SPSFAM Heavy Metals ERP Book

Does the method perform according to the method"s applicability as written? If No, please explain why the method did not perform according to the method"s applicability as written.

The method performs according to the method's applicability, with the exception of infant formula. Section 1.3 of the method states "Many food matrices may be analyzed with this method, including solid chocolate, fruit juice, fish, infant formula, and rice." The ILS results show that the labs could not achieve the RSD (r) and RSD (R) required.

2. SAFETY CONCERNS

Are there any safety concerns identified while using or regarding use of the method? If Yes, please identify the safety concerns regarding the use of this method.

No Safety Concerns

3. STATISTICAL REVIEW

Is the documentation for the statistical review prior to AOAC First Action Official Methods status available and completed?

Yes, available and completed.

4. REFERENCE MATERIALS

Are there available reference materials? Were there any concerns identified while using or regarding use of the method?

Yes, the method used 6 QC samples, 4 SRMs and 2 QC samples (SRM 2384 Baking Chocolate, SRM 1946 Lake Superior Fish Tissue, ERM-BD 150 Milk Powder, SRM 1568b Rice Flour, Apple Juice Concentrate, Infant Formula QC Material). This is where the red flag is on this MLV study. There was not enough samples spiked at various levels for each of the different matrices. There wasn't enough data points.

5. SINGLE LABORATORY VALIDATION