Microsoft Word - BYLAWS 9_26_10

OMB MEETING MATERIALS

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Straw Man: This document is a starting point for future drafts and is not an approved document. Please do not distribute to laboratory staff for use.

Note: Cost or availability may preclude the use of a CRM for routine analysis. In these cases, the laboratory is encouraged to use the CRM to qualify a secondary reference material and to provide traceability (ISO Guide 80:2014, Guidance for the in-house preparation of quality control materials (QCMs).

7.7.2 . Ensuring the validity of results - Proficiency Testing

Pre-Accreditation: The laboratory shall have successful proficiency testing or interlaboratory comparison results to qualify each test method for which the laboratory wants to become accredited.

Ongoing:

The laboratory is required to demonstrate competence through the participation in proficiency testing based upon the scope they have:

 For a Biological scope, the laboratory is required to participate in one proficiency testing event each year for each method on the scope.  For a Chemical Scope, the laboratory is required to participate in one proficiency testing event each year for each method on the scope unless it can provide evidence in the form of additional justification showing the similarity of process between each of these methods. o How the laboratory will cover its entire scope annually including commercial and alternate programs o If applicable, justification showing similarity of tests on a Chemical scope. How the laboratory accomplishes this must be included in this PT plan. o the scheduled PT for four years.  When a relevant and appropriate PT program is not available the laboratory shall document in their plan its planned participation in interlaboratory comparisons other than proficiency testing, where available and appropriate. When no PT or interlaboratory comparison is available, the laboratory shall develop and justify an alternative plan for monitoring data  Proficiency test samples shall be analyzed following the normal working practices operated in the laboratory. They are not intended to represent individuals in the laboratory, unless this represents the normal mode of operation where only one person is involved in the analysis. They shall be rotated among qualified analysts.  The laboratory shall have a documented proficiency testing (PT) plan. This plan must include:

Note: When selecting a PT provider, preference should be given to one accredited to ISO/IEC 17043.

Note: initial and ongoing proficiency testing for laboratories with flexible scopes shall be performed in accordance with the accreditation body’s requirements.

7.7.3

Quality control material acceptability

The laboratory shall have procedures that define quality control material acceptance criteria and what constitutes a trend in the Statistical Process Control (SPC) data. When quality control material data does not meet acceptance

08/09/2018