Technical procedures or Standard Operating Procedures (SOPs) describe or reference all activities necessary to conducting tests and describe in detail how specific tests or calibrations are conducted. While it is not necessary to transcribe the contents of a kit insert or manufacturer’s procedure manual once the documented format is appropriate, however, these documents must form part of the controlled documentation of the laboratory and be numbered appropriately. SOPs could be presented as drawings, pictures, kit inserts, analytical methods and models. They may originate within the organization, be provided by the customer or from international scientific references.
TECHNICAL PROCEDURE/SOP OUTLINE
A technical procedure must normally be supplemented by additional information. It can be written in a very condensed form with considerable cross-referencing. For Technical Procedures, the following headings may be applicable:
3.5.1 Title
All Test Methods should have a title that clearly states the intent of the document. The title should be concise and descriptive. E.g. “Determination of Calcium in drinking water”
Because a procedure describes how to do something, the title should use direct language to declare what is being done to what. A procedure titled "Maintenance Chemical Analyser" is not descriptive of the procedure's content; a more appropriate title would be, "Preventive Maintenance Procedure for the Photometer."
3.5.2 Principle of test
The scientific basis behind the reactions which occur in the test 3.5.3 Responsi bility
Who is responsible for performing the work described? Who is responsible for reporting the work?
Are there special training or certification requirements? i.e., who will be qualified to perform the work described?
3.5.4 Reagents and Media
The Method should include a list of the reagents or media used, which should include:
List of required reagents and/or media, Reagent name or chemical formula
Special safety requirements
Step-by-step instructions for reagent or media preparation
Degree of accuracy and any special handling instructions for measuring device
QC of reagents or media (e.g., pH testing or visual assessment)
Labelling requirements, including expiration, Storage requirements, including containers and stability
Note
Only provide instructions for preparing reagents when the reagents are to be prepared each time the procedure is performed
3.5.5 Equipment
Only include a list of equipment. Instructions for calibrations and maintenance are written as separate procedures. They are only included in the technical procedure where they are performed each time the procedure is done.
3.5.5.1 Procedures for equipment calibration sho uld inclu de the followin g:
Schedule for performing the calibration – daily, weekly, monthly, semi-annually
Schedule for performing calibration verifications (Assaying of calibration materials in the same manner as patient samples to confirm that the calibration of the instrument, kit or test system has remained stable throughout the laboratory’s reportable range for patient test results)
Calibration material specifications, preparation and storage
Source of the calibration material
Step-by-step instructions for performing the calibration, including expected readings
Troubleshooting guidelines
Documentation methods and storage requirements for calibration data
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3.5.5.2 Procedures for equipment maintenance should i nclude the following:
Schedule for performing preventative maintenance – daily, weekly, monthly, semi-annually
Step-by-step instructions for performing preventative maintenance or references to equipment manuals containing instructions
Troubleshooting guidelines
Records for documenting results of maintenance 3.5.6 Supplies
The method should include a list of the supplies (consumables) used in performing the procedure.
E.g., disposable pipettes, pipette tips 3.5.7 Sample Information
The analytic procedure should include the following information regarding the sample required:
Sample type and source
Amount of sample required, including minimum requ irements
Acceptable collection containers
Sample stability and storage requirements, Preservative/Additive
Criteria for acceptable samples and follow-up action 3.5.8 Special Safety Precautions
This is included when ADDITIONAL safety requirements - beyond the basic handling of hazardous materials are necessary. They should include the following:
Engineering controls (E.g., Use of Fume hood)
Personal protective equipment (E.g., Respirators, gloves, face shields)
Work practice controls (E.g., Beginning a step only after certain conditions have been met or precautions have been taken)
3.5.9 Quality Control
Instructions for QC are usually written as separate procedures. They are only included in the technical procedure where they are performed each
QC procedures should include the following information:
time the procedure is done.
Type of QC material to be used
Instructions for preparation and handling of control materials
Frequency with which controls must be run, number of controls to use
QC expected values and/or ranges
Explanation of control criteria (E.g., Accept or reject runs or batch criteria)
Corrective action, to be taken if controls do not meet the expected criteria
Instructions for documentation of QC data
Alternate QC measures (E.g. correlation) 3.5.10 Process/Method
Write in a step-wise fashion rather than lengthy paragraphs. Provide a COMPLETE listing of the steps required to accomplish the analysis.
3.5.11 Interpretation of Results This section should include:
Comparison of the results to the expected values or to determine if the result is normal, abnormal, or indeterminate. Follow-up for indeterminate results
Recognition of results that fall outside the reportable range, and reference back to the Method Limitations section of the original procedure
Recognition and follow-up of results that exceed critical limits
3.5.12 Calculations (Quantitative procedures )
Quantitative analytic procedures should include the equations for calculations when they are applicable to the test. Include:
The full equation
Step-by-step instructions to solve the equation, An example of how to solve the equation Normal Values (Where applicable)
Include a range of expected values for the test result, where necessary or applicable.
Method Limitations
The limitations may be due to the method itself or interfering substances. Include the following:
Analytic sensitivity and specificity
Reportable range
Appropriate dilutions or reporting measures if the reporting range is exceeded
Interfering substances such as chemicals (E.g., Preservatives).
Procedure Notes (Hints, special precautions, comments)
Insert appropriate comments which could include special hazards in performing the test. If special reporting of results is required it should be noted in this section.
3.5.13 References
Procedures should include the references that were used as the source of the information, when applicable. References may originate from any of the following:
Manufacturer’s product literature
Text books
Published standards and guidelines
Laboratory policy manuals
Applicable regulations 3.5.14 Related Document s
Reference (List) other related procedures, e.g. Procedure for cleaning glassware Records such as Forms used or data sheets produced
END OF PROCEDURE OUTLINE
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