Standard Operating Procedures

 To understand: › The purpose of having SOP’s and how they affect the daily workings of laboratories.  To discuss: › What is an SOP › Purpose of SOP › Components of SOP › Identification process of SOP

 SOP’s are written instructions that document a routine or repetitive activity followed by an organization.  They addresses all requirements to perform laboratory procedures safely.  SOPs will fail if they are not followed, therefore, the use of SOPs needs to be reviewed and re-enforced by management.

 SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization.  They document the way activities are to be performed to maintain consistency with technical operations and to support data quality.  They describe the analytical processes, and processes for maintaining, calibrating, and using equipment.  SOP’s maintain quality control and quality assurance processes and ensure compliance with governmental regulations.  SOPs are usually specific to the organization or facility

 SOPs must address:  Process Identification  Controls  Equipment Checks  Potentially Hazardous Situations  Waste Management  Any Requirements for Obtaining Authorization

 The chemicals, process or equipment involved are identified. Including: › The stock chemicals › The chemicals produced in the process › The intermediates › The final compounds and wastes involved and also such factors as use of catalysts, inert compounds, heat, cold, and varied operating pressures which are involved in the process.

 This section lists required methods to control potential exposures.  Three types of controls › Engineering controls › Administrative controls › Personal protective equipment (PPE)

 Engineering controls involve specific information on the environments involved in the procedure to maintain safety.  Engineering controls state: › Work environment (ventilated area, fume hood, ext.) › Storage of toxic materials › Restricting access to the area protect from hazards or potentially explosive situations.

 Involve maintaining standards and mandatory laboratory practices including:  substituting pre-formulated liquids instead of powders to be weighed and prepared  hygiene practices such as hand washing  procedures for removal and disposal of contaminated PPE

 This section covers information on the types of PPE to use such as gloves, lab coats, etc. The type of PPE must be specified, such as the type of glove.

 The Equipment checks section describes ways to verify that equipment is operating correctly prior to using hazardous chemicals.  The Hazardous situations section provides guidance for handling spills and identifying if a spill is causing a hazardous situation. This also provides guidance when purchasing a chemical, as to the maximum size of container.

 Waste management section identifies safe disposal methods for routinely generated wastes, including waste treatment ways to make handling safer.  Particularly hazardous substances section provides additional details if hazardous substances are used. Details should address: › using specific containment device(fume hoods or glove boxes) › authorizations for using the particularly hazardous substances › describing additional procedures for decontamination and safely handling contaminated waste materials

 Include requirements for obtaining authorization before being allowed to perform the procedure, operation or activity.  This section may include: › special training prior to using equipment/chemicals › completing a medical examination before using certain equipment

 Use clear, simple, direct wording in short sentences  Write procedures as chronological sequences  Use ‘shall’ or ‘must’ for mandatory actions and ‘should’ for advisory actions  Procedures should reflect current practice  If any section is not applicable to the procedure, include “N/A” under the heading –DO NOT leave blanks.

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