MDSAP stands for Medical Device Single Audit Program. It was a program that was created as an alternative to FDA auditing in conjunction with international regulators. With MDSAP, there is an opportunity to participate in international auditing for five different countries. The countries include Australia, Canada, Brazil, the US, and Japan. As it relates to the current COVID-19 crisis, the MDSAP can allow you to navigate your operation between regions and prepare your recovery to a full operation based on the recovery of countries you have participated in.
The MDSAP helps to fulfill the role of providing a single regulatory audit for all medical device manufacturers’ quality management systems. Also, the MDSAP meets all the laws and regulations required in several international jurisdictions. With the MDSAP companies can develop acceptable audits by FDA standard and reduce the number of auditory inspections and expedite the recovery of your manufacturing in the sequence of the recovery of your MDSAP covered regions.
It is crucial to note that only recognized organizations can conduct the MDSAP. Likewise, manufacturing companies can choose to voluntarily join the MDSAP pilot program. The program aims to be recognized internationally for participating countries. The pilot program kicked-off in 2014 and concluded in 2016. More detail about the MDSAP pilot program will be highlighted in this series.
It is no secret that international regulators have been seeking a standardized global approach to the monitoring and auditing of medical device manufacturing companies. In the last ten years, the community of international regulations has taken significant steps to build a sustainable framework. Leveraging works from previous organizations like the Global Harmonization Task Force, the International Medical Device Regulators Forum (IMDRF) have spearheaded the efforts in the creation of this framework. As a result, they were able to develop explicit criteria for MDSAP.
The people/parties responsible for the creation of MDSAP and MDSAP pilot include;
MDSAP is the fruit of over 10 years of planning by International regulators responsible for the IMDRF. The IMDRF is a group of voluntary medical device regulators from various parts of the world. They often gather to discuss the future and plans for medical device regulatory convergence and harmonization.
The IMDRF also discuss the following subjects when they convene;
In February 2011, the International Medical Device Regulation Forum (IMDRF) was born. Similar to other international regulatory groups, IMDRF recognizes the impact of having a global approach for auditing and overseeing medical device manufacturers. With a global approach, they could enhance both oversight and safety on an international scale.
The first meeting of the IMDRF took place in Singapore in 2012. During the meeting, the group selected a workgroup with the sole purpose of developing documents for a single audit of the program. The single audit program is the MDSAP and as a result, they launched the MDSAP pilot study.
The IMDRF workgroup made sure that MDSAP had documents that cover the following;
The purpose of the MDSAP Pilot is as follows;
Between the periods of January 1st, 2014 to December 31st, 2016, the FDA and other participating international regulators were part of the Medical Device Single-Audit Program Pilot. A report detailing the outcome of various perspectives, criteria, and proof-of-concept, to establish the viability of the MDSAP Pilot Program. The report was released on June 29th, 2017. The outlined outcomes were based on the foundational data gathered during the three-year pilot phase.
The final outcomes are as follows;
In 2012, the IMDRF launched the Medical Device Quality Audit Program. The goal of this initiative to pool resources together and ensure the safety of medical devices sold to the customers. The IMDRF put up a working group to cater to the details of the program. The MDSAP program has its foundations in various international standards and procedures. Some of which include;
Based on these foundations Orcanos creates a state of the art eQMS platform that handles all product lifecycle stages in one single system. Just as the single auditing system impacts the acceleration of innovation, the Orcanos single processing system is able to integrate natively with the Design Control, Quality, Regulation, and Manufacturing.
|MDSAP Series of Articles Overview||Support during the COVID-19 pandemic|
The purpose of this MDSAP series of articles is to examine the process of preparing and applying for the Medical Single Audit Program (MDSAP). The series is outlined in a way that benefits any medical device company that is planning to join or just joined the MDSAP program. Additional benefits include an overview of the program and links to more resources on certain topics.
The purpose of this series of articles is to help medical device companies understand the following;
The learning objectives of this series of articles are as follows;
The MDSAP series of articles is for people in the Life Science industry that are responsible for quality assurance, quality control, or the implementation of a quality management system in accordance with ISO 13485 2016, and preparing for is an MDSAP audit. Below is a glossary of terms you are likely to encounter in this series of articles.
As well as global operation companies who may need to move some operations across sites under the same single audit program.
ANVISA: Agencia Nacional de Vigilancia Sanitaria (Brazil)
AO: Auditing organization
CMDCAS: Canadian Medical Devices Conformity Assessment System
CRO: Contract Research Organization
DUNS: Data Universal Numbering System
EU: European Union
FDA: Food and Drugs Administration (USA)
GHTF: Global Harmonization Task Force on Medical Devices
IMDRF: International Medical Device Regulators Forum
IVD: In-Vitro Diagnostics
MAH: Marketing Authorization Holder (Japan)
MDAP: Medical Device Application Procedure
MDSAP: Medical Device Single Audit Program
MHLW/PMDA: Ministry of Health Labor and Welfare/ Pharmaceuticals and Medical Devices Agency (Japan)
PMA: Pre-Market Approval
eQMS: Electronic Quality Management System
QSIT: FDA Quality System Inspection Technique
RAC: Regulatory Authority Council
SME: Subject Matter Experts
TGA: Therapeutic Goods Administration (Australia)
UDI: Unique Device Identification
ALM: Application Life Cycle Management (SDLC) – Design Control
WHO: World Health Organization
Orcanos: Design Control and Quality Cloud Platform
There are 6 modules in the MDSAP series of articles. They are;
To get started, we will be going over modules 1 and 2.
Please stay tuned and follow our next articles on this series INTRODUCTION TO MDSAP.
|INTRODUCTION TO MDSAP||Coming Soon|
The coronavirus pandemic has shuttered schools, canceled major events, disrupted travel, and interrupted many business services we take for granted. Orcanos is working tirelessly to provide all the support and resources we can to help our global customers during this difficult time.
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1 Remote Working
The coronavirus pandemic has transformed many organizations into fully remote operations, but managing the change isn’t always easy. We’re here to help. Orcanos gives the ability to collaborate using the devices you already have, providing a comprehensive resource for anyone working from home.
2 Compliance & Governance
Many quality personal are scrambling to move their audit online as their offices around the world temporarily shut down. We’re making sure quality and regulation engineers, production line, customer service, and employees around the world can spin up remote quality events, participate in online design reviews, and successfully use Orcanos for e-signator approval.
Orcanos is helping by lifting the 40-minute training sessions on customers affected by the coronavirus
Already 5 years ago someone tried to spread this idea that our current efforts are not pointing to the right place. He is talking about many important things, there is no one solution for all but it was easy to identify some pitfall on our current state. For over 15 years Orcanos is building solutions around collaboration and speeding up the data process among teams and external organizations. It was already said one of the blockers to the cancer disease if the knowledge that is captured by the paper that can not be processed or analyzed or transferred.
Orcnanos paperless system for both R&D and QMS is just part of the overall solution needed for the fast transfer of data and knowledge between different regulatory bodies and medical device vendors. Our solution already operating in large enterprises such as GE, J&J, and Medtronics as well on many other SMB’s helping them to collaborate across continentals and groups.
It is time to concentrate on the right infrastructure of your organization and equip your team with cloud base tools that are easily accessed to streamline your data.
In this post, we will be sharing the basic information that you as a medical device manufacturer should know about Failure Mode and Effect Analysis (FMEA).
What is FMEA?
FMEA stands for Failure Mode and Effect Analysis. One can describe as a continuous quality process that helps to identify potential manufacturing and design errors. Furthermore, FMEA helps to determine the effects of these errors before they actually happen. As a result, if a medical device company suspects vulnerability in their system or process, FMEA is an inductive and proactive way to logically get to the root cause of the problem and develop solutions. In simple terms, it is a way to estimate what could go wrong and develop a prevention plan. FMEA can be simplified as follows;
Failure Mode: The stage of contemplating what is wrong with a product? Or how a processor device can fail?
Effect: What will be the result of the failure in the product or process? How would it impact a patient, the company and overall performance?
Analyze: Discover the root cause of the failure as well as the chances of it occurring before there is an actual incident.
Firstly, below are the 9 major advantages of a comprehensive FMEA.
Advantages of FMEA
In several industries, one of the most efficient ways to analyze reliability problems in the early stage of product development is through FMEA. Due to FMEA, manufacturers can act proactively toward reducing or removing potential failure.
One of the tools that the FDA endorses to help manufacturers deal will medication errors is FMEA. It is worth noting that prevention is always better than cure.
The Origins of FMEA
We can trace the history of FMEA back to NASA in the 60s when the organization was concerned about the safety and reliability of space program hardware. Since that time, any industries with a reputation for high-cost or high-risk makes use of FMEA. As of today, the FMEA method is commonly used in the medical device and pharmaceutical industries.
FMEA method is an effective way to identify potential errors, failures and problems in the design, systems, processes and service before customer consumption. Making it easier to implement and document corrective actions. In the ICH Quality Rick Management Q9 guide, FMEA is the primary tool listed for Quality Risk Assessment.
The ICH Quality Risk Management Q9 Guide
According to Section 1.12 of the ICH manual, FMEA is;
In determining the use of FMEA, it is possible to use FMEA to prioritize risks, while monitoring the effects of various control measures. Likewise, it can be used in various equipment and manufacturing facilities. Similarly, it can be used to pinpoint high risk and critical requirements in various system and process development cycles.
The relative risk score is the output of an FMEA process and it is used to rank various failure modes by their potential risk threat.
Application of FMEA in the Pharmaceutical Industry
The most popular risk management methodological term is FMEA. As a result, it features in numerous instances. For example;
What can FMEA do for you?
Below are some of the benefits of applying the FMEA method in your manufacturing processes;
Therefore, we can summarize that effective FMEA helps to enhance the safety, quality, and reliability of a developmental process. In doing so, the company will be able to save time and money while ensuring customer satisfaction.
So, with FMEA, you can create time to handle other pressing activities while saving cost and time on risk management.
When to Perform FMEA?
FMEA can be conducted at the following times;
Therefore, make it a rule to systematically and periodically perform FMEA throughout the life cycle of a system, design or product. That way, there is a way to track updates, improvements and threats to the process. It is crucial to deal with RISK NOW rather than face FAILURE later.
What does it take to succeed in the Automotive Industry? Well, the majority of the stakeholders in the industry agree that success comes with product quality. It is hard to argue the impact that product quality plays in automotive success. Likewise, evidence from surveys shows that when it comes to success and profitability in the world of automotive. Product Quality ranks above other factors.
The Industry Demands Product Excellence Ask people in the Automotive industry what leads to success and you’ll hear that product quality has a major impact. As you might expect, survey respondents report product quality as a profitability and success driver more frequently than any other factor.
But innovation reported as a profitability driver more frequently by Automotive companies than any other industry in our survey isn’t far behind. Perhaps this isn’t surprising given the major changes facing the industry.
The top success factors – quality, innovation, reliability, performance, and cost – are all related to product excellence. But today’s dynamic market also demands agility. In fact, OEM’s were almost twice as likely as suppliers to report time-to-market as a critical success driver.
The ALM & QMS, Together, Delivers Product Excellence and Agility Our research shows that an effective ALM & QMS can help improve all of these factors. These platforms, incorporating engineering tools (ALM) and QMS capabilities, are proven to drive better product development results. The cloud is reducing the barriers between these ALM & QMS solutions and provides benefits in multiple dimensions, including affordability, flexibility, and agility. We explore these further in the research.
Most Important Factors to Automotive Industry Success & Profitability
If you are looking to leverage on the factors that will drive your company to success. Reach out to us at Orcanos and we will show you how to enhance your product while reducing the cost. After working with us, you can be sure that you will be a symbol of innovation in the automotive market.
Product Innovation Platforms
ALM & QMS Innovation Platform
According to an industry survey, we can define Application and Quality Innovation and Manufacturing Software as a software to support product lifecycle covering the following;
Evolution of ALM & QMS Innovation Platforms
It is crucial to understand the development and growth of ALM & QMS solution before exploring cloud opportunities. Thanks to engineering solutions, companies can design innovative products. Also, it is possible to simulate and model manufacturing methods, new materials, systems and any other factor that will aid product prediction and behavioral analysis. Not less important is our we asses those impacts and translate them into the RISK management system and prediction of possible results if we do not address them correctly.
To support programs, products, and processes, automotive engineering tools are fused with process management solutions and data. With the aid of Orcanos ALM and QMS tools, companies can analyze various support systems on their product from the idea stage to launch.
The Demand for Digital Enterprise
The demand for digital transformation in the manufacturing sector continues to grow. As a result, solutions need to have model-based systems, data-driven design, and integrated engineering. Similarly, it is crucial that there is overall support in the digital community to embrace various engineering fields so they can collaborate to building a cohesive model when it comes to design. Furthermore, there has to be secure collaboration on all domains in real-time, anytime and anywhere.
Orcanos ALM and QMS offer a more comprehensive digital solution and solution. It eliminates the problems with the file-base systems and comes with a cloud package.
Requirements traceability from the cradle to the grave is the key to quality in our development of medical device systems. Orcanos gives us this tracking ability and provides us with high flexibility, comprehensive reports along with good office integration. This enables us to implement our workflow effectively.
With Orcanos, we have one tool that supports our way of working and gives good visibility to our KPI’s and internal operational status. We now have a tool that can be customized to exactly our requirements and provides quality feed-back, making regulatory submission more integrated and streamlined.
Jason Reece, CTO of Genomtec
Do not know what methods can be used for Risk Management? Below is the list of methods widely used for risk management provided by the ISO 14971, ICH Q9, ASPICE Management Process.5, ISO 26262 guideline for quality risk management.
Preliminary Hazard Analysis (PHA): This is the first trial in a system safety process. This method is applied to categorize and determine dangers/hazards, related to the operation of a proposed procedure or system
These methods can be used:
Basic Risk Management methods: This method is widely used to hasten decisions in failed investigations and Root Cause Analysis.
The features of Basic Risk Management methods are listed below:
Hazard Analysis and Critical Control (HACCP): It is a systematic process whereby food is protected from chemical, physical, and biological danger. These dangers will make any finished product unsafe if they are left unchecked during production. Hence, the need for a design process to help reduce the risk. HACCP is useful for the following;
Fault Tree Analysis (FTA): In the safety analysis, system maintainability and reliability, FTA method is widely used. It is a deductive procedure that is often used to identify both human mistakes/errors, and different combinations of software/ hardware failures that could lead to unwanted occurrences known as top events.
FTA can be used to:
Supporting Statistical Tools: its major functions are:
Failure Mode Effects & Criticality Analysis (FMECA): It is an extension of the Failure Mode Effects Analysis (FMEA). Criticality analysis is included in the FMECA method that distinguishes it from the FMEA method. It sets the chances of failure modes against the severity of their consequences on a chart. The FMECA methods are applied to risks and failures associated with the manufacturing process.
FMEA and FMCEA methods require the following information.
Risk Ranking & Filtering: It is one of the easiest methods to use in risk management.
Other names for this method include:
When there is a lot of complicated risk examples or possible risks in a system. With the help of Risk Ranking and Filtering, the focus can be directed to the critical risks in the system. It functions as follows;
Hazard Operability Analysis (HAZOP): It is a systematic approach that examines complicated plans, operations, and procedures. In so doing, companies can find solutions to potential risks to both equipment and personnel.
It is used for the following;
Failure Mode Effects Analysis (FMEA) Tool: It is a systematic approach for proactively solving process issues. Hence, it will help in identifying when failure will occur and where it will occur.
Therefore, making it easier to determine which failed parts require replacement. FMEA is one of the most popular methods to use in life sciences. It helps with;
Any of the tools highlighted in this post can be used for risk assessment. However, it can be challenging for risk management teams to decide or settle on a suitable risk management tool. To achieve an efficient QRM, it is crucial to consider flexibility in the tool selection process.
Before choosing a risk management tool, there should be a consideration for the level of risk, the product,
ORCANOS FMEA Settings
and the process. That way you can channel both the tool and effort accordingly. Likewise, it is important to set standards and criteria for the usage of the risk assessment tool.
In the Pharmaceutical industry, the tool most experts use is the Failure Mode Effects Analysis(FMEA).
It is our hope that you have enjoyed our series on the introduction to Quality Risk Management. Also, having gone through this course, you come to appreciate the importance of QRM in a robust Quality Management system. The entire series covers the following;
Orcanos QMS system as well our deisng control includs FMEA software that allows you to implement any of the above techniques.
|Risk Management – orcanos||FMEA Risk Management Tool|
|Generate Risk Management File||Risk Management (ISO 14971) by Orcanos, based on FDA 2017 Recalls|
|Orcanos Risk Management – Add Traceability Matrix||ALM Requirements Traceability Matrix Tools|
|10 Reasons why to use EQMS||21 CFR Part 820|
|Risk Management (01) – Introduction to Quality Risk Management (QRM)||Risk MANAGEMENT (02) – THE BENEFITS OF FAILURE MODE AND EFFECT ANALYSIS (FMEA)|