NCDA&CS Sampling Agreement

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NCDA&CS Sampling Agreement. Jim Melvin Assistant Director of Regulatory Programs Audrey Pilkington Assistant Director of Laboratory Services North Carolina Department of Agriculture & Consumer Services Food & Drug Protection Division . March 10, 2014. The Sampling Agreement… . - PowerPoint PPT Presentation

Transcript of NCDA&CS Sampling Agreement

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NCDA&CS Sampling AgreementJim MelvinAssistant Director of Regulatory Programs

Audrey PilkingtonAssistant Director of Laboratory Services

North Carolina Department of Agriculture & Consumer ServicesFood & Drug Protection Division

March 10, 2014

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The Sampling Agreement

must be developed in conjunction with the State manufactured food regulatory programmust 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 basisconsideration should also be given to sample collectionmust support the laboratory achieving, maintaining or expanding the scope of ISO 17025 accreditation and the goals of the cooperative agreement programmust be risk-based and support the food safety priorities of FDAmanufactured food products regulated by FDA

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Lab / Customer Relationship

Communication, Communication, Communication

Establish a point of contact

Establish a communication process Email, conference calls, online meetings, face-to-face meetings

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Risk-Based Surveillance SamplingSurveillance 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.9

NC Risk-Based Surveillance Sampling

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NC Risk-Based Surveillance Sampling

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NC Risk-Based Surveillance Sampling

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Sample CollectionSurveillance Sampling ProcessInspector Reference the Target Survey ScheduleReview 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.

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Sample CollectionSurveillance Sampling ProcessCollect 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. 14

Sample CollectionSurveillance Sampling ProcessComplete submission information and submit sample Enter all sample information into the Sample collection database. Complete the Chain of Custody RecordPack and transport the sample per the Shipping Refrigerated and Frozen Sample Procedure15

Sample Collection - Chain of Custody

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NCDA&CS Sampling PlanQuestions?17

Contact Information

Jim MelvinAssistant Director of Regulatory ProgramsNC Department of Agriculture & Consumer [email protected]

Audrey PilkingtonAssistant Director of Laboratory ServicesNC Department of Agriculture & Consumer [email protected]

18ISO CAP Sampling AgreementISO 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 program4.4.1.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"

ISO CAP Sampling AgreementISO 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 program4.4.1.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"