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Standard Operating Procedures

The document discusses requirements for Standard Operating Procedures (SOPs) in laboratories according to the 2008 revisions to NR149. Laboratories must have SOPs that detail procedures and activities, and the code provides flexibility in how they are designed. For each analytical method, the laboratory must generate a specific SOP. The code also requires documenting procedures for 19 specific subjects either in separate SOPs, one combined SOP, or the Quality Manual. Analytical SOPs describe how the lab performs methods and can reference published methods with an addendum noting deviations, be created entirely from scratch including required elements, or consist solely of the published method if followed exactly.

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700 views2 pages

Standard Operating Procedures

The document discusses requirements for Standard Operating Procedures (SOPs) in laboratories according to the 2008 revisions to NR149. Laboratories must have SOPs that detail procedures and activities, and the code provides flexibility in how they are designed. For each analytical method, the laboratory must generate a specific SOP. The code also requires documenting procedures for 19 specific subjects either in separate SOPs, one combined SOP, or the Quality Manual. Analytical SOPs describe how the lab performs methods and can reference published methods with an addendum noting deviations, be created entirely from scratch including required elements, or consist solely of the published method if followed exactly.

Uploaded by

renjithv_4
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Standard Operating Procedures (SOPs)

The 2008 revisions to NR149 contain many new requirements regarding


laboratory SOPs. Laboratories must have SOPs (written documents) that detail
lab activities and procedures. The code allows a great deal of flexibility in the
way the SOPs are designed which leaves it up to the lab to decide. The SOPs
may be in electronic form or hard-copy.

The code requires that for each method being performed that the laboratory
generate a specific analytical SOP. In addition to the analytical SOPs, the code
requires that the lab document their procedures for at least 19 specific subjects.
These 19 issues can be documented in separate SOPs, grouped together in one
SOP, or documented in the Quality Manual as long as they are all covered.

Analytical SOPS

Analytical SOPs are SOPs that describe exactly how the lab performs the
method. There are generally three ways for the lab to create their own
analytical SOPs.

Option 1: the analytical SOP may consist entirely of the referenced published
analytical method. Keep in mind that this option will only work if the lab follows
the method exactly (very unlikely).

Option 2: the lab may reference a published method and include an
addendum that details exactly where the lab deviates from the published
method. Note that when this option is used, the addendum must include a
date of issue or a date of revision. Generally speaking, this option is considered
the most practical approach for small wastewater laboratories.

Option 3: the lab may choose to create their own SOP from scratch . If this
option is chosen the code specifically requires that the SOP includes each of the
following elements:

1. Identification of the test method
2. Applicable analytes
3. Applicable matrices
4. Method sensitivity
5. Potential interferences
6. Equipment and analytical instruments
7. Consumable supplies, reagents and standards
8. Sample preservation, storage and hold time

9. Quality control samples and frequency of their analysis
10. Calibration and standardization
11. Procedure for analysis
12. Data assessment and acceptance criteria for quality control measures
13. Corrective actions and contingencies for handling out of control or
unacceptable data

Analytical SOPs created from scratch must include a date of issue or a date of
revision These SOPs can be done in any format/style the lab chooses as long as
all of the required elements are included and understandable.

Analytical SOPs can be kept in an analytical methods manual, can be
included as part of the quality manual or can be kept as individual SOPs.

As with all other procedures in the laboratory, SOPs should be reviewed
periodically to ensure that they remain current.

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