What is the MDSAP program?
In Singapore in 2012, the International Medical Device Regulators Forum (IMDRF) began development of a Medical Device Single Audit Program (MDSAP). MDSAP allows approved auditing organizations to conduct a single regulatory audit of a medical device manufacturer. This single audit expands the scope of the audit to previously unaudited areas of large organizations, standardizes a consistent auditing model, and replaces as many as five separate . It also satisfies the regulatory requirements of the authorities participating in the program – even ISO 13485:2016. MDSAP focuses on defined and linked processes and is based on requirements for risk management. The goals of MDSAP are:
- to improve audit effectiveness and the influence the audit can have on outcomes that improve patient safety, and
- to reduce the resource demands on both regulatory bodies and auditees in organizations having to comply with a variety of global standards and .
The core processes in scope for the MDSAP audit include:
- Measurement, Analysis and Improvement
- Design and Development
- Production and Service Controls
MDSAP also extends to the critical supporting activities that directly impact public safety, including: Device marketing Authorization and Facility Registration and Medical Device Adverse Events and Advisory Notices Reporting. Organizations can work with an authorized Auditing Organization (AO) to perform the single Quality Management System (QMS) audit and address the requirements of all participating regulatory bodies.
Currently, MDSAP includes the following regulatory jurisdictions and agencies:
- Australia: Therapeutic Goods Administration or TGA (TG(MD)R Sch3)
- Brazil: Agência Nacional de Vigilância Sanitária or ANVISA (RDC ANVISA 16/2013)
- Canada: Health Canada or HC
- Japan: Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency or MHLW/PMDA (MHLW Ministerial Ordinance No. 169)
- United States: Food & Drug Administration or FDA (Quality System Regulation 21 CFR Part 820)
Notable observers in MDSAP include the World Health Organization (WHO), Medicines and Healthcare Products Regulatory Agency (MHRA), and Health Products Regulatory Agency (HPRA).
The IMDRF conducted a three-year pilot project from January 1, 2014 to December 31, 2016 to assess the viability of MDSAP globally. The findings from that project are available on the FDA website. These findings demonstrate that the MDSAP initiative is a viable one and that it has the support it needs to improve patient safety.
3 Ways MDSAP Improves Audit Effectiveness:
1. Improved Product Quality and Patient Safety
Prior to MDSAP, multi-national corporations or organizations sometimes overlooked parts of their businesses for auditing simply because the business was too large to account for every area. Since they can’t audit everything, these organizations perform audits on a sample basis, so it’s critical that audits verify that processes work as expected and that the QMS is performing up to expectations while satisfying regulatory and customer requirements. With MDSAP, the increase in available resources and capacity among the shared global regulatory agencies enables them to audit previously untouched areas of the business and provides the additional scrutiny needed to ensure that independent third party assessments improve product quality and patient safety. Audits now penetrate more deeply into an organization while following the defined audit model and audit sequence. This helps organizations uncover hidden connections between processes, such as those between the measurement, analysis and improvement processes of Medical Device Adverse Events and the reporting processes of Advisory Notices.
2. Standardized Audits
The MDSAP audit model ensure consistency in the processes that will be assessed, evaluation of linkages between processes, and expectations for both auditors and auditees. The specific audit sequence, supporting guides, and checklists help to remove ambiguity in the process and ultimately save time during preparation, planning, and execution phases of the audit. This also ensures that everyone across a variety of organizations can incorporate and incrementally improve upon industry best practices as they use the tools. As an example, the FDA’s MDSAP QMS Implementation Assessment checklist is available for any organization to use. Proven and templated tools like this go a long way in helping organizations achieve the MDSAP goals of reducing risk associated with patient safety, improving QMS effectiveness, and making better use of auditor and auditee resources.
3. Improved Resource Management
Harmonization of the requirements across 5 regulatory agencies is no small feat. As such, MDSAP is a significant advance in auditing as a general practice. The audit model allows medical device manufacturers to undergo a single regulatory audit rather than 5 separate audits, depending on the geographic regions in which they operate. Just think of all the work involved in preparing for and responding to an audit and multiply that effort by a factor of five! Now think of the savings in effort and cost in going from five audits performed by different global agencies to a single standardized audit. The significant reduction in business disruption for both authorized Auditing Organizations (AO) and auditees brings lasting benefits to medical device manufacturers around the world. Thanks to MDSAP, organizations will only need to go through a single audit at recurring review periods.
Lessons Learned and Additional Applications
Lessons learned from MDSAP can help in other audit intensive processes such as Layered Process Audits in the automotive industry, where there is a focus on standardization of audit activities across the organization. The MDSAP model could also potentially help in other audit activities such as supplier audits, internal audits, and even dock audits.
For the medical device manufacturing sector, the benefits of the MDSAP audit model is clear. What about in other industries? Could a similar approach be applied as part of your audit program planning? Is there an opportunity for you to consolidate internal audits to help maximize the impact of your process outputs? Is there a way we can develop de facto standard modelss and templates by industry to help free up resources for both auditors and auditees? These best practices would help suppliers become more effective and to focus on what matters most – delivering products and services for their end customers. To learn more about why life sciences organizations are transitioning to cloud QMS and how INTELEX can assist your Quality department with its digital transformation initiatives, view our on-demand webinar with Glemser Technologies Inc.