Topic of the blog: Understanding Technical SOP
This blog deals with the concept and the importance of Technical SOP. But before we talk about the Technical SOP, let’s understand the SOP.
WHAT IS SOP?
SOP stands for Standard operating procedure. In order to carry out the routine operations, organization follow the step-by-step instructions, these instructions are called as SOP. Efficiency, Quality output and conformity of performance shall be achieved by the SOP.
WHAT IS TECHNICAL SOPs?
To perform the specific method or task in the field or laboratory, the written instructions which is been used for the same purpose is called as “Technical SOP”. Technical SOP is usually in the form of an “inspection”, “recurring work order”, and “preventive management work”.
GUIDELINES FOR WRITING TECHNICAL SOPs
- Technical SOPs are basically written for the purpose of activities.
- Examples are “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), or 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), or how to conduct a bio-assessment of a freshwater site”.
- To cover the activities such as “data processing” and “evaluation (including verification and validation)”, “modeling”, “risk assessment”, and “auditing of equipment operation”, “Technical SOPs” are required.
- It is not acceptable always citing “published methods” in SOPs as the pertinent information may not be present in the cited “published methods” for the aim of controlling the procedure-in-house.
- Within the framework which is been presented, Technical SOPs should be fitted.
- It is also very important that there should be modification, reduction, expansion of the Technical SOP Format.
IMPLEMENTATION OF TECHNICAL SOPs THROUGH DIGITAL SOLUTION
Technical SOPs are implemented through the “digital solution” which includes “MaintainX”. With the help of “MaintainX”, person can:
- For the relevant employees, “MaintainX” automate SOP assignments.
- In order to complete the SOPs, it is to be ensured that employees are trained in a proper manner.
- Employee performance of SOPs is been monitored.
- It is very important that SOPs are reviewed, updated and revised.
- With “Maintain X”, a person shall adapt the “changing safety”, “compliance” and “quality-control regulations”.
ELEMENTS OF TECHNICAL SOPs
There are five elements of Technical SOPs. These elements include:
- “Title Page”
- “Table of Contents”
- “Quality Assurance/Quality Control”
- “Title Page”
Each SOP’s first page or cover page shall carry the following information: a “title” that clearly identifies the ‘activity or procedure’, “an SOP identification number”, “date of issue and/or revision”, “the name of the applicable agency”, “division”, and/or “branch” to which this SOP is tried, and “the signatures” and “signature dates” of those people who made the SOP. Those SOPs which are maintained on a computerized database shall be accepted via electronic signatures.
- Table of contents
For quick reference, a table of contents may be needed. In case if the SOP is very long, there is a need of table of contents. Also, for the purpose of locating information relating to SOP, table of contents plays an important role. We can also take the help of table of contents for changes and revision.
There are some of the Procedures that have been added in the technical SOPs. Some of them include:
- “Scope and Applicability (describing the purpose of the process or procedure and any organization or regulatory requirements, as well as any limits to the use of the procedure)”
- “Summary of Method (briefly summarizing the procedure)”
- “Definitions (identifying any acronyms, abbreviations, or specialized terms used)”
- “Health & Safety Warnings (indicating operations that could result in personal injury or loss of life and explaining what will happen if the procedure is not followed or is followed incorrectly; listed here and at the critical steps in the procedure)”
- “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)”
- “Inferences (describing any component of the process that may interfere with the accuracy of the final product)”
- “Personnel Qualifications/Responsibilities (denoting the minimal experience the user should have to complete the task satisfactorily, and citing any applicable requirements, like certification or “inherently governmental function”)”
- “Equipment and Supplies (listing and specifying, where necessary, equipment, materials, reagents, chemical standards, and biological specimens)”
- “Procedure (identifying all pertinent steps, in 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)” and
- “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)”
- “Quality Control and Quality Assurance Section”
In order to allow self-verification of the quality and consistency of the work, quality control activities have been designed. “Quality Control procedures” and “Quality Control material’s” preparation shall be described in order to indicate that are required to demonstrate method’s performance. Each shall accompany the specific criteria. “Frequency of required calibration” shall be described and there will also be check on “Quality Control” and reasons shall be given for the decisions. Limits and criteria for Quality Control data shall also be described. When Quality Control data exceed Quality Control limits, actions are required. The reporting of the Quality Control data and results shall be described.
- “Reference section”
There should be proper reference of the documents, materials and procedures that has alliance with the SOP. References include “published literature”, “methods manuals” and “Citations”.