OH NO!! Why is there water everywhere??


Water is flowing out of the lobby!

When I mention the words Ice – Water – Rupture, the first images that probably come to mind involve the Titanic!

Not quite the situation that we experienced last week. However, when the office manager came running in to a meeting saying, “There is water running out the doors of the lobby”, I had images of the picture below in my mind.


Luckily, it was not that bad. Only ankle deep and the source was quickly shut off. What happened?

The extreme cold had caused a water line to freeze.



We resolved the issue with no interruption in work. As you can see from the pictures, we had some major work being done to repair the broken piping. As viewed from the second-floor lobby, the backdoor entrance was completely blocked.

This situation could have played out very differently. I have personally been at two facilities where there was major interruption in services due to water damage. One was caused by torrential rains and the other by a burst pipe.

In both cases, there were no plans in place for what to do. There was only reaction to the situation. I know – you can’t have plans in place for every scenario. The list of issues can range from a host of causes – floods, tornadoes, earthquakes, fires or even man-made issues such as terrorism.

My advice to you is not to have long planning sessions trying to determine actions for every potential disaster. Instead, consider having some immediate actions specified and then next steps determined by a team that you have identified. Your key team of people that will probably be making the first decisions and actions are your front-line supervisors. Therefore, it is imperative that your supervisors be developed to provide the initial “triage” to the situation.

Here are some thoughts:

  • First and foremost, it is to provide for the safety of personnel.Things can be rebuilt.People cannot.

  • Communicate – who do I call?What is their phone number?Who is their backup?People have lives and may not answer the phone immediately.If I’m at a theater or having a formal dinner, I have been known to even…shut off the phone!!Gasp!!

  • Can you stop the source of the problem?Can you turn off the water?Turn off the flow of gas or flammable liquid?Shut down the power?If so, should you?

  • Assessment – This is the point where you need a cross functional team.What is the impact?Think of EH&S.Think about FDA.What is the impact to the facility, utilities, equipment, raw materials, product, etc.

  • Have a plan – Someone must lead the team, make decisions, control the situation.Be ready for a rapidly changing situation as more information becomes known.

  • Isolate – It may be necessary that you pull material or equipment to a quarantine status.Isolate – Assess – Decide.There may be a lot coming at you as the situation unfolds.Doing this action is a “triage” approach in that you identify what must be dealt with first (critical) and then deal with other items later.

  • Clean up!It may not be pretty, but you must think about cleaning up the mess at the end of the situation.Can you clean while other activities are on-going?What do you need to consider – chemical cleaning, microbiological concerns?

  • How do we keep making product?As with any business, it’s life depends upon generating Pure – Safe – Effective products.Disasters can impact the schedule for hours, days or weeks.Do we have sufficient stocks?Can we work with a CMO? Should we notify the FDA of a potential drug shortage?

There are so many issues that can come up during an emergency which makes it impossible to plan for everything. You should evaluate your plans, if you have them, and determine if they are suitable and flexible enough. Work with a team that encompasses all stakeholders. I wrote the aforementioned ideas from the perspective of a GMP Compliance Officer.

Finally, let me ask you a few questions:

  • Are you ready?

  • How do you know?

  • Are your supervisors developed to lead, serve and manage?

  • Lead change

  • Serve stakeholders in a meaningful and valuable way

  • Manage the system

Good luck!


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