RISK MANAGEMENT (02) – THE BENEFITS OF FAILURE MODE AND EFFECT ANALYSIS (FMEA)

Rami.Azulay November 26th, 2019 Posted by Rami Azulay( ) ISO 14971, RISK Assessment, Risk Management

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)

 

 

 

 

 

 

 

 

 


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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