Posts by Rami.Azulay


January 26th, 2020 Posted by ISO 14971, Requirements Management Tool 0 thoughts on “RISK MANAGEMENT (05) – FMEA GENERAL OVERVIEW”

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

  1.   An effective FMEA will lead to improved quality, upper reliability, and enlarged safety.
  2.   It makes it easier to develop ideas and concepts that will help improve similar processes and designs
  3.   Using FMEA will allow companies to improve both manufacturing and design efficiencies.
  4.   It allows for proper documentation of Corrective Action implementation that led to improvements.
  5.   It helps to remove or eliminate the possibility of late changes and the crisis it brings.
  6.   It reduces the chances of repeating similar of the same mistakes in the long-term.
  7.   It helps to lower the cost and time need for system development.
  8.   It allows for co-operations between co-workers at all levels. As a result, there is a better exchange of ideas and teamwork.
  9.   Companies get the benefit of improving their market competitiveness and overall image.

 FDA Endorsement

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;

  • FMEA (IEC 60812) opens an opportunity to evaluate various modes of potential failure and predict the possible effects it will have on product performance.
  • Once failure modes are determined, it is possible to use risk reduction to reduce, remove or control likely failures. However, it works when there is a proper understanding of the process and product development.
  • With the help of FMEA, a company can break down the analysis of complex processes into gradual steps methodically. It is a tool that allows for the summarizing of crucial failure modes, the factors responsible for the failure and their possible effects.

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;

  1.  When it comes to drug substances and products, it can be used to define the design space for their manufacturing processes. During the design phase, FMEA can help outline design options, select the best one, as well as improve the design and processes.
  2.  It helps with the setup of both the manufacturing and design of equipment. Also, it aids the optimization and improvement of qualification and maintenance plans for equipment. If a device, process or system can fail then you can apply FMEA to it.

 What can FMEA do for you?

Below are some of the benefits of applying the FMEA method in your manufacturing processes;

  • It will assist you in discovering and analyzing likely failures mores ahead of time.
  • You will be able to quantify the effects of those potential failures.
  • It will help you estimate the probability of having the failure modes occur.
  • Using FMEA, you will be able to identify as well as prioritize corrective actions that will result in the reduction or removal of the potential failure threat.
  • It is a valid way of documenting and implementing plans that will reduce risks in a system.

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;

  1.   When you start a new product cycle.
  2.   When there is an update in the current design, system or processes.
  3.   There is a change in the operating parameters of a system.
  4.   A current process or design is been used for something different.
  5.   There are new regulations governing a design, process, system or product use.
  6.   When customer feedback point to a problem.
  7.   When analyzing failures in an existing system or process.

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.


How to Succeed in the Automotive Industry?

January 19th, 2020 Posted by ASPICE, Automotive, Requirements Management Tool 0 thoughts on “How to Succeed in the Automotive Industry?”

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

Success Rate


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 Quality is vital to the success of an automotive company
  • The factors to success in the industry can be summarized as agility and product excellence.
  • ALM and QMS tools will allow companies to achieve product excellence.
  • The cloud makes ALM and QMS tools easy and affordable to use.
  • Orcanos is the company to meet for help with how to leverage cloud and


Why Automotive Industries Uses Product Innovation Cloud Platforms?

January 15th, 2020 Posted by Requirements Management Tool 0 thoughts on “Why Automotive Industries Uses Product Innovation Cloud Platforms?”

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;

  • Manufacturing Execution Systems (IMES)
  • Quality Risk Management (QRM)
  • Computer Requirement Management System (RMS)
  • Training Management System
  • Verification and Validation System (V&V)
  • Product Lifecycle Management
  • Electronic Device History Records (eDHR)
  • Document Control System (DMS)

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

January 1st, 2020 Posted by Requirements Management Tool 0 thoughts on “Requirements Traceability from the Cradle to the Grave”

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


December 7th, 2019 Posted by ISO 14971, Requirements Management Tool, RISK Assessment, Risk Management 0 thoughts on “RISK MANAGEMENT (04) – WIDELY USED METHODS AND TECHNIQUES”

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.

  1.   Preliminary Hazard Analysis (PHA).
  2.   Basic Risk Management Methods.
  3.   Hazard Analysis and Critical Control (HACCP).
  4.   Fault Tree Analysis (FTA).
  5.   Supporting Statistical Tools.
  6.   Failure Mode Effects & Criticality Analysis (FMCEA).
  7.   Risk Ranking &Filtering.
  8.   Hazard Operability Analysis (HAZOP).
  9.   Failure Mode Effects Analysis (FMEA).

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:

  • Early in project making when there is little information on designs or operating procedures.
  • To solve the danger types for the product class, general product type, and the specific product.
  •  Analyze existing systems or prioritize

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:

  • Cause and Effect Diagrams
  • Check sheets
  • Flowcharts

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;

  • Monitoring of critical points in the manufacturing process.
  • Identify and manage risks associated with chemical, physical and biological dangers.
  • When there is a broad understanding of the process as it relates to identifying critical points (critical parameters/ valuables). 

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:

  • Establish the pathway to the root cause of this problem.
  • Investigate deviations or complaints to fully understand their root cause.
  • Ensure that intended improvements will fully resolve the issue and not lead to other issues.
  • Evaluate how multiple factors affect a given issue. 

Supporting Statistical Tools: its major functions are:

  • To deal with warning limits or trend analysis.
  • Monitor critical parameters
  • Provide information to determine the process, control, variability, and capability.

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.

  • Recommended Actions.
  • Failure(s).
  • Causes of failure(s).
  • Effects of failure(s).
  • Functions.
  • Item(s).
  • Current Control(s).
  • Any other relevant detail.

Risk Ranking & Filtering: It is one of the easiest methods to use in risk management. 

Other names for this method include:

  • Relative Risk Management.
  • Risk Indexing.
  • Risk Matrix and filtering.

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;

  • To help in situations where the level of risk and its consequences is difficult to be controlled by a single tool.
  • To evaluate both quantitatively-assessed and qualitatively-assessed risks within the same organizational framework.
  • To prioritize manufacturing sites for inspection/adult by regulators or industry. 

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;

  • Start a HACCP process.
  • Identify and manage risks associated with equipment and facilities.
  • Identify the operator or user error.
  • Identify and manage risks associated with the manufacturing process.
  • Evaluate process safety hazards.

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;

  • The monitoring of risk effectiveness.
  • Analysis of a manufacturing process to identify high-risk steps or critical parameters.
  • To prioritize risk.
  • To monitor equipment and facilities.

Quality Risk Assessment Tools Selection.          

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,


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;

  • The concept of Quality Risk Management.
  • The source of risk.
  • Where to apply QRM.
  • Regulatory Requirements.
  • The various types of Risk Management Tools.

Orcanos QMS system as well our deisng control includs FMEA software that allows you to implement any of the above techniques.

Reference Links

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)





Risk Management (03) – The Regulatory Requirements For Risk Management

December 5th, 2019 Posted by Requirements Management Tool 0 thoughts on “Risk Management (03) – The Regulatory Requirements For Risk Management”

Pharmaceutical/Medical Device/Automotive Regulatory Requirements

According to regulatory bodies, medical devices, pharmaceutical or automotive manufacturers should be implementing Quality Risk Management (QRM) systems when accessing the risks that come with the production of products that introduce safety issues to the user/operator/technician of the device. In this post, we will be addressing the relevant quality standards and regulatory guidelines.

The United States Food and Drug Administration (FDA)

Below are 5 crucial points from the FDA Guidance for Industry: Quality Systems Approach to mentioned industries cGMP regulations (2006).

21 CFR Part 11 – Scope and Application 2003: This guidance is the documentation of the FDA’s approach for electronic records and signatures. They recommend that for implementation of key requirements of Part 11 they should base the decision on a documented and justified risk assessment. Also, consideration should be given toward the potential of the system to influence product quality, record integrity, and safety. 

  • Additionally, the decision to include audit trails should be based on justified and documented risk assessment.
  • The Orcanos QMS system fully complies with the regulatory requirements and it includes a built-in electronic signature and audit trail according to 21 CFR Part 11. It comes with a complete validation package to assist users to include it in their audit inspection.

 Orcanos Electronic Signature

European Regulations: There is a legal status for Annex 15 to the EU GMPs Validation and Qualification. It utilizes a risk-based process for validation of changes to components, systems, facilities, and equipment. To determine the extent and scope of validation, use a Risk Assessment Approach. It crucial to always evaluate the possible effect of changes in facilities, equipment, and systems on the product. Also, do not forget to include a risk analysis report.

In the Orcanos Design Control module, there are several tools that allow you to conduct the assessment of a change. It gives you tools to raise subspecies indicators which are based on existing traceability between artifacts or to asses risk to newly introduce change as part of the risk assessment process.

Orcanos Suspicious Effect on Change Report

There is a legal status for Annex 11 to the EU GMPs for using computerized systems. It mandates that control for computerized systems be based on a document and justified risk assessment. Likewise, the level of validation and data controls have to be in line with a proper and documented risk assessment.

Orcanos computerized system is a validated system and it comes with a validation package that is complying with the regulatory requirements for both the USA and EU.

International Conference for Harmonisation ICH Q9/ISO 14971/ISO 26262: It is regarded as the most important document when it comes to risk assessment for the pharmaceutical/medical device/automotive correlated sector.  The ICH focuses on how scientific knowledge plays a role in the protection of patients in the life industry and ISO 14971 focuses on the hazardous situation and potential mitigation while the ISO 26262 focus on safety issues related to critical components. These reference documents provides guidance on implementation processes. The three major principles that govern quality risk management are; 

  • Always use scientific knowledge were possible, as a base for evaluating risks to product quality and relate it to patient protection.
  • The extensiveness of the documentation, effort, and formality regarding risk management processes should reflect the level of risk.
  • Learn from the existing market what could go wrong in your device.

It might not always be necessary or appropriate to make use of a formal risk management process. For instance, using a well-known tool for an internal process like a standard operating procedure. Similarly, it is acceptable to use informal risk management processes or standard operating procedures for internal processes.

International Standards Organisation (ISO): The organization has three standards that address risk management. They are;

  • ISO 14971 – Medical Devices
  • ISO 31000 – General purpose risk management projects
  • ISO 31010 –  General purpose risk management projects


NOTE: There is a major difference between ISO 31000 and ISO 31010 despite addressing the same risk management problems. ISO 31000 highlights principles and guidelines, while ISO31010 describes risk assessment techniques.

ISO 14971: 2012 (Application of Risk Management to Medical Devices): While this document is for medical devices, the FDA recommends it to the pharmaceutical industry, others recommended it for the automotive as well. In this international standard, there is an outline that manufacturers can follow to identify potential hazards that concern medical devices. Also, it covers in-vitro diagnostic devices (IVD). Using the stipulated process, manufacturers can evaluate, and estimate the level of risk and take actions to control and monitor the risks. Likewise, the manufacturers will have criteria that will help them determine the effectiveness of the controls.

Throughout the lifecycle of any medical device, the requirements in this standard are applicable. However, it does not extend to clinical decision making, neither does it specify what risks levels are acceptable. Finally, the standard does not mandate that manufacturers use a quality management system. Nevertheless, a risk management system is a crucial part of the quality management system.

Reference Links

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)



November 26th, 2019 Posted by ISO 14971, RISK Assessment, Risk Management 0 thoughts on “RISK MANAGEMENT (02) – THE BENEFITS OF FAILURE MODE AND EFFECT ANALYSIS (FMEA)”

The Quality RISK Management system 9 major benefits and what are the 5 top areas you should consider using it?

Here in this post, you will hear all about the QRM system and the fundamental of the FMEA process. This post and all other future posts refer to not just the Medical Device industry but also the Automotive and Pharma so some adaptation to your world may be required but still, all principals will be uncovered here. For the automotive it is common to say that the severity of the failure mode is taken into consideration as well as the effect the failure mode, should it occur, will have on the component, system, process, vehicle, or customer. The two main types of FMEAs used in the automotive industry are design FMEAs (DFMEA) and process FMEAs (PFMEA).


  1.   An effective FMEA will add to upper reliability, enhance safety and improve quality.
  2.   There will be a shortage of innovative ideas that will help improve similar designs or processes.
  3.   Manufacturing and design efficiency will increase.
  4.   Documents on the improvements made as a result of corrective action implementation will be available (better CAPA effectiveness).
  5.   It will prevent late changes in issues.
  6.   It will reduce the chances of repeating the same failure in the future.
  7.   The cost and time for system development reduce.
  8.   There will be an encouragement for teamwork and effective communication between functions – collaboration.
  9.   It helps improve company competitiveness and image.

Patient Safety

In the industry of live science, manufacturers, vendors, and quality analyst have to combat challenges that involve Patient Safety, Staying Competitive, and Regulatory GxP requirements. The challenges are unavoidable due to the rapidly changing and evolving environment. It is up to these professionals to produce products that are;

  • Fit for purpose.
  • Right first time.

Regulatory agencies always expect a risk-based compliance model that will balance Cost and Compliance effort against Product Quality and Patient Safety. It is impossible to test quality into products, hence, it is imperative that they come with the design. One of the ways to ensure built-in quality with the design is to incorporate some of the latest theories and technology into the design control, manufacturing and post-marketing surveillance process.

Following encouragement from regulatory bodies, the medical device, automotive and pharmaceutical industry are using Quality Risk Management and Quality by Design to incorporate new standards. In some standards such as ICH Guidance Q9 (Quality Risk Management) and ISO 14971, three major topics are addressed namely;

  1. Risk Management
  2. The Identification of Risk
  3. Risk Minimization

Quality Risk Management is a systematic process of assessing, controlling, communicating and reviewing of risks that might disrupt the quality of a Medical/Automotive/Pharma product. However, to achieve QRM, Quality Assurance should be treated as a proactive process. In other words, try to identify potential problems, effects and find solutions to them before they occur. This is the reason for practicing Failure Mode and Effect Analysis (FMEA) is necessary.


FMEA Risk Management

Orcanos RISK management reports

Explaining Risk

As we go further into the discussion of Quality Risk Management, it is important to define Risk. Risk is the combination of the potential for harm to occur and the severity of that harm.

Mathematically, Risk = Probability * Severity.

For example, there is a low probability of occurrence of a hazardous event happening during a drug/car/device manufacturing process. The reason is that it has happened just once in the last ten years. However, the severity of the hazard is high, since it can lead to death and destruction of many to use it. Therefore, the resulting risk in such an event is high and it must not be ignored.

Orcanos quality system includes fully comply RISK management system which allow your to configure and practice the FMEA. You can change the calculation factors according to your device level of concern and to make sure it is all audit traced for all changes and modifications. Orcanos system will generate for your the FMEA table automatically with the traceability to mitigation by design.

Source of Risk

A lot of risks comes with the manufacturing process of medical/automotive/pharmaceutical products. The sources of these risks include;

  • Poor Facility Design
  • Poor Process Design
  • Poor Control Plans and SOPs
  • Poor Storage
  • Poor Material Flow
  • Safety Hazards
  • Poor Logistics
  • Raw Material Variation
  • Unclear Customer Expectations
  • Poorly Developed Specifications and Limits
  • Cross Contamination
  • Lack of Product Understanding
  • Poor post-marketing surveillance
  • Poor CAPA processes 

To manage risk effectively, it is crucial to understand the level of risk at each stage of production or application.

Understanding Quality Risk Management (QRM)

Quality Risk Management (QRM) is a systematic way of identifying risks to patient/passenger  safety and product quality, then analyze the risk and design a plan to either reduce or manage the risk. It is important that QRM follows the scientific rationale and the approach should follow scientific principles based on;

  1. Quality Risk Management (ISO 14971)
  2. Quality By Design (QbD)

The goal of QRM is to convert scientific knowledge on the design control, manufacturing process, post-marketing surveillance (PMS) and product into documentation. For example, both equipment qualification and design specification are documentations that highlight product use and ways to reduce risk to product quality and patient safety. It is the same standard principle that experts and regulatory bodies follow. It can be summarized as;

  1. Identify the risks: What can go wrong?
  2. Analyze the risk: What is the probability of something going wrong? What will be the impact? How severe will the damage be?
  3. Estimate the risk priority number (RPN): determine the level of risk and decide if it is high or acceptable.
  4. Should the risk be too high, develop and implement control measures to manage or reduce the risk
  5. Analyze the remaining risks and determine if they are acceptable.
  6. Validate the risk mitigation
  7. Conduct effectiveness check on the 

Risk Full Traceability Matrix

Potential Areas for Quality Risk Management and Application

In the life science industry, below are some of the areas to consider when deciding to implement or apply QRM.

Integrated Quality Management: it includes the following area;

  1. Documentation
  2. Auditing/Inspection
  3. Change management
  4. Change Control
  5. Quality Defects
  6. Training and Education
  7. Periodic Review
  8. Quality Events
  9. Customer Compliant

Development: it covers the following;

  1. Critical Process Parameters (CPPs)
  2. Specification
  3. Verification and Validation
  4. Manufacturing Controls

Facilities, Equipment, and Utilities: it includes;

  1. Design of Facility and Equipment
  2. Hygiene
  3. Computer Systems and Computer Controlled Equipment
  4. Qualification of Facility/Equipment/Utilities
  5. Aspects of Facilities
  6. Calibration/Preventive Maintenance
  7. Cleaning of Equipment and Environmental Control


Materials Management: it includes;

  1. Use of Materials and Storage
  2. Assessment and Evaluation of Supplier
  3. Logistics and Distribution Conditions

Production: it covers the following;

  1. In-process /Sampling and Testing
  2. Validation
  3. Production Planning

Laboratory Control and Stability Studies: it includes the following area;

  1. Retest Periods and Validation
  2. Out of Specification Results

Packaging and Labelling: it includes;

  1. Selection of Container Closure Systems
  2. Package Design
  3. Label Control

Reference Links

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











November 23rd, 2019 Posted by Requirements Management Tool 0 thoughts on “RISK MANAGEMENT (01) – INTRODUCTION TO QUALITY RISK MANAGEMENT (QRM)”

Are you new to the ISO 14971:2012 & FMEA system or seeking to improve your processes?

As a QA representative or Functional Safety Manager, you will find in the following series of posts all the knowledge you need to get started implementing GDP for your Risk process.


FMEA Risk Management

RISK Summary Report


Quality Risk Management is the evaluation of product quality and risk to patient / passenger / doctor / nurse / operator health or anyone that may be exposed to safety issues when using the device based on data, scientific knowledge, and data. According to regulators, when using a lifecycle approach to implement either an informal or formal risk tool in line with ISO 14971 or ICH Q9 (Pharma) or the Automotive used of the FMEA. The Quality Management System (QMS) should incorporate Quality Risk Management (QRM) for the following purposes:

  • Acceptance of Residual Risks
  • Risk Assessment
  • Communication of Identified Risks
  • Risk Review
  • Risk Control

What will we be covering this series of posts discussing the QRM?

In this series of posts, we will be covering the following topics;

  1.     The concept of Quality Risk Management (QRM).
  2.     How to identify the source of risk.
  3.     Possible areas to apply QRM application.
  4.     Regulatory requirements.
  5.     Risk Management Tools.

People that will benefit from learning Quality Risk Management include people in the following departments:

  • Risk Management
  • Quality assurance
  • Engineering Service Providers
  • Commissioning
  • Product Development
  • Compliance
  • Project Engineers and Managers
  • Validation
  • Manufacturing Operations and
  • All Management related departments should be aware of QRM.


In this series of articles we will cover 3 module categories which include;

  1.     Introduction to Quality Risk Management (QRM)
  2.     Regulatory Requirement
  3.     Risk Management Tool


It is crucial to understand the terms that often appear when discussing Quality Risk Management, hence the need for a dictionary. Some popular terms are;

  • Corrective Action (CA): The action to take to correct a deviation.
  • Critical Control Point (CCP): A point in the process where you can apply a control measure to either remove or reduce to an acceptable level a (pharmaceutical) quality hazard
  • Failure: When an item fails to work as it should work.
  • Failure Mode: How the item failed.
  • Failure Mode and Effects Analysis (FMEA): It is a technique for determining fail modes and their effects. It addresses possible scenarios of what causes failure for low-level components and its impact on the system or application.
  • Failure Modes, Effects, and Criticality Analysis (FMECA): A way of adding an analysis of criticality of severity, detectability, and occurrence of FMEA.
  • Fault Tree Analysis (FTA):  A technique that analysts use to trace the source of failure in a high-level system.
  • Hazard Analysis and Critical Control Point (HACCP): A systemic approach for identifying, evaluating, and control of food safety hazards.
  • Harm: Physical damage to people, environment, and property.  
  • Hazard: A possible source of harm.
  • Hazard Analysis: A way of determining relevant information on the potential hazard to food and how to address it in the HACCP plan.
  • Preliminary Hazard Analysis (PHA): A way to identify hazards and design solutions for them.
  • PIC/S: It stands merely for Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme.
  • Probability of Detection: Estimating the chances of detecting a hazard before it causes harm to the patient.
  • Risk: It is the presence of potential harm as well as its severity.
  • Risk Acceptance: The choice or decision to accept risk.
  • Risk Analysis: The ability to use the information to identify hazards and estimate the risk
  • Risk Assessment: The process of gathering the information that justifies the actions to be taken to manage risk. The process will involve risk identification, analysis, and risk evaluation.
  • Risk Communication: The process of sharing information on risk that exist between stakeholders and decision-makers.
  • Risk Control: The process of reaching a decision that would allow for risk management with the system. In the process, there will decisions on how to identify the risk, measures to take, timeframe, and much more.
  • Risk Evaluation: A way to compare risk criteria to the risk estimate in order to reach a level of acceptance.
  • Risk Identification: A way of using the available information to identify potential hazards in a system or application.
  • Risk Level: A quantitative measure to evaluate the degree of risk in a system.
  • Risk Management: a systematic way of using policies, procedures, and practices to address the tasks of identifying, analyzing, evaluating, control, and monitoring of risk.
  • Risk Priority Number: The total measure of risk in a system. It is evaluated by multiplying severity with the rate of occurrence. The higher the number, the higher the risk in the system.
  • Risk Reduction: Actions that are taken to reduce both the probability and severity of risks.
  • Risk Review: A way of monitoring the outcomes of various risk management plans and strategies.
  • Risk Treatment: The process of selecting and implementing measures to change risk.
  • Risk Management Master Plan (RMMP): A framework that applies to all projects, and it can be used to draft a risk management plan.
  • Risk Management Project Plan (RMPP): This applies to individual projects and the plan specific to that project.
  • Severity: The measure of effects of a hazard

Now that we have covered the list of terms used by the QRM system, we can start to see how they are working together. We will identify events and actions around some of these terms and allow you to practice them in the ORCANOS QMS system.


Reference Links

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


Passing MDSAP with no paperwork

November 10th, 2019 Posted by Requirements Management Tool 0 thoughts on “Passing MDSAP with no paperwork”

MDSAPOrcanos has passed the MDSAP audit successfully with one of its leading medical device customer, led by Irit Bouwman.

Irith testified that this was a very successful audit, done purely online. “I was impressed of how powerful the tool is, it was as easy as clicking a button to get the information I needed, during the audit…..

“You are the first company I gave 0 grade since I have started giving audits on MDSAP…” said the auditor for STEP I

As Irith Bouwman, Director of QA with over 20 years of experience explained, the MDSAP audit is a very unique audit in a way that it takes both the standard of the ISO 13485:2016 together with the regulation of the regions the company is about to act and making sure that the SOP reflects those regulations in the SOP.

The lowest the grade is the better your audit. Grade Above 4 it is not recommended to go to stage II. If there is missing regulation in the SOP the grade start from 2, and more points are added during the audit finding.

In addition, during the audit, there is a new factor added to the audit grade is the RESPONSE TIME of the organization to request of the auditor. In that sense, it usually gives 10 min to retrieve a document from the quality system. During the audit, the retrieval time that it took our customer was less than 30sec. You may see the auditor put a stopper on the desk during the audit.

The reference to documents is also tested and the revision of the documents and the obsolete management of documents. Orcanos e-DMS system serves all those requirements electronically with almost zero human interaction and 0 errors.

Orcanos is proud to serve some of the leading medical device manufacturers, helping them to move their paper-based quality management system into an electronic template-based system, thus saving time and money  and reduces overall cost.

Get your MDSAP audit-ready today


November 6th, 2019 Posted by Requirements Management Tool 0 thoughts on “cGMP – DESIGN AND DEVELOPMENT TRANSFER (DMR) (11)”

The Device Master Record (DMR) is the ultimate document for ensuring efficient design transfer. It is not a mandatory requirement according to ISO 13485. The DMR is mostly theoretical as it is a compilation of documents required to complete the design process. The documents consist of all the documents above and the validation master plan.

DMROrcanos DMR system

In time, the document will need revising and subject to change. The DMR will help index each document as well as their note their current revision. To achieve a successful design transfer, you need the DMR. The transfer could be an internal transfer, manufacturing, or involving a customer manufacturing organization (CMO).

There are several ways to capture the design transfer process. They are;

  • A transfer checklist
  • A checklist that forms a part of the product’s lifecycle SOP.
  • An entirely new form.

The checklist comprises of activities to complete to aid a successful design transfer.  The list will include the following;

  • Facility preparedness
  • Product specification
  • Training activities
  • Test method
  • Component properties
  • SOPs and WIs
  • Success criteria

Also, the design transfer process comes with a design transfer plan with well-defined criteria. A report should be made available upon completion. The report will contain all the activities and proof a successful transfer.

Page 1 of 14
1 2 3 14


8 Tozeret Ha'aretz Street
Tel Aviv, Israel

Copyright © Orcanos, All rights reserved. | Privacy policy | Terms of use