Traceability of Samples, Reference Materials, Reference Standards, and Reagents is a Key Component of Reliable DataEnsuring Reliable Data
Oral Presentation
Prepared by M. Wade
Pace Analytical Services, Inc., 9608 Loiret Boulevard , Lenexa, KS, 66219-2406, United States
Contact Information: [email protected] ; 913-449-5223
ABSTRACT
Laboratories are required to have procedures for achieving traceability of measurements. The chain of traceability can be weak, and thus the data may be characterized as unreliable, when pieces of meta data are missing; worse yet the chain can be broken when links are missing all together. This presentation will identify the components (i.e., Certificate of Analysis, Receipt, Usage, Prep and Disposal records, etc.) that have the potential to comprise the chain of traceability for testing laboratories as discussed in Section 5.6 (Measurement Traceability) of EL-V1M2-2016-Rev2.1: Quality Systems General Requirements.
