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risk management and analysis

  1. Marcelo Antunes

    Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão

    ISO TC 210 JWG 1 met last week in Stockholm to discuss the last steps of the revision of ISO 14971 and ISO 24971. The group finalized the discussion on the comments of ISO TR 24971 (with only a couple of comments awaiting discussion in the next weeks) and it is expected to circulate ISO TR 24971...
  2. R

    The difference b/w FMEA & Risk analysis as per iso 14971

    Hi Can somebody help in understanding the difference b/w FMEA & Risk analysis as per iso 14971??
  3. D

    IEC 60601-1 - Essential performance doesn't make sense

    Hello, When determining essential performance, the guidance in 60601-1 is to assume with 100% certainty that a device's performance has degraded beyond some limit (determined by the manufacturer) which results in unacceptable risk. In reality if this was to happen, since a patient is getting...
  4. T

    IEC 60601-1 - Risk assessment to determine the liquid - 11.6.3

    IEC 60601-1 - Risk assessment for liquid determination - 11.6.3 how to deal with risk management
  5. P

    Looking for Risk Assessment Template - Not necessarily Asset based

    Hi, Most of the Risk assessment templates that I have seen are all Asset based. You start with asset register, and look for risks and mitigation plans. I guess that was a standard approach in ISO 27001:2005. There are a couple of templates on the internet, however they are again asset based...
  6. P

    What is the exact difference between Risk and Opportunity in context of ISO 27001?

    Hi All, ISO 27001:2013 defines planning for Risks and Opportunities. It's bit confusing to understand Opportunity as a positive risk. Unfortunately there's no documented definition of Opportunity available in ISO 27000 vocabulary. Can someone help me understand the exact difference between...
  7. S

    Can anybody share a sample risk assessment prepared based on ISO 17025:2017?

    Hi All Can anybody share a sample risk assessment prepared based on ISO 17025:2017 accredited laboratories??
  8. D

    Risk management according to ISO 14971 - When to document risk controls?

    Hello, When conducting risk management according to 14971 should you document risk controls that are already part of the "prototype" design. For example, a mains powered medical device might be designed with a power cord permanently attached to the device, rather than a detachable power cord...
  9. R

    Customer supplied material - risk and policy advice needed

    My employer has a couple of legacy customers who supply material which we laser cut, form, or weld, and they then buy the finished product. If everything goes well, and there is no scrap, this work is profitable. When scrap does occur, the cost of replacing material, or crediting the customer...
  10. J

    Software for Techfiles and Risk management

    Hello Everyone, Just wondering if anyone has good suggestions for software solution for risk management? Also, if that same software can be used for updating tech files? Thank you!
  11. K

    Risk Analysis Updates due to complaints

    Currently I am having issue trying to get everyone (Quality, Regulatory, Engineering) on the same page regarding the risk analysis. We basically use a FMEA approach for our risk analysis then list mitigation, risk acceptability, risk benefit analysis, you get the point. We have it set up so...
  12. T

    DFMEA/PFMEA and SCCAF alignment

    Hello everybody, I work as a quality engineer for the past year and I am very much interested in DFMEA/PFMEA and SCCAF The engineers where I work are unable to tell me the following: 1 ) should DFMEA and PFMEA be aligned in terms of SC and CC (Significant and Critical Characteristics). When I...
  13. Marcelo Antunes

    Informational ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019

    Um vídeo sobre a reunião em São Paulo do ISO TC 210 IEC SC 62A JWG 1 Aplicação da Gerenciamento de Riscos a Dispositivos Médicos com comentários dos participantes. A video about the São Paulo meeting of ISO TC 210 IEC SC 62A JWG 1 Application of Risk Manegement to Medical Devices with comments...
  14. Marcelo Antunes

    Medical Device News ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019

    Um vídeo sobre a reunião em São Paulo do ISO TC 210 IEC SC 62A JWG 1 Aplicação da Gerenciamento de Riscos a Dispositivos Médicos com comentários dos participantes. A video about the São Paulo meeting of ISO TC 210 IEC SC 62A JWG 1 Application of Risk Manegement to Medical Devices with comments...
  15. Q

    Information for safety EN ISO 14971:2012 - Customer Risk Reduction

    Hi, According to EN ISO 14971:2012, information for safety can no longer be used to reduce risk. In that case, how do you reduce the risk of the customer using the device in the wrong environment (for example, using an MR Unsafe device in an MRI room)? For hardware in particular, I don't...
  16. Marcelo Antunes

    Informational ISO TC 210 JWG 1 meeting in São Paulo – Revision of ISO 14971 and ISO TR 24971 – Medical Device Risk Management

    Reunião do ISO TC 210 JWG 1 em São Paulo – Continuação da revisão da ISO 14971 e ISO TR 24971 – Gerenciamento de risco de dispositivos médicos ISO TC 210 JWG 1 is meeting in São Paulo this week to continue the revision of ISO 14971 and ISO TR 24971 – Medical Device Risk Management Continue...
  17. A

    PFMEA - How long should the recommended actions remain in the recommended actions column?

    How long should the recommended actions remain in the recommended actions column? The person who updates our PFMEA's doesn't ever want to remove them. So there are actions listed from 2 years ago. We are doing an annual validation PPAP and he's updated the PFMEA but he wants to keep it there...
  18. C

    Resource allocation problems in Software DFMEA

    Dear all, While working on Software FMEAs we realized that each piece of software made certain use of common resources: Execution time, RAM, ROM, etc... If a failure of a characteristic of that piece of software is defined as: Execution time is too long Its mother function will only fail in a...
  19. Ed Panek

    Root Cause CAPAs from internal audit

    We recently upgraded our QMS to ISO 13485:2016. Prior to that we had an internal audit performed by a consultant. We have 5 minor non conformances relating specifically to the new 2016 standard. In our root cause analysis I would like to present the idea that we knew there was a risk in moving...
  20. B

    ISO 9001:2015 6.1.1 b - Enhance desirable effects - No opportunities were addressed

    Our CB Auditor issued a Minor Nonconformance stating "Risks identified show enhancement of desirable effects, and no opportunities were addressed." This was a recert audit. He is recommending us for recert, but the NC has to be addressed. Regarding opportunities, we just need to do a better...
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