Sampling Plans for Microbiological Analysis

1

• Microbial Sampling for

• HACCP Verification

2

• Sampling for HACCP Verification and Validation

• Regulatory Requirements
• HACCP Plan Changes
• Determine if Plan is Controlling Hazards or to
  Audit Supplies

3

• Sampling Plans

• What is a sampling plan??
• Sampling Plan Should be a Written Document
• What to Include

4

• Types of Samples

• Sponge/Surface Samples
• Liquid Samples
• Solid Samples
• Sample Collection
• Sample Handling

5

• Sample Sizes

• 100 Assurance is NOT Possible
• Low Occurrence
• E. coli Example
• Data Interpretation

6

• REMEMBER

• NEGATIVE TESTS DO NOT GUARANTEE AN ABSENCE OF
  PATHOGEN, ONLY A CERTAIN AMOUNT OF CONFIDENCE
• THATS WHY WE USE HACCP PLANS!!!!

7

• Sample Sizes/Types

• For HACCP Verification and Validation, test for
  INDICATOR ORGANISMS
• Sample Collection Usually Described in
  Regulations or in USDA Guidebook or BAM
• Sampling Frequency
• Changing a CCP

8

• Decision Making Based on Testing

• Must Have Limits
• Determines Acceptable or Unacceptable
• Limits are Microbiological Criteria
• Guidelines
• Standards
• Purchase Specifications

9

• Randomness of Sample Collection

• Randomness Can Be Achieved a Number of Ways
• Pull Number out of a hat
• Computer Generated Numbers
• Random Number Tables
• Get a Random Number, Collect data from that
  specific package/area.
• Areas must be assigned a number

10

• Example Sampling Plan for

• Control of Listeria

• The Guidelines in this Plan Can Be Applied to
  Control of Other Pathogens

11

• Sampling for Listeria Control

• Ready to Eat Products-Product Intended to be
  consumed without any further safety preparation
  steps
• Process Categories-USDA
• Not Heat Treated - Shelf Stable
• Heat Treated - Shelf Stable
• Fully Cooked - Not Shelf Stable
• Product with Secondary Inhibitors - Not Shelf
  Stable (only RTE in this category)

12

• Sample Considerations

• Sample - a collection of product that represents
  a sampled lotthat has passed the establishments
  pre-shipment review. Must be in consumer-ready
  package and processed in the same manner as the
  rest of the lot
• Sampled Lot - all product produced under a
  single HACCP plan between performance (clean-up
  to clean-up)

13

• FSIS Policy

• HACCP Systems Verified
• Collecting and Testing RTE products for microbial
  hazards
• May test of Salmonella and/or E. coli O157H7
  from sample
• Positive Sample
• Corrective actions and Preventive measures must
  be taken
• Recall of product represented by sample

14

• FSIS Exemption from Sample Collection

• Establishment Tests AT LEAST one RTE product per
  HACCP plan for pathogen every month.
• OR
• Establishment tests one RTE product per HACCP
  plan once every 3 months AND
• Conducts on-going food contact surface and
  non-food contact surface testing for indicator
  organisms and
• Conducts targeted product testing for LM when a
  positive result for Listeria spp. occurs

15

• Protocol for Testing

• Establishment MUST have a written protocol for
  testing that includes
• Frequency of testing
• Randomness of sampling
• Recording of results
• Actions taken if positive
• Establishments must develop scientifically-based
  frequency for testing

16

• Testing Frequency

• Scientific Basis
• Journal Articles
• Recommendation from Scientific Experts
• Scientific Journal Articles
• FSIS Guidance Materials
• Establishment History

17

• Other Requirements

• Product Testing must be incorporated into the
  HACCP plan as an on-going verification activity
• Environmental and food-contact surface testing
  must be a part of sSOPs. It can be a part of the
  HACCP plan.
• Documentation to support testing protocol must be
  in the facility
• Preventive and corrective actions must be taken
  when a positive result occurs

18

• Environmental Monitoring

• Test for Generic Listeria/Listeria spp. as an
  Indicator of the Potential Presence of LM
• More Likely to Find. LM not frequently Found and
  Not Uniformly Distributed
• Non-Pathogenic
• Test Results Available More Quickly

19

• Common Reservoirs - Environmental

• Floors
• Drains
• Walls
• Ceilings
• Overhead Structures
• Catwalks

• Insulation
• Cleaning Tools
• Maintenance Tools
• Equipment Framework
• Condensate

20

• Areas To Test

• Support Structures
• Overhead Areas
• Walls
• Floors Drains
• Room Air
• Product Contact Surfaces

21

• Frequency

• Wet Areas weekly
• Dry Areas monthly or Bi-Monthly
• Over Time, Repeated Negative Results May Allow
  You to Reduce Frequency
• Composite Sampling Acceptable, but Further
  Testing Needed if Positive
• Sample Every Line on Weekly Basis
• Do Not Randomize
• Sample More Frequently During Construction

22

• Sampling Method

• Swab Sampling Acceptable, but Only Small Area
  Tested
• Sponge Sampling Strongly Recommended
• Use a Constant Area Each Time
• 2 ft x 2 ft
• 3 ft x 3 ft, etc.

23

• Actions

• A Positive Result for Generic Listeria Warrants
  Further Action
• Aggressively Sanitize Positive Areas and Re-Test
• Process and Environmental Conditions Should be
  Investigated to Determine Cause
• Sample and Test Areas Surrounding Positive Sample
• If After Aggressive Sanitation, Results are
  Negative then Plant Can Continue Routine
  Monitoring

24

• Actions

• Verify That Problem Has Been Corrected
• Sample Daily Until 3 Consecutive Negatives are
  Obtained

25

• Food Contact Surface Testing

• Frequency
• Weekly or When Environmental Testing Indicates
  Problem
• If Positive-
• Determine Cause
• Aggressively Sanitize and Re-Test Until Negative
• A modification of cleaning and sanitizing
  program, a redesign of equipment or employee
  retraining may be needed
• Product Testing Is Needed if Food Contact Surface
  is Positive

26

• Product Testing

• Frequency
• When Food Contact Surface is Positive
• Randomly on Scheduled Basis
• Monthly if NO Environmental Monitoring
• Every 3 Months if Environmental Monitoring Occurs
• All Lots Should be Held Until Test Results are
  Know
• REMEMBER LM is Random so one negative does not
  mean that all are negative

27

• Problem Solving

• Even with Effective Control Program, LM may
  become Established in a Niche
• Must Detect the Original Source or Nest

28

• Problem Solving

• Assemble all Data and Look For Patterns
• Note Sites,Date,Time, etc. where Positives Have
  Been Found
• LM Generally Flows Downstream
• Where Do First Positives Occur?
• Observe Flow Diagram

29

• Problem Solving

• During a Problem
• Sample More Frequently
• Do NOT Collect Composite Samples
• Sample Additional Sites Along Line
• Supplement With Product Testing Collected at
  Various Points in Process

30

• When Niche is Identified-

• Equipment
• Dismantle Equipment
• Collect and Analyze Samples from Areas that are
  Suspicious
• Clean and Sanitize Aggressively Before Reassembly
• If Chemical Sanitizers Ineffective then Steam/Hot
  Water may be Necessary

31

• LM Sampling Plans

• Must Be Written and Include Elements Previously
  Mentioned
• Must be a Part of HACCP and/or sSOPs in order to
  avoid FSIS product Testing
• Must be Scientifically Sound