P1_M01_Manuel Qualité FR - V5 20200327.pdf

Quality policy and goals of our quality assurance strategy:

The BRC IGE-PCV (Biological resource center for gene x environment interactions in cardiovascular pathophysiology) is considering the implementation of a quality assurance strategy. The quality manuel can be downloaded below.

The main goal of such a strategy would be to improve current procedures for compliance with BRC requirements (premises, sample storage, monitoring of lab equipment (processing and storage), database management and sample/data traceability) in order to provide the best possible conditions for sharing the center's resources.

General logistics

The collections covered by our quality assurance project are currently located at the EA_1122; IGE-PCV unit (University of Lorraine).

Quality management system (QMS)

The quality management system is based on seven main processes:

• Reception: process intended to manage the receipt of samples at the unit following delivery of the packages to the University of Lorraine. This process is intended to monitor the receipt of samples.
• Preparation: process consisting of several sub-processes depending on how the sample is to be treated (EDTA, Heparinate, etc.).
• Storage: process intended to ensure proper storage and continuously monitor sample storage conditions.
• Order Management:  process intended to manage inventories and orders.
• Distribution: process intended to ensure that samples and data are provided according to quality requirements.
• Data management process.
• Biobank management: process intended to ensure the traceability of samples and related data.

The schema below shows the relationships between the different processes.

It should be noted that each process incorporates several procedures and acts as a reference for the main tasks, such as receipt and sample preparation, etc. A series of documents and records, mentioned in the specifications for each process, give detailed descriptions of these tasks.

• Chief scientific officer:

The chief scientific officer acts as project leader and is accountable to the bodies that fund the BRC. For information, the BRC was founded by INSERM in 2002 and is directed by Sophie Visvikis-Siest. It received funding from the ANR-CEBS (2006) after application by Sophie Visvikis-Siest.

• ROLE

The chief scientific officer:

• provides governance and oversight for the BRC by implementing the quality and scientific policies approved by the board of directors,
• sets forth operational quality goals that are consistent with both the quality and scientific policies,
• informs the board of directors of progress at the BRC by means of an annual report,
• informs the scientific council of annual activities and submits any project proposals that require the council's approval,
• is responsible for ensuring that all BRC staff understand the importance of meeting the requirements of interested parties (in particular partner organizations, donors, investigators, depositors and collection users),
• appoints the BRC quality manager,

• coordinates BRC activities in order to optimize use of the collections.

The quality manager:

APPOINTMENT

The quality manager is appointed by the chief scientific officer of BRC.

ROLE

The quality manager:

• is responsible for implementing and monitoring the quality policy,
• must submit any proposals for improvement to the chief scientific officer of BRC,
• promotes awareness among staff in order to satisfy both internal requirements and the requirements of interested parties (donors, investigators, users and other partners). 

The quality advisor:

APPOINTMENT

The quality advisor is appointed by the chief scientific officer of BRC.

ROLE

• monitors that the quality policy is implemented according to planned standards,
• reports to the chief scientific officer of BRC.