PRODUCTION AND PERFORMANCE MANAGEMENT DATA HISTORIANS FOR INCIDENT AND DEVIATION MANAGEMENT IN THE REGULATED INDUSTRIES

Transcription

1 PRODUCTION AND PERFORMANCE MANAGEMENT DATA HISTORIANS FOR INCIDENT AND DEVIATION MANAGEMENT IN THE REGULATED INDUSTRIES

2 DATA HISTORIANS FOR INCIDENT AND DEVIATION MANAGEMENT

3 DATA HISTORIANS FOR INCIDENT AND DEVIATION MANAGEMENT Introduction Responding to incidents and deviations is a critical, but time-consuming activity for regulated industries. Regulations, such as the U. S. Food and Drug Administration s (FDA) 21 CFR Part 11 for production, inventory and laboratory work or the U. S. Environmental Protection Agency s (EPA) CFR Title 40 for environmental protection reporting requirements require a manufacturer to investigate all incidents and deviations. This investigation includes determination and documentation of the root cause of all events and the corrective actions taken. These activities take away valuable operational resources and place continuing production at risk if the problems are systemic. Furthermore, these same regulations require companies to have their investigation data available for auditors and official reports. Unfortunately, the required data is often scattered throughout multiple sites and systems in multiple locations with different time stamps and is often collected by multiple departments. The data is difficult to obtain and even harder to use for near real-time corrective action. A new generation of historical data collection applications provides the capability to reduce significantly the time and effort required to manage these incidents and deviations. Now referred to as operations management (OM) historians, these applications collect, synchronize and correlate historical data from a variety of process and operations management sources for efficient and effective incident and deviation tracking. Long-term data storage and contextual accessibility significantly reduce the time and effort required for all forms of investigations. The OM historian supports a company s Corrective Action and Preventive Action (CAPA) procedures. This paper defines the specific requirements and benefits for this new solution class for today s manufacturing or process facility. The Rockwell Automation FactoryTalk Historian SE (Site Edition) is now available with the capacity to provide a valuable and effective tool for investigations and improvements for regulated industries such as pharmaceutical, biotechnology, medical device, food and beverage. Incident and Deviation Tracking The best-run manufacturing company is where nothing goes wrong, where all products are on-specification, and where nothing unexpected happens. Unfortunately, the unexpected often happens, products are sometimes out-ofspecification (OOS), and things do go wrong. Well-run companies learn from these events, called incidents and deviations, and improve their processes and procedures to eliminate the root causes of the problems using CAPA procedures; continuous improvement programs use these events as triggers to address and improve control procedures and operations. A key goal for manufacturers is to consolidate incident and deviation data quickly (near real-time) and then use it to trigger events or alarms to minimize effects. The degree of response is what reduces the overall effort and cost of deviations and significantly reduces or eliminates the need for rework or reprocessing. It All Starts with Incidents Typically, incidents are unexpected events related to maintaining plant operations, safety, regulatory compliance, or security. Incident management includes 1

4 PRODUCTION AND PERFORMANCE MANAGEMENT investigations to determine root causes, a short-term corrective action, and then the creation and documentation of the preventive actions necessary to prevent future similar incidents. Incidents are typically related to factory floor processes and production associated with equipment or materials. Examples are: An unexpected chemical process release that requires a report to the EPA A production incident contaminating product with no discernable cause requires a report to the FDA An equipment incident such as a failure of a newly installed pump that requires investigation of the supplier A material-related incident that creates an unexpected change in quality of a stored API (Active Pharmaceutical Ingredient) suggesting a failure in storage conditions or incomplete incoming testing Production Impact Deviations Deviations are measured differences between an observed value and an expected or normal value for a process or product condition or are an anomaly from a documented standard or process. Product deviations would include: Crystals are too large after a crystallization operation Tablets have too high a friability after a compression operation Active ingredient percentage in blend or mix is below specification Equipment deviations would include: A temperature setting spiking in a dryer Temperature profile curves not being followed in a lyophilizer Pressures in a reaction vessel trending out of a normal setting Deviations may also be triggered by customer complaints or comments when the customer company s standards do not meet critical attributes as delivered per certificate. In October 2006, the FDA released Guidance for Industry Investigating Out-of- Specification (OOS) Test Results for Pharmaceutical Production stating that the records and documentation of the manufacturing process should be fully reviewed to determine the possible cause of the OOS result(s). FDA also requires a thorough investigation of any discrepancy, including documentation of conclusions and follow-up. 2

5 DATA HISTORIANS FOR INCIDENT AND DEVIATION MANAGEMENT The Road to Continuous Improvement Investigating incidents and deviations is a vital part of continuous improvement (CI) processes such as Six-Sigma and lean manufacturing initiatives. Companies often begin CI processes due to some unexpected failure or a realization that normal operations are not cost effective. For example, some batches or production runs are better than the norm with lower variability or higher yield. These are identified as golden batches, and CI investigations compare the golden batches to the normal batches to determine what went right and then characterize the control process. CI processes require the same type and amount of information as incidents and deviations. Without the right data collection and storage systems in place, experience on CI projects consistently shows that data collection can be over 50% of the effort in any investigation! Incidents and Deviations Solution Investigations of incidents and deviations require retrieving and assembling the data that described what happened before, during and after the event. Most plants have this data scattered and stored in relational databases, HMI systems, manufacturing operations systems, and other ad hoc electronic formats. Because incidents are unexpected, collection of baseline information prior to the incident is critical in determining the incident root cause, yet this is often the hardest data to obtain. A typical investigation requires data from seven or more normal production runs in order to determine statistically significant relationships. The data collection also requires the assistance of trained production and quality personnel who must search equipment and maintenance logs, production reports, MES and HMI databases to collect the required data. These requirements place an unnecessarily heavy load on scarce production and quality resources when their focus needs to be specifically on the analysis and response time. In regulated industries, a basic requirement of an operation management data collection system, such as an OM historian, is to collect data in real-time, time and date stamp the data, correlate data with the appropriate events (for example, start of an operation), and make data available online without requiring any production or quality personnel time. Incident and deviation data is collected from a wide variety of sources, including process control and automation systems, spreadsheets, HMI systems, local databases, corporate databases, instruments, sensors and smart field devices. Capturing data at the required level of detail for important short-term events requires high-speed data capture in combination with selectable deadband support to ignore the noise. Based on post-incident analysis, the system must continuously improve by flagging events based on identified and predefined production and process events such as the start of a batch, start of an operation, shift number or equipment startup. Event flagging moves the OM historian into a predictive application that allows comparisons across batches, production runs and machine cycles. 3

6 PRODUCTION AND PERFORMANCE MANAGEMENT Configuring an OM historian data collection system can be a time consuming and error prone process, so automated configuration help and support for standard interfaces such as OLE, ODBC and OLEDB are must-have features. The new generation of OM historian has advanced import methods to eliminate manual and error prone copying of automation and HMI tag database configurations for rapid tie-in to existing data sources. Consolidating and collecting plant information is only half the job. The information must be stored efficiently, backed up safely, and correlated for reports and analysis. Regulatory authorities do not accept the loss of critical data as a reason to not complete an investigation or provide a request for information. The collected data may also be very large, potentially generating gigabytes of data per day in a large site, so efficient data compression is required but should not slow down retrieval for investigations. The final requirement for a regulated incident and deviation solution is that the data must be easily available to the engineers and scientists performing the studies and to the operators and supervisors optimizing their processes. These knowledge workers require the data from their desktops or PDAs in the form of standard spreadsheets and databases for analysis using familiar tools optimized for each person s task and role. The role-based applications are the key to predictive solution to reduce the abnormal events or downstream effects. Alarm and event solutions in combination with analysis tools perform batch-to-batch or run-to-run comparisons, SQA tests, sophisticated calculations and conversions, multivariate analysis and primary component analysis. These are the requirements for the next generation of OM historian solution for regulated industries. FactoryTalk Historian SE The Rockwell Automation FactoryTalk Historian SE (Site Edition) meets and exceeds the described requirements for OM historian for incident and deviation tracking in the regulated industries. As part of the complete FactoryTalk solution suite, it provides the OM historian with a backbone for collecting the time-tagged and event-flagged data critical to investigating incidents and deviations. FactoryTalk Historian SE consolidates data from multiple sources and time stamps all data to the same time source, eliminating time-sequencing errors. Data is made available to client stations for reporting, analysis and reviews. FactoryTalk Historian SE is an integrated set of data collection, storage and decision-making tools that provides real-time access to product and process historical information. FactoryTalk Historian SE also provides high availability and fidelity of the data in a secure architecture through hardware (server and disk) redundancy and through the use of Microsoft clustering technologies. These capabilities protect all data critical to investigations and reporting to ensure its rapid availability to scientists, engineers, operators and supervisors. 4 FactoryTalk Historian SE provides efficient and robust historical data management and collects high speed and in real time at selected data resolution. Using compressed data storage algorithms to keep large amounts of information in a small storage format, it filters data using deadbands to eliminate noise and eliminate duplication so that only significant changes are stored. This allows FactoryTalk Historian SE to save and retrieve vast amounts of varied data quickly.

7 DATA HISTORIANS FOR INCIDENT AND DEVIATION MANAGEMENT The features of FactoryTalk Historian SE address the hardest part of a historian implementation identifying the data to collect and linking the data collection system to the numerous data sources (as shown above) for investigating incidents and deviations. Reporting of incidents and deviations is streamlined through FactoryTalk Historian SE by providing multiple integrated analysis and visualization tools, including timeseries trends, bar charts, pie charts and tabular trends. Calculations are provided automatically using standard totalizers and performance equations. An embedded advanced computing engine allows programming of more complex calculations in the reports. The information is correlated through the following methods: FactoryTalk Historian SE data is interfaced to other database systems using an SQL interface to allow the investigation and study data to be accessed by the favored statistical and data analysis tools. FactoryTalk Historian SE data is available through OLE automation for tools such as Microsoft Visual Basic and Microsoft Excel. A simplified Microsoft Excel interface allows users to generate reports and perform analysis using their own desktop tools. 5

8 PRODUCTION AND PERFORMANCE MANAGEMENT Conclusion FactoryTalk Historian SE is an optimal operations management historian for incident and deviation investigation solutions for any regulated industry. The power and flexibility is provided to handle the data consolidation requirements for incident and deviation management and the needs of continuous improvement projects as well as at-line response through proactive alarm and event notification. FactoryTalk Historian SE provides the basic requirements of high-speed, real-time data collection, redundant storage of data, easy integration of existing systems, and powerful tools for reporting and analysis. Companies in the regulated industries are now able to meet their regulatory requirements to free up valuable production resources and to give them the information to improve their operations and reduce their bottom line. FactoryTalk and Rockwell Automation are trademarks of Rockwell Automation, Inc. All other trademarks are the property of their respective companies. Publication FTALK-WP010B-EN-E January 2010 Supersedes FTALK-WP010A-EN-E June 2008 Copyright 2010 Rockwell Automation, Inc. All Rights Reserved.