This suite covers the entire part of the laws and regulations as well as the dealings of change management, through the evaluations, audits and documents, with the consequent preventive and corrective actions when necessary. All the analyzed causes of these non-conformities are performed in this suite through consecrated methodologies or specific to the customer.
Compliance Suite – SIQ Systems Laws and Regulations Management Is composed by the following modules:
Internal Controls such as standards, procedures, fact sheets, drawings, work instructions, preventive maintenance, security, others, and can be used locally or corporately within the company. External controls (suppliers of products and services) such as: Standards, Procedures, Good Manufacturing Practices – GMP, Certifications, Licenses, Contracts and other documents according to the quality policy of the company. Most common examples: ISO 20000, Hazard Analysis and Critical Control Points (HACCP), Environmental Licenses, Operating License, Production License, Supply Contracts, Licenses of public agencies such as Federal Police, Military Police, IBAMA.
Legislation and Regulatory Requirements Evaluation/ Audit
Apply and manage audits performed 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. Example of audits: Production Process / Self-Assessment / Quality System / Environmental Audits / Price Level / Negotiation Flexibility / Communication / ISO 22000 / Risk Analysis and Critical Control Points / others.
Corrective and Preventive Actions (CAPA)
To manage the process of solving problems and non-conformities detected in the audit and / or evaluations, through methods such as 8D, 5PB’s, among others, where the nonconformity generator itself responds to the phases of the applied method, drastically reducing the workload of the Quality area of the company.
The Change Management module allows a structured approach, ensuring compliance and ensuring a seamless and integrated implementation of the changes. It is designed to manage every aspect of the change management process from its initial request, which can come from the customer, the supplier or an internal member of the company. Through a thorough record of all stages of change, it identifies the affected documents, planned projects, and action plans, triggering the appropriate individuals for approval, and monitoring all associated activities until the full implementation of the approved changes. It also allows you to execute changes in parallel, making them to be executed faster.
Quality Competitive Intelligence. PPM, Average, Standard Deviation, Dispersion, Failure Trends, IDF, Audit Grades. Pareto Charts, Trends and management reports.