Languages
Pages
Legal
NCDA&CS Sampling Agreement
Jim MelvinAssistant Director of Regulatory Programs
Audrey PilkingtonAssistant Director of Laboratory Services
North Carolina Department of Agriculture & Consumer Services
Food & Drug Protection Division
March 10, 2014
The Sampling Agreement…
1) must be developed in conjunction with the State manufactured food regulatory program
2) must outline a minimum number of samples, types of analyses, and frequency of testing that will be performed in support of the manufactured food regulatory program on an annual basis
3) consideration should also be given to sample collection4) must support the laboratory achieving, maintaining or
expanding the scope of ISO 17025 accreditation and the goals of the cooperative agreement program
5) must be risk-based and support the food safety priorities of FDA
6) manufactured food products regulated by FDA
ISO CAP Sampling Agreement ISO 17025 4.4 Review of requests, tenders and contracts
Developed in conjunction with the State MFR program 4.4.1.a) "the requirements... are adequately
defined, documented and understood" Number of samples...
...in support of the State
manufactured food
regulatory program
4.4.1.b) "the laboratory has the capability and resources (capacity) to meet the requirements"
Types of analyses... 4.4.1.c) "appropriate test method is selected and capable of meeting the customer's requirements"
Frequency of testing... 4.4.1.b) "the laboratory has the capability and resources to meet the requirements"
Consideration should also be given to sample collection.
4.4.1.c) "appropriate test method is selected and capable of meeting the customer's requirements"
Lab / Customer Relationship
Communication, Communication, Communication
Establish a point of contact
Establish a communication process • Email, conference calls, online meetings, face-to-face meetings
ISO CAP Sampling Agreement ISO 17025 4.4 Review of requests, tenders and contracts
Developed in conjunction with the State MFR program 4.4.1.a) "the requirements... are adequately
defined, documented and understood" Number of samples...
...in support of the State
manufactured food
regulatory program
4.4.1.b) "the laboratory has the capability and resources (capacity) to meet the requirements"
Types of analyses... 4.4.1.c) "appropriate test method is selected and capable of meeting the customer's requirements"
Frequency of testing... 4.4.1.b) "the laboratory has the capability and resources to meet the requirements"
Consideration should also be given to sample collection.
4.4.1.c) "appropriate test method is selected and capable of meeting the customer's requirements"
Risk-Based Surveillance Sampling
Surveillance vs. Inspectional Sampling
Surveillance Sampling - Sampling conducted to take a random snapshot of targeted products. Lot size unknown and the number of samples/subsamples is dependent on volume of product needed to perform analysis
Inspectional Sampling - Sampling conducted to validate possible violative conditions observed during an inspection or an investigation. Sample size and sampling plan critical to assure the the sample is representative of the lot being sampled.
NC Risk-Based Surveillance Sampling
NC Risk-Based Surveillance Sampling
NC Risk-Based Surveillance Sampling
Sample Collection
Surveillance Sampling ProcessInspector Reference the Target Survey Schedule• Review the Target Survey Sample Schedule for the
assigned list of products to be collected.• Some assignments may require specific direction
from the Surveillance Program Supervisor. This will be noted on the schedule.
Sample CollectionSurveillance Sampling Process
Collect Samples • Collect the assigned type of sample and the appropriate
number of sub-samples.
• Use aseptic sampling technique when collecting unpackaged samples that will be submitted for Micro testing.
• Unpackaged Retail Raw Ag products, Cilantro, and Packaged Raw Ag products without adequate code information on the package must be collected from an unopened case in the produce cooler so that complete product information can be recorded. Do not collect directly from the retail display case.
Sample Collection
Surveillance Sampling ProcessComplete submission information and submit sample • Enter all sample information into the Sample
collection database. • Complete the Chain of Custody Record• Pack and transport the sample per the Shipping
Refrigerated and Frozen Sample Procedure
Sample Collection - Chain of Custody
NCDA&CS Sampling Plan
Questions?
Contact Information
Jim MelvinAssistant Director of Regulatory Programs
NC Department of Agriculture & Consumer [email protected]
Audrey PilkingtonAssistant Director of Laboratory Services
NC Department of Agriculture & Consumer [email protected]
Top Related