Page 1 of 10 The Value of Runtime Knowledge Management: Stop Business Insanity A White Paper by Michael Andrews and Selim Nahas Abstract In clinical and commercial manufacturing when measures are taken to prevent deviations, the findings aren’t often shared across the enterprise and when corrective actions are taken to resolve an issue, they often don’t address the actual root cause(s). The Applied SmartFactory ® Rx ™ Knowledge Management solution allows knowledge captured in the R&D and design phases to be used throughout the manufacturing process. Capturing knowledge and experience helps improve production and reduce quality events, enabling facilities to improve process quality, reduce human errors, respond faster to events, and minimize operational delays. The Same Thing—Over and Over Insanity has been defined as “doing the same thing over and over and expecting a different outcome.” Whether it was Albert Einstein, Mark Twain, or Benjamin Franklin, the original author of this definition has been debated over the years. Regardless of who defined it first, the statement is self-evident, particularly in the context of business. Many companies fall victim to business insanity, or repeating the same mistakes in terms of deviations, failures, quality events, waste, and loss of valuable knowledge. The Business Value of Knowledge Consider the following industry statements: ▪ British Petroleum had to halt 400,000 barrels/day of production to deal with a 250,000- barrel oil spill on the Alaskan North Slope due in part to loss of a senior corrosion engineer (Foss, 2006) ▪ After offering early retirement to 9,000 employees in 2008, Boeing had to take a $1.6B charge; this was a result of the disruption it caused with aircraft assembly operations because of failing to adequately transfer the required knowledge to the succeeding generation (DeLong, 2004) ▪ An estimated 80% of corporate value is associated with “intangible” assets like knowledge (Mitrović et al., 2008) ▪ Part of the knowledge management program at IBM’s Global Business Solution pr ovides an expertise location system with 110,000 subscribers that saves the company $5.5M per year (O’Dell and Hubert, 2011) Get the correct information to the appropriate people at the right time, enabling rapid response, quick recovery, and 360-degree feedback
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The Value of Runtime Knowledge Management: Stop Business Insanity A White Paper by Michael Andrews and Selim Nahas
Abstract
In clinical and commercial manufacturing when measures are taken to prevent deviations, the findings aren’t often shared across the enterprise and when corrective actions are taken to resolve an issue, they often don’t address the actual root cause(s). The Applied SmartFactory® Rx™ Knowledge Management solution allows knowledge captured in the R&D and design phases to be used throughout the manufacturing process. Capturing knowledge and experience helps improve production and reduce quality events, enabling facilities to improve process quality, reduce human errors, respond faster to events, and minimize operational delays.
The Same Thing—Over and Over
Insanity has been defined as “doing the same thing over and over and expecting a different outcome.” Whether it was Albert Einstein, Mark Twain, or Benjamin Franklin, the original author of this definition has been debated over the years. Regardless of who defined it first, the statement is self-evident, particularly in the context of business. Many companies fall victim to business insanity, or repeating the same mistakes in terms of deviations, failures, quality events, waste, and loss of valuable knowledge.
The Business Value of Knowledge
Consider the following industry statements:
▪ British Petroleum had to halt 400,000 barrels/day of production to deal with a 250,000-barrel oil spill on the Alaskan North Slope due in part to loss of a senior corrosion engineer (Foss, 2006)
▪ After offering early retirement to 9,000 employees in 2008, Boeing had to take a $1.6B charge; this was a result of the disruption it caused with aircraft assembly operations because of failing to adequately transfer the required knowledge to the succeeding generation (DeLong, 2004)
▪ An estimated 80% of corporate value is associated with “intangible” assets like knowledge (Mitrović et al., 2008)
▪ Part of the knowledge management program at IBM’s Global Business Solution provides an expertise location system with 110,000 subscribers that saves the company $5.5M per year (O’Dell and Hubert, 2011)
Get the correct information to the appropriate people at the
right time, enabling rapid response, quick recovery, and
360-degree feedback
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Figure 1 illustrates survey results for knowledge management key business drivers [1] and highlights the need to solve the greater approach to managing knowledge which produces benefits across many facets. The business value of knowledge management projects is so self-evident that around half of them are undertaken without quantitative financial justification (Skryme, 2002).
Figure 1. Key Business Drivers for Knowledge Management
More specific to manufacturing quality in pharma, figure 2 shows a categorical summary of deviations at a highly automated biotech plant. As illustrated, 43% of these deviations cited are due to human errors and over half of these resulted in quality investigations. Even when measures are taken to prevent deviations, the findings aren’t often shared across the enterprise. When corrective actions are taken to resolve an issue, they tend to be “bandages” and don’t always address the true root cause(s). In addition, knowledge about successes is often not shared and capitalized on.
Figure 2. Causes of Failures at a Highly Automated Biotech Plant
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Knowledge and Experience Capture
Developing value from both deviations and successes to truly maximize an improvement lifecycle requires a new approach to traditional knowledge management. To maximize this improvement, the SmartFactory Rx Knowledge Management solution focuses on knowledge captured at runtime for use in R&D and commercial manufacturing phases. Capturing such knowledge and experience at runtime helps improve production and reduce quality events.
As illustrated in figure 3, SmartFactory Rx Knowledge Management is at the center of the SmartFactory Rx platform, providing a crucial piece that bridges quality management on the production floor, which is key to maintaining a competitive advantage.
Figure 3. Within the SmartFactory Rx Platform, SmartFactory Rx Knowledge Management Captures Runtime Knowledge & Experience from Manufacturing Processes
SmartFactory Rx Knowledge Management standardizes event responses to reduce human error and variability and transfers the knowledge from experienced personnel to enable rapid resolution. The solution frames the analysis of classified events and triage, using an automated workflow to ensure that events are visible and delivered to the right disciplines at the right time (including quality, safety, operations, engineering, manufacturing science, etc.).
As shown in figure 4, the solution focuses on advising manufacturing groups at runtime about what remedial actions to take when equipment faults occur.
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Figure 4. SmartFactory Rx Knowledge Management Focuses on Advising Manufacturing Groups at Runtime [4]
Application in Life Sciences
In the life sciences industry, regulatory agencies like the U.S. Food & Drug Administration (FDA) have issued guidance that robust knowledge management needs to be demonstrated. The FDA has listed two common areas where risks need to be mitigated: (1) Deficient Facilities and Processes and (2) Ingredient Variability. This paper explores the former. Common causes of deficient facilities and process as listed by the FDA [5] include:
▪ Aging Manufacturing Platforms
▪ Manufacturing Variability
▪ Lack of Leveraging Current Technology
▪ Process Stops Due to Unplanned Downtime and Manual Sampling
▪ Open vs. Closed Process and Unit-Op vs. Integrated
▪ Manually Intensive Operations vs. Automation
▪ Human Error
▪ Lack of Analyzing Failure Modes to Develop Automated and Corrective Strategies
▪ Lack of Human Error Analysis to Further Improve Controls
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We can group these common causes into four areas:
▪ Legacy systems
▪ Variability and poor manufacturing control
▪ Overly manual intensive steps
▪ Lack of solutions to address risk and improvement which lead to human error
Legacy Systems
Large companies that have grown over time and across regions typically have manufacturing sites that span a wide range of data automation (e.g., digital maturity), combining a mix of various platforms. A complete overhaul to update a facility or enterprise to new technology platforms often isn’t feasible when implementing a knowledge management solution. Figure 5 illustrates the flow of knowledge management across various levels of digital maturity and how this flow is applied to help manufacturers improve quality and throughput. Those facilities forced to rely primarily on human observation are still in a favorable position to improve quality and increase throughput by tracking and reducing human errors, responding faster to events, and minimizing operational delays no matter what level of data automation is available.
Figure 5. Knowledge Management Data Automation (Digital Maturity)
Variability and Poor Manufacturing Control
Both variability and poor manufacturing control can be due to many contributing factors. The semiconductor industry found that automating knowledge management by collecting, analyzing, and prescribing responses to runtime faults greatly reduced, and in many cases, eliminated errors and delays - making electronics more affordable to consumers. Variability is also improved by using SmartFactory Rx Analytics & Control, which notifies operators when specifications are trending out of control using a wide range of analysis methods, including by prescribing standardized responses and implementing statistical process control (SPC), univariate/multivariate analysis, principle component analysis, artificial intelligence (AI), machine learning (ML), and so forth.
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Manual Intensive Steps
Manual processes are often more difficult to control. The FDA states that human error is the number one reported root cause attributed to quality events [2]. The semiconductor industry has learned how to virtually eliminate many human errors. SmartFactory Rx Knowledge Management provides automated step-by-step guidance at runtime, helping to achieve required precision and efficiency. This additional guidance includes notifying when sampling is required, which is detected by a watchdog trigger based on process conditions.
Lack of Solutions to Address Risk and Improvement
All GMP facilities have dedicated quality departments with detailed procedures and systems, but these often fall short because they lack focus on knowledge management. Not deploying an effective knowledge management system means crucial knowledge will be lost. In addition, current root cause investigations are written as narrow as possible to address an exact issue and aren’t exploratory enough to evaluate systemic cause and effect. They seek to find a singular root cause while rarely addressing that a minimum of two causal factors typically exist. If one reviews the Apollo Root Cause [3] methodology this becomes apparent.
Knowledge management seeks to reduce or eliminate these root cause(s) by starting with good engineering practices to develop control plans. Figure 6 from the FDA depicts the role of knowledge management and highlights the importance of its spanning drug development through discontinuation [2]. In addition, the figure highlights the complimentary nature of product and process quality systems (PQS) and quality risk management. This effort is only possible when management owns and leads the quality culture for change and provides resources in support of the efforts and systems which are required.
ICH Q10 PHARMACEUTICAL QUALITY SYSTEM
Figure 6. The Role of Knowledge Management in GMP Manufacturing
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A Tale of Two Plant Solutions
The solutions below illustrate the difference in outcomes between a deviation found without and with SmartFactory Rx Knowledge Management.
Problem
▪ During a weekend second shift, a chromatography process stopped and went into hold due to an alarm condition. The new operator was not aware that a manual valve needed to be reset and other preparation steps were needed to be performed prior to restarting the process.
▪ As a result, 10% of the product batch was lost down the drain.
Current Solution: Deviation Without Relying on SmartFactory Rx Knowledge Management
▪ This event had occurred before.
▪ An investigation concluded that the root cause(s) was due to human error.
▪ Corrective Action Preventative Action (CAPA) was deployed to update the standard operating procedure and implement comprehensive training for all relevant operators.
▪ The investigation failed to address the true cause (in this case human error) and treated the symptom not the cause.
▪ Two weeks later a similar event occurred but on a different piece of equipment.
▪ Both investigations found the same root cause(s) and treated them as separate events even though this was a systemic failure.
Optimal Solution: Deviation Relying on SmartFactory Rx Knowledge Management
▪ Because the plant had SmartFactory Rx Knowledge Management, the deviation was captured and managed in an active workflow.
▪ Engineering realized that they needed to do the following:
– Address detectability—the current alarm only occurred after the event.
– Deploy SmartFactory Rx Knowledge Management to automatically trigger a decision tree to guide operators when a deviation event is detected and prompt the operator how to respond.
▪ From this point forward, any re-occurring events generate an automated trigger decision tree, enabling operators to follow step-by-step information to resolve the deviation. Figure 7 illustrates how process data is captured before, during, and after the deviation, and then the workflow is passed to quality, triage, and engineering to work on a resolution.
Knowledge management allows engineers to deploy effective solutions in days to mitigate risk; in contrast, traditional procedures, training, automation, and equipment changes can take 8-12 months
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Figure 7. SmartFactory Rx Knowledge Management Workflow Automates Human and Equipment Data, While Creating Actionable Response Plans
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The Impact of Using SmartFactory Rx Knowledge Management
In either case, with or without SmartFactory Rx Knowledge Management, a drug manufacturer will encounter issues that result in quality or manufacturing events that will provide sizeable risk and monetary loss. Every company spends time in three categorical areas: detection, corrective action (including root cause(s) analysis), and prevention.
SmartFactory Rx Knowledge Management requires initial upfront design to understand the engineering principles of failure modes that exhibit Out of Control (OOC) events; however, this understanding ensures these modes aren’t Out of Specification (OOS).
A measurable value difference exists with SmartFactory Rx Knowledge Management. The solution helps ensure manufacturers will not relive OOC anomalies by providing a way to define detection and correction. In contrast, without knowledge management the chances increase that manufacturers will relive anomalies by depending on “word of mouth” and “tribal knowledge” to ensure knowledge transfers to the appropriate party.
Figure 8 illustrates the time manufactures spend on detection, corrective action, and prevention. The blue line represents manufacturers using SmartFactory Rx Knowledge Management to eliminate the chance of reliving OOC event anomalies. The red line represents manufacturers who are not using SmartFactory Rx Knowledge Management; these manufacturers see a high probability that OOC events will resurface because they depend on “word of mouth” and “tribal knowledge” vs. relying on automated knowledge transfer to ensure information transfers properly to the appropriate disciplines (e.g., quality, safety, operations, engineering, and so forth).
Figure 8. Time Spent on Detection, Corrective Action, and Prevention
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Achieving Effective Knowledge Management
An effective knowledge management solution is achieved by capturing knowledge that is transformed into advisory instructions on how to achieve specific objectives or solve problems that can easily be understood and acted upon. This effort leads to insight and value gained from knowledge and its re-use across the enterprise. Figure 9, illustrates the implementation flow, providing companies a powerful roadmap for improvement. The SmartFactory Rx platform delivers an integrated solution, which enables facilities to improve process quality, reduce human errors, respond faster to events, and minimize operational delays regardless of the number of platform silos or number of multiple-site locations. The platform provides value for all plants regardless of the level of data automation (digital maturity) available.
References [1] Copyright Knoco Ltd., 2018, Knowledge Management Survey. The introduction is available online: https://www.knoco.com/knowledge-management-survey.htm.
[2] FDA: Pharmaceutical Quality Systems: US Perspective. Available online: https://www.fda.gov/downloads/drugs/developmentapprovalprocess/manufacturing/ucm288108.pdf
[3] Gano, D.L., (2008) Apollo Root Cause(s) Analysis: A New Way of Thinking. 3rd Edition, Yakima, Washington: Apollonian Publications. ISBN 1883677114, 9781883677114.
[4] APQC’s ‘teachable moment’ design framework, based on concepts originally developed by the 2009-2010 Knowledge Management Advanced Working Group (AWG).
[5] FDA: Current Expectations for Pharmaceutical Quality Systems. Available online: https://www.fda.gov/downloads/drugs/developmentapprovalprocess/manufacturing/ucm324354.pdf (summarized by authors)
