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ASSESSOR CHECKLIST: FOOD MICROBIOLOGY PROGRAM
REQUIREMENTS
June 2001
The following pages present the criteria from the “Food Microbiology Program Requirements” in
a checklist format. The laboratory’s policies and procedures must meet these requirements.
Quality System documentation and supporting records must be available for the assessor’s
review.
Laboratory Instructions: If the requirements include the need for a written policy, procedure or
arrangement, that requirement statement in this checklist is shaded. It is strongly suggested that
the laboratory complete the document reference identifiers in the checklist’s second column
(labeled “Reference”) for each shaded requirement. The appropriate “reference” can include
quality manual, laboratory manual, SOP, record, etc. references. The references provided should
specify procedure number, page number and section number, where possible. Every checklist
item should be accompanied by a tick mark in the yes (Y), no (N) or not applicable (NA) space.
Assessor Instructions: Review the laboratory’s documented quality system to verify compliance
with the applicable Food Microbiology Program documentation requirements. Assess to verify
that the documented quality system is indeed implemented as described. Record comments
related to any requirement in the space provided and sign on the appropriate line on page 2.
Assess the laboratory’s technical competence to perform specific tests or specific types of tests.
Record comments related to tests on the Test Method Matrix. Additional comments can be noted
on the draft scope(s) or supplement. All deficiencies must be identified and explained in the
assessor deficiency report.
Laboratory Name: _______________________________________________________________
City: _______________________________________________________ State: _____________
Date: ______________________
Lab Code: ______________________
Assessment ID: ______________________
Certificate #(s): ______________________
Assessor(s) Name(s): _____________________________________________________________
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Food Microbiology Program Requirements Checklist
I, hereby, attest that all laboratory document references below as well as actual laboratory practice have been assessed for compliance with the A2LA Food
Microbiology Program Requirements. Any areas of noncompliance have been fully described in the Assessor Deficiency Report.
Assessor Signature: _________________________________________________________________________ Date: ____________________________
Compliance
REQUIREMENT
Y N NA
Document Reference Comments
4. Management Requirements
Organization (No Additions)
Quality System
For multi-functional laboratories, those sections of
the quality manual pertaining specifically to the food
microbiology laboratory shall be easily identifiable.
Document Control (No Additions)
Review of Requests, Tenders and Contracts (No Additions)
Subcontracting of Tests (No Additions)
Purchasing Services and Supplies (No Additions)
Service to the Client (No Additions)
Complaints (No Additions)
Control of Nonconforming Testing (No Additions)
Corrective Action (No Additions)
Preventive Action (No Additions)
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Control of Records
All records shall be traceable to the sample
and testing performed including the equipment,
materials, calibration, maintenance, performance
verifications, environmental data and analyst(s). All
records shall allow traceability through the following
progression of events:
Sampling (where applicable)
↓
Sample Receipt and Check-In
↓
Sample Preparation
↓
Sample Handling, Storage and Disposal
↓
Sample Analysis
↓
Equipment Performance (CRC, proficiency
checks, daily checks)
↓
Calibration Records (CRC)
↓
Analyst Training (RM, proficiency checks)
↓
Media Performance (CRC, RC)
↓
Final Results
↓
Review of Results
↓
Issuance of Report (via mail, fax or electronic
transmission)
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Internal Audits
The laboratory shall conduct an internal audit on
an annual basis. All audit records shall be kept in the
laboratory.
Management Reviews (No Additions)
5. Technical Requirements
General (No Additions)
Personnel
The laboratory shall have a selection procedure
and training system to ensure technical competence of all
staff members. Microbiological testing shall be done by or
supervised by a competent microbiologist or technician.
For the purposes of this document, there are two types of
laboratories: full service laboratories and limited service
laboratories.
In full service laboratories (where most
organisms – if not all – of significance to foods are
tested) there shall be a trained, competent supervisory
microbiologist on staff having at least a Bachelors
Degree in microbiology, food science or a related
discipline with at least two years of laboratory
experience. The person filling this position shall have
successfully completed at least 20 credit hours in
microbiology, public health, food safety or other
related topics.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
In small, limited service laboratories (usually of
no more than 5 people; where 1-3 tests are performed) the
technician performing the tests or supervising the tests shall
be trained with demonstrated competence in the limited
number of tests performed by the laboratory. The person
filling this position shall have at least two years of
laboratory experience with the testing concerned.
Training shall include all methods or portions of
methods and techniques that each person is responsible for
performing. At a minimum, each analyst shall demonstrate
competency through observation by management and
verification using replicate and/or check samples. For
technicians performing only portions of a specific method,
competency may be confirmed/verified by observation
only.
The continued competence of staff must be
monitored/appraised using appropriate means (., by
objective measurements or visual observation as
appropriate.
Training records shall include documentation of all
relevant internal and external education and method
performance verifications.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Accommodation and Environmental Conditions
The laboratory shall be arranged to minimize
cross contamination and shall be segregated from
other activities in the laboratory with limited access.
Suggested means of accomplishing this are:
! Carry out procedures in a sequential manner using
appropriate precautions to ensure test and sample
integrity (., use of sealed containers) (Eurachem);
! Segregate activities in time and space (Eurachem);
! Use biological containment hoods;
! Restrict highly contaminated samples to separate areas;
! Restrict operations to selected areas when high levels
of pathogens may be encountered (., pre-
enrichments, selective enrichment transfers).
Laboratories located in facilities where products or
ingredients are manufactured shall not test for infectious
pathogens (such as Listeria monocytogenes, Salmonella,
Escherichia coli 0157:H7, Shigella, Campylobacter, Vibrio
cholera), unless the laboratory is physically separated with
limited access, negative air flow and supervision by a
qualified microbiologist.
The laboratory shall be ventilated to reduce the
levels of contamination. The laboratory test area should be
air-conditioned to control humidity and temperature.
Work space temperature and test area humidity
shall be monitored. The recommended relative humidity in
the test area is 45-50% RH and the temperature in the test
area should be 20-25°C.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Excessive numbers of environmental bacteria,
yeasts and molds shall be controlled by air systems with
filters. Verification and monitoring of control shall be
performed using air sampling devices, air settling plates,
surface swabs or other appropriate means. These checks
are critical to aerobic plate count procedures and yeast and
mold tests.
Bench tops (work surfaces) and floors shall be
made of impervious, smooth, easily cleaned materials.
There shall be at least six linear feet of bench or surface
workspace for each analyst while working. Walls and
ceilings should be made of materials that are smooth and
easily cleaned.
Pathogen testing shall be strictly controlled so as
to prevent cross contamination. Critical work surfaces shall
be monitored for pathogens pertinent to the laboratory’s
scope of testing (Salmonella, Listeria monocytogenes and
E. coli 0157:H7) - after sanitation but before testing
operations begin.
Handling of microorganisms, laboratory hygiene
and housekeeping shall be consistent with the essential
elements described in “Centers for Disease Control, 1988,
Biosafety in Microbiological and Biomedical Laboratories,
2nd Edition, . Government Printing Office, Washington,
.”
Full service laboratories handling infectious
agents shall implement the essential elements of “Biosafety
Level 2”.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Small, limited service laboratories, not generally
testing for infectious agents, shall implement the essential
elements of “Biosafety Level 1”.
The laboratory shall have a pest control program.
There shall be at least 50 (preferably 100) foot-
candles intensity at working surfaces.
Where applicable, the laboratory shall comply
with the Public Health Services Policy of Human Care and
Use of Animals, Public Law 99-158, November 20, 1985,
“Animals in Research”. (A supporting document for
animal care is “The NIST Guide for the Care and Use of
Laboratory Animals”, Pub. No. 86-23, Rev. 1985.) In some
circumstances, it may be desirable to obtain American
Association of Laboratory Animal Clinicians (AALAC)
certification.
Reference cultures and certified reference cultures
shall be kept separated from samples at check-in and during
storage.
Sample check-in and storage shall be segregated
(ideally, in a separate area from the testing laboratory) and
shall include proper sanitation to exclude the possibility of
cross contamination.
The pre-enrichment set-up area shall be
segregated or separated from the main testing area. (It is
also recommended that the media preparation and
sterilization area be separated from the testing areas.)
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
The laboratory shall have a Chemical Hygiene
Plan (CFR ) and documented, regular safety
meetings.
Test Methods and Method Validation
The laboratory shall have documented QA/QC
procedures, including, but not limited to, media QC,
incubation times and temperatures, equipment calibration
and maintenance process control QC and standards for
approving/rejecting results.
Test methods and/or procedures shall include:
Scope
Description of the food types to be tested
Quantities to be tested
Material, equipment and tolerances required
Description of procedure
Physical and environmental conditions required
Sample identification
Method of recording observations and results
Safety measures
Data required for reporting
Sensitivity of method
Method of data analysis and reporting
The laboratory shall use test methods that meet the
needs of the client. Where possible, these methods shall
comply with the essential/critical elements of international,
national and/or regional standards. Where no method is
specified, the laboratory shall use an appropriate method
that is traceable to a recognized, validated method.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
All methods not taken from authoritative,
validated sources shall be agreed upon by the laboratory
and client, with clearly defined expectations and
requirements. Validation of the appropriateness of these
methods (including nonstandard, commercialized tests
systems (kits) and new test methods) shall be performed
and documented and shall be subject to review by and
agreement with the client to ensure that the range and
accuracy of values obtainable from the method (.,
detection limit, selectivity, matrix effects,
repeatability/reproducibility, ease of use, etc.) are relevant
to the client’s needs. Where methods exist that are
superior to officially recognized methods, these methods
may be used if agreed upon with the client and validated as
meeting their intended purpose. (For . purposes, official
methods – including commercialized test systems (kits)
from the AOAC International Official Methods of Analysis,
FDA Bacteriological Analytical Manual and the USDA
Laboratory Manuals – are considered validated.)
The laboratory shall validate standard methods
applied to food matrices not specified in the standard
procedures.
Qualitative test methods shall be validated to
demonstrate estimated sensitivity and specificity, relative
accuracy to official methods (where appropriate), positive
and negative deviation, limit of detection, matrix effect,
repeatability and reproducibility.
Quantitative test methods shall be validated
to demonstrate specificity, sensitivity, relative accuracy,
positive and negative deviation, repeatability,
reproducibility and limit of determination.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
In cases where new methods are developing
rapidly (., for emerging pathogens), normal validation
procedures may be circumvented. In these cases, the
laboratory shall – at a minimum - demonstrate qualitative
recovery of a microorganism (CRC) for enrichment
procedures carried out in replicate and demonstrate
quantitative recovery of a microorganism (CRC) for an
enumeration procedure carried out in replicate.
The suitability of the method shall be checked
and confirmed by comparing with specified requirements
typical for the intended use of the method. For example, a
filtration method for a non-filterable food, a five day test
where three days are required, a 1 gm test where 100 gm
are required, surface area specific tests for CFU/sq. area
where CFU/gm is required.
When sampling is performed by the laboratory,
there shall be procedures ensuring that representative
samples are obtained.
Electronic records, electronic signatures and
handwritten signatures executed to electronic records shall
be demonstrated as being equivalent to records and
handwritten signatures executed to paper per 21 CFR Part II
(Docket No. 92NO251) RIN 0910-AA29; Federal Register:
March 20, 1997, 1 Volume 62, Number 54, Rules and
Regulations, pages 13429-13466.
The laboratory shall have procedures (for both
hardware and software) for safeguarding adjustments that
would invalidate test results.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Equipment
The laboratory shall be furnished with all
items of sampling, measurement and test equipment
required for the correct performance of the tests,
including sampling, preparation of test items,
processing and analysis of test data.
All equipment (especially those items having an
impact on the uncertainty of the results) listed in the
methods shall meet the specifications relevant to the
method and shall be calibrated and/or verified to those
specifications.
The laboratory shall have documented procedures
for the handling, transport, storage and use of measuring
equipment to prevent contamination or deterioration.
The laboratory shall document maintenance
schedules and procedures. Maintenance records shall be
maintained. The following equipment shall undergo
maintenance and servicing as specified:
Incubators shall be cleaned and sanitized at a
frequency specified by the laboratory.
Refrigerators shall be cleaned and sanitized at a
frequency specified by the laboratory.
Freezers shall be cleaned and sanitized at a
frequency specified by the laboratory.
Ovens shall be cleaned and sanitized at a
frequency specified by the laboratory.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Water baths shall be cleaned and sanitized at a
frequency specified by the laboratory.
Centrifuges shall be serviced annually and
cleaned and sanitized monthly.
Safety cabinets shall be serviced annually and
cleaned and sanitized with each use.
Laminar flow hoods shall be serviced annually
and cleaned and sanitized with each use.
Microscopes shall be serviced annually. The
eyepiece and objective lens shall be checked and, if
necessary, cleaned with each use.
pH meters shall be serviced annually. The
electrodes shall be cleaned with each use.
Balances shall be serviced annually and cleaned
with each use.
Vial fillers shall be cleaned at a frequency
specified by the laboratory.
Autoclaves shall be serviced semi-annually.
Visual checks shall be performed at a frequency
recommended by the manufacturer.
The deionized water/reverse osmosis system
cartridges shall be replaced at a frequency recommended by
the manufacturer.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Stills shall be cleaned per manufacturer’s
instructions and at a frequency specified by the
manufacturer.
Glassware and plasticware shall be cleaned and
sterilized with each use.
Spiral platers shall be cleaned and
decontaminated with each use.
Spectrophotometers shall be cleaned per
manufacturer’s instructions and at a frequency specified by
the manufacturer.
Other special incubation equipment shall be
cleaned and sanitized with each use.
The laboratory itself shall be cleaned and
sanitized at a frequency specified by the laboratory.
All media shall be labeled utilizing an appropriate
identification scheme (preferably a number or alphanumeric
system) and dated.
There shall be a lot acceptance procedure for
evaluating media lots for suitability. (This can be satisfied
by manufacturer QC data following the CDC Lab Manual,
Quality Control: Microbiology, 1987, . Dept. of Health
and Human Services, United States Public Heath Service
(USPHS), CDC, Atlanta, GA for all lots of prepared
dehydrated media or prepared media.)
Laboratories that compound their own media
shall follow the protocol specified parenthetically in
.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Upon receipt of dehydrated media, records shall be
kept including media name or description, manufacturer’s
lot number, laboratory-assigned number, date received, date
opened, date prepared for QC, manufacturer-assigned
expiration date, discard date and initials of responsible
person.
All dehydrated media shall be labeled with
laboratory number, identification and date approved.
The laboratory shall have policies/procedures for
the disposition of expired media.
Each batch of media prepared internally or
purchased must be examined for suitability. Records
of these checks shall include:
(a) laboratory media identification number;
(b) batch number;
(c) date of media preparation;
(d) date results were read/taken;
(e) productivity (+ culture);
(f) selectivity (optional);
(g) sterile control; and
(h) date approved or rejected with initials of
person approving/rejecting.
All media shall be identified and traceable to QC
results and each test. This includes preparation, traceability
to media, pH (before and after sterilization), appearance,
sterilization batch (with related records), fill volumes (if
appropriate), batch size and quantity.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
For reagents, kits and identification systems, each
lot shall be labeled upon receipt. Each lot shall be approved
following a specified procedure. Each lot shall be
identified with a laboratory number or alphanumeric system
that includes the date approved.
Records shall include:
(a) a description of the material;
(b) manufacturer lot number;
(c) date received;
(d) date opened;
(e) appearance; and
(f) date of approval/disapproval with initials of
responsible person.
Serological tests shall include a positive control
and a saline negative control.
All batches of media and reagents shall be
traceable to autoclave records which shall document:
(a) date;
(b) run number:
(c) autoclave number (where appropriate);
(d) media and reagents/load;
(e) time into autoclave;
(f) time at desired temperature;
(g) time out of autoclave; and
initials of responsible person(s).
Sterilization equipment and sterilization
processing cycles shall be validated and documented.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
All batches of media and reagents, sterilized
by means other than an autoclave, shall be traceable to
sterilization or decontamination processing records
which shall document:
(a) date;
(b) media or reagent;
(c) confirmation of heating conditions (or filtration);
and
(d) initials of responsible person(s).
The laboratory’s water source shall be tested to
ensure that it is inhibitor free (., “microbiologically
suitable water”). Documentation of performance of the
following tests shall be maintained:
Daily Testing resistance shall be >
megohms/cm at 25°C;
Monthly Testing: Total residual chlorine shall
be < aerobic plate count shall be < 1000 colony
forming units (cfu)/mL.
Annual Testing: Heavy metals (Cd, Cr, Cu, Ni,
Pb, Zn - individually) shall be < mg/L; Heavy metals
(total) shall be < 10 mg/L; Bacteriological Suitability shall
be “passing”.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Measurement Traceability
The laboratory shall have a program for
calibrating/verifying the performance of all critical
equipment and media, traceable to national standards
or cultures. For the purpose of food microbiology,
media are critical materials that shall be
calibrated/verified against national standards –
reference cultures and/or certified reference cultures.
The following equipment shall be calibrated/verified
at the specified frequency:
Calibration
The NIST reference thermometers shall be
recertified every five years.
Reference thermocouples shall be calibrated to
the boiling point and ice point annually.
Working thermometers shall be calibrated
against the NIST reference thermometer annually.
Working thermocouples shall be calibrated
against the reference thermocouple or by other NIST
traceable means annually.
Reference weights shall be recertified (traceable
to NIST) every five years.
Balances shall be calibrated (traceable to NIST)
annually.
Timers shall be calibrated to a national time
standard annually.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Volumetric glassware (non Class A) shall be
calibrated gravimetrically (traceable to NIST weights)
annually.
Microscope stage micrometers shall be calibrated
at installation.
Hydrometers shall be calibrated to a reference
chemical compound annually.
Autoclaves shall be calibrated to NIST
traceable thermometers or thermocouples annually.
Calibration for Use
The stability and uniformity of temperature for
all incubators shall be verified at installation.
The stability and uniformity of temperature for
all refrigerators shall be verified at installation.
The stability and uniformity of temperature for
all freezers shall be verified at installation.
The stability and uniformity of
temperature for all ovens shall be verified at
installation.
The stability and uniformity of temperature for
all waterbaths shall be verified at installation.
The uniformity of temperature for all
autoclaves shall be verified at installation and annually
thereafter.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Spectrophotometer wavelengths shall be
calibrated/verified at installation.
The mass/volume delivery of vial fillers shall
be verified at installation and daily thereafter for each
volume.
Safety cabinets and laminar airflow cabinets
shall be inspected for particulates at installation and
annually thereafter.
Spiral platers shall be verified against
conventional testing at installation.
Performance Verification (Note: “Daily” refers to each day of use)
Incubator temperatures shall be monitored daily
– once in the morning and once in the evening/afternoon.
Refrigerator temperatures shall be monitored
daily – once in the morning or once in the
evening/afternoon.
Freezer temperatures shall be monitored daily –
once in the morning or once in the evening/afternoon.
Oven temperatures shall be monitored daily –
once in the morning or once in the evening/afternoon.
(Note: If an oven is used at different temperatures on
different days, temperature shall be monitored and recorded
each time samples are entered into and removed from the
oven.)
Waterbath temperatures shall be monitored
with each use.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Autoclave time and temperature readings shall
be monitored daily and with each load. All media shall be
sterility controlled and spore vials or strips shall be used to
verify sterility weekly.
A blank spectrophotometer reading shall be
taken daily.
The mass/volume delivery of micropipettors
shall be verified daily.
Each lot of pipettes shall be cleaned and
sterilized. The mass/volume delivery of each lot of pipettes
shall be verified. (NOTE: Certification of sterility and/or
cleanliness from the manufacturer fulfills this requirement.)
Glassware cleanliness shall be monitored via
residue tests; glassware sterility shall be verified with each
lot or load.
The sterility of each lot of petri dishes shall be
verified. (NOTE: Certification of sterility and/or
cleanliness from the manufacturer fulfills this requirement.)
Balances shall be verified daily using at least 1
weight within the expected range of use.
Prepared media shall be checked for sterility,
productivity (and + culture), pH and appearance with each
batch.
Rapid test kits shall be checked for +/- reaction
with each lot of +/- culture reference.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
The ID system shall be checked for +/- reaction
with each lot of +/- culture reference.
Test reagents shall be checked for +/- reaction
with each lot.
pH meters shall be calibrated daily using
standard buffers covering the expected range of use.
The deionized water/reverse osmosis system
and stills shall be checked for conductivity (weekly) and
microbial density (monthly).
Open medium control sterility checks shall be
performed on safety cabinets and laminar airflow cabinets
with each use. The airflow of these cabinets shall be
monitored monthly.
Colony counters shall be verified against a
manual count annually.
Spiral platers shall be compared to
standard plating procedures annually. Siphon
condition shall be checked daily and volume dispersal
shall be checked monthly.
When national or international standards are
not available for the calibration/verification of the
performance of microbiology procedures, there shall
be a documented procedure for demonstrating
appropriate recovery each time a method is
performed. This may be accomplished through:
Participation in a suitable program of
interlaboratory comparison or proficiency testing;
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
The use of RCs and CRCs to quantify recovery
on every occasion that a test is performed;
Mutually agreed-upon expectations of the
laboratory and client.
The laboratory shall have procedures for the
safe handling, transport, storage and use of reference
standards, reference materials, reference cultures and
certified reference cultures to prevent contamination
or deterioration.
Reference standards (., reference thermometers,
weights, etc.) shall be used for calibration or verification
purposes only.
Certified reference cultures shall be traceable to a
nationally or internationally recognized type culture
collection.
Reference cultures from laboratory sources shall
be identified and traceable to standard reference sources.
Reference cultures shall be handled to
maintain their biochemical reaction and physiological
characteristic integrity.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
RCs and CRCs shall not be transferred more than
five times from the original sources. After the fifth transfer,
the laboratory may purchase another culture from a type
culture collection or re-identify the culture for key
biochemical and physiological characteristics using
nationally or internationally recognized reference sources.
Alternatively, the type culture may be grown then freeze
dried, kept in frozen storage, etc. and used periodically
thereby extending the length of time after which they must
be repurchased or reidentified.
The laboratory shall ensure that their suppliers of
CRCs comply with the requirements of ISO/IEC Guide 25
relevant to calibration laboratories.
Sampling (No Additions)
Handling of Test Items
The laboratory’s system for the identification of
samples shall include the following information, records of
which must be retained throughout the testing life of the
sample:
unique and unambiguous sample identification
(usually a number or alpha numeric identification);
name of the person(s) to whom the final report
will be sent;
manufacturer’s name or sample source and date
of sampling (if available);
identification number or description from client
(if any);
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
product description;
tests desired and/or methods requested;
date of receipt;
delivery carrier;
sample condition and physical appearance
(including temperature);
sample identification (if different from ).
If any deviations from specifications are noted,
the continued suitability of the sample for testing shall be
discussed with the client. Cross contamination is the most
critical issue – resulting from broken or leaking samples –
for both qualitative and quantitative tests. However, it is
much more important to the qualitative (infectious
pathogens) tests.
The laboratory shall have documented procedures
for the handling, sampling, transport, storage, preparation,
retention and disposal of test items.
Sample handling and storage procedures shall
include precautions for preventing cross contamination and
deterioration (death or growth of microorganisms).
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Assuring the Quality of Test Results
All laboratories shall have a daily (every test day)
control using CRCs (+ culture), where available, or RCs (+
culture) for running concurrently with all tests. There shall
be procedures and policies for interpreting these results as
related to the validity of the tests. In cases where there is
adequate control and documentation, this procedure can be
used to verify the acceptability of media (concurrent with
the test).
CRC, CRM, RM and RC shall be used to evaluate
performance on a daily basis to include media and daily
process control checks. These data shall be used to
evaluate the validity of the test results following written
procedures available before testing.
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Compliance
REQUIREMENT
Y N NA
Document Reference Comments
Reporting the Results
For microbiological testing of infectious
agents where diagnostic (qualitative) tests can
differentiate serological types or biotypes, there shall
be policies and procedures for interpreting, evaluating
and reporting unequivocal results, since
environmental factors/data may invalidate or cast
doubt on the integrity of the results. (This is
especially pertinent to Salmonella analyses where
serological tests are well developed.) The client shall
be notified of any factors that have affected or may
potentially affect the integrity of reported results and
shall be informed of any data interpretations or
evaluations that are made.
(NOTE: On a case-by-case basis, exceptions will be made
for the report content requirements outlined in ISO/IEC
Guide 25, Section for laboratories reporting results for
regulatory purposes and not utilizing the A2LA logo on
these reports.)
ASSESSOR CHECKLIST: FOOD MICROBIOLOGY PROGRAM REQUIREMENTS
Food Microbiology Program Requirements Checklist
REQUIREMENT
Calibration
Calibration for Use
