FMEA (Failure Mode Effect Analysis) use in Medical Device industry.

1. FMEA (Failure Mode Effect Analysis) use in Medical Device industry. FMEA is very important word in risk management. We all know that risk management is an integral part of QMS and regulatory compliance. As the name starts one must be thinking that this has something to do with failure in medical device. This is very incorrect, and this tool is to avoid potential failure. Origin of this is very old like in 1940 US military used this tool for looking at potential failure at design, production process, assembly of weapons and equipment. Let us just analyse FMEA. Failure mode: what can go wrong? Thinking and discussing potential failurelisting them down, Effect: What can be the impact of this failure if at all happens, what will be impacted, process, product or consumer, the analysis exercise of all in advance before we start is FMEA. Without going in the detail of when, what, where and how of this tool, know more about use of this tool in key element of medical device, design phase. Design phase is such an important phase where product is in formation and can be modified the way we need so even scrapping will cost company only man hours and some resources but not any compliance issue or customer related issue. So, Design FMEA we call it DFMEA. Use the tool at design phase. This will highlight potential problem of faulty design and technological issues that design is likely to face. You could avoid failures of critical type consequences; you can optimise design by limiting failure to very small occurrence with small acceptable impact. This will also tell you that how much you can stretch a design beyond which it is uneconomical and not acceptable. This limitation can also be further improved by providing improved detection control points or some other techniques of detection. So DFMEA will let you know in the beginning itself, product performance, limitations, and failure detection before it happens so use can be stopped. So, failure elimination can be improved by addressing its occurrence and better detectability. Another important aspect is process FMEA or PFMEA. Once you froze the design and product goes at process stage, apply this tool to forecast the probable issue that may arise during processing. Company can have documented guiding management policy for design, processing staff as to what number of scores is allowed as maximum beyond which only next level permission is needed. This also helps better control yet with freedom to operate. Usual scoring system like Severity (S), Occurrence (O) and Detectability (D) and RPN number can be used. To make this system strong, scoring number must be assigned. Many companies assign their own system of numbering with degree of severity, occurrence, and detection. WHO has presented a guide called deviation handling and quality risk management? This is made for vaccine manufacturer who can supply the vaccines to UN agencies. Scoring system: Severity: Score 2 4 Severity Low Moderate Description of severity Minor GMP non- compliance, No possible effect Significant GMP non-compliance, Possible impact on patient, Moderate impact on yield or production capability Major GMP non- compliance and probable impact on patient is high, Impact on yield and production capability. Serious GMP Non-compliance, probable serious harm to 6 High 54 critical

2. patient even death. Critical impact on yield and production capability Occurrence: Score Score 2 4 6 8 Occurrence Extremely low Low Moderate High Description Very highly unlikely to occur (Rarely) Highly Unlikely to Occur Probable to occur Highly probable to occur Score 2 Detectability High Description High probability of detection either through control system or technology use Only through control system which can detect the defect or its impact Control system has limitation to detect with low probability of detecting defects or its impact Not possible to detect the defect 4 Moderate 6 Low 8 Non existent From above numbers RPN can be derived which will be guideline as follows: CRITICAL if RPN Value is >216 This needs an immediate attention and consider as critical deviation for FMEA purpose YELLOW Major if RPN is >40 but<216. Address with timely action and treat this as major deviation for FMEA purpose. GREEN: Minor if RPN is <40 Address in timely manner as per your QMS and treat it as minor deviation for FMEA purpose. This exercise is very important and design impact is very high to organisation and is very specialised job and requires having proper documentation. It is better to hire design services for medical device you want to produce. This service will help you use FMEA tool and create best design and design documentation for your medical device which will also fulfil compliance requirement in multiple countries. UK parliament introduced ALARP (As low as reasonably practicable or tolerable risk region) this was made for safety at work but now it has been widely accepted in engineering, pharma, and medical device. 1. Intolerable risk: Must take action to reduce the risk at whatever the cost may be. 2. Tolerable risk (if ALARP) Must perform case specific ALARP demonstration and generate documentation. 3. Broadly acceptable risk: You can demonstrate that you achieved ALARP by using standards and through established best practice procedures. ALARP is also used now with FMEA. Best way to use is asking various questions

3. 1. Is the best practice implemented for this process steps? 2 What else can be done to further reduce the risk? 3. What additional control can be introduced? Once it is determined that use of resources is too high compared to the reduced risk, ALARP is reached, and risk becomes tolerable. If not, you need to invest more resources to bring risk to broadly acceptable level. RPN number of WHO may be used as guideline.