SIR #: 339
Section: V1M4, Section 1.6.1 (c)
1.6.1.c) In cases where an individual has prepared and/or analyzed samples using a method that has been in use by the laboratory for at least one (1) year prior to applying for accreditation, and there have been no significant changes in instrument type or method, the ongoing DOC shall be acceptable as an initial DOC. The laboratory shall have records on file to demonstrate that an initial DOC is not required.
Question: Would like clarification on the wording in this section. Is the section saying that if a lab applies to add accreditation for a method the lab has been performing in house for at least one year, the analyst performing the test can submit an On-going DOC for accreditation rather than an Initial DOC? The wording almost suggests that the analyst does not need an IDOC for a test method the lab has held certification for over one year, only an On-going.
TNI FINAL RESPONSE:
The question has been posed in two parts, and is answered accordingly. For the first question, if the individual has been performing the method, preparing and analyzing samples, and meets all the laboratory requirements for an Ongoing DOC (Section 1.6.3), the Standard allows substitution of an Ongoing DOC for an Initial DOC, aside from any other program requirements. It should be noted that the requirements for an Ongoing DOC (Section 1.6.3) include any one of five approaches, one of which is "another" Initial DOC.
Section 1.6.1.c) is not relevant to the second issue, in which "the lab has held certification for over one year". This posits a situation in which a new analyst is being trained for an already-accredited method or new analytes are being added to an already accredited method; these requirements are set in Section 1.6.2 (the Initial DOC) since the laboratory already hold accreditation for the method.
It should also be noted that Section 1.2 specifies that: "Additional QC requirements that are either specified by method, regulation or project shall be met by laboratories," and these specifications could require the performance of Initial Demonstration of Capability despite what Section 1.6.1(c) allows.