A guide to practical Risk Management [ISO14971 and IEC62304]

Risk management being a mandatory component of almost any activity in the medical device industry.

Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.

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To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

Risk management with emphasis on the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.

The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software and usability related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.

The course is mainly based on international consensus requirements such as ISO14971, IEC62366 and IEC62304. It will cover European (MDD), US (FDA) and international risk management requirements from a regulatory and practitioner’s perspective.

Following personnel will benefit from the course:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Project managers
  • Design engineers
  • Software engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Medical affairs
  • Legal Professionals

200+ followers. WOWWWWWW…

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Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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Best Practices in Vendor Risk and Compliance Management

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Best practices in vendor risk and compliance management need to be inculcated by vendors who deal with them because of the enormous risk their activities carry. Implementation of best practices in vendor risk and compliance management goes a long way in checking risks and with it, the adverse fallouts of a vendor management program.

First of all, why do organizations have a vendor partnership? It is because this kind of arrangement helps them to take care of their logistics and other aspects of their business in a much more streamlined and economical fashion, and this in turn helps them to concentrate and focus on their core business better. A strategic vendor partnership helps organizations manage their products and services better, and more economically. The root to this is inculcation of best practices in vendor risk and compliance management.

vendor-risk-and-compliance-managementThe importance of best practices in vendor risk and compliance management can be understood from the fact that when companies outsource their operations, or particular parts of them, or some of their activities, this does not include organizational responsibility. So, the onus of ensuring compliance with regulatory guidelines and making sure that the vendor has implemented best practices in vendor risk and compliance management lies squarely with the organization that outsources.

Burden is on the organization that hires vendorsThis places a heavy responsibility on them, since of late regulatory guidelines for best practices in vendor risk and compliance management have become all the more stringent. While outsourcing part of their activity or operations or logistics or even parts of product development to vendors; companies have to be very sure that they are in tune with best practices in vendor risk and compliance management.

vendor-risk-and-compliance-managementThe basis to implementing best practices in vendor risk and compliance management is to get a clear comprehension of vendor responsibilities. Many organizations make the mistake of assuming that best practices in vendor risk and compliance management need to be implemented only at the stage of selecting the vendor. This is disastrous thinking, because selection of the vendor is just the beginning of the outsourcing program. These organizations have to make sure that best practices in vendor risk and compliance management is a continuous program and activity, and hence utmost care has to go into managing them at all times.

Reasons for increased need for implementation of best practices in vendor risk and compliance managementThe need for adaption and implementation of best practices in vendor risk and compliance management has become all the more acute and necessary in view of the following factors:

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Quality Risk Management in the FDA-Regulated Industry

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Quality risk management in the FDA-regulated industry is a vital area of regulation for the FDA. Risks to quality may arise from many sources. The FDA has entrusted itself with the responsibility of making sure that the quality of the products it regulates is maintained through a due process.

Quality risk management in the FDA-regulated industry is an extremely broad area that straddles Quality in almost all areas that the FDA regulates. The FDA has regulations for particular areas of Quality, such as pharmaceuticals, medical devices, drugs, life sciences and so on. Quality risk management in the FDA-regulated industry is aimed at utilizing core principles in many areas of health and public safety.

Benefits should outweigh the risksThe rationale for Quality risk management in the FDA-regulated industry is that the benefits a product brings for its users, namely patients, should be greater than the risk it brings in its wake. Risk, as we all know, is something like a side effect or a shadow, which accompanies the product just whenever and wherever it is used, and the products itself is unthinkable without the risk. Risk managers and regulators alike acknowledge the fact that risk is not only avoidable; it is not something that can be eliminated fully.

quality-risk-management-in-fda-regulated-industrySo, how feasible is Quality risk management in the FDA-regulated industry when it is a given that risk is inherent in any product or activity? As mentioned above; the FDA (or for that matter, any other regulatory agency) proceeds on the belief that risks can only be mitigated. This certitude is the cornerstone of formulation of policy concerning Quality risk management in the FDA-regulated industry. So, the FDA formulates best practices and regulatory requirements for containing risk.

Quality risk management as laid out by the FDAThe FDA formulates risk management strategies and best practices that help manufacturers understand the ways of risk mitigation and hazard control, so that the maximum possible safeguards are put in place to ensure risk mitigation. The FDA goads manufacturers to imbibe risk management into their core, suggesting that they make it a part of their culture.

quality-risk-management-in-fda-regulated-industryThe proper use of the principles of Quality risk management in the FDA-regulated industry is aimed at fostering compliance with regulatory requirements. Quality risk management in the FDA-regulated industry is tied to a few important principles such as Good Manufacturing Practices and Good Laboratory Practices, among many others.

The Q9 Quality risk management guidelineThe primary guidance set out by the FDA for compliance that ensures Quality risk management in the FDA-regulated industry is the Q9 quality risk management guideline. Among the fundamentals required in the quality risk management process of this guideline are:

  • Assumption of responsibilities for implementing and ensuring Quality risk management in the FDA-regulated industry by people in an organization who are entrusted with the task of decision making regarding quality
  • Initiation of a process for quality risk management
Risk assessment is a major exercise at which the following need to be taken into consideration:

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Quality risk managementRisk assessment is also built on a triad of principles as part of Quality risk management in the FDA-regulated industry:

quality-risk-management-in-fda-regulated-industryFurther, the next steps in Quality risk management in the FDA-regulated industry are:

  • Risk control, consisting of issues such as:
    • Ways by which to reduce it
    • Striking a balance between risks, benefits and resources
    • Identification of possible new risks in the process
  • Reduction of risk
  • Acceptance of risk
  • Communicating of the risk in the proper manner and to the right person(s)
  • Review of the risk.

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What are the potential areas of risk management?

 

What are the potential areas of risk management.jpgThe most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark.

In a very broad sense, the potential areas of risk management include all areas of a business, because simply no area of the business is exempt from a risk. Talk about finance, and it comes with a risk. What about manufacturing? And what about operations or marketing? How about human resources? In this very expansive sense, every area or activity of the business is among the potential areas of risk management.

Potential areas of risk management could lie simply anywhere

potential-areas-of-risk-managementOn top of these potential areas of risk management that each part of the business is prone to; there are also the other industry-related risks that inhere into any business. The risks of running, say, a firecracker business, are much higher than running a grocery store. So, potential areas of risk management should ideally include a very broad discussion on every aspect of risk management.

However, when one takes an overview of the potential areas of risk management instead of trying to break down the elements of each function in which there are potential areas of risk management; one can classify these among them:

Generic risks: As we have been discussing, any business, absolutely any business, comes with some degree of risk. And, each business comes with its own generic risk, such as falling short of funding at crunch times, core people leaving the organization at important times, logistics failures at critical times, and so on.

potential-areas-of-risk-managementProduct specific risks: As the title suggests, this kind of risk is specific to the product that the business deals with. Some products come with their unique risks, and hence, this kind of risk counts among the potential areas of risk management.

People-specific risks: These can happen in a business in which much depends on a few important people. The inefficiency or departure of such people could be among the potential areas of risk management for businesses or projects that are dependent on people.

potential-areas-of-risk-managementFinancial risks: Obviously among the top potential areas of risk management; financial risks come into play when the organization is not able to meet its bottom lines due to a variety of factors. Not getting funds on time, not getting payments from customers on time, not being able to service debts are some of the factors of financial risks.

Technology risks: Technology is a high area of risk, because it keeps changing at a breakneck speed. If organizations don’t keep up with the pace, technology risks could count among potential areas of risk management.

potential-areas-of-risk-managementMarket risks: Market risks are yet another of the potential areas of risk management because most businesses are run on the assumption or speculation that a market is going to grow at a certain rate or pace. If the estimate of this market goes wrong, it affects the business negatively.

Customer risks: The ultimate decider of the business is the customer. If a customer gets irate at a bad product or service and issues bad press, it could become one of the biggest of the potential areas of risk management.

potential-areas-of-risk-managementReal estate risks: For some businesses, especially retail, the location of the business is a major factor. In many instances, the choice of location could often decide the fate of the business. Imagine setting up a high end retail store in the vicinity of a slum. Does that make sense? Yet, even if a business chooses the right location, it could sometimes be forced to relocate due to factors such as legal issues of the property, making this among the potential areas of risk management.

Finally, what needs to be said is that the list above is by no means a comprehensive one. The potential areas of risk management, as we have discussed at the beginning, are simply too many and too fluid and subjective. They could vary from market to market, product to product and business to business. A business that is perceptive about the market has to make the right assessment of the potential areas of risk management before it starts one. It should also be ready to face the potential areas of risk management if it is up against any factor that lies beyond its reach or forecast.

 

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Understanding the importance and benefits of auditing Quality Management Systems

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Auditing Quality Management Systems is a core requirement for ensuring that Quality Management Systems – defined as “…a set of policies, processes and procedures required for planning and execution” in the core business area of an organization, meaning those that impact the ability of the organization to meet customer requirements – are updated and kept in compliance with regulatory requirements. The ISO 9001 set of standards is a step towards helping organizations achieve this end.

The ISO 9001 series, aimed at facilitating and ensuring that organizations of various kinds audit their Quality Management Systems in tune with regulatory requirements set out in this standard; was first implemented in the 1980’s. Today, across the globe, over a million organizations have been certified for complying with its requirements. The ISO 9001 is a tool for auditing Quality Management Systems across all kinds of organizations: big, small or medium to one stop providers to multinational organizations that operate in various geographies.

Why is auditing of Quality Management important?

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ISO standards have been arrived at after years of practice, observation and trial and error endeavors. These standards have evolved over continuous implementation of many best practices that are suited to particular organizations based on the size of their operations and the nature of their business.

An organization that has been in the practice of auditing Quality Management Systems is said to be implementing a better way of dealing with risk management. It is also considered an organization that enjoys enhanced stakeholder and customer confidence, as well as an improved, efficient and effective management and operational systems.

More than anything else, auditing Quality Management Systems are the surest means to ensuring that products and services from an organization meet certain prescribed processes and standards. An auditing Quality Management System officially certifies that the organization task a risk-based, process oriented, streamlined approach to ensure the safety, reliability and consistency of its products and services. A company that puts auditing Quality Management Systems in place is said to be more conscious of meeting customer expectations and makes continuous efforts and improvements into its products and services and complies with the law.

Certification is proof that the organization is auditing its Quality Management Systems

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Certification is like the proof of the pudding in Quality Management Systems audits. A company may claim to be implementing quality standards, but how does the world come to know about it? It is only through auditing Quality Management Systems certification that this happens. For a company to earn auditing Quality Management Systems certification; it has to be audited by the ISO. Upon careful scrutiny of its practices, the ISO awards the organization the 9001 Quality Management Certification.

What are the benefits of auditing Quality Management Systems certification?Certification from the world’s leading Quality Management Systems auditing certifying body gives such an audited and certified company a host of credentials and benefits. These are some of them:

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Good Manufacturing Practices are essential for ensuring quality

Good Manufacturing Practices (GMPs) constitute one of the core components that go into the manufacture and distribution of foods, drugs and other pharmaceutical products. Good Manufacturing Practices are prescribed by regulatory agencies from around the world, the FDA and the EMA being among them.

The guidelines set out by these regulatory agencies are aimed at bringing about standardization in the process of manufacture of these products and to ensure their quality. The utmost diligence of organizations that manufacture these products is called for.

goodManufacturingPracticesThe FDA attaches the highest importance to quality, since drugs and pharmaceuticals are consumed by millions of Americans for a variety of diseases and conditions. Keeping this in mind, the FDA has formulated guidelines with which manufacturing maintains set quality standards across a range of products ranging from foods to pharmaceuticals. The whole set of guidelines for manufacturing products in a variety of industries and activities is clubbed under the collective term, “Good Manufacturing Practices (GMP)”. The FDA attaches the highest importance to quality, since drugs and pharmaceuticals are consumed by millions of Americans for a variety of diseases and conditions. Keeping this in mind, the FDA has formulated guidelines with which manufacturing maintains set quality standards across a range of products ranging from foods to pharmaceuticals. The whole set of guidelines for manufacturing products in a variety of industries and activities is clubbed under the collective term, “Good Manufacturing Practices (GMP)”.

Since these best practices keep changing from time to time and the latest developments overshadow the existent ones; the FDA expects manufacturers to keep abreast of the latest regulations it passes, called cGMP, meaning “current” Good Manufacturing Practice.

No single set of standardsgoodManufacturingPracticesGMPs and cGMPs are not a single, rigid and monolithic set of standards or rules that everyone is expected to implement in their manufacturing systems. The regulatory agencies prescribe a broad set of general principles, from which a manufacturer from particular industries have to implement at a minimum level of quality requirements, the ones appropriate to it. Further, these guidelines offer options on the ways by which those regulations that are relevant to it can be accomplished. The organization needs to determine the one that suits it best for implementing that system.

Purpose of Good Manufacturing PracticesgoodManufacturingPracticesWhy the regulatory agencies take this task upon themselves is because the consumer is not in a position to identify a spurious product or one that has not been through all these scientifically designated processes. The fundamental purpose for which the regulatory agencies require adherence to the CGMP regulations is that compliance to these guidelines is a means to assuring the following:

goodManufacturingPracticesIn order to achieve this, drug manufacturers have to take all the steps needed to control the manufacturing operations. This includes establishing strong Quality Management Systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.

The FDA believes that putting all these steps and processes in place through this formal system of controls by a pharmaceutical company is a means to prevent mix-ups, contamination failures, deviations and errors. In addition to ensuring that drug products that go through these processes meet their quality standards; the cGMPs help to put in place systems with which proper design, monitoring, and control of manufacturing processes and facilities are assured.

Highlights of GMPs/cGMPsThe nature and role of current Good Manufacturing Practices can be summarized into the following:

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The GMP regulatory requirements in the EU

The EMA, being the regulatory agency for the EU; oversees the implementation of cGMP guidelines. The EMA’s guidelines apply to all the Member States of the European Union. The purpose for which these guidelines are set out by the EU is more or less the same as that for which other agencies such as the FDA lay out these rules. The essential reason for which this is done is to ensure that the pharmaceutical or any other regulated products:

goodManufacturingPracticesThe EU’s directives on GMP are listed out in its important legal frameworks and guidelines. These include:

  • Regulation No. 1252/2014 and Directive 2003/94/EC, which are for active substances and medicines for human use
  • Directive 91/412/EEC, which relates to medicines for veterinary use
  • Directive 2001/83/EC and Directive 2001/82/EC, which prescribe related provisions.

 

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