Orcanos e-QMS 4.0 – The new MRB process, getting it all in one place, how it works!?

Rami.Azulay November 10th, 2018 Posted by Rami Azulay( ) Requirements Management Tool

The Orcanos e-QMS Material Review Board (MRB) software module within the Orcanos e-QMS and manufacturing software enables you to electronically document, manage and track discrepancies with materials, whether it is raw materials, work in process or finished goods. MRB (plural MRBs) (manufacturing) Initialism of Material Review Board, a system of recorded investigative checks done on failed components or processes to improve quality.

Together with the MRB, there is another process that needs to be discussed which is the RMA. RMA is Return Material Authorization; it means you are being authorized to return the material back to the supplier. The reason you need an RMA is when it reaches the receiving department of the supplier then they don’t know what to do with it. This gives you the paper trail you need to be able to do the credits. Orcanos e-QMS system allows you to define the RMA and to give you an electronic form to manage the process, at any point of time you can export this RMA form to other format and to send it out to your supplier together with Orcanos e-Signature system according to the CFR 21 Part 11 regulation requirements. While the MRB could be something which you get from your supplier which you think is of suspect quality. Isolate it so that you can review it, look at it and figure out what to do with that.

Here is an example that will illustrate the flow between processes and documentation. Customer reports a problem into Orcanos Service Call center and issues a complaint form (according to the ISO 13485 Sec. 8.2). The analysis of the complaint results in two decisions, one that there is a RISK (according to the ISO 14971) to be handled and second that there is a need for a CAPA. The RISK assessment that will result in additional actions that all are addressed by Orcnoas RISK management (RMF) system the other activity around the CAPA will result in 3 types of actions. The corrective action (CA) which may direct to some immediate action items such as training, supply chain etc. The preventive action (PA) may result in an MRB process which will create additional action all documented electronically inside Orcanos e-QMS system. The 3rd type of action shall be the effective action which will measure the effectiveness of the PA/CA actions on the forecast of such event to occur again.

Here is one   example how the MRB get into action:

MRB

Orcanos e-QMS, MRB example:

MRB Form

The new Orcanos e-QMS edition 4.0 now includes the MRB as part of the system templates and allows you to start working with it immediately.

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About the author, Rami Azulay

Rami has over 20 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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