The tangible steps behind the process of achieving operational excellence.

Regardless of how a company defines “operational excellence” and its specific application in a given company or field of work, there are key facets that act as the foundation.

Patricia Santos-Serrao, RAC, Senior Product Manager, describes MasterControl’s approach to these building blocks of operational excellence:

1. Provide a company with the tools to help define (internally) what their standard for quality is regardless of functional area.
2. Define and document those standards so that everyone knows the processes.
3. Use tools to measure if a company is maintaining the desired level of quality.
4. Use tools to identify if something goes wrong.
5. Expand a company’s quality standards to manage—or even mitigate—the risk.

Building Blocks for Pharmaceutical Manufacturers

Santos-Serrao elaborates further: “We want to look at it from all angles—all things that affect excellence.”

The building blocks, according to Santos-Serrao, that need to be in place in order for pharmaceutical manufacturers, specifically, to achieve operational excellence include:

• Documenting: Recording the processes that need to be put in place.
• Processes Management: Identifying who should execute specific tasks (and when) in order to get the desired end results.
• Training: Ascertaining people know documents and SOPs.
• Auditing: Checking to make sure all things are done correctly.
• Risk Mitigation and Management: The sooner you can identify the possible areas of risk that might go wrong, the sooner it can be adjusted and fixed.

“The building blocks that 95 percent of our customers ask for are document management, training management, and CAPA (corrective action and preventative action),” said Santos-Serrao. “Most of the time it involves a lack of training or folks not completely understanding an aspect of the training.”

At MasterControl, the phrase “operational excellence” is defined a little differently.

“To me the term ‘operational excellence’ means setting the bar high on how we do our jobs and produce products, and then constantly excelling at that,” said Santos-Serrao. “Not just meeting the bar of what’s expected.”

But not all facilities have a proactive approach to operational excellence.

“One thing that I have found,” said Santos-Serrao, “is that many organizations are reactive to quality. Many feel that quality is something that can be easily addressed, but it isn’t that simple. They often take it for granted until they are fined or have an issue and must recall a product.”

Where to Next?

In order to achieve operational excellence, there are tangible steps that can be taken:

• See where there are gaps in training or in your business.
• Find where there is no documentation of what is expected to be done.
• Look at how things were being done before and how it was being managed.
• Address what Santos-Serrao terms as “tribal knowledge.” This is when people make assumptions that others know what they are supposed to do without any documentation or SOPs to explain/verify. If there is no documentation, you cannot prove what people need to do.

Some of the positive outcomes in achieving operational excellence through systems such as MasterControl’s (which is available on the cloud), according to Santos-Serrao, include:

• Once they make quality documentation, people start to learn that the tools are in place to ensure consistency, efficacy, and efficiency in their business.
• Having validation behind auditors once changes are made.
• Efficiencies are improved—specifically the ability to find select documents and to figure out where issues are originating from.

“Once they put something in place and see the positive outcomes that come from it, they are much more understanding about investments and being proactive about putting quality solutions in place,” said Santos-Serrao.

Room for Improvement

When asked where pharmaceutical manufacturers have room for improvement in their overall systems in order to achieve operational excellence, Santos-Serrao identified two areas that are “under-estimated and under-addressed.”

1. Supplier Management

Many companies are so focused on if they are doing their things correctly (internally), that they forget to manager their vendor’s quality.

“Everyone is outsourcing these days,” said Santos-Serrao. “There are so many suppliers that go into making one product. An organization needs tools to manage vendors’ quality.”

2. Executing Vendor Audits

According to Santos-Serrao, companies should make an educated selection of vendors they work with based on tangible evidence of their quality of work. These vendors should be audited to make an informed selection.

She even went so far as to recommend “supplier scoreboards,” which score vendors based on performance and outcomes of audits—this ensures that companies always pick the “cream of the crop.”

Going Forward:

Maintaining a level of operational excellence, according to Santos-Serrao, starts from the top-down. “Leaders have to look at quality systems and be more involved,” she said.

The future of operational excellence looks promising and is steeped with more innovations.

“It really is about getting business intelligence systems that can give you overall pictures of everything—all the difference aspects of your manufacturing process,” said Santos-Serrao. “And avoid having to manually go get information you need.

“Give the power back to management so that processes are automated (on a weekly or monthly basis)—so that when issues occur, you will be automatically notified on critical events. To me, that is the real power of a quality system.”

This article can also be found in the November/December 2015 edition.