Laboratory Animal Support

SOP Support

Standard Operating Procedures (SOPs) are a critical component of quality research and are required to perform preclinical studies. Often SOPs are viewed as a document for “show” rather than multifunctional documents capable of increasing quality and efficiency. SOPs may be written by personnel who do not understand, have never performed or observed the procedures. When this occurs, personnel performing procedures may not follow the SOP resulting in immediate problems or serious errors that may only be discovered several years after a study is completed. Other serious errors can occur when SOPs are reviewed/updated infrequently.  Many laboratory animal facilities review or update SOPs only in preparation for AAALAC site visits or inspection by regulatory groups.

Development of SOPs is often delegated to personnel lacking formal training on writing SOPs. Additionally, SOP review is an administrative task that takes away from the limited resources available to perform critical tasks. As a result, many find it easier to update SOPs when it’s absolutely necessary. For SOPs to be useful and effective a new approach is needed. A transformation is needed so SOPs are maintained current and are written for those who will use them.

In difficult economic times, it is more important than ever to get the most from every effort. Therefore a new approach is needed for SOP development, implementation and maintenance. This new approach can transform documents previously written for “show” into a component of your business that will insure that tasks are performed efficiently and reflect the quality of work your customers demand.

This transformation involves writing SOPs from the USER’s perspective. Written from this perspective, the basic element of a procedure is the Action Step. Theseus has developed a set of 10 basic principles that will lead more effective, action oriented SOPs.

Principle 1 – Use Simple Command Statements
Principle 2 – Keep Action Steps Simple
Principle 3 – Avoid the Passive Voice
Principle 4 – Identify the Responsible Person
Principle 5 – Use Quantitative Information
Principle 6 – State the Condition First
Principle 7 – List Multiple Objects
Principle 8 – Use Parallel Structure
Principle 9 – Emphasize Important Information
Principle 10 – Use Referencing and Branching

These steps are described in more detail in this document, 10 Principles for Writing SOP Action Steps. Theseus Professionals can provide training, Writing SOPs that Work and Technical Writers to support an organization’s effort to have SOPs that are more action oriented.

SOP Reengineering Services

For organizations that want to upgrade their current SOP documents to a more structured and sustainable program an SOP framework is needed. Theseus has developed and successfully implemented SOP frameworks that consist of three components:

1. Organizational Structure
2. Architecture
3. Infrastructure.

To bring about a change like this requires a need to rethink and redesign the way facilities think about their SOPs, This type of change can best be described as a reengineering (Hammer and Champy 1994) effort. Below is an example of the tasks and subtasks needed to reengineer a facility’s SOP program and implement an SOP framework.

A typical SOP Framework project involves the following tasks:

Task 1: Develop SOP Profile

Task 2: Develop Organizational Structure for SOP Program

1. Subtask 2.1: Create Organizational SOP Committee
2. Subtask 2.2: Design SOP Architecture
3. Subtask 2.3: Submit SOP Program for Acceptance

Task 3:  Support SOP Infrastructure

Task 4: Develop SOPs

1. Gather information
2. Observe work in progress
3. Draft SOP
4. Conduct peer review
5. Resolve comments
6. Submit to SOP Committee for comment
7. Resolve comments
8. Resubmit to SOP Committee for acceptance
9. Validate SOP
10. Revise and resubmit as needed

Task 5: Project Coordination

IACUC Support

How efficient and effective is your IACUC? Are tasks not getting accomplished due to limited resources? Are critical deadlines not being met? Does the prospect of accomplishing more with the current resources seem unattainable? In these times of increasing demands and limited budgets, everyone is looking for ways to be more efficient and effective. Theseus Professional Services’ has provided IACUCs with proven, effective ways to increase efficiency and productivity with a number of simple steps.

The table below outlines the principal tasks that every IACUC is responsible for, the activities associated with each task and Theseus’ proposed methods for improvement.

In some cases there may not exist the expertise or time to carry out the improvements suggested. Theseus Professionals can help. Below are some of the services that Theseus Professionals can provide.

• IACUC Workflow Analysis
• IACUC Protocol/Animal Tracking
• Development of forms to help streamline review process:
• Standard IACUC meeting minute forms
• Animal Use Application Forms designed to guide investigators in proper completion of the document
• IACUC member AUA form review guides
• Development of systems to track IACUC business to insure compliance
• Protocol Reviews
• Follow up review of approved protocols
• Review of facilities and program to prepare your organization for AAALAC and USDA inspections
• Outsource IACUC Coordinator Position, i.e., perform remotely
• Develop training materials targeted for your specific IACUC needs

WORKFLOW ANALYSIS

Theseus can perform a workflow analysis of your IACUC program to identify ways to improve efficiency and effectiveness. The initial step of the analysis is the development of an IACUC Profile. The IACUC Profile, based on our successful SOP Reengineering Profile, will identify the current state of the IACUC program. Using generally accepted methods for diagramming workflows such as flowcharting or process mapping, existing workflows will be created. Armed with the Profile and workflow diagrams a plan can be developed to improve the efficiency and effectiveness of your IACUC program.