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Proficiency Testing Guidance Document

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77 views3 pages

Proficiency Testing Guidance Document

Uploaded by

Manoj Sah
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Proficiency Testing

Edition 9 Guidance Document

Proficiency Testing
Definition
Proficiency testing is interlaboratory comparison that calibrates the performance of laboratory
personnel and other relevant staff, who conduct microbiological, chemical, or physical analyses
of ingredients, materials, work-in-progress, finished products and the processing environment.

Applicable Code Requirements Review Glossary Terms


1. 2.4.4.2 1. Inspection Area
2. On-Site Labor
3. Validation
4. Verification
Implementation & Audit Guidance
What does it mean?
According to ISO/IEC 17043:2010, proficiency testing (PT) is the evaluation of participant
performance against pre-established criteria by means of interlaboratory comparisons.
A proficiency test is a method used to demonstrate competency and validate a laboratory’s
measurement process by comparing the in-house results to the results of a reference laboratory
and/ or other participant laboratories.

Why is it in the Code & why is it important?


Proficiency testing is part of the SQF Code requirement for in-house laboratory testing. The SQF
Code requires that when internal laboratories are used to conduct input, environmental, or
product analyses, the sampling and testing methods are to be in accordance with the
applicable requirements of ISO/IEC 17025, which includes annual proficiency testing. This means
that a site that conducts laboratory tests, critical to food safety, is required to verify the
accuracy and reliability of the testing methods used on site through a proficiency test. The
applicable proficiency tests are to be conducted annually, at a minimum.
Proficiency testing is not about products but testing procedures. For example, tests critical to
food safety such as Aw, pH, or pathogen testing use the same method across many different
products.
The table below helps to explain some of the common misperceptions of what is and is not
proficiency testing.

Proficiency Testing is NOT Proficiency Testing IS

Training Calibration
Intra-Laboratory Comparison Inter-laboratory Comparison
For product quality testing (or sensory) For food safety testing (product or
environmental)
Conducted for testing sent to a 3rd
party Conducted for testing completed on-site

April 2021 Copyright © 2021 FMI | www.sqfi.com 1


Proficiency Testing
Edition 9 Guidance Document
Proficiency testing is a round-robin type of test in which duplicate samples are selected in
identical fashion and tested via intra-laboratory. The proficiency test samples could either come
from the site or the external laboratory. Regardless of the source of the sample, the goal of the
proficiency test is to verify the testing methods conducted by the site. When developing a
proficiency testing process consider the following:
1. Selection of the external laboratory.
a. The external laboratory is to be accredited to ISO/IEC 17025.
b. The laboratory should be able to demonstrate that they are able to conduct
proficiency testing. This could be identified through accreditation to ISO 17043 or
included in the scope of accreditation.
c. There are many 3rd party laboratories that conduct proficiency testing.
Laboratory equipment providers or the CB may have suggestions.
2. Handling and testing of the materials
a. Follow the same methods as the identified in-house procedure.
b. Use the same equipment and personnel that routinely perform the task.
c. Determine the acceptability range of the test results. Depending on the test, the
results may not be identical, and an acceptable difference should be identified
to determine if the proficiency test results would be acceptable or
unacceptable.
3. Proper submission of the test results
a. Evaluation should be conducted on the final, not presumptive, results.
b. Both the internal and external laboratories used should not forward or share the
results of the tests until after the results have been finalized.
4. Review of the summary reports
a. A review of the results is to be compared to the level of acceptability.
b. Unacceptable results would warrant corrective action that may include:
i. Investigation of unacceptable, trending results.
ii. Review of the sampling and testing process.
iii. Repeat of the proficiency test.

See RIO Chart on following page.

April 2021 Copyright © 2021 FMI | www.sqfi.com 2


Proficiency Testing
Edition 9 Guidance Document

RIO Road to Audits (Records, Interviews, and Observations)

Records Interviews Observations


The following are examples of The following are examples of The following are examples of
records to assist in the people to interview to assist in observations to assist in the
implementation and review the implementation and implementation and review
of this topic: review of this topic: of this topic:

 Identified tests critical to  Laboratory staff  Site staff conducting a


food safety test
The following are examples of
 Testing methods
questions to ask to assist in
 Laboratory accreditation
the implementation and
documentation for
proficiency testing (for review of this topic:
the tests conducted at  What type of tests are
the site) conducted at this site?
 Proficiency testing  Explain the proficiency
program testing process.
 Proficiency testing results  What is the corrective
action when the
proficiency testing results
in a failed test?
 How was the external lab
selected?

Additional References
 June 2019 Learning Lunch Webinar: Proficiency Testing for your SQF Audit (Safe Quality
Food Institute YouTube Channel).
 SQF Guidance document for Product Sampling, Inspection and Analysis
 Centers for Disease Control and Prevention (CDC): Clinical Laboratory Improvement
Amendments (CLIA) Brochure #8: Proficiency Testing
 Search A2LA Directory of Accredited Organizations:
https://customer.a2la.org/index.cfm?event=directory.index
 ISO/IEC: 17043:2010 – Conformity assessment – general requirements for proficiency
testing
 ISO/IEC: 17025- General requirements for the competence of testing and calibration
laboratories

April 2021 Copyright © 2021 FMI | www.sqfi.com 3

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