develop consensus standards for use by TNI's programs. This group has a support role in assisting other programs with activities such as guidance and standards interpretation.
fosters the generation of data of known and documented quality is through the National Environmental Laboratory Accreditation Program, or NELAP. The purpose of this program is to establish and implement a program for the accreditation of environmental laboratories.
is to establish and maintain a national PT program to support TNI’s National Environmental Laboratory Accreditation Program, and other activities.
Field Activities Program (NEFAP) Executive Committee is to establish and implement an accreditation program for field sampling and measurement organizations (FSMOs).
Audit Sample Program is to develop consensus standards for the manufacture and analysis of audit samples for source emission testing.
on a variety of topics of interest to the environmental measurement community. TNI also hosts two regularly scheduled meetings per year, typically in January and August. Both are a week long and involve open meetings of TNI committees as well as training courses and other special sessions.Standard Interpretation
Standard: 2009 TNI
Section: V1M2, Section 5.6.4.2
REQUEST:
This section requires the lab to retain records of the standard or reagent manufacturer's Certificates of Analysis. One of our largest standard manufacturers recently stopped automatically sending hard copies of the C of A with the material, stating that it can be accessed electronically from their website. The manufacturer says an advatange of this, among other things, is "immidiate accessibility for audits".
My question is if hard copy of the C of A onsite at the lab is stictly required, or if access to the electronic copy "on-demand" is sufficient.
TNI FINAL RESPONSE:
(Quality Systems Expert Committee and NELAP AC, 3-31-13)
The laboratory must maintain copies of the Certificates of Analysis (CoAs), whether in hard copy or electronic format, in accordance with the lab's records and document control procedures and as required by the TNI Standard. The laboratory must maintain and control all records used to document lab activities, including CoAs, and all records must be made available to the accreditation body. The laboratory must retain all records (hard copy or electronic) for a minimum of five years (V1M2, section 4.13.3), and labs must incorporate procedures to maintain CoA from manufactures that do not have the same retention schedule for electronic CoAs.