“Fit For Use”

Jim MelvinAssistant Director of Regulatory ProgramsNorth Carolina Department of Agriculture

and Consumer Services

3/12/148:00 A.M.

What happens to Programs when their Knowledge Base leaves?

In a two year period after June 2010, NCDA&CS experienced the following staff losses:

•Joe Reardon, (29 yrs.) Director >FDA•Wendy Campbell, (8 years) RRT PI> FDA•Larry Gabriel, (35 yrs.) Assistant Director>Retired•Anita MacMullan, (17 yrs.) Compliance Supervisor>FDA•Brett Weed, C and P Administrator>FDA•Erin Coleman, Reg. Program Coordinator>FDA•Johnny Peele, (38 yrs.)Reg. Supervisor>Retired•Eddie Radford, (20 yrs.) Reg. Supervisor>Transferred to Drug Program•Tommy Harold, (30 yrs.) Dairy Supervisor>Retired

What happens to Programs when their Knowledge Base leaves?

How do I assure continuity of operations when 180 years of knowledge disappears?

The answer is to have documented processes that: –Define your regulatory processes, –That are “fit for use” in carrying out job task, –That can be utilized to train new employees –That can be utilized as a base to make the same

regulatory decisions as you did before.

Fit for UsePURPOSE

Why is this procedure needed and what will be accomplished by executing it?

The purpose of this procedure is to describe the Target Survey Sample program and the process to be followed when collecting products assigned per the Target Survey Sample Schedule.

Fit for UseSCOPE

What does this procedure apply to?

This procedure applies when field inspectors collect assigned products according to the Target Survey Sample Schedule.

Fit for UseRESPONSIBILITY

Who are the responsible parties and what are their roles?

Director – The Director shall review this procedure and issue final approval with a signature in the Approval/Document History section.Assistant Director - The Assistant Director shall review this procedure and issue approval with a signature in the Approval/Document History section.Food Regulatory Supervisors - The Food Regulatory Supervisors will ensure that Food Regulatory Specialists are trained in this procedure. Food Regulatory Specialists (FRS) – Food Regulatory Specialists will perform the task described in this procedure.

Fit for Use

RELATED DOCUMENTS What other documents are needed to be able to execute this procedure?

Walk-In Samples ProcedureSample Packaging and Security ProcedureShipping Refrigerated and Frozen Samples Procedure

Fit for UseREFERENCES

What laws, regulations or rules are utilized to authorize the actions defined in this procedure?

Federal Food, Drug, and Cosmetic Act (FD&C Act)

Fit for UseDEFINITIONS

What is the meaning of specialized terms used in the procedure?

Target Survey Sampling Program - A routine surveillance sampling program of products available at retail level designed to evaluate the efficacy of good agricultural and manufacturing practices. The inspector collects the assigned products from retail firms on a regular basis and submits those products for testing to the laboratory.

Target Survey Sample Schedule and Criteria– A three month schedule of sample assignments which details the category of product to be collected, the number and size of samples to be collected, and the Requested Analysis to be assigned on the sample collected

Sub-samples – Multiple containers or units of the same product bearing the same code and package size.

Fit for UseEQUIPMENT/MATERIALS NEEDED

What equipment and materials will be needed for the inspector to perform this procedure?

• Laptop and Bar Code Printer• Gloves• Hand Sanitizers• Permanent Marker and Pens Sterile Whirl-Pak Bags• Packing Tape, Plastic Bags for Packing Samples• Insulated Coolers and Cold Packs• Division Supplied Packaging Materials• Sample Shipment Form/Chain of Custody Record and Supplemental

Page

Fit for Use

PROCESS DESCRIPTIONWhat steps are to be taken to perform the procedure?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 main office supervisor. This will be noted on

the schedule.

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.

Pack Samples for shipment to the laboratory – Pack samples in accordance to department procedures.– If collecting samples in a refrigerated or frozen state, pack and ship in accordance with department

procedures specifically addressing refrigerated or frozen.

Contact Information

Jim Melvin

Assistant Directory of Regulatory Programs

NCDA&CS Food and Drug Protection Division

Email: jim.melvin@ncagr.gov