SIR #: 10026
Standard: 2003 NELAC
Link to relevant standard
Assessors require that each analyst perform an Initial Demonstration of Capability prior to running samples. This IDOC is, as referenced in Appendix C, is 4 aliquots of a quality control sample.
188.8.131.52.2 states 'The laboratory shall confirm that it can properly operate all methods before introducing the environmental tests. If the method changes, the confirmation shall be repeated.'
Q1 - Since the definition of method does not include 'analyst', does the introduction of a new analyst mean the method has changed?
184.108.40.206.2 a) states (in part - I believe I have not left out any language germane to the question) 'Prior to acceptance and institution of any method, satisfactory demonstration of method capability is required. (See Appendix C and 220.127.116.11.b)'.
18.104.22.168.2. b) states 'Thereafter, continuing demonstration of method performance, as per the quality control requirements in Appendix D (such as laboratory control samples) is required.'
22.214.171.124.2 e) states 'A demonstration of capability must be completed each time there is a change in instrument type, personnel, or method.'
Q2 - Does the order in which these items are presented determine the requirements, such that a demonstration of capability is required prior to acceptance of any method, but thereafter laboratory control samples can be used to demonstrate an analyst's (even a new analyst's) capability?
Thank you for considering these two questions.
TNI FINAL RESPONSE:
(Quality Systems Expert Committee/NELAP Board, 10-25-08)
126.96.36.199.2.a and b refer to the institution of any method in the lab. Unless there is an analysis that does not require an analyst, the analyst is considered the lab for the purposes of DOC.
188.8.131.52.2.e requires a repeat of demonstration for each analyst or instrument type or method change.
So if a new analyst is introduced, yes he/she must perform a DOC. No, the order in which items are presented does not determine the requirements.