Implemented process improvement program

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. ... 

Because of the underlying statistical processes used with control charts, the safety manager can identify safety performance problems when they become statistically significant. The safety manager can also use control charts to implement continual improvement programs related to safety activities. 

Safety professionals can draw upon voluntary standards and national consensus standards to develop safety performance programs, implement continuous improvement programs related to safety, and develop measures of safety performance. National consensus standards are developed through a process of obtaining input from industry representatives on the development of the standard. This representation can include manufacturers, trade associations, professional organizations, as well as other standards development bodies in the United States, in other countries, or from international coalitions such as the European Community. 

Quality assurance programs are designed to serve two functions (1) assessment of collected air quality data and (2) improvement of the data collection process. These two functions form a loop as air quality data are collected, procedures are implemented to determine whether the data are of acceptable precision and accuracy. If they are not, increased quality control procedures are implemented to improve the data collection process. 

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. 

Corporate Leaders—those providing the leadership commitment, setting the expectations, for a process safety performance and the supporting metrics system including the resources necessary to develop and implement such a program throughout the corporation to improve process safety. 

Different metrics may be used to describe past performance, predict future performance, and encourage behavioral change. They are a means to evaluate the overall system performance and to develop a path toward superior process safety performance. This is accomplished by identifying where the current performance falls within a spectrum of excellent-to-poor performance. Such information will allow executives and site management to develop plans to address the specific improvement opportunities that could lead to measurable improvement in process safety. Good process safety metrics reinforce a process safety culture that promotes the belief that process safety incidents are preventable, that improvement is continuous, and that policies and procedures are necessary and will be followed. Continuous improvement is necessary and any improvement program will be based on measurable elements. Therefore, to continuously improve performance, organizations must develop and implement effective process safety metrics. 

The quality and mechanical reliability areas have used statistical methodologies to design and implement their successful improvement programs. Using statistically valid data and analysis provides a rational assessment of a system s performance. Applying these techniques to process safety systems will support an efficient and effective improvement effort. Statistically valid data will also avoid overreaction to short-term performance anomalies that may not accurately reflect performance of the process safety system such data will help identify the actual performance improvement opportunities. 

The patient safety program must include the development of a continuous assessment process to prevent error occurrence. Event information from data and incident occurrence reports should be reviewed by the multidisciplinary team to prioritize organizational efforts. Sources of data could include incident reports, medication errors, adverse drug reactions, transfusion reactions, sentinel events, and other adverse events. The patient safety program encompasses the patient population, visitors, volunteers, physicians, and staff and addresses improvement issues in every department. Senior leadership must be responsible for ensuring full implementation of the program, with an emphasis on the following functions ... 

Safety audits are systematic procedures for reviewing management systems and practices implemented to achieve safety. They can include a compliance review, similar to a safety inspection. The audit process also allows for reviewer suggestions and recommendations for improvement. Audits may be part of more general practices to ensure that management systems are in place and followed as written. Audits can apply to systems, processes, products, programs, or services. 

Management of the overall change process and of the individual changes involved in achieving the improvements, based on the development and implementation of action programs to close the gap between a company and the best-in-class companies with the most relevant key performance variables. 

Fourth, the benchmarking process requires a considerable amount of time from when the decision is made to benchmark to when measurable results are realized. As with any safety program activity designed to improve performance, the results of the performance may not be evident for some time. In the case of measuring activities designed to increase the workers use of personal protective equipment, results may be evident in a relatively short period of time following the implementation of the program. Supervisors can go out to the production areas and observe worker performance. However, in the case where the activity is supposed to reduce the number of recordable injuries, the lag time may be a year before the decrease in cases can be substantiated. 

The primary objective of measuring safety performance is to provide a feedback mechanism that will foster continuous improvement. A process for implementing such a program relies on the following steps (Krause and Hidley 1990,161) ... 

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