Schedule –
1. Octagon will communicate the whole schedule to the participants for receipt & dispatch of PT item(s).
2. Octagon will communicate the schedule to the individual participants after receipt of registration through website, which includes laboratory code, date of dispatch from Octagon and participant, and measurements date allocated for participant laboratory. For this PT program, each participant will be allotted [three working days] for measurements from the date of receipt of the PT Item(s). The Laboratory has to dispatch the PT item as per the given schedule.
3. Octagon will release the interim report (Intermediate Report) to every participant within a weeks time, after receipt of results from the participants to verify the correctness of the data entry. If the participant laboratory wishes to analyze their performance they can contact Octagon for further guidance.
4. Distribution of final report to all participants. Generally, the report is issued within 15 days of the PT closing date but Octagon reserves the right to extend this period in cases where the statistical evaluation proves to be atypical.
4. Participants will be kept informed by email if a delay arises at any of these stages.
5. For any changes in PT Design or operation of this PT Round, participants will be informed promptly, through email.
Participation Criteria –
Participation criteria defined in the registration form, is based on present NABL practice of ILC, where CMC of reference lab should be superior (smaller measurement uncertainty) than the participant’s CMC. However as per ISO/IEC 17043:2010 management system, a standard for PT provider’s accreditation, do not restrict PT provider to include any participant whose CMC’s are superior than reference lab. Octagon provides such choice to the participants to decide their participation in the above PT scheme.
Participation Fee for PT –
If the participation criteria meets then participant laboratory can proceed with registration for PT scheme(s) as per fees structure available on the website oms.octagon.co.in
Handling, Storage, Packaging, and Transportation –
1. It is the responsibility of the participant laboratory for careful handling & Storage of PT item(s) during the period it remains in possession of participating laboratory. The participant laboratory should ensure effective handling to avoid any contamination, degradation, and/or loss, of PT items.
2. PT Program is arranged in a sequential PT Scheme. Octagon will arrange delivery of the PT item(s) to your laboratory as per the sequence schedule. Octagon will use a reputed courier agency for proper transportation and will take care of the packaging.
3. In case of sequential PT Scheme The participating laboratory should arrange the dispatch with proper packaging, dispatch note, and recommended courier agency by Octagon. The courier charges need to be borne by the participant Laboratory.
4. In case of Simultaneous PT Scheme – Testing Octagon will arrange to deliver the PT items through reputed courier services and due care will be taken for proper packaging of PT items. After completion of testing of PT items all participants needs to send back tested samples to Octagon by reputed courier with proper identification on test samples. The cost for courier has to be borne by participant laboratory.
5. In case of damage and loss of the PT item(s) by the participant laboratory, a penalty of INR 20,000/- up to INR 1,50,000/- (As per the PT item price and value added to it for PT Services) whatever higher, will be charged to the participant.
Methodology-
1. Octagon has designed a PT scheme as per ISO/IEC 17043. The details of the PT scheme will be separately communicated in the form of a protocol for proficiency testing.
2. Octagon has procured & conditioned above mentioned PT items for this scheme for ensuring uniformity in measurement by the laboratories.
3. On confirmation of participation in the above PT scheme, Octagon will generate a unique code for your laboratory w.r.t. this PT scheme. For confidentiality purposes, all further communications will be done with this unique code number.
4. Octagon does not have any laboratory facilities of its own. The PT items homogeneity/stability testing is carried out by subcontractors. Octagon maintains a list of approved subcontracting laboratories and regularly reviews the service received. Octagon will only use subcontracting laboratories that hold accreditation for measurements to recognized international standards (ISO/IEC 17025).
5. Octagon has established a steering committee (Advisory Group) who have technical expertise in Calibration / Testing in respective fields. Their expertise is utilized for planning PT Design, preparation, and maintenance of stability and homogeneity of PT items. The technical experts also contribute their expertise to ensure stable assigned value and resolution of technical difficulties raised by participants.
6. Octagon will evaluate the PT performance of the laboratory by statistical analysis of the measurement data and will provide the report in one/ two stages. In the case of sequential PT, the scheme is too long as no. of participants are more, an interim report can be issued before final results are disclosed. However, the reliability of such an Interim report is not fully conclusive as it is based on the analysis with limited data. For this reason, an Interim report can be considered for reference purposes only. An interim report is mainly for those participants, who have to demonstrate their participation in the PT program, to initiate corrective action for any audit observations. In conclusion, Octagon recommends using the final PT report only, Since the Final report is based on robust statistical analysis, it has higher reliability.
7. Final PT reports will be provided at the end of the PT round which includes data covering the results of all participants together with an indication of the performance of each participant.
8. Results subjected to statistical analysis by Octagon with reference ISO 13528.
9. Statement of Participation or performance to the participant – On the request of the participant Octagon may state participation to the individual participant which includes the performance of that participant. This statement of participation will be extracted from the original PT report.
10. In the instance, if the interested party requires that PT results be directly provided by Octagon then Octagon will inform all participants in advance of the participation or approval will be taken from the participant laboratories.
11. In the instance, if Regulatory Authorities requires PT Results to be directly provided to the authority by Octagon, the participants will be communicated by email.
12. For any deviation in the contract or agreed PT round design Octagon will inform its customer, participant laboratory. If a request or contract is amended after the PT round is underway, the same review process will be repeated any amendments will be communicated to all affected personnel.
Determination of Assigned value and Criteria for evaluation of performance –
Octagon will determine the assigned value from Reference Laboratory and En score will be used as criteria for evaluation of performance.
Stability of PT items-
Octagon will ensures Stability of PT items after completion of Study (The criteria for stability is mentioned in PT design for all respective PT schemes). If PT Item found to be unstable, than the PT round will be temporary withdrawn and new round will be initiated and accordingly inform to the participant. Octagon may decide to release the final PT report with reference value (Assigned Value) established before start of the PT round.
Confidentiality and Impartiality –
1. We Octagon follow a higher level of business ethics; we are committed for avoiding falsification and collusion of results. By signing this contract, the participating laboratory also agrees to maintain confidentiality and avoid falsification and collusion.
2. Octagon is committed for impartiality & operational integrity in the entire process of PT program.
3. In case of any dispute, disagreement participant laboratory may contact the PT coordinator. In case of unsatisfactory complaint handling by Octagon, participants deserve the right to appeal Octagon’s Management.
4. Octagon is committed to maintain confidentiality at all levels of the PT program. When an interested party requires the PT results to be directly provided by Octagon, the participant’s approval will be taken. In exceptional circumstances when Regulatory Authority or customer requires PT results to be directly provided to the authority by Octagon the affected participants will be notified in writing.
Cause Analysis / Re-Measurement (Re-Verification) of PT Item –
The participant must release their result sheet and return of PT item(s) on time, as per instructions issued in the technical protocol. On receipt of the PT item(s) with measurement results back to Octagon, interim (preliminary) report will be issued within a week. However, participant should take a note that reliability of such Interim Report is not fully conclusive as it is based on the analysis with limited data.
In case, based on the results of the interim report, if participants wish to re-measure Pt item (re-verification) and submit revised results, then PT item(s) will be made available on special request on a chargeable basis. The Final PT Report may include a performance evaluation with revised results together with a statement of corresponding corrective actions communicated by the participant.
Refunds / Cancellation Fees –
a. If any participant registers for a PT round and Octagon doesn’t get enough participation for that PT round then Octagon reserves the right to cancel the PT round and in this case, full PT fees will be refunded to the participant. The participant also has the choice to migrate from the canceled PT round to another one, with the same PT fees applicable. The participant laboratory should coordinate with PT Coordinator for this support. If the participant registers for a PT round and by his choice or whatsoever circumstances the participant cancels the PT round registration then
i) 5% of total fees will be deducted and balance fees will be refunded to the participant if a cancellation request is received from the participant by email within 30 days from the date of registration.
ii) 10 % of Total Fees will be deducted and the balance fees will be refunded to the participant if a cancellation request is received from the participant by email after 30 days from the date of registration.