proficiency testing...

TERMS AND CONDITIONS OF PEP IST - Alimentos e Bebidas

Proficiency Testing Schemes

March 2020 Chapecó/SC

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SUMÁRIO

1. INTRODUCTION .................................................................................................... 3

2. PROFICIENCY TESTING SCHEME – INTERLABORATORY ................................ 3

2.1. SCHEME OBJECTIVES .................................................................................... 3

2.2. PARTICIPATION CONDITIONS ........................................................................ 3

2.3. PREREQUISITES FOR CARRYING OUT ROUNDS......................................... 3

2.4. SAMPLES DISPATCH ...................................................................................... 4

2.5. TEST ITEM DAMAGE ....................................................................................... 4

2.6. PARTICIPANT SAMPLE RECEIVING ............................................................... 4

2.7. TEST ITEMS’ ANALYSIS .................................................................................. 5

2.8. REPORTING RESULTS .................................................................................... 6

2.9. STATISTICAL ANALYSIS AND PERFORMANCE ASSESSMENT ................... 6

2.10. REPORTS ....................................................................................................... 7

2.11. CERTIFICATES .............................................................................................. 7

2.12. PAYMENT ....................................................................................................... 7

2.13. CONFIDENTIALITY AND INFORMATION SECURITY .................................... 8

2.14. CONLUIO AND FALSIFICATION .................................................................... 9

2.15. COMPLAINTS AND APPEALS ....................................................................... 9

3. PROFICIENCY TESTING SCHEME – INTRALABORATORY ............................. 10

3.1. SCHEME OBJECTIVES .................................................................................. 10

3.2. PARTICIPATION’S CONDITIONS ................................................................... 10

3.3. PREREQUISITES FOR CARRYING OUT ROUNDS....................................... 10

3.4. SAMPLES DISPATCH .................................................................................... 10

3.5. TEST ITEM DAMAGE ..................................................................................... 11

3.6. PARTICIPANT SAMPLE RECEIVING ............................................................. 11

3.7. TEST ITEMS’ ANALYSIS ................................................................................ 12

3.8. REPORTING RESULTS .................................................................................. 12

3.9. ANÁLISE ESTATÍSTICA E AVALIAÇÃO DE DESEMPENHO ......................... 12

3.10. REPORTS ..................................................................................................... 13

3.11. PAYMENT ..................................................................................................... 14

3.12. CONFIDENTIALITY AND INFORMATION SECURITY .................................. 14

3.13. CONLUIO AND FALSIFICATION .................................................................. 15

3.14. COMPLAINTS AND APPEALS ..................................................................... 15

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1. INTRODUCTION

The SENAI Technology Institute of Food and Beverage, in Chapecó city, provides

technological services such as proficiency tests, reference materials production,

physical-chemical and microbiological tests, research, consultancy, and education.

The proficiency testing provider PEP IST - Alimentos e Bebidas is accredited by CGCRE

according ABNT NBR ISO 17043:2011 requirements by the code PEP 010, and licensed

by REBLAS by the code REBLAS 74. The accreditation scope can be consulted at

http://www.inmetro.gov.br/credenciamento/pdf/PEP0010.pdf. The PEP IST -

Alimentos e Bebidas parameters and matrices are registered in the EPTIS Proficiency

Testing Scheme Database, as well.

The schemes are carried out according ISO/IEC 17043:2011 and ISO 13528:2015 (E)

requirements.

2. PROFICIENCY TESTING SCHEME – INTERLABORATORY

2.1. SCHEME OBJECTIVES

The participation in a proficiency testing schemes enables a continuous evaluation of the

laboratory work and rating the participant’s individual performance, allowing errors

detection, refining operational techniques and improving the quality of measurements.

Good results in these schemes ensure greater reliability for customers and play an

important role in accreditation or certification requisition.

2.2. PARTICIPATION CONDITIONS

The interlaboratory rounds of PEP IST - Alimentos e Bebidas are open to anyone that

works, or intends to work, with the offered matrices, simply filling in the online registration

and accepting the Terms & Conditions, available at http://sc.senai.br/pep, within the

schedule established and informed at the website. The priority is the inscriptions’ receipt

order.

2.3. PREREQUISITES FOR CARRYING OUT ROUNDS

The proficiency testing rounds will only take place if there are at least 6 (six) participants

registered in the quantitative parameters and 3 (three) participants in the qualitative

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parameters. In cases where the minimum number of participants in the round is not

reach, the participant subscription will be automatically canceled. To request a new

subscription, the laboratory must register in the next round that the parameter is

available.

In cases where the round for a certain parameter must be canceled, the participants will

be informed in advance by e-mail.

The cancellation of the laboratory participation in a round parameter(s) and matrix(ces)

will only be accepted if requested by e-mail by the responsible until 24 hours after the

subscription.

2.4. SAMPLES DISPATCH

The samples are dispatched to participants in room temperature and suitably packaged

in a box or bubble mailer through a carrier selected by PEP IST - Alimentos e Bebidas.

The test items are sent to the address informed by the participant in the round

registration.

The shipment date will be informed one week before the distribution of the test items by

e-mail. PEP IST - Alimentos e Bebidas is in charge of the samples dispatch costs.

The average time to the test items arrive is, from the shipment date, 05 working days to

participants from Brazil and 10 to 15 days to participants from other countries.

2.5. TEST ITEM DAMAGE

In cases where the test item has been losing or damaging during transportation, the staff

of PEP IST - Alimentos e Bebidas will analyze the possibility to resend the sample. If it

is possible to resend the sample, the Provider will request the participant agreement by

e-mail. If it is not possible to resend, due the program schedule, the parties will agree a

new subscription in a following available round, since registration fee refund is not

possible. At the end of the program, if the Provider finds out that the test items lose its

stability, participants will be communicated by email and the test items will be send again

in the next available round, since registration fee refund is not possible.

2.6. PARTICIPANT SAMPLE RECEIVING

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After the sample be received, the participant must fill the checklist for the received

material in 24 hours. The participant must check the test items received at arrival and

will have a 24 hours deadline to make any complain by e-mail or phone. After this

deadline, complains about test items damage will not be accepted.

The participant is responsible for the sample receiving, and must provide all the

conditions necessary to receive it in the laboratory, including documents required by the

country customhouse.

If the sample do not arrive in the stipulated period, the participant must inform PEP IST

- Alimentos e Bebidas by e-mail of phone. The staff will analyses the possibility to transfer

the participant to the next round where the same parameters are offered, since

registration fee refund is not possible.

The test item storage in the participant laboratory must be done according the round’s

instructions that is sent by e-mail one week before the test items distribution, regarding

the round schedule available at http://sc.senai.br/pep.

2.7. TEST ITEMS’ ANALYSIS

The participant laboratories must treat the test items in the same way they will treat a

sample in the laboratory routine. The analytical method selection is a choice of each

laboratory. The use of validated methods, changes or validated extensions is indicated.

Information about the test items handling and preparation will be given to the participant

laboratories by the round’s instructions.

The range of values for microbiological tests is defined between the method minimum

quantification limit until 100,000 CFU/g, CFU/ml, MPN/g or MPN/100mL.

The analytical methodology must be stated by the participant laboratories when reporting

results. For interlaboratory schemes programs, it must be declared in the PEP’s website.

For intralaboratory schemes, by completing the forms received by e-mail.

The laboratory must execute the tests in accordance with the parameters received and

the round’s instructions sent to the participants by email.

The range of values for pH test is 1-14 pH at 25°C and for conductivity test is between

100-1999 μS/Cm. For the other tests, the range of values is between the method

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quantification limit until the higher values allowed by the actual law for each type of

matrix.

2.8. REPORTING RESULTS

Each participant will receive login and password to access the results screen by email.

Additional information about filling in the forms will be send by email along the round’s

instructions.

The deadlines for carrying out the tests and for sending the results are informed in the

round’s instructions. This information is also available on the round schedule presented

in the PEP’s website.

The results can be published for as long as the website page is enabled, as well as

changing the results if necessary. The participant is the responsible for the information

filling in concerning the results and the analytical method.

2.9. STATISTICAL ANALYSIS AND PERFORMANCE ASSESSMENT

The results are evaluated according to statistical techniques described in ABNT NBR

ISO/IEC 17043:2011 and ISO 13528:2015.

For quantitative tests, the provider may use the participants' consensus values when the

number of participants is equal or greater than 12, or the homogeneity mean value

considering the provider as the reference laboratory to determine the designated value.

When the participants' consensus value is used, the standard uncertainty will be

calculated based on the robust standard deviation, such as "u = 1.25s/Root (p)", where

“s” is the robust standard deviation and “p” is the number of participating laboratories.

When the characterization value is used, the uncertainty will be calculated based on the

standard deviation of the characterization test, such as “u = s/Root (n)”, where s is the

standard deviation and n is the observations number. The target standard deviation may

be pre-established by the provider (regardless of the participants’ performance), based

on previous programs or robust standard deviation. The provider may use Horwitz

Standard Deviation as appropriate to the purpose or to the standard’s requirement.

The laboratories will be evaluated by the Z-score, which enable evaluate their accuracy

and compare their performance with that of other participants.

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The criteria for performance assessment are those recommended in the Item B.4.1.1. of

the standard ABNT NBR ISO/IEC 17.043:2011’s Annex B.

|z| lower than or equal to 2.0 indicates a satisfactory performance;

2.0 higher |z| lower 3.0 indicates a questionable performance;

|z| greater than or equal to 3.0 indicates an unsatisfactory performance.

The laboratories that report the results inadequately and/or with gross errors as defined

in the round’s instructions will not be considered in the statistical treatment and will not

have their performance evaluated.

For qualitative tests, only the laboratories participants that present the expected result in

each sample formulation or present the same result obtained in the test items

homogeneity tests will be considered proficient.

The rounds reports will include the basis to determine the designated value and its

uncertainty, information about the samples, homogeneity and stability tests, comments,

tables and graphs.

2.10. REPORTS

The round final report is elaborated according ABNT NBR ISO/IEC 17043:2011

requirements and will be available on the PEP’s website as stated at the round schedule

presented in the round’s instructions and on the website. PEP IST - Alimentos e Bebidas

can also provide a physical report, if the participant request it (value on request).

2.11. CERTIFICATES

At the end of the scheme, the certificates for participants who obtain satisfactory results

will be sent by email. PEP IST - Alimentos e Bebidas can also provide a physical

certificate, if the participant request it (value of each certificate on request).

2.12. PAYMENT

2.12.1. Laboratories Located In Brazil

The invoice and the bank payment slip will be sent by e-mail informed by the participant

at the website. The payment term is 30 (thirty) days from the invoice issue date.

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Special Conditions of Payment: the request must be formalized by letter or e-mail signed

by the responsible, being subject to approval.

PEP IST – Alimentos e Bebidas do not accept bank deposit.

The participant with defaults will not have access to the report and certificate.

2.12.2. Laboratories Located In Other Countries

The invoice will be sent with the values in Brazilian real (R$) by e-mail to the informed

responsible registered on the PEP’s site and the payment must be done by bank

exchange in U.S. dollar (U$). Payment details are:

INSTRUCTIONS FOR MONEY TRANSFER TO BANCO DO BRASIL S.A.

CURRENCY: USD

Intermediary: 56a BANCO DO BRASIL S.A. _ NEW YORK, NY _ USA

SWIFT CODE: BRASUS33

FINAL CREDIT TO: 57 A BANCO DO BRASIL S.A. _ CURITIBA, PR _ BRASIL

SWIFT CODE: BRASBRRJCTA

ACCOUNT/IBAN NUMBER (field 59): BR5300000000003210000071528C1

BENEFICIARY'S NAME: SENAI CET DE CHAPECO

All fees involved in the exchange process are the participant's responsibility. The

parameter value must be considered in U.$. dollar.

PEP IST – Alimentos e Bebidas does not accept payment by credit/debit card.


2.13. CONFIDENTIALITY AND INFORMATION SECURITY

PEP IST - Alimentos e Bebidas ensures information security and assures participant

data, results and performance assessment confidentiality by assigning a unique random

identification code to each participant. The PEP IST - Alimentos e Bebidas is responsible

for appoint the random code. The participant laboratory will receive its identification code

by e-mail.

The results presentation will refer only the identification code of each participant, not

declaring its name and/or corporate name.

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The participating laboratory must maintain confidentiality of its code and not disclose it

to third parties.

2.14. CONLUIO AND FALSIFICATION

PEP IST - Alimentos e Bebidas prevents collusion by avoiding participants from knowing

about each other, so do not disclose a list of participating laboratories.

The participant must commit itself in maintain absolute confidentiality, avoiding collusion

between the participants in the following points:

Do not disclose any information about the results of the test items measurements to

any other participant;

Maintain the strictest confidentiality all the time.

If there is suspicion of collusion or falsification, the staff of PEP IST - Alimentos e Bebidas

will inform the participants and may request raw data from the tests. In the case where

the collusion is confirmed, the participants will be informed that their results will not be

evaluated and the laboratory may be excluded from the scheme.

2.15. COMPLAINTS AND APPEALS

The participant laboratories have the right to complain and/or appeal when they disagree

with the proficiency testing scheme aspects. PEP IST - Alimentos e Bebidas analyses

and settle all complaints and appeals received.

PEP IST - Alimentos e Bebidas offers several customer service channels where

complaints and appeals can be received, but it is recommended that they be formalized

within the deadline set in the round instructions via email, by the option “Entre em

contato” at the website www.sc.senai.br or through the PEP’s webpage:

http://sc.senai.br/programas-de-ensaios-de-proficiencia/alimentos at the option “Contato

> Clique aqui e entre em contato”.

The provider will analyze the complaints and appeals and will reply the participant. If the

complaint and/or appeal causes change in the report, the participants will be

communicated and the report will be reviewed. No complaints will be accepted due to

wrong insertion of analytical methods and/or results at the result forms sent to the

provider.

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3. PROFICIENCY TESTING SCHEME – INTRALABORATORY

3.1. SCHEME OBJECTIVES

The participation in a intralaboratory proficiency testing scheme enables a continuous

evaluation of the laboratory work and rating the participant's individual performance,

allowing errors detection, refining operational techniques, improving the quality of

measurements and checking training efficiency.

The intralaboratory proficiency tests can indicate how accurate are the results of the

laboratory, what is the difference between two results obtained by the same laboratory

technician, the difference between two results obtained by different laboratory

technicians, and if the laboratory precision is as described in the method (in cases where

the repeatability and reproducibility of the method are known).

The participation in these schemes ensure greater reliability for customers and play an

important role in accreditation or certification requisition.

3.2. PARTICIPATION’S CONDITIONS

The intralaboratory schemes of PEP IST - Alimentos e Bebidas are open to anyone that

works with the offered matrices, simply filling in the online registration and accepting the

Terms & Conditions, available at http://sc.senai.br/pep, within the schedule established

and informed on the website. The priority is the inscriptions’ receipt order.

3.3. PREREQUISITES FOR CARRYING OUT ROUNDS

The proficiency testing scheme’s rounds will only take place if there are at least 3 (three)

laboratory technicians to allow statistical treatment.

In cases where the round for a certain parameter must be canceled, the participants will

be informed, by e-mail, in advance.

The cancellation of the laboratory’s participation in a round parameter(s) and matrix(ces)

will only be accepted if requested by e-mail by the responsible until 24 hours after the

subscription.

3.4. SAMPLES DISPATCH

The samples are dispatched to participants in room temperature and suitably packaged

in a box or bubble mailer through a carrier selected by PEP IST - Alimentos e Bebidas.

11



The test items are sent to the address informed by the participant in the round

registration.

The shipment date will be informed one week before the distribution of the test items by

e-mail. PEP IST - Alimentos e Bebidas is in charge of the samples dispatch costs.

The average time to sample arrive is, from the shipment date, 05 working days to

participants from Brazil and 10 to 15 days to participants from other countries.

3.5. TEST ITEM DAMAGE

In cases where the test item has been losing or damaging during transportation, the staff

of PEP IST - Alimentos e Bebidas will analyze the possibility to resend the sample. If it

is possible to resend the sample, the Provider will request the participant’s agreement

by e-mail. If it is not possible to resend, due the program schedule, the parties will agree

a new subscription in a following available round, since registration fees’ refund is not

possible. At the end of the program, if the Provider finds out that the test items lose its

stability, participants will be communicated by email and the test items will be send again

in the next available round, since registration fees’ refund is not possible.

3.6. PARTICIPANT SAMPLE RECEIVING

After the sample be received, the participant must fill the checklist for the received

material in 24 hours. The participant must check the test items received at arrival and

will have a 24 hours deadline to make any complain by e-mail or phone. After this

deadline, complains about test items damage will not be accepted.

The participant is responsible for the sample receiving, and must provide all the

conditions necessaries to receive it in the laboratory, including documents required by

the country customhouse.

If the sample do not arrive in the stipulated period, the participant must inform PEP IST

- Alimentos e Bebidas by e-mail of phone. The staff will analyses the possibility to transfer

the participant to the next round where the same parameters are offered, since

registration fees’ refund is not possible.

The test item storage in the participant’s laboratory must be done according the round’s

instructions that is sent by e-mail one week before the test items distribution, regarding

the round schedule available at: http://sc.senai.br/pep.

12



3.7. TEST ITEMS’ ANALYSIS

The participant laboratories must treat the test items in the same way they will treat a

sample in the laboratory routine. The analytical method selection is a choice of each

laboratory. The use of validated methods, changes or validated extensions is indicated.

Information about the test items handling and preparation will be given to the participant

laboratories by the round’s instructions.

The range of values for microbiological tests is defined between the method minimum

quantification limit until 100,000 CFU/g, CFU/ml, MPN/g or MPN/100mL.

The range of values for pH test is 1-14 pH at 25°C and for conductivity test is between

100-1999 μS/Cm. For the other tests, the range of values is between the method

quantification limit until the higher values allowed by the actual law for each type of food

matrix.

3.8. REPORTING RESULTS

Each participant will receive login and password to the results filling webpage by e-mail.

Additional information about filling in the results at the webpage will be provided by the

round’s instructions. The deadlines for carrying out the tests and for filling in the results

are informed in the round’s instructions. This information is also available on the round

schedule presented in the PEP’s website. Results can be filling in for as long as the

webpage is enabled, as well as changing the results if necessary. The participant is the

responsible for the information filling in concerning the results and the analytical method.

3.9. STATISTICAL ANALYSIS AND PERFORMANCE ASSESSMENT

The results will be evaluated according to statistical techniques described in The

International Harmonized Protocol For The Proficiency Testing Of Analytical Chemistry

Laboratories from IUPAC/ISO/AOAC.

For quantitative tests, the results reproducibility will be evaluated, which is the test

accuracy under different conditions. It is verified by means of different laboratory

technicians carrying out the tests on different days and/or with different instruments. The

reproducibility is the biggest difference that can occur in results obtained under

reproducibility conditions within the 95% confidence level.

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The reproducibility calculation is the combination of standard deviation between

laboratory technicians with the laboratory technicians standard deviation (ANOVA, single

factor). These data, as well as the other information obtained in the intralaboratory

proficiency test, allow each laboratory technician’s accuracy and precision be evaluated.

Moreover, this evaluation can be used as technical competence evidence for the test

competence requirement of ABNT ISO/IEC 17025.

The accuracy indicates the results dispersion between independent tests in the same

sample. In the intralaboratory schemes, the accuracy is stated by reproducibility through

variance analysis (ANOVA, single factor). If the F value is less than the tabulated F value,

the laboratory technician’s accuracy is evaluated as good.

The precision aims to verify how close the obtained results are to the real ones when a

known values sample is analyzed. The precision evaluation is based on the Z-Score

index that follows the rating below:

|z| lower than or equal to 2.0 indicates a satisfactory performance (Laboratory

technician shows good precision in the respective test);

2.0 higher |z| lower 3.0 indicates a questionable performance (Warning);

|z| greater than or equal to 3.0 indicates an unsatisfactory performance (Laboratory

technician shows poor precision in the respective test).

For qualitative tests, the laboratory technicians will be evaluated as proficient when they

present the expected result in each sample formulation or present the same result

obtained in the test items homogeneity tests.

The rounds reports includes information about the statistical treatment, samples,

comments, tables and graphs.

3.10. REPORTS

The round report will be available on the PEP’s website as stated at the round schedule

presented in the round’s instructions and published on the website. PEP IST - Alimentos

e Bebidas can also provide a physical report, if the participant request it by e-mail and

pay the fee (value on request).

14



3.11. PAYMENT

3.11.1. Laboratories Located In Brazil

The invoice and the bank payment slip will be sent by e-mail informed by the participant

at the website. The payment term is 30 (thirty) days from the invoice issue date.

Special Conditions of Payment: the request must be formalized by letter or e-mail signed

by the responsible, being subject to approval.

PEP IST - Alimentos e Bebidas do not accept bank deposit.


3.11.2. Laboratories Located In Other Countries

The invoice will be sent with the values in Brazilian real (R$) by e-mail to the informed

responsible registered on the PEP’s site and the payment must be done by bank

exchange in U.S. dollar (U$). Payment details are:

INSTRUCTIONS FOR MONEY TRANSFER TO BANCO DO BRASIL S.A.

CURRENCY: USD

Intermediary: 56a BANCO DO BRASIL S.A. _ NEW YORK, NY _ USA

SWIFT CODE: BRASUS33

FINAL CREDIT TO: 57 A BANCO DO BRASIL S.A. _ CURITIBA, PR _ BRASIL

SWIFT CODE: BRASBRRJCTA

ACCOUNT/IBAN NUMBER (field 59): BR5300000000003210000071528C1

BENEFICIARY'S NAME: SENAI CET DE CHAPECO

All fees involved in the exchange process are the participant's responsibility. The

parameter value must be considered in U.$. dollar.

PEP IST – Alimentos e Bebidas does not accept payment by credit/debit card.


3.12. CONFIDENTIALITY AND INFORMATION SECURITY

PEP IST Alimentos e Bebidas ensures information security and assures participant data,

results and performance assessment confidentiality by assigning a single letter (A, B, C

15



…) to each laboratory technician participant. The laboratory’s responsible is in charge to

identify the laboratory technicians and only the laboratory knows the information. The

results presentation will refer only the letter of each laboratory technician participant, not

declaring his/her name.

3.13. CONLUIO AND FALSIFICATION

PEP IST - Alimentos e Bebidas prevents collusion by avoiding participants from knowing

about each other, so do not disclose a list of participating laboratories.

The participant must commit itself in maintain absolute confidentiality, avoiding collusion

between the participants in the following points:

Do not disclose any information about the results of the test items measurements to

any other participant;

Maintain the strictest confidentiality all the time.

3.14. COMPLAINTS AND APPEALS

The participant laboratories have the right to complain and/or appeal when they disagree

with the proficiency testing scheme aspects. PEP IST - Alimentos e Bebidas analyses

and settle all complaints and appeals received.

PEP IST - Alimentos e Bebidas offers several customer service channels where

complaints and appeals can be received, but it is recommended that they be formalized

within the deadline set in the round instructions via email, by the option “Entre em

contato” at the website www.sc.senai.br or through the PEP’s webpage:

http://sc.senai.br/programas-de-ensaios-de-proficiencia/alimentos at the option “Contato

> Clique aqui e entre em contato”.

The provider will analyze the complaints and appeals and will reply the participant. If the

complaint and/or appeal causes change in the report, the participants will be

communicated and the report will be reviewed. No complaints will be accepted due to

wrong insertion of analytical methods and/or results at the result forms sent to the

provider.

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