Implementing Process Improvements

Since the 1960s, the prevailing solvent at the 36,000 dry cleaning establishments in the United States has been perchloroethylene (also called perc or PCE) (USEPA, 1998). Process improvements implemented in the dry cleaning industry have greatly reduced perc usage in recent years, but annual consumption is approximately 53 million kg (Mannsville, 1997). 

It needs to be recognized that the data for PEAl and PEA B/WP represent engineering estimates. In addition, there is good reason to expect improvements in the actual performance versus the estimates. Despite years of development work, the commercial manufacturing process for PEA is in its infancy. If the experience from petrochemical-based polymers offers any instruction, it is that process improvements implemented in the early years of a technology typically lead to substantial cost improvements. This is because the pursuit... 

Process Hazards Analysis. Analysis of processes for unrecogni2ed or inadequately controUed ha2ards (see Hazard analysis and risk assessment) is required by OSHA (36). The principal methods of analysis, in an approximate ascending order of intensity, are what-if checklist failure modes and effects ha2ard and operabiHty (HAZOP) and fault-tree analysis. Other complementary methods include human error prediction and cost/benefit analysis. The HAZOP method is the most popular as of 1995 because it can be used to identify ha2ards, pinpoint their causes and consequences, and disclose the need for protective systems. Fault-tree analysis is the method to be used if a quantitative evaluation of operational safety is needed to justify the implementation of process improvements. 

The context is action refinement making decisions that implement or put more detail into an abstract (set of) actions. This may be part of a computer system design (Pattern 16.8, Basic Design) or part of the reengineering of a business process (Pattern 14.1, Business Process Improvement) and may in particular be the engineering of the business process of which using a computer system is a part (Pattern 15.5, Make a Context Model with Use Cases). 

The President s Critical Infrastructure Protection Board and the Department of Energy (DOE) have developed the steps outlined below to help organizations improve the security of their SCADA networks. DOE (2001) points out that these steps are not meant to be prescriptive or all-inclusive. However, they do address essential actions to be taken to improve the protection of SCADA networks. The steps are divided into two categories specific actions to improve implementation, and actions to establish essential underlying management processes and policies. 

With the increasingly competitive enviromnent in the manufacturing sector, organizations are always searching for new ways to reduce costs, improve efficiency and product quality. To remain competitive, many companies have devised and implemented corporate-based continuous improvement initiatives. As part of continuous improvement, process analytical implementations should be periodically evaluated to determine if they are still necessary and adding value to the production process. 

Planning quality improvement, implementing the plan, analysing the results and re-plamung is a continuous cycle (Plan-Do-Check-Act). Interrelated improvement plans are deployed at all levels of the laboratoiy (corporate, department, process, individual). It is essential to note that the commitment of laboratory personnel is maximized when such personnel is actively involved in the generation and deployment of the improvement plans. 

A quality management system s process should follow a standard Six Sigma process improvement life cycle that includes the following steps define (process and metrics), measure and control (identify problems and issues), analyze (analyze problems and issues), and improve (implement) circling back to measure and control [11]. An example of a process improvement life cycle can be seen in Figure 9. 

Monitoring, measurement, and analysis of these processes and implementation of actions necessary to achieve planned results and continual improvement of these processes. 

To support the user, step-by-step guiding dialogs are implemented in the database. As long as the site-specific BOM has not been modified by the user, all data entries are marked to be estimates since they are only derived from the default BOM. To accommodate process improvements that are expected over time, the BOM modeling can be further detailed to include time-dependent changes. 

In this step, a core team is selected which consists of four to six people who are best able to lead the program, perform the waste assessments, and implement the recommended process improvements. At smaller and medium-sized facilities a single individual may undertake the bulk of the pollution prevention tasks, or consultants can be used. 

After purification the DMT group from the oligonucleotide is removed by acid treatment, such as, acetic acid or some other milder acid in aqueous solution. After final detritylation, the salts if excessive are removed via precipitation, and then the product is lyophilized. Several process improvements have been tried and implemented to enable processing at the kilogram scale in our GMP facilities.1,47... 

For medical devices, inspectors expect to see a process improvement program in place encompassing all activities within the supply chain, including the systems that support it. Activities that would provide evidence that such a program is in place include the implementation of documented processes such as Corrective and Preventative Action (CAPA), self-inspection, and internal audits." Organizations should ensure that where an SOP has been put in place to initiate a process improvement activity, the SOP is adhered to. For example, if a quality audit SOP states that all areas shall be subject to audit at least once every 2 years, then inspectors will expect to see evidence that this has been the case. Failure to do so is likely to result in a citation similar to that issued to Krieger Medical, Inc. ... 

With respect to comphance, quahty and security, the pivotal portion of the contract should be an appendix that covers the ongoing conditions and controls by which the client company can demonstrate ongoing compliance and robust security measures, especially with respect to FDA 21 CFR Part 11 requirements. This will hold the service provider (and the client company) accoimtable for implementing and sustaining these controls, and thereby sustaining compliance over the life of the contract. This appendix should also make provision for process improvement and/or additional measures to be implemented in the future, should any changes in requirements arise. Table 37.4 summarizes subjects suggested in Appendix 37A. 

With the writing of this entry, the authors hope to encourage the proper use of these important process improvement and process evaluation tools, especially within the pharmaceutical industry. We also hope that some of the barriers to their implementation within the pharmaceutical industry that were discussed within this entry can be overcome through cooperation with the FDA and a mutual desire to improve pharmaceutical processes. 

The most analytically unfavourable feature of DPHSE is that analytes are diluted in the liquid extract, which requires concentration (usually by static liquid-liquid or solid-phase extraction). However, the increased flexibility of DPHSE relative to ASE has been used to develop various approaches to the partial or complete automation of methods based on the use of hyphenated techniques. Such approaches not only allow the dilution problem to be overcome but also enable automation and/or facilitate the development of other steps of the analytical process such as filtration, detection or chromatographic separation. The principal approaches to automation and improved implementation of analytical steps subsequent to DPHSE are discussed below. 

Six Sigma This section covers using the quality management system and tools that assist organizations in implementing a process improvement methodology. 

---