Qualigen
     

 
 
Quality   |   Quality system   |   Quality control   |    
 
Our aim is to satisfy our clients with high quality products and services, respecting the environment, and with a strong vocation of innovation and continuous improvement.
The key elements of our Quality System are:
Personnel
The company has an adequate number of personnel with the necessary qualifications, practical experience and training (both initial and continuing).
The firm has suitable written instructions relating to the health, hygiene practices and clothing of personnel. Medical examinations are conducted periodically for all employees.
 
Validations/Qualifications
We conduct the following kind of validation activities: analytical methods, manufacturing processes, cleaning methods, computer systems, equipment and facilities. We get documented evidence that each one will provide the expected results.
 
 
Premises And Equipment
Premises and equipment are located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design minimizes the risk of errors and permits effective cleaning and maintenance in order to avoid cross-contamination, build up of dust or dirt and, in general, any adverse effect on the quality of products.
Premises are designed, constructed, equipped and maintained to prevent entry of insects or other animals. Steps are taken in order to prevent unauthorized people from entering.
Production areas are effectively ventilated with air control facilities (temperature, filtration and, where necessary, humidity) appropriate to the products handled.
There are suitable washing, changing and rest areas.
Measuring, weighing, recording and control equipment are calibrated and checked at defined intervals by appropriate written methods. Records of such test are maintained.
 
Continuous Improvement
Our Quality System has tools to detect improvement opportunities, such as handling of complaints, deviations, incidents, self-inspections findings, customer audit recommendations, etc... We record and review each one and, when appropriate, measures are taken to achieve continuous improvement.
Self-inspections are conducted in order to monitor the implementation and the respect of Good Manufacturing Practice principles.
Self-inspections are conducted in an independent and detailed way by Quality Assurance, which is independent of other departments.
 
Suppliers Audits
In order to increase the quality assurance of our products, we audit our main suppliers and our potential new suppliers.
Audits are conducted by experts of Quality Assurance, Quality Control and Purchases.
 
Documentation

 
 
 
 
 
 
 
 
 

 
We have clearly written documentation that prevents errors and permits traceability.
Documents are prepared, reviewed and approved, by appropriate, competent and authorized persons; and distributed with care. Documents are regularly reviewed and kept up-to-date.
Operations are performed in accordance with written procedures or instructions and, where necessary, recorded.
We have a database for Documentation Management that also permits users to access on line to the text of documents from their computer
 
 
 
 
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