Serving customers with excellence, with products and services that exceed their expectations, is certainly at the top of any entrepreneur’s list of priorities. This is what reinforces the positioning of brands in the minds of their consumers and maintains business, towards the growth, conquest and expansion of markets.
Many are the processes behind the manufacture of products, mainly in the area of Life Science. All procedures, from product idealization, manufacturing and delivery, must follow a number of stringent regulatory agency requirements – for example, from Anvisa to pharmaceutical manufacturers.
When a company has a “quality team”, it is ensuring that all its manufacturing processes are in full compliance with industry standards and that its products are produced and delivered, without failures or risks to its users.
Benefits of a multidisciplinary quality team
A quality team, composed of experts with multiple skills and experiences in key areas of the business, brings great gains to the organization as a whole and its consumers.
The performance of these professionals together, in favor of the quality of the processes, brings greater visibility into the challenges and risks that may exist in the processes of product development and manufacturing. More than that, with the joint collaboration of these professionals it is possible not only to find the root cause of the gaps, but also to solve them immediately or prevent them, before they happen through the implementation of quality standards.
All this, combined with the use of state-of-the-art technologies, which automate and accelerate quality management processes. Among them, bug tracking and test management tools are among the main technologies that can be used by the quality team, aiming at reducing costs and risks in manufacturing.
Next, we will score some recommended areas of quality to make up the quality team of an industry (pharmaceutical, cosmetic, veterinary, sanitize, food, etc.) so that the daily routine, operations and continuous improvement projects succeed:
Quality assurance:
- Technical Manager: This professional can be part of any quality or regulatory area, being commonly found as part of the QA area. The responsible technical pharmacist is responsible for releasing the products in the industry, as well as verifying that tudo está correndo em compliance em todas as frentes e operations that may compromise the quality of the product or consumer health.
- QA Supervisor/Coordinator: This leader must provide the resources and directions necessary to conduct the activities of analysts. Because he has a systemic vision, he is the one who allocates quality professionals to ensure the expected results of QMS, as well as in the monitoring of inspections and direction in the realization of continuous improvement.
- Senior Quality Analyst: more experienced analyst, who can contribute relevant knowledge about qualifications and validations, besides having the skills to perform a leadership position in the team in the absence of the supervisor/coordinator.
- Full quality analysts: this professional can perform his/her role and contributing to the team with vital work, such as: procedure management, supplier qualification, equipment qualification, validations (process, cleaning, systems and transportation) thus avoiding deviations and rework.
- Junior Quality Analyst: The junior analyst is a professional beginner in this area, but it is of paramount importance for data acquisition. He is responsible for assisting other analysts in the conference and monitoring of processes, distribution of procedures of manufacturing processes, organization of documentation, etc.
Quality Control:
Supervisor/Coordinator by laboratory: with the new RDC 512/2021, it becomes necessary to have a technical responsible in the laboratory with a decision-making power over the processes. This leader must organize laboratory routines, as well as direct analysts according to the necessary release and compliance demands to be met. The challenge is to meet the various fronts such as: Raw Material Analysis, Analysis of Plant Water Points, Analysis of Intermediate Products (Products in Process) and Batch Release Analysis. Remembering that when we mention laboratory, we should consider all fronts: physical-chemical, microbiological, process control and quality control of packaging.
- Senior QC Analyst: Lab verification, has the decision-making power over procedures, and in the event of lack of an RT or quality manager, he is the most apt to replace them.
- Full QC analysts: The number of analysts needed for a good progress of the processes can vary according to the amount of products being analyzed, a full analyst has the responsibility of performing the necessary procedures.
- Junior QC Analyst: The junior analyst is a professional beginner in this laboratory area, but it is of paramount importance for the preparation of equipment and materials before the other full/senior analysts start the work. It is fundamental to the laboratory is responsible for assisting in conducting preparations that the laboratory, both to gain agility in the analysis, as well as ensure compliance of data. Some of its functions are: preparation of scales, sampling of products, preparation and solutions, in addition to the preparation of equipment before the start of analysis such as dissobeters, HPLC, greenhouses, etc.
Remember, it is always important to have more than one analyst in the quality sector of your company, because it is always necessary to review procedures and processes, without conflicts of interest, according to the various laws of the areas of Life Science regulated by Anvisa / MAPA.
Constant training of professionals
To ensure an updated QMS, regulatory agencies (Anvisa, MAPA, Inmetro…) and the market constantly announce new standards and updates related to industry regulation, requiring continuous improvements in addition to procedures to ensure compliance.
Therefore, frequent training of the quality team is fundamental, so that professionals are able to carry out the processes according to the latest market requirements.
Constant reviews and quality testing, through the use of innovative features, can generate consistent manufacturing insights and data for the quality team, which needs criticality to analyze and use them to promote continuous improvements in operations.
We have experts ready from the quality area to help your company
Now that you know some of the benefits of having a multidisciplinary quality team for your business, know that we at Kivalita Consulting can help your company structure a team of multidisciplinary professionals in this area, including analysis and extensive mapping of product manufacturing processes focused on quality management.
Kvalita Consulting has been working for years in the area of quality management and technology validation for companies in the area of Life Science. We have extensive knowledge in this field and, therefore, we are always able to help companies and manufacturers of products, to overcome the challenges related to this theme.
Talk to us and learn more!