Quality and Compliance in the Productive Process Management

Quality management

Quality and Compliance in the Productive Process Management

Ensure Quality and Safety in the production environment, also identifying problems caused by the use of items purchased from suppliers. This Suite serves the monitoring and control of PRPs, OPRPs and PCCs, evaluations and internal audits, treatment of nonconformities and improvement projects (Kaizen or DMAIC).

Quality Management Processes of the Life Sciences Industry

  • Control and monitoring of PRPs, OPRPs e CCPs

    Monitor and control all elements of the prerequisite programs and critical control points required to ensure the safety of the production process, minimizing or eliminating the risk of contamination.

  • Inspection in manufacturing and finished product

    Control products in manufacturing and final inspection, through sampling tables (parameterizable), skip lot, control plans, automatically generating the Performance Indicators (PPM) and notices of non-conformity internally.

  • Assessment/Audits

    Apply and manage audits and evaluations carried out in the internal processes and also in the suppliers of services, products, raw materials and packaging. Control of results and upcoming audits. Follow-up actions.

  • Non conformities

    The main objective of the Nonconformities module is to identify and completely eliminate all existing Non-Conformities, minimizing undesirable situations with the application of Corrective Actions and Preventive Actions, always focusing on the Continuous Improvement of activities. The module directs users to a methodology for solving nonconformities, according to the method applied by the company, being: 8D, 5PB’s, Ishikawa Fish Diagram, among others, these methods being established according to the customer’s preferences.

  • Capacitation Management

    The Training Management module manages employee training to ensure that your workforce has the knowledge and qualification to meet your responsibilities. Acting integrated to the other SIQ modules, it allows the identification of employees and the management of their responsibilities, authorities, training and certification requirements for the processes where it operates through access control, thus helping to maintain GMP’s.

  • SPC

    Statistical Process Control (SPC) is a tool that applies statistical methods to actions to prevent nonconformities, improve the quality of products and processes, and reduce costs and waste. The SPC establishes easy tracking of statistical information, detection of causes of instabilities in the processes, taking of corrective and preventive actions and reports.

  • Asset Management, Tooling and Measuring Equipment:

    The purpose of this module is to control all existing assets, tools and measurement equipment in the company, offering greater reliability and agility in the use of information and providing managers with better planning of CAPEX and OPEX:

    • Assets:monitoring and tracking of assets and their activities throughout their useful life, informing the need to carry out routine, preventive and / or corrective maintenance. You can control all asset-related documentation centrally, improving the visibility of information by the people in the organization.
    • Tooling: tooling control, mainly the values of these assets, their location, useful life and technical conditions, which allows a better budget planning for the next periods, taking into account the item’s demand and tool construction time.
    • Measurement equipment: it provides managers with a complete history of all equipment calibration information, including the date of last calibration, previous calibrations, as well as dates of maintenance and repairs.

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