Guidelines for Technical SOP Text
Organization follow certain processes and procedures on a regular basis. Thus, SOPs may be written:
- for any repetitive administrative activity
- for any technical procedure
- for any operational or functional process.
Examples are technical SOPs instructing the user:
- how to perform a specific analytical method to be followed in the laboratory or field (such as field testing using an immunoassay kit)
- how to validate a specific software
- how to handle unblinding information in clinical research activities
- how to report serious adverse events
- how to collect a sample in order to preserve the sample integrity and representativeness (such as collection of samples for future analysis of volatile organic compounds or trace metals)
- how to conduct a bioassessment of a freshwater site.
Technical SOPs are also needed to cover:
- activities such as data processing and evaluation (including verification and validation)
- risk assessment
- business operations and
- auditing of equipment operation.
It is not always acceptable to cite published methods in SOPs. This is because cited published methods may not contain relevant information and appropriate guidance for conducting the procedure-in-house. Technical SOPs need to include the specific steps aimed at initiating, coordinating, and recording and/or reporting the results of the activity, and should be tailored only to that activity. Technical SOPs should fit within the framework presented here, but this format can be modified, reduced, or expanded as required. IntelliSOP supports all SOP documentation formats: the user simply clicks on the link on their browser. A native viewer opens all files: there is no special software needed to open usual business formats. MS Office, PDFs, all graphical formats,… even Visio files are supported.
In general, technical SOPs will consist of five elements: Title Page, Table of Contents, Procedures, Quality Assurance/Quality Control, and References:
1. Title Page
2. Table of Contents
The following are topics that may be appropriate for inclusion in technical SOPs. Not all will apply to every procedure or work process being detailed.
a. Scope and Applicability: describes the purpose of the process or procedure and any organization or regulatory requirements, as well as any limits to the use of the procedure.
b. Summary of Method: brief summary of the procedure.
c. Definitions: identifying any acronyms, abbreviations, or specialized terms used that are not self-explanatory.
d. Health & Safety Warnings: indicate operations that could result in personal injury or loss of life and explain what will happen if the procedure is not followed or is followed incorrectly; listed here and at the critical steps in the procedure.
e. Cautions: indicating activities that could result in equipment damage, degradation of sample, or possible invalidation of results; listed here and at the critical steps in the procedure.
f. Interferences: describe any component of the process that may interfere with the accuracy of the final product.
g. Personnel Qualifications/Responsibilities: denoting the minimal education and experience the user should have to complete the task satisfactorily, and citing any applicable requirements, like certification or “inherently governmental function”.
h. Equipment and Supplies: listing and specifying any necessary, equipment, materials, reagents, chemical standards, and biological specimens.
i. Procedure: identifying all pertinent steps, in the right order, and the materials needed to accomplish the procedure such as:
- Instrument or Method Calibration and Standardization
- Sample Collection
- Sample Handling and Preservation
- Sample Preparation and Analysis (such as extraction, digestion, analysis, identification, and counting procedures)
- Data Acquisition, Calculations & Data Reduction Requirements (such as listing any mathematical steps to be followed)
- Computer Hardware & Software (used to store field sampling records, manipulate analytical results, and/or report data)
j. Data and Records Management: e.g., identifying any calculations to be performed, forms to be used, reports to be written, and data and record storage information.
4. Quality Control and Quality Assurance Section
QC activities are designed within the procedure to allow self-verification of the quality and consistency of the work. E.g.:
- Describe the preparation of appropriate QC procedures (self-checks, such as calibrations, recounting, re-identification) and QC material that are required to demonstrate successful performance of the method.
- Specific criteria for each should be included to ensure consistency.
- The frequency of required calibration and QC checks should be described and a discussion of the rationale for decisions should be included.
- A description of the limits/criteria for QC data/results and actions required when QC data exceed QC limits or appear in the warning zone should be added, as well as a description of the procedures for reporting QC data and results.
5. Reference Section
Documents or procedures that interface with the SOP should be fully referenced (including version), such as related SOPs, published literature, or methods manuals. Citations are not a substitute for the description of the method being followed in the organization.