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Our Synergy

We met some years ago at common clients premises and we started working together on  development and engineering processes.

Since the beninning we did appreciate the diverse competencies coming from past experience, and we started comparing and sharing our different viewpoints, with the aim of meet regulatory requirements while satisfying company needs.

We then decided to continue this process, making views and skills converge in a -Lean Six Sigma approach, which can provide to customers:
Development process Improvement
Support customers product engineering from the earliest stages of development, through lab and pilot scale, up to industrial scale. The goal is to meet quality requirements while minimizing development time and costs, through effective and efficient project management.
Product /process Engineering
The transition from laboratory scale to industrial production and sale is still a critical step, in particular for pharmaceutical companies. Information and requirements communication and sharing are fundamental in this process, and if not correctly designed it can be sub-optimized, and sometimes even fail.
So we work for precise user requirements definition, based on key rationals to maximize results during the industrialization phase
This step in the field of "medical devices" means supporting industrialization by optimising the logistic/production impact, with objectives of "design to ..." assembly, maintainability, cost, depending on specific needs of the individual entity and relevant market.
6 Sigma Quality
A robust IPC (In Process Control) system can assure high standards of quality and productivity. With advanced statistical tools, we are able to analyze production data and assess whether the process is actually in control. The knowledge of how process parameters impact product quality attributes also enables real time process control. This, at the base of Process Analytical Technology (PAT), allows for a considerable reduction of tests normally carried out after manufacture.
Regulatory Compliance – Quality Risk Management (QRM)
Many methodologies underlie a consistent, robust and optimized development process or industrialization. Quality Risk Management (QRM) is Fundamental among them, containing the principles to identify, assess, monitor and report the risks related to products or processes as for guideline ICHQ9, transposed as Annex20 in EudraLex Vol .4 - March 2007.
What we propose is a systematic approach to QRM for a shared and structured risk definition, thus improving the decision-making process, by communicating to Regulatory Authorities the capability of the pharmaceutical industry to respond to potential risks.
Regulatory Compliance - Design Control
In the medical devices area, before starting production for sale it is necessary to provide Regulatory with the evidence that the product has been designed following a structured process of objectives definition and test.
We support companies in implementing this system, guaranteeing, in addition to Design for Compliance, an increased probability of meeting customer requirements, while reducing time to market, costs and risk of project failure.
Regulatory Compliance - Quality by Design (QbD)
Quality by Design key concept, underlying ICH Q8 guideline on Pharmaceutical Development, is to design and build Quality within the product, instead of testing it, emphasizing product and process knowledge, improving development and minimizing costs and resources.
We support the creation and implementation of this new culture to lead to reduced regulatory costs, maximized effectiveness/efficiency and better product quality.
Production process Optimization
One of the starting points in Lean Six Sigma projects, where the production process is analyzed to realize a value stream as continuous as possible, pulled by customer demand (internal and/or final).
We support the entire process flow mapping in order to determine VA/NVA activities and tasks, and designing and implementing a new stream that guarantees both efficiency improvements and Regulatory Compliance.
Logistica
Today Businesses competitiveness is based on service level, that must guarantee the customer the availability, quantity and quality really needed, when needed!
This goes through materials management process optimization throughout the entire stream (from supplier to final market), balancing quantities and reducing overall costs.
That is to say streamline materials distribution throughout the flow, reduce stocks, smooth materials management process, and quickly improving reliability and service level.
Operational objective is to decrease warehouses value, improve inventory rotation (shelf life guarantee) and increase presence on "patient" without adversely impact distribution.
Supply chain (screening - optimization)
We support companies in the identification and selection of products and services suppliers, using tools to define their effectiveness, efficiency and quality levels, providing the solution that best suits customer needs.
Experience in project risk management also allows careful management of processes and project steps to optimize resources, timeliness and related costs, the primary keys to project sustainability and success.
Experience in supply chains analysis and re-design ensures effective management by combining flexibility, safety and cost reduction, within a continuous improvement approach.
Lean to Compliance
A quality product is the output of a quality process, in all its aspects. The first Lean Six Sigma principle focus on customer value: regulators are a major customer of the pharmaceutical world, a milestone to bring quality to the end user. Our approach aims to build “Door to Door” quality through continuous analysis and standardization, because lean, clear and shared processes allow to proactively highlight potential deviations, and systematically manage them: compliance by design.
LAB Lean Six Sigma
The objective is to bring in the physical, chemical, microbiological or metrological lab a management system incorporating  Lean Six Sigma principles; a laboratory that :
·         provides value service (without waste) to internal and external customer, because it knows its own processes and tools to continuously improve, simplify and standardize them
·         uses Lean Six Sigma tools to control variability
·         monitors and continually improves its performances through team work and effective interaction with other business processes