Posts in ISO 14971

RISK MANAGEMENT (04) – WIDELY USED METHODS AND TECHNIQUES

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,

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).

Conclusion

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 (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
RISK MANAGEMENT (01) – INTRODUCTION TO QUALITY RISK MANAGEMENT (QRM)

 

 

 

 

 

 

 

 

 

Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies

January 9th, 2019 Posted by ISO 14971, Recall, RISK Assessment, Risk Management, Safety 0 thoughts on “Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies”

Orcanos issues new risk system including risk made by medical devices in the field of Neurosurgery Software Recalled Due to Display Inaccuracies. The software, when used with the medical device Navigation System, provides 3D images of a patient’s brain to help neurosurgeons navigate surgical tools and implants used during surgery.

The Software glitch may affect the intended use of the device. This new risk, the following does not include reported problems that included a patient death potentially linked to the case.

It was a Class 1 recall alert for MRI-guided surgery device. Class 1 recalls, the highest severity level, involve product problems that can cause death or serious injury.

Hazard: The software displays incorrect information during biopsy procedures that could result in serious or life-threatening patient harm. During the procedure, the software monitor may show that the tip of the surgical tool has not reached the target and could prevent the neurosurgeon from accurately seeing the location of the tools in the patient’s brain.

Failure Cause: The offset appears to have been caused by an interaction between the device probe and the MRI environment

Failure Effect/ Harm: The surgeon could potentially insert the tool too deeply, damaging the patient’s healthy tissue, brain or blood vessels.

Risk Control (RISK-5005):

 

The third-leading cause of death in US most doctors don’t want you to know about

March 1st, 2018 Posted by ISO 14971, Risk Management, Safety 0 thoughts on “The third-leading cause of death in US most doctors don’t want you to know about”

ORCANOS released a new RISK management system ver. 3.0.0.135 (ISO 14971) based on 2017 recalls by the FDA

December 16th, 2017 Posted by ISO 13485, ISO 14971, Requirements Management Tool, RISK Assessment, Risk Management, Safety 0 thoughts on “ORCANOS released a new RISK management system ver. 3.0.0.135 (ISO 14971) based on 2017 recalls by the FDA”

ORCANOS released a new RISK management system (ISO 14971), based on recent RECALL CLASS 1 by the FDA, to include RISK analysis covering recent incident of potential flammability of battery used by the device. The new release includes also mitigation procedure for that case as well.

Hazard: Battery overheated on the device unit while charging in standby mode during a routine procedure

Failure Cause: Manufacturing Failure

Failure Effect/ Harm: System flammability causing fire or wrong function

Risk Control (RISK-2277): Register for the free trial on: https://lnkd.in/ghv8YX6

Please share with us more ideas on this topic.

 

Related Links

Risk Management

Quality Management

Document Control Software (ISO 13485)

What is ISO 14971

 

WHITE PAPER ACHIEVING ISO 26262 COMPLIANCE WITH ORCANOS ALM and QMS

December 8th, 2017 Posted by ISO 14971, Risk Management, Validation and Verification 0 thoughts on “WHITE PAPER ACHIEVING ISO 26262 COMPLIANCE WITH ORCANOS ALM and QMS”

ISO 26262 is an automotive standard that places requirements on the quality of software, for which tools such as ORCANOS ALM and QMS are ideally positioned to enforce. With the highest adoption in the industry and a strong heritage in safety-critical applications, ORCANOS ALM and QMS have been certified as being “fit for purpose” to be used as tools by development teams wishing to achieve ISO 26262. This document describes the parts of the standard that are addressed by using ORCANOS ALM and QMS.

Read More: https://www.linkedin.com/pulse/achieving-iso-26262-compliance-orcanos-alm-qms-rami-azulay/?published=t

Orcanos QMS: Regulation Compliance & Governance Engine

August 7th, 2017 Posted by Document control, IEC 62304, IEC60601, ISO 13485, ISO 14971, regulation compliance 0 thoughts on “Orcanos QMS: Regulation Compliance & Governance Engine”

Orcanos is about to launch its QMS-Regulation-Compliance engine as part of Orcanos integrated ALM and Quality Management Software System.

Abstract

Compliance best practices lie at the heart of all standards-based regulations and good quality management, such as ISO 14971, IEC 62304 and ISO 13485. However, it is a challenge to keep compliance without electronic QMS, or using traditional ALM tools, as most of them are R&D driven, and lack the support of the quality management software system. Compliance remains a leading concern for regulated industries such as Medical Device, Pharma and automotive.

Orcanos QMS Compliance engine

The powerful new capabilities of Orcanos Compliance Engine would simplify the way companies govern and control quality and regulations, and will provide a “Virtual Auditor” that would scan the project data in respect for specific industry regulation, and quality best practice, such as compliance with ISO 14971, IEC 62304 and ISO 13485 and more.

Orcanos QMS Compliance Engine is a flexible tool that allows companies define any regulation in a simple Excel or Google Sheet, defining the standard, section, classification in case of medical device (CLASS I, II, III), Remediation, and many other parameters, ans then import these regulations into Orcanos ALM and QMS platform and connect it to their projects records.

Orcanos QMS Compliance Engine then scans project data based on the specific regulations, and specific logic attached to it, and shows the faults in a graphical presentation. Together with Orcanos dashboard and notification mechanism we provide quite a good control and monitoring platform

Defining a compliance audit item

Define any compliance audit, setup and customize each compliance item

Compliance Audit

Running a compliance audit check

This is an example of an “Virtual Auditor” that inspects the compliance of specific product with the ISO 14971.

Running Compliance Audit Check

 

Why there is a change in the approach regarding labeling as RISK mitigation

July 24th, 2013 Posted by 510(k), CE Marking, FDA, IEC60601, ISO 14971, Recall, RISK Assessment, Risk Management 0 thoughts on “Why there is a change in the approach regarding labeling as RISK mitigation”

A recent recall on Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: class 1 recall – mislabeled packaging – See more at: http://www.healthcarepackaging.com/trends-and-issues/regulatory/bryan-medical-tracoe-mini-30mm-tracheostomy-tube-class-1-recall/ has proven some of the justification regarding the change in approch when putting labeling as part of the RISK mitigation. In the above case in the RISK assessment we should expect to see that not just labeling should be used to differentiate between the different devices but also packaging and coloring could be a good way to use on the device. Such mistake in labeling could affect patient safety since an oversized tracheostomy tube may cause permanent injury to the trachea. This product may cause serious adverse health consequences, including death. When we come to RISK assessment and decide to use labels as mitigation we may want to consider mistakes in packaging and address such cases as well or even perform change by design to avoid use of the device on the wrong application.

QPack Medical Webinar, October 2012

November 11th, 2012 Posted by IEC 62304, ISO 13485, ISO 14971, Requirements Management, Risk Management, Software Lifecycle Management, Test Management, Validation and Verification 0 thoughts on “QPack Medical Webinar, October 2012”

QPack Risk Form According to ISO14971

October 23rd, 2012 Posted by IEC60601, ISO 14971, Risk Management 0 thoughts on “QPack Risk Form According to ISO14971”

Following is breakdown of each phase in the risk management process described in ISO 14971:

4. Risk Analysis
4.3. Hazard Identification

  1. Describe the hazard
  2. Select risk category
  3. Define the feature/function hazard relates to
  4. Describe Potential harm
  5. Describe Cause of failure

4.4. Risk Estimation

  1. Define probability of harm due to hazard
  2. Define severity of harm due to hazard
  3. The risk level (RPN=Risk Priority Number) is automatically calculated

5. Risk Evaluation

Decide whether risk should be controlled by the predefined acceptability zone (Acceptable, ALARP, Unacceptable)

6. Risk Control

6.2 Risk Control Measures

Define control type

6.4 Final Risk Evaluation – Residual Risk

  1. Define probability of harm due to hazard
  2. Define severity of harm due to hazard
  3. The residual risk level (RPN=Risk Priority Number) is automatically calculated

6.6. New Hazard

A new   hazard created? (yes/no)

7. Verification and validation

Evaluation of overall residual risk acceptability

Use QPack traceability to relate artifacts used for risk control.

The test cases (verification) should be connected to design artifacts to assure verification

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