result in the involuntary removal of the laboratory from the program if a resolution cannot be found and implemented.
Three intermittent unsatisfactory analyses in 10 consecutive check samples, regardless of the approval year, will result in a discussion between the laboratory and the Program Manager. An on-site review may follow as may suspension of USDA’s approval until corrective action has been taken and the laboratory has demonstrated its ability to correctly analyze samples.
(B) International proficiency check sample program: All approved laboratories are required to participate in an international proficiency check sample program in pistachios, at least once a year, and provide the final report on results to the Program Manager for review upon request.
Annual On-site Laboratory Review
All participating laboratories will have an annual announced or unannounced laboratory review by S&T personnel. The review will include all of the elements of the initial on-site review. The laboratory will receive a laboratory review report. Within five working days of receiving the report from USDA, the laboratory must provide acknowledgement of receipt of the report to the Program Manager. Within 20 working days of receiving the report, the laboratory must confirm that all necessary changes have been implemented and provide supporting documents to the Program Manager.
The Program Manager may approve an extension that would allow the laboratory a maximum of 45 working days to complete necessary changes. Laboratories failing to provide the required written responses to USDA or failing to implement corrective actions for non-conformance items within the agreed timeframes will be suspended from the program.
Notification of Laboratory Changes
If a laboratory wishes to modify an approved method or equipment, it must conduct a complete method validation study and submit all of the validation data to the Program Manager for approval. Additionally, the laboratory must inform the Program Manager when the following changes occur:
- Personnel (such as analyst, contact person, manager, etc)
- Ownership-Transfer of ownership of laboratory operations in the same building will require maintenance of previous laboratory quality assurance and other laboratory records to be transferred as well for auditor review [Note: a laboratory relocating to a new building will require reapplication for new entry into the approved program.]
Payment of Maintenance Fee
A non-refundable maintenance fee is $5,750.00 for each approval year. The fee must be paid in full in order for the laboratory to continue operating as an approved laboratory. This fee permits the laboratory to operate as an approved laboratory for one year. The fee will be reviewed yearly, and if necessary, adjusted to meet USDA operational costs.