FA Quality - Other Services

Industries are evolving rapidly, in part due to changing standards and new scientific advances. That's why, at FA-Quality, we look ahead, focused on developing ever more innovative solutions. In the meantime, we have specialized in various fields of knowledge within the industrial sector. FA-Quality offers you an extensive range of services to support you in complying with national and international standards, including:
- Document Creation and Updating
- Process Validation
- Process Capability
- Repeatability and Reproducibility (R&R)
- FMEA
- Other Services

 

 

 

Creation and elaboration of documents

Management System standards require specific documentation. The purpose and benefits of Quality Management System documentation are manifold:
It provides a clear framework of the organization's operations.
It allows for consistency of processes and a better understanding of the quality management system.
It provides evidence for the achievement of objectives and goals.

 

 

It allows for consistency of processes and a better understanding of the quality management system.

 

 

Provides evidence for the achievement of objectives and goals.

 

 

Creation and elaboration of documents

The Quality Management System documentation can be composed of different types of documents. Generally, it includes documents such as quality policy, quality manual, procedures, technical instructions, quality plans and records. The Quality Management System documentation can be represented as the hierarchy shown in the diagram:

 

ISO standards require documenting different types of information; however, not all information needs to be documented as a separate document. It is flexible for the organization to decide on the size of the documentation and the level of detail to be documented. For example, small companies may have documented procedures that can be included in the Quality Management System manual. We know that small companies generally do not have the time or qualified personnel available to produce documents. FA-Quality will prepare, for you, any type of document applicable to the Quality Management System that you desire.

  

 

Process validation

Does your company require Manufacturing Process Validation? All companies that require GMP (Good Manufacturing Practices) certification must perform process validation, as this guarantees the quality of the product for consumption. Validation is the compilation and evaluation of data collected from the process design stage to the final production, where evidence is collected to ensure that a process meets the quality required for product sales.

 

 

 

 

 

How can FA-Quality help you?

  1. Making or updating your Validation Master Plan, in a simple way, so that you can comply and follow up quickly.
  2. Developing all the required documentation (IQ, OQ, PQ Validation Protocols) to comply with the process validation and also helping you to define the control parameters.
  3. Assigning you experienced FA Quality consultants for a certain period of time or for a particular project.
  4. Giving you peace of mind that the validation complies with national and international standards.

 

Steps to follow:
 

Process Design

From design and development activities, manufacturing parameters are defined to obtain a commercial product. This step in the validation of processes is crucial because it is where different types of raw materials, packaging materials, packaging, equipment, areas, etc., can be tested to obtain the expected result.

 
 

Process Qualification

In this stage of process validation, the product design is evaluated to identify, based on data collection, whether it has a commercially reproducible behavior.
 

Continuous process verification

To maintain a constant verification of the process validation, a constant verification must be maintained during the production of the product, a routine verification is maintained to corroborate that the state of the process is controlled. One of the ways to do this is by means of process control charts.