Methods and solutions for controlling product quality

Sept. 17, 2010 - PRLog -- Alongside observing legal and regulatory requirements, achieving optimum price-performance takes top priority for a production company.
This can be kept under control, provided the resources and equipment on hand work consistently and as desired. However, both technical systems and the people that operate them can change their behavior over time or based on their situation.
Operator actions can be laid down in instructions or SOPs (standard operating procedures) to ensure that the desired consistency is met.
However, machines and production systems are subject to constant change. This also applies to the materials being processed which, despite commitments on the part of the suppliers, are themselves subject to deviations in terms of quality, composition and consistency. Despite comprehensive quality control and strictly governed specifications, certain aspects can still fail to be given proper consideration and then develop into a costly problem.


CAPA as an integral part of deviation management at companies
Since process deviations are hard to avoid, even in well organized enterprises, it makes sense to implement an effective and easy-to-use system of deviation management here. And such systems are today increasingly being conceived based on the rules of CAPA (corrective action – preventive action).

The purpose of the CAPA process is not just to determine and correct deviations ( corrective action), but also to define and execute steps/measures to prevent such issues from occurring in future ( preventive action).

The pioneering role of the pharmaceutical industry for other sectors
The pharmaceutical industry is subject to strict and regular examination by the US FDA (Food and Drug Administration). Any deviations from legal stipulations are recorded in publicly accessible warnings sent to the producers. In 2006 and 2007, warnings issued due to a lack of preventive processes ranked among the top 10 of all written warnings issued to industry, which further underlines their importance. To protect themselves from potential damage to their reputation and the costs associated with this, companies should undertake to securely prevent this through the introduction of appropriate measures.

The importance of this subject is further reinforced by the fact that the ISPE (International Society for Pharmaceutical Engineering; www.ispe.org) dedicates a whole chapter to CAPA in its GAMP Guide (Good Automated Manufacturing Practice). It portrays the CAPA process in simplified form in a flow chart (Figure 1).


CAPA for all sectors of industry
Massive cost pressure and the growing demand for traceable processes are making deviation management, together with CAPA, an ideal quality and cost control tool in all production industries.
In contrast to their colleagues working at pharmaceutical enterprises, the manufacturers of less strictly regulated consumer goods are being subjected to ever more critical examination by their consumers. Loss of reputation can have devastating effects on the success of a business here. So having a tool that not only detects and eliminates faults, but also helps prevent these from occurring again in future will protect the reputation of production companies and their position in the market.
There are also many other processes critical to health that have to be controlled and monitored in other industries. Examples in the food industry include the addition of ingredients such as vitamins and flavor enhancers or complete process chains such as milk or meat processing.

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