(Seed LAAP version 4.0
- December 2006)
CFIA Saskatoon
Laboratories
Seeds Section
Suite 310, 421 Downey Road
Saskatoon, SK
S7N 4L8
Table of Contents
The Canadian Food Inspection Agency (CFIA), through a variety of
acts and regulations, has the responsibility to ensure the health, safety,
quality and wholesomeness of food and agricultural products. To be credible and
fair in the assessment of these products, a laboratory's results must be
accurate, reliable and reproducible. CFIA requires that
laboratories which provide results for product assessment through the various
Canadian Food Inspection programs, meet the requirements outlined in the
Laboratory Accreditation and Audit Protocol (LAAP). The
LAAP has
been developed to assess specific test competence in the scientific disciplines
of chemistry, biology and microbiology. The Seed LAAP is an
elaboration of the Canadian Food Inspection Agency's LAAP to make it
specific to the Canadian seed testing program.
The principle criteria for a laboratory wishing to be accredited and
maintain its accreditation under this protocol which is verified by an on site
audit/assessment are:
- The laboratory's organizational structure must have the capability to
operate and maintain testing activities.
- Adequate facilities and equipment must be available to carry out testing
activities.
- The laboratory must have in place a documented and acceptable quality
system.
In addition:
- The laboratory must demonstrate its capability to perform the specific
tests for which accreditation is requested (pre-accreditation samples).
- To maintain its accreditation, the laboratory must demonstrate its
capability by successful participation in the post-accreditation proficiency
test program and assessments.
Previous and other accreditations are taken into consideration to eliminate
duplication and minimize the burden on laboratories.
Laboratories, which meet and maintain the requirements of the Seed LAAP, will be
considered to have demonstrated their ability to perform and maintain
competence in seed testing.
For the purposes of this document the following are defined:
Accreditation
Formal recognition by CFIA that a laboratory is
considered competent to carry out seed purity and/or germination tests.
Accredited Analyst
An analyst who has completed training in seed purity and/or germination testing
and has passed the qualifying examination set by CFIA.
Accredited Laboratory
Testing laboratory to which accreditation has been granted.
Accredited Report/Certificate of Analysis
A seed testing report/certificate of analysis, issued by an accredited
laboratory, which meets the information requirements of the Canadian Methods
and Procedures for Testing Seed, address and contact numbers and a statement
that the laboratory has been accredited under the CFIA Seed Laboratory
Accreditation program and the assigned accreditation number.
Accredited Tests
Purity or germination tests on named crop kinds, using a recognized standard
method.
Auditor
A person who undertakes to conduct a quality audit.
Agent:
Third party conformity body. eg. Canadian Seed
Institute (CSI).
Assessor:
A representative of the third party conformity body who undertakes to conduct a
quality assessment.
Calibration
Measurements taken to ensure accurate operation of an instrument or piece of
equipment throughout its working life.
CFIA
Canadian Food Inspection Agency
CSI
Canadian Seed Institute
Proficiency Test Sample (PT)
A seed sample of known quality, distributed to laboratories for the purpose of
assessing proficiency.
Pre-Accreditation Audit
An examination and assessment of competency of a laboratory which has applied
for accreditation, as measured by pre-accreditation proficiency samples and an
on-site quality audit.
Post-accreditation Audit
An ongoing examination and assessment of a laboratory's competency as
measured by the results of proficiency testing and quality audits.
Post-accreditation Proficiency Testing
Determination of the laboratory testing performance by means of
inter-laboratory comparison using sets of proficiency test sample panels and
/or split samples.
Pre-accreditation Proficiency Sample
A sample or panels of samples prepared for the express purpose of testing
proficiency of a laboratory which has applied for accreditation.
Quality Audit
An independent review of a laboratory's quality system.
Quality Manual
A document stating the quality policy, quality system and quality practices of
an organization.
Quality Assurance
All those planned and systematic actions necessary to provide adequate
confidence that test results satisfy predetermined requirements for
quality.
Quality Control
The operational techniques and activities that are used to fulfil requirements
for quality.
Quality Systems
The collective activities and events that provide an organized plan to ensure
that the quality of a product, process or service satisfies the needs of the
users.
Split Sample
A sub-sample of an accredited laboratory's sample, drawn for the purpose of
monitoring the laboratory's performance.
Non-Accredited Test: Any test not covered under the scope
of testing for which the laboratory is accredited.
Canadian Food Inspection Agency will:
- Amend the protocol as necessary to meet the purpose of accreditation.
- Consult with accredited laboratory representatives and representatives of
the Commercial Seed Analysts Association of Canada (CSAAC) to
discuss and resolve problems concerning the Seed LAAP or any
aspect of the accreditation process.
- Prepare a yearly report of activities.
- Conduct the seed laboratory accreditation program.
- Follow up on complaints or concerns regarding the performance of accredited
seed laboratories.
Any comments, concerns or inquiries about seed laboratory accreditation
should be made to:
Chief, Purity, Germination and Accreditation Programs
CFIA Saskatoon
Laboratory Seed Science and Technology Section (SSTS)
Suite 310, 421 Downey Road
Saskatoon, SK
S7N 4L8
Phone: (306) 975-5832
Fax: (306) 975-6450
- To provide a uniform and technically sound process to ensure the validity
of results which may be used for the grading of seed and the release of
imported seed lots.
- To identify competent laboratories able to perform accredited tests.
- To add credibility and status to competent laboratories.
- To improve laboratory operations by promoting quality practices and by
identifying and correcting deficiencies.
- To identify and correct methodology deficiencies and training needs and to
confirm performance specifications in a operating laboratory environment.
- To promote the acceptance of an accredited laboratory's results.
- To facilitate international trade through acceptance of test data from
accredited laboratories.
This protocol applies to laboratories and companies which have chosen to
become accredited to establish the acceptability of their laboratory's test
results for the purposes of the Seeds Act and Regulations.
Relevant portions of other accreditation programs in which a laboratory
participates may be used to fulfil some or all of the requirements of this Seed
LAAP.
Facilities, labour relations, safety and accident prevention are the
responsibilities of other government agencies and the laboratory. The auditor
will comment upon any deficiencies. However the auditor will only request
corrective action for deficiencies which affect accredited test results.
6.1 The laboratory shall have a Quality Manual.
The laboratory must be operating, have all the required equipment including
sample and results entry and quality procedures in place at the time of the
pre-accreditation audit.
6.2 All accredited purity and germination tests must be
conducted in accordance with the Canadian Methods and Procedure for Testing
Seed. Non-accredited tests reported on a Report/Certificate of Analysis must be
clearly identified as being non-accredited tests.
6.3 The laboratory shall test all pre-accreditation
samples, without reimbursement, and report the results to CFIA within a prescribed time
period. The lab shall also participate in the CSI post-accreditation proficiency
testing program.
6.4 All Reports/Certificates of Analysis containing results
of an accredited test must be signed by the supervisor taking responsibility
for the analysis, or by the accredited analyst. The supervisor taking
responsibility for the analysis must be an accredited analyst.
6.5 The laboratory shall submit to audits by CFIA or its agent for the
purpose of auditing facilities, personnel, equipment, quality systems /quality
control procedures, analytical procedures, and any manuals/documents/records
pertaining to the above. The frequency of audits/assessments will vary
according to a laboratory's performance with an anticipated frequency of
once every three years.
6.6 Laboratories which a) pass the pre-accreditation audit
and b) meet or exceed pre-accreditation testing requirements will be accredited
for the specific crop kinds in the Grade Tables for which accreditation is
sought.
6.7 The laboratory and Canadian Food Inspection
Agency's Seed Section will be notified that accreditation has been granted.
The Accredited laboratory may elect to be identified on a list which will be
made public and distributed on request to potential users of their
services.
6.8 The laboratory must promptly notify the Chief, Purity,
Germination and Accreditation Programs of any changes in supervisory personnel,
laboratory name, laboratory ownership or physical facilities as they relate to
accredited analyses or to conditions for accreditation.
6.9 Having attained accreditation, the laboratory shall
continue to be an accredited laboratory for as long as it complies with the
conditions laid out for accreditation, including on-going post-accreditation
testing, with maintenance of an acceptable rating.
6.10 Unsuccessful laboratories may withdraw or appeal the
findings. The appeal process will require the following;
- A letter to the Director, Saskatoon Laboratory within 30 days after the
original decision was made, requesting an appeal of the decision.
- Written documentation to support any allegations of errors or omissions
that may have occurred.
- Presentation must be made directly to the appropriate CFIA personnel.
- The decision of the CFIA will be
final.
- Application: Laboratories must apply in writing to the
Chief, Purity, Germination and Accreditation Programs, Saskatoon Laboratory
Seed Science and Technology Section (SSTS). The application
will be assessed against the eligibility criteria and program applicability,
acknowledged and accepted or rejected.
The Application for seed laboratory accreditation must clearly include the
following information:
- The name of the laboratory.
- The type of accreditation sought, ie.
purity, germination, or both.
- The crop kinds to be included in the accreditation.
- The name(s) of the accredited analyst(s) and copies of their analyst
accreditation certificates.
- The approximate number of samples tested by the laboratory.
- The expected date of submission of the Quality Manual.
- Quality Manual: The laboratory must submit its Quality
Manual to CFIA for
review within four months of submission of the application.
- Pre-accreditation testing: Accepted labs will be sent a
set of pre-accreditation samples to be analysed within a given time period
according to the specified test protocol.
- Pre-accreditation Audit: Arrangements will be made for the
CFIA laboratory
auditor(s) to visit the lab at a mutually convenient time. The purpose of the
audit is to verify the organizational structure, human resources, physical
resources, quality system/quality control procedures, and record keeping
procedures for the tests under accreditation, as outlined in Section 8. The
laboratory must be functional at the time of audit.
- Audit report: A final CFIA auditor's report is
prepared and submitted to the Director, Saskatoon Laboratory within 30 days of
the lab visit. This is conditional on the applicant laboratory satisfactorily
completing all corrective actions identified during the audit.
- Correction of non-conformances : Any non-conformances
identified during the audit may be verified, depending on the nature of the
non-conformance, by another audit or by documentation provided by the
laboratory.
- Accreditation: Laboratories which have successfully
completed the above will be accredited.
- Appeals: Any complaints or appeals for rejection of an
application can be made to the Director, Saskatoon Laboratory.
Before accreditation, the laboratory will be assessed on each of the
following areas:
The organization must have the capability to operate and maintain the
testing activity for which accreditation has been requested. Management must be
committed to the quality system policy.
The organization must have knowledgeable, adequately-trained employees to
perform the testing activities according to specified protocols, and to manage
and maintain all documentation and reporting procedures. An accredited test
must be conducted by, or under the supervision of, a seed analyst accredited
for the test.
8.2.1 A laboratory which is applying for germination-only
accreditation for any of Grade Tables 7-17 and 19 -20, must have working in the
laboratory an accredited analyst qualified to conduct purity tests on the crop
kinds in these grade tables. Where the laboratory is requesting
germination-only accreditation for crop kinds in Grade Tables 1 to 6 and 18,
the laboratory must have an accredited analyst or have access to an individual
who is an accredited GB grader for Grade Tables 1 to 6.
Adequate facilities and equipment must be available to carry out testing
activities for which accreditation is sought. Minimum specifications are given
in Appendix A.
The laboratory must have in place a quality system/quality control program
to ensure the integrity of accredited testing activities. This should include
the following:
- Records must be maintained for each item of equipment significant to the
tests performed. Regular inspection and maintenance of this equipment must be
carried out and recorded by the responsible lab personnel.
- Laboratories must maintain daily records of germination and pre-chill
cabinet temperature measurements.
- All measuring and testing equipment having an effect on the accuracy or
validity of tests must be calibrated (eg.
balances, thermometers) or verified (eg.
thermometers, germinators, precision blowers) before being put into service and
thereafter, and records of the calibrations and verification must be kept.
These calibration records must be traceable to a National Standard or
International Standard.
- All related seed testing rules, handbooks, manuals and instructions must be
maintained up-to-date and readily available to staff.
- Samples must be uniquely identified to ensure there can be no confusion
regarding identity. The condition and integrity of samples must be protected
before, during and after analysis. Samples must be held for one year following
analysis. In the case of purity analysis, each portion analysed shall be
packaged separately and identified.
Any impurities found shall be packaged separately and identified. All
impurities removed as part of the analysis shall be kept separate and with the
sample.
- Results of tests must be reported accurately, clearly, unambiguously and
objectively. Records for each test must contain sufficient information to
permit satisfactory repetition of the test. Worksheets shall clearly indicate
who conducted the test or activity.
The laboratory shall keep records of qualifications and training for all
personnel.
The laboratory shall keep records of laboratory and analyst proficiency
(split sample and inter-laboratory proficiency test samples, internal
proficiency checks).
- The laboratory shall have a policy and procedure for resolutions of
complaints received from clients or other parties. Records must be kept of all
correspondence received related to testing or reporting errors, and corrective
action taken.
- Internal Audits: The laboratory shall periodically, and in accordance with
predetermined schedule and procedures, conduct internal audits of its
activities to verify that its operation continues to comply with the
requirements of the quality system and the SLAAP.
- The laboratory must have policies and procedures for the selection and
purchasing of the services and supplies it uses that affect the quality of
tests and or calculation.
- All quality records such as test results, corrective actions, maintenance
and repair of equipment, proficiency testing results (split samples and
proficiency test samples), management reviews, internal and external audit
reports must be kept for 5 years.
- The laboratory shall have procedures and the appropriate equipment for
obtaining samples for testing.
- Management shall periodically conduct a predetermined scheduled review of
the laboratory's quality system and testing activities to ensure the
systems continuing suitability and effectiveness and to introduce necessary
changes and improvements. The result of this review must be documented. The
review shall take into account the following:
- The suitability of policies and procedures;
- Reports from managerial and supervisory personnel;
- The outcome of recent internal audits;
- Corrective and preventative actions;
- Assessments by external bodies;
- The results of post-accreditation testing;
- Changes in the volume and type of work;
- Client feedback;
- Complaints;
- Other relevant factors, such as quality control activities, resources and
staff training.
Items 8.1, 8.2, 8.3 and 8.4 are to be collated and submitted as the Quality
Manual.
The Quality Manual must document the quality system . A member of the
laboratory staff shall be designated as the Quality Manager. The quality
manager shall ensure the quality manual is current, maintained and
relevant.
The laboratory site will be audited to verify that quality management
practices, organization, facilities and quality system /control are maintained
as stated. A lead auditor is appointed by the Chief of Purity, Germination and
Accreditation to conduct the audit and lead the audit team.
Before a laboratory is accredited, it must successfully demonstrate its
capability to perform the specific tests for which accreditation is
requested.
- Canadian Food Inspection Agency will provide pre-accreditation proficiency
samples, and testing instructions for each of the accredited tests under
consideration. The samples will be sent out with an acknowledgement letter, a
copy of which the lab personnel must sign and return to CFIA.
- The laboratory will report non-receipt or delayed receipt of samples to
CFIA and will
arrange for sample replacement from the sample originator.
- The laboratory will analyze the samples, following the provided testing
instructions and report all results within the specified time period and keep
records of results.
- If the samples are not forwarded to CFIA within a specified
period, work on the accreditation request will be suspended until such time
that CFIA is
contacted.
- The results will be evaluated for test procedures, reporting and compared
with the expected results.
- CFIA will
prepare a pre-accreditation proficiency sample report and provide a copy to the
laboratory.
A laboratory must submit to audits by a third party conformity body,
currently the CSI, and
successfully participate in post-accreditation proficiency testing to maintain
their accreditation status and to have results accepted by the CFIA.
A laboratory's on-going capability to test is monitored by the
post-accreditation testing program.
The laboratory site will be audited by CSI agents or CFIA, if required, to verify
that quality management practices, organization, facilities and quality control
are maintained as stated in the laboratory's quality manual.
- Laboratories will have their accreditation suspended as a result of
significant post-accreditation non-conformance and testing failures as
determined through the post-accreditation assessments. Lack of appropriate and
timely corrective action could lead to de-accreditation.
- Laboratories will be de-accredited if there is evidence that the laboratory
has willfully taken actions that are contrary to the Seed LAAP process and
thereby calls into question the credibility of the results produced by the lab.
Examples of such actions are the falsification of results or data or the
willful destruction of evidence, samples or records that would demonstrate
incompetence in the testing of a particular sample or groups of samples.
- Suspension of accreditation and de-accreditation action are subject to
appeal.
(See section 6.10)
- The manager of a laboratory can re-apply for accreditation by writing to
the Director, Saskatoon Laboratory.
- Evidence of compliance with the requirements of the Seed LAAP will be
required and/or evidence of corrective action may be requested, prior to
accepting a request for re-accreditation.
Laboratories may withdraw from the accreditation program at any time by
informing the Director, Saskatoon Laboratory in writing.
Also, failure to meet Seed LAAP requirements
could lead to de-accreditation which can be initiated by CFIA.
Samples may be distributed to laboratories to verify methodology and to
develop or confirm performance standard of a method. Laboratories are requested
to participate in these tests, but participation is voluntary and not a
mandatory requirement for maintenance of accreditation status.
Accredited Seed Testing Laboratory
Note: Equipment may be shared between a purity and a germination laboratory
General facility
- Testing must be conducted in an area dedicated to seed testing.
- The laboratory must be operational
Mechanical mixer/divider: At least one of the following, of
a size appropriate for the kind(s) of seed included in accreditation.
- Centrifugal divider (Gamet)
- Boerner divider
- Riffle (soil) divider
- Any device which can be shown to randomly mix seed
Documentation:
- Report/Certificate of Analysis must contain the information stated in the
Methods and Procedures as well as the laboratory's accreditation
number.
References
- Methods and Procedures for Testing Seed (current edition)
- Canada Seeds Act and Regulations (current edition)
- At least one flora, eg. Gray's Manual
of Botany, or access to the USDA/ARS/GRIN website on
the internet.
- AOSA Rules
current version (including the current versions of the applicable handbooks
ie. AOSA Seedling
Evaluation Handbook 35, AOSA Uniform Blowing
Procedure Handbook 24 and AOSA Uniform
Classification of Weed and Crop Seeds Handbook 25).
- ISTA
Rules current version.
Sample storage area
- Capacity to store samples for one year following analysis.
- Storage system adequate to maintain integrity of samples.
Germination bench space
- Sufficient space for planting and evaluating samples
- Sufficient illumination.
Germination chamber
- Capable of maintaining the temperature prescribed for the crop kind(s)
included in the scope of accreditation, ± 2°C.
- If alternating temperatures are prescribed, then either must have;
- a chamber capable of automatically alternating temperatures, with the
changeover being accomplished in less than one hour; or
- a second chamber capable of maintaining the second prescribed temperature,
± 2°C.
- The germination chamber system must be capable of maintaining high humidity
around the seeds in the test, either with a humidified chamber, or enclosed
tests.
- If accreditation covers species for which light is prescribed, the chamber
must be equipped with cool white fluorescent lights with a light intensity of
at least 750 lux (75 ft.c.)
Prechill chamber (required only if accreditation includes
crop kinds requiring prechilling)
- Capable of maintaining a specified constant temperature between of
5°C to 10°C, +/- 2°C
Water for moistening substrate
- Must meet the specifications of 4.5.3 of the M&P.
- Must be reasonably free of chemical and organic impurities.
- pH must range between 6 and
7.5.
Water for cleaning equipment
- There must be a source of running water within the laboratory, enough to
allow for routine cleaning of trays, containers , housekeeping etc.
Balance (for preparation of chemical solutions)
- Capacity at least 100 g.
- At least two decimal places.
Thermometers
- One for each germination and prechill chamber.
Magnifier in the range of 3X to 7X
Sand, for use as a primary substrate and/or as a retesting
medium
- Must meet the specifications given in Section 4.5.2.a of the M&P.
- Must be non-phytotoxic, as determined by the phytotoxicity test described
in Section 4.5.6 of the M&P.
Soil or potting mix, etc.
For use as a retesting medium
- Must meet the specifications given in Section 4.5.2.c of the M&P.
- Must be non-phytotoxic, as determined by the phytotoxicity test described
in Section 4.5.6 of the M&P.
Paper substrata (towels, blotters, filter paper), for use
as a primary substrate. (Not required if accredited only for crop kinds for
which sand is an allowed substrate).
- Type depends on M&P
prescription and laboratory preference.
- Must meet the specifications given in Section 4.5.2.b of the M&P.
- Must be non-phytotoxic, as determined by the phytotoxicity test described
in Section 4.5.6 of the M&P.
Test containers
- One or more of cardboard, aluminum, glass, plastic boxes, petri dishes,
etc. Type depends on laboratory preference. Must
be appropriate for the use.
- Must be non-phytotoxic, as determined by the phytotoxicity test described
in Section 4.5.6 of the M&P.
Potassium nitrate (KN03)
Tetrazolium (2,3,5-triphenyl tetrazolium chloride)
Miscellaneous equipment
- Calculator
- Seamless mixing pans, at least four
- Forceps
- Purity knife
- Scalpel
- Dissecting needles, at least two
- Seed envelopes
- Record cards and/or germination worksheets
- Cleaning brush
- Containers/implements for mixing sand
- Sieve and pan set for separating seedlings from sand
Additional References:
- The current version of the ISTA Handbook on
Tetrazolium Testing
Purity workbench
- Clear working surface
- Sufficient illumination
Stereo microscope (required if accreditation includes crop
kinds of Grade Tables VII-XX)
- Magnification with a range of at least 10X to 30X
- Illuminator
Top-loading balance
- Capacity of at least 1500 g.
At least one decimal place. (Required if
accreditation includes crop kinds of Grade Tables I-VI, XVI and XVIII).
- Capacity of at least 150 g.
At least two decimal places. (Required if accreditation includes crop
kinds of Grade Tables VII-XV, XVII, XIX, XX).
Analytical balance (Required if accreditation includes crop kinds of
Grade Tables VII, XV-XIII)
- Capacity of at least 150 g.
- At least four decimal places
Seed blower and calibration samples (required only if
accreditation includes Poa or Dactylis)
- Precision blower equivalent to General or Ottawa blower
- Kentucky bluegrass calibration sample as set out in M&P.
- Orchard Grass calibration sample as set out in M&P
Diaphanoscope (required only if accreditation includes crop
kinds of Grade Tables XI-XIII)
Ultra-Violet light (35 nm)
(required only if accreditation includes Agropyron)
Brassica boards, at least two (or equivalent) (required if
accreditation includes Brassica)
Reference seed collection containing:
- Weeds listed in the Reference Collection of Weed Seeds (all noxious weeds
and common other weeds)
- Common crop species
Screen set.
Miscellaneous equipment
- Calculator
- Seamless sub-sample containers, eg. cups,
at least ten.
- Seamless mixing pans, at least four
- Hand lens, magnification between 3X and 10X.
- Forceps
- Purity knife
- Scalpel
- Dissecting needles, at least two
- Seed envelopes
- Record cards and/or purity worksheets
- Cleaning brush
Additional References:
- At least one seed identification reference, eg. USDA Handbook
219