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 Servicesjim.melvin@ncagr.gov

Audrey PilkingtonAssistant Director of Laboratory Services

NC Department of Agriculture & Consumer Servicesaudrey.pilkington@ncagr.gov