They say it takes a village to raise a child, and not too-ironically, it also takes a village to run a Stability program. Today’s article explores the Stability Village and the people Stabilitarians need to achieve success. You may be surprised at the number and types of citizens your village has. Continue reading for the whole story on the Cowboys, Construction Workers, Soldiers and Policemen in your Stability Village.

The Stability Village People may otherwise be known by the less pop-cultural term of Stability Stakeholders. Rather than Cowboys and Policemen, we have HVAC technicians and Regulatory Specialists, not to mention Metrologists, Informatics, LIMS Team, Custodial, Facilities, Security, Formulators, Toxicology, Packaging, Analysts, Microbiologists, Quality Control, Reference Standards, Method Development, Change Control, Stability Operations, Warehouse, Shipping, Technical Writing, Quality Assurance, Validation Team, Data Reviewers, Statisticians, CRO Liaisons, Risk Management, Project Team, Manufacturing Schedulers and many others. Collectively, that’s more people than some actual villages have.

Governmental villages have a great deal of interactive structure, and so should our Stability Village in order to stay viable and productive. Stability Review Boards are the counterpart of Town Planning Boards, bringing representatives and experts together to design and approve study protocols, decline non-productive efforts, address issues, and remove studies when they’ve completed their objectives. Interdepartmental Meetings are the Block Parties of the Stability Village; informal gatherings of neighbors/colleagues to get to know each other better. It’s to the benefit of Stabilitarians to proactively build relationships with their Village People. Let’s consider what that might entail.

Managing the Stability Community Includes:

  • Producing an accurate inventory of Stakeholders, Quality Systems, and Resources
  • Conducting a Risk Assessment for all activities and areas impacting Stability
  • Building relationships and maintaining ongoing interaction with stakeholder liaisons
  • Monitoring trends through critical metrics
  • Continuously re-assessing & improving your efforts

In your regular Stability Team Meetings: Stability staff members report on their stakeholder liaison plans/progress. Guest Stakeholder liaisons report on efforts from their side.

In joint Stakeholder Meetings: Rotate through your Stakeholders to get to know their key staff and practices. Target identifying & correcting misalignments from both sides. Establish 1:1 personal links with Stability Stakeholders. Harness the personalities, interests & connections of your staff. Link efforts to goals & performance appraisals. Introduce stakeholders to your group’s purpose, objectives and what benefits can be achieved through cooperative ventures. Monitor progress closely as a team. Share milestones and tips for success as well as what to avoid.

Use Metrics to focus your Village People on key challenges. What’s “stability indicating” for your Stability Function?

  • Sample pulls within assigned time window
  • Sample loss (or unintended gain)
  • Tests completed in assigned time window
  • Trends in preventable errors
  • Data review in assigned time window
  • Chamber excursions
  • Training completions in assigned time window
  • Audit Observations /repeat observations
  • Stability-related discrepancy closures on time

Align the Stability Process with Stability Stakeholders’ Procedures

  • Subscribe to your Stability stakeholders’ SOP lists and make sure that they subscribe to yours
  • Identify those that impact the Stability Function
  • Join the list of those who review and comment on new and updated SOPs
  • Meet with your stakeholder Liaison to assure that your procedures do not conflict with each other or introduce practices detrimental to the Stability Function

In summary, there is much we can and must do for the success of our Stability Village. Our focus has to be on getting to know the Stability Village People; what they need from us and informing them of what we need from them. When we work in harmony with our stakeholders, we succeed together in operating exemplary Stability programs.