Lab Standard Operating Procedures (SOPs)
Biohazardous laboratories must maintain a laboratory manual which contains standard operating procedures for all work done within the laboratory. It is the supervisor's responsibility to create and manage this manual. This manual may be in any format (print or digital) that incorporates the 3 general requirements below:
- Access to Documents: training documents must be made available to all lab individuals (i.e. hardcopy binder, shared computer, cloud or networked file sharing or any combination that allows ACCESS)
- Update of Documents: there must be evidence that safety-based procedural documents have been evaluated for new or emerging hazards and that the risks have been mitigated (i.e. word doc versions with review date or revision history, PDF versions with annotated changes, document properties to include description of changes or any combination that demonstrates the documents are REVIEWED on a prescribed basis)
- SOP Sign Off: documented evidence of knowledge and proficiency of safety-based procedural documents. SOP sign off can be done in any manner that includes: (1) Indication to demonstrate that Trainee has READ and UNDERSTAND the procedure (2) Indication to demonstrate that Trainer/Supervisor attest that the trainee is PROFICIENT and COMPETENT on the procedure.
Note: SOPs from other institutions or collaborators are great resources! Just make sure to update the SOP to have information specific to McMaster and your laboratory!
MBSO SOPs
The MBSO has created a repository of SOPs common to biohazard laboratories. These SOPs can be downloaded and added to your lab manual. MBSO provided documents are listed below or can be found directly on the MBSO MacDrive. MBSO provided documents can be used as guidance or templates. SOPs that have been left in a .docx format contain blue highlighted sections - these sections MUST be customized with lab specific information.
Mandatory SOPs: any document that is labelled as 'MANADATORY' covers content or procedures that MUST be in place for biohazard labs. Your lab must have procedures in place for these topics either through completion of the template MBSO SOPs or within your own lab SOPs. These SOPs will be inspected during your regularly scheduled Biosafety Audit.
If you would like to see additional templates/SOPs or have an SOP you would like to share please contact mbso@mcmaster.ca.
MBSO MacDrive
Document Management
Documentation requirements for working with biohazardous materials can be quite extensive. In order to streamline and simplify the process, we suggest incorporating digital solutions as much as possible. The lab may choose any method which incorporates the general requirements below.
Access to Documents
The required documents (including Mosaic training prescription) must be made available to all persons within your area of responsibility. This may be accomplished in any of the following ways:
- all documents in digital form on a shared computer OR
- all documents on a cloud or network drive such as MacDrive OR
- all documents stored within a Teams, Planner or Forms group created from portal.office.com using your free Microsoft Office 365 through UTS's site license OR
- any combination of the above OR
- any method which allows for access to all required documents.
Update of Documents
There must be evidence that safety-based procedural documents have been evaluated for new or emerging hazards and that the risks have been mitigated. This may be accomplished through:
- Word-doc versions of all procedures includes review date or revision history OR
- PDF versions of all procedures annotated with changes OR
- document properties for any digital document to include a description of changes OR
- any combination of the above OR
- any method which demonstrates that the documents are reviewed on a prescribed basis.
SOP Signoff
Documented evidence of knowledge and proficiency of safety-based procedural documents can be done in any manner that includes:
- Indication to demonstrate that Trainee has READ and UNDERSTAND the procedure, AND
- Indication to demonstrate that Trainer/Supervisor attest that the Trainee is PROFICIENT and COMPETENT in the procedure.
It is the responsibility of the Supervisor to ensure that the worker is proficient in the SOPs or protocols they will require to undertake the work prescribed in a safe manner.
All MBSO SOPs and documents provided within the MBSO MacDrive are directly linked below.
Note: SOPS marked as "Mandatory ✔" cover procedures that must be in place for all biohazard labs. Mandatory SOPs (or lab specific SOPs that outline the procedures) will be inspected during your Biosafety Audit.