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Combined Interpretations of the 2003, 2009, and 2016 Standards that apply to Volume 1 of the 2016 TNI Standard


MODULE 2: QUALITY SYSTEM GENERAL REQUIREMENTS
Section: 5.2.6

Question:  The standard no longer contains the wording "environmental" analysis in the area of experience for sections 5.2.6.1 (b) and (c).  Since it now states "such analysis" does this pertain to any type of laboratory experience in chemical, physical or environmental sciences (not just environmental)?
The terms "such analysis" indicates that the technical manager shall have experience in the fields of accreditation for which the laboratory is seeking accreditation. The experience required is of environmental analysis in the first question, and environmental microbiological analysis in the second. In both cases, the Standard requires that the analyses performed which would qualify as experience are those that would be performed by the laboratory at which a person would be the technical manager.

TNI Response:  With respect to the wording about experience in 5.2.6.1, paragraph (a), sentence number one states "...and at least two (2) years of experience in the environmental analysis of representative inorganic and organic analytes for which the laboratory seeks or maintains accreditation."  Paragraph (b) in sentence 2 states... “In addition, such a person shall have at least two (2) years of experience performing such analysis.”

 

Question #1: What is the difference between "..experience in the environmental analysis of..." , as stated in paragraph a  and "...experience performing such analysis", as stated in paragraph b.

Question #2: Relating to the interpretation of "representative organic and inorganic analytes".... to what degree does methodology/technology coming in to play. Can the word "representative" be better defined? We do not find anywhere in the document that requires experience in multiple technologies. For example, if the director has experience with Analyte A using an automated inorganic method (such as segmented flow) and experience with Analyte B using a conventional wet inorganic method (such as titration) but the lab runs analyte A wet and analyte B automated, would this person have the requisite experience in that area?
TNI Response:  Question 1 - There is no difference in the meaning of the wording of the two paragraphs. Each refers to two years' experience in the analysis of samples (not oversight/management of sample analysis). Question 2 - Representative - exemplifying a group or kind; typical: a representative selection of analytical methods. A Technical Director must have experience in the typical methods/technologies used by the laboratory.

 

Question:  Please clarify 16 hours of microbiology and biology. Is it 16 hours combined total of microbiology and biology in 5.2.6.1(c)? Is it 16 hours of microbiology and 16 hours of biology 32 hours total?

TNI Response:  The requirement is for a combined minimum 16 hours of microbiology and biology, not for 16 hours of each.

 

Question:  5.2.6.1(f) reads: Any technical manager of an accredited environmental laboratory engaged in the examination of radon in air shall have at least an associate’s degree or two (2) years of college and one (1) year of experience in radiation measurements, including at least one (1) year of experience in the measurement of radon and/or radon progeny. The list of requirements has no separating punctuation. Please clarify whether the intent is to have one of the two education options, and then experience regardless of education.

TNI Response:  Yes, the requirement is to have one of the two education options in addition to the requisite year of experience in the measurement of radon.