The Team/Workgroup Charter, and When to Revisit

Teams and Work-Groups need ground rules, they should have a charter, which includes a nice vision of how the team sees itself.

Let’s be honest, we do not spend enough time building and maintaining these charters. If you are like me you tend to dive right in, and that will always cause some problems. Luckily, it is never too late to take a step back and do the work.

Start by answering these eight questions about the team and its place in the organization.

  1. Consistency with organizational objectives: The team vision should be aligned with and derive from the organization’s overall purpose and strategy. Teams are sub-elements in a wider organization structure and their success will be judged on the extent to which they make valuable contributions to the overall purpose of the organization. In some circumstances, a team may decide that it is important for its own values, purposes, and orientations to act as a minority group that aims to bring about change in organization objectives – perhaps like a red team.
  2. Receiver needs: How a team focuses on providing excellence in service to their customers, whether internal or external.
  3. Quality of work: A major emphasis within organizations is the quality of work. The relationship between quality and other functions like efficiency is important.
  4. Value to the wider organization: Understanding the importance of the team just not for the wider organization but beyond, leads to team cohesion and greater team effectiveness. Team members need a clear perception of the purposes of their work.
  5. Team-climate relationships: Team climate refers to aspects such as warmth, humor, amount of conflict, mutual support, sharing, backbiting, emphasis on status, participation, information sharing, level of criticism of each other’s work, and support for new ideas.
  6. Growth and well-being of team members: Growth, skill development and challenges are central elements of work-life, and teams can be a major source of support. Teams provide opportunities for skill sharing and support for new training. Teams need to be concerned for the well-being of their members, including things like burnout.
  7. Relationships with other teams and departments in the organization: Teams rarely operate in isolation. They interact with other team and departments within the organization. Teams must be committed to working effectively and supporting other teams. Avoid silo thinking.

From there you can then generate the 10 aspects of the charter:

  1. Team Ground Rules: What positive behaviors/values will the team seek to embrace and exemplify?
  2. Trust Damagers and Destroyers: What negative behaviors would damage/destroy trust in the team and how will the team avoid/deal with these?
  3. Conflicts of Interest: Are there any possible conflict of interest scenarios and, if so, how should they be handled?
  4. Team Boundaries: What are the boundaries of the team and the different types of team participation?
  5. Information Sharing: Where will there be transparency of information sharing and where will there be privacy and restricted sharing within the team?
  6. Issue and Conflict Resolution: How will issues and conflicts be resolved?
  7. Decision Making Practices: How will decisions be made?
  8. Meetings: Type, frequency, purpose, attendees and channels
  9. Induction, Mentoring, Buddying: How (and if) will new members be brought into the team?
  10. Communications: What tools will be used for communications and what are the agreed to “Reply-by” times

Do not short communication

How much time do you spend communicating every day? Whether this is through phone calls, IM, texts, email, written reports, face-to-face conversations, or meetings, many of us spend a large proportion of our day dealing with messages that demand our attention.

Be deliberate in how we manage these interactions so that people communicate efficiently and effectively. Outline preferred methods of communication, how to use different channels effectively, and what people want to achieve. By improving communication you can drive for effective meetings, reduce the volume of emails, ensure that exchanges are professional, and free up time for high-value tasks.

Include the following in your communication section:

  • When people need to reply to emails and when they don’t.
  • When people should “Reply All” to emails and when they should avoid it.
  • How to organize regular team meetings, who should attend, whether people will “dial in” remotely, what to include in the minutes, who will circulate them, and so on.
  • How your team communicates with customers internal and external.
  • How team members interact on internal social media (chat, slack, etc).
  • When making a video or audio call is appropriate.
  • How people engage with others face-to-face.

Signs of Team/Work-Group Misalignment

There are some behaviors to look out for, when you see them, it’s time to return to the charter, and improve.

Vague Feelings of Fear. You know what the team is supposed to deliver on, but you don’t know how exactly you’re supposed to work with anything in your power or control to “move the needle.”

Ivory Tower Syndrome. Things aren’t clear or different people have different expectations for a project or initiative. No one is really able to clarify.

Surprises. Someone committed you to a task, but you weren’t part of that decision.

Emergencies. How often are you called on to respond to something that’s absolutely needed by close of business today? How often are you expected to drop everything and take care of it? How often do you have to work nights and weekends to make sure you don’t fall behind?

Cut Off at the Pass: Someone else is doing the same work unaware to all.

Not Writing Things Down. You have to make sure everyone is literally on the same page, seeing the world in a similar enough way to know they are pursuing the same goals and objectives. If you don’t write things down, you may be at the mercy of cognitive biases later. How do you know that your goals and objectives are aligned with your overall company strategy? Can you review written minutes after key meetings? Are your team’s strategic initiatives written and agreed to by decision-makers? Do you implement project charters that all stakeholders have to sign off on before work can commence? What practices do you use to get everyone on the same page?

Know When and How to Compromise

Quality as a profession is often put into the position of being the cop or gatekeeper. There are a set of regulations and standards that must be met, and it can be easy, especially early in one’s career and without proper mentoring, to start to see absolutes.

It is important to always have a vision of what good and great look like. But the road to that will be filled with compromise, so get good at it.

Compromise is not a weakness in a quality professional, it is a strength.

There are times when, instead of ramping up your argment fill fore to make a case, it is better to step back and think about where you can comprise and still convince the organization to implement most, if not all, of your ideas.

This is where the change accelerators come in. Articulate the vision, and then utilize compromise the build and evolve the guiding coalition and turn that into an army of the willing.

Pilot programs, soft launches, workshops. These tools will help you find your allies and facilitate a solution.

Part of comprise is knowing what you can and will settle for. These questions can help:

  • What is the first thing I am willing to cede? It may be the timeline or a small adoption of your solution, such as a pilot project.
  • What is my backup plan? If the stakeholders don’t adopt my plan but offer a counterproposal, what am I willing to accept and jump on board with?
  • What is fueling the stakeholders’ reluctance? Ask questions, engage in “yes…but…and” practice.
  • Can I rework my argument? Is there an opportunity to come back with a revised pitch? Can you simplify or emphasize specific parts of your argument? Can you break it down into smaller parts – such as building blocks – first gaining support for the concept, ten gaining support for the first step to test its success, and then building support for the next step or phase?

Compromise is negotiation, and it requires all your emotional intelligence skills – patience, active listening, respect for the stakeholders’ position.

Have a vision, a plan, can really help. You will never get to 100% of meeting a requirement but being able to articulate what great looks like and then showing a plan that builds at a good clip, that allows compromise, will allow you to make continued progress and adjust as you go. Your systems will be stronger as a result.

Dealing with Naysayers

Every process improvement, every experiment, requires us to persuade others. There is a diversity of ideas, of needs, of requirements from stakeholders. I’ve written before about practicing “Yes..But…And“. Sometimes you just find people who are in naysayer category and you should have strategies for dealing with them. Try these:

  • Have you acknowledged the individual and their concerns? Sometimes the person simply wants to acknowledged. Although the naysayer’s actions can be frustrating because they are delaying the process of implementing, it can be worth it – and save time in the long run – to meet with the individual and listen to their concerns and thoughts.
  • What is the person not saying? Do they feel threatened or excluded?
  • As the individual how they would handle the challenge your idea seeks to solve. When you listen to them, you may find you have a kernel of common agreement upon which to build. Listen to their arguments against your idea – that could help you as you sell your idea to stakehoders and build an army of volunteers.
  • Does your idea potentially affect the naysayer’s area? Could it be a matter of a turf war? Can you gain insights by seeing things from their perspective – for example how would you feel if someone offered a similar idea that affected your team?
  • Does the person have someone whom they respect and will listen to? Can you discuss your idea with that individual and ask them to speak with the naysayer?
  • Are there other allies whom you can persuade and whom you can gain as allies to counter the naysayer? You may have to accept that the naysayer won’t come around to your idea.
  • Reach out to the naysayer for casual conversation to try to establish a collegial bond and build a better relationship for the long term.
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Escalation of Critical Events

Event management systems need to have an escalation mechanism to ensure critical events are quickly elevated to a senior level to ensure organization-wide timely reactions.

Consistent Event Reporting

There are many reasons for a fast escalation.

  • Events that trigger reporting to Regulatory Agencies (e.g. Serious Breach, Urgent Safety Measures (UK), Field Alerts, Biological Product Deviation, Medical Device Report)
  • Events that require immediate action to prevent additional harm from across the organization
  • Events that require marshalling resources from large parts of the organization

GMP

GCP

GPVP

GLP

Research

IT

         Impact to data integrity

       Impact to product quality/supply

       Impact to data integrity

       Data/privacy breach

       Event impacting on-time compliance rates (not isolated/steady state)

       Impact to data integrity

       Impact to data integrity

       Reference GxP area for Impact resulting from/linked to system error/failure

       Product Quality/ CMC events in accordance with MRB criteria (or other events of similar scope of impact)

       Impact to study integrity

       Impact to subject’s safety, rights or welfare

       Gaps in reporting/ collection of potential AEs

       Impact to study integrity

       Impact to study integrity

       System design, testing, deployment, upgrade, etc. event impacting GxP data integrity or regulatory compliance

       Recurring event with broad scope of impact

       Recurring event with broad scope of impact

       Recurring event with broad scope of impact

       Recurring event with broad scope of impact

       Recurring event with broad scope of impact

       Recurring event with broad scope of impact

       Impact to program milestones & corporate goals

       Impact to program milestones & corporate goals

       Impact to program milestones & corporate goals

       Impact to program milestones & corporate goals

       Impact to program milestones & corporate goals

       Potential Falsified or Counterfeit Product

       Potential Fraud or Misconduct

       Potential Fraud or Misconduct

       Credible Risk of Product Shortage

       Quality event with patient safety risk/gap

       GxP Data Breach

       Potential Product Recall

       Significant Quality Event Notified to Regulatory Authority

       System error or failure with significant GxP compliance impact

·       Potential Critical Finding Resulting from Regulatory Authority Inspection or Audit by External Body/Third Party

·       Quality Event/Observation Classified as Critical (Event or Internal Audit) Notification from Regulatory Authority or other External Authority of Findings of Significant/Critical Quality Deficiency (inspection or other than through inspection)

o   e.g.; Refusal to File, Notification of Inadequate Response to Inspection Findings (e.g.; Other Action Indicated (FDA classification), Warning Letter

 

You can drill down to a lower, more practical level, like this

Escalation Criteria

Examples of Quality Events for Escalation

Potential to adversely affect quality, safety, efficacy, performance or compliance of product (commercial or clinical)

       Contamination (product, raw material, equipment, micro; environmental)

       Product defect/deviation from process parameters or specification (on file with agencies)

       Significant GMP deviations

       Incorrect/deficient labeling

       Product complaints (significant PC, trends in PCs)

       OOS/OOT (e.g., stability)

Product counterfeiting, tampering, theft

       Product counterfeiting, tampering, theft reportable to Health Authority (HA)

       Lost/stolen IMP

       Fraud or misconduct associated with counterfeiting, tampering, theft

       Potential to impact product supply (e.g., removal, correction, recall)

Product shortage likely to disrupt patient care and/or reportable to HA

       Disruption of product supply due to product quality events, natural disasters (business continuity disruption), OOS impact, capacity constraints

Potential to cause patient harm associated with a product quality event

       Urgent Safety Measure, Serious Breach, Significant Product Compliant, Safety Signal that are determined associated with a product quality event

Significant GMP non-compliance/event

       Non-compliance or non-conformance event with potential to impact product performance meeting specification, safety efficacy or regulatory requirements

Regulatory Compliance Event

       Significant (critical, repeat) regulatory inspection findings, lack of commitment adherence

       Notification of directed/for cause inspection

       Notification of HA correspondence indicating potential regulatory action