Originally published in 2015

Are you ready to act if an inspector shows up? Are you ready to act if you have a failure in your product? How will the CEO find out? What if there is an accident? What if you are made aware of a potential case of fraud? How do you know if it is a small crisis or a big crisis?

Several years ago, one our auditors contacted me while at a clinical site because she was concerned about a specific issue.  She called me in a panic and said “can you believe this, what do we do now? and who do we need to inform?”. I explained, because it’s my job, she had done the right thing to contact me (first step in the escalation plan) and I explained our escalation approach. Fortunately, it was a misunderstanding and we were able to resolve it without further escalation but it was a good reminder to ensure our escalation plan was adequate.

We had a look at our procedures and confirmed when issues needed to be escalated, to whom and how quickly. An escalation plan can be very simple and concise.

Generally speaking, an escalation plan is a set of procedures set in place to deal with potential problems in a variety of contexts. The more serious the crisis, the higher up in management you need to share the information and identify which actions/decisions are required.

You identify a few individuals who need to react and they have access to this procedure. You can set up a system with phone calls, emails, phone texts, voice mails…whatever system works best for you. Some companies even do drills….

I recommend trying on your escalation plan for size. Yes, it may sound a bit silly and there may be team members who consider this lame…but, remember fire drills in elementary school? It is the only way to see if the system actually works.

Make sure you plan works and reflects current realities and technologies! Communication management is a big part of escalation planning – it can unravel very quickly if the wrong info gets out ahead a company’s official response.

An escalation plan is an excellent way to transfer knowledge quickly and efficiently. Also it is a key requirement for a robust compliance system.

Trust me, you do not want to wait until you have an issue and you have a crisis on your hands to figure out who you need to contact…

Plus…wasn’t it fun to escape outside for a few minutes and catch up with your friends knowing that nothing was actually wrong but you were just practicing?

Tip: It is vitally important to have an escalation plan in place.

  • Prepare it.
  • Test it, for real!
  • Capture your lessons learned.
  • Update your plan.
  • Test it again!

If you are not sure where to start with your Escalation Plan, I can help you develop it to ensure an efficient and compliant transfer of knowledge.

Skillpad help clients in Pharmaceuticals, Biotechnology & other regulated industries to reduce costs, increase profitability and improve efficiencies. 

Nathalie Bourgouin, PMP – Vice-President Compliance, Skillpad Canada Inc. –Compliance subject matter expert with an extensive background in risk-based quality assurance processes and training in clinical trials and manufacturing areas. Skillpad encourages an innovative integration of project management concepts into compliance.

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