SPSFAM Heavy Metals ERP Book

AOAC Expert Review Panel for Heavy Metals 

ER 8

Yes If yes, please explain and note whether the method author has addressed those concerns.

ER 1 There was user feedback from participants in the MLT. At lease 10 out of 13 MLT labs agree that  the method can be followed by those with intermediate knowledge of HPLC‐ICP‐MS, that the  method is easy to understand, that the method is reliable and consistently provides accurate  results, that the method produces few erroneous results and that the quality control measures  are reasonably to achieve. ER 2 The most important update was the author added Arsenocholine (AsC) to be used as a  substitute for AsB, as asked by the users if AsB is necessary and it is expensive.  AsC is  significantly cheaper than AsB, the applicability is enhanced.  ER 3 Author has already addressed feedback and submitted an edited method. ER 4 Feedback from users include improvements but not addressing any concerns. Concern around  quality control not reasonable to achieve noted with a comment that method did not followed  as written. ER 5 There were 13 labs that participated in the MLV.  The comments were not method  modifications, instead the comments were related to clarity of the SOP and equipment. ER 6 MLT mss reviewer comment ‐ Repeatability was not measured appropriately under  repeatability conditions. Instead, pseudo‐ repeatability was measured. As repeatability is part of  reproducibility, reported reproducibility is also then suspect. True repeatability and  reproducibility variation are likely larger than values reported from the study. I am not able  follow these comments and what does reviewer intends to state is not clear. ER 8 Reviewer suggestions were incorporated into edit version of the method on page 119  Has the method author addressed any specific AOAC Final Action requirements as noted by  the ERP, if any? ER 1 Yes. There were many suggestions made during the method review process. The revised  method red‐line version addresses these concerns like calculating the quantitation limits in a  standard AOAC manner rather than the statistically conservatively FDA way. For example the  FDA estimate for LOQ is 30*sigma whereas the AOAC estimate and more standard way is  10*sigma. Other suggested changes listed in the redline version include a safety warning about  using ammonium hydroxide, clarification about using either MMA as a solid or as a pre‐made  standard solution, Helium cell gas flow range recommendation and a caution about pH induced  retention time shift of analyte peaks. ER 2 Yes. Author response was included for review. It clearly documented the changes and updates  as required.  ER 3 Yes. ER 4 YES, Refer to AOAC OMA 2016.04 Final Action Requirements – Method Author Response  ER 5 Yes, the details were provided and the authors have addressed the comments. ER 6 ER 7

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