Standard Methods For Acrediatation

NATIONAL STANDARD METHOD
GUIDANCE NOTE
RECOMMENDED MINIMUM
INTERNAL QUALITY CONTROL
IN FOOD MICROBIOLOGY
TESTING LABORATORIES
QSOP 18
Issued by Standards Unit, Evaluations and Standards Laboratory

Centre for Infections
RECOMMENDED MINIMUM INTERNAL QUALITY CONTROL IN FOOD MICROBIOLOGY TESTING LABORATORIES

Issue no: 4.2 Issue date: 01.09.05 Issued by: Standards Unit, Evaluations & Standards Laboratory Page 1 of 10
Reference no: QSOP 18i4.2
This SOP should be used in conjunction with the series of SOPs from the Health Protection Agency
www.evaluations-standards.org.uk
Email: standards@hpa.org.uk
STATUS OF NATIONAL STANDARD METHODS
National Standard Methods, which include standard operating procedures (SOPs), algorithms and
guidance notes, promote high quality practices and help to assure the comparability of diagnostic
information obtained in different laboratories. This in turn facilitates standardisation of surveillance
underpinned by research, development and audit and promotes public health and patient confidence
in their healthcare services. The methods are well referenced and represent a good minimum
standard for clinical and public health microbiology. However, in using National Standard Methods,
laboratories should take account of local requirements and may need to undertake additional
investigations. The methods also provide a reference point for method development.
National Standard Methods are developed, reviewed and updated through an open and wide
consultation process where the views of all participants are considered and the resulting documents
reflect the majority agreement of contributors.
Representatives of several professional organisations, including those whose logos appear on the
front cover, are members of the working groups which develop National Standard Methods. Inclusion
of an organisation’s logo on the front cover implies support for the objectives and process of preparing
standard methods. The representatives participate in the development of the National Standard
Methods but their views are not necessarily those of the entire organisation of which they are a
member. The current list of participating organisations can be obtained by emailing
standards@hpa.org.uk.
The performance of standard methods depends on the quality of reagents, equipment, commercial
and in-house test procedures. Laboratories should ensure that these have been validated and shown
to be fit for purpose. Internal and external quality assurance procedures should also be in place.
Whereas every care has been taken in the preparation of this publication, the Health Protection
Agency or any supporting organisation cannot be responsible for the accuracy of any statement or
representation made or the consequences arising from the use of or alteration to any information
contained in it. These procedures are intended solely as a general resource for practising
professionals in the field, operating in the UK, and specialist advice should be obtained where
necessary. If you make any changes to this publication, it must be made clear where changes have
been made to the original document. The Health Protection Agency (HPA) should at all times be
acknowledged.
The HPA is an independent organisation dedicated to protecting people’s health. It brings together the
expertise formerly in a number of official organisations. More information about the HPA can be found
at www.hpa.org.uk.
The HPA aims to be a fully Caldicott compliant organisation. It seeks to take every possible precaution
to prevent unauthorised disclosure of patient details and to ensure that patient-related records are
kept under secure conditions1.
More details can be found on the website at www.evaluations-standards.org.uk. Contributions to the

development of the documents can be made by contacting standards@hpa.org.uk.
Please note the references are now formatted using Reference Manager software. If you alter or delete text
without Reference Manager installed on your computer, the references will not be updated automatically.
Suggested citation for this document:

Health Protection Agency (2005). Recommended Minimum Internal Quality Control in Food
Microbiology Testing Laboratories. National Standard Method QSOP 18 Issue 4. http://www.hpa-
standardmethods.org.uk/pdf_sops.asp.

INDEX
STATUS OF NATIONAL STANDARD METHODS ................................................................................ 2
INDEX...................................................................................................................................................... 3
AMENDMENT PROCEDURE ................................................................................................................. 4
1.0 INTRODUCTION ........................................................................................................................ 5
2.0 ACCREDITATION SCHEME REQUIREMENTS ....................................................................... 5
3.0 GENERAL REQUIREMENTS.................................................................................................... 5
4.0 PREPARATION OF SERIAL DILUTIONS ................................................................................ 6
5.0 PREPARATION OF SPIKED SAMPLES .................................................................................. 6
6.0 DUPLICATE TESTING .............................................................................................................. 6
7.0 REPLICATE TESTING .............................................................................................................. 7
8.0 DETECTION METHODS............................................................................................................ 7
9.0 ENUMERATION METHODS...................................................................................................... 7
CONTACT ............................................................................................................................................... 9
REFERENCES ...................................................................................................................................... 10

AMENDMENT PROCEDURE
Controlled document QSOP 18
reference
Controlled document title Standard Operating Procedure for Recommended Minimum Internal
Quality Control in Food Microbiology Testing Laboratories
Each National Standard Method has an individual record of amendments. The current amendments
are listed on this page. The amendment history is available from standards@hpa.org.uk.
On issue of revised or new pages each controlled document should be updated by the copyholder in
the laboratory.
Amendment Issue no. Insert Page Section(s) involved Amendment

Number/ Discarded Issue
Date no.
5/ 4.1 4.2 1 Front page Redesigned
01.09.05
2 Status of document Reworded
4 Amendment page Redesigned

GUIDANCE NOTE ON THE RECOMMENDED
MINIMUM INTERNAL QUALITY CONTROL IN
FOOD MICROBIOLOGY TESTING
LABORATORIES
1.0 INTRODUCTION
1.1 This Guidance Note makes recommendations for the minimum internal
quality control (IQC) that food microbiology testing laboratories should
implement to meet UKAS requirements.
2.0 ACCREDITATION SCHEME REQUIREMENTS
2.1 Accreditation schemes stipulate some requirements for IQC. UKAS

accreditation requires laboratories to have quality control procedures for
monitoring the validity of tests undertaken1.
3.0 GENERAL REQUIREMENTS
3.1 Each member of staff should aim to process at least one IQC sample per year
for each UKAS accredited test for which they are trained. This is to
demonstrate ongoing competency and to demonstrate that each method is
giving satisfactory performance. Staff who are not trained in an entire method
should process the parts in which they are competent.
3.2 Laboratories should also aim to perform IQC tests at a frequency related to
their level of sample testing.
3.3 Results should be recorded on worksheets. Copies of the worksheets may be

stored in the individual members of staff training records or reference made to
them to provide traceability.
3.4 All unexpected results should be investigated and corrective action taken
where required2. Investigations and actions should be documented.
3.5 Although this Guidance Note recommends preparing suspensions of

organisms from reference cultures an alternative to this is to use ready
prepared materials deemed suitable for the purpose. Such samples should
provide a standardised inoculum at any pre-determined count for the required
organisms.
3.6 EQA samples can also be used to demonstrate competence and method
performance.

4.0 PREPARATION OF SERIAL DILUTIONS
Serial dilutions are prepared as follows:
4.1 Inoculate 1ml of an overnight broth culture (approximately 109 cfu/ml) of the
target organism into 9ml of a suitable diluent (eg maximum recovery diluent) to
give a 10-1 dilution. Using a separate pipette for each dilution, prepare serial
10-fold dilutions to 10-7.
4.2 Perform a colony count on the serial dilution to calculate the actual cfu/ml of
organisms.
5.0 PREPARATION OF SPIKED SAMPLES
Spiked samples are prepared as follows:
5.1 To prepare a spiked sample containing approximately 102 cfu/g add 2ml of the
10-6 d dilution to 225ml of food suspension (225ml of diluent containing 25g of
food).
5.2 To prepare a spiked sample containing approximately 104 cfu/g add 2ml of the
10-4 dilution to 225ml of food suspension (225ml of diluent containing 25g of
food).
5.3 To prepare a spiked sample containing very low numbers (10-100) of cfu/25g
add 1ml of the 10-7 dilution to 225ml of food suspension (225ml of diluent
containing 25g of food). For detection methods the food is suspended in pre-
enrichment or enrichment media.
NOTE: any food matrix used to prepare spiked samples should be sterile
or have a very low background count or be negative for the target
organism.
NOTE: Preparation of spiked food samples should not be done in the

routine food laboratory. For details see Health Protection Agency
guidance note on avoiding cross-contamination risks in the food
laboratory3.
6.0 DUPLICATE TESTING
6.1 Duplicate spiked or real samples should be set up and tested by different staff
if possible. Processing duplicate samples using different staff allows variation
between staff to be monitored as well as between different portions of the
same sample.
6.2 One set of results from duplicate samples should be designated in advance to
be used for reporting. The other should be used for comparison only. An
exception to this may be where duplicate testing forms part of the test protocol
agreed with the customer, in which case the mean result should be used. If
the results differ then the designated senior member of staff should be
notified.
6.3 Duplicate counts from enumeration procedures should fall within 0.5 log10.
7.0 REPLICATE TESTING
7.1 Guidance on replicate testing used to estimate the uncertainty of testing is

documented4.
8.0 DETECTION METHODS
Spiked samples for detection methods are processed as follows:
8.1 For detection methods such as Campylobacter, Escherichia coli O157,

Listeria, Salmonella and Vibrio species.
8.1.1 Prepare a spiked sample containing very low numbers of cfu/g (see 5.3) of
one of the following organisms:
• Campylobacter jejuni NCTC 11322

• Escherichia coli O157 NCTC 12900 *
• Listeria monocytogenes NCTC 11994
• Salmonella poona NCTC 4840
• Vibrio parahaemolyticus NCTC 10885
NOTE: If a verocytotoxin producing strain of E.coli is used then cultures

must be handled in containment level 3.
8.1.2 Process according to the specific test method(s) for the target organism.
8.1.3 For detection methods, isolation of the target organism indicates that the
method has worked satisfactorily. If the organism has not been isolated then
the process should be repeated using two or more spiked samples
9.0 ENUMERATION METHODS
Spiked samples for enumeration methods are processed as follows:
9.1 For enumeration methods such as aerobic colony count, coliforms,

Escherichia coli, Listeria species, and Staphylococcus aureus.
9.1.1 Prepare a spiked sample containing 102 cfu/g (see 5.1) of each of the
following organisms:

• E. coli NCTC 9001
• L. monocytogenes NCTC 11994
• S. aureus NCTC 6571
9.1.2 Process according to the following specified test method(s):
• Aerobic colony count at 30oC/48h

• Enumeration of coliforms/E. coli
• Enumeration of Enterobacteriaceae
• Enumeration of Listeria species
• Enumeration of S. aureus
9.2 For enumeration methods such as Bacillus cereus and Clostridium

perfringens.
• B. cereus NCTC 7464

• C. perfringens NCTC 8237
9.2.2 Process according to the following specified test method(s):
• Colony count at 30oC/48h

• Enumeration of B. cereus and other Bacillus species
• Enumeration of C. perfringens
9.3 For enumeration methods such as yeasts and moulds.
• Saccharomyces cerevisiae NCPF 3178

• Aspergillus niger NCPF 2275
9.3.2 Process according to the following specified test method:
• Enumeration of yeasts and moulds
9.4 For enumeration methods, counts should be compared with those expected to
ensure adequate recovery and check that calculations are correct.
Laboratories should have a range for acceptable counts (eg within 0.5 log of
expected count) that allows for a decision to be made as to whether the test
has passed or failed.

CONTACT
Any queries relating to this Guidance Note should be made to:
Valerie M Bevan, Director, Evaluations & Standards Laboratory

Sam Gillanders, Head of Standards Unit, Evaluations & Standards Laboratory

REFERENCES
1
BS EN ISO 17025:2000. General requirements for the competence of
testing and calibration laboratories. British Standards Institution, London
2
Health Protection Agency. Guidance Note: Procedure for dealing with
presumptive pathogens isolated from ready-to-eat foods. QSOP 37;
London: 2003
3
Health Protection Agency. Guidance Note: Avoiding cross contamination
risks in the food laboratory. QSOP 12; London: 2003
4
Health Protection Agency. Guidance Note: Uncertainty of measurement
in testing. QSOP 4; London: 2003


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NATIONAL STANDARD METHOD

Issued by Standards Unit, Evaluations and Standards Laboratory

RECOMMENDED MINIMUM INTERNAL QUALITY CONTROL IN FOOD MICROBIOLOGY TESTING LABORATORIES

More details can be found on the website at www.evaluations-standards.org.uk. Contributions to the

Suggested citation for this document:

RECOMMENDED MINIMUM INTERNAL QUALITY CONTROL IN FOOD MICROBIOLOGY TESTING LABORATORIES

STATUS OF NATIONAL STANDARD METHODS ................................................................................ 2

AMENDMENT PROCEDURE ................................................................................................................. 4

1.0 INTRODUCTION ........................................................................................................................ 5

2.0 ACCREDITATION SCHEME REQUIREMENTS ....................................................................... 5

3.0 GENERAL REQUIREMENTS.................................................................................................... 5

4.0 PREPARATION OF SERIAL DILUTIONS ................................................................................ 6

5.0 PREPARATION OF SPIKED SAMPLES .................................................................................. 6

6.0 DUPLICATE TESTING .............................................................................................................. 6

7.0 REPLICATE TESTING .............................................................................................................. 7

8.0 DETECTION METHODS............................................................................................................ 7

9.0 ENUMERATION METHODS...................................................................................................... 7

RECOMMENDED MINIMUM INTERNAL QUALITY CONTROL IN FOOD MICROBIOLOGY TESTING LABORATORIES

Amendment Issue no. Insert Page Section(s) involved Amendment

4 Amendment page Redesigned

RECOMMENDED MINIMUM INTERNAL QUALITY CONTROL IN FOOD MICROBIOLOGY TESTING LABORATORIES

2.0 ACCREDITATION SCHEME REQUIREMENTS

2.1 Accreditation schemes stipulate some requirements for IQC. UKAS

3.0 GENERAL REQUIREMENTS

3.3 Results should be recorded on worksheets. Copies of the worksheets may be

3.5 Although this Guidance Note recommends preparing suspensions of

RECOMMENDED MINIMUM INTERNAL QUALITY CONTROL IN FOOD MICROBIOLOGY TESTING LABORATORIES

Serial dilutions are prepared as follows:

5.0 PREPARATION OF SPIKED SAMPLES

Spiked samples are prepared as follows:

NOTE: Preparation of spiked food samples should not be done in the

6.0 DUPLICATE TESTING

7.0 REPLICATE TESTING

7.1 Guidance on replicate testing used to estimate the uncertainty of testing is

8.0 DETECTION METHODS

Spiked samples for detection methods are processed as follows:

8.1 For detection methods such as Campylobacter, Escherichia coli O157,

• Campylobacter jejuni NCTC 11322

NOTE: If a verocytotoxin producing strain of E.coli is used then cultures

9.0 ENUMERATION METHODS

Spiked samples for enumeration methods are processed as follows:

9.1 For enumeration methods such as aerobic colony count, coliforms,

RECOMMENDED MINIMUM INTERNAL QUALITY CONTROL IN FOOD MICROBIOLOGY TESTING LABORATORIES

9.1.2 Process according to the following specified test method(s):

• Aerobic colony count at 30oC/48h

9.2 For enumeration methods such as Bacillus cereus and Clostridium

• B. cereus NCTC 7464

9.2.2 Process according to the following specified test method(s):

• Colony count at 30oC/48h

9.3 For enumeration methods such as yeasts and moulds.

• Saccharomyces cerevisiae NCPF 3178

9.3.2 Process according to the following specified test method:

• Enumeration of yeasts and moulds

RECOMMENDED MINIMUM INTERNAL QUALITY CONTROL IN FOOD MICROBIOLOGY TESTING LABORATORIES

Any queries relating to this Guidance Note should be made to:

Valerie M Bevan, Director, Evaluations & Standards Laboratory

RECOMMENDED MINIMUM INTERNAL QUALITY CONTROL IN FOOD MICROBIOLOGY TESTING LABORATORIES

RECOMMENDED MINIMUM INTERNAL QUALITY CONTROL IN FOOD MICROBIOLOGY TESTING LABORATORIES

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