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Standard Interpretation



SIR #: 192
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.