From time to time we each experience the hurry to get somewhere, only to end up waiting for someone or something else. Today's air travel seems to be nothing but “hurry-up-and-wait”: After you race to the airport two hours before your flight time, the plane ends up departing two hours late. Businesses suffer from the same disorder. For example, in the biopharmaceutical industry, this phenomenon is often evident in all the documentation that must be completed before a product can be released for shipment. Most of us seldom give it much thought, but delaying the shipment of a drug (especially a blockbuster) can cause business executives to become quite agitated. “Delayed shipments of our blockbuster drug could mean another ‘beating’ from Wall Street analysts and our shareholders,” an executive might bemoan, “more warehousing costs associated with quarantined product, and making more concessions to retain our customers. It just seems like we are always hurrying up and then waiting.”

Amazingly, when we stop, look, and listen to what is causing these daily battles — in both our personal and company lives — we can often identify not only the root cause of the problem, but also ways and means to improve the situation.

When the US Food and Drug Administration (FDA) announced its “Operational Excellence: Quality by Design” initiative in 2002, a major inclusion focused on quality systems:

Best practices in quality management methods, particularly in other high-tech industries, have undergone significant progress since 1978 when the CGMP regulations were last updated. The FDA wants to ensure that its regulatory practices encourage similar progress in the pharmaceutical industry. The draft guidance for industry Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice describes a comprehensive quality systems model that manufacturers could use and highlights the model's consistency with the CGMP regulations for manufacturing human and veterinary drugs, including biological products. The guidance explains how manufacturers implementing such a comprehensive quality system can ensure that they comply fully with the CGMP regulations (21 CFR parts 210–211 and 600–680). This guidance is intended to serve as a bridge between the 1978 regulations and our current understanding of quality systems. (1)

Within the biopharmaceutical industry, the term operational excellence (OpEx) has become popular for describing the big-picture vision. This vision is one everybody is striving to achieve, but the picture too frequently becomes clouded by daily battles to meet product delivery commitments. Among the many challenges that often affect a company's ability to efficiently deliver product is successful manufacturing coupled with all the associated documentation required.

CALCULATING ROIC

Return on invested capital (ROIC) is a measure of how effectively a company uses the money (borrowed or owned) it has invested in its operations. ROIC is calculated by dividing company's (or unit's) net income after taxes by its total assets, not counting excess cash or non-interest-bearing liabilities.

Making a product according to its predefined specifications — and doing it as efficiently as possible — is a battle that can often be won predominantly by replacing as many manual processing steps with instrumentation and automation as possible. Simultaneously producing the necessary documentation that proves a drug or biologic was manufactured in accordance with its predefined specifications is a battle that can be won through organizational commitment and the proper design and use of automation and manufacturing execution systems (MES).

The ultimate goal is to produce both the product and its accompanying documentation correctly the first time, and to do so minutes after the drug or biologic is manufactured. We realistically understand that attaining this ultimate goal is a stretch. But ways and means are available that have repeatedly demonstrated how possible it is to move companies closer to achieving “right-the-first-time” every time (RTFT-ET).

Daily Skirmishes

Overcoming the daily skirmishes to achieve RTFT-ET products and documentation requires owning up to the fact that such skirmishes actually exist within a company. This admission is sometimes difficult for people to accept. But think about your own experiences. Have you ever delayed the release of a product or contemplated the inefficient use of resources in your organization for document-related issues because of…

• Missing and/or illegible data entries?

• Missing and/or illegible signatures?

• Numbers being transposed (e.g., 1,243 instead of 1,234)?

• Equipment log book entries made improperly?

If your production and documentation processes are mostly manual, then you are very likely nodding your head in the affirmative. Here are some common excuses describing why lot progress, document review, or lot release is delayed. If your production and documentation processes are mostly manual, it is likely that these and/or similar issues occur:

• “Changes to the master batch record were not implemented and approved on time, so we need to mark up the existing record and log a deviation or open a change request to use it.”

• “Some materials we needed were in the wrong location, so it took extra time to find them.”

• “After materials were staged in the production area, a quarantine was issued; however, we did not catch that before using those materials on the production floor.”

• “We needed X amount of materials, but only Y amount was actually available.”

• “We did not notice that procedure pages were stuck together (or were out of order or missing) so we added ingredient A and B before adjusting the pH or temperature, or we missed a step in the batch record.”

• “We did not realize that the equipment (or transfer path) ‘clean hold or dirty hold’ time had expired, or we miscalculated the expiration time.”

• “We were distracted during manual addition and overshot the target.”

• “We did not realize that an instrument needed to be calibrated before we began to add material.”

Some biopharmaceutical companies can honestly report that they have almost completely overcome many of those sorts of daily documentation and product-release “skirmishes.” Do such companies have their own daily skirmishes to overcome? Of course they do, but theirs are new rather than recurrent. They no longer allow a skirmish to morph into a “that's just the way it is” excuse. They are winning the battle by focusing on each and every skirmish.

What those winning companies have learned to use is a proven methodology that defines, measures, analyzes, and institutes permanent controls that help them win the RTFT-ET battle. This methodology is called lean six sigma (LSS), and it is based on conducting real-time, in-depth analysis of business problems.

A 2007 Business Week article implied that six sigma was “dead” (2). But consider that we need to recognize when an approach is being adopted as a “religion” rather than merely a tool. Six sigma, lean manufacturing, footprint rationalization, premier resource management, and similar other quality and efficiency improvement methodologies are tools that can be used at the right time, in the right way, by experienced professionals to identify and “repair” problems.