The Only Constant in Life is Change

The only constant in life is change.”

This famous quote from Greek philosopher, Heraclitus, rings true today.

Every day ends with a sunset. Depending on where you live, it can be breathtaking. The sun eventually hides behind the mountains for the evening.

In some places, the sun dips into the water until the next morning.

Do you remember the last time you sat still to watch the sun set into the sea?

To watch the light of the day grow dimmer.

To watch the colors of the day turn into deepening shadows.

To watch the day change into night.

If the last few years have taught us anything is how we must continually adapt to change.

Not only adapt to it, but come to expect it, grow with it, and thrive with it.

Here’s the thing though, at a biopharmaceutical facility, constant is a good thing. Your customers – and the FDA – expect a consistent product.

They expect that every time they use your drug therapeutic, it will work just like the last one.

Indeed, constant is a great thing.

But as we know, things change all the time. Being able to adapt to these changes can make or break a company.

So how do you balance the need for a consistent product against the backdrop of a fluctuating … well, everything?

What is Change Control?

At a biopharmaceutical facility, the essence of this saying is captured in a system called Change Control (CC) or Management of Change (MOC). The Change Control process helps the facility document the current state and expected state of a piece of equipment following a change. The Change Control documentation process is critical to manufacturing operations.

Years from now, someone must be able to go through your Change Control package and understand exactly what was done without you in the room.

Think of that for a second. Your documentation needs to be able to speak to a new reader years, maybe even decades down the line.

A good Change Control process allows you to walk through every component of the change that you want to make, one small step at a time.

What are the Core Elements of a Good Change Control Program?

The Change Control process is unique to each biopharmaceutical facility depending on your needs and size. However, there are some core elements of a good MOC program.

Name:

Who is doing the work?

Will all the work be performed in-house?

Will some or all of the work be outsourced to an external company?

Is this company on your approved contractor list?

Scope:

What are we doing?

Is it just the equipment that’s being changed, or do you also need to upgrade the graphics?

Do you need any new alarms as a result of this change?

Justification:

Why are you doing this?

Is it a business need?

Is it as a result of an incident, near miss or other accident?

Is it an optimization project?

Impact:

Do you need to alert any regulatory bodies about this change?

FDA? EPA? OSHA?

What about country-specific regulatory bodies?

Quality:

Will the product work just like before?

Environmental, Health & Safety (EH&S):

Safety is inherent to your design. Did you run this change by your EH&S Lead to ensure compliance?

Do you need handrails?

Do you need to add guarding to the equipment, especially if it rotates?

Do you need to post warning signs for new hazards?

Do you need to modify the safety interlock system?

Drawings:

How are you going to capture the changes in your drawings?

Are the most correct drawing revisions easily accessible?

SOP Revisions:

How are you training your team on these new changes?

Are you doing the training, or will the external vendor be doing the training?

Will a “read-and-accept-the-SOP” model work?

Does the training need to be held “on-the-job”?

Are the right people being trained?

Who only needs to be made aware of this change?

Whose role is most impacted by this change?

Signatures:

Yes, I understand and approve this change.

The more complicated the change is, the more thorough the MOC process needs to be.

What are the benefits of a Good Change Control Program?

A good Change Control program brings out the best from your entire team and by extension, your company.

Everyone will know what a good Change Control looks like and drive improvements without being prompted.

All they have to do is look up the last well-written Change Control and point a new employee to the right direction.

New employee says “Wow, I need to step my game up if I want to be part of this company”.

And the cycle continues.

What are the benefits of a good Change Control program?

There are many benefits of a good Change Control program:

Drawings that actually match what’s in the field or on the production floor
Safety of your employees since every Change Control has to address the impact to your employees
Equipment reliability as critical upgrades are processed the right way, the first time
Reduction in rework since the change is communicated out in a timely manner
Increased profits over time as these changes improve production output while maintaining quality

Although change can be tedious and difficult, if it is managed well, the outcomes will be well worth it.

The Beauty of the Sunset

The sun changes position every minute of each day.

At the end of the day, the sunset alerts you that it is now time to change from day to night.

Even though the sunset brings about change, its beauty remains constant.

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To learn more about how you can digitalize your equipment data and keep up with an ever-changing landscape, schedule a call today.