Every organization within a regulated area has identified a set of QA tools, which support the organization layout and the business area where it operates. Some of these QA tools are specific for the organization, some QA Tools are common for the business area and others are more common.
Within the medical devices business area, the minimum required tools are defined in legislations (i.e. FDA 21CFR820) or international standards (i.e. ISO 13485). Examples of general tools are Non-conformity Handling and Reporting (NCH/NCR), Corrective and Preventive Actions (CAPA), Complaint Handling, Vigilance, Validation, Risk Management etc.
Audit
Today there is, in regulated businesses, an increased pressure to demonstrated compliance with current quality regulations, standards and best practice. One of the key tools in doing this is a robust internal audit and audit management system. This should cover both the internal audit process and planning, as well systems for handling external audits and inspection. This requires sufficient internal auditors and audit specialists.
Madsen Quality Consulting can support you both as an internal auditor, audit planning and maintaining your internal audit system. Especially if you need an independent person to audit the quality function and top management. We can also support you in the external audit process whether this is in setting up the audit, during the audit itself or after audit activities.
Non-conformity Handling and Reporting (NCH/NCR)
All organizations experience variations in manufacturing processes, raw materials, human behavior or even their work processes. This will eventually lead to products or processes which do not meet requirements. All major medical device regulations and standards require organizations to have documented procedures for handling these non-conformities. Non-conformities (NC), non-conformity handling (NCH) and non-conformity reporting (NCR) are thus central tools in all quality management systems.
At Madsen Quality Consulting we have long experience in working with NC and NCR. We can be the extra resource if you have more NC’s than normal, needs to get a backlog cleared or have a more complex NC. We can also support you on data analysis and system improvement.
Corrective and Preventive actions (CAPA)
One of the core concepts in modern quality management is that problems must be investigated, solved and prevented in a structured manner. Likewise, should continue improvements be a core part of the system. The main tool in doing this is Corrective and Preventive actions (CAPA). Including CAPA into the Quality Management System (QMS) is core for being in FDA and EU-MDR compliance.
Implementing and running a well-functioning CAPA system requires both resources and experience. AT Madsen Quality Consulting we have long experience working with CAPA and CAPA systems. We can support you in both implementing and improving your system. We can also be your extra resource at a time, where the CAPA system demands more manpower than normal.
Complaint and Vigilance systems
Complaint handling is one of the most complex QA systems in any regulated Quality Management System, and Medical Devices are no exception. Complaints can be caused by device malfunction, software not performing as expected, manufacturing variations, user not understanding the product or even maluses.
FDA has historically had a focus on complaint handling. Especially through investigations of all complaints. The EU has with the MDR put a special focus on the complaint chain from distributor over importer to manufacturer. The MDSAP program has also enhanced the focus on complaints. Likewise, there has been an increasing focus on the vigilance systems. This both in terms of when to inform the authorities, how to inform and the amount of information if anything goes wrong.
Madsen Quality Consulting can support you in improving and streamlining the complaint system, handling complex complaints and in worst case support the vigilance process. We can also support you on using the complaint and vigilance data in your Post Market Surveillance (PMS) system.