In the current environment, more and more regulated, the factor Hygiene, Health, Safety and Environment (HSE) is critical to the daily operations of contamination control business. Due to the number of regulations imposed by government agencies (21 CFR CFR 25-40, and ISO 14001), monitoring of issues and actions HSSE, although more complex, is essential.
To date, the process most commonly used and most effective way to ensure the safety and quality management departments of contamination control is a corrective and preventive action system (Corrective Action and Preventive Action CAPA) in closed loop. Proper management of corrective and preventive actions to quickly and efficiently deal with any problems control unexpected contamination during the manufacturing process, the process used to ensure that these problems do not recur. This allows companies to anticipate possible problems with regulators and save a lot of time and resources which may impact on the ability to generate profits from clean manufacturing.
The concept of management of corrective and preventive actions is probably not new to most professionals contamination control. This concept has existed for several years in various forms among manufacturers, is generally regarded as an effective way to manage quality problems occurring during the manufacturing process.
But in reality, few enterprises have adopted a management process corrective and preventive action effective closed loop, and very few have implemented a system for managing quality processes in place to monitor and report problems with corrective and preventive actions. In fact, many of them still use rudimentary tools such as spreadsheets, databases and paper documents to track problems encountered and the measures taken in respect of corrective and preventive actions. Why are companies so if they reluctant to adopt effective management of corrective and preventive actions, and why those who have done so are they behind the methods used? More importantly, what should be done to ensure that companies are realizing that the management of corrective and preventive action does not necessarily require much time and resources as they think?
In this paper, we study the need for and effectiveness of a proper control of corrective and preventive as well as how to implement an effective action, and we will determine why corrective and preventive actions are still important.
The issue at hand
Although the needs of professionals and departments contamination control may vary depending on the industry (pharmaceuticals, semiconductor and food), the goal of most of these departments is often the same: to produce and deliver products as efficiently as possible and with the least adverse impact on the production environment. In other words, whatever the sector, professionals must always maintain a production environment free of pollutants, contaminants or potentially harmful impurities that can make a defective or dangerous product (in the case of food and pharmaceutical products).
This challenge becomes even more difficult when government regulations are introduced. Knowing that new lawsuits make headlines almost daily and that the survival of companies depends on their ability to maintain an environment free of contamination, the presence of a process of effective quality management in the production environment takes on a new importance. Minimize risk and comply with regulations while maintaining an efficient and profitable business is a balance that companies constantly seek to achieve, and many succeed.
However, despite all efforts to implement processes and systems to control the production environment, it is absolutely impossible to prevent any incident. When these incidents do occur, businesses must be prepared to manage them as quickly as possible.
It was at this time that the management of corrective and preventive action comes into play, appearing as an essential process to solve the problems associated with the contamination of the production environment. Theoretically, the management of corrective and preventive actions should be at the heart of initiatives quality management because it would allow companies to record the events and issues, to examine and determine the cause, propose action plans corrective and preventive measures to ensure that these problems are anticipated and will happen again, and finally, to measure their effectiveness to ensure that the problem has been eliminated. This kind of system usually requires an approach that includes a business intelligence system that allows to track all of the above problems and to provide an effective treatment.
Why companies are they are more likely to adopt?
Among the executives, the myth is that the management of corrective and preventive action is a waste of time and resources for the company. Ultimately, many companies never reach the stage of implementation of effective corrective actions, let alone preventive actions to ensure that similar problems do not recur. These companies are doing so because when a pollutant or contaminant entering the manufacturing process, they go directly into "panic mode" and are eager to find a temporary solution rather than a preventive solution to any future incidents . It is only once the contaminated product is shipped the problem is discussed as it should be to identify the cause. Play Inspector finished work is too widespread.
The irony is that companies fail to implement appropriate corrective and preventive action process is that when the management of corrective and preventive actions and working properly as originally planned, it can actually allow companies to save time and resources if they are reluctant to devote to implement. Ideally, a corrective and preventive action system operates as intended should reduce costs by consolidating redundant systems, improving collaboration between departments and increasing savings for the implementation process. It eliminates the costly recurring problems in accelerating the discovery of the source of incidents and eliminates the risk of data loss by managing electronically and securely, all the information necessary to meet the industry standards.
This is the promise that many companies have not managed to hold out until then. The next step is to determine how to properly implement a corrective and preventive for the results of actions system.
React with corrective and preventive actions
When management system corrective and preventive action in closed loop is implemented in an environment of contamination control, it is essential to keep in mind that it is not a miracle cure to treat all the ills of the company's regulations. At best, the proper management of corrective and preventive actions can reduce the costs associated with quality initiatives within other organizational departments. But, as we have seen, corrective and preventive actions can contribute significantly to the taking of measures to enhance the effectiveness of future efforts in terms of quality.
The first step is to check your system for corrective and preventive action is centralized and managed in one place, thereby enhancing operations and eliminating duplication between departments. Centralized system that is based in a corporate office or headquarters, does manage corrective and preventive actions from this unique avoids confusion incident and reduces the cacophony and avalanche e-mails sent between departments, each claiming to know the origin of the problem and pretending to know how to solve.
The next step is to build an effective system to monitor all incidents and events. Electronic imperative, it must be based on a centralized accessible to smaller number of people in the company to avoid confusion between departments system. Some companies use databases or spreadsheets such as system monitoring, while others still manually record the problems on paper documents. At a time when technologically advanced where you can easily get the new electronic management solutions quality from various vendors, this should no longer exist. Centralized systems of quality management for monitoring incidents should be the de facto solution adopted by any company, regardless of its size.
Whatever system is in place, the implementation of a centralized system of quality management enables organizations to record and manage all incidents and problems they have encountered. They can thus solve problems, determine the causes and take the necessary measures to prevent their recurrence, according to the goals they have set.
Once the foundations are laid for management of corrective and preventive actions through a centralized electronic system for tracking incidents, the company is ready to deal effectively with incidents, the real work of solving unexpected problems can begin. This is in the form of a corrective action. In other words, these are the steps to follow when the incident occurs. For this, the company must be able to stop the errors faster and more efficiently than previous processes. Moreover, the incidents must be reported with minimal hesitation, to minimize response time.
Once again, an electronic quality management is the only way to effectively report incidents which, ultimately, allows the company to get faster answers and solve the problems of contamination occur during the production process. This also assumes that transmission procedures are applied so that the persons concerned are informed of the incident and that these cases do not ébruitent is more than necessary. Companies should definitely take the time to develop a procedure for efficient transmission that incorporates quality management while providing a transmission path that does not involve employees.
The proposal can be tricky. If procedures are manual transmission and if the people involved do not pay attention to people informed and processes used, the problems can be even more important. This is why we must resolve internally, before they "through the door" and tarnish the reputation of the brand. It is surprising how easily the problems may go unnoticed by the current "clean" manufacturers who do a lot more work with less people. To summarize, the quality can easily be relegated to the background in favor of production and profits. However, it is essential that companies include the transmission procedures in their plans for corrective and preventive actions, and that in order to achieve a balance between income and quality commitment.
Once an effective corrective action is taken and the problem is treated, preventive action can begin. The major components of preventive action is the investigation and analysis of the origin, which can be, once again, achieved through the quality management. Transparency must be ensured by the parties responsible for investigating the instigator of the problem of contamination control, and these parts must meet strict deadlines to find out what caused the problem, otherwise it is possible that the appropriate solution never be found.
A system of quality management can automate this process and alert managers on deadlines and ongoing investigations, providing increased visibility for executives and provides transparency between departments. In addition, quality management can be an effective way to monitor and determine the progress of the analysis of the origin of a problem so that deadlines are met and that the achievement of results is effective and correct.
The last part of the corrective and preventive action process in a closed loop through the contamination control is monitoring the effectiveness of controls, which is the measure of the effectiveness of preventive solution after implementation. When these controls are streamlined and monitored effectively, appropriate staff is responsible for assessing the success of preventive action and to determine the effectiveness of the solution. This allows you to "close the loop" of the corrective and preventive action process and provide managers with the tools they need to ensure compliance with the standards of regulatory authorities, while anticipating and preventing potential problems arising from these authorities.
Not perfect, but good
Even when the corrective and preventive actions are properly managed within a company, it does not allow it to cure all ills for compliance or to provide complete protection against possible incidents. It is in the order of things. Pollutants will always have an impact on the process of cleaner production and give headaches to companies of all sizes in regard to compliance.
However, from the available to effectively deal with emergencies related to contamination systems, it has been shown repeatedly that the management of corrective and preventive action was the most effective system to prevent problems from happening again, requiring a minimum time and resources that businesses generally as a barrier to profitability. Successfully implement a system for managing corrective and preventive actions in the context of a comprehensive initiative to quality management can reduce costs and resources, and provide businesses with the tools they need to anticipate emergencies and continue to grow in the years to come.
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