Standard Operating Procedure (SOP) for Labs

Labs Industry

When laboratory work involves hazardous chemicals and substances, specific guidelines are to be incorporated and followed to comply with the health and safety considerations. This is crucial, especially with particularly hazardous substances that contain carcinogens, toxic chemicals, and reproductive toxins. SOP is written instructions that illustrate the step-by-step procedure that needs to be followed during an experimental program. These contain information about the hazardous chemicals that are being used and how these hazards can be mitigated whole during the procedure. An SOP document safeguards the safety of the environment by documenting the key risks that can be associated with a particular activity and how these risks can be controlled or eliminated. The aim of the SOP document is to ensure the laboratory procedures are performed safely and in the correct manner. SOP’s are written with the guidance of laboratory personnel who are directly involved in the key activities of the lab and perform routine experimental procedures.

A Written SOP for Laboratory Ensures the Following:

  1. Consistency – the written step-by-step instructions ensures that every person irrespective of age, experience performs the same steps the same way in a way that the same result and be expected regardless of who performs the test. In the case of clinical laboratories, this helps people to use laboratory results to observe changes with a particular patient over time. In case it is required, to compare the results generated by different laboratories, the same SOP’s can be used so that all the staff follow the same procedures.
  2. Accuracy – With written instructions set out, it is no longer required for laboratory staff to rely on memory and consult the SOP on a daily basis to perform tasks, which in turn helps produce more accurate results by eliminating human error.
  3. Quality – SOPs are critical standards for ensuring the quality of a laboratory, as they provide a general framework ensuring efficient implementation and functioning of all functions and activities. These serve as a written commitment to regulatory bodies, ensuring the completion of tasks in a reliable and consistent manner.
  4. Training tool – With proper documentation of training materials and routine tasks, there will be no misunderstandings or confusion in the learnings being transferred from another person. The new employee would simply have to follow the procedures as defined in the SOP.

Characteristics of a Good SOP

  • A good SOP should be clear, simple and precise – so that a staff who normally does not do the work normally should be able to read and understand the requirements, including all the necessary details like temperature control and the timing instructions. Some of the critical information that should be included in all SOPs are:

– Type, quantity, and nature of the chemical used. Safety Data Sheet (SDS) lists important information that needs to be considered to prevent risks or hazards like toxicity, inflammability, reactivity, warning properties etc.

– Location where eth chemical is used or contained such as any containment devices or fume hood

– Experimental procedures that need to be performed with reduced exposure

– Use of safety equipment like personal protective equipment

– Waste collection, storage, and disposal process

  • Should be easily legible for students and new trainees and written in layman terms.
  • Reviewed and approved by the laboratory management indicating the renewal and approved date – so that it ensures that the processes followed are up-to-date and appropriate.
  • SOPs should be dynamic and constantly updated

Sop’s must be comprehensive and cover all necessary details that the staff should know before handling certain substances or performing a procedure. They should equip a language that is easily understood by even the basic staff working in the laboratory and checked for accuracy and quality on a regular basis. Principal Investigators are to ensure that the protocols and procedures defined in the SOP’s are implemented in the work areas and labs. However, they should be made accessible to every employee in the lab to review product quality specifications when relevant.

Preparing an SOP

There are certain key points to be evaluated while writing an SOP:

  1. Asses the scientific validity of the procedure that is being conducted
  2. When writing the procedure, make sure to include all the steps on how to perform the procedure carefully and precautions that should be taken while implementing the procedure
  3. Any relevant procedures that must be conducted prior to or post the specific procedure must be referred to separately, such as instructions for quality control or sample collection
  4. There should be an established mechanism for keeping the Sop’s regularly updated.

SOPs should consist of the following:

– Title – referring to the test performed

– Purpose of the test – the objective of the test; why it is done, how it is done and whether the test result will be used for screening; diagnosis or treatment.

– Instructions – should explain the entire testing process, including pre-testing, testing and post-testing phases

– Name of the person writing the SOP

– Signatures of approving authority and dates of approval – in line with the laboratory’s quality policy and regulatory requirements

Pre-examination instructions should also include conditions for sample collection and transportation of samples and proper sample handling methods to be used. For example, instructions should include if the sample needs to be preserved chemically, refrigerated, or frozen or kept at room temperature. Instructions should also include information that needs to be specified on the sample label, such as the date of sample collection, verification of more than one type of patient identification, and any information that needs to be included in the test request form.

Post-examination instructions need to address the action items for reporting the results like measurements to be used, normal range, the panic or life-threatening range, and instructions on the action to be taken in the case of an urgent report. References to prove that the procedures followed are scientifically valid and any relevant references to the published sources of the procedures.

An SOP writing team needs to be established with experienced laboratory personnel and should arrange to meet whenever required or at the beginning of the project to establish the writing objectives, targets, and responsibilities. Parts of the Sop can be written or produced independently, and then the individual combinations can be combined as relevant. Once written, the draft SOP should be circulated among initiators and other stakeholders of the project before establishing a final draft for review by supervisors and subsequent supervised testing by employees. An SOP should be reviewed by as many people at stake in the project or experiment who are qualified to evaluate the clarity and completeness of the instructions written. Final approval should be by the authorised signatory and ideally should include more than one or two individuals. SOP’s should be systematically reviewed regularly so that policies and procedures remain current and in congruence with scientific validation.

If you are looking for an expert on writing a Standard Operating Procedure and review your overall compliance system, Business process Xperts can provide you with the required assistance to establish a regular mechanism for writing, approval and review of SOPs.

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