Check List for APMP-TCT SPRT CMC submission

Document History

Version
& Date / Edited by / Revisions
0.9
2007/11/16 / K. Yamazawa (NMIJ, AIST) / Created
0.95
2007/11/22 / K. Yamazawa (NMIJ, AIST) / Minor change
0.98
2007/12/06 / K. Yamazawa (NMIJ, AIST) / Add forewords to resolve the complexity.
1.0
2008/11/10 / K. Yamazawa (NMIJ, AIST) / Form revised

Foreword

This document is intended to ease each laboratory in submitting their CMC proposal to the APMP-TCT. Since the CMC review process has been built upon the history, and furthermore, the rules are determined at various organizations, the process itself is very complex.

Upon submission of the CMC proposals, the minimum requirements of the documents are only the three following,

1.Excel file for CMC submission

2.Technical supporting documents

3.Quality system review files

However, in practical, various rules apply to the contents of these documents.

As asystematic solution, the APMP-TCT review committee asks the submitter tocheck their content by the following check list. Furthermore, APMP-TCTreview committee also asks the submitter self judge against the CMCreview rules, and kindly decline their submission if it would not meetthe criteria.

NMI name

Please check the following items before submitting your CMC claim to the APMP-TCT chair (and the SPRT CMC review committee)

Please check the check boxes () and text fields ()

  1. Excel file for CMC submission

Please fill in the Excel file for CMC submission. Detailed instructions for filling the table could be found here.
Please fill in the number of CMC claims in this submission, and the list “NMI Service Identifier” for those entries.
Number of entries included in this submission: 2 entries
Please list up the “NMI Service Identifier” for those entries(e.g.NMIJ-T-1, NMIJ-T-4):
  1. Technical supporting documents

Please attach to your submission,

Index documentcontaining
Glossary explanation of their CMC claim.(e.g. how the national reference is determined, participation in international comparisons, external traceability links to other NMIs, etc.)
Detailed uncertainty budget
Explanations for the scrutiny criteria (for those entries that have scrutiny criteria determined by the CCT-WG8)
Reference list which shows the links to each factor of uncertainty / WG-8 scrutiny item.
A table showing the relations between each factor of uncertainty in their detailed budget list and the WG-8 scrutiny items (if the relation is not obvious (e.g. when a factor in the NMI’s uncertainty budget combines several items in the WG8 scrutiny items, when the title of the uncertainty factor may be different to other institutes, etc.))
(For those institutes that have changed their national reference since their previous international comparison) Information about the history and the linkage to the previous KC.
NMI name
Notes
Examples of index document are placed here. WG8 scrutiny criteria are shown in each review protocol placed in the CCT-WG8 documents
Please keep in mind that supporting documents (such suggested below) would be necessary to support your CMC. The reviewer would obviously ask for further submission of supporting documents, if there is any lack of information to technically support your CMC.
Please make index files for each CMC claim individually, since each CMC claim might be reviewed individually.
Other supporting documents.
The following material would obviously help the reviewers to conduct their review activities, and the review committee encourages each NMI to submit such information upon necessity.
Equipment lists.
Copies of reference documents (technical papers, documents) supporting the uncertainty budget.
Technical papers showing the method and validity of your test methods, uncertainty analysis, etc.
Example of a calibration report.
Graphs demonstrating your ability(e.g. melting and freezing curves, immersion curves)
(For those institutes that have changed their national reference since their previous international comparison) Detailed information about the history and the value DT and u(DT)
Peer review report.
Final attestation report of the assessment
Accreditation certificate.
Instruction manuals, calibration procedures, etc. to achieve small uncertainties.
  1. Quality system review files

Please submit the material necessary for quality system review according to the latest “APMP Procedure for CMC entry in Appendix C”. At the time of 2007/11/16, the current version is APMP-G1 ver4, which requires both the CMC claim and QS information to be submitted at the same time.

The documents necessary would differ upon whatever pathway your NMI selects, and please refer to whoever responsible in your institute and the document APMP-QS1 for the details. Many of the institutes in the APMP region has selected pathway (a), which requires APMP-QS1 form to be filled out, copy of peer review report and a copy of the accreditation certificate to be attached as the QS documents. Institutes not following pathway (a) (such as KRISS and NIM) should follow the relevant procedure.

Note: Many entries within thermometry were submitted before the APMP-G1 ver4 has got effective, however, the APMP requires all CMCs to be reviewed according to the current rules. Upon this concern, the CMC review committee recommends each NMI to check their QS review status, and re-submit their QS upon necessity.

  1. Self judgments of your CMC claim against the CMC review protocols

As called from the APMP-TCT chair at APMP-TCT 2007 meeting in Sydney, each NMI should self judge their CMC claim and should not submit claims that would obviously fail the criteria, upon concern of wasting the time of the review committee. Upon submission, please refer to documents, APMP-G1 ver4, CCT-WG8 documents, and JCRB rules.

For your reference, you might also read the documents in the table“Guidance on CMC reviews” of the JCRB page to learn the procedures until CMCs are published on the BIPM-KCDB.

Please summarize your self judgments below.

Document preparation
All those documents necessary listed above are prepared and ZIPped?
Technical review
Checked the review protocol in CCT-WG8 documents
Attached supporting documents upon necessity (especially for scrutiny)
Classifications
Upon self judgments, the CMC claims that are submitted this time are,
Automatically accepted: for “NMI Service Identifier”
Should be accepted upon RMO review : for “NMI Service Identifier”
Should be accepted upon RMO review and CCT-WG8 review for “NMI Service Identifier”
Would not be accepted: PLEASE DECLINE THAT CLAIM
QS review
The QS requires a QS review (upon the current APMP-G1)
If so,
APMP-QS1 form filled
If following pathway (a), Peer review report and Accreditation certificate attached. If following other pathway, relevant required documentation completed.

Contact information

Questions upon this document should be forwarded to the mailing list for the APMP-TCT SPRT CMC review committee,

Files and links related to the APMP-TCT SPRT CMC review committee would be placed upon the website,

Check List for APMP-TCT SPRT CMC submission page 1/5