Standards Matter for Laboratory Quality Control

Standard operating procedures (SOPs) are a crucial element of laboratory quality control. SOPs provide guidelines for employees and managers, ensuring a consistent approach to lab processes from specimen handling to equipment calibration.

Here are some best practices that reinforce the concept that standards matter for laboratory quality control.

Scope of SOPs for laboratory quality control
An effective SOP is about repetitive consistency. The United Nation’s Food and Agriculture Organization (FAO) defines SOP as a “document which describes the regularly recurring operations relevant to the quality of the investigation. The purpose of a SOP is to carry out the operations correctly and always in the same manner.”

While SOPs can vary from organization and industry, the FAO recommends that labs use a broad range of SOPs, including:

• Fundamental SOPs that provide instructions for creating other SOPs
• Methodic SOPs that cover the entire testing system or investigation method
• Operational SOPs for the following
  • Operating instruments and apparatus
  • Safety precautions
  • Reagent preparation
  • Receiving and registering samples
  • Analytical methods
  • Quality assurance
  • Archiving
  • Complaint management

By comparison, the Biorepositories and Biospecimen Research Branch of the National Cancer Institute suggests some of the following SOPs be included:

• Informed consent, detailing the procedures for obtaining consent and protecting data confidentiality and the privacy of any human research participants

• Data collection and management (informatics), managing records and procedures that define access to data, data collection methods, reporting standards and standardized medical terminology

• Biosafety, including recording staff injuries and precautions for blood-borne pathogens, safety equipment, handling hazardous materials, and disposing of medical waste and other biohazards

• Training of staff members on each biospecimen, including procedures related to resolving shipment and inventory discrepancies, corrective actions, and sample storage, and management of power outages, natural disasters and emergencies

• Security, including administrative, physical and technical security which includes information systems security, points of contact and backup personnel contact information
  
  

Processes of creation and use of SOPs
The FAO guidelines include effective processes to follow regarding SOPs, including initiation, preparation, and administration, distribution, and implementation.

To begin, a lab should create the SOP on SOPs, including who can make each type of SOP, review processes for SOP drafts, approval procedures, determination of implementation dates, and how revisions will be made or an SOP withdrawn from use.

In the preparation phase, there are several procedures to enact. For one, specific details should appear on each page, including date of approval, version number, title, SOP number, page number and total pages, headings or logos of originals in a color other than black.

Other recommended preparation instructions on every SOP include the material to include on the title page, a detailed list of equipment and reagents required, clear descriptions, control criteria, a list of contents and list of references.

Importance of Sample Management Software
The importance of SOPs reinforces the criticality of a robust sample management system. At Freezerworks, we provide comprehensive LIMS software for labs of all sizes, ensuring that technicians work optimally and consistently. Request a demo to learn how Freezerworks systems, workflow management and barcoding products can keep your lab operating smoothly.