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Videos with the most frequently asked questions about the Spectroquant® USEPA methods equivalency

Dr. Edward Askew of Askew Scientific Consulting took some time at Pitcon 2017 to address some of the Frequently Asked Questions regarding his work in helping Merck obtain USEPA Equivalency Reports for our Spectroquant Test Kits.

Watch the full video about the 8 questions to the USEPA Equivalency of the Spectroquant® test kits.
Each question below is also addressed in separate videos as well as in the downloadable PDF‘s.

Download PDF Introduction

1. What methods currently have USEPA approval?

USEPA has issued approval letters for:	Equivalency reports are available also for the following:
COD Chromate Chlorine Phosphate Sulfate	Ammonium / Ammonia Nitrate Nitrite

All documents and all the details can be found at www.merckmillipore.com/usepa

2. What kind of documentation is provided for customers and for auditors?

Merck provides 5 sets of documents according to the USEPA requirements. These documents are available for all parameter and measuring ranges:
Equivalency report Method in EPA format Equivalency Checklist for the Laboratories Equivalency Checklist for the Laboratory Management Certificate Letter for every parameter and range

All documents can be found at www.merckmillipore.com/usepa. For further details please download the PDF.

3. What are the benefits of using these test kits?

The Advantages of the Spectroquant® Test Kits:
Multiple quality control procedures Control of the chemical use Pre-measured chemicals, ready and easy-to-use chemistry Quality documentation of the test kits available for all parameters Equivalency documentation for selected test kits are provided

All documents can be found at www.merckmillipore.com/usepa

4. Can you explain what you mean about the quality of the Spectroquant® chemistry?

To provide the best product possible, we consider all aspects of production and quality to ensure accuracy and precision by:
Using high quality of glass in the sample vials to eliminate variations that can occur in the results because of poor glass Using high quality reagents in the test kits that are also measured precisely when added to the cells Providing all certification and documentation required by the USEPA for all test kits Combining our high quality chemistry with a robust and precise instrument (When using the Prove Spectroquant)

To provide the best product possible, we consider all aspects of production and quality to ensure accuracy and precision by:

Using high quality of glass in the sample vials to eliminate variations that can occur in the results because of poor glass
Using high quality reagents in the test kits that are also measured precisely when added to the cells
Providing all certification and documentation required by the USEPA for all test kits
Combining our high quality chemistry with a robust and precise instrument (When using the Prove Spectroquant)

The above factors provide you the assurance that your laboratory can defend your data, should an auditor or lawyer walk through the door.

5. What exactly do the regulators expect?

What does Merck provides to satisfy the auditors:
Accuracy and precision of the work assures correct results Defensibility of the results because of high quality reagents and precise measuring during manufacture High quality of glass in the sample vials eliminates the variation in the results that can occur because of poor glass Provided certification and documentation for all test kits Quality, defensible instruments

The above factors provide you the assurance that your laboratory can defend your data, should an auditor or lawyer walk through the door. Download the PDF.

6. What must the laboratory staff do to meet the regulators requirements?


The laboratory must follow the checklist which Merck, provides. Details are on the following slides. Download the PDF. With these details and the documentation of the data the laboratory will be able to explain why their used method is equivalent and show the results accordingly.

7. What are future requirements from USEPA for our test kits?


40 CFR 136.6 is not changing in the current method update role and in the proposed method update there is no change either. Method equivalency for the clean water act methods and all the work that have been performed already will meet those requirements. Safe drinking water will probably incorporate the same requirement. They are looking for an method update role for drinking water. In the interim we are following an Expedited ATP, if required. We are committed to providing exceptional documentation as required by the USEPA. For the next 10 to 20 years we don’t expect a principle change in the requirements. This means, our current efforts ensure our customers are on the safe side.

40 CFR 136.6 is not changing in the current method update role and in the proposed method update there is no change either.
Method equivalency for the clean water act methods and all the work that have been performed already will meet those requirements.
Safe drinking water will probably incorporate the same requirement. They are looking for an method update role for drinking water. In the interim we are following an Expedited ATP, if required.
We are committed to providing exceptional documentation as required by the USEPA.
For the next 10 to 20 years we don’t expect a principle change in the requirements. This means, our current efforts ensure our customers are on the safe side.

8. How does ISO 17025 requirements differ from EPA requirements?


ISO 17025 requires that the lab have a standardized method and that they follow that method. If this standardized method meets all the technical section mentioned in ISO 17025 by following these requirements you met the requirements from the USEPA. In the method of Merck, all requirements from ISO 17025 and USEPA are addressed and described. If the lab follows the procedure and use the laboratory checklist, the lab will meet the requirements from ISO 17025 section 5 and USEPA.

ISO 17025 requires that the lab have a standardized method and that they follow that method.
If this standardized method meets all the technical section mentioned in ISO 17025 by following these requirements you met the requirements from the USEPA.
In the method of Merck, all requirements from ISO 17025 and USEPA are addressed and described. If the lab follows the procedure and use the laboratory checklist, the lab will meet the requirements from ISO 17025 section 5 and USEPA.

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