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Quality and Process Analytical


The real importance of quality is evident when you are missing. The lack of quality leads quickly to complex consequences on the value chain: dissatisfied customers, trade deficits and damaged reputation.

Integrate quality in the production process through its management both inside and outside of the manufacturing line, is vital for the industry to ensure quality levels both for global consumers as for market regulators organisms.


PAT-IPC-SPC/SQC: Quality integrated into the process and the manufacturing line

The quality integrated into the line (IPC) is a set of procedures and methods to monitor, inspect, measure, analyze and assess risks in the execution of processes and operations. Using statistical control (SPC / SQC), we supervise the results of the production lines providing significant deviations that may result in waste products. To minimize inspections and controls in the line, is recommended a precautionary approach to evaluate the risks in a systematic way from the design of the production process.

Having powerful technology interfaces with real-time process analysis technology (PAT) is essential for processing the captured data and detecting multi-variants trends to reset the controllable parameters of the process. This way you can move forward in the optimization of the process based on contrasted behavioral rules and the knowledge contributed by industry specialists.


MES – LIMS: Integration of the Laboratory Information Management System.

The quality control tests performed outside the manufacturing line and usually managed from the labs, require sampling and data logging of product quality and process. The Laboratory Information Management System (LIMS) coordinates and models the workflow in the laboratory and optimizes the collection, analysis and evaluation of material and product quality data, based on sampling and testing plans.

From the reception of raw materials from suppliers, through the release of half-finished materials for use in a production phase and to dispatch of finished products, is necessary sampling and data collection depending on the batch and production order. These operations and tests are easily incorporated within the paths defined in the MES system and provides to LIMS the in-line quality data and the required samples for further laboratory analysis or for legal stores.


MES – EQMS: Integration with Enterprise Quality Management System

The manufacturing world is becoming increasingly complex. Manage the growing changes, customizations and developments of products and processes, as well as the variability in a global network of suppliers is an organizational challenge of business processes and technology involved.

To ensure the final quality of the products is necessary to establish common quality management tools that incorporate features:

  • Document management procedures, specifications and best practices.
  • Fulfillment of the internal rules and lawmakers on regulated markets.
  • Exceptions Management and NC / CAPA (Non Conformance / Corrective Action and Preventive Action)
  • Quality audits management (internal / suppliers)
  • Information management and human resource certifications (internal / external)

The MES system facilitates the implementation of operations following the procedures, specifications and best manufacturing practices, enhance the fulfillment of the actions set out by the regulations, by trained users and certified systems.

With exception handling, the MES system records the incidences at the time and in scope, requesting the impact reasons to users or to systems, proposing corrective actions, recording the effective actions performed and approving or rejecting the performance conclusions.


CIWG – Continous Improvement Working Groups

Working groups in cooperative and autonomous teams for continuous improvement consist in communication and coordination between individual executives of production and operations in a specific area to add the value of individual initiative towards collectively accepted actions, based on experience, experimentation, results, data and analysis.

Advanced tools in this area allow access to process information, direct communication within the team and sharing of progress towards the goals of continuous improvement. The coordination of activities can be carried out through integrated systems MES and EQMS.