2016年11月11日星期五

HKAS Training on RMP and PTP Accreditation

Hong Kong Accreditation Service (HKAS) organized a training course entitled “Training on RMP and PTP Accreditation” on 11 Nov 2016.  ISO 17034, the future standard for the accreditation of reference material producer (RMP), is expected to be published soon.  Many other ISO guides and standards relevant to RMP and proficiency testing provider (PTP) operation have also been revised recently or are under review.  This training course aimed at enabling participants to gain a better understanding of the new requirements.  Before the start, I met my old friend Mr. K. Gabuji (Technical Assessor and Lab Test Expert) and took a photo for memory.


In the beginning, Dr. Wolfram Bremser (BAM Federal Institute for Materials Research and Testing) was the first speaker and his topic entitled “Competence of RMP and the transformation of ISO Guide 34”.  


Dr. Bremser said CRM needed for legal and contract regulations setting.  It could be used for External and Internal Control.  Then he briefed the development of that standard on the transformation of ISO G34 into an international Standard by REMCO and cooperation with CASCO since July 2014.   


After that Dr. Bremser showed the ISO/FDIS 17034 “Conformity assessment – General requirements for the competence of reference material producers” structures to us as follows:
1.      Scope
2.      Normative reference
3.      Terms and definitions
4.      General requirements (4.1 Contractual matters; 4.2 Impartiality; 4.3 Confidentiality)
5.      Structure requirement
6.      Resource requirement
7.      Technical and production requirements
8.      Management system requirement
Annex A – Summary of production requirement for reference materials and certified reference materials
The requirements to RM and CRM were discussed in clause 7.1.1 and 7.1.2.


Finally, Dr. Bremser mentioned the structure requirement of RMP such as legal status, management system, roles and responsibilities, etc.  In Management System Requirement, Option A was to maintain a documented management system and Option B was based on ISO 9001 and to fulfil ISO 17034 requirements.  For internal audit, it was according to ISO 17025 and ISO 17034.  At the end, he stated the rules and procedures of corrective actions and customer relations.


Dr. Takeshi Saito (National Metrology Institute of Japan) was the second speaker and his presentation named “ISO17034”.   Firstly, Dr. Saito stated the definition of RM and CRM based on ISO Guide 30:2015.
2.1.1 Reference material (RM) – sufficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in a measurement process
2.1.2 Certified reference material (CRM) – RM characterized by a metrologically valid procedure for one or more specified properties, accompanied by an RM certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability


Then Dr. Saito explained What, When, Why, Who and How about reference material (5W1H).
What? ISO Guide 30:2015 and ISO/IEC Guide 99:2007 has an analogous definition (5.13)
When and Where? Checking performance and Calibration of measurement instruments; Method Validation, Characterization of materials and establishing Metrological Traceability
Why? Monitor consistency, QC, Reliability of measurement results, etc.
Who? Lab Analysts, Researchers, etc.
How? ISO Guide 33:2015 “Reference materials – Good practice in using reference materials”


After that Dr. Saito briefed ISO 17034 which was prepared by the ISO Committee on Conformity Assessment (CASCO), in collaboration with the ISO Committee on Reference Materials (REMCO).  The first edition of ISO 17034 canceled and replaced ISO Guide 34:2009 which had been technically revised.  Dr. Satio introduced some major changes which had been made compared with ISO Guide 34:2009 including 6.1 Personnel, 6.2 Subcontracting, 7.2 Production planning, 7.3 Production control, 7.4 Material handling and storage, 7.6 Measurement procedures, 7.7 Measuring equipment, 7.8 Data integrity and evaluation, etc. 


Dr. Wolfram Bremser (BAM Federal Institute for Materials Research and Testing) continued the topic on “ISO 17034”.  He discussed the data integrity and evaluation that computer software developed in-house or off-the-shelf software further developed for specific use is validated and shown to be adequate for use.  (Remark: The training for Validation of Computer Systems cost USD 1755!)


Then he discussed the assessment of homogeneity, assessment and monitoring of stability, characterization, as well as, assignment of property values and their uncertainties of RM. 


After that lunch, Dr. Takeshi Saito (National Metrology Institute of Japan) presented the topic entitled “Revision of ISO Guides 30, 31 and 33”. 
ISO Guide 30 – Reference material – Selected terms and definitions
ISO Guide 31 – Reference material – Contents of certificates, labels and accompanying documentation
ISO Guide 33 – Reference material – Good practice in using reference materials
(ISO Guide 32 – Calibration in analytical chemistry and use of certified reference materials (Obsoleted and revised by ISO G33))


Dr. Saito showed the diagram about ISO/REMCO related guides and others (in which ISO 17034 would replace ISO Guide 34).  Then he also mentioned the good practice in using RM and CRM in ISO Guide 33.  He introduced 6 common forms of RMs as follows:
a)      Pure substances
b)      Standard solutions and gas mixtures
c)      Matrix reference materials
d)     Physical-chemical reference material
e)      Reference objects or artefacts
(P.S. period of validity < lifetime)


Dr. Saito also discussed the relevance to the measurement system below.
a)      Level; need to cover target level (e.g. concentration)
b)      Matrix; need to be similar matrix
c)      Form; should be used in the same form
d)     Minimum sample intake; need a sub-sample representative of the bulk
e)      Quantity; sufficient for the entire experimental programme
f)       Stability; instruction for handling and use of the RM certificate is important
g)      Acceptable uncertainty of the certified value
h)      Commutability
At the end, Dr. Saito demonstrated the sample CRM certificate to us.


The last speaker was Mr. Dan Tholen (Dan Tholen Statistical Consulting) and his topic was “Statistical approaches in reference material production and proficiency testing: ISO Guide 35 and ISO 13528”.  Firstly, he briefed the definition of Proficiency Test (PT) items as follow:
-     Sample, product, artefact, reference material, piece of equipment, measurement standard, data set or other information used to assess participant performance in proficiency testing


Then Mr. Tholen briefed top ten changes of ISO 13528.
10.  Invalid/obsolete techniques removed – ISO 13528 (Remove obsolete requirement – ISO Guide 35)
9.      Symbols consistent with proper statistical protocol – PT (Terms consistent with proper statistical protocal – RM)
8. Could not resolve all issues - ISO 13528 (Could not resolve all issues in Guide 35)
7. Guidance on PT evaluation with Total Measurement Error (Guidance on RM stability due to usage conditions)
6. Can use z’ with consensus mean and standard deviation (More flexibility in CRM characterization)
5. Align ISO 13528 and ISO Guide 35 (ISO 13528 / Guide 35 components for uncertainty of the assigned value)
4. Allow Robust techniques
3. Flag questionable participant uncertainties in PT (ulab) (Guidelines on questionable components in CRM)
2. New Statistical Model for PT (Guide 35 additional statistical designs: Balanced nested designs, Randomized block designs, Accelerated & Isochronous stability study)
1. PT: Link statistical methods to objectives for the PT scheme 


Finally, Mr. Tholen said the choices in ISO 13528 and ISO Guide 35 made PT providers and RM producers look like a supermarket, but accreditation bodies needed to assess whether the chosen procedures are appropriate to provide a competent assessment of statistical methods.  He also showed us the standard and discussed “small numbers of participants”, “identifying outliers” and “statistical expertise”.  


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