We interview our Quality Manager at Biovac
We are living a key moment at a sociological, economic and health level. The pandemic has marked a before and after in many areas and, of course, also internally in companies.
Traceability is not just a concept that came with the pandemic, but it has been directly affected. It is a very current issue in our sector, as it helps us to measure both reliability and trust in production chains, as well as to ensure the health of users.
A traceability system is necessary. First of all, to increase reliability levels. But, in addition, it helps us to optimize, in a more appropriate way, the information for decision-making.
Today we interview Vicente, an industrial engineer and Quality Director at our company. Vicente is in charge of developing, maintaining and improving the quality system at Biovac and to achieve the correct traceability of the prosthesis coating process in our company.
Vicente Climent: Quality Manager and in charge of traceability in prosthesis coating.
What are your specific functions in the company?
As Biovac Quality Manager, my job is to ensure the maintenance of the Biovac Quality Management System. This includes all tasks related to the preparation and management of documentation related to Quality (Quality Manual, Procedures, Specifications, Work Instructions, Plans, etc.), as well as the technical documentation provided by the client.
In addition, tasks such as Purchasing and supplier management, Control and calibration of measurement and test equipment, Quality Control of the production process, issuance and preparation of technical reports and a long etcetera are an important part of the functions that as Head of Quality correspond to me.
Of course, within these tasks, ensuring traceability in all activities carried out in Biovac is essential. Maintaining traceability throughout the production process is a very important aspect for companies that work with Biovac, since at all times we have to guarantee that their own traceability is maintained, an essential requirement for implant manufacturing companies. and being able to identify the parts and the process that each of them has followed at all times, a key aspect of maintaining traceability.
Who is the public/private body in charge of auditing this process, and what documents are issued to certify it?
Our quality system meets the requirements established in international quality standards, specifically ISO 9001, of general application to all companies, and ISO 13485, of specific application to companies in the health sector.
In order to offer a guarantee to our client-companies that the Quality Management System complies with the requirements set out in said standards, our quality system is periodically carried out by a certifying company, which reviews our system and certifies adequate compliance, issuing the corresponding certificates. In our case, the certifying entity is SGS, a company of recognized international prestige in the field of Certification.
In turn, Biovac client companies, when they market the implants, have to meet the requirements established by the different regulatory bodies for medical devices, such as the Spanish Medicines Agency in Spain, or the U.S. Food and Drug Administration (FDA) in the United States. These organizations establish a whole series of requirements, including that their critical suppliers have the corresponding ISO 13485 certification, as is the case with Biovac.
From when to when does the traceability process cover the company? How many people are responsible for this process?
Traceability affects all areas and all stages of the Biovac production process. Said traceability not only affects the traceability of the products sent by the client, a fundamental part of it, but also other aspects such as raw materials, labor, production process, quality control tests, etc.
Since traceability has to be guaranteed in all the processes carried out in Biovac, the involvement of the staff is key and each and every one of them participates in it.
Our quality system establishes with a whole series of procedures and specifications how traceability is ensured. Thus, procedure PC#007 Identification and traceability establishes the general bases for compliance with traceability, but then a whole series of related procedures such as PC#001 Control of documentation and records, PC#010 Inspection and testing, IT-PC#010/1 Identification of the states of inspection and testing of materials and products, PC#013 Handling and storage, among many others, establish the provisions established to ensure the maintenance of traceability during the whole process.
What risks is it possible to trace at Biovac thanks to the traceability process?
The guarantee of traceability maintained at Biovac, allows at all times to be able to reproduce what has been the process that a part or batch of implants has followed in our facilities, throughout the entire production process.
In this way, the client is guaranteed the maximum information regarding the coating process carried out in case he requests it.
Do you consider that since COVID-19 the safety and quality parameters have increased?
The healthcare industry since before the pandemic has had very high standards related to quality assurance, as set out in the ISO 13485 standard and in the Medical Devices Directive.
What the pandemic has undoubtedly done is make visible the importance of having a healthcare industry that offers guarantees and reliability when it comes to offering solutions to problems that arise. With this idea in mind, aspects related to product quality, safety and traceability are more important than ever. That is why Biovac, with its quality system and traceability guarantee, is able to meet these expectations.
How traceability affects product quality at Biovac?
The traceability of the products is a fundamental piece within the Biovac quality system, which affects both the products and the rest of the production process, as we have previously indicated.
Taking this into account, we could not affirm that Biovac’s production processes have the quality required for our clients if their traceability is not strictly guaranteed. That is why the traceability guarantee that Biovac offers, is a great tool to demonstrate the high quality of the processes and services that we offer to our customers.
Do you need more info?
Contact Biovac and ask us any questions you may have. We will be pleased to help you.