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Sampling Plans

Susanne Dahms

IAFP, San Diego, 2002

Overview

Introduction

Sampling plans: Design and means to study their

performance

• Two-class attributes plans for qualitative data

• Two-class and three-class attributes plans for

grouped quantitative data

• Variables plans for quantitative data

Microbiological sampling plans and Food Safety

Objectives

Summary

ICMSF Books on Microbiological

Sampling Plans

Microorganisms in Foods 2.

Sampling for Microbiological Analysis: Principles and

Specific Applications.

(2nd ed. 1986, University of Toronto Press, out of

print)

Topics:

The statistical principles underlying attributes

sampling plans and their application to foods.

ICMSF Books on Microbiological

Sampling Plans

Microorganisms in Foods 7.

Microbiological Testing in Food Safety Management.

(2002, Kluwer Academic/Plenum Publishers)

Topics:

Concepts of probability and sampling

Appropriate sampling plans

Selection of cases and attributes plans

Establishing micro criteria for lot acceptance

ICMSF Cases

handling/preparation on the hazard, and intended population

reduce hazard cause no change increase hazard

in hazard

Utility Case 1 Case 2 Case 3

Types of Microbiological Sampling

Plans

Attributes plans:

Qualitative analytical results (presence/absence) or

quantitative results that have been grouped

(e.g. <10 cfu/g, 10 to 100 cfu/g, >100 cfu/g)

Variables plans:

Non-grouped quantitative analytical results

Require distributional assumptions be made

Two-Class Attributes Sampling Plans

acceptance or rejection of a lot consist of

independently and randomly from the lot

m – a microbiological limit (i.e. in cfu/g);

a sample is defined to be positive, if its microbial

content exceeds this limit

c – maximum allowable number of sample units

yielding a positive result (presence/absence testing)

or exceeding the microbiological limit m;

for pathogens c is usually set to 0

OC Curve for Two-Class Plans

two-class sampling plans:

Probability of lot acceptance calculated for possible

proportions defective in lot

Acceptance probability

Plot of OC curve to visualize

sampling plan performance

dependency on n and c

Proportion defective

Probability of Acceptance by Proportion Defective

1.0

n=5, c=0

0.8

Probability of Acceptance

0.6 P(rejection)

0.4

0.2

P(acceptance)

0.0

Proportion Defective

Probability of Acceptance by Proportion Defective

1.0

P(acceptance)=95%

n=5, c=0

0.8

Probability of Acceptance

0.6

0.4

0.2

P(rejection)=95%

0.0

Proportion Defective

Probability of Acceptance by Proportion Defective

1.0

n=5, c=0

0.8 n=10, c=0

n=20, c=0

Probability of Acceptance

0.6

0.4

0.2

0.0

Proportion Defective

Three-Class Attributes Sampling Plans

n – number of sample units to be chosen

independently and randomly from the lot

m – a microbiological limit that separates good

quality from marginally acceptable quality

M – a microbiological limit above which sampling

results are unacceptable or defective

c – maximum allowable number of sample units

yielding results between m and M (marginally

acceptable);

the number of sample units allowed to exceed M is

usually set to 0

OC Function for Three-Class Plans

three-class plans:

Probability of lot acceptance depending on two

proportions

marginally acceptable: between m and M

defective: above M

Acceptance probability

ta bl e

c ce p

a l lya

in

OC function plotted as a arg

rop. m

P

three-dimensional graph

Proportio

n defectiv

e

Client - meeting - _____ - 13

OC Curve Referring to Mean Log CFU/G

Distributional assumption for sampling results

e.g. log-normal with standard deviation known from

previous experience

Frequency Distribution Describing Lot Quality

0.6

mean

0.5 s.d.: standard deviation

(=0.8)

0.4

Probability Density

0.3

s.d. s.d.

0.2

0.1

0.0

0 1 2 3 4 5 6

Log cfu/g

OC Curve Referring to Mean Log CFU/G

Distributional assumption for sampling results

e.g. log-normal with standard deviation known from

previous experience

Determine proportions acceptable,

(marginally acceptable), and defective

for possible mean log cfu/g

Two-class sampling plan:

0.6

m

0.5

0.4

Probability Density

0.3

0.1

0.0

0 1 2 3 4 5 6

Log cfu/g

Three-class sampling plan:

0.6

m M

0.5

Probability Density

acceptable

0.3

0.2

0.1

Proportion

defective

0.0

0 1 2 3 4 5 6

Log cfu/g

OC Curve Referring to Mean Log CFU/G

Distributional assumption for sampling results

e.g. log-normal with standard deviation known from

previous experience

Determine proportions acceptable,

(marginally acceptable), and defective

for possible mean log cfu/g

Calculate acceptance probabilities and

plot against mean log cfu/g

m

Probability Density

Log cfu/g

m

1.0

Proportion defective, pd

0.8

0.6

0.4

0.2

0.0

1.0

0.8

0.6

pd

0.4

0.2

0.0

P(accept)

OC curve

n = 10,

c=2

Probability of acceptance

1.0 pd

0.8

0.6

0.4

0.2

0.0

Probability of Acceptance by Mean Log cfu/g (s.d.=0.8)

1.0

0.8

Probability of Acceptance

0.6

0.4

0.2

P(rejection)=95%

0.0

-2 -1 0 1 2 3 4

Mean Log cfu/g

Probability of Acceptance by Mean Log cfu/g (s.d.=0.8)

1.0

0.8 n=10, c=0, m=100 cfu/g

n=20, c=0, m=100 cfu/g

Probability of Acceptance

0.6

0.4

0.2

0.0

-2 -1 0 1 2 3 4

Mean Log cfu/g

Probability of Acceptance by Mean Log cfu/g (s.d.=0.8)

1.0

0.8 n=10, c=0, m=100 cfu/g

n=20, c=0, m=1 cfu/g

Probability of Acceptance

0.6

0.4

0.2

0.0

-2 -1 0 1 2 3 4

Mean Log cfu/g

Probability of Acceptance by Mean Log cfu/g (s.d.=0.8)

1.0

0.8 n=10, c=0, m=100 cfu/g

n=20, c=0, m=1 cfu/g

Probability of Acceptance

0.6

0.4

0.2

0.0

-2 -1 0 1 2 3 4

Mean Log cfu/g

Performance of Sampling Plans

location of critical lot qualities (95% probability of

rejection, 95% probability of acceptance)

depend on

Plan specifications n and c

Microbiological limits m and M

Probability of Acceptance by Mean Log cfu/g, s.d.=0.8

1.0

Two-Class Plan:

0.8

n=5, c=1,

m=1000 cfu/g

Probability of Acceptance

n=5, c=1,

m=1000 cfu/g,

0.4 M=10 000 cfu/g

0.2

0.0

Mean Log cfu/g

Probability of Acceptance by Mean Log cfu/g, s.d.=1.2

1.0

Two-Class Plan:

0.8

n=5, c=1,

m=1000 cfu/g

Probability of Acceptance

n=5, c=1,

m=1000 cfu/g,

0.4 M=10 000 cfu/g

0.2

0.0

Mean Log cfu/g

Probability of Acceptance by Mean Log cfu/g

3-Class Plan: n=5, c=1, m=1000 cfu/g, M=10000 cfu/g

1.0

s.d.=0.8

0.8 s.d.=0.4

s.d.=0.2

Probability of Acceptance

0.6

0.4

0.2

0.0

Mean Log cfu/g

Performance of Sampling Plans

location of critical lot qualities (95% probability of

rejection, 95% probability of acceptance)

depend on

Plan specifications n and c

Microbiological limits m and M

Standard deviation s.d.

Difference M-m in relation to s.d.

ICMSF Three-Class Plans: Mean CFU/G

Rejected With 95% Probability

n=5, c=3 n=5, c=2 n=5, c=1

5128 cfu/g 3311 cfu/g 1819 cfu/g

n=5, c=3 n=5, c=1 n=10, c=1

3311 cfu/g 1819 cfu/g 575 cfu/g

With:

m = 1000 cfu/g, M = 10 000 cfu/g,

and standard deviation s.d. = 0.8

ICMSF Three-Class Plans: Mean CFU/G

Accepted With 95% Probability

n=5, c=3 n=5, c=2 n=5, c=1

138 cfu/g 115 cfu/g 63 cfu/g

n=5, c=3 n=5, c=1 n=10, c=1

115 cfu/g 63 cfu/g 35 cfu/g

With:

m=1000 cfu/g, M=10 000 cfu/g,

and standard deviation s.d.=0.8

ICMSF Two-Class Plans: Mean CFU/G

Rejected With 95% Probability

n=5, c=0 n=10, c=0 n=20, c=0

1 cfu / 32g 1 cfu / 83g 1 cfu / 185g

n=15, c=0 n=30, c=0 n=60, c=0

1 cfu / 135g 1 cfu / 278g 1 cfu / 526g

With:

m = 0 cfu / 25g,

and standard deviation s.d. = 0.8

ICMSF Two-Class Plans: Mean CFU/G

Accepted With 95% Probability

n=5, c=0 n=10, c=0 n=20, c=0

1 cfu / 1515g 1 cfu / 2439g 1 cfu / 3846g

n=15, c=0 n=30, c=0 n=60, c=0

1 cfu / 3125g 1 cfu / 4761g 1 cfu / 7142g

With:

m = 0 cfu / 25g,

and standard deviation s.d. = 0.8

Variables Sampling Plans: Design

quantitative analytical results (i.e. log cfu/g).

Specifications:

Number of sample units: n

Acceptable quality limit: V (in log cfu/g)

Maximum proportion above V: p0

Probability to accept a non-conforming lot: α

Variables Sampling Plan (s.d.=0.8)

0.6

Mean0 = V - u1-p0 * s.d.

0.5 V: acceptable

quality limit

0.4

Probability Density

0.3

0.2

p0: acceptable

0.1 proportion

defective

0.0

0 1 2 3 4 5 6

Log cfu/g

Variables Sampling Plans: Decision Rule

confidence interval to estimate true lot mean.

For acceptable lots the estimate is expected to be

lower than mean0 corresponding to V and p0.

Decision rule:

Rejection of lot, if average + k * s.d. > V

Acceptance of lot, if average + k * s.d. <= V

k is depending on n, p0, and α.

Sampling Plans and FSOs: Example

salmon at time of consumption

No inactivation, growth assumed not to occur

case 11: n = 10 samples with c = 0 and m = 100 cfu/g

No inactivation, growth assumed to occur

case 12: n = 20 samples with c = 0 and m = 100 cfu/g

CODEX ALIMENTARIUS COMMISSION, August 2001, CX/FH 01/6 ANNEX 3.2

Client - meeting - _____ - 39

Performance of Sampling Plans for

Listeria Monocytogenes

Mean cfu/g rejected with 95% probability: 30 cfu/g

Mean cfu/g accepted with 95% probability: 1 cfu/g

Mean cfu/g rejected with 95% probability: 13 cfu/g

Mean cfu/g accepted with 95% probability: 0.5 cfu/g

Lot quality rejected with 95% probability (s.d.=0.8)

0.6

Case 11: 2-class plan, n=10, c=0, m=100 cfu/g

0.5 m = FSO

Probability Density

0.4

0.3

0.2 26%

0.1

0.0

-1 0 1 2 3 4

Log cfu/g

0.6

Case 12: 2-class plan, n=20, c=0, m=100 cfu/g

0.5 m = FSO

Probability Density

0.4

0.3

0.2 14%

0.1

0.0

-1 0 1 2 3 4

Log cfu/g

Variables Sampling Plans and FSOs

salmon; FSO = 100 cfu/g at time of consumption

Variables Plan:

Number of sample units: n = 10

Acceptable quality limit: V = FSO = 100 cfu/g

Maximum proportion above V: p0 = 5%

Probability to reject a non-conforming lot: 1-α = 95%

L. m. number in sample can be reliably quantified !

Summary (1)

and adopted (e.g. microbiological criteria), their

implications are not fully understood:

Hypothesis tested

Reliability of decision

Performance: steepness of OC curve / stringency,

quality rejected / accepted with given, say 95%,

probability

Justification of number of samples, n

Summary (2)

of a frequency distribution for sample results

even attributes plans can be used to assess mean

microbiological concentrations in lots of foods.

Performance depends on:

Sampling plan specifications (attributes plans: n and c)

Microbial limits set (attributes plans: m and M)

Validity of assumptions for the frequency distribution

(standard deviation s.d.)

Reliability and precision of the analytical technique

Summary (3)

performance and its statistical background is

required to use them effectively,

for instance,

to design sampling plans that are in agreement

with given Food Safety Objectives.

www.icmsf.org

Client - meeting - _____ - 45

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