C. Reporting of results

Sr.No.	Measurand (Analyte/Parameter)	PT Item Code	Test Method	Results* (Qualitative)	Units of Measurement
1.	Salmonella	2024MF41R1-V1	IS 5887 (Part 3)/BAM chapter 5		Per 25g
2.	Escherichia coli	2024MF41R1-V1	IS 5887 (Part 1)		Per g
3.	Listeria Monocytogenes	2024MF41R1-V2	IS 14988 (Part 1)/ BAM chapter 10		Per 25g
4.	Total Plate Count	2024MF41R1-V3	IS 5402: (Part 1)/ BAM Chapter 3		cfu/g
5.	Enterobacteriaceae	2024MF41R1-V3	ISO 21528: (Part 2)		cfu/g
6.	Yeast & Mould	2024MF41R1-V4	IS 5403/ BAM Chapter 18		cfu/g

KEY INSTRUCTIONS

1. 1. Results shall not be accepted after the last date of results submission.


2. 2. Fill in all the results, put Signatures and Organizations Stamp scan in PDF Format and Email at pt@envirocare.co.in (Don’t email in JPG format or by clicking pictures from mobile as these are not clear on print) We shall not be responsible for any illegible entries. Reports are not to be sent by post.


3. 3. Check filled result sheet thoroughly before submitting. No changes for any reason are accepted.


4. 4. The PT provider does not require any raw data sheets or supporting records of analysis done, however, participants are advised to keep a record of raw data to demonstrate that testing is done by them in their lab. The PTP is not seeking this information along with test reports but may ask for the same if required. The said information may also be verified by regulatory authorities or accreditation bodies during their audits. The said information is also useful in doing root cause analysis. The failure of the laboratory to provide the above information may lead to the cancellation of its results and the decision of PTP in this regard shall be final.


5. 5. Please email your result sheet at email pt@envirocare.co.in once only. Post-submitting the result sheet via email, kindly avoid making phone calls to confirm its receipt. We will reach out to you if we have not received the result sheet. In case you email result sheets again and again unless asked to do so, the sheet which is sent the first time will only be considered.


6. 6. The participant is to use a specified method or methods in accordance with the design of the proficiency testing scheme as given in the scheme (PT Item Details). The participants should preferably use a different test method only with prior permission in writing e.g. if they want to validate a method; otherwise, the risk of results not being considered or failure in the scheme lies totally with the participant. The participants should also highlight in the result sheet if a different method is used.


7. 7. Where multiple methods are given, homogeneity & stability studies are done by the same & equivalence is established. Otherwise, PT provider may use separate assigned values & performance evaluation for different methods.


8. 8. Report results in the units as mentioned in the report format only. We are not responsible for use of any different units; multiple entries and ‘Results not Considered’ thereby.


9. 9. If you are not participating in a parameter leave the results column blank.


10. 10. Results reported in a semi-quantitative manner as “less than” or “more than” a value, or results reported as zero except where it may be appropriate to report a result of zero together with qualitative results, will be collated and listed in the PT round report but they cannot be included in the statistical analysis including any results that are tagged i.e. any comments are given.


11. 11. For small data sets where less than 8 results have been submitted and the assigned value is derived using a consensus value from the participants’ results. In these circumstances, there may be increased uncertainty of the assigned value, given the low number of participants, and performance scores will be given for information only.


12. 12. Participants should preferably write file name for attachments as Lab Code followed by PT scheme code and Number e.g. if the participant is sending results for scheme 2024MW01R1and its lab code is X1 and pdf file has two pages it should save the file as X12024MW01R1. Later no claim for any additional pages is entertained. Please read general instructions also carefully.

Instructions for Participants – General

1. Introduction

Envirocare Labs. Pvt. Ltd., herein referred to as EL, facilitates knowledge sharing and skill development through employment-centric capacity-building programs focused on environment, food, and related areas. These programs include year-round proficiency testing schemes.

2. Purpose and Scope of Proficiency Testing

Proficiency testing (PT) evaluates participant performance against set criteria through interlaboratory comparisons. EL organizes various schemes to assess laboratory competence in analysis, sampling, and interpretation by comparing their results with peers.

The program follows NABL criteria NABL-181A, ISO/IEC 17043:2010, and ISO 13528:2015 standards.

3. Scheme Organization

The scheme is organized by EL, with Dr. Nilesh Amritkar serving as the PT Coordinator.

Envirocare Labs. Pvt. Ltd. – PT Cell
A7 A8 Enviro House, MIDC Main Road, Wagle Industrial Estate, Thane 400604, Maharashtra, India.
Tel: 022 25838286
CIN: U99999MH1988PTC045938

4. Scheme Name and Code

Details are provided in the enclosed annexure.

5. Subcontracted Activities

EL uses ISO/IEC 17025 accredited subcontractors for test material preparation, sample stability, and storage for its schemes. Details for the current scheme are in the enclosed annexure.

6. Joining a PT Scheme

To join a scheme, participants should complete the registration form and submit it to the Proficiency Testing Provider (PTP) via email. Participation is open to both accredited and non-accredited laboratories. Participation details, including possible restrictions, will be clearly outlined in scheme documents.

Non-accredited labs should use calibrated equipment and CRMs for traceability. Their results may not be used for evaluation if these standards are not followed, and this will be noted in the PT report.

7. Fees:

The fee for taking part in EL PT is provided in calendar and registration form.
If EL is not able to issue any particular program due to circumstances beyond its control including requisite numbers of participants are not available for a particular scheme by the announced date, the date may be extended or participant may be given an option to participate in next announced schedule. Fee is refunded except for tax part only when extension option for next schedule is not given in same calendar year. Sometime schemes are run with threshold number only and some participants may not report results for a particular parameter. If number of participants for a particular parameter are less than eight (quantitative schemes) in such cases performance scores will be given for information only.

EL endeavours to keep to the published time scale if any but EL reserves the right to occasionally delay the scheme. Prior information is given to participants.

Schemes may have to be re-run due to problems in homogeneity and stability or any other technical or unavoidable circumstances. Fee is refunded if PTP is neither able to re-run in next three months nor able to offer another schedule within the calendar year.

Fee refund is else otherwise subject to sole discretion of PTP on such grounds as found to be satisfactory. If it is found that participant are registering initially only to claim participation in PT to meet the requirements of accreditation or regulatory bodies and subsequently drop their registration, the PTP has a right to bring the same to the notice of the accreditation or regulatory body and disclose the identity of such participant including taking appropriate action where participant default on payments for any reason.

8. Use of Advisors and Advisory Group:

EL maintains an Advisory Committee named Steering Group (Technical and Systems) that have on board a range of stakeholders as per the requirements of the relevant schemes (I) Personnel from regulatory authorities (II) Personnel from Institutions of repute or individual academicians (III) Personnel from laboratories (IV) Personnel from subcontractor (V) Independent experts well versed in ISO/IEC 17025; ISO/IEC 17043 etc. The details are available from PTP on request and where required relevant person’s association is declared to registered participants for a scheme.

9. Proficiency Test Items:

Selection of the measurand(s) or characteristic(s) of interest, including information on what the participants are to identify, measure, or test for in the specific proficiency testing round as well as description of the range of values or characteristics, or both, to be expected for the proficiency test items is provided.

For measurand(s) or characteristic(s) of interest and test methods refer to Calendar or details send to participants or on website. The schemes in general follow range /methods in Indian standards / protocols / regulations. There may be minor changes in given range or a parameter may be removed or added due to unavoidable circumstances and participants are informed. Participants may clarify any doubt by calling PT Coordinator.

The determinants in PT Items may either be at natural levels, incurred or spiked at a particular formulation level and or manipulated. The range of PT Items will usually be varied from round to round in order to be realistic and challenging.,

10. Homogeneity and Stability:

A number of factors will be taken into consideration when determining the quality control testing required to be performed on each type of test material. These include the degree of natural homogeneity, the stability of the test material, and the use of process control during production.

Homogeneity and stability of proficiency test items is done in line with ISO 13528:2015. IS: 4905:1968 RA 2001 is used for methods for random sampling from the bulk lot. Details of homogeneity testing data are retained by EL but not published in PT reports. The PT items are sufficiently stable for the duration of the test. This includes the time between their participation and the start of the test, as well as during transportation of test materials and for the period of time set for participants to analyse them. During trials stability is also established through a combination of simulated conditions; expert advice and assessment of historic data comparing preparation and homogeneity data with the assigned values. Some PT Items may have a reduced timescale where a long time might affect analytical results. Some PT items may be shipped in insulated packaging to ensure their continued stability. However, once the PT item is delivered with the participants, it is their responsibility to store the PT items as advised on the instruction letter, regardless of the transportation conditions.

The schemes as on Sampling and data Interpretation and Transformation may not require proficiency test items as usual and may be conducted by way of case studies. Such scheme does not involve homogeneity and stability testing.

12. Packaging and Transportation

Test materials are sent in appropriate packaging and under conditions intended to maintain the integrity of the test materials during transit. The guidelines as given in standard test methods or on the basis of experience and trials are followed in choosing a suitable packaging.

The quantity of material in a distribution unit is sufficient for the analysis required, including any reanalysis where permitted by the scheme protocol.

Once packages have been delivered, EL cannot be held responsible if they subsequently fail to reach the correct personnel or are not stored under the recommended conditions. Delays to the dispatch of test materials occasionally arise. If the dispatch of a test material has to be delayed for any reason, then participants will be notified of this fact by email prior to the advertised dispatch date. PTP cannot be held responsible if participants overlook this notice of delay. PTP cannot be held responsible for the delay in receipt of materials due to unforeseen circumstances or causes beyond their reasonable control, including but not limited to acts of God, war, riot, embargoes, and acts of civil or military authorities, fire, floods, energy, labor, or material shortages.

Participants should check the contents of packages immediately upon receipt and contact EL if there are any issues with the condition of the test materials or accompanying documentation. If packages are received damaged, it would be helpful if participants could supply photographic evidence to assist with investigations. PTP can supply additional material in such circumstances subject to verification of the issue’s genuineness. The decision of PTP in this regard is final.

Participants must fill out a ‘Sample Receipt Acknowledgement Form’ and send a scanned PDF copy back to PTP by email to acknowledge receipt of the material.

For schemes based on sampling and/or opinion and interpretation, packaging and transportation of samples are not applicable.

13. Reporting of Results

Results should be reported clearly in the provided Results Sheet format, using the specified units. A single result for each analyte must be reported as specified on the results form supplied with the sample. The laboratory should calculate the result after analyzing its normal number of replicates. Individual replicate values are not to be reported to EL PT schemes unless explicitly requested. Once submitted and received, results cannot be amended. An instruction sheet for handling and analyzing PT items, along with the sample(s), will be sent to registered participants.

Only the results sheet should be sent back by participants as a scanned PDF attachment via email within the specified timeline. Participants are advised to keep records of all calculations, graphs, and other raw data to demonstrate that testing is conducted in their lab. While PTP is not seeking this information with test reports, it may request it if required. Regulatory authorities or accreditation bodies may also verify this information during audits. This information is also useful for root cause analysis. Failure to provide the above information may lead to cancellation of results.

Results reported in a semi-quantitative manner as “less than” or “more than” a value, or results reported as zero, except where appropriate, will be listed in the PT round report but cannot be included in the statistical analysis.

Results may be rounded up or down for reporting purposes and may not be identical to the original reported result. Rounding effects may also cause percentage totals to not add up exactly to 100%.

It should be noted that EL cannot be held responsible for misinterpretation of results submitted for a PT scheme. For example, a comma can be ambiguous, as it may be interpreted as a decimal point or a thousand separator. Participants are advised to type the results rather than write by hand. The test results used by PTP are made available in a draft report to enable participants to verify their data’s accuracy. The purpose of providing a draft report is to address such concerns.

EL cannot be held responsible for ‘Results Not Considered’ due to non-compliance with instructions, varying case studies, using unauthorized methods in the PT scheme, selecting different sampling scenarios than provided case studies, or submitting manipulated formats or partial information in sampling or opinion and interpretation schemes.

Data values are rounded to decimal points as per standard practice laid down by IS, e.g., if a 2-decimal point (DP) is requested and the lab reports 23.445, it will be recorded as 23.45; if the lab reports 23.444, it will be recorded as 23.44.

For sampling and/or opinion and interpretation schemes, specific formats and information may be requested in provided formats or in formats used by participants.

14. Test Method and Analysis of Test Materials

Participants are advised to treat the test material or case studies as routine samples as much as possible.

Participants should use a specified method or methods in accordance with the design of the proficiency testing scheme as outlined in the scheme (report sheet). If participants wish to use a different test method, they should preferably obtain prior written permission, for example, if they intend to validate a method. Otherwise, they assume the risk that results may not be considered or may fail the scheme. Participants should also indicate on the report sheet if a different method was used. This applies to methods used for sampling as well.

For some parameters, there may be considerable variation in test methods among labs due to the non-availability of standards or other reasons. In such cases, PTP may provide a copy of the test methods to be followed. This also provides participants an opportunity to validate the methods.

15. Timeline

Please refer to the enclosed annexure for the timeline.

16. Prevention of Collusion and Falsification

Collusion is strongly discouraged. Participating laboratories are assigned code numbers, and assigned values are not disclosed to anyone before the report is issued. No results are accepted after the report’s publication. EL has a comprehensive system in place, as per laid-down procedures, to prevent collusion and falsification. Participants will be contacted if there is clear evidence of collusion. However, the responsibility ultimately rests with each participant to maintain professional conduct.

17. Analysis of Data and Performance Assessment

EL follows ISO 13528:2015 and ISO/IEC 17025 for statistical analysis and for evaluating participant performance. In quantitative schemes, participants are assessed based on the difference between their result and the assigned value, represented by a performance score known as a z-score or z’ (z prime) score.

For qualitative schemes, participants are assessed according to Section 11 of ISO 13528:2015.

18. Assigned Values (X or xpt)

The assigned value is selected as the best estimate of the ‘true value’ for the parameter under test. For quantitative tests, all assigned values are derived in accordance with ISO 13528:2015. A consensus value of participants or formulation as stated is almost invariably taken by EL PT as the assigned value. When the assigned value is determined from the consensus value of participant results, robust statistical methods are used for calculation. Assigned values derived from participant results or a subset of results are not traceable to an international measurement standard. The uncertainty of the assigned value is then estimated according to ISO 13528:2015.

When the assigned value is derived from formulation, it denotes the use of an assigned value based on sample preparation details where known and exact quantities of analyte were used to prepare the sample. Assigned values calculated from the formulation are traceable to an international measurement standard through an unbroken metrological traceability chain. The measurement uncertainty of the assigned value is calculated using the contributions from each calibration in the traceability chain.

As part of the procedure, gross errors or blunders are removed from the data. These results are excluded from the final calculation of the assigned value and other summary statistics, though they will still receive a performance score as ‘Excluded Results’.

In initial PT Trials, the assigned value may also be based on general averages for homogeneity. The expected Standard Deviation for Proficiency Assessment (SDPA or σpt) is chosen from literature, expert experience, or from the Thompson-predicted model based on the Horwitz equation. Once results from participants are available, the robust average assigned value and robust SDPA are used, and homogeneity and stability are revalidated. When there is concern about the uncertainty of an assigned value u(xpt), such as when u(xpt) > 0.3σpt, the z’ (z prime) score is calculated and reported.

For qualitative schemes, the assigned value is given as per Section 11 of ISO 13528:2015. For sampling and opinion-based schemes, assigned values refer to predesigned criteria decided by experts.

19. Z Score Calculations

The z-score is calculated as follows:

z score = (x – X) / SDPA

• x = the result reported by the participant
• X = the assigned value
• SDPA = Standard deviation for proficiency assessment

For quantitative data, the uncertainty of the assigned value is calculated to ensure a negligible effect on participants’ performance scores. If the uncertainty of the assigned value exceeds 0.3 x SDPA, a z’ (z prime) score is calculated instead to account for the measurement uncertainty of the assigned value.

The z’ score is calculated using the following formula:

z’ = (x – X) / √(SDPA² + UxAV²)

• X = Assigned value
• SDPA = Standard deviation for proficiency assessment
• UxAV = Uncertainty of the assigned value

Expanded SDPA = √(SDPA² + UxAV²)

For qualitative results, satisfactory performance is based on participants reporting the same result as the assigned value, such as “Absent” or “Present.” Scoring is done with color coding: green (satisfactory) for exact matches and red (unsatisfactory) otherwise (ISO 13528:2015, Section 11.4.3).

For qualitative results in schemes on sampling or opinion and interpretation, evaluation uses the “Overall Performance Index (OPI) Model,” which incorporates several latent performance indicators called “Key Criteria.” OPI reflects the overall evaluation of individual key criteria indicators. This approach emphasizes the operational performance of individual steps according to standard procedures.

Assigned Performance Scores by Expert Consensus

Assigned Performance Score (PS)	Remarks
3	Acceptable (Fully compliant)
2	Followed to a large extent
1	Followed to some extent
0	Unacceptable (Non-compliant)

The performance scores in sampling and data interpretation schemes are converted to an Overall Performance Index (OPI) to reflect the lab’s overall performance:

OPI = [Total PS obtained by Lab ÷ (n x ACV)] x Absolute Compliance Value for PS

• Absolute Compliance Value (ACV) for PS = 3
• n = Number of Key Criteria Indicators
• Total PS obtained by Lab = Sum of individual Performance Scores (0, 1, 2, or 3) against each criterion

20. Standard Deviation for Proficiency Assessment (SDPA or σpt)

All SDPAs are derived in accordance with ISO 13528:2015 from the dispersion of participant results, using robust statistical methods for the standard deviation. Where applicable, the SDPA value is reported in the Scheme Description and/or report.

SDPA is not applicable for qualitative schemes.

In special cases, if the robust SDPA from participants’ results is zero using the algorithm, SDPA may be calculated using the Horwitz function, in line with ISO 13528:2015, for Z/Z’ score calculations. The PT design in such cases is amended for future schemes to address this issue.

21. Interpretation of Results

For quantitative examinations, the following interpretation is applied to z or z’ (z prime) score results:

Z / Z’ Scores	Interpretation	Coding
|z| ≤ 2.00	Satisfactory result	Normal Black
2.00 < |z| < 3.00	Questionable result	Bold Black
|z| ≥ 3.00	Unsatisfactory result	Bold Red
Blunders	Greater than the assigned value ± 5 x SDPA – No score given	B in Red Bold
Results Not Submitted	Results not reported by laboratory – No score given	RNS
Results Not Considered	For results reported as zero, non-numerical, or qualified with symbols; participants assess based on assigned value – No score given	RNC

For schemes with fewer participants, ISO 13528:2015 is followed. When fewer than 8 results are submitted, results are not evaluated, and participants may assess their performance based on the average.

OPI Interpretation for Qualitative Schemes

OPI	Interpretation
OPI ≤ 0.75	Unsatisfactory – Needs comprehensive action/training on test parameter
0.75 < OPI ≤ 1.50	Questionable – Needs action/training on key parameters
1.50 < OPI ≤ 2.25	Satisfactory – Some areas for improvement
2.25 < OPI ≤ 3.00	Good – No further action required, unless any score ≤ 1.5

For qualitative results, satisfactory performance is based on participants reporting the same result as the assigned value (e.g., “Absent” or “Present”). Scoring uses color coding: green (satisfactory) for exact matches, and red (unsatisfactory) otherwise (ISO 13528:2015, Section 11.4.3).

22. Reports

Reports are made available only electronically in PDF format. The content of reports varies by scheme but generally includes details of the composition of test materials, assigned values, and tabular and/or graphical representations of participants’ results and performance, as required by ISO-17043.

23. Confidentiality

Each laboratory is assigned a unique code number in the PT report issued by the PT provider to ensure the confidentiality of reports, data, and other relevant information shared by participants. Code numbers may differ across PT schemes by chance.

The report is released by the PT provider in soft copy, PDF format only. Printed copies, including scans of colored prints, are uncontrolled. In case of doubt, a third party (e.g., regulatory authorities, accreditation bodies) may request authentication with the PT Provider via email, which will be done with the laboratory’s consent unless prohibited by law. As per NABL-181A Issue-2 dated 5.2.18, records of PT scheme participation shall be accessible to NABL if required.

If a laboratory refuses consent to share information with a third party, the third party will be informed of the laboratory’s decision.

Data and insights from PT programs may be used by the PT provider for future developments, including research publications. However, participant confidentiality will be strictly maintained.

This report is produced by the PT provider in good faith and in accordance with best industry practices. Neither Envirocare Labs Pvt. Ltd. nor any individual involved accepts liability for the application or use of the information contained therein.

Use of Reports by Participants

Copyright of all reports remains with EL Proficiency Testing. Participants are granted permission to make copies for internal use, to validate results, improve processes, or show to regulatory authorities, accreditation bodies, or customers as part of audit requirements. Other copies or uses require prior permission and cannot be circulated or used for any other purpose.

24. Post-Programme Support

A feature of the program is to assist participants in conducting investigations and taking actions in response to unsatisfactory or questionable results, thereby promoting quality improvement. Laboratories seeking further assistance to improve their performance may request additional support, which can be provided through online meetings (Skype, Google Hangout), email, or telephone. Specific on-site inputs may incur additional costs, depending on the nature of support required.

Additional test materials may be available after each PT round to enable participants to repeat testing if necessary.

Annexure

Scheme Name & Code	2024MF41R1
Analyte	Salmonella, Escherichia coli, Listeria monocytogenes, Total plate count, Enterobacteriaceae, Yeast & Mould
Sample Preparation	PTP
Subcontracted Activities	Homogeneity and Stability testing
Subcontractor	NABL Accredited Lab
Scheme Details	Nutritional supplements (Salmonella, Escherichia coli, Listeria monocytogenes, Total plate count, Enterobacteriaceae, Yeast & Mould)

Tentative Timeline

Participants are requested to strictly adhere to the timeline. Reports received late will be dealt with according to procedure and are likely to be rejected unless there are compelling reasons accepted by the PT provider. The decision of the PT provider in this regard is final; no complaints will be entertained, and fees will not be refunded.

Event	Date
Registration Closure	30.09.2024
Sample Dispatch	04.11.2024
Suggested Dates for Sample Analysis	Within 48 hrs after receipt of the sample
Acceptance of Results	25.11.2024
Draft Report	30.11.2024
Final Report	15.12.2024